Wednesday, February 24, 2016

MolDX NGS/CGP Article V2 2016/02/16

Next Generation Sequencing Coding and Billing Guidelines 

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Next Generation Sequencing (NGS)
NGS testing platforms allow identification of somatic and/or germline alterations in multiple genes at the same time. This guideline focuses on two main types of somatic, tumor tissue-based, testing panels.  Germline panels will be addressed in another article as needed.
Targeted (aka Hot Spot) Tumor Panels
Targeted NGS panels identify somatic alterations known to occur in certain areas (i.e., 'hotspots') in specific genes of interest. Generally, these NGS panels can detect single nucleotide variants (SNVs or point mutations) and small (typically ≤10 bp) insertions or deletions. These alterations typically represent genomic targets with corresponding targeted cancer therapies. Identification of a genomic target guides use of the corresponding targeted therapy.
To bill for targeted NGS services, review CPT codes 81445, 81450 and 81455. Base the selected code on the number of genes in your laboratory’s NGS panel and the test indication for solid organ and hematolymphoid neoplasms. The UOS for the NGS panel is one.
Note: Individual gene tests performed in the NGS panel should NOT be registered and reported with multiple CPT Tier 1 and/or Tier II codes. 
Comprehensive Genomic Profile (CGP) TestingCGP refers to NGS-based testing that has been optimized to identify all types of molecular alterations (i.e., SNVs, small and large insertions and deletions, CNVs, and rearrangements/translocations/fusions) in cancer-related genes in a single test using complex proprietary bioinformatics. 
Because CGP includes SNVs, small (≤ 10 bp) and large (> 10 bp) insertions and deletions, CNVs, AND rearrangements (i.e., translocations/fusions), CPT codes 81445, 81450, and 81455 do NOT describe a CGP service. Therefore, to report a CGP service, test providers should use CPT code 81479 - Unlisted molecular pathology procedure.

Thursday, February 11, 2016

CMS CR 9501 (Feb 5 2016; Withdrawn)

This is the text of the temporarily posted and withdrawn CMS TRANSMITTAL about drug pricing demonstration projects.

Pub. 100-19 Transmittal: 137 Date: February 5, 2016 Change Request: 9501 

SUBJECT: Implementation of the Part B Drug Payment Model (Phase 1) 

EFFECTIVE DATE: July 1, 2016

*Unless otherwise specified, the effective date is the date of service.



A. Background:

 The purpose of the Change Request (CR) is to instruct CMS shared system maintainers to implement a mechanism that will allow the use and testing of different Average Sales Price (ASP) payment limit values in certain defined geographic areas based on ZIP code. The replacement values would be used in Part B settings such as hospital outpatient departments, physician offices, and pharmacies that currently submit claims for Part B drugs. The information in the background document of this implementation CR is to be construed as final, but this information may be modified as details regarding the implementation of this payment model are finalized.

Medicare pays for most drugs that are administered in a physician’s office or the hospital outpatient department at ASP plus 6 percent by statute regardless of the price a provider pays to acquire the drug. Medicare makes an additional separate payment for administration of the drug under the physician fee schedule or the hospital outpatient prospective payment system (OPPS). The ASP is calculated quarterly using manufacturer-submitted data on sales to all purchasers; rebates, discounts and price concessions are reflected in the ASP. The statute does not identify a reason for setting the payment limit at an additional 6 percent above ASP, although physicians and others have asserted that it is needed for handling and overhead costs.

The ASP methodology does not take into account the effectiveness of a particular drug, or the cost of comparable drugs, when determining the Medicare payment amount. The ASP methodology has been criticized for encouraging the use of more expensive products because the add-on to the drug’s cost is a percentage of the sales price while handling and overhead costs may not vary with the drug’s price.

Medicare is developing methods to test the impact of changes to Part B drug payments. One approach that is being considered would focus on the 6 percent add-on to the ASP. This approach would be implemented via a grouping of five digit ZIP codes, grouped into MSAs or similar units. In this approach, ZIP codes not assigned to an alternative payment would continue to receive payment as ASP+6 percent; these ZIP codes may be grouped together to capture an MSA or similar units. The ZIP code groupings would be done by CMS and the pricing flag field that would be added in existing filler on the ZIP code file sent to the contractors would indicate which ASP pricing methodology applies to any specific ZIP code. Medicare could test the impacts on changes to the ASP add-on percentage for their effects on spending and prescribing patterns to determine, for example, if the changes affect the financial incentive for physicians or hospitals to choose higher cost drugs that do not offer additional clinical value.

Medicare is also developing methods to test the impact of targeted pricing changes to payments for individual Part B drugs beyond changes to the ASP-based payment. These targeted drug payments could vary across a different set of ZIP codes than those assigned to the different ASP methodologies. CMS is targeting a July 5, 2016 implementation for the system changes to support these new pricing methods discussed above, but additional approaches that test other methods of targeted pricing would likely be phased in later. Also, since this model is going through notice and comment rulemaking, there is a possibility that the new ASP and Zip 5 and Zip 9 files that contain the new pricing values developed under rule making will be available and effective sometime between August 1 and September 15, 2016 rather than on August 1, 2016 exactly.

B. Policy: 

Section 1115A of the Social Security Act (the Act) (added by Section 3021 of the Affordable Care Act) (42 U.S.C. 1315a) authorizes CMS’s Center for Medicare & Medicaid Innovation to test innovative health care payment and service delivery models that have the potential to lower Medicare, Medicaid, and Children's Health Insurance Program spending while maintaining or improving the quality of beneficiaries’ care.

Contractors shall implement necessary changes to their respective systems in order to accommodate a new Part B Drug Payment Model to test different approaches for the payment of Part B drugs.

Contractors shall refer to the attachment(s) to this CR for a more detailed outline of the programmatic requirements of the Model. Contractors shall also refer to the attached proposed revised layouts for the ZIP code files and ASP file that CMS will create for this model.

Please note that the new payment indicator will appear on both the Zip 5 and the Zip 9 files; the indicator is the same on both files based on the first five digits of the Zip. CMS is providing the indicator on both files in case that will help to simplify implementation logic changes. *

*NOTE** - The CMS supplied payment indicator that will be included on the revised ZIP 5 and ZIP 9 files is only based on the first 5 digits of the particular ZIP code. However, CMS is replicating the ZIP 5 payment indicator on the ZIP 9 file per FISS request. **NOTE** - Once the new drug pricing payment model is in effect (that is, once the one-time off-cycle ASP and ZIP Code files are installed per instructions below), there is no need for MACs to adjust (either when brought to their attention or by searching their own files) any previously adjudicated claims in order to ensure they are priced using the new model. Any claim adjustments necessitated by the normal course of claims processing  shall be adjudicated and priced based on the “FROM” date of service on the claim.


Thursday, February 4, 2016

Brief Excerpt: St Jude Earnings Call re NCDs and LCDs

St Jude Earnings Call re Q4 2015 (brief excerpt, 1/27/2016)

So a quick update here on where we are and what our plan is around the CardioMEMS product line. As you know we got off to a quick start last year, and about mid-year we had a negative determination at First Coast, which then spiraled in to several articles resulting in [Novitas] beginning a process to make a determination.

All of that has caused a lot of unrest in the customer base on two levels, and it really is around the fear of reimbursement. The physician feedback and patient outcomes have been outstanding, and the performance of the product actually in the field is better than we had expected and better that what we had seen in the champion trial.

So the product line itself is on track. The business dynamics and the market dynamics and this is also feedback directly from our customers. This is the product that they’ve been looking for in trying to get at not only the expense but the quality of life issues of managing this disease. So we think CardioMEMS is an important clinical advancement and will in fact change the way heart failure is managed.

The process that we’re going through is first, we continue to work with the local MACs. We are making sure that they have all of the most current data, the latest data from [Lansing] was very encouraging from a real world perspective, 31 months of follow-up with a 48% reduction in hospitalization. This is significant data, and again bringing the real world perspective in the play.

At the same time, we’ve had ongoing discussion with CMS, and so the strategy is really to make sure that our customer base in informed, make sure the local MACs are informed and up-to-date with the latest data and that we’re going through the process which we will update on February 5 with CMS to apply for national coverage to make sure that we can begin to plan and begin to work with heart failure centers around the country in getting their programs up and going without a concern that they would make both time and cost commitment to find out that they could end up in a negative reimbursement situation.

So we have short term strategy, again education of the heart failure community and the MACs as well as the work that we’re doing with CMS. We think the timeline for these things will be first quarter, working its way with a submission will take anywhere from 9 to 12 months with CMS.