The Cures Act (https://www.congress.gov/bill/114th-congress/house-bill/6t ) 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 CMS website 45 days before implementation. Unfortunately, that is a distinction without a difference, in my opinion. In reviewing multiple Medicare Contractor (MAC) websites, the almost verbatim requirements are already required and stated.
So what would a meaningful LCD cure look like? The Healthcare Business Management Association (HBMA) believes 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 and thus remove all ambiguity and 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 October 1, 2016 until an estimated date of January 1, 2017, providers in one jurisdiction do not know if some services will or will not be covered. They know it was covered on September 30. There is just no information about why it was not covered on October 1 and no reconsideration will be addressed.
I strongly believe this type of confusion and unclear local coverage creates great angst among beneficiaries and their providers. It is very difficult to explain why the 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 very LCD process 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 the procedure and 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 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 rectifying mistakes and even longer for them to be implemented locally.
The Cures Act did not cure local coverage decisions. Perhaps because they cannot be cured. They are the equivalent of the most virulent antibiotic resistant organisms. Let’s hope it does not worsen with the implementation of all the new procedure codes and MIPS on January 1. Let’s really address the cure and eradicate local coverage determinations.
Holly Louie, RN, CHBME, is the compliance officer for Practice Management Inc. and the 2016 HBMA president.