Contractor Medical Director J-E and J-F CCLA – Medicare Policy Gary Oakes, M.D., FAAFP Contractor Medical Director J-E and J-F

ICD-10 News Pleased to announce no Y2K like syndrome occurred. Noridian systems performing well. A few LCD ICD-9 to ICD-10 code items that were easily fixed Rejection rates so far at or near baseline for JE and JF

Other News MolDX program is now active in Jurisdiction F. Noridian reached out to J-F Part A facilities prior to the go live date and continue to work with those that have challenges. Frontier states are doing well. We have had good rapport with the JF based clinical labs.

MolDX Policy Process Palmetto GBA has the prime lead for development of MolDX coverage policies and payment. Noridian Healthcare Solutions works collaboratively in implementing these policies.

MolDX Policy Process What does that mean? Palmetto GBA develops a coverage policy based on the latest available peer reviewed evidence. If a test/array requires a technical assessment Palmetto GBA solely conducts this aspect of the review.

MolDX Policy Process Next is the clinical utility. Palmetto GBA performs the initial review and composes the draft policy. Once completed Palmetto GBA and Noridian meet and jointly review the clinical coverage indications.

MolDX Policy Process Next the draft LCD, including a listing of all published evidence utilized is published on the Medicare Coverage Database and notices sent out. The open public meeting is held where anyone may attend. For those wishing to present, Noridian requires registration and any slides beforehand*. This process is prescribed by CMS in the IOM 100-08 Chapter 13. *All material released to Noridian for the open meeting is considered to be public information and not protected/confidential.

MolDX Policy Process Following the open meeting we begin state Carrier Advisory Committee meetings. The policies and their implications to beneficiary care are discussed. These discussion help us to tweak the language to optimize coverage and minimize practice impact. Any restrictive component is documented in the published comments article.

MolDX Policy Process The public comment period begins and lasts no less that 45 calendar days. The closing date for each policy is published on the MCD and Noridian website. On closure the comments and literature received are reviewed and if indicated amendments to the draft policy are made. Final Policy version is released to notice (no less than 45 days).

MolDX Policy Process So when are Palmetto GBA and Noridian going to sync up your dates? The goal for this is February 2016. The public release and other dates mentioned will be synchronized to minimize impact of the timing on national labs.

MolDX LCDs Reconsideration Molecular diagnostic testing is rapidly evolving and maturing and change is expected. The LCD reconsideration process is clearly delineated in the IOM 100-08 Ch. 13 and must be followed. As it applies to clinical utility, peer reviewed, evidence based literature published in the core medical journals must accompany the request to be a valid recon.

MolDX Redeterminations Noridian handles these as we do all redeterminations with a de novo reviewer. Medical necessity appeals require submission of clinical records to support the appeal. All orders must be have a provider (MD/DO/MLP) signature or have intent to order in a progress note that is properly signed. If signature not legible include a signature log. Noridian has provided CCLA with a letter to the provider you may wish to use when requesting records.

ALJ Process First step after an unfavorable redetermination is to request a QIC review. QIC is an independent CMS contractor Submission information is included in the response letter to you. Generally the QIC expects a good explanation as to the specifics why you disagree with the MAC decision. If unfavorable may proceed to ALJ if the amount in question is >$150.00 Have added several judges but case load still large.

Avoiding the ALJ – Your CMD Noridian has been pleased to work with several of the national labs to resolve issues both in regards to policy and to reimbursement snags. If a policy issue approach either Dr. Elaine Jeter or me. We work together to resolve such issues. For changes in policy we will require new EBM literature that has been published in the peer reviewed core medical journals. Phone calls are nice but emails with attachments work better.

Noridian Contact Information Claims related issues start with the Provider Contact Center J-E 855-609-9960 J-F 877-908-8431 Policy Questions? Ronda Sears, Policy Analyst ronda.sears@noridian.com Gary Oakes, M.D. gary.oakes@noridian.com