Knowledge Base Article

On February 15, 2018, CMS issued a national coverage Decision Memo that contained some significant changes to the National Coverage Determination (NCD) 20.4 for Implantable Cardiac Defibrillators (ICDs). On November 21, 2018, CMS finally issued the transmittal updating the NCD – this transmittal indicated an effective date of February 15, 2018 and an implementation date of February 26, 2019 (for MAC local edits). On December 13, 2018, CMS revised the transmittal to emphasize that this coverage policy no longer requires trial-related coding on claims for dates of service on or after February 15, 2018.

February, November, December, February - so many dates! As often occurs with NCD updates, the question becomes when can providers change their practices and submit claims that follow the new guidelines. First let’s review a summary of the significant changes from the NCD revision.

• Adds MRI to the list of imaging studies that can evaluate left ventricular ejection fraction (LVEF);
• Requires optimal medical therapy (OMT) for at least 3 months for certain patients who have severe non-ischemic dilated cardiomyopathy;
• Requires a patient shared decision making (SDM) interaction prior to ICD implementation for certain patients;
• Removes the Class IV heart failure requirement for cardiac resynchronization therapy (CRT);
• Adds an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
• Adds an exception for patients with an existing ICD and qualifying replacement; and
• Ends the data collection requirement.

As CMS did in the December transmittal revision, I want to emphasize this last point. Prior to the NCD changes, beneficiaries receiving an ICD for primary prevention had to be enrolled in either a clinical trial

or a qualifying data collection system (e.g. a registry). This required reporting the “Q0” modifier on the claim line item with the implantation CPT code when performed for a primary prevention diagnosis. Modifier Q0 identified patients whose data was submitted to a data collection system in accordance with the regulations. ICD procedures on claims with primary prevention diagnoses that did not contain the Q0 modifier were denied. Since the unadjusted national payment rate for these procedures is generally greater than $25,000, a missing modifier resulted in a denial with a significant financial impact on the provider.

For a more thorough discussion of the new rules, see the prior Wednesday@One article from December, 2018. Also bear in mind that this is a long and complex NCD with many detailed requirements. One of the benefits of now no-longer-required registry participation was that it compelled the provider to review and answer all of the NCD requirements for Medicare coverage. Providers still need to be diligent in ensuring their ICD implantations for Medicare patients meet the NCD requirements. A few years ago, the Department of Justice (DOJ) investigated and recovered significant overpayments from numerous providers who failed to meet the ICD NCD guidelines.

But let’s get back to the effective date issue. Medicare is a huge bureaucracy and to change rules is not simply a snap of the fingers – there are manuals to update, Medicare contractors and providers to educate, and electronic systems to tweak. This means changes are not instantaneous and take some time to fully implement.

First, a Decision Memo is not immediately binding on Medicare contractors though they are encouraged to consider it. Here is the language from the Medicare Program Integrity Manual, Chapter 13 concerning decision memos:

“Coverage Decision Memorandum- CMS prepares a decision memorandum before preparing the national coverage decision. The decision memorandum is posted on the CMS Web site, that tells interested parties that CMS has concluded its analysis, describes the clinical position, which CMS intends to implement, and provides background on how CMS reached that stance. Coverage Decision Memos are not binding on contractors or ALJs. However, in order to expend MR funds wisely, contractors should consider Coverage Decision Memo posted on the CMS Web site. The decision outlined in the Coverage Decision Memo will be implemented in a CMS-issued program instruction within 180 days of the end of the calendar quarter in which the memo was posted on the Web site.”

As we saw with the ICD NCD revision, CMS does not always meet the “180 days of the end of the calendar quarter” deadline for posting the implementation instructions. Once these instructions are posted, the effective date is generally (if not always) the date the decision memo was released, but the implementation date is sometime still in the future. This allows the Medicare Administrative Contractors (MACs) time to adjust edits and complete other tasks prior to full implementation. For example, if you look at the Business Requirements from Transmittal R211NCD, you will notice that in addition to being instructed to “cover ICDs for patients that meet the specific coverage indications and criteria described at Pub. 100-03, NCD Manual, section 20.4,” there are also instructions that MACs shall, among other things:

• work together collaboratively from a clinical aspect to ensure consistent national editing across jurisdictions,
• attend up to 4 1-hour calls to discuss feedback regarding implementation of coding for this policy and how to ensure consistent national editing across MACS, and
• implement local edits in each respective jurisdiction until such time as CMS may determine shared edits to be appropriate, which will be relayed via a subsequent CR.

This delay until full implementation also allows providers time to make any adjustments to their systems. With all of these various dates, when are providers to change their processes and when are they to start submitting claims that follow the revised guidelines?  Here are the dates for the ICD NCD revision once again and my recommendations for a timeline for provider actions:

ICD Decision Memo:  February 15, 2018

NCD Transmittal:  November 21, 2018 (revised December 13, 2018)

Effective Date NCD:  February 15, 2018

Implementation Date:  February 26, 2019

1. When a decision memo is issued, begin at that time to add any new requirements to your facility practices. For this ICD NCD, the new requirement for the shared decision making is a great example. Although this obviously could not be instituted overnight, providers need to start working to implement this as soon as possible, knowing the final NCD will have an effective date the same as the date of the decision memo release.
2. I do not recommend discontinuing any of the “old” requirements at least until the official transmittal is published since the decision memo is not officially binding.
3. For claim submission, bear in mind the MACs “old” edits will be place until they have clear directions from CMS (the NCD transmittal) and then time to modify their edits (until final implementation date). This means claims that follow the new guidelines may continue to be denied after the effective date. For example, claims without a Q0 modifier for primary prevention may continue to be denied until the edits are changed, even though we have an official new NCD and are already past the effective date of the new NCD. Provider options are:
4. Continue to follow the guidelines of the old NCD for claim submission until the implementation date,
5. Follow the new NCD guidelines, but hold your claims until the implementation date for submission, or
6. Submit your claims following the new NCD guidelines, but realize they may be denied under the old NCD requirements and you will have to appeal these claims to obtain proper payment.

I understand that decision memos often share good news for which providers have been anxiously awaiting and the tendency is to want to make the changes immediately. Practice patience! After all, you have waited this long – a few more weeks or months won’t hurt.