Friday, November 15, 2019

Very Brief Blog: CMS Follows Administration Goals, Releases Price Transparency Rules

A major theme of the Trump Administration this year has been healthcare pricing, including surprise billing (here) and price transparency (for June 2019 executive order, here.) In late September, a number of stakeholder groups urged the Hill to move forward with surprise billing legislative, which had lost momentum.

For price transparency, the eagle has landed; on Friday, November 15, the Trump administration releases final and major price transparency regulations.  HHS views price transparency as a matter it can address through de novo regulation, whereas most surprise billing issue fall outside of Medicare or Medicaid and would require legislation.

Somewhat confusingly, today's release is a second part to the annual OPPS final rule, most of which was released November 1 (here).  In that rule, CMS merely stated concisely that "We intend to [issue] a forthcoming final rule."

  • For CMS/HHS press release, here.
  • For CMS fact sheet on the rule (CMS-1717-F2), here.
  • For the actual rule (in typescript form, 331pp), here.
  • For WSJ article, here.
    • For a September background WSJ article, here.  ("Push Sparks Furor")

Thursday, November 14, 2019

Very Brief Blog: CDC Releases Antibiotic Resistance Report; CMS Tie-Ins

Watching the 6 am cable news in a Boston hotel prior to today's Personalized Medicine Coalition conference held at Harvard Medical School, local news provides a 30 second clip about a new CDC report on antibiotic resistance in the US.

Some sources for New CDC Report:
  • STAT summary of new CDC report on antibiotic resistance, here.
  • CDC homepage for the new 2019 report, here.
  • Download the actual 148-page report from CDC, here.
    • The new report updates the prior 2013 report.
    • Pages 41-47 focus on diagnostics.
Some policy tie-ins at CMS:
  • CMS administrator Seema Verma had an Op Ed in Stat last wek on CMS efforts on antibiotic resistance.
  • November 6 Op Ed in Stat, here.
  • August 2 Op Ed by Verma in Health Affairs, here.
As detailed in her November 6 Op Ed, recent CMS efforts to encourage antibiotic best practices and drug development include (1) raising the New Technology Add-on Payment for inpatient costly drugs (albeit only for 2-3 years per new drug), (2) upgrading the DRG payment for some DRGs that involve sepsis, and (3) finalizing Conditions of Participation to require hospital antibiotic stewardship committees.   Updates 1 and 2 were in August final inpatient rulemaking (entry point here); the CoP requirement was a special rule issued September 25 (entry point here).


For those who aren't familiar with it, the national biodefense agency BARDA provides substantial funding for antibiotic resistance technologies (including diagnostics as well as drugs), and an international public-private funding agency, CARB-X, is an innovative approach to funding.

There is a President's Advisory Commission on Antibiotic Resistance (PAC-CARB), which last spring held a special session to urge HHS to finalize the Conditions of Participation for hospitals to require antibiotic stewardship committees.   HHS also is producing a second five-year National Action Plan for coordinated federal efforts in antibiotic resistance policy and investments (here).

Antibiotic Stewardship Programs: JC, CMS, CDC

Antibiotic Stewardship Programs (ASPs) are required both by the Joint Commission on hospital accreditation and CMS, but CMS worked to insure its requirements were met by meeting JC requirements.   Both sets of rules are predicated on Core Elements of ASP's, produced several years ago by CDC.  CDC is said to be in the midst of revising the Core Elements in the next month or two.

IDSA, Pew Foundation

Two of the independent organizations heavily involved in antibiotic stewardship policy are Infectious Disease Society of America (IDSA) and Pew Foundation.

Diagnostics and Hospital Budgets

On October 31, 2019, 360Dx ran an excellent (subscription) article discussing how "one of the hottest categories in diagnostics is antibiotic resistance testing," while such new molecular tests frequent collide against fixed hospital inpatient budgets.  And fixed outpatient budgets too - Medicare since 2014 bundles all clinical chemistry and microbiology tests to hospital outpatient visits or surgeries (with an exception only for human genetic tests). 

DISARM Bill and AdvamedDx

On the Hill, the DISARM bill has been introduced in both houses.  This is the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2019, see press release here and full bill here (S. 1712).  DISARM would pay for certain priority antibiotics on an average-sales-price basis for Medicare inpatients, on the requirement that hospitals participate (1) in the CDC national data registry for antibiotic resistance (NHSN) and (2) have ASP in place [the latter is now required by CMS, which it wasn't when the bill was introduced]. 

In a six-page public letter to the Senate, in July 2019, AdvamedDx suggested that the DISARM bill should have more policy initiatives related to diagnostics (here).  Advamed's proposed revisions include requiring a lab director on ASP committees, and upgrading lab technology with faster turnaround times and clearer reports with better decision support capabilities electronically integrated. 

(On the latter point, Biomerieux is supporting advanced analytics software to take the diagnostics lab far beyond historic "sensitivity and resistance" reporting; here. BARDA is also supporting Beckman Coulter to integrate advanced EHR-based algorithms with lab test reporting in sepsis, here.)

Medicare Won't Cover FDA-Approved HIV-1 Genotyping Due in Cancer Patients, Due to Stupid Policy Glitch

In March 2018, CMS released a blanket policy for all uses of NGS testing in Medicare patients with cancer.  The policy limits NGS testing to patients with "advanced cancer" (metastatic, recurrent, stage 3 or 4).   By my reading of the NCD, and I think most readings, the limits are absolute, as the policy is worded, it applies to all NGS tests and doesn't distinguish by type of NGS test.  Therefore, if you had a small skin cancer and a doctor ordered the FDA "Sensa" HIV-1 NGS-based resistance test, Medicare wouldn't pay for it. 

Obviously, CMS staff were thinking of tests like NGS Foundation One test (which they were reviewing at the time) when they limited all NGS test payment exclusively to "advanced cancers."   The policy really has got to be updated to only control testing in areas the NCD actually reviews (I read Medicare law this way; here).   If an NCD reviews A and B, they can then create policy cover A and perhaps not cover B; but they can't non-cover topics C or D that they never reviewed.

Wednesday, November 13, 2019

Very Brief Blog: Digital Therapeutics Alliance Release Suite of Documents

In September, the FDA released a number of documents in its continuing efforts to stay abreast of digital health (entry point here).

This week, the Digital Therapeutics Alliance issues a press release and its own suite of documents.
  • See the DTA website here.
  • See the new press release here, with a series of links therein.
    • Topics include:
    • Code of Ethics here.
    • Product Best Practices here.
    • Categorization of Digital Health (umbrella), Digital Medicine, Digital Therapeutics here.
    • Another product categorization table here.

Partial screenshot of DTx table

I've put today's document versions into a zip file in the cloud here, but check DTxA website for updates.

Tuesday, November 12, 2019

FDA Clears Whole Exome Tumor Test for NantHealth; 510(k)

On November 12, 2019, NantHealth announced it had received a first in class FDA clearance for an NGS-based whole exome test.   In addition to sequencing some 19,000 genes and 39 million base pairs, the test reports the same 468 cancer-relevant genes reported by the Memorial Sloan-Kettering IMPACT test, a predicate test for NantHealth.  IMPACT was a de novo clearance in November 2017.  Nanthealth's test also reports tumor mutational burden (TMB.)

The branded name is OMICS CORE.
  • See NantHealth press release here.
  • See open access summary at Genomeweb here.
  • See open access at Clinical Omics here.
  • FDA tracks the test as K190661 here.
    • Within a few weeks, the FDA technical will review will appear on the above website.
The 57-page 2017 FDA evaluation of MSK IMPACT (DEN 170058) is online here.  it will be very interesting to see the FDA's published validation requires for whole exome. 

It's hard to be sure from the short press releases, but it may be that the test reports the 468 genes (like IMPACT) but uses exome to calculate TMB (or for research data).

NantHealth's most recent investor call, November 7, is online here.  NantHealth was up 10% today, to $0.76 with a market cap of $85M.  (Current assets are about $28M; retained earnings are -$918M; initial valuatoin was $1.7B.)  In 2017 and 2018, each year NantHealth had about $85-90M revenue against net lincome (loss) of about $175-190M.

Wednesday, November 6, 2019

Horizon Watch: The FDA's Payer Communications Page (Includes CMS Parallel Review)

I noticed that the FDA has updated its consolidated Payor Communications webpage, with multiple sections and links, as of September 2019.
  • See the FDA Payor Communications Page here.
  • See the FDA Drug & Device Payor Communications Guidance, here.
    • 26 pages, PDF, June 2018.
  • See Gottlieb statement about the value of FDA-Payor interactions, here.
  • See an archived commercial webinar on FDA's package of  payor communications at Icon, here.
Sections on the FDA Payor Communications Page include:

  • An overview and background section; 
  • A voluntary Commercial Payor section
    • Includes Aetna, Kaiser, Cigna, Humana, etc., and evidence groups like ECRI; 
  • Instructions and contact information for the "CMS-FDA Parallel Review" process.  
Note that the CMS Parallel Review process is very rare, used in full only twice in a decade. 

At the bottom of the webpage are a number of links to various Commissioner statements, Federal Register publications, etc.    For example, FDA last held a "Payor Summit for Medical Devices" three years ago, in 2016.

You can also request an FDA speaker to come talk about these policies at an event or conference (instructions on the webpage).

Monday, November 4, 2019

CMS Updates PAMA and ADLT Pages; Offers to Create G Codes in Lieu of PLA Codes

I don't have screen shots of every CMS page edition, but I think they've significantly revamped their webpages for PAMA regulations, PAMA reporting, ADLT applications, and rapid quarterly HCPCS codes.

They now have a sort of consolidated PAMA Regulations page under the Clinical Lab Fee Schedule division that offers one-stop shoping, usually to online documents but sometimes to other web pages.

See the CLFS home page here.

See the PAMA regulations home page here.

There are successive sections, each with a few links, for PAMA reporting rules, PAMA reporting computer system, ADLT applications, and an application for a quarterly CMS code (in lieu of a PLA code.)

Of note, there is a webpage, updated 10/15/2019, that I hadn't seen before.  Here, CMS welcomes your quarterly application of a lab code, which will start with "U" (rather than G).  The codes move as fast as PLA codes; for a January 1 deadline, you get an April decision and a July effective date.  CMS won't give you a unique HCPCS code if you have, or if you are applying for, an AMA CPT code.

CMS will issue codes for ADLTs and FDA cleared or approved tests.  The 7 page PDF application is here.

Sunday, November 3, 2019

Very Brief Blog: CMS Posts Final PFS, OPPS Annual Rules On Time

Despite not posting proposed annual policymaking for the physician fee schedule and hospital outpatient policy until late July, with comment periods running until ;ate September, CMS was able to release final rulemaking for CY2020 on November 1, giving the public the required 60 days notice before January 1.

CMS releases "inspection copies" or typescripts now; typeset Federal Register versions will appear around November 12 (OPPS) and November 15 (PFS).

  • The consolidated Federal Register page for CMS announcements is here.
  • Hospital Outpatient Policy page here.
    • OPPS inspection copy typescript here. 1113pp.
    • OPPS Fact Sheet here.
    • OPPS Addendum ZIP Files (Such as APC rates and CPT to APC assignments) here.
  • Physician Fee Schedule Policy page here.
    • PFS inspection copy typescript here.  2475pp.
    • PFS Fact Sheet here.  Quality Program Fact Sheet here (28pp PDF).
    • A PFS press releases emphasizes reducing provider burden and improved quality metrics, here.
    • PFS addendum ZIP files online here.
  • Consolidated Discoveries Zip File
    • To save hunting and pecking, I've putting the several rules, press releases, OPPS Zip Excel files into one 32 MB open access zip file in the cloud - here.
The PFS rules includes several new opioid abuse policy programs, one for general outpatient care, one for new bundled payments for Opioid Treatment Programs (OTP, aka methadone centers).   The latter program had threated to bundle all monthly urine tox lab fees into a single payment of a few dollars but CMS revised this to include more sophisticated testing.  See a public letter from Aegis, a leading tox lab, on the problems CMS would have caused with the original proposal (here).  The opioid test policies get their own press release here.

The OPPS rule, for the lab industry, was notable for proposed changes to the infamous and complex outpatient hospital Date of Service rule.  CMS is making no significant changes except to add an exclusion re blood banks at 42 CFR 414.510(b)(5) [typescript p. 1105].  (Text here).  Within the 1-14 day time period after an outpatient blood draw or biopsy, the lab that performs a human molecular test must bill for the test and the date of service is the date of test performance.  This means that whether a hospital or an outside reference lab performs, for example, an EGFR test on a lung biopsy, it must be billed as "date of performance" not "date of collection" which is the usual CMS DOS.  Said differently, if a hospital runs an EGFR gene test and a PSA test on the same vial, the EGFR test has "DOS" as date of performance, while the PSA test would have DOS as date of collection, except that in the OPPS setting the PSA but not the EGFR is bundled.  Note the same distinction of two DOS from one vial applies also for a physician origin blood sample handled and run the same day at Quest or Labcorp.  

CMS proposed to start a new Part A/B program for prior authorization with several surgeries that CMS feels are likely to be abused, like blepharoplasty.  Despite complaints, CMS is finalizing this.  I had my doubts that this was likely a program that CMS could implement well, due to the very minimalistic staffing of its MACs with RN or MD staff, but maybe it can if volumes are low.  Prior auth services will be CPT codes associaited with blepharoplaty, botulinum injections, panniculectomy, rhinoplasty, vein ablation.  Particular providers can be released from prior auth rules if they have high pass rates on submitted cases.  There were questions whether CMS had authority to institute Part A/B prior auth (see inspection copy, 992ff).  

Also in the OPPS system, CMS proposed cutting payments for the Heartflow advanced digital imaging service from $1500 to $750; the final price chosen will be around $900.  (Earlier article here). (Inspection copy, 255ff).   Flipping from the OPPS to the PFS rule, CMS proposes that some 3D imaging rendering CPT codes (e.g. 76376, 76377) may be misvalued (inspection copy, 174ff).


CMS floated a plan for hospitals to push standard charges for increased transparency; CMS deferred action on this topic (inspection copy, 926ff).  Much ink had been spilled since July on this topic; entry point here.


Related to the July announcement of multi-modal programs to improve CKD, ESRD, and renal transplant care, CMS proposed changes to the "expected donation rate" which is part of qualifying as a transplant procurement center; see OPPS inspection copy 927ff.

Thursday, October 31, 2019

Very Brief Blog: CDx Forum; Illumina Forum; PMC in Boston; Many More Meetings

The flurry of conferences and events marches on.  These crossed my inbox in the last few days.  (One or two of them, unfortunately, seem to cross my inbox daily.  Ok, I get it already.)

On October 29-30, see the Fourth Annual Companion Diagnostics Forum in Princeton. Here.

On November 6-8,  see the California Clinical Lab Association in Orange CountyHere.

On November 7-9, see the Association for Molecular Pathology in BaltimoreHere.

On November 13-14, see the 15th Annual Personalized Medicine Coalition at Harvard Medical School in BostonHere.

My Linked-In feed brought advertisements for an Illumina "Market Access Symposium" in NYCNovember 15 - right after PMC in Boston.  Here.  The agenda is an interesting read.  Illumina brings you lots about payers.

On December 3-4, see the Diagnostic Coverage and Reimbursement Conference from Q1 in BostonHere.  (Or see the West Coast version, February 11-12, San Diego).

January 21-24, see the Precision Medicine World Conference in Silicon Valley.  (I'm a panelist).  Here.

On February 11-12, see the West Coast edition of the Diagnostic Coverage and Reimbursement Conference from Q1. San DiegoHere.

On February 27, the Foley Lardner Business of Personalized Medicine Summit in South San Francisco. (I'm a panelist.)  Here.

On March 1-4, the 27th International Molecular Medicine Tri-Con in San Francisco.  (I'm running a workshop).  Here.

Very Brief Blog: Center for Innovation Role Open at CMS; New Leader Likely Soon

Recently, Adam Boehler stepped down as head of the Center for Innovation (CMMI) at CMS.  He spoke this week at the HLTH conference (here), and remarked that his successor was likely to be named soon.

According to an article in Politico a few weeks ago, Brad Smith was a favored contender (here).  Smith, not to be confused with the Brad Smith who is President at Microsoft, is a 36-year-old former Rhodes scholar and McKinsey consultant.  (The first head of CMMI, Patrick Conway, also served a stint at McKinsey between college and med school).  Smith served as staff under Sen. Bob Corker and developed the palliative care firm Aspire, sold to Anthem for several hundred million dollars in 2018. 

CMMI recently rolled out new payment models that include capitated payments for primary care (here) and direct-contracting models (here, here).  (It takes some expertise, though, to recognize the difference between "total care capitation" and regular Medicare Advantage.)

Tuesday, October 29, 2019

Very Brief Blog: Snapshot of CY2018 MoPath Payments at CMS

Each fall, CMS releases CPT code payments for Part B in the prior year (for CY2018, here).

I've done a quick review of MoPath spending in CY2018.  Cloud excel here.

By my tally,  MoPath payments (81162-81599, plus U and M codes) was about $1,151,475,000.  This compares to $480M in the same data for CY2017, so PAMA 2018 did not kill MoPath.

As in prior years, the billing is highly concentrated.

Out of 204 codes, the top 5 gathered 50% of payments.   The top three were Cologuard (81528, 335,455 uses, $171M; see also here), Unlisted Code (used almost exclusively in MolDx states, 89,721 uses, $136M) and MoPath Tier 9 (62,280, $123M). 

click to enlarge  -MoPath CMS Pt B CY2018

Corus CAD
The 9th largest test was Corus CAD, at $30M - at the end of 2018, coverage was discontinued and the company quickly folded, here.

PLA Codes
The largest PLA code, 0037U, FMI F1 CDx, gathered $37M.  It was active beginning April 2018 and under NCD coverage (the CMS NGS NCD) for three quarters of 2018.  The $37M represents circa 10,000 patients.  (PLA Excel here; See additional PLA chart at bottom).

GSP Codes
Among GSP codes, 81432/81433 (HBOC panels) were used in 19,448 and 16,492 patients, respectively, for $16M and $9M (total $25M).   5-50 gene tumor panel 81445 was used 3,244 times for about $2M.  81455 (50+ tumor genes) was used 7,494 times for $21M.  While MolDx generally insists "we don't pay for 81455," 7,006 of the 7,494 payments (94%) were in Noridian Jurisdiction E under MolDx, suggesting the Z-code and master edit system is somewhat leaky.

Whole exome 81415 was paid 1 time; whole genome 81425 paid 0 times.

CMS data shows claims paid and gives no insight into denial rates.  Based on 2018 data, XIFIN showed that payor denial rates for 81445, 81450, 81455 ranged from 82%-96% (here).

BRCA Codes

CY2018 was the first year in which CPT codes 81211/81213, legacy BRCA codes, were deleted and replaced by less expensive code 81162.  Although BRCA remains a top-ten revenue item in MoPath, revenues trended downward due to this coding/pricing change.  See article on Myriad revenue changes due to coding, Genomeweb, 11/5/2019, here.

Tier 2 Watch

Tier 2 codes altogether tallied $190M uses, bigger than Cologuard.  Most of this was 81408, Tier 2, Level 9 (big genes).

click to enlarge - MoPath Tier 2

Despite the profusion of CPT codes and PLA codes, 25-30% of payments still flow through an unlisted code.

Each fall, OIG releases a report on CLFS spending in the context of PAMA implementation.  The 2017 reported appeared in 9/2018, but the 2018 report has not appeared yet.  That report includes hospital outpatient labs, which my Part B data does not.


PLA Code Concentration

2 codes were 98% of PLA code usage (CMS listed about 40 codes in CY2018 data).  In round numbers, FMI F1 CDx was 90% of PLA usage and Oncotype Prostate was the next 10%.

Most PLA codes had no usage followed by some that had a few dozen uses or less. PLA Excel here.



Exact Sciences is working on an improved Cologuard test; here.

Opko 4KScore, code 81539, had 25,572 uses for $19.4M.  Early press here.  Parent company Opko was recently down 30% (here).

Category I MAAA Codes (excluding PLA  or Admin MAAA codes, the U and M codes) tallied $443M, though a large share was Cologuard 81528 and no other tests approached its volume or revenue. Leaving out Cologuard (which has a huge volume at about $500), the average MAAA paid $2500.  The average 81479 payment was $1500, while the average 81599 payment was $4000.

Category I MAAA Codes

Very Brief Blog: CMS Releases Part B Utilization Data at National and State Levels

Each fall, CMS released data on the prior year's Part B CPT code utilization and payments both at the National and the State levels.   CY2018 data has been released.

See national data here.

See state level data here.

The state data is actually by historical Medicare Part B carrier zones, so some states have two parts (e.g. NCalif and SCalif).  Also, the Excel files are given cryptic contractor numbers and you need to decode with a provided PDF.  (Noridian Contract 03102 = CMS Excel 03102 = Arizona).

Separately, and on a longer delay, CMS releases physician-level CPT code payments.  These appear around June for the year 18 months earlier.  Here.

Example: BRCA

For example, the CY2018 National data file #04 contains 80,000-series codes, and in CY2018 CMS Part B paid for 22,615 uses of 81162 (BRCA Seq + Dup Del) totaling $50,896,967.

If we turn to the CY2018 state data, we find that Utah is File #03502, where there are 12,459 uses of 81162 paying $28,069,254. (In 2018 in Utah, older BRCA code 81212 had only 496 uses for $28,240.)   Research can be done at national and state levels for any code.

Example: FMI CDx Test

In national data, Code 0037U for Foundation Medicine FDA test was paid $33,396,800 (used 9,870 times).   However, I believe this code was effective in April 2018, so this may reflect only FMI payments in three quarters of 2018.   I believe there are 100,000-200,000 incident Medicare patients with advanced cancer (and multiples of that number as prevalent patients), so the FMI tests was not used in too many of them in CY2018, despite the NCD becoming effective in March 2018.

0047U is the Genomic Health prostate panel, which tallied 1,277 uses for about $4M in 2018.

Payments for all the other PLA codes 0U-70U were only about 4M more than payments for 0037U and 0047U.  Many had 0 CMS payments.

CMS Releases Revision for Comment of NCD for Next Gen Sequencing in Cancer

On October 29, 2019, CMS released a revision of its NCD for next generation sequencing in cancer patients.

The original NCD, released in March 2018, was criticized for being liable to ambiguity but potentially adverse to NGS testing in Stage 1/Stage 2 cancer patients or those who require repeat testing.   This criticism accelerated after some restrictive additional interpretative statements released by CMS in November 2018.   CMS held a comment period in May 2019, and received uniformly negative comments (here).
  • The tracking sheet for the NCD revision is here.
  • The revised NCD, for new cycle of public comment, is here.
  • I've put a PDF version in the cloud, here.
Scroll down to Appendix B for a redline proposal to revise the NCD decision.  I've also clipped the redline proposal as the bottom section of this blog.

Comments are during on Thanksgiving, Thursday, November 28, so many stakeholders may want to view Friday November 22 as an effective corporate pseudo-deadline.  The final NCD is due about 60 days from November 28, e.g. January 28.

Coverage at Genomeweb here.

What Happened in Brief

Warning - these are my first-pass interpretations; it could be that other readers will find textual ambiguities or problems I haven't noticed.
#   #   #

click to enlarge

NCD Coverage.  Previously, CMS nationally guaranteed coverage for NGS testing for NGS tests approved as CDx, if the patient had advanced cancer (metastatic, stage 3/4, etc).   For example, the FMI F1 CDx test was covered per its FDA labeling in such patients.

   >>> Now, CMS also proposes to nationally guarantee coverage for FDA approved or cleared tests (NOT necessarily CDx) in patients with ovarian or breast cancer, indications for germline testing, risk factors for inherited cancer.   Such patients have no stage restrictions like Stage 3/4.

In short, the areas of the NCD which nationally guarantee coverage pivot on being an FDA CDx test, and now it adds coverage for FDA tests that are not CDx for any indicated genes (per FDA) in breast and ovarian cancer.

LCD Flexibility.  Previously, CMS gave MACs discretion to cover non-FDA-approved (LDT) NGS tests, or FDA tests off-label, as long as it was ONLY for one test and ONLY in advanced cancer patients.

   >>> Now, CMS will let MACs allow coverage for NGS testing with LDT tests in patients with diagnoses other than breast and ovarian cancer (e.g. colon cancer), as long as they have inherited cancer risk factors and not prior tested with NGS.  There are no stage restrictions. 

#   #   # 

I see three issues right away.

  1. HBOC patients get only FDA tests that don't exist.  Breast and ovarian cancer patients can only get germline (inherited) testing for FDA cleared or approved tesst.  The only ones are for BRCA, and in fact, the Myriad germline BRCA test is not NGS (it's Sanger) and the Foundation BRCA test and Myriad MyChoice BRCA test are NGS but are somatic tumor tests.  Oops.
    1. The standard of care is almost certainly more than BRCA gene testing alone, it's panel testing, while only BRCA has FDA approvals (albeit defective ones relative to the NCD, as just stated).
    2. Myriad CEO Marc Capone also remarked that the NCD text here was very important and that the NCD points to FDA tests that don't exist, in a November 4 investor call (here).
  2. Still a one test per patient rule.  Only one test per patient, so not obviously helpful yet to recurrent disease detection.   
  3. Glitch re types and classes of testing.  The new passages about germline testing preclude any prior NGS method testing, but, for example, you might have to use one somatic FDA test for genes like EGFR and KRAS, and a different germline FDA test for BRCA.  The NCD doesn't seem to contemplate this problem.   For sure, there isn't any one FDA test today that covers both somatic CDx mutations and germline management mutations.   The NCD would cover both, as long as you don't do more than one.  Oops.
    1. The new parts of the NCD allow germline testing as long as "patient has not had a prior NGS test."  Really? Any prior NGS test?  FDA has approved an NGS HIV test - if you've had that, it's a prior NGS test, so you can't have BRCA testing?  Here.
NCD has confusing different sections applying to stage.  The new germline sections don't refer to stage.  And it's clear from the body of the NCD that CMS staff want to cover germline testing in breast and ovarian regardless of stage.  But CMS leaves in place a "section C" which is a blanket ban on NGS test coverage for patients who don't meet rules in "section B.1" which gives coverage to only metastatic/advanced patients.  (Eye-crossing.)

CMS distinguishes breast and ovarian cancer patients because they found the best germline literature in these groups.  Throughout the NCD, they are cautious to refer only to published NGS literature for outcomes, which is a little daffy, since a particular mutation sequenced by Sanger or by NGS gives the same outcomes.

There's also still a barrier to technology modernization that I dislike.  Many women with breast cancer get the Oncotype Dx or similar tests, which aren't NGS so they aren't under this NCD.  But if they were migrated to NGS platforms (and Mammaprint had been able to do this), they would be under the NCD but in very limiting or counterproductive ways. 

click to enlarge

Nerd Points.

The prior NCD covered certain tests, if that test hadn't been used in that patient before.   The new language covers certain germline testing, if the patient hasn't recent [any] NGS test before.  This is confusing.   Although it's now rare, someday, a patient might have e.g. NGS microbiology testing, which would be "a prior NGS test."  Who would track that?  Obviously an unintended issue.   Or a patient might have an NGS epilepsy panel as a child, but need NGS testing for cancer as an adult.  The NCD doesn't seem to contemplate that, since it blocks testing if the patient had "a prior NGS test."   This will hopefully be fixed in the final revision.


Medicare National Coverage Determinations Manual
We are seeking public comments on the proposed language that we would include in the Medicare National Coverage Determinations Manual. This proposed language does not reflect public comments that will be received on the proposed decision memorandum, and which may be revised in response to those comments.
Table of Contents
(Rev. in Redline)
90.2 Next Generation Sequencing (NGS) for Patients with Advanced Cancer
A.  General
Clinical laboratory diagnostic tests can include tests that, for example, predict the risk associated with one or more genetic variations. In addition, in vitro companion diagnostic laboratory tests provide a report of test results of genetic variations and are essential for the safe and effective use of a corresponding therapeutic product. Next Generation Sequencing (NGS) is one technique that can measure one or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic test.
Patients with cancer can have recurrent, relapsed, refractory, metastatic, and/or advanced stages III or IV of cancer. Clinical studies show that genetic variations in a patient’s cancer can, in concert with clinical factors, predict how each individual responds to specific treatments.
In application, a report of results of a diagnostic laboratory test using NGS (i.e., information on the cancer’s genetic variations) can contribute to predicting a patient’s response to a given drug: good, bad, or none at all. Applications of NGS to predict a patient’s response to treatment occurs ideally prior to initiation of such treatment.
B. Nationally Covered Indications
Effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements are met:
1. Patient has:
  • either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and,
  • either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and,
  • decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
2. The diagnostic laboratory test using NGS must have:
  • Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and,
  • an FDA-approved or -cleared indication for use in that patient’s cancer; and,
  • results provided to the treating physician for management of the patient using a report template to specify treatment options.
^ Effective for services performed on or after [Month/XX] [Day/XX], [20XX], the CMS, proposes that NGS as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:
The patient has:
  • ovarian or breast cancer;
  • clinical indications for germline (inherited) testing,
  • risk factors for germline (inherited) cancer breast or ovarian cancer; and
  • not been previously tested using NGS.
The diagnostic laboratory test using NGS must have all of the following:
  • FDA approval or clearance;
  • an FDA approved or cleared indication for use in that patient’s cancer; and
  • results provided to the treating physician for management of the patient using a report template to specify treatment options.
C. Nationally Non-Covered
Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with cancer are non-covered if the cancer patient does not meet the criteria noted in section B.1. above.
D. Other [aka local coverage section]
Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of other NGS as a diagnostic laboratory test for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by a treating physician, and the patient has:
  • either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,
  • either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test was performed only when a new primary cancer diagnosis is made by the treating physician; and,
  • decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
^ Effective for services performed on or after [Month/XX] [Day/XX], [20XX], Medicare Administrative Contractors (MACs) may determine coverage of other Next Generation Sequencing (NGS) as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when all the following conditions are met:

The patient has:
  • a cancer diagnosis other than breast or ovarian cancer,
  • clinical indications for germline (inherited) testing,
  • risk factors for germline (inherited) cancer other than inherited breast or ovarian cancer, and
  • not been previously tested using NGS.

Monday, October 28, 2019

Very Brief Blog: AMA PLA Code Watch: 9 New Proposals

AMA takes applications for PLA codes (proprietary lab codes) quarterly, and processes them very rapidly.   For codes accepted October 10, they were posted for comment October 17 and comment closed October 22.   They will come to a panel vote in early November, be published January 1, and effective April 1.

Ten New Applications

There were ten new code applications in the current cycle.   There is also one code deletion ("detection of 120 medications, substances, supplements, foods") and two code revisions (therascreen FGFR kit, therascreen  PIC3CA).

The AMA calendar for 2020 is not published yet, but applications are about the 10th of each quarter (about January 10, April 10, July 10, October 10).

  • PLA home page here.
  • PLA codes for October 2019 here.
  • PLA calendar home page here.
The next publicly available PLA call is Tuesday, November 12, 7 ET 4 PT.   However, this calls are often quite short (the codes may be stated to be a "consent agenda" with rapid "aye" votes and the meeting closes.)

Friday, October 25, 2019

Very Brief Blog: CMS releases Panel Actions from September 2019 AMA CPT Seattle Meeting

About a month after each AMA CPT public meeting, AMA releases summary actions of the panel.  They've just released the summary actions for the Seattle meeting in September.

Find them online here.

There were about 80 main agenda items and about 10 executive committee actions (merely editorial).  Using a word search function, I tallied 46 accepted proposals, 5 postponed, 18 withdrawn, and 13 rejected.   Applicants get feedback regarding association positions on their proposals, and typically most applicants withdraw if it is clear that major associations will vote down the item.  If we tally the "withdrawns" as "rejected," they would total 31.

On the lab side, a number of genes were lifted from CPT Tier 2 to Tier 1.  A gene panel code for epilepsy was withdrawn.  Several infectious agent applications were also withdrawn.  A new MAAA code was created for cutaneous melanoma (815XO).


Some of the Category I codes are revised for January 2020 instead of January 2021, even though this September meeting occurred after the 2020 book had gone to press.  New to me, and potentially a little confusing.

Since it was revised, my attention was drawn to process code 3170F, used when flow cytometry baseline studies are performed prior to initiating hem-onc therapy.

Newswatch: German commission dings LBx cancer researcher re molecular screening tests

On October 25, 2019, Science published an open access news item with the provocative title, "German university finds ‘severe’ misconduct by researcher who promoted questionable cancer blood test."  I recall news items about this test over the past year; it concerns a new LBx test sensitive and specific enough to be used for cancer screening.   Now it's being labeled "questionable" in some news reports.  (For early favorable press, here.  For skepticism as far back as April 2019, here.)
  • See the new article by Hinwerk Feldwisch-Drentrup in Science, online here.
In fact, the article describes a flip-flop series of events.  In February 2019, a press release described the screening cancer liquid biopsy test as "revolutionary."  In past months, however, "the hospital has been rocked by scandal" including "criminal proceedings."   According to Science, "in July, an external panel established by the hospital board presented the results of a preliminary investigation, criticizing the press releases as premature and 'yellow press instead of serious science communication.' "

Then there is another twist, the accusatory report was pulled from its public release, and a court ordered a press conference on the alleged wrongdoing to be cancelled.

For full details, see Science link above.  See website of the company HEISCREEN, here.

Some Heiscreen webtext after the break.