BruceDocumentBlog

Saturday, August 11, 2018

Tapestry Consultancy and Precision Medicine

For several years, I've been hearing about TAPESTRY, a multi-industry consultancy, and its efforts to enhance dialog and practice/policy change in genomics.

Tapestry Networks is based in Waltham, MA, and in London and works across several industries, including "corporate governance" in general, the financial industry, and healthcare. Homepage here. They state, "Tapestry Networks was founded in 2002 by George Goldsmith, motivated by his belief that the performance of organizations and individuals can be improved dramatically through constructive collaboration and confrontation of barriers to progress."

See their Healthcare home page here and their Precision Medicine home page here. The acronym for their precision medicine in oncology group is: Sustainable Predictive Oncology Therapeutics and Diagnostics (SPOT/Dx) Working Group.

For a 14-page, vintage 2014 white paper on molecular diagnostics in oncology, here. This was part of the SPOT/Dx initiative.
They've also had a genomics diagnostics quality assurance effort, 2016/2017, see here and here.
For a 24-page, 2018 white paper on "new frontier for genomics, here.

This was based on a December 14-15, 2017, meeting of the "DxIN," the "Diagnostics Innovation Network."

Outside of diagnostics, see a 2018 white paper on alternative payment models in oncology, here.

Lancet Publishes Article on Value-Added Radiology; Applications to All Diagnostic Tests

The August 11, 2018, issue of Lancet includes an interesting letter on "The Future of Radiology: Adding Value to Clinical Care" (392:472-3). The author, Marc Dewey, is at the Charite' hospital in Berlin.

Dewey opens by saying radiology has to change, since subjectively ordered tests contribute to overuse, tests are inconsistently diagnosed, and reports are often vague. He provides a worthwhile link to a 2017 article by Brownlee et al., also in Lancet, "Evidence for Overuse of Medical Services Around the World" (390:156-68; open access here). Dewey argues for better integration of radiology with AI and other advanced informatics, citing Brink et al. (2017). He also cites to a Commonwealth Fund study in Lancet 2017 that "mroe money leads to poorer performance of health care systems" (2017). Principally, he notes that the foreseeable integration of AI, value-added healthcare delivery, and AI would require large scale changes in current practices and systems.

People have been talking about the evolving role of the radiologist for a decade or more; see Knechtges 2007 (here) and European Society of Radiology 2010 (here) and Charalel 2014 (here). The Journal of the American College of Radiology, JACR, is now is in its 15th year and and has always devoted a large share of its articles to the evolving practice, role, use, and future of radiology.

The other specialty dedicated to diagnostics, pathology has parallels. CAP has talked about the evolving future status of pathology for a decade or more, and there are a number of themes, conferences, and articles about "Laboratory 2.0" (also here) which are similar to the themes touched by Dewy 2018. The role of AI and pathology are being discussed, e.g. Sharma and Carter, 2017.

Tuesday, August 7, 2018

NGS MAC Updates Hematolymphoid Sequencing LCD - Not Ready for CPT 81455 (51+ genes)

This year, NGS MAC consolidates two LCDs into one LCD for sequencing in hematolymphoid diseases.

They cover various applications for 5-50 genes, but that Medicare code pays only $600, which may be below costs for many fully-loaded tests with overhead, etc. NGS MAC notes there are no guidelines that name and require 51+ genes.

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As of early August 2018, the draft LCD DL37606 was online here and the final online here. Comments from AMP/CAP were online here. Responses to comments were online here (A55974).

The LCD doesn't specifically refer to the recent NCD on next generation sequencing, which places different rules and restrictions on NGS based testing as opposed to other technologies for gene testing. (In addition, the NGS NCD applies to "advanced cancers" which some borderline blood disorders may not be, while advanced blood cancers are "advanced cancers.")

81450 versus 81455
Coverage is based on code 81450, 5-50 genes in hematolymphoid disorders.

AMP/CAP requested, but NGS MAC didn't seem to provide, coverage for 81455 (51+ genes in any cancer). 81450 pays only about $600, whereas the latter code 81455 pays about $2900. The CMS NCD covers all FDA approved gene panels (where <50 or >50 genes) in advanced cancer, so it might provide coverage whereas this LCD does not, and the reader would have to figure out the difference. Or the MAC would have to process claims for 81455 one way under the NCD and another way under the LCD. (FDA approved tests could, but might not, have PLA codes).

Other Notes
NGS MAC added some ICD-10 codes to describe unusual or borderline clinical states, as suggested by AMP/CAP.

An informal redline test didn't show any other differences between draft and final LCDs.

I've put the key documents in a cloud zip file. Here.

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As a bonus, the zip file includes comments on NGS MAC LCD L35000, their catch-all MDX LCD. AMP/CAP provide 12 pages of comment (mostly ICD10 codes by length) and then attach a 7 page comment written by the IGNITE consortium, which is funded by NHGRI for translational research on genomics. The IGNITE consortium supported a range of additions including pharmacogenetic ones. NGS right now lists the relevant LCD L35000 as "RFT" or released to final (see pic above), but hasn't seemed to actually post the final version (see "NA" in pic) or its Q&A response.

Monday, August 6, 2018

How to Find BRCA or other Correct Coding Edits at CMS

In October 2017, I wrote a blog on the discovery that CMS has edits against paying for 81211 and 81213 on the same day - here. This was surprisingly, because public data for 2015 and 2016 showed that CMS regularly paid for 81211 and 81213 on the same day - in fact, this code pair was about the most common genetic test there is.

In December 2017, I noted that CMS had changed the reason for this code edit, although the code edit itself remained identical. Here.

The reason for the edit became: "HCPCS/CPT procedure code definition." This makes sense to me, because when you do 81211 81213 on the same day, the sequencing and dup del result is the same as 81162 (BRCA seq + dup del). CMS priced 81162 by adding the prices of 81211 and 81213, plus a 10% discount.

There isn't any similar edit for Lynch sequencing and dup del analysis (81435+81436). This is because there isn't any comprehensive code, and you report the results via the two codes. Were there a comprehensive for 81435+81436, presumably for consistency CMS would price it at 90%x(81435+81436). This is how it priced 81162 (81211+81213).

How Do You Find This Stuff?

Correct Coding Edits have existed since around 2000. There are two types. The first is "MUE" or medically unlikely edits. These are based on the quantity of ONE code. For example, per day you get one heart transplant, or one BRCA test, or one appendectomy. It's medically unlikely or unbelievable to do otherwise.

The other type of edit is code-to-code edit. These are codes where you can't bill both on the same day. In some cases, these are fixed edits, in some cases they can be overcome by a modifier. For example, you don't normally bill an office visit with a colonoscopy, but in some rare situation you might, so a modifier would be used.

The CMS home page for all this stuff is here:
https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html

You can get ZIP files for MUE edits, updated each quarter, and ZIP files for procedure to procedure or P2P edits, which are far more voluminous.

Currently, BRCA Procedure Edits and MUE edits are as shown below:

click to enlarge

BruceDocumentBlog

Saturday, August 11, 2018

Tapestry Consultancy and Precision Medicine

Lancet Publishes Article on Value-Added Radiology; Applications to All Diagnostic Tests

Tuesday, August 7, 2018

NGS MAC Updates Hematolymphoid Sequencing LCD - Not Ready for CPT 81455 (51+ genes)

Monday, August 6, 2018

How to Find BRCA or other Correct Coding Edits at CMS

Sunday, August 5, 2018

August 2018: Some SEP-1 Articles on PubMed

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August 2018: Some Open Access Articles on SEP-1 Measure

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