Friday, October 19, 2018

CMS Posts Final Gapfill Codes for CY2019: Whole Genome Raised from $349 to $5031

On Friday evening, October 19, 2018, CMS published the final contractor gapfill codes for the year.  (Proposed prices had been released in early June with comments due in early August).   The 18 codes were placed into the gapfill process last fall; some were codes with no pricing through PAMA and a few were new codes that couldn't be assigned a fall 2017 crosswalk.

  • On the CMS CLFS webpage here, see the final "2018 Final Gapfill Determinations."

CMS provided summary rationales for each price.  MACs varied more from one another in the final price proposals than in the preliminary ones in June; the final price is set by the median, which is controlled by MolDx-system MACs which essentially acts as a voting bloc of 30 states.

Most of the codes being gapfilled were either "PLA" (new rapid) codes, ending in "U" such as 0001U, or administrative MAAA codes (ending in M, such as 0001M).  See table below.

Whole Genome Analysis

The biggest price change was for whole genome analysis (81425), sibling/family member analysis (81426), and reanalysis (81427).   These rose from a uniform price of $349 (?!) to $5031, $2709, and $2337, respectively.   (Over 20 comments letters were submitted to CMS, if I can summarize, generally portraying the $349 price as ridiculous.)    The whole genome price of $5031 is a little higher than the whole exome price of $4780, as set by market rates under PAMA.  Use of these tests is likely to be rare in the Medicare population but a growing literature has documented the usefulness of whole genome in special cases including gravely ill newborns.

How the MACs priced WGS-related codes is shown in the next table.   By my count, 32 MolDx-related CLFS zones proposed $5031 for 81425.  Novitas and FCSO had 14 zones, at $4780.   NGS MAC had 12 zones at $349.   See table:

click to enlarge


Disclosure:  I served as a consultant this summer to several entities working to raise the median price from the initial $349 to $5000 or better.


See the original CMS spreadsheet at the link early in the blog.  I've put a slightly tricked-out Excel with highlighted tabs for short summary views and comments views in the cloud, here.

MAC rationales for 81425, 81426 were stated to be:

Some contractors based initial recommendations on laboratories with similar test with charges of $349.00. Upon further review, however, several contractors revised their recommendations.  Some contractors looked to similar tests on the CLFS, specifically 81415, a Whole Exome Sequencing code, and adjusted the payment rate based on input from several laboratories.  Other contractors simply followed public recommendations to use CPT 81415 as a similar test on the CLFS to recommend a payment rate. 

MAC rationales for 18427 were stated to be:

Initially, several contractors felt this code represented interpretation only and thus averaged two comparable codes (G0452-26 and 88291).  Upon further review, some contractors followed public recommendations to use CPT 81417 as a similar test on the CLFS. Others did not recommend this similar payment rate and instead estimated a professional labor rates for the code. 


DTC testing on Amazon - for you and maybe your dachshund too...

Very Very Brief Blog: The Coming Valuation Boom for Quant-IHC and FISH

This past summer, CMS announced a massive revamping of capital equipment and supply inputs used to value Part B services in relative value units (RVUs).   This follows 2018 law in PAMA Part 218, allowing CMS to commission or require a wide range of information resources to value capital equipment and supplies.   The massive new pricing system was announced fairly briefly in July 2018 proposed rulemaking, but engendered comments by many groups.

College of American Pathologists published a chart showing that some selected ISH and FISH codes are proposed to rise sharply in price between CY2018 and CY2019:

For example, the payment  for 88360 rises from $136 to $289 (+112%) and the technical component of ISH, 88365, rises from $137 to $304.


RVU prices are based on incredibly complex "bottom up pricing" that includes line items for minutes of physician time, minutes of staff time, minutes of use of capital equipment, and all supplies large and small (e.g. a surgical tool one time use supply might be $800 while an alcohol swab might be one-half penny).

While it's not elegant Excel, below I show a snippet of the supply inputs for 88360.  This previously used 2 units of estrogen receptor monoclonal antibody SL493 at about 2x14 ($28.94), and now uses two units at a new unit price of $91.45, or $192.41.   Just a few of the supplies used to total $49.91, but now total $206.33, or about +$156.

(Note that there is some significant price compression before these item prices are converted to CMS payment RVUs. Through complex math and rules, the prices are stored in dollars, converted to RVUs, and then multiplied by about $30 per RVU to convert back into dollars).

For 88365, similarly, EBER DNA Cocktail Probe rises from $13.71 to $178.31, along with some other increases.

In 2017 data, code 88360 had about 110,000 uses, so at +$150 per payment, total payments would rise by about $16M.

With apologies they are very simplistic, I store the Excel worksheets I used in the cloud here.

Very Brief Blog: New Medical Director at MolDx Program, Dr. Bien-Willner

This past summer, MolDx positioned a new medical director, Dr. Paul Gerrard (blog here).   Dr. Gerrard continues to work on MolDx issues, and MolDx has added a full time medical director, a molecular pathologist, Dr. Gabriel Bien-Willner.

Dr. Bien-Willner's Linked In page is here.   He started as MolDx medical director in September, 2018.   He became chairman of the molecular pathology practice, Bien Willner Physician Group (BWPG), in 2015.   He served as Executive Medical Director for Molecular Health GmBH from June 2014-May 2018.

Bien-Willner holds an MD-PhD from Baylor and completed his residency and molecular genetic pathology fellowship at Washington University.

See an interesting ten-page interview with Dr. Bien-Willner, conducted in November 2016, at American Journal of Managed Care, here.

Very Brief Blog: MolDx Retires LCD for LDT Lung Cancer Tests; "Obviated by NCD"

On September 24, 2018, MolDx posted a notice that it was retiring its LCD for gene panel testing in non small cell lung cancer, effective 10/1/2018.   A link to the retired LCD is here.  Several key screen shots are listed below.

In March 2018, CMS released an NCD covering FDA-approved gene panel tests (NGS tests) in advanced cancer.   However, MACs are allowed to write their own LCDs for LDT-type tests that are not FDA approved, if they choose to. 

Based on publicly available announcements, Foundation Medicine's Foundation One LDT test was covered under this Palmetto LCD when the LDT test was run at Foundation's North Carolina center.   The non-FDA FMI LDT test was discontinued on September 28, 2018, according to an FMI announcement.

See screen shots below.

Rationale: Need for LCD obviated by NCD.

Wednesday, October 17, 2018

Very Very Brief Blog: CMS and FOIA (Freedom of Information Act)

The usual cliche' about getting Freedom of Information Act materials from CMS is that "it takes forever - it takes years."   In the past year, I've gotten several document sets from CMS (or a MAC) and typically in a couple months.  They require submission of FOIA requests by mail - on paper and with a postage stamp.

Each MAC has a FOIA process page.  CMS also has a rather gaudy consumer-facing FOIA page, here.

What I had never noticed, CMS has a "FOIA Reading Room" with some interesting documents.  It's here.  There is a 26-page PDF guide to the CMS FOIA process, here.   Requests can be escalated higher in the agency, if denied. 

From the opposite perspective, avoiding information release under FOIA,  CMS's 26-page PDF discusses exemptions from release (primarily FOIA exemption #4, trade secrets or confidential information.  Stamp your documents accordingly.)   However, DOJ has a webpage stating that courts expect FOIA exemptions from release (under 5 USC 552(b)) to be narrow, not wide (here).  National Parks v Morton, 1974, et seq.   You can't gratuitously claim that everything you send to CMS is exempt confidential information.

What caught my attention this morning, CMS maintains public line item FOIA logs monthly back to 2015.  For example, the most recent is a FOIA log for June 2018 (here).  It looks like they get over 150 requests a month.  Requests come from law firms large and small, newspapers, research groups, and other entities as diverse as the health plan Oscar, the Democratic National Committee, Buzzfeed, and Providence St Joseph health system.  In addition to the FOIA spreadsheet reports, the 26-page CMS PDF notes that "CMS receives the highest number of FOIA requests of any FY2011, CMS received over 52,116 FOIA requests."

click to enlarge
So if you do submit a FOIA request to CMS, within a short time, CMS will post your request in a table such as the one clipped above.


I've always heard that FOIA allows requests for existing documents (e.g. all emails with keyword X from person A to person B) but never requires the agency to undertake creation of new documents.


FOIA exemption 2 exempts "internal personnel rules and practices" from release.  I used to hear that this allowed an agency to refuse to release its own internal "deliberative" documents.   However, the CMS 26 page PDF (here) on page 10 informs us that based on a 2011 Supreme Court case, this exemption-from-release has now been read to apply solely and literally to personnel rules.   Thus, it now is understood as exempting release of [personnel rules and personnel practices] and no longer read as broadly allowing the agency to withhold [personnel rules and (internal agency) practices (of all types).]


FOIA responses aren't necessarily internally consistent.  I once asked MolDx under FOIA for its scope of work (statement of work), and received a reply this was a confidential internal agency document.  However, the very same request to CMS got me a copy of the MolDx statement of work in a couple weeks (here).

Monday, October 15, 2018

Very Brief Blog: CMS Issues One of the Most Unusual CMS Regulations Ever (Drug Pricing on TV)

On October 15, 2018, CMS released proposed regulations that would require TV advertisements to include drug pricing information, if they are drugs that are covered under Medicare "directly or indirectly."
  • See a trade journal article here.  Follow-up trade journal here.
  • See the actual 42 page proposed regulation here
    • Seema Verma press release here.
    • Seema Verma same week at AHIP, here.
Since this new regulation is directed at consumer ads, it is a bit surprising to see it as falling under CMS's legal authority rather than e.g. some other part of HHS or maybe the FTC.   The regulations on price advertisement will be tucked among other routine CMS regulations at 42 CFR 403.1200ff.

CMS Works to Justify Why It Can Do This

Anticipating reactions between skepticism and surprise, CMS dives directly into a long and elaborate discussion of whether it has authority to regulate content of TV ads because it pays for drugs. 

Many pages of the regulation read like an overcaffeinated litigator's legal brief, citing a dizzying cascade of court cases and precedents.  For example, we learn that Massachusetts Law 94 295C requires retail dealers of motor fuel to public display on each pump the price per gallon.  Well, yes.  And that 7 CFR 59.301(a) and (b) require that meat packer processing plants must daily report to the Secretary of Agriculture the sale price for lambs.  (Quiz later.)   The authors reach back to a 42-year old economics article on drug pricing (by John F. Cady, then an assistant professor at Harvard MBA school and today still in service at Indiana University). 

The authors then start running down a list of federal court citations like Colorado Indian River Tribe v Indian Gaming Commission 466 F 3d 134, 139, and Thorpe v Housing Authority of Durham, 393 US 268, 277 (see esp. n. 28).   At this, point, Lexis was threatening to overheat.

Pivoting the reader toward the argument on the table, that CMS can regulate the TV display of drug prices, CMS notes that Section 1102(a) of the SSA allows CMS to make "such rules and may be necessary to the efficient administration of functions" under the SSA.   Section 1871(a) allows CMS to "prescribe such regulations as may be necessary to carry out the programs."

CMS "has concluded that the proposed rule has a clear nexus to the Social Security Act."   They note that CMS spent $174B in 2016 on Part B & D drugs, and $64B on Medicaid drugs.  This $238B was 53% of $448B spent on "retail and non retail" prescription drugs.

Most of the CMS regulation is about consumer behavior and consumer advertising, something never directly addressed in the enabling legislation for Medicare and Medicaid.


There is a 60-day comment period (about December 15, 2018). The regulation is CMS-4187-P.


See a trade journal article in MedCityNews - noting that only New Zealand and US allow DTC drug advertising; here.  PHRMA had been discussing voluntary price disclosure guidelines.  For some additional ins and outs of drug price transpareny, MedCityNews also here.


Note that this isn't primarily about the drug prices - you can already get many drug prices for free by digging around the CMS website - it's about lifting those prices into TV ads.

CMS also requests comment on whether it should just make drug prices more transparent on its government websites (e.g. imagine  Yes, it could do a lot there, and very fast.

CMS argues that consumers will want to compare prices.  However, if drug prices are so hard to get, seeing the price of just ONE single drug in ONE ad is a terrible way to comparison shop for drugs for your disease.  Would you have to sit in front of a TV all day, all week waiting for the very very rare Crohn's disease commercials (at two a.m.?) and jotting down prices?

Would there be a boomerang effect?  Who dying of heart disease or cancer wants the cheapest drug?  Might they not assume that logically, the more expensive drugs will be the higher quality and more effective drugs they need? 

Very Brief Blog: Tracking Scott Gottlieb's 20-Tweet Tweetorial on Drug Price Competition

This past week, President Trump signed legislation on drug price transparency, including specific authorities for FTC to pursue companies that work to block market entry of biosimilars.  For entry points see CNN here and BioPharmaDive here, BioSpace here.

FDA"s Commissioner Scott Gottlieb is also active in public forums at promoting drug price competition.  This weekend, he released an elaborate 20-tweet "Sunday Tweetorial" on all the efforts he's promoting at FDA to increase U.S. drug price competition, here, by speeding the entry of generics.   Historically, and in most cases, prices fall once there are several generics in a market.
  • You should be able to see and read the Sunday Tweetorial here in sequence.
  • I've put a PDF of the whole tweetorial in the cloud, here.
    • Read as a 15 page PDF.   
  • This is Gottlieb's twitter feed.  @SGottliebFDA
    • As of today, 6220 tweets.

Gottlieb is often outspoken on market entry forces (and the government's role).  See his address on antibiotics policy in mid September 2018 (here) and his views on antibiotics pricing paradigms from June 2018 (here).


See the HHS Drug Pricing Homepage here including the Administration's May 2018 drug pricing blueprint ("Patients First," PDF, 44pp.)

Interestingly, given the rising billions of dollars in biologicals, the Biosimilars Competition Act received an "unofficial 10 year score" from CBO of only $100M, according to one source, here.  See the July House version HR 6478  here.   FDA Law Blog here.


The day after Sunday's Tweetorial by Gottlieb, CMS released proposed regulations requiring advertisements to include drug pricing information, if they are drugs that are covered under Medicare "directly or indirectly."   Since this is directed at consumer ads, it is a bit surprising to see it as falling under CMS's legal authority rather than e.g. some other part of HHS or the FTC.   Here is a trade journal article and here is the 42 page draft regulation in PDF.  The regualations on price advertisement would be tucked among other CMS regulations at 42 CFR 403.1200ff.

CMS dives directly into a discussion of whether it has authority to regulate content of TV ads because it pays for drugs.   CMS notes that Section 1102(a) of the SSA allows CMS to make "such rules and may be necessary to the efficient administration of functions" under the SSA.   Section 1871(a) allows CMS to "prescribe such regulations as may be necessary to carry out the programs."  CMS "has concluded that the proposed rule has a clear nexus to the Social Security Act."   They note that CMS spent $174B in 2016 on Part B & D drugs, and $64B on Medicaid drugs.  This $238B was 53% of $448B spent on "retail and non retail" prescription drugs. 

Wednesday, October 10, 2018

Very Brief Blog: ACLA's PAMA Lawsuit Tossed from Federal Court in September 2018

Last winter, ACLA filed a lawsuit against CMS for inappropriate implementation of the PAMA lab pricing law, resulting in underpricing of new median rates for lab tests.  The primary concern was that CMS had written, interpreted, or implemented the PAMA law's conditions in a way that nearly  excluded reporting by hospital reference labs. 

News sources reported circa September 24, 2018, that a US district court judge had dismissed ACLA's case on the grounds that the court lacked jurisdiction.
  • For the 33 page, December 11, 2017 complaint, see here.
  • For an open access 13 page PDF of the judge's dismissal, see here.
  • For open access reporting on the September 2018 dismissal, see MedTechDive here.  Fierce Healthcare here.  HealthLeaders here.  Seeking Alpha here ("Labcorp down 2%").  Becker's here.  Reuters here.
    • For coverage and quotes at 360DX, here.
  • For ACLA's statement on the dismissal, here.
  • For CAP's statement lamenting the dismissal, here.

The judge's decision is readable and hinges on Congress's statute that shields PAMA 216 from judicial review.   ACLA had attempted to parse the procedures for setting up the rules (which they object to) from the actual fee schedule rates, which were clearly shielded from judicial reviews.  Judge is dismissive of ACLA's position, and uses quotations from the law to show (in her view) the shield from judicial review applies to all of PAMA 216.   This follows an earlier discussion that "federal courts are courts of limited jurisdiction" and rather like a person is innocent until proven guilty, cases are assumed to be outside judicial review until proven they are inside it.   There is an interesting twist on page 12 (that Congress required PAMA implementation through notice and comment rulemaking, so it is inconsistent to shield that rulemaking from judicial review, as it enabled the Secretary potentially to undertake reckless (but required) notice-and-comment rulemaking with no later recourse for stakeholders).*  However, this interesting side-road does not change the decision.

Separately: for ACLA's comment on Summer 2018 Part B rulemaking, which includes extensive comments on PAMA, see here.  AMP's 5-page letter on Part B rulemaking is here.  CAP's website for CMS letters appears to list its September 2016 and September 2017 PFS comment letters but not its September 2018 letter. CAP does have webinar slides on the PFS 2019 proposals (here).


As a non-attorney working full time on federal policy, I've always been puzzled by laws written by Congress which include a clause stating the implementation of the law is "shielded from judicial review."  Checks and balances?

According to news reports, the judge's dismissal hinges on lack of jurisdiction.  Even if the judge had jurisdiction, the section of law regarding which labs can report (with a 50% rule regarding Medicare Part B billings) is (or was or remains) problematic to craft around the issue of hospital labs.  ACLA  offers a mathematical solution on pages 9-11 of its comment letter.

CMS proposed to use 1450 claims forms in regard to its definition of hospital reference lab reporting.  AMP and ACLA seem to take diametrically opposed positions on the wisdom of this CMS suggestion.

From summer proposed rulemaking, 1799 documents to the 2019 rule (CMS 1693 P) cited "PAMA" (here).


* As quoted by judge:  ACLA wrote, "It would raise constitutional concerns of the highest order if Congress were to require the Secretary to promulgate substantive legislative regulations that directly regulate primary conduct on threat of civil penalties but then [also] attempt to insulate those regulations and the Secretary's enforcement of them, from any form of judicial review."   [Decision, page 12].

Tuesday, October 9, 2018

Very Brief Blog: Baker Tilly's Checklist for Medical Devices & Market-Facing Evidence

This week, MedCityNews runs an article on, "What can digital health companies learn from medical devices?" in terms of evidence and reimbursement success.  Here.

Inside that, find a link to a "Market Access Checklist" from Baker Tilly, presented as a one page PDF infographic.   Download it here.

While the checklist is commonsensical to reimbursement experts, it may be an eye opener to newer investors, CEO's, or board members.   Topics include:

  1. Clinical Evidence
  2. Economic Evidence
  3. Medical Society Guidelines
  4. Provider Communications
I would say....Yup.

Regarding communications, I ran across a quote from a 1976 booklet called "Thoughts of Jerry Brown."  Regarding the endless funding requests and justifications that crossed his desk as governor, he wrote:  "Even though they might be right, if they can't clearly state their case such that I can understand it, in the limits of time available, then I'm voting no.  That's my philosophy."   I'd suggest you assume the medical director at CMS or BCBS is thinking the same way.


Baker Tilly is a "full service accounting and advisory firm."  The cited MedCityNews articles is preparatory to a conference and features, among others, an interview with Baker Tilly's principal, David Gregory.  For his 2016 deck, "The Value Driven Provider," here.


If you enjoyed Baker Tilly's four-point evaluation program for market entry and reimbursement, consider these two posts.   The first is a "12 step program" for what VCs should consider when investing in healthcare technology.   The second is about medtech and payers.

Venture Valkyrie blog, 12 steps to VC investment due diligence, here.
Venture Valkyrie blog, medtech and payers, here.

Sunday, October 7, 2018

Very Brief Blog: $28M in All of Us Genomics Awards: Centers Span Coasts, Silicon Valley to Boston

On September 25, 2018, the NIH All-Of-Us program announced plans to sequence 1M genomes via initial funding at $28M to three genomics consortia.

The first brings together Boston's Partners Laboratory for Molecular Medicine, the Broad Institute, and Color Genomics in Silicon Valley. 

The second brings together Baylor, UT-Houston, and Johns Hopkins.

The third is run solo by University of Washington (Northwest Genomics Center). 

Click to enlarge.  Don't bother if you're in a flyover state.

  • See the NIH press release here.
  • See the Broad Institute press release here.
    • Color will analyze, interpret, and report results from the genomic data sequenced at Broad, working in collaboration with the Partners LMM, which will manage an expert team to address the most challenging genomic variants. 
  • Genomeweb here.
    • The funding announcement was issued in May 2018 (see technical Q&A here) with applications due in July 2018.
    • For a December 2017 report on what All of Us expected to be asking for (e.g. including its rising emphasis on exome/genome), here.
I'm not an expert on the greater Harvard system nomenclature, but my understanding is that Partners Lab for Molecular Medicine serves as a central germline clinical genetic center for Harvard-related hospitals.  According to Genomeweb, MLL director Heidi Reim "left for MGH's Center for Genomic Medicine" in August.


Collateral Ideas

If you're interested in All Of us collecting genetic and phenotypic data on huge numbers of people for future use, you might be interested in LunaDNA.  It's "the first people powered platform where you share data, advance science, and take part in the value created" and received $4M from Illumina Ventures (and others) in May 2018.  See a July 2018 article here. LunaDNA will be able to "issue company shares in exchange for genomic data," here.

If you're interested in Partners LMM as a cross-organizational hub for genetics in the diverse health system, you might be interested in the history of the MGH Pathology Department, where the chapters of a recent 300 page book are online as PDFs here.

For interests in The Broad Institute, a May 2018 podcast with Amalio Telenti (a pioneer in the area of molecular multi drug resistant bacteria) on his sabbatical at the Broad, here.

Thursday, October 4, 2018

Very Brief Blog: Guardant Health Raises $238M in IPO; Stock Reaches $33

According to Investors Business Daily and Yahoo Finance, Guardant Health garnered some $238M in an IPO. 

The projected or actual share price has moved upward.  Early estimates forecast an IPO at $15-17 a share, while the final IPO finally priced at $19 a share. Rising above that, the market opened at $27 a share, and during Day One, shares rose as high as $33. 

Market cap was $1.6B according to one trade journal (here).   I believe that's at the nominal $19 per share price.  That market cap value compares favorably to the circa $550M invested so far.

Guardant Health received Medicare coverage for its liquid biopsy gene panel test this past summer (here), for lung cancer patients.

Click to enlarge: Yahoo Finance screen shot

CMS Releases Widespread Changes to LCD Process !

On October 3, 2018, CMS released a 32-page PDF that lays out substantial changes to the LCD creation and review process.
  • See the actual CMS document here.  
    • It's filed as "Change Request 10901."
  • See Medicare's own summary of the change here at the CMS Fact Sheet center.
    • Administrator's Blog covers the change, here.
  • See trade press at MedTechDive here.
    • Headline is, "Speed access to medical technologies."
    • I don't see that.  Every acceptable LCD request (e.g. new info submitted) seems to require a full LCD publication, comment, and review process, including entering a formally named backlog.   If a MAC can do 15 LCDs a year and gets 100 requests that "qualify," then it has a ten-year-backlog right there.  A manufacturer might also complain that its product never-ever leaves the "backlog" for opaque reasons.
  • See trade press at HealthCareFinance News, here.
This change primarily implements new law in the 21st Century Cures bill from a couple years ago.  However, it incorporates some other changes CMS has been planning over a period of years.

Note that there is ANOTHER, NEWER piece of LCD law that was recently passed at the House and is sitting at the Senate, H.R. 3635.  This bill has been supported by AdvaMed, CAP, and other groups.   See entry points and links on that topic here.

Contractor advisory meetings will be open to the public and webinar access will be allowed.  There will be an option to request, not only to revise, an LCD (   Preliminary meetings with stakeholders are allowed but not required (  MACs will be required to have a standardized format for summarizing evidence.   Draft LCDs will expire after 1 year if not finalized.

No Pre-emptive LCDs?

The format seems to make it impossible to make pre-emptive LCDs with no further explanation.  For example, LCDs that simply add the names of 20 or 30 new AMA CPT category III codes to a listing of non-covered codes.  Doing that wouldn't meet the requirements for evidence review and explanation.

What Is An "Explanation?"

Come key points remain unchanged (although perhaps reformatted).  For example, a reconsideration request shall receive an explanation of why the request was invalid.  In the past, that explanation (sic) has been in some cases, a clear two paragraph discussion.  But in other cases, the "explanation" has been a mere preemptive phrase "Evidence not sufficient" (3 words).

Consider the NCD Format

NCDs have a now-classic format where, after a decision summary and some introductory material, there are two main sections.  The first is "Evidence Summary."  (Smith et al. 2015 is a 300 patient RCT showing A, B, and C with one year outcome data.)    The next section is "Analysis."   (Smith et al. is an RCT against the standard of care, but we believe a different standard of care would be an important comparator.  We see several risks for bias in the trial design, including X, Y, Z.)   Analysis supports a final "Conclusion."   The LCD content isn't quite the same but the NCD structure provides a backdrop.

LCD "Content" Bullets: Section 13.5.3
"In every proposed and final LCD, the MAC must summarize the evidence that supports coverage, limited  coverage, maintenance of existing coverage in cases of LCD reconsideration or non-coverage.  At a minimum, the summary should include the following:     • a complete description of the item or service under review; • a narrative that describes the scientific evidence supporting the clinical indications for the item or service;  • the target Medicare population; and • whether the item or service is intended for use by health care providers or beneficiaries. 
If the item or service is regulated by the FDA, and determined by the MAC to be reasonable and necessary, information regarding the use of the item or service subject to the FDA indication, as applicable, shall be included.   
In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.  Proprietary information, submitted by a requestor, not available to the public shall not be considered. Medicare data considered as part of the evidence review for an LCD shall be reported in the evidence summary."  [Also, MACs may consult associations or experts; 13.2.3).

Role for a "Dossier"

Depending on the topic, stakeholders may prepare a very long "Dossier" or evidence summary.  This is accepted practice in some circles, for example, new drugs, where there is a template for an AMCP dossier on the drug.   However, I have also seen cases where CMS medical directors pay very little attention to a "dossier" but simple set it to one side and focus instead on the submitted PDFs of published trials.   The new instructions say that "proprietary evidence submitted by the requester shall not be considered."

However, an earlier section also requires the request to "address the relevance, usefulness, clinical health outcomes, or medical benefits" and "fully explain the design, purpose, of the item or service and "a justification supported by the peer reviewed evidence."  That sounds like a "dossier."  So you have to write up a justification of the evidence and explanation, but not say any proprietary concepts or ideas while doing so since only published evidence is considered.


"MACs shall record (video, audio or both) the CAC meetings and as part of the LCD record, assure the recording is maintained on their contractor website." []   This is interesting in that some public CMS meetings are webcast, but, are as of now no longer archived on the CMS website or CMS youtube channel although CMS had done so in past years.  (My article on this, here).

Valid LCD Request => Reopening?

If I read this correctly, a "valid LCD request" results in a reopening of the LCD or putting the LCD on the MAC's waiting list.  [13.3.3]

This is a big change, since previously most reconsideration requests were handled by medical director staff resulting in a letter back to the requester.  This could also create a lot of confusion, since some reconsideration requests point out, for example, an omitted ICD-10 code, which the contractor would add to the LCD in a week or two, without a year's adventure in the LCD process.   I'm not sure I have interpreted this section correctly.

I think the "escape valve" (stated in the CMS press release) is that ICD10 codes and CPT codes are being moved OUTSIDE the LCD itself (as they are outside an NCD).   This could either allow a lot of flexibility, or a lot of mischief, depending on your level of paranoia. MACs must follow "the full reconsideration process for valid requests" but the code lists are no longer inside the LCD, so it is a bit of a puzzle.

Unintended Consequences?

Formerly, the LCD chapter had a clear statement of if and when an LCD had to be reopened through a public process.  Additions could be handled by simply expanding the LCD and posting it (no comment process).  Restrictions had to be handled through the full LCD posting and comment process.   Here, any requested changes (even a correction or minor expansion) appears to require the lengthy full LCD process.  The result could both delay coverage and create interminable backlogs, if I read it correctly.

Will the rules speed access or create a years-long LCD backlog list?

Wednesday, October 3, 2018

FDA Authorizes Highly Novel Sequencing Test; FDA Cites Commitment to Genomic Innovation

On September 28, 2018, FDA issued a press release with extensive comments by Commissioner Dr. Scott Gottlieb regarding availability of a novel form of sequencing for use in acute leukemia (ALL).

The test is the ClonoSEQ in vitro diagnostic, which will be able to offer new levels of sensitivity in detecting minimum residual disease (MRD).   The test can be positioned as a more sensitive alternative to conventional flow cytometry or PCR assays.   It produces a patient-specific or "fingerprint" analysis with sensitivities below 1 per million cells.  ClonoSEQ uses PCR amplification of target sequences and NGS detection.

FDA Praises Its Commitment to Genomic Innovation, While Calling for Legislative Improvements

Gottlieb speaks of the test as "an important step forward for patients suffering from ALL and multiple myeloma."

In addition, he highlighted that FDA itself is "continuing to maximize opportunities for innovation" and that "The FDA is applying novel regulatory approaches to make sure that these rapidly evolving NGS tests are accurate and reliable."   In what I see as a key perspective, he stressed that the FDA "is doing as much as we can...under current authorities.  But we believe that to fully unlock these innovations, we need to modernize the regulatory framework for all in vitro clinical tests."   In making these statements, Gottlieb was explicitly referencing the FDA's own proposal for legislative innovation which it recently made to Congress.   See his September 13 speech here

Further reporting at Genomeweb here.  At OncLive, here.


MolDx released proposed coverage for ClonoSEQ in August, here.

MolDx recently updated its Technical Assessment Checklist (web here, M00151 V4, cloud PDF here).  This September 2018 document contains reference to a September 14, 2018, Excel spreadsheet checklist specific to "Somatic Variant Detection by Comprehensive Genetic Profiling for Myeloid Tumors Checklist M00153".  See link here, my cloud copy here.   This M00153 spreadsheet has some very specific requirements, such as "copy of current CLIA certificiate" (which Medicare would already have on file for a lab),  a table to fill in that is about 250 lines long and about 10 wide, and other requirements at bottom. 

In M00153, I was surprised to see a query whether "Reports are issued by a physician, board certified by ABP or ABMGG" since molecular reports are classically signed out by either a physician or a PhD lab director.  There is also question whether the lab submits variants to ClinVar, which seems irrelevant questioning if not this is not part of the coverage decision, or very important to note if it is part of a coverage decision.

Why the October 9, 2018, PLA Code Submission Deadline is Like a Solar Eclipse

October 9, 2018 will be the closest triennial conjunction between the quarterly AMA PLA code creation cycle and the triennial CMS PAMA paid claims data cycle.


For over a year, AMA has been issuing rapid codes for any sole source lab test or FDA approved lab test.   These are called Proprietary Laboratory Analyses, or PLA codes.  As the of quarterly September 2018 update, the AMA has issued about 80 of these - see home page here, calendar here, and PDF of codes here.

This coding system is based on the Congress's instruction to CMS in 2014, in PAMA section 216, to create new codes rapidly for Advanced Diagnostic Laboratory Tests (ADLTs) and/or FDA cleared or approved tests.   The AMA's code production system is broader, as it will create a code for any sole source lab test whether it will or won't be an ADLT (something AMA wouldn't know at the time of code creation).

The Solar Eclipse Angle

PLA codes are initially priced by local MACs, and they reach official CMS national price-setting in the first possible June after the code's creation.   For example, a new PLA code in May hits CMS quickly, but a September PLA code won't hit CMS until the next summer.   CMS treats the new codes like any other new lab code- CMS decides with public meetings and a summer of careful thinking, whether to crosswalk the code to an existing code, or whether to gapfill it officially in the next calendar year.   (For discussion of June-September CMS policymaking this year in 2018, see here.)

Meanwhile, the new PLA code is also on another calendar: to enter the triennial PAMA pricing cycle, through which CMS sets a price data claims period, a price reporting submission period, and a final price posting schedule.   While the future can't be perfectly predicted, most of us think the next PAMA price/payment period will be 1H2019, with data reported in 1Q2020, and prices set in 4Q2020 for CY2021,CY2022, CY2023.  (See a July 2018 OIG report, OEI-09-17-00050, stating that "In 2020, labs will report data collected from January-June 2019.")

The upshot.  A PLA code submitted to AMA on October 9, 2018, will reach the AMA's pathology panel vote on November 6, 2018, and by published November 30, 2018, effective January 1, 2019.   This mean this code set will be the last code set to meet the expected January-June 2019 collection period for the 2021-22-23 pricing period.

Whatever CMS does to your PLA code's price in Summer 2019, for better or worse, in will only last during CY2020.   The CMS price for 2021, 2022, and 2023 will be based by PAMA on completed private payer payments to the lab solely in 1H2019.   This might be much than the price CMS assigns by crosswalk.

I've noted earlier that labs have a lot of opportunity to make decisions during this payment collection period.  For example, if the lab submits claims for $1000, $1000, and $1000, and the first is paid at $1000, the next $300, the next $200, the lab would probably appeal the low pricing of the $300 and $200 claims.  This private payer appeal (or sequential higher appeals) process could easily extend final adjucation of the $200 and $300 claims beyond the PAMA six month claims finalization window.  The "last man standing" would be the $1000 claim, for reporting. 

The Tuesday, October 9, 2018 AMA PLA submission deadline results in the closest temporal connection between code creation, price setting, and a new PAMA cycle. 

click to enlarge

(Legal eagles might note that a January 2019 code submission could result in an April 1 effective date, falling within 1H2019.   But whether any claims would be logged and paid by June 30 for the 1H2019 paid claims interval becomes dicey.  For example, you might have 50 claims submitted and 50 denials, 0 reaching the goal line of being appealed and paid by June 30).  

Monday, October 1, 2018

Two Day Conference on Pharmacogenetics: San Diego, October 15-16, 2018

This  year, the annual meeting of the American Society for Human Genetics will be in San Diego, October 16-20, 2018.  ASHG conference website here.

In parallel, the Pharmacogenomics Research Network (PRGN) will hold a two-day preconference on pharmacogenetics on October 15-16, 2018.   See the meeting website here.  The conference runs 1:00-7:30 on Monday and 8:00-4:00 on Tuesday.

I've clipped the conference summary below.  See the PRGN conference website for full agenda.


The Pharmacogenomics Research Network (PGRN) is bringing together scientists who study the interactions between genomes and drug response.  This symposium, organized by the PGRN and open to all ASHG attendees and others, explores current topics in pharmacogenomics with sessions on the role of genetics in drug development, pharmacogenetic implementation, multiple genome considerations and precision drug therapy.  In addition, a joint session with ASHG on Day 2 will focus on drug development for rare genetic diseases and immunopharmacogenomics.

We hope this symposium will help bridge the pharmacogenomics and genetics communities and enable scientists to identify new opportunities for advancing research in basic and translational pharmacogenomics.

The agenda includes the following sessions (scroll down to view full agenda):

  • Session 1: The Role of Human Genetics in Drug Development from Target Identification to Clinical Trials
  • Session 2: Challenges and Opportunities in Pharmacogenetic Implementation
  • Session 3: Dual Genomes in Pharmacogenomics
  • Session 4: Panel Discussion on Genomics and Precision Drug Therapy
  • Session 5: Pharmacogenomics: Rare Diseases and Rare Adverse Drug Reactions
  •     Part 1: Drug Development for Rare Genetic Diseases
  •     Part 2: Immunopharmacogenomics