February 2019: Myriad's Comments on CMS Issue re NCD and Germline Testing

Myriad recent investor call

February 6, 2019

https://seekingalpha.com/article/4238451-myriad-genetics-inc-mygn-ceo-mark-capone-q2-2019-results-earnings-call-transcript

Doug Schenkel

Okay. And another recent controversy is CMS seemingly moving to apply the NGS NCD the germline test, such as myRisk. Clearly, there's a lot of debate in the community, meaning the clinical community about the appropriateness of this change, but the final outcome definitely remains unclear as we sit here today.

So for Myriad specifically, recognizing those questions whether the supplies to you given that you use CE sequencing for at least a part of myRisk that remains even more unclear. So can you just provide us with your view, how your treating this development in guidance and comment on whether or not any commercial payers have indicated that they are contemplating following on (inaudible)?

Mark Capone

Yes. So let's start with the commercial payer part first. I think it's -- I appreciate the question because there's been some confusion. I want to be very clear. There is 0 chance, and I mean, absolute ZERO chance, that commercial payers would in any way preclude early-stage breast cancer patients from getting hereditary cancer testing. First of all, remember hereditary cancer is already in the -- BRCA testing is in the USPSTF requirements.

It must be offered to patients that no patient out-of-pocket cost. It has been in NCCN Guidelines regardless of cancer stage for a decade or more. And so there is no chance that commercial payers would in any way try to remove that benefit from patients. That's just not going to happen. Now from a Medicare perspective, as you know, the industry as a whole was quite surprised by these.

Obviously, you're well aware Doug, the NCD as originally approved -- was approved, it was really viewed as a somatic tumor test, whereas the germline tests were all done on an LCD at a local contractor basis. So the fact that you took what was to everybody in the industry a somatic test and merged that into the germline test that's where we end up today with next-generation sequencing only applying for patients that are late stage for breast cancer.

Obviously, that's under significant discussion from the entire industry. To your point, what is true though is that Sanger sequencing can still be used for all stage breast cancer patients that meet Medicare eligibility. That's early-stage, that's late stage. And as you also mentioned, we, of course, have Sanger sequencing capability. BRACAnalysis is the only FDA-approved product from the FDA and it is based on Sanger sequencing and BART technology.

So for us, none of this has changed what we've been doing. We continue to do what we always have been. And there was no change from a Myriad perspective. There will be no change from a commercial perspective, but we, along with the rest of the industry, are very actively engaged in making sure the confusion from the merger of the LCD and the NCD gets resolved.

My UCSF Talk / Intro to Reimbursement for Entrepreneurs / Feb 13, 2019

Note:
For my regular medical business blog, see DiscoveriesInHealthPolicy.

DECK
Deck on a presentation I gave to a UCSF course, Startup 101, for bio-entrepreneurs here.

TYPED NOTES
Summary notes (patter) that go along with the deck, here.

Short link:      tinyurl.com/QuinnUCSFStartup101

CMS Writes: Overpayment Rule Applies Despite Tardy NCD and LCD Implementation

http://www.discoveriesinhealthpolicy.com/2019/01/very-brief-blog-reviewing-aca-rules-on.html

https://www.govinfo.gov/content/pkg/FR-2016-02-12/pdf/2016-02789.pdf

81 FR 7956-7 (February 12, 2016)

Comment:

A number of commenters requested that overpayments not caused by the provider or supplier or that were otherwise outside of the provider or supplier’s control should be excluded from our proposed definition of overpayment.

Examples of this situation offered by commenters included—
(1) a CMS system error classifying a Medicare beneficiary as fee-for-service when the beneficiary was enrolled in a MA Plan; or
(2) if the Medicare contractor makes a duplicate payment,
pays for a noncovered service due to a contractor system edit problem, or
fails to implement a national or local coverage decision correctly, resulting in an erroneous payment.

Response: 

We disagree with the commenters that certain types of payments, including those made as a result of an error by any particular party, should be excluded from the definition of an overpayment.

We do not see any basis to exclude an overpayment from the requirements of section 1128J(d) of the Act because it may not have been caused by or was otherwise outside the control of the provider or supplier.

The plain language of section 1128J(d)(1) of the Act states that providers and suppliers are obligated to report and return any overpayment that they have received within the specified statutory timeframes.

We do not believe it is necessary for providers or suppliers to make determinations regarding whether they were the cause of an overpayment in lieu of reporting and returning any identified overpayments as required by this rule.

___

CMS also states, on the following page, that not only are repayments due, after a carrier payment error interpreting an NCD, but also, CMS may issue clarifications that in some "circumstances" clarify that a past payment should now be viewed as an overpayment.  Adding that, overpayments are usually charged based on the effective date of a policy.

click to enlarge

A Quirk When BRCA Policies Require Common Mutation Screening First

For some recent client research, I had cause to go back to a 2008 Medicare LCD for BRCA testing and other germline testing.

The LCD is here.

The LCD requires Ashkenazi patients to be first screened for the 3 founder mutations, then if they are negative, reflex to sequence testing:

This actually loses money for Medicare.  It doesn't save money.

Using current codes, under direct BRCA sequencing, for 100 patients you'd pay 100 x $2027 (code 81162), or $202,700.

Under the recommended screening test, you pay more.  You'd pay for 100 patients at 100 x $440 (code 81212), and 5 would be positive.  The other 95 now progress to BRCA sequencing, 95 x $2027 (code 81162), or $192,565.  Adding together, this pathway costs $236,565. 

It's cheaper to move to direct sequencing than to hotspot mutations followed by sequencing, when the hit rate is so low (1-5%) as here.

I've seen this in more recent BRCA policies but I haven't made a systematic study of it.  A lab would have no reason to point out the anomaly to the policymaker.  You just have to count on the policymaker being unable to do fourth-grade math.

2019/1/17 Clonoseq Assay Coverage Article A56270

(Screen capture 1/17/2019)

https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=56270&ver=2&Cntrctr=378&ContrVer=1&CntrctrSelected=378*1&DocType=All&s=48&bc=ABAAAAIAAAAA&

Local Coverage Article: 
MolDX: Clonoseq® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies (A56270)


Article Text:

Medicare published a National Coverage Decision, 90.2 Next-Generation Sequencing for Patients with Advanced Cancer with an effective date of 03/16/208. This coverage decision allows Medicare Administrative Contractors to cover a next generation sequencing test for cancer diagnoses in beneficiaries with advanced cancer who are seeking additional treatment. Contractors may cover up to one test per beneficiary per cancer diagnosis.

Minimal Residual Disease (MRD) refers to a measure of cancer cells that remain in a person during and following treatment. Clinical practice guidelines in a number of hematological malignancies recommend MRD testing and recognize MRD status as a reliable indicator of clinical outcome and response to therapy, which is currently recommended in the course of treatment of patients with acute lymphoblastic leukemia (ALL) or multiple myeloma (MM). (1,2)

The clonoSEQ Assay was granted de novo designation by the FDA and is the only MRD assessment tool to have received FDA clearance for the measurement of MRD in patients with B-Cell ALL or MM. (3) The test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making and in conjunction with other clinicopathological features. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies Corporation using multiplex polymerase chain reaction and next generation sequencing of DNA, which is able to detect lower quantities of MRD than flow cytometry (4).

Testing for MRD using the clonoSEQ Assay is constituted by a series of assays in time, starting with a baseline assay that identifies clonal sequences, which will be tracked. Measurements of residual disease based on quantification of clonal sequences identified during the baseline are then reassessed in subsequent assays, allowing a provider to monitor response to therapy. Information obtained from this testing is recommended to be used to decide on whether and when to pursue additional treatment.

Effective 03/16/2018, molDX has determined that clonoSEQ Assay testing is reasonable and necessary when performed on bone marrow specimens in patients with B-Cell acute lymphoblastic leukemia (ALL) or multiple myeloma. Medicare will pay for a single episode of testing using clonoSEQ in these patients. For a patient with ALL or multiple myeloma in whom clonoSEQ is being used according to its FDA cleared indications and clinical guidelines, it is anticipated that an episode of testing will typically require a baseline assay and 3 follow-up assays. This service should be billed at the start of the episode of testing.

Coverage of clonoSEQ for other lymphoid cancer indications and episodes of care, and modifications to the definition of an episode of care will be evaluated on an annual basis.

To report a clonoSEQ episode of testing service, please submit the following claim information:

• Select the CPT 81479 for claims on or after 3/16/2018.
• Enter 1 unit of service (UOS)
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
  • Loop 2400 or SV101-7 for the 5010A1 837P
  • Box 19 for paper claim
• Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
  • Line SV202-7 for 837I electronic claim
  • Block 80 for the UB04 claim form

The following diagnoses are appropriate for the test. Select the appropriate ICD-10-CM code:

Multiple Myeloma

• C90.00 Multiple myeloma not having achieved remission
• C90.01 Multiple myeloma in remission
• C90.02 Multiple myeloma in relapse

Acute Lymphoblastic Leukemia (ALL)

• C91.00 Acute lymphoblastic leukemia not having achieved remission
• C91.01 Acute lymphoblastic leukemia, in remission
• C91.02 Acute lymphoblastic leukemia, in relapse

References:

1. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Acute Lymphoblastic Leukemia (Version 1.2019). Accessed 12/16/2018
2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Multiple Myeloma (Version 2.2019). Accessed 12/16/2018
3. Food and Drug Administration. FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma. Accessed 12/17/18
4. Adaptive Biotechnologies. clonoSEQ® Technical Information. Accessed 12/17/2018

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Very Brief Blog: Decibio Issues Market Report on Liquid Biopsy

With my offices being based in SF and Los Angeles, I frequently have a chance to work with Decibio, a Santa Monica-based life sciences consultancy.  I had a chance to contribute to their new report on liquid biopsy markets both US and world wide, and covering both cfDNA and other modalities like circulating tumor cells. 

Read more about the offering here.