DAB Draws Fence Around Categorical vs R&N Decisions and Appeals Processes

Medicare ALJs are allowed to review LCDs for validity, and prior decisions have held this is true even if the LCD is couched in other formats such as an "article."   DAB has ruled that in some cases the articles are de facto LCDs and therefore they reach legal review channels as LCDs.

However, not every published adverse coverage decision gets to ALJ review under this concept of the broad category of LCD and de facto LCD.

In case 2782 in April 2017, the Department Appeals Board rules that a MAC published viewpoint that CGMs are considered "precautionary and non covered under the DME benefit" could not be reviewed as if it were an LCD. 

Link here.
https://www.hhs.gov/sites/default/files/board-dab-2782.pdf

The risk, of course, is that MACs could be wily and insulate non coverage decisions from review by tactially saying that XYZ, whatever XYZ is, is "precautionary or screening and therefore not a benefit," rather than stating that it is not reasonable and necessary.  For any topic.  Because DME category decisions include findings of fact about medical purpose, the category decision can have areas of conceptual overlap with an R&N decision.  And I agree with the poor over-ruled ALJ that "precautionary" is a weird concept, not found in CMS manuals or regulations.   Even regular  glucose blood tests could be seen as "precautionary" to find out if your insulin dose must be raised or lowered, and things like INR testing in warfarin patients is "precautionary" to find out if the INR level is too high or low.   For a patient with severe unilateral headaches, an MRI is "precautionary" to see if there is a brain tumor.

Brain teaser for the reader.  Since ALJ's are only allowed to review LCDs based on "reasonable and necessary" decisions, can a MAC frame its decisions in an Article and as "investigational and experimental" and thereby evade ALJ review?   In this hypothetical, MACs could stop putting out LCDs that services are "not reasonable and necessary" and instead put out articles that  services are "investigational and experimental," wording that is not reviewable by an ALJ...Perhaps double insulating its decision by stating the service is "not a benefit category" because it is "experimental and investigational."

Consultants Corner: Successful Deck Used in Changing the CMS 14 Day Rule

This deck came from a July 2017 article in AXIOS by Bob Herman, here.  For some additional follow-up, here.  For my cloud copy of the deck in case the original goes away, here.

A group of industry and association stakeholders met with CMS in May 2017 to discuss long-postponed and much-needed changes to the 14 Day Rule.  Below, I use the document's pagination (large numbers on the pages).   This PPT and meeting didn't sway CMS alone; there were many other touchpoints and stakeholders involved over a couple years.   But since this deck was associated with a success, it's probably worth study.

1. The title is "The Impact of the Date of Service 14 Day Rule."  So the "point" is "The Impact" and the "topic" is the 14DR.
• The stakeholders were Biodesix, Boehringer-Ingelheim, Guardant Health, LUNGevity, Myriad Genetics, Veracyte.  
2. Slide 2 is a detailed OVERVIEW with three sections, about ten bullet points, and a concluding signal to the "recommendation" or ask.
• So if you walk out after slide 2, you know everything the meeting was about.
3. Slide 3 is a detailed "history of the problem" from 2001-2017.
4. Slide 4 actually explains the whole 14DR, with a lot of text, but in a friendly "[Question]?" format.
• Note they chose to place "the history of the problem" ahead of "what the 14DR is."  In part, they could be confident the people they were talking to knew what 14DR was.   On the other hand, and we don't know, if this was a meeting with The Administrator, rather than mid level policy staffers, you couldn't assume that content knowledge.
5. Slide 5 is clinical: "Impact on Lung Cancer Outcomes."  ("Delay in treatment can result in worse outcomes, ^tiny journal footnote.")
• "Impact" here echoes the title of the whole deck.
6. Slide 6 is similar, but colorectal cancer.
7. Slide 7 is a fancy flow chart infographic of the whole landscape presented visually and organized L to R by time.
• Is the message "here's how the Swiss watch works" or "This damn thing you've created is more complex than a Swiss watch! It hurts my eyes!"
8. "Consequences of These Billing Policies."  Three bold categories, visual, "Inconsistent billing," "Beneficiary Access Problems," "Reduced Efficacy of Treatment" due to 14DR delay.
• From "Impact" to "Consequences."
9. Slide is titled, "Real World Examples" but consists of a bullet description of the 7 stakeholders.   Possibly this slide was a "backdrop" for a planned discussed segment with a script for each stakeholder.
• Make the problem real.  Tell a story.
10. "Evaluating the DOS Rule Effects."  This is actually a short description of a CMS demo (requested by Congress) in 2012-2014, reported in 2016, that had no conclusions.
• Years go by and you CMS do nothing.  At the least, do the following, next slide:
11. ASK.   Recommend that CMS Solicit Comments on DOS in Proposed Regulation."   Flagged for CMS what points to request comment on.   Stakeholders, in this deck, did not tell CMS what an "edit" or "redline" should be.
12. "Additional Outreach."   Coalition has a broad swatch of Hill meetings and has previously met with CMS at different level, and with groups like OMB.  Notably, the group had already also formally asked in 2016 that CMS take public comment on 2017, the same ask that is already on record and being repeated in this deck.
13. "The Landscape of Precision Diagnostics."  Unclear why this occurs here, but it states that typical precision medicine tests are by a "lab that is unaffiliated with a hospital and specialized in one type of molecular testing."   It states that "some" ADLTs are performed by a "single laboratory" but I think all ADLTs must be sole source.
14. Landing slide; Simple "Thank you" (not an ask or other message.)

How FDA Approved KEYTRUDA for All Solid Tumors based on MSI status

In 2017, FDA approved KEYTRUDA for all solid cancers based on LDT "MSI" status ("locally developed PCR tests for MSI-H").

Labeling here
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s014lbl.pdf


Clinical study table 24, table 25, page 41.  In colorectal cancer, N=90, ORR rises from 36% to 46%.  But Duration of Responses rises from 1.6 months to 22 months.

Other cancers were studied - in total 59, of which 14 endometrial, 11 biliary, 9 gastric, etc.  Many cases were studied N of 1.  There were variable but meaningful increases in ORR but big increases in DOR.

Click to enlarge.

For the Keytruda discussion in a December 2017 article on precision medicine in Nat Rev Clin Onc, by Moscow, Fojo & Schilsky (NCI, Columbia, ASCO), see here and clipping below.

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The December 21, 2017 NEJM has an interesting letter from Yarchoan and colleagues at Johns Hopkins plotting three things together:  ORR, TMB, and Tumor Type in one graphic. 

Foundation Medicine PMA Approval Summary (Product Group PQP)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_template.cfm?id=p170019


DeviceFoundationOne CDxClassification NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemGeneric NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemApplicant

Foundation Medicine, Inc.

150 Second Street, 1st Floor

Cambridge, MA 02141

PMA NumberP170019Date Received06/02/2017Decision Date11/30/2017Product Code

PQP	[ Registered Establishments With PQP ]

Advisory CommitteePathology

Expedited Review Granted?Yes

Combination ProductNo

Approval Order Statement

p170019

FoundationOne CDx™ (F1CDx) is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.

The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

Additionally, F1CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. The F1CDx assay is a single-site assay performed at Foundation Medicine, Inc.

Table 1: Companion diagnostic indications
Indication    Biomarker     Therapy
Non-small cell lung cancer (NSCLC) EGFR exon 19 deletions and EGFR exon 21 L858R alterations Gilotrif® (afatinib),Iressa® (gefitinib), orTarceva® (erlotinib) EGFR exon 20 T790M alterations Tagrisso® (osimertinib) ALK rearrangements Alecensa® (alectinib),Xalkori® (crizotinib), orZykadia® (ceritinib) BRAF V600E Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib)
Melanoma BRAF V600E Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib) BRAF V600E and V600K Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib)
Breast cancer ERBB2 (HER2) amplification Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), orPerjeta® (pertuzumab)
Colorectal cancer KRAS wild-type (absence of mutations in codons 12 and 13) Erbitux® (cetuximab) KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) Vectibix® (panitumumab)
Ovarian cancer BRCA1/2 alterations Rubraca® (rucaparib)

2014 MOLDX Statement of Work (Part of Palmetto JM Contract)

In 2014, Palmetto GBA won a competitive bid for Jurisdiction M, which includes in its statement of work a special section "C.7.38" for the "Molecular Diagnostic Test Project."

The recompete document archive is online at FedBizOpps, here.

The SOW is titled, "JM J.01 AB MAC Statement of Work 07 16 14.doc".  I've put a cloud copy here, and the SOW C.7.38 is clipped below (page 181 forward).

C.7.38.1 Develop Molecular Diagnostic Test Pricing Process

The Contractor will establish/maintain a documented process to detail a pricing for complex gene/mutation panels, new technology based tests, and multi-analyte assays with algorithmic analyses (MAAAs) that are not priced nationally. The process will enable analysis, coverage, and pricing strategy recommendations for these tests.

The Contractor shall compile and maintain a file of established molecular diagnostic tests defined by AMA CPT© Tier I and Tier II molecular pathology codes that are not nationally priced. This file will identify lab developed tests (LDTs) and FDA cleared tests.  The Contractor shall provide file updates on an as needed basis to the CMS COR and/or designee.

In addition to the master file, the Contractor will establish/maintain a documented process to detail a payment methodology for complex gene/mutation panels, new technology based tests, and multi-analyte assays with algorithmic analyses (MAAAs) that are not nationally priced. The process will enable the Contractor to evaluate and provide pricing recommendations for these tests.

The Contractor will append the current MoIDx activity with the following responsibilities:

• ·       Review/update the file on a quarterly basis
• ·       Assist CMS in all efforts to address pricing and coverage challenges

 

C.7.38.2 Maintain Master Test Registry [aka Z codes]

Maintain a Master Test Registry with a user interface that allows test providers an avenue to register individual tests and allow stakeholders a tool to look-up registered tests.  The Master Test Registry will enable the following functions:

• ·       Create and/or adopt, and maintain a unique identifier (code) for each unique test
• ·       Provide an automated registration process that enables submission of all required information in a standardized, electronic format
• ·       Maintain an online test listing resource for registered test look-up
• ·       Safeguard required proprietary data elements

C.7.38.3 Review of Evidence

To support the efficient review of tests in light of the rapid technological advancements in the MoIDx industry, the Contractor will establish a consistent methodology which the Contractor will use for reviewing evidence for requested test indications. The methodology will use an evidence framework that is consistent with the ACCE criteria developed by the Centers for Disease Control and Prevention (CDC) for the evaluation of genetic tests. 

The Contractor shall consider the analyses articulated from 2009 onward in national coverage determinations (NCDs) pertaining to molecular diagnostic tests to be examples of the application of the ACCE criteria to Medicare coverage. The Contractor will establish methods to collect and analyze claims data. As requested, the Contractor will provide recommendations to CMS regarding local coverage variation and system edits.

C.7.38.4 Develop Master Edit File

The Contractor will expand the current file developed through the J1 MoIDx work [California] and prepare this file for shared system (SS) integration. Once the SS edit module is complete and activated, on a quarterly basis the Contractor will produce and submit to CMS a Master Edit File for MAC distribution. This file will include all necessary identifier/CPT/NPI crosswalks, coverage assigned and any non-fee-schedule pricing required. To develop this file the Contractor will perform the following tasks:

• ·       Review all newly registered tests
• ·       Establish price (non-fee schedule)/coverage by ID
• ·       Develop a list of recommended edits including but not limited to the following as appropriate:

o   Frequency

o   ID to procedure code editing

o   ID to ICD-9-CM/ICD-10

o   LCD recommendations

• ·       Assist CMS in the development and maintenance for Shared System (MCS/FISS) edits to utilize the MoIDx Master Edit File.

C.7.38.5 Prescribed Methodology of Evidentiary Review for Complex Molecular Tests, New Test Methodologies

The Contractor, with an established network of technical and clinical experts, will employ recognized and generally accepted technical assessment methods to perform the following tasks:

• ·       Create a complete submission process for all supporting application documentation that includes information needed to make evidence based coverage decisions for each test. Maintain the submitted documentation in a retrievable format that supports evidence based decision making.
• ·       Maintain appropriate evidence/administrative records connected to all coverage policies and make this information readily available to CMS upon request.
• ·       Publish and maintain any LCDs and related articles on the Medicare Coverage Database.
• ·       Maintain the submitted documentation in a test specific retrievable format that supports the medical review process.

• ·       When the available evidence is insufficient to support coverage for routine use in some indications, consider whether the use of the test for beneficiaries enrolled in certain clinical studies will support beneficiary access to covered testing for one or more of those indications. Approved clinical studies would:

o   Be registered on www.clinicaltrials.gov; and

o   Have a methodologically appropriate study protocol to answer the relevant evidence questions regarding beneficiary health outcomes; and

o   Provide assurance that findings are published peer-reviewed clinical literature; and

o   Provide CMS with interim and final data as requested.

·       

• Provide 1^st level of appeals “white papers” that support evidence based decision making for non-covered molecular assays.  [Eg help CMS win the appeal by justifying the non coverage]

C.7.38.6 Ongoing MoIDX Program Education

To support the MoIDX Program, the Contractor will develop a robust educational program to perform the following tasks:

• ·       Develop program launch materials
• ·       Develop MoPath correct coding manual
• ·       Create educational articles for MAC/CMS
• ·       Provide MAC and Provider Community SME POCs

CMS Releases Quality Measures Under Consideration; Hints at New Drug Payment Systems

CMS releases 32 new "measures under consideration" for quality metrics; Healthcare Dive December 4, with further links to CMS, here.

Fierce Healthcare covers Seema Verma remarks on new approaches to drug pricing, Fierce Healthcare December 5, here.

FMI NCD Questions to Address

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CMS Payments to ASSUREX in CY2015, CY2016

CMS has a provider-specific data set for CY2015, and has released state-specific data for CY2016.

CY2015

Using the provider-specific data, NPI 1235363052, Assurex Health, received about $21M for payments from 9,840 services for code 81479 at $2177 per service.  Presumably, this is the CMS volume and payment rate for Genesight.

CY2016

CMS has released only state-level data for 2016 so far.  (Provider level data will be released in about 05/2018).

In Ohio, providers were paid about $28M for 13,067 Genesight services at about $2,170 per service.  This is presumably almost entirely Genesight payments, but final data won't be out until about 05/2018.

See picture below; click to enlarge.

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