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EDITOR’S NOTE: Last week, the Senate passed the 21st Century Cures Act by a vote of 94-5. The bill is headed to the White House where it is expected to be signed into law by the President.

The Cures Act does many things for improving biomedical research and advancing clinical trials. Subtitle E, Local Coverage Decision Reforms, addresses the requirements for local coverage decisions (LCD).

This section specifies the required documentation to support coverage policies and that the policy must be posted on the Centers for Medicare & Medicaid Services (CMS) website 45 days before implementation. Unfortunately, that is a distinction without a difference, in my opinion. In reviewing multiple Medicare Administrative Contractor (MAC) websites, the almost verbatim requirements are already required and stated.

So what would a meaningful LCD cure look like? The Healthcare Billing and Management Association (HBMA) believes that LCDs are long past any relevant and useful purpose. In fact, the organization advocates for LCD elimination. How can you have valid quality or care comparison metrics when what is medically necessary in one jurisdiction is not medically necessary in another? Once a national coverage determination (NCD) has been made, it should suffice for the nation. Multiple interpretations of what that means are not necessary. Diagnoses that support medical necessity could easily be incorporated into the final determination, thus removing all ambiguity and eliminating idiosyncratic interpretations. In addition, in some cases, the MAC will not respond to LCD reconsideration requests because they must wait for clarification from CMS on the policy. As a result, from Oct. 1, 2016 until an estimated date of Jan. 1, 2017, providers will not know if some services will or will not be covered. They knew those services were covered on Sept. 30. There is just no information about why they were not covered on Oct. 1, and no reconsideration will be addressed. 

I strongly believe that this type of confusion creates great angst among beneficiaries and their providers. It is very difficult to explain why a test or service was covered at the time it was ordered but is not covered, or coverage is unknown, by the time service is provided, even if it is one day later. Is it even possible to issue a valid advance beneficiary notice with the reason for expected non-coverage stated as, “no one has any earthly idea what Medicare will decide?”

The LCD process itself is fraught with errors. As we have discussed in previous articles and presentations, we have seen numerous examples of 2015 ICD-10 conversion errors and 2016 update errors and omissions. Sadly, it appears that the procedure itself and the incredible onus to have these errors corrected falls on the providers.

In addition, when errors are made in an NCD, they permeate the entire program and even trickle down to some commercial payors and Medicaid plans. Although MACs have the ability to interpret correct national policies, it seems that they are not permitted to have an LCD interpretation that overrides obvious and admitted errors in national coverage policies.

A real cure would be an expedited process to correct errors promptly in national coverage policies, rather than waiting many months for the rectifying of mistakes – and even longer for them to be implemented locally.

The Cures Act did not cure local coverage decisions. Perhaps that is because they cannot be cured. They are the equivalent of the most virulent antibiotic-resistant organisms. Let’s hope the situation does not worsen with the implementation of all the new procedure codes and the Merit-Based Incentive Payment System (MIPS) on Jan. 1.

Let’s really address this matter head-on, find a cure, and eradicate local coverage determinations.


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