Friday, October 30, 2020

Policy Worth Watching: CMS Announces Diverse Modifications to DME Policies, including CGM

Earlier this week, CMS released a wide-ranging set of policy modifications to DME policy, ranging from HCPCS code procedures to benefit category determination rules to some specific policymaking, such as for Continuous Glucose Monitors (CGMs).

  • See the CMS fact sheet here.
  • See the CMS Press Release here.
    • "Today, under the leadership of President Trump [etc]."
  • See the Proposed Rule Homepage here.
  • See the "inspection copy" or typed rule here [211 pages]. [Fed Reg Publication Nov 4]
  • The official Fed Reg publication will be November 4 at the homepage cited.
CGM Revisited

CMS policy for CGM has been tortured, with non-coverage for a number of years under the vaguest of rationales, court cases, and interim policy changes on the CMS or the DME MAC websites.  The new rule classes CGM as DME.

I've covered CGM weirdness in a number of skeptical blogs since 2016, several being here, here, and here.  Parrish Law Offices has won a number of CGM cases for clients (here and here). The rule cites several CGM legal cases (e.g. "Finigan v Burwell 2016").

Elevated Volume of DME/HCPCS Rulemaking

In most years, a few pages of DME policy changes are tucked inside the annual summer ESRD rule.  This year, DME gets a standalone rule.   In addition, the rule contains histories of many of the obscure policy rules of DME, a history of CGM coverage that discusses DME payment concepts for glucose devices back to the early 1980s.


I've borrowed the phrase "Policy Worth Watching," from Indiana's Lance Geiger (here), who runs a YouTube channel of colorful ten-minute history vignettes several times a week (see "The History Guy" channel here), and his tag line "History that Deserves to be Remembered."


In last year's rulemaking, CMS proposed making a public advisory panel that would advise it on gapfill pricing for DME based on costs.  I was alarmed this could occur and could be later applied to genomics also.  For example, the panel might have little insight into costs and investments and return on risk capital; they were instructed to look at the end-product and estimate its costs.   Here.  CMS deferred action on the "pricing  panel."

Thursday, October 29, 2020

CMS Issues Two Rules: National Healthcare Price Transparency, and COVID Price Transparency

CMS had two major announcements this week - one, a national rule on price transparency in healthcare payments, and second, a "fourth interim final rulemaking" on COVID regulations, which includes a section on COVID test pricing.

Healthcare Price Transparency

For two years, a major push of the Trump administration has been healthcare price transparency.  Proposed rules have already entered court battles.  Nonetheless, CMS has released final rulemaking on price transparency.    

See the press release here, the fact sheet here.

> MACs avoid price transparency.   The irony wasn't lost on me, since in the interests of price transparency, I obtained some locally priced code values from the Palmetto MAC (a type of information that some MACs say explicitly is released under FOIA).  After I reported several clear-cut pricing errors to the MAC, resulting in clear-cut overpayments of Medicare funds, the Palmetto MAC responded with a cease and desist attorney's letter (here) that the overpayment rates to a few favored parties were "business secrets," which was covered in the trade press (at Genomeweb here.)    
> Medicare Part B avoids payment transparency. In addition, CMS itself has declined to release its own Medicare 2018 physician and lab payment data, which under clear-cut federal policy is normally released in May./  I believe the May data has been withheld from release because it would show the level of egregious fraudulent payments (almost exclusively in Red states) under the Trump CMS administration in 2018 (here).  

New Rulemaking; COVID Lab Pricing

Here's the CMS Fact Sheet on the fourth interim rulemaking for COVID policy - link.

See the Fed Reg official publication (85 FR 71142), November 6, 2020 - here.

I haven't reviewed in full but a key section on COVID test pricing is described in the CMS fact sheet as follows.  It appears to implement in regulation some text that Congress had already provided in prior COVID law.  (Section 6001 of FFCRA, March 18, 2020).

[CMS fact sheet...] Price Transparency for COVID-19 Diagnostic Tests

Section 3202(b) of the CARES Act establishes a requirement for providers to publicize cash prices for COVID-19 diagnostic tests during the PHE. For purposes of implementing section 3202(b) of the CARES Act, this IFC adds a new 45 CFR part 182 to our regulations. This new requirement applies to every “provider of a COVID-19 diagnostic test” (or “provider”), which is defined as any facility that performs one or more COVID-19 diagnostic tests. Additionally, it requires that each provider of a COVID-19 diagnostic test make public the cash price, defined as the charge that applies to an individual who pays cash (or cash equivalent) for a COVID-19 diagnostic test, for such tests on the internet. If the provider does not have its own website, the provider must make the cash price available in writing within two business days upon request and through signage (if applicable). Additionally, this IFC gives CMS discretion to take any of the following actions, which generally, but not necessarily, will occur in the following order if CMS determines the provider is noncompliant with these requirements:

  • Provide a written warning notice to the provider of the specific violation(s).
  • Request that a provider submit and comply with a corrective action plan (CAP) if its noncompliance is not corrected after a warning notice.
  • Impose a civil monetary penalty (CMP) on the provider if the provider fails to respond to CMS’ request to submit a CAP or to comply with the requirements of a CAP approved by CMS.

Wednesday, October 28, 2020

Regarding Diagnostics, How Confused Were Authors of Medicare's Breakthrough Coverage Proposal?

Nearly two months ago, CMS released a groundbreaking proposal to cover medical devices reviewed under the FDA Breakthrough Pathway for four years, based on the indication for use and the date of FDA approval.  I covered the release here on August 31 and discussed some ins and outs here.   

The comment period winds up on Monday, November 2, and there are already 94 comments submitted (here, see "comment' box.)

I'd like to circle back to my remarks, "Ins and Outs, #3" in an earlier blog. I'm still bothered and puzzled by ambiguities in the text, regarding diagnostics.

Regulation Includes Diagnostics by Definition; Body of Text Makes Odd Statements

In German, they have the word "Jein" meaning "ja" and "nein" at once.  Does the Breakthrough Coverage proposal encompass diagnostics?  Jein?  Yes, but with some weird text that raises confusion.

YES: Diagnostics are Part of Breakthrough Coverage

CMS creates breakthrough device coverage under a proposed new regulation at 42 CFR 405.603.  Devices are covered under Medicare Coverage for Innovative Technologies (MCIT) if they are within a Medicare benefit category, used according to their FDA indication, and are "FDA-designated breakthrough devices."  A definition says simply that breakthrough devices are those designated under the FDA breakthrough regulation (FN1).  

There's no question that FDA breakthrough law includes diagnostic devices (e.g. IVDs).  A number of breakthrough diagnostics have already been approved, and press releases indicate many more in the FDA breakthrough pipeline.  There's no question that FDA categorizes IVDs as medical devices (for one source on that, see Medicare's own quotation of the FDA definition of medical devices including diagnostics - here.)

So if the regulation at 405.601, 405.603 is finalized, it applies to the array of medical devices under Breakthrough, and that is well-known to include diagsostics.

NO:  Puzzling CMS Text in Rulemaking

CMS writes on page 54331, Column 2:

  • We specifically seek public comment on whether the MCIT pathway should ALSO include:
    • diagnostics,
    • drugs and/or biologics that utilize breakthrough or expedited pathways,
    • or all diagnostics, drugs, and/or biologics.
  • We seek data to supporting including THESE ADDITIONAL ITEM CATEGORIES in the MCIT pathway.
It sure sounds to me like the author of this paragraph thought that, as proposed, diagnostics were NOT included under the rubric "medical devices," but MIGHT be included as an "ADDITIONAL" type of coverage to that which was proposed.  Weirdly, CMS scrambles together a category covered by Breakthrough Devices terminology (diagnostics) and something entirely outside breakthrough device terminology (drugs).

Resolution: Does It Matter?  

If the regulation is finalized with the wording proposed, the legal regulation will include diagnostics (as it encompasses all breakthrough devices without qualification.)   

However, my concern is, some author or authors at CMS did not want to include diagnostics.  They think of "medical devices" as med/surg devices - pacemakers, artificial hips.  At their most perverse, CMS could state that, "In our original discussion, we clearly indicated to the public that we did not intend to include diagnostics, unless we would be convinced to do so by public comment and data. We referred to diagnostics as an additional category that might be included under MCIT, at our discretion. Therefore, in finalizing the rule, we have edited the regulation to clarify, as we intended, that it does not include diagnostics, bringing the regulatory text into alignment with our public discussion."   I think this would be a pretty unhappy outcome, but I'm not sure it's impossible.   

Let's hope this plays out well for diagnostics but re-reading this text for several additional weeks I continue to feel that it's worth paying attention to. 




I'm not sure the regulatory reference in the CMS rule to breakthrough devices as FDA Act 515B(d)(1) or USC 360e-3(d)(1) are correct.


Fine point.

I've seen comments that a phrasing on page 3 of the Federal Register document narrows the rule to medical devices other than diagnostics.  This says, "At this time, we are limiting MCIT to medical devices because that is a category of products explicitly identified by E.O. 13890, and we have identified that breakthrough devices can experience variable coverage across the nation shortly after market authorization."  Unlike some letters I have read, I wouldn't say this sentence excludes diagnostics, which FDA considers clearly includes as "medical devices."   I would say this sentence explains why the MCIT is limited to breakthrough medical devices in general, and CMS didn't write it to include, for example, accelerated approval drugs.

And lest their be any confusion that Medicare had (somewhere, somehow) previously defined "medical devices" as only med-surg devices, it didn't.  The official and manualized Medicare definition of "medical devices" quotes from FDA and explicitly includes diagnostics (here).

USPSTF Releases Draft New Report on Colorectal Screening: Comment to November 23

On October 16, 2020, CMS released a proposed NCD which would allow FDA-approved colorectal cancer screening tests by liquid biopsy on a rolling basis, if they meet certain pre-defined CMS criteria (here).

On October 27, 2020, USPSTF released an updated draft position on its recommendations for colorectal cancer screening.   See website here.   Comments must be submitted by November 23.   (After comments, a final report may take 6-12 months).   New USPSTF guidelines are binding on commercial payers under the ACA, after a one-to-two year roll-in period.

USPSTF recommends (among other tests, like colonoscopy) the Cologuard test EITHER at 1- or 3-year intervals.  I believe it recommends "either" because it wants to support annual testing but does not want to disallow 3-year testing as a standard of care at this time.

Regarding age, USPSTF recommends screening age 50-75 ("A") and 45-49 ("B") but only selective use of screening age 76-85 ("C").   


See an archival cloud copy of the draft report here.

Tuesday, October 27, 2020

Very Brief Blog: Exact Sciences to Aquire THRIVE for $2B

Exact Sciences, whose Cologuard test is the largest single molecular test paid by Medicare in 2019, has been on a roll since October 2014, when it received CMS coverage for Cologuard under a Parallel Review NCD.  Share price and market cap are up 10X since then.  Exact acquired Genomic Health for $2.8B in July 2019, just over a year ago (here).

October 27, Exact announces it will acquire THRIVE, in a deal valued up to $2.1B ($1.7B up front).   Concurrently, Exact acquires DNA methylation analysis company Base Genetics for $410M.  Exact also announced a $879M fundraising event.  

According to Genomeweb, THRIVE has garnered over $350M in investments.  In the same space, note that Illumina recently agreed to acquire GRAIL for $8B (here).  

Policy Events Contribute

Policy events are contributing to the roll in minimal detection and screening uses of liquid biopsy in cancer.  A few weeks ago, CMS announced a proposed NCD under which it would cover all FDA approved liquid biopsy cancer screening tests if they meet pre-determined CMS performance standards.  (Here).  The MolDx program announced it was proposing to cover minimal disease detection tests for cancer monitoring (such as recurrence and chemotherapy response) in both hematopoeitic and solid cancers.  (Here, here.)

EXACT is up 12X from $9 to $125 since October 2015.  Since a Covid dip of $58 on March 1, it's more than doubled to $125 today.  (The DJIA is up from 20,000 to 27,000 during the same interval).


My video on the CMS liquid biopsy policy is online here; it's a 5 minute overview and a 10 minute deep dive.  


See an open-access, JPM-inspired article in January 2020 in BioWorld on "Wall Street Wonders Where is Exact Sciences Headed" here.


Interestingly, when Illumina acquired Grail in mid September, its share price dipped from $350 to $270, before quickly bouncing back up to $320.   

In contrast, Exact's share price popped 18% on today's announcement (Exact market cap now $19B, about 40% of ILMN's market cap of $47B today.)  Note that the mid-September Grail acquisition was several weeks before the October 16 CMS NCD announcement that it was planning to issue open-ended FDA-approved colorectal test coverage.  

Monday, October 26, 2020

Very Brief Blog; JAMA Posts Article Series on Sequencing, WGS, Clinical Implementation

JAMA posts a UCSF new article on the clinical value of sequencing, including whole genome sequencing, and the need for implementation (translational) research.  JAMA includes callbacks to two recent articles.

  • The new entry point is Phillips, Douglas, Marshall in JAMA online October 26, "Expanding Use of Clinical Genome Sequencing and the Need for More Data on Implementation."
    • Here.
      • Note the online supplemental table here.
      • Webpage includes podcast interview with Howard Bauchner, Editor-in-Chief, and Prof. Phillips of UCSF (18 min).  Here.
  • JAMA provides Wu et al., JAMA Pediatrics, June 2020, as a callback.
    • "Ending the Diagnostic Odyssey: Is WGS the Answer?"
    • Here.
      • This article refers in part to the Diagnosic Odyssey Act, proposed as HR 4144.
  • JAMA also links back to Feero, 2018, "Precision Medicine, Genome Sequencing, Population Health."
    • Here.
    • Feero in turns cites a National Academies 2018 conference report on implementing genomics, here.

Friday, October 23, 2020

MolDx (And Noridian) Finalize Prostate Cancer Tissue Prognostics LCD

Since May 2020, MOLDX watchers have often been perplexed by the new discrepancies between system-wide MolDx LCDs (in four MACs) and unique maneuvers of the western Noridian MAC which differ from final MOLDX decisions elsewhere.  See for example here.  

By late September, I felt confident enough to call a pattern (here).  

  • Noridian was declining to finalize LCDs from MOLDX that it felt were too specific to a single product. (In some cases, Noridian declined to finalize such an LCD even if MOLDX changed the headline title of the LCD).   
  • Noridian does go along with MOLDX, verbatim, when an LCD is clearly designed in a holistic way to cover a whole domain of test types.

Prostate LCD Finalized, From Specific to General

A good example is the finalization of last year's draft LCD DL38341.  The original title was, "MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease (DL38341)."   Note that there are at least three covered prostate cancer tissue risk classifiers - Myriad, Oncotype, and Decipher - but there are multiple context (biopsy tissue pre surgery, postsurgical resection tissue, before and after various definitive or invasive therapies).

DL3841 has now been finalized, even in Noridian, as " Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (L38341)."  It comes with a Response to Comments document A58511.  It comes with a Billing and Coding article A57236.   I've made a redline comparing the text of DRAFT versus FINAL.

  • I've put the whole set in one zip file in the cloud, here.
    • See upper right hand "down" arrow to download zip.

The coverage article appears to provide equal coverage for 81541 and 81542, which are Myriad Prolaris and Decipher Bioscience, Decipher Test.  81541 is $3873 while 81542 has been in the 2020 gapfill process, recently given a price of $3159 (new, subject to appeal).  

Oncotype Prostate, 0047U, is not listed in the coding article A57236.  (Current fee schedule $3873).

Thursday, October 22, 2020

CMS Releases Final Gapfill Pricing for CY2021 Lab Codes

 Each year, CMS considers all new lab codes in a summer pricing meeting, and CMS sets some quickly by "crosswalk" to an existing price.  Others are sent to "gapfill," a process in the second year where MAC medical directors proposed then finalize pricing for the "gapfilled" lab codes.  

While CMS sets "gapfill" at the median rate of all the states, MolDx controls pricing in 28 states and therefore sets the next year's median regardless of pricing proposals in the other 22 states.

On October 22, 2020, CMS released final gapfill prices for CY2021 on 37 codes.  (I say final; technically the prices can be appealed to CMS administrators til November 22).

  • See the public meeting home page here.
  • Look near the bottom for the 2021 final gapfill file, it should be here.
  • I've made a summary cloud file comparing June proposed and October final on one spreadsheet, here.

CMS revised 4 prices upwards and left 33 the same.  Prices on the elevated tests are shown:

CMS had comments to change pricing on 7 codes, acting as requested on 4.  CMS turned down 3 requests for higher prices.  CMS also logged comments "supporting the proposed price" (no action needed) on 2 codes.


0092U Magarray REVEAL.  Initial price proposal $1534, 45% of comparable code 0080U (XL2, $3520).  Final price, $2488, 70% of $3520.  

Tuesday, October 20, 2020

AMA Releases 4Q2020 PLA Code Applications; Meeting November 5.

AMA takes PLA code applications every quarter (e.g. circa July 1, circa October 1) and briefly posts them for public inspection a couple weeks later.  This also gives you a chance to register for the public meeting for those PLA codes, which is essentially a 15 minute version of a regular CPT editorial meeting.  (Between the applications and the CPT meeting, there is an internal meeting of a review group called PLA-TAG to which applicants may be invited for questions if needed.)

AMA has posted the applications for new or revised PLA codes, received October 7 earlier this month.

  • See the webpage  here and the PDF of applications here.

The BioFire is Out!

It's pretty interesting.  Biofire is deleting its FilmArray respiratory panel codes, possibly because they have been replaced by panels containing added COVID (that's only a guess, and they are deleting their RESP codes, not their GI codes.)  These are PLA codes 0098U, 0099U, 0100U.  

It's especially interesting because in CY2019 data, only four PLA codes out of well over 100 - the FMI tumor test, the Oncotype Prostate test, and two Biofire codes 0097U GI, 0099U Resp - had any significant usage (with a rapid dropoff, being in sequence paid: $78M, $20M, $3M, $2M).  Nearly all other PLA codes were essentially unused by CMS in CY2020, paying 0-$10,000.

New PLA Codes

There are only a handful of new code applicants this fall; in the past there have been as many as 20-30 in a single quarter.

The six new applications (see PDF linked at top) are Guardant G360CDx, PIGF pre eclampsia screen, a MAAA immunoassay, Onctype MAP, 257 genes, ThyGeNext Thyroid Oncogene Panel, Precision Blood (51 antigens by DNA), and PreTRM, an LC-MS preterm birth risk predictor MAAA.

Both Guardant and Foundation Medicine have recently approved (FDA PMA) CDx liquid biopsy tests, and both were Breakthrough Devices.  Foundation Medicine applied for a liquid biopsy oncogene test PLA code in a prior quarter.

click to enlarge


The descriptors posted by AMA for these new PLA codes are subject to edits by the PLA committee.  


The next regular CPT deadline is November 6, here.

Saturday, October 17, 2020

My Video About the New CMS Colorectal Liquid Biopsy NCD

Here's my video and deck about Medicare's October 16, 2020, announcement of an all-new approach to covering future liquid biopsy tests that screen for colorectal cancer.

The first six minutes explain what happened and why it's important.  For those who want a deep dive, the next ten minutes provide that.  The jump-point between the overview and the deep dive is clearly marked.

If you'd rather go straight to the deck alone, I provide the PowerPoint link below, as well as at the YouTube channel.

Video here:

Video also here:

A second version of video with better audio here:

See my October 16 breaking-news blog here.


On October 16, 2020, the Medicare agency proposed to cover FDA-approved blood tests to screen for colorectal cancer. No such tests are currently covered, but they would be covered in the future as they emerge from FDA approval and receive medical association endorsements. Comment period is open for 30 days. Below, I provide links to the original documents and my blog on the topic. This video covers the essentials in the first 3-4 minutes, and then takes a deep dive in the last ten minutes. NCD PROPOSAL: -- TRACKING SHEET (HOME PAGE) -- DRAFT PROPOSAL (COMMENT BOX AT TOP) MY BLOG http://www.discoveriesinhealthpolicy.... POWERPOINT USED IN THIS VIDEO

  Informal transcript

Friday, October 16, 2020

CMS Posts Administrator's Ruling That Creates $75 and $100 Tiers for COVID testing

On Thursday, October 15, CMS announced it would drop the price of COVID high throughput testing from $100 to $75, at the same time, that it will implement a performance bonus of $25 per test for a 48 hour turnaround.

See yesterday's posting here Seema Verma had flagged the changed in a September speech, without this level of detail.

Today, Friday, CMS released the actual 10-page legal document supporting the policy change.  It's Ruling 2020-1-R2.  See it here:

On the same day, October 16, WSJ ran a story on rapid mass testing by Broad Institute for numerous New England colleges.  The WSJ says that some labs provide COVID testing on a 4 day timeline for $100, while Broad provides testing in 18 hours for $25.   (That assumes coordinated mass testing programs in place, though, it's not one-off retail testing of any patient.)

On October, Reps. Sherrill, DelBene, Sewell introduced the "SPEEDY COVID-19 Tests Act" with payment tiers of +25% over CMS for <24 hours, standard pay to 48 hrs, and no pay after 72 hours. Here, here.


Collection to "Completed Test"

CMS clearly refers to a two calendar day turnaround from the time of specimen collection to the time of "completing the test."  I had a few calls from labs hoping the 48 hours was going to be from the time of lab receipt, not patient test.

Completed Test Means: Ready to Release

CMS defines a "completed test" as one that is complete and the report is "ready to be released."  Sounds like that has to occur by 11:59 pm on the third calendar day (e.g. Monday to Wednesday). 

Two Calendar Days

The policy refers both to "two calendar days" (not 48 hours).  I suspect a test taken at 8 am Monday and returned Wednesday is two calendar days, whether 8 am or 8 pm on Wednesday (but that's just a hunch).  I'm assuming that "two calendar days" does not mean a test taken Monday and reported Tuesday, which I would call "one calendar day."  

Don't Mess With Us and Wait Five Days by Batching

CMS strongly defends its reasoning in the Administrator's R2 ruling.  It notes that it priced  high throughput tests at $100, assuming they required high resources for fast turnaround.  CMS comments that some labs may have taken advantage of  the agency, and use economical limited resources and batching to produce tests at long delays of 3-6 days.  Continue doing that, and pay a financial penalty, says CMS.

Don't Just Push Part B to Front of Queue

CMS provides a rational for the "majority of cases in previous month" clause - a 51% rule - because it doesn't want labs to merely push Medicare Part B cases to the front of a queue and delay everyone else.  

Where is U0005?
In transmittal R1 last spring, CMS announced inside the Administrator's Transmittal the text of the new rapid codes U0003, U0004.  This new transmittal R2 does not seem to show us the text of the new code U0005, the $25 add-on payment.

Medicare FFS 
The program for $25 add-on payments applies only to Medicare fee for service.  Over a third of Medicare patients are in Medicare Advantage, half of patients in a few states.

Hospital Outpatient and ER
Normally, since about 2014, CMS has "bundled" or not paid separately most lab tests in the hospital outpatient and E.R. settings, including clinical chemistry and microbiology.  (Human genetic testing is paid separately).    However, CMS has specifically made COVID testing separately payable in the E.R. and hospital outpatient settings.

How Solid Are Administrator's Rulings?
Generally, CMS policy decisions and fee schedule changes must go through public comment (administrative rule making.)  I've heard it said that the positioning of these pop-up internally generated Administrator's Rulings is a little dubious under the Administrative Procedures Act, depending on the weight and content of the matter involved.

CMS sets up coverage for FDA colon cancer screening LBx tests - but proposes Epi proColon falls short

The Epigenomics Epi proColon test was the first liquid biopsy test to receive FDA approval, in April 2016 (here).  The test detects epigenomic DNA changes in the blood that are indicative of the patient having colon cancer, without the need for a fecal matter test or colonoscopy.   (Multiple companies such as Guardant, Exact, and others are now hoping for new tests with similar colon screening indications).

On January 28, 2020, CMS opened an NCD on the Epi proColon test (here).  The expected draft decision date was August 28, which CMS missed (here).

Meanwhile, this year, AHRQ is doing a broad evidence survey of liquid biopsy, presumably at the request of CMS (here).

Today, October 16, CMS released a response to Epigenomic's letter, a dramatic decision which will provide open ended coverage of FDA approved liquid biopsy colon cancer tests (or any blood-based biomarker) on a rolling basis, if they meet the criteria of 74% sensitivity and 90% specificity.  This proposed decision is big news, because it would mean rapid coverage for companies like Guardant and Exact and others with large FDA trials for liquid biopsy CRC screening tests underway.   However, the stated criteria (as a draft decision) leave the Epigenomics test non-covered.

On October 17, I posted a 15 minute deck and YouTube video about the NCD - here.

See Genomeweb coverage here.

On Monday, October 19, Exact Sciences was up +4%, Guardant Health up +2%, but both within their 5-day trading range.

The back story and links

On October 16, 2020, CMS released a proposed non-coverage decision on the Epi proColon test.

Tracking sheet here:

Request letter from company, April 2019:

(Note it was almost a year from the request to the opening).

The proposed position, with comment to November 15, is here:

It's an Interesting Decision

The decision is important for several reasons:

  • The decision sets out that in the future, similar LBx tests WILL be covered, if they have an FDA marketing authorization for CRC screening, AND
  • The test has sensitivity of 74% or better and specificity of 90% or better, against a colonoscopy gold standard, AND
  • The test is recommended by USPSTF or one major professional society guideline.
CMS likely chose 90%/74% because it's about the statistics achieved by a standard of care, the FIT test (here).  It's the performance expected by FDA for a first-line blood screening test that would substitute for FIT with similar performance.  

My reading? This is probably a big win for companies like Guardant if there test meets the 90%/74% rules provided in the NCD.  These are draft guideposts, and could change in the final NCD.

After the November 15 comment period, a final decision is expected by January 14.

I've clipped the full rules below the break.

A Nerd Note - That Really Matters  

There is a nuance here - generally, CMS NCDs have authority to cover screening tests AFTER they receive an A/B rating from USPSTF, and go through the additional later NCD process.  For example, a pancreatic cancer screening test.

There is a special clause in Medicare's statue that CMS can produce an NCD directly (without USPSTF) if the test is for screening prostate or colon cancer.  

A Signal How to Fix the Medicare Statute

I think this provides a good argument that Congress can drop the requirement that CMS coverage decisions for preventive tests can take place only after USPSTF approval (outside of colon and prostate tests).   

Here's why.  CMS has had the authority to make NCDs for preventive colon and prostate tests for twenty years, and has used that authority very cautiously and carefully.   CMS can also make similarly prudent, cautious and careful coverage for possible future FDA approved ovarian, pancreatic, or other tests, without waiting an unknown 2 or 5 or 8 years for such a test to be taken up by an underfunded and very slow USPSTF process.

CMS Oddity: CMS Issues Notice, No National Decision, Only LCD's, for ALLOMAP test.

CareDx is one of the leading genomics companies, with a market cap today of $2.5B (here).  Their pioneering product, covered by CMS since about 2008, was the ALLOMAP test, a test of WBC activation that can help manage heart transplant recipients.  More recently, CareDx has had a major achievement in the commercialization of the AlloSure test, which detects DNA secreted from damaged graft kidneys and helps manage renal transplant rejection.

In a proposed decision memorandum released today, October 16, 2020, CMS announces it plans NOT to do an NCD on the Allomap test.  CMS remarks in the procedural history, that an NCD had been requested in January 2013 (!) from Marc Halushka, Johns Hopkins.  

CMS concludes that 

We believe the proposed decision to continue to allow MACs to determine coverage of AlloMap® Molecular Expression Testing for Detection of Rejection of Cardiac Allografts is clinically appropriate and in the best interest of beneficiaries....due to the very low number of tests, which are used by << 1 percent of the Medicare population, and the need for careful patient selection, CMS believes that coverage of AlloMap is an appropriate determination made by the Medicare Administrative Contractors (MACs).  The MACs are structured to be able to take into account local patient, clinician and institutional factors, which are important when the overall prevalence is low.

CMS proposes this position as a public comment period for 30 days.

See decision here: 


Note the "comment" box in the header above.

See the tracking sheet here:

The PDF of the 2013 request letter (84pp with attachments) is online here:

Very, Very Nerdy Note: CMS Again Updates Proposed CLFS Prices for CY2021 (V4)


CMS holds public meetings each summer to price 100+ new lab codes for the coming calendar year.  CMS released proposed prices about September 22 with a comment period to October 21.   CMS has slightly updated this spreadsheet several times, most recently to "Version 4."  

If you want to be completely up to date, go to the CMS lab page here and look for Payment Determinations header and then for the zip file for CY 2021 - Clinical Laboratory Fee Schedule Test Codes Preliminary Payment Determinations (ver. 4) (ZIP).

Or Ver 5, if there is one....Tab B provides edits or corrections, there are now about 12, for example, code 81XX1 was granted ADLT status so it's being removed from the crosswalk decisions.

For example, there was a series of codes where public comment AND panel recommended crosswalk to 81315, but the CMS initial recommendation was to crosswalk the set of codes successively to 81315, then 81316, then 81317, then 81318.  It's now corrected so each crosswalk to the same and correct code 81315.

Thursday, October 15, 2020

CMS to Reprice COVID Testing: $75 for Slow High Throughput, $100 for Fast High Throughput



Initially this year, CMS paid $51 for COVID testing.   In April, CMS announced high-throughput codes that would be priced higher, at $100, to encourage investment, development, and rapid expansion of test resources.   This $100 price was announced via an Administrator's Ruling on April 14 - here.

On October 15, CMS announced a new policy that will pay $100 only for two-day turnaround of results.  Otherwise, even high-throughput testing will be discounted to $75 beginning January 1.

CMS made the announcement in a press release - here.   

  • CMS watchers will recall that Seema Verma flagged that some major change in COVID pricing was coming in a speech one month ago, on September 17 (news report here).

On Friday, CMS also posted the actual 10 page ruling - here.  This refers multiple times to 2 days time, relative to the specimen being COLLECTED (not accessioned at the lab door, as some labs hoped).

CMS argues that the full $100 payment for intensive resources and staff are only applicable in a lab that is resourcing fully for 48 hours turnarounds.

CMS estimates that the costs ($100) associated with high throughput technology, hiring staff, and other resource costs, are only incurred when laboratories complete the majority of molecular genomic CDLTs that make use of high throughput technology for the detection of SARS–CoV–2 or diagnosis of the virus that causes COVID-19 within 2 calendar days of specimen collection for all patients, not just for a subset of patients. 

According to the press release, the upcoming R2 will leave the existing codes intact, reduce the $100 price to $75, and create a new code U0005 for a $25 supplement.

In an interesting twist, while the CMS payment will apply only to Medicare payments, the payment of $25 will be given for Medicare patient IF the lab had two day turnaround time on "THE MAJORITY OF ALL" of its COVID testing in the previous month.  This seems to be written as an "AND" clause, see quote below, so the test for a certain Medicare patient this month must be in two days, AND ALSO, the tests for all patients in the previous month must (in the majority) be made in two days.  However, I'm not sure that the syntax, which is repeated after the (a)/(b) statement, is perfectly clear.   Clipped below. 

Not that this applies only to Medicare FFS patients (Traditional Part B); some experts think that in a few years this will only be half of Medicare patients, the rest being under Medicare Advantage. 


CMS writes,

"Starting January 1, 2021, the amended Administrative Ruling (CMS 2020-1-R2) will lower the base payment amount for COVID-19 diagnostic tests run on high-throughput technology to $75 in accordance with CMS’s assessment of the resources needed to perform those tests. Also starting January 1, 2021, Medicare will make an additional $25 add-on payment to laboratories for a COVID-19 diagnostic test run on high throughput technology if the laboratory: 
a) completes the test in two calendar days or less, and 
b) completes the majority of their COVID-19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients (not just their Medicare patients) in the previous month. 
Laboratories that complete a majority of COVID-19 diagnostic tests run on high throughput technology within two days will be paid $100 per test by Medicare, while laboratories that take longer will receive $75 per test."  


Wednesday, October 14, 2020

Medicare's Unorthodox Spending on Code 81408 in CY2019: 80% in Red States

81408 Isn't Just a Code, It's the HIGHEST PAID Genetic Code

81408 isn't just any CPT code, it's the highest-paid genomic code in 2019 (here).  Growth exploded, in round numbers, from $5M in 2017, to $100M in 2018, to $300M in 2019.   Everything about this story is bizarre.

80% of the 2019 payments for 81408 go to 2016's red states, and 100% of the 2019 payments go to red states plus NJ and DC, which are served by a MAC in an adjacent 2016 red state.


The Bizarre Explosion of 81408 Billing

I've previously reported that Medicare's overall molecular pathology spending has been rising dynamically, from about $500M in 2017 to about $1B in 2018 to about $1.7B in 2019.   See previous blogs, one focused on 81408 spending as a whole (here), one focused on the spending being 99% from Novitas and FCSO MACs (here), including data on who in particular billed that code in the most recent year with NPI-level data, which is 2017 (here).   

Early billing on 81408 in CY017 is associated with DOJ genetics fraud press releases and news stories in 2019.  

81408 in Medicare is ALWAYS Highly Anomalous

81408 is what AMA calls a "tier 2 level 9" code which holds a grab-bag of genes studied by full sequencing whose use is by definition rare, and often for obscure fatal pediatric disorders.

As I've discussed earlier, payments for 81408 are de facto extremely anomalous, because nationwide Medicare payments were almost zero in 2017 and earlier, and because later payments occur only in two MACs, which have policies that explicitly have no edits for 81408.  

In the other five MACs, 81408 is nonpayable as not medically necessary.  Said differently, the highest-paid CPT code in 2019, 81408, is medically nonpayable in 5 of 7 MACs.  

81408 Paid Mostly in RED States in 2019

A new data analysis today shows that 81408 in CY2019 was paid 78.5%, almost 80%, in RED states.

A few more findings.  

In Blue states, payment, if any went to NJ & DC.

First, while around 20% of 81408 payments were in blue states, it was highly focused, and never occurred in either NGS MAC or MOLDX MACs.   

Said differently, 19/21 blue states got ZERO payments for 81408.

Nearly 100% of the spending on 81408 in BLUE states was in either D.C. or in New Jersey, two (2016) blue states whose payment policies are governed by the Novitas MAC, which is in Pennsylvania, a 2016 red state.   

CMS MUE Edits for 81408 - OMG

Second, CMS medically unlikely edits are in place to help stem fraud, and provide no more than units of 1 for most genetic tests, but allow TWO UNITS PER DAY of 81408.   Again, absolutely unbelievable data. (I almost wrote, un-effing-believable.)

Why hasn't CMS released missing May 2020 date on CY2018 payments?

Third, and finally, in a departure from official policy, CMS has declined to release CY2018 payment data by NPI and CPT code, which it should have released in May 2020.  See blog on this topic here and see background here including my correspondence with CMS this fall.   

Since CMS isn't releasing the 2019 NPI/CPT data on the standard CMS website for this data, I've separately put in my own FOIA request this week, here.

Note that this data (NPI/CPT) should be released annually by CMS in May.  It's not ad hoc.  It reflects official policy positions of CMS (see here and see Federal Register, 79FR3205, January 14, 2014 here.)

Helping Voters Decide 

If 2018 data were released by CMS, as would normally happen last May, stakeholders could see ahead of the election whether recipients of the anomalous payments were also big political donors.


I note that 2019 81408 payments were 78% in red states.  

Obviously, in 2016 there were more red states, with an electoral count, roughly reflecting population, of 57%.  

However, as to the circa 44% population in blue states, who got 20% of 81408 billings, 100% of that went to only two places, NJ and DC, under the Novitas MAC.  19 of 21 Blue states, including New York, Illinois, and California,  had exactly 0% of the 81408 gravy train.  Which, as far as we know, may be as fast or faster in 2020 as it was in 2019.

Monday, October 12, 2020

Reimbursement is not Inherently Dangerous, but Unforgiving of Neglect

This morning I had the chance to do a 45 minute interview on diagnostics and payers for a class being held at ASU in its diagnostics policy center.   

Both the interviewer, Pierre Casseigneul (founding CEO of CareDx) and I have pilot's licenses, though mine's been inactive for quite a while.   

The discussion reminded me of a plaque I've had for decades:  Aviation is not inherently dangerous, but it's terribly unforgiving of any carelessness, incapacity, or neglect.

Like aviation, health-tech reimbursement is partly intuitive but our health system is overlaid with very complex, unavoidable, and arcane rules that take a long time to master.   And they are unforgiving of neglect.

And any major mistake can trap a company very fast.  

  • For example, a company might start with $500,000 in angel funds and only learn a year later, after much invested time and late nights, when seeking Series A funds, that its inpatient product is bundled to a hospital inpatient DRG and will be nearly impossible to sell or to get further funding.  
  • Or a scientist founder may have no grasp at all of the cost and time and effort to obtain "share of mind" with doctors and become a standard of care.  

But like aviation, when everything goes right, it can be thrilling!

Friday, October 9, 2020

Very Brief Blog: Startup with Tiny Handheld Raises $60M, Gets FDA EUA, Raises Extra $10M from NIH RADx

Visby Medical, a team I was able to help in their early planning phases for commercialization a couple years ago, has had a run of good news this year.  Their product is a tiny molecular testing POCT handheld device. See my September note here.

In April, early in the COVID epidemic, the Stanford spinout raised $70M.   In September, they got an FDA EUA for their highly innovative device.   In October, they announced an additional $10M from the NIH RADx tech investment fund.

See latest announcement here.

Very Brief Blog: Medicare Genetic Testing, $117M Indictment

DOJ announces an indictment for "bribes and kickbacks leading to improper billing" - $117M against the owner of "Specialty Drug Testing LLC" in Monroe, Alabama.

DOJ here.   Local news story here.

Easy Internet Research - Will CMS Release 2018 Data?

In the past several weeks, I've run a series of articles showing that a lot of Medicare fraud - in the many hundreds of millions of dollars - can easily be gleaned from available CY2019 data at the state and national level.   This can be tied to specific CPT codes and specific edits (or lack of edits) at a minority of CMS MACs.   DOJ has estimated the fraudulent charges in the last year or two, on genetic codes alone, exceeded $2 billion dollars.  This creates large anomalies in the public CMS data.  

The DOJ press release we're discussing today gives the lab here as Specialty Drug Testing LLC.  A quick google search gives the NPI as being 1639577091.  (Here.)   Then turn to the Physician (Lab) Utilization Database at CMS, which is currently updated through 2017.  (2018 data should have been released in 6/2020).   There, go to CY2017 and search on the NPI number.  

This gives you all paid claims by CPT code and dollar amount for Specialty Drug Testing LLC from CY2017.  The 2017 claims were modest, only $864,426 in total.  The spectrum of 2017 claims was as follows (click to enlarge):

Whatever resulted in $117M of charges found by the DOJ by 2020, it clearly occurred after CY2017.

Where is CMS CY2018 Data?

CMS normally releases provider/calendar year claims paid data on an 18 month delay - e.g. June 2019 for CY2017, and June 2020 for CY2018.  CY2018 data has not been released yet (here).  

CMS data staff are vague as to the cause of the delay (see prior link and here).   

In addition, I've had a personal encounter with a MAC declining to release typically available data, and a client has had a MAC state that no FOIA data was available on a topic that HAS to have FOIA data available.   So:  Is a picture emerging that CMS cracking down on release of FOIA data in the weeks before an election?   You decide.

If so, CMS would be backtracking on publicly made policy decisions from 2014/2014 following FOIA-based court cases (here)(cloud copy here).

Wednesday, October 7, 2020

Legislators Attack HHS Decision on LDTs, FDA Stops EUA Review for LDT Tests

In mid-August, HHS abruptly announced that FDA was blocked (by HHS) from reviewing LDTs.  (See entry point and links here).

Letters from House to HHS

On October 7, several legislators in the House released a public condemnation of this decision, via a press release and via a public letter to HHS Secretary Alex Azar.  See the six-page public letter here.   The press release is clipped below the break.

More: FDA Stops EUA Review for Local LDTs

Also on October 7, FDA announced that it would not review LDTs for COVID EUA status - here.  

This latter FDA move is important because some COVID testing laws for commercial insurers and payments depend on whether tests have been FDA-reviewed (e.g. cleared, approved, or EUA).  See page 3-4 at this HHS PDF here

Regarding FDA stopping LDT review for EUAs, articles here and here.  It's been suggested that FDA wants to prioritize review of POCT and high-throughput IVD tests, rather than local LDT tests. "To make the best use of our resources for the greatest public health benefit, FDA is declining to review EUA requests for LDTs at this time," stated OIVD director Tim Stenzl.  "We are currently in a different phase of the pandemic with respect to tests than we were previously," he added.

Back Story: HHS Memo to End LDT Review

The House letter cites an October 2 Politico story that revealed a 17-page legal memo drafted at HHS that undercut FDA's arguments it had statutory authority to review LDTs in the first place.  Politico here, PDF of memo released here.  (24 mb).  The legal memo dates to June 22.  It amounts to a master class in FDA history regarding LDTs, written toward the endpoint that FDA can't regulate LDTs.  

There is also a "two-pager" FAQ at HHS about the recent changes in FDA and LDT policy (here).  The FAQ notes (its last question)  that FDA review is required to get certain legal benefits for COVID tests.


I've bundled some key documents in one zip file in the cloud, here.

Brief Blog: Comparing Medicare Molecular Pathology Spending in the Non-MOLDX States

As recently as CY2017, Medicare Part B spending on molecular pathology told a fairly simple story: Most of it was in the MolDx states.  

  • As recently as CY2017, about 70% of MoPath spending was in MolDx states, rising closer to 90% if one excluded one line item, the spending for Cologuard (in Wisconsin, a non-MolDx state).

By CY2019, the picture had changed drastically.   MolDx states garnered only 35% of MoPath spending, the 70% of spending going to NGS MAC, Novitas, and FCSO MAC.   

However, it quickly becomes evident that Novitas/FCSO spending is highly anomalous, with very suspicious (?fraudulent) spending becoming dominant - here.

Spending in Non-MolDx MACs

There are three non-MolDx MACs, NGS MAC, Novitas, FCSO.   NGS MAC has Jurisdictions J6, JK, with 7,047,841 beneficiaries in 2019 per CMS dataNovitas has JH and JL jurisdictions, with 9,188,988 beneficiaries.  FCSO has 2,604,216 beneficiaries in Florida (JN).


NGS MAC spending on MoPath codes in CY2019 was $349,404,055, or $49.58 per beneficiary.  However, this includes $79.5M on FMI F1 CDx test, governed by an NCD, and $243M for Cologuard test, governed by an NCD.  If you leave out just those two line items, NGS MAC spending on MoPath drops to $27.0M, or $3.83 per beneficiary.

Novitas, FCSO MACs

Spending on MoPath in CY2019 at Novitas was $528,842,240, or $57.55 per beneficiary.  Spending at FCSO MAC in CY2019 was $123,653,432, or $47.48 per beneficiary.   I noted previously that spending year-on-year in some Novitas/FCSO states like Florida and Oklahoma rose as much as 7X.


We can do the same data analysis for 28 states in the MolDx consortium (WPS, Noridian, CGS, Palmetto), although the data is harder to interpret since so many national labs bill in MolDx states, especially California.  (You can't really segregate local vs national lab spending in MolDx, but in NGS MAC, you can segregate local and national spending by just removing FMI and Cologuard).  

Birds-eye view, there are 19.1M beneficiaries in MolDx states, and CY2019 MoPath spending of about $570M, or about $29.80 per beneficiary.  That's about half of the per-beneficiary spending (even including MolDx's national labs) as FCSO and Novitas.


National spending on Part B beneficiaries was about $1.7B in CY2019, as I've reported in the past couple weeks, although that's misleading because there are hundreds of millions of dollars of fraudulent spending mixed up in it (see DOJ program "Operation Double Helix" in 2018/2019).   There are about 40M FFS beneficiaries, so the average spend per bene was $40.