Monday, December 11, 2017

Very Brief Blog: LInk to December 11, 2017 ACLA lawsuit against CMS over PAMA (33p)

ACLA sued CMS over PAMA rules and changes in the lab fee schedule.   A link to the PDF lawsuit is here.

The corresponding press article at Reuters is here.   The ACLA press release is here.

The case has been written by Mark Polston of King & Spalding LLP in Washington.

Congress required CMS to collect private payment payer rates from laboratories which receive "the majority of its revenues under the Medicare program from the CLFS or the PFS."  CMS also interpreted that it had authority to set rational size limits for reporting laboratories (e.g. excluding a physician office lab that reporting 25 urinalysis to CMS a year).

Reverse Engineering CMS's Position, Unpleasant Though It Seems

CMS bundles the payments for all DRG inpatients and the vast majority of the lab test payments or allocated budget for hospital outpatients as well.   So none of those CMS payments are from "CLFS or PFS."   CMS probably felt that figuring out the "majority of payments rule" for a lab administratively embedded within a hospital would be very difficult (some mix of CMS payments - completely unspecified and unpriced - for inpatients and outpatients, and then also, CLFS or PFS revenue for reference lab activities.)   Perhaps throwing out the baby with the bathwater, CMS ruled that applicable reporting labs had to be those that were, already, receiving or reporting all CMS payments under their own NPI.   This left a set of ... almost nobody.    However, it's easy for CMS to say exactly what proportion of payments such labs get from CLFS if it's based on an NPI: CMS can just look up its own computer NPI records.  (Actually, it might not be that easy, because the lab might have its own NPI, bill CMS for reference lab tests, yet the "same lab" also get some revenue from a hospital cost center through internal financial transfers for running some tests on inpatients, AKA Medicare origin revenue). 

Very Brief Blog: Trade Journals on 2017 Changes in 14 Day Rule

Two trade journals have discussed the CMS 14 Day Rule scheduled to become effective on 1/1/2018.

There was a story in the recently created web news agency AXIOS, here.  It actually appeared in mid July 2017.   Note this Axios article links to a 16p cloud deck used in May to successfully explain the problem to CMS.

The news website DARK DAILY follow up with an extension of the storyline, on December 11, here.

image as seen in DARK DAILY article (see link in text)
I believe there is at least one major error in the TEXT of the rulemaking, which I discussed in a prior blog.   The new regulation and the basic concept of the rulemaking is to have Medicare "molecular pathology tests" - which they have been defining in practice for several years as human DNA RNA tests - be billable by the "performing lab," whether that be the hospital or an outside lab.   However, the body of the rulemaking discussion says that this change in billing excludes "genomic sequencing procedures" which makes no sense, and excludes PLA codes, which of course may be genomic sequencing procedures, tests of human DNA, and so on.   I  try to tell the story in a 4 slide online deck PDF, here, and the summary or finale slide is this:


For nerds, I discuss the communications methods used in the CMS deck obtained via AXIOS, here.

Sunday, December 10, 2017

CMS Code Edits for CY2018 Block Use of BRCA Code 81211 At Same Time as BRCA Code 81213

Each quarter, CMS updates its "Correct Coding Initiative" edits, typically with a larger update for each new calendar year.

CMS has released its Procedure to Procedure Edits for lab codes for CY2018, available at the CMS CCI website, here.

  • CMS has changed the edits to block joint use of BRCA Sequencing (81211) and the add-on or stacked code 81213 (BRCA dup del analysis).   CMS has altered the rationale to "HCPCS/CPT procedure code definition."   
  • I believe the underlying rationale has to be that if you do BOTH, BRCA sequencing and BRCA full dup-del analysis, they are replaced by the comprehensive AMA CPT code 81162, which is for full BRCA sequencing with full Dup Del analysis as one code.   

This has important fiscal implications for CMS, because under PAMA, the price for the code stack (81211+81213) rises (to about $2900 total) but the price for 81162 as a comprehensive code falls steadily.

81162 will pay $2253 in 2018, and $2018 in 2019, and $1825 in 2020.

Fiscal Impact for CMS

For example, at 20,000 BRCA cases per year, for CY2020 CMS would have paid $58M at the code stack rate; but only $36M at the comprehensive code rate, an instant savings of $21M.  Private insurers may follow CMS edits like this, but are not required to.

Screen shot from the 2018 CMS edit instruction:

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Manual for 2018 Available

The CMS CCI staff also released a manual of instructions (in PDF text form) in December, available online here.  See the link at bottom of the CMS webpage for NCCI Policy Manual (zip file of PDF chanters).

The "1" modifier in the table means that the edit can, or could, be overridden, but CMS manual instructions state only to allow that in uncommon circumstances where a special circumstance is justified by review of the medical record.

Note that CPT code 81432 (BRCA panel sequencing) is NOT blocked against 81433 (BRCA panel Dup Del) because there is no single code that represents the services 81432+81433.  

Friday, December 8, 2017

The Foundation Medicine NGS NCD: Did CMS Accidentally Roll Over Leukemia and Liquid Biopsy?

On November 30, 2017, CMS released a detailed and complex NCD that originated in a Parallel Review assessment of the newly FDA approved Foundation Medicine CDX test based on paraffin block analysis in solid tumors (here).

The NCD, which is under comment until December 29, provides coverage for PMA-approved NGS tests as long as they are used in a patient with an on-label cancer for that test.  It covers the Foundation One PMA CDx test, as well as other PMA-approved NGS tests like the Thermo Fisher OncoMine Target Dx tests.  Tests are defined as covered now and on a rolling basis in the future.

However, the NCD states that it governs use of testing in all advanced cancers when NGS testing is used.   The NCD doesn't mention differences between solid tumors paraffin based tests and liquid biopsy based tests, and it doesn't call out any differences for tests in hematopoeitic cancers (leukemia/lymphoma.)  The NCD would have unexpected results for patients needing a liquid biopsy test under NCCN guidelines, for all patients who have leukemias or lymphomas, and for all Medicare patients with have cancers outside the top 4 or 5 like lung and colon.  (Medicare Advantage patients could get medically necessary tests in these categories, but no available coverage would be possible for patients in Traditional Medicare.)  The NCD works differently for each group, as presented below.


Here is an overview of the landscape.  (FIGURE 1).   Working from the bottom of the chart upwards, there are solid cancers, and hematopoeitic cancers.   Solid tumors can be assessed with paraffin block tissue; or NCCN recommends oncologist consider liquid biopsy when solid tissue isn't available.   Testing has progressed from single gene tests (e.g. BCR ABL alone) to multiple gene separate tests to gene panel tests.   NCCN guidelines cover all of this, and there are pretty tightly written LCDs.   Overall usage of gene panel codes is not high, about 1000-3000 uses for codes 81445, 81450, 81455 in Medicare data for 2016.  This indicates that LCD controls are tight.  As FIGURE 1 shows, in the upper left, the chart culminates in 2017 with the FDA approval for several paraffin block based, solid tumor NGS tests.

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AFTER the FDA had issued PMAs for several paraffin block test, and in coordination with the FDA, CMS created the NCD, as shown in FIGURE 2.

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So far so good.

The tricky part is, CMS waited until there were several paraffin NGS panel tests on the market before releasing the NCD.   But the NCD provides coverage ONLY for PMA approved tests, and the FDA' library of PMA-approved tests is currently very incomplete compared to the wide range of major human cancers.   Over half of cancers have no PMA approved CDx, immediately shunting hundreds of thousands of patients into complex and very costly "CED" immediately, on the day the NCD is finalized.


Yikes.  There aren't yet any PMA approved NGS panel tests for hematopoietic tumors, or for liquid biopsy in refractory scenarios in solid tumors, or for over half of the incident U.S. cancers (pancreatic, leukemia, lymphoma, kidney, etc).  So we get FIGURE 3:

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The text of the NCD provides de facto coverage only for paraffin tumor block NGS tests used in a small number of solid tumors, because these are the only type of PMA tests approved by FDA so far

Wait, what about the CED coverage in the NCD?   

CMS provides back-up coverage by allowing Coverage with Evidence Development (CED) clinical trials for gene panel tests, if they have NYS and FDA 510(k) clearance.  But there are still two big problems, big enough to make this channel essentially impossible.

Problem 1:  Many gene panel tests are NYS approved, but FDA hasn't even created a 510(k) pathway for leukemia, or lymphoma, or liquid biopsy tests.  Nor has FDA approved any tests in these several broad categories.  That's a pretty big problem.  These are the entry points for the CED channel, and they're not even opened yet. 

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In the preceding pie chart, I estimated incidence of advance cancers based on NCI death rates; mapped the cancers with at least one PMA NGS CDx gene (green); categorized other solid tumors as CED (red); allow about 5% for solid tumor liquid biopsy per guidelines (pink); and separately show the population for leukemia/lymphoma (maroon).   The total pie chart in the US represents 450,000 advanced cancers (deaths); as a rule of thumb you could estimate 1/2 of that is the Medicare, >65 population.  So far circa 100,000 Medicare patients, the NCD covers the $3000 NGS test; for the rest of the circa 100,000 patients, it would cover the $3000 FMI NGS test off label but require ?$10,000 or $20,000 of CED as well.  If it was all paid for, it would be 100,000 PMA NGS patients for $300M (green slice), and circa 100,000 off label CED patients at a similar $300M for testing and perhaps 100,000 x $10,000 or $1B for CED.

Problem 2:  In addition, in all practical terms, CED trials for 510(k) gene panels tests and off label PMA tests will be impossible as proposed.

The most severe issue is that the CED requires RECIST testing (special whole body imaging tests, typically conducted monthly) in order to have accurate ORR and PFS data.  This could mean monthly, $1000 scans surveillance imaging (MRI or CT) - $12,000 in the first year.  Obviously, a lab can't spend $10,000-20,000 on CED research in return for the patient's Medicare payment of $600-$2900 test.  It's a non starter.[*]   This concern - that CED is impossibly costly - also applies directly to all the Medicare cancer patients who are unlucky enough to have each and all of the many solid tumors that aren't approved at the PMA level on Foundation's test.
Cost of Proposed CED?  I peg the cost of the CED section of the NCD at two billion dollars. NCI lists about 450,000 patients dying each year of the 13 major cancers.  Of these, about 250,000 have NGS CDx tests (lung, colon, etc).  About 200,000 do not.   If half of these advanced cancer patients are Medicare patients, it's 100,000.  If the CED with monthly RECIST studies costs $20,000 per year, the cost of the CED research would be  $2B annually.   See my table based on NCI data, here.  
An additional problem, for Medicare patients with leukemia, is that the CED is written to require mandatory RECIST testing, which is impossible for these patients.  Dr. Gottlieb of the FDA strongly supported the NCD in testimony on the Hill on December 7; but today if he was a Medicare patient and had a relapse of his lymphoma or a recurrence as leukemia, he couldn't get any genomic testing.  So either CMS envisions no genetic testing in leukemias, or, would have to admit to substantially mis-writing the basic scope of the NCD and/or major high level requirements of the CED, despite the NCD being the result of a 2-year process.

CMS should defer imposing either [non coverage or $20,000 CED registries] on cancer patients before there are at least several PMA approved test for that patient's category of cancer.  

Issues of quality are over-rated in the NCD.   Recall that FDA now equates NYS approval with FDA clearance and clinical use of tests (e.g. the MSKCC IMPACT test was cleared in this new pathway).  And tests like Foundation One are essentially the same before and after the FDA approval.  And all cancer patients in Europe, Canada, Japan, Australia are getting NGS testing without FDA PMA approval.   And the FDA has regularly approved major on-label drugs on a rolling basis (based on KRAS, ROS1, MSI testing) ahead of the existence of any PMA approved test, suggesting the FDA isn't as concerned as CMS is.  Concern about test quality has a place, but doesn't need to be directed against presently NYS and CAP approved tests that are in NCCN guidelines and are in pipelines for FDA approval.  (CMS also seems to conflate the medical necessity of gene-drug pairs that have been FDA endorsed, like ALK-Xalkori, with the function of analytically accurate tests for the same gene).  For broad categories of patients that have no PMA-approved gene panel test, in the short term, over the couple of years, LCD coverage has already proved to be stringent and frugal and it will be enough to control overuse.

Note on Process.  NCD clearly directly only to solid tumors in its body.  CMS didn't justify "non coverage" in these additional cancer areas (shown in red).  CMS studied the NGS literature in paraffin tissue from solid tumors, using Pubmed search keywords like "lung cancer" or "melanoma" (not leukemia or lymphoma) and assisted by Foundation Medicine publications on its paraffin based test use in solid cancers.

Also, as mentioned above, CMS demands that all patients in CED must have RECIST studies, which makes no sense in leukemia patients, and suggests the NCD authors were not actually thinking of applying the NCD to leukemia/lymphoma.  This implies that CMS may have miswritten the legal scope of the NCD (all cancers) relative to the available body of facts and research inside it (some cancers).

Another Note on Process.  NCD predicated on today's 510(k) & PMA terminology, while FDA is racing ahead to other concepts.  The NCD is based on the current 510(k) and PMA processes.  These have been changing substantially; for years, FDA refused to give 510(k) approval based on accuracy of genetic testing in CDx tests, and then it opened the 510(k) pathway in cancer for analytically accurate tests with NYS approval in November.   The FDA is also opening up important non-PMA, non-510(k) pathways for germline human genetic tests, such as for hereditary recessive genes, an enormous change in policy based  fundamentally on the accuracy of modern NGS testing and sequencing (82 Fed Reg 51560, 51563, 51567, links here).  The NCD doesn't contemplate these recent FDA publications.  In addition, if Congress passed a new diagnostics law, it would create terminology and approval categories other than PMA and 510(k) for diagnostics, which the NCD doesn't contemplate.

A final note on Access and Process.   CED Channel is Burdensome, but FDA itself approves drugs ahead of their CDx tests. Sometimes by a couple years.   The NCD has only a VERY burdensome CED channel, and it's available only to 510(k) or PMA approved tests, but is triggered whenever a cancer is off label (e.g. outside the top 4 cancers).  However, on a regular basis, FDA has released drug approvals ahead of any PMA test.  For example, there was approval for use of KRAS testing a full couple years before a PMA KRAS drug.  There was approval for ROS1 drugs long before  a PMA ROS1 test (the Oncomine test in June 2017).   There is currently approval, right now, for MSI based drug use for Keytruda, but no PMA test.  (MSI is in the FMI test, but it's not PMA CDx).  All of these categories of gene-drug get shunted into burdensome or impossible CED if and when the FDA drug approval precedes the PMA test approval by a year or two.   Another example of problems in this category would be the discovery of important genes that act on the effectiveness of generic drugs, or limit the optimal population for an existing drug.  These aren't going to be funded and researched by wealthy biopharmas and will never reach on-label PMA gene tests, no matter how strong the evidence and how wide the use.   No one is going to spend $50M out of their pocket getting FDA PMA approval for a generic gene on a generic drug.

[*] Technically, CMS can cover $20,000 in RECIST research costs or other costs implied by the rigorous CED.  Congress gives CMS carte blanche to cover costs related to research that furthers any purposes of AHRQ (which is to study and improve the health of the US population).  If it's $20,000 per CED cancer patient x 100,000 patients, that's $2 billion.  I don't believe CMS has ever attempted to cover research costs in CED rather than only medical costs, but CMS can pay for costs that are not medically necessary but are necessary for AHRQ research.

AMA Has Pre-Posted Lab Codes for Feb CPT Meeting; Will Post All Codes Posted December 8 for Comment

AMA  posts a universal calendar of key dates for upcoming CPT meetings (here).  For the February 8-10, 2018, meeting, all code titles will be posted on December 8 for a brief public comment period.

Look for "next-meeting-specific" PDFs and links, posted and updated by AMA on a rolling basis, here.

In addition, the Pathology application titles are posted even earlier, December 1.  These have an early comment period til December 8, I believe to facilitate December subcommittee meetings for lab codes.   Here.   However, I believe that despite this early December 1-8 cycle, the Path Codes are also included in the universal comment cycle that begins when all codes are posted together for comment on December 8.

The lab specific early posting (which may get updated)  calendars tabs 13-21 for lab codes.   These include (13) BRCA coding, (14) NUDT15 tier 1 gene, (15) SMN1-SMN2 set of 3 codes, (16) TERT Tier 1 gene for glioblastoma, (17) Tier 1 status for over a dozen triple repeat disorders being moved from Tier 2 to Tier 1, (18) a MAAA for bladder cancer recurrence, (19) a MAAA for bladder cancer risk, (20) a MAAA for thyroid cancer risk, (21) finally a dyhydrotestorerone chemistry test described as "reinstate code 82651."

The purpose of posting agendas and code titles is to allow public stakeholders to request copies of the CPT applications and submit comments.  However, the comment periods are short.

Thursday, December 7, 2017

Very Brief Blog: Speaking at MEDCITY / INVEST2018 (May 1, Chicago)

Agenda just posted for the MEDCITY - INVEST2018 conference in Chicago, May 1-2.

Overview of the conference in a MedCityNews article here.  Agenda for the conference here.   Clip of my session title and agenda, below.

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Show me the Money: How Investors Are Seeking Robust Reimbursement

A well-thought out regulatory pathway alone cannot win venture capital dollars. More and more, VCs are requiring entrepreneurs articulate the business model and reimbursement plan for their novel idea. Hear from experts about how startups need to develop their health economics chops.

Bruce Quinn, M.D., Ph.D., 
Principal, Bruce Quinn Associates LLC, 
Senior Strategic Advisor, Faegre Baker Daniels

FDA issues Major New Digital Guidances, Like Clinical Decision Support

On December 7, 2017, FDA issued three new guidances on digital health topics.

The guidances include two in draft, one final, and follow naturally from recent initiatives such as the "Digital Health Innovation Action Plan" *8pp) of the FDA.   Guidances today include:
  • Clinical and Patient Decision Support Software (draft)
  • Policy Changes per 21st Century Cures Act (draft)
  • Software as a Medical Device (final)
For full information and links, see the FDA's heavily hotlinked press announcement, here.  I've also put the 3 guidances and the Innovation Action Plan in one open acess cloud zip file, here.

Coverage at Fierce Healthcare, here. RAPS here.

The FDA has also announced a two day workshop (January 30-31, 2018) on its software precertification program.  Note that, Dr. Gottlieb has previously flagged the precertification program may be increasingly applicable to diagnostics at some future point.

Extra credit assignment; See Bradley Merrill Thompson's detailed multi page (web) essay on CDS history at FDA, here.  Although undated, I believe from internal references it may cover until 2012, e.g. "there will be changes in 2012."  It's a reminder that the issues in play in today's guidances have percolated many years.

See also links about the recently formed "Digital Therapeutic Alliance," here.

Wednesday, December 6, 2017

Very Brief Blog: Old School Lab Fraud: Strip clubs and bags of cash in NJ

A few years ago, I was talking to a senior lab industry colleague about trends in Medicare fraud.  Old school, I said, was giving the physician a brown paper bag full of $50 bills.   New school, was having the physician enrolled as a "consultant" for a "registry" and giving him $200 per head or some other figure.  (See 2014 OIG bulletin here).    My colleague said, "Well, there's still plenty of the Old School approach, in New Jersey."  Total earnings of the lab were >$100M during its run.

For a colorful article on the colorful and seamy side of the clinical chemistry business, see a December 5, 2017 article in New Jersey Dot Com, here.  (Medicare payments to the lab were only $2.1M in 2015, available via here; but that's 2 years after initial arrests made in 2013; BCBS cases against the lab dated to 2009).

Tuesday, December 5, 2017

Brief Blog: MOLDX Statement of Work (Jurisdiction M, 2014)

In the past month two different people have asked me about the MOLDX statement of work.  It's online at a federal RFP website, and I've clipped it here on my documentation blog.

Features of the SOW include:
  • pricing of tests not priced on the CLFS, 
  • maintaining a test code registry (e.g. Z codes), and 
  • providing standard formats for evidence and conducting systematic evidence review.   
  • MolDX is also to advise CMS on new national edits.  
  • There's an interesting section that very clearly authorizes "coverage with evidence development" or "coverage with data development," although LCDs from MOLDX do not currently use that. 
MOLDX has some policies which don't trace as easily to the SOW, which I discussed here.  These included (1) altering prices of codes that do have CLFS prices, (2) not using CMS CPT codes for two or more tests, because they become "panels," and (3) employing local edits (such as blocking payment of 81433 when 81432 is used) that have not been migrated to "national" edits in the public CCI system.

Monday, December 4, 2017

Very Brief Blog: Silicon Valley Bank "Diagnostics and Tools," November 2017

In mid-November, Silicon Valley Bank issued a 22 page report specific to "Diagnostics and Tools," subtitled, "NGS and AI drive Moonshot Investments." 

The SVB home page for the report is here; the PDF is online here.

A few weeks ago, we highlighted their more general mid-year 2017 report on health investment trends (here).

Friday, December 1, 2017

Very Brief Blog: Harry Glorikian Releases New Book on Data Driven Healthcare with Coauthor Malorye Alyson Branca

Harry Glorikan, a well-known consultant and expert on the diagnostics and biopharma industries, has released a new book titled, "MONEYBALL MEDICINE: Thriving in the New Data-Driven Healthcare Market," coauthored with  Malorye Alison Branca 

In 2016, Glorikian published, "Commercializing Novel IVDs: Comprehensive Manual for Success," here.

The book already sold out its first printing on Amazon; but ebooks currently are available.  See the Amazon website here.

From the Amazon summary:

MoneyBall Medicine: Thriving in the New Data-Driven Healthcare Market, which includes interviews with dozens of healthcare leaders, describes the business challenges and opportunities arising for those working in one of the most vibrant sectors of the world’s economy. Doctors, hospital administrators, health information technology directors, and entrepreneurs need to adapt to the changes effecting healthcare today in order to succeed in the new, cost-conscious and value-based environment of the future. The authors map out many of the changes taking place, describe how they are impacting everyone from patients to researchers to insurers, and outline some predictions for the healthcare industry in the years to come.

Two other books on related topics in the recent weeks include FOURTH WAVE: DIGITAL HEALTH by Paul Sonnier (here), and REALIZING THE PROMISE OF PRECISION MEDICINE: Patient Data, Mobile Technology, Consumer Engagement, by Paul Cerrato and John Halamka (here).

Very Brief Blog: New Paper on Competitive Dynamics of Precision Medicine in Pharma Development

For years, there has been much ink used in discussing when biopharma should develop mass market drugs and when CDx targeted drugs are a better investment and focus for R&D.

Berndt & Trusheim have released a new 40-page paper on the topic.   The paper is available for $5 from the National Bureau of Economic Research Archive (NBER).   See this link.

New pun = "Pharms race."

I've included the title and abstract below.  It was presented at a national conference on "Economic Dimensions of Precision Medicine" in September 2017.

 The Information Pharms Race and Competitive Dynamics 
of Precision Medicine: Insights from Game Theory

Ernst R. Berndt, Mark R. Trusheim
NBER Working Paper No. 24020
Issued in November 2017

Precision medicines inherently fragment treatment populations, generating small-population markets, creating high-priced "niche busters" rather than broadly prescribed "blockbusters". It is plausible to expect that small markets will attract limited entry in which a small number of interdependent differentiated product oligopolists will compete, each possessing market power.

Multiple precision medicine market situations now resemble game theory constructs such as the prisoners' dilemma and Bertrand competition. The examples often involve drug developer choices created by setting the cut-off value for the companion diagnostics to define the precision medicine market niches and their payoffs. Precision medicine game situations may also involve payers and patients who attempt to change the game to their advantage or whose induced behaviors alter the payoffs for the developers. The variety of games may predictably array themselves across the lifecycle of each precision medicine indication niche and so may become linked into a sequentially evolving meta-game.

We hypothesize that certain precision medicine areas such as inflammatory diseases are becoming complex simultaneous multi-games in which distinct precision medicine niches compete. Those players that learn the most rapidly and apply those learnings the most asymmetrically will be advantaged in this ongoing information pharms race.