1. Elaine K Jeter, MD MolDX, Palmetto GBA
9/22/2018
Medicare Update
Elaine K Jeter, MD
MolDX, Palmetto GBA

2. New MolDX Medical Director
Dr. Jim Almas
Pathologist
s/p Private practice of pathology
Medical officer at CMS – 1 year
11/2/2017

3. Functional Roles Dr. Almas Dr. Jeter Director Overall MolDX program
TAs – work with SMEs
Dr. Jeter
Policy development & management
Anything else the director needs
11/2/2017

4. Jurisdiction J Mike Barlow – Program Director
Messaging to JJ regarding MolDX
Providers instructed to begin DEX registration
Part A cutover – 1/29/2018
Part B cutover – 2/26/2018
Claims submission – June 1, 2018
11/2/2017

5. PAMA Changes What’s likely to change? Z-codes – no changes
IHC & FISH expansion – on hold
CPT codes – no changes
PLA codes – non-covered until TA review & coverage determination
11/2/2017

6. PAMA Projected impact to established tests/codes? New tests
Proprietary tests – rate hike
Commodity tests – rate decrease
New tests
ADLT – multiple biomarker of DNA, RNA, or proteins with algorithm with single patient result; FDA cleared/approved; similar criteria via CMS
Carte blanche
List price for 9 months
Weighted median of private payer rates
11/2/2017

7. PAMA Changes
Will approved panel ( z-code)/MAAA tests remain the same in 2018?
Ex: BCR/ABL major + minor + other breakpoints => Z1234
For panels – MolDX will review final CMS pricing and apply appropriately
For MAAAs – CMS PAMA determination
11/2/2017

8. Coverage Determinations
Full or restricted to specific population(s)
TA with AV, CV & CU
FDA approved/cleared assay – expedited review
Limited with ongoing CU assessment
For large unmet clinical need
Assay demonstrates limited but promising CU
Non-coverage
11/2/2017

9. Coverage with CU Assessment
TA – Promising CU data
Develop prospective study protocol to mature CU data
Clearly defined endpoints – MolDX team will assist
IRB approval; list on clinical trials.gov
Data accrual via independent broker
De-identified data q 6 months
Develop LCD
Endpoints provided in LCD
Terminate coverage - failure to accrue patients or demonstrate CU
11/2/2017

10. Questions from CCLA Greater transparency into how this works?
What their options are?
Review time frames?
Endpoints?
How lab works with docs to get clinical data?
Docs want $ for their time & expense
11/2/2017

11. Questions?
11/2/2017