Wednesday, November 22, 2017

Very Brief Blog: Updated Resources for Center for Innovation Reform & New Directions

In September, with a WSJ editorial, CMS Administrator Seema Verma kicked off an open comment period on ways that CMS could adapt and improve the Center for Innovation (aka CMMI).   (Here).

The comment period closed on November 20, and several public comments are available now.
  • The Center for Healthcare Quality and Payment Reform issued a 20 page whitepaper, here.
  • Hospitals:
    • The American Hospital Association made its CMMI comments public in a 17 page letter, here.
    • Federal of American Hospitals, 17 pages, here.
  • Digital: 
    • Healthcare Informatics trade journal, here
    • Electronic Health Record Association (EHRA), 3 pages, here.  
    • American Telemedicine Association (ATA), 4 pages, here.
  • Premier made public a 19-page letter, here.
  • Physicians:
    • Review of physician group comments, at MedPage Today, here.  
    • Internists' viewpoint at MedicalXpress, here.  ACR, here.
  • See a short review at Fierce Healthcare, here.  And at Healthcare Dive, here.  Becker's Hospital Review, here.
    • Blog by Micklos & Wrobel at Health Affairs, here
    • Open access article by David Pittman at Politico, here.
    • I haven't found any consolidated, open access database for all comments.
  • Kaiser Health News says that Canada admires the CMMI, here.
Get the cited public comments in one zip, here.

To my eye, there are three general topics that CMMI should address to speed all its projects.   

First, CMMI has an amazing (an legally un-tested) authority to waive any Medicare law in the process of doing a demonstration.   However, this legal authority seems clearly pointed (to this non-attorney) at only its demonstration authority, not its permanent project implementation authority.  CMS should figure this out and take a clear position. 

Second, Congress allows CMMI to implement permanent projects when they are certified to be cost neutral or cost saving, and quality neutral or quality improving.  From the extremely limited use of this certification process in six years, there don't seem to be clear guidelines as to how certain is certain enough for certification (no model can perfectly predict later costs and outcomes in a nationwide population).

Both the above topics are fundamental to all CMMI model designs, tests, and expansions, and leaving them fuzzy means that the designers and evaluators don't have clear guidelines and guardrails and targets in the business of  planning for and achieving success.

Third, CMMI has always stated it does not intend to test technologies and services, but rather broad schemes like ACOs.  Yet there are all kinds of technologies that fall outside current narrow or dated rules, and this could be a very fruitful use of CMMI projects.  For example, the Diabetes Prevention Program (DPP) has been the first program shifted by rulemaking into a new, innovative benefit, and it's a technology-or-service.  GAO has encourged CMS to look at cost saving new technologies even when they slip outside current benefit structures (here), but CMS poo-poo'd the recommendation.  

It's easy for some projects to be cost-saving and yet be bogged down in Congress for years.   Congress and CBO rated a telehealth expansion (targeted to fixing certain nuances of Medicare Advantage financing rules) as cost-saving for CMS and taxpayers yet it's bogged down on the Hill for several years without passing.  Dumb!   (It might be moving now, by extracting current HR 3727 from a slow moving Senate bill CHRONIC, and then tacking HR3727 onto a pending Medicare Extenders omnibus bill.)  The point is it takes the Hill 3 years or more to pass even an endorsed, cost-saving slam dunk bit of legislation, and CMMI could accomplish this in two hours.  



Tuesday, November 21, 2017

Very Brief Blog: ACLA Again Asks CMS to Stop PAMA Implementation

CMS released final PAMA rates on November 17; ACLA has issued an urgent press release  asking CMS to stop implementation of PAMA.   See ACLA webpage, here; PR Newswire here.


How To Comment on CMS 14 Day Rule Revision Errors

On November 2, CMS released outpatient hospital final rulemaking for CY2018.   CMS revised the "14 Day Rule," with the general intention that genomic tests that are currently billable by the hospital, on outpatients, in less than 14 days, can be billed by the performing reference laboratory.  Thus, the rule should be cost neutral while shifting the pains and burdens of billing MACs to the reference laboratory.

However, CMS struck some unusual positions in the rulemaking. 

The rule hinges on "molecular tests" (which CMS does not define very clearly in the first place), while excluding "PLA code tests and genomic procedures."   Since CMS has already been classifying genomic PLA code tests and GSPs as "molecular tests" that are billable by the hospital, "Status A," and CMS has introduced no new modifiers or status indicators for implementing the new 14 day rule revision, the exclusion by of some Status A tests by"text" and the inclusion of the same tests by "status indicator A" in tables is confusing. 

In addition, CMS had proposed in the original rulemaking that it would include ADLTs of the MAAA type (Type 1) but exclude ADLTs of the FDA approved type (Type 2).   You would only have noticed this if you had read the proposed rule citations and cross-references to regulations by number extremely carefully.   The world is still waiting for CMS to create ADLT application forms, but some tests would qualify for both Type 1 and Type 2 ADLTs, or shift from Type 1 to Type 2 based on a new FDA approval, and since all ADLTs are sole source and not performed by the hospital, the rationale is unclear.  Also, why classify ADLTs as in or out based on FDA approval when other molecular tests are "in" (such as EGFR or BRAF tests) regardless of FDA approval.

To my understanding, CMS's internal definitions of "molecular pathology tests" relative to the 14 day rule have mostly been intuited by reading what tests they do and do not classify as "Status A" for hospital billing purposes on a rolling basis.[*]   Those billing status classifications - including for 2018 - simply don't match the verbal text of the final rule.   Also, it makes no sense to exclude PLA tests that are genetic tests, or genomic sequencing procedures that are generally less expensive than code stacking the relevant single genes.   These comments about excluding PLA and GSP codes appear only in the final rulemaking so the world didn't have a chance to tap CMS on the shoulder until now.

CMS formally only takes comment on "new" things appearing in the final rule.  CMS proposed no regulation in the July rulemaking, so the whole regulatory text for 14 day rule is "new."  Also, it appears CMS has made clear errors in the verbal text relative to the intended concepts.  All CMS remarks about PLA and GSP tests are "new."  The public can make comment to CMS now.

I've made a ZIP file that contains all the documents that might be relevant to a comment.  This includes
  1. The original July rule proposal;
  2. The final November version;
  3. Addendum B, which classifies all CPT codes by outpatient billing status;
  4. Addendum D, which explains the cryptic status indicators;
  5. Current text of 42 CFR 414.510, including the new section created by rulemaking this month.
In Addendum B, I've tried to collate all the U codes, M codes, and molecular CPT codes on one sheet, since they are scattered in different places in the CMS spreadsheet.  I might have missed something, so the entire 16,000 line original table is also there.

The Formal Comment Page is here.
The ZIP FILE is here.

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[*] I flagged this obscure phenomenon for readers back in May, 2017, here.  (I also noted then that some of the "A" classifications appear wrong by CMS's own protocols. For example it generally excluded genetic sequencing of pathogens but erratically included one or two.)


Friday, November 17, 2017

CMS To Abandon Longstanding Chemistry Panel Pricing in 2018, Opening a Two-Billion-Dollar Vulnerability

CMS has long had complex, manualized rules (not present in regulations) for pricing clinical chemistry panels. These panels are a "big deal" - $700M a year, and panel pricing saves AT LEAST $50M a year (see my article here), but may save several times that, because of current behavioral incentives not to report partial panels.  And if panels were priced at the summed cost of analytes, with no panel discount, payments would be over $3B, not $700M.

CMS will discard its longstanding chemistry panel pricing in 2018.   While CMS says it will "continue to review the issue," based on 2016 data already available, payments for analytes will go up at least by $40-50M dollars and potentially more, because there will be brand new massive incentives to submit partial panels of analytes for line item payments that are multiples of the panel price.  Why bill a 15 analyte panel for $13 when just 14 analytes will pay $75?  (See analysis at bottom).  

CMS writes,
How will CMS determine the price of automated testing profiles (ATPs) under the private payor rate-based CLFS payment system?
     For CY 2018, payment for tests that were bundled into ATPs will instead be made at the individual HCPCS code level. In other words, we will pay for each appropriately billed HCPCS code based on the CLFS amount for the specific code billed by the laboratory.
     Moving forward we will continue to consider the efficiencies of ATPs and the appropriate payment methods for these tests under the new private payor rate-based CLFS.
     Medicare administrative contractors will continue to apply editing to ensure that if a laboratory panel HCPCS code is submitted and is payable, an individual laboratory HCPCS code that is part of the same panel is not also paid separately
My answer: OK, we'll see how that works for you.


EXAMPLE - Two Billion Dollars of Free Money !




For example, the 15-analyte Comprehensive Metabolic Panel is the most popular panel, with 29M orders in 2016 and $323M in payments (CMS Part B; code 80053).   The new price for 80053 in CY2018 is $13.04, as set by PAMA.

However, at 2018 prices, the 15 analytes add up to $82.88.   If you leave off any one analyte - almost all of which are $5-6 - the remaining 14 analytes will pay about $75.  

Back of envelope math suggests that if, with the maximum behavioral element, all 29M panels were ordered in the 14-analyte format, CMS payments would rise from 29M x $13.04, or $377,000,000, to 29M x $75, or $2,175,000,000 (over $2B).   That's almost two billion dollars of free money in 2018 alone!

Check my math.  It's about $18M more taxpayer money automatically paid out for every 1% of tests converted from 80053 billing to 14-analyte billing, so eventually at the maximum, with 100% converted, the payout is about $1.8B higher.

Click to enlarge.

Note - You'd want to delete a code that disables several panels at once, such as "chloride," otherwise some of the 80053 line items codes would condense around some smaller panels and shrink the payment away from the item maximum. 

Use Secretary of Health Units of Measurement that People Can Understand

Just 5,500 tests converted to N-1 billing (0.01% of tests out of 29M tests) would cost CMS $400,000 - the same dollar amount that Secretary Price was fired over.

CMS RELEASES FINAL PAMA LAB FEE SCHEDULE FOR CY2018

On November 17, 2017, after market close, CMS released the final PAMA fee schedule for 2018.   This is a new lab fee schedule based on market rates surveyed over the past year.

CMS also issued final crosswalk/gapfill determinations for new codes for 2018.

See all files online at CMS, here.   Note that the Excel spreadsheet is only PAMA-based prices (codes used in 2016 and priced based on 2016 data; no new 2017/2018 codes).    CMS issued a separate PDF of new crosswalk/gapfill prices.

CMS commented that it is still working on an ADLT application, which is overdue.

Crosswalk/Gapfill: Unprecedented Number of Price Reversals

CMS handled 127 agenda items in the gapfill/crosswalk process.  This included new standard CPT coedes, new PLA codes, codes crosswalked in 2016 and re-crosswalked to the same values again due to a technicality, and codes lacking prices in the PAMA reporting process. 

An unprecedented proportion of codes, 51/127, or almost half, had price changes between the proposed and final version.   This includes about 35 of the first 59 decisions (over half), which were on new or reconsidered codes.[*] 

While only one or two codes were referred to "gapfill" in the initial proposals, 20 are referred to the contractor gapfill process in the final decision.   This includes several codes that seemed to almost spontaneously jump to gapfill, after CMS and panelists had already settled on a crosswalk.    In some cases this made a lot of sense; the "genome" sequencing code was proposed as a $600 crosswalk, even though the "exome" sequencing code had a PAMA price of about $3000.   In the final version, "genome" will be gapfilled.

CMS proposed a number of MAAA tests with list prices in the $3000 range to be crosswalked to the Cologuard test 81528, about $500.   Such codes were finally crosswalked to 81519, Oncotype DX, circa $3400, in the final decision.

Several novel gene panel tests, such as for neuropathies, were crosswalked to the Lynch syndrome or colorectal gene panel test, 81435.  This is unfortunate as this code received an unbelievably low PAMA price of $38 (!), although it will only fall in 10% increments from the 2017 price of about $800. 

PAMA Policy

CMS released a PDF with some comments on its PAMA policy (basically, nothing in the PAMA pricing files or medians changed.)   CMS recognized there were illogical outlieres, like 1 penny or $99,999, but did not discard these because they would have little impact on medians.   CMS discussed again its limited use of hospital reference lab data.

CMS dealt with a few odds-and-ends, such as special price rules when the NLA is 0 but some local fee schedules are grater than zero; and a few special statutory prices such as HA1c and Pap smears.   CMS corrected a few phase-in prices that were wrong due to "transcription errors." 

Panel Pricing Chaos - Or Boondoggle?

The biggest announcement was that CMS will suspend its automated test panel aka clinical chemistry test panel rules effective January 1, 2018.   These rules forced payments for single analytes to always be lower than a corresponding panel.  Now, partial panels can receive a la carte stack prices that are higher than the panel the analytes are found on.   It would not be surprising to see a Congressional fix of 10 or 20 words to repair this, since it will cost CMS $50M or more per year (see here).  For example, 15-test-code 80053 is used about 30M times per year.   The panel payment will be $13, but any 14 analytes will add up to $75 at a la carte prices.  At the $13 rate, CMS payments will be around $380M, but if every doc prudently ordered a smaller, 14-analyte or "N-1" panel, CMS payments would be about $2.2B.   For every 1% of docs that orders the 14-analyte panel, CMS gives out $18M extra.

___
[*] Action count based on word search of the boilerplate phrase "We initially believed."  Gapfill count based on the phrase "CMS and its contractors..."

Very Brief Blog: CMS Releases Proposed Rulemaking for Medicare Advantage CY2019

On November 17, CMS released annual proposed rulemaking for Medicare Advantage, with updated proposals for CY2019.

The document (713 pp) is online here.   Comments are open until January 16, 2018.   For an early trade journal summary, here.  

CMS expects beneficiary costs to drop, more choices to be available, and enrollment to increase almost 10% to 20.4M.   CMS is also trying to shift cost savings in drug plans to be passed through to beneficiaries rather than to first benefit PBMs.  The rule handles both Medicare Advantage health plans and Medicare Part D drug plans, although the former usually include the latter.

In other news, a House "Medicare Extenders Bill" - a perennial exercise - is in the works.  This is a recurrent grab bag of small renewable "fixes" to the Medicare Act.  Here.

Thursday, November 16, 2017

Brief Blog: Links, White Paper for "Digital Therapeutics Alliance"

In late October 2017, a new digital health organization, the Digital Therapeutics Alliance, was launched.   See trade press at MobiHealthNews here, at Dive Health here.

The organization now has an elaborate website, here.



The Digital Therapeutics Alliance is also holding its European launch in conjunction with the November 16-17 "Frontiers Health" conference in Berlin.  See press release here.

Concurrently, the Alliance has supported a 32-page white paper on digital medicine, "The Future Is In Policymaking, Paying, and Protecting."   The home page to download the white paper is here.







Wednesday, November 15, 2017

FDA Creates New Pathway for NGS Tests in Tumors under 510K Clearances

On November 15, 2017, the FDA and Memorial Sloan Kettering Cancer Center (MSKCC) announced a landmark new approach to NGS diagnostic test approvals.   The pathway will be a special 510(k) approval for genetic tests in tumors. 

Previously, FDA had declined to approve such tests under 510(k) because of the assumption, by the FDA, that the genes reported would serve as drug selectors, and must be approved under the PMA route.  For for the first time, tumor genetic tests will be certified on accuracy rather than requiring a direct correlation between the accurate gene analysis and a clinical outcome.   Just as glucose or sodium tests are approved based on accuracy, this is a positional outcome that was going to come sooner or later for the FDA, but the timing was unpredictable (whether 2014, 2017, or 2020).
The posture the FDA strikes is that the tumor gene analysis (e.g. finding an EGFR mutation or ALK rearrangement) is reportable to the doctor and cancer patient but "is not conclusive for use of a therapy" under a 510(k) test, whereas a PMA test of the same gene with same method and same result would be "conclusive" for therapy.   FDA has decided to live with the fact it has two nearly identical sounding product categories (PQM (of the PMA type) and PQZ (pf tje 510k type)).  Maybe someone at FDA used to say, "We couldn't do that," and now someone else has said, "Sure we can.  We just did."
  • See press release at FDA, here.  
    • See the FDA's new one-page "Fact Sheet," here.
      • The Fact Sheet explicitly compares PMA clearance of Thermo Fisher Oncomine Target Dx and 510(k) clearance of MSKCC IMPACT.  
      • Only the PMA test can make clinical companion diagnostic claims.  (Oncomine approved under Class III Product Code PQP, here.)
      • Apparently, a 510(k) test can assert genes with "evidence of clinical significance" or the lesser "potential clinical significance."
      • Regulatory Category is 21 CFR 866.6080, "NGS Tumor Test," and was created in April 2017.  To my eye, it's found at FDA.gov but not at the federal CFR, which is quirky.
      • IMPACT uses "Product Code PZM," different than the Oncomine product code PQP.  
        • For some deep dive comments and links on 866.6080, PQM, and PQZ, see side blog here.
  • See news at OncLive, here.   At RAPS, here.  At Medscape, here.  At Endpoints News, here.  At Genetic Engineering & Biotech News, here.  At Fierce Healthcare here, including aspects of data sharing.
    • See Genomeweb (subscription), here.   
    • Second Genomeweb article with strategic analysis, here.
      • The second Genomeweb article notes that MSKCC is working on clearance for CNV, dup/del, and total mutational burden (TMB).
  • Specific to the IMPACT clearance and classification:
    • The FDA immediately released its 57-page Decision Summary (here).
      • At least part of the annotation used in IMPACT reflects the OnkoKB database; see article here.
    • The De Novo 510(k) Classification Order (7p) is here.
      • This legally downclassifies the product (and future product category) from PMA Class III to 510(k) Class II via the de novo reclassification and clearance method.
The newly reviewed test, IMPACT, includes 468 genes and MSI testing.  Earlier in November, MSKCC had highlighted its role in the first approval of a drug and gene combination based on a "basket trial," here

FDA recently announced a "precertification" approach to approval of genetic health risk germline tests (here) and a precertification approach to some digital health software (here).

The 510(k) clearance pathway is closely linked to New York State Department of Health approval.  FDA states:
Moving forward, laboratories whose NGS-based tumor profiling tests have been approved by NYSDOH do not need to submit a separate 510(k) application to the FDA. Instead, developers may choose to request that their NYSDOH application, as well as the state’s review memorandum and recommendation be forwarded to the FDA for possible 510(k) clearance. 
The full FDA press release is clipped below the break. 

The tumor sample is apparently run with a matched normal DNA sample "when available" (or else an "unmatched" normal DNA sample.)  The FDA intended use statement is:
The MSK-IMPACT assay is a qualitative in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed paraffin-embedded tumor tissue matched with normal specimens from patients with solid malignant neoplasms to detect tumor gene alterations in a broad multi gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. MSK-IMPACT is a single-site assay performed at Memorial Sloan Kettering Cancer Center.
Publications for the IMPACT test include Zehir et al. (May 2017, Nature Medicine), finding that 37% of 10,000 patients had an actionable mutation.   Mandelker et al. (September 2017, JAMA), conducted universal screening for germline risk mutations in 1000 patients who were undergoing tumor gene testing anyway.   They found many more germline risk genes than would have been found if only a subset of patients (getting tumor testing) had had guideline-based germline testing.

Very Brief Blog: Technology for Precision Health Summit, SF, December 12, 2017

Health 2.0, a HIMSS "innovation company," brings the Bay Area a one day conference called "Technology for Precision Health."   The venue is the Julia Morgan Ballroom in the SF financial district.   Registration is $899.[*]

Conference website here.   Agenda here  Promo for the conference at THCB, here.

The conference summary is here:
     Precision Medicine has come a long way in the last 10+ years thanks to advances in diagnostics, computing, and consumer tools. The ongoing quest to better understand disease predisposition and prevention through genomic and environmental factors is key to increasing the quality and length of life. Technology for Precision Health will explore how technology can help.
     How can we think differently about gathering, analyzing and sharing information? Which incentives can be offered to structurally change the system toward longer term care of patients? Which mechanisms will empower patients with their data and create virtuous partnerships with providers to truly drive value? Conference delegates will learn about the latest tools in Precision Medicine and Health as well as be part of the discussion on new ontologies and policy changes needed to bring these technologies to patients.



_____

[*] A discount is offered for joint registration in this summit and the January 8-10, 2018, Medtech and Digital Medicine Showcase conference that parallels JP Morgan in SF.

Tuesday, November 14, 2017

Very Brief Blog; Ceratto & Halamka Release Book on Precision Medicine

This fall, Academic Press has published a new serious book on precision medicine by Paul Cerrato and John Halamka.   Halamka is CIO of Beth Israel Hospital in the Harvard system. 

The book is available from Amazon here

See interviews with the author at MedCityNews here,  and at Healthcare IT News, here.


Brief Blog: AMA Supports New Policies for Precision Medicine

See an article in the November 14, 2017 FierceHealthcare covering a new 15 page report by the AMA House of Delegates supporting better access to precision medicine. 

  • FierceHealthcare article, here.
  • Full AMA report online at AMA, here.
  • Cloud version of the 15 pages re: Precision Medicine, here.
The report in part collates existing AMA positions on precision medicine, and adds new material.   For example, the new report highlights AMA's (and CAP's) support for the "LCD Clarification Act," see prior blog here.   The report discusses AMA's (e.g. CAP's) unhappiness with some Palmetto GBA (i.e. MolDx) LCDs.   

The report recommends some homework for AMA:  collating and merging 7 existing policies in precision medicine.   It also cites some allied topics, such as the need for precision medicine integration with EHR's and digital health.   The report concludes with 13 recommendations and has a 22 publication bibliography.    


Thursday, November 9, 2017

Very Brief Blog: Most Active Investors in Diagnostics & Tools (Silicon Valley Bank Report)

At the SoCal Bio digital health conference this week I had the chance to talk to staff from Silicon Valley Bank, who pointed me to their mid-year investments report.   The report is available online here.   A screenshot show the most active investors in diagnostics & tools, by number of deals.

AME Cloud Ventures is led by Jerry Yang, co-founder of Yahoo.  Investments in genomics include Color Genomics, uBiome and Whole Biome.  Khosla Ventures manages investments in genomics firms like Color Genomics, Genalyte, Guardant, and Whole Biome.

click to enlarge

Footnote: San Diego-based  Genalyte is the company working on a one-drop-of-blood compact fast multi analyte test that isn't Theranos.

Wednesday, November 8, 2017

Very Brief Blog: Nature Reviews: Flurry of Articles on Tumor Evolution and Resistance

Nature Reviews publishes a flurry of articles on tumor evolution and drug resistance.  Some appear in Nature Reviews Cancer, focusing on biology; others in Nature Reviews Clinical Oncology, focusing more on therapy.

An open access article by Maley et al reviews "evolutionary and ecological features" of cancers.  This is an open access article that includes proposals for new terminology and standards.  Here.

Dagogo-Jack and Shaw review the general topic of tumor resistance and heterogeneity, here.   Rotow & Bivona review development of resistance specifically in NSCLC, here

Along this line, see also a new paper by Blakely et al. in Nature Genetics on the complexity of EGFR and passenger mutation profiles in NSCLC; here and Genomeweb here.    

Her2 Patients Should Be Subdivided
Also in the field of precision and biomarkers, Gingras et al. argue we have to get into subdivisions and precision within the class of Her2-positive cancers, here, describing the status quo as "lost in translation" and creating a plateau in patient benefit that we shouldn't accept.  Nishino et al. update readers on the current state of checkpoint biomarkers (and confusion) in immuno-oncology, here.

$205M for Women's Molecular Diagnostics: $125M Progenity, $80M Counsyl

Within hours of each other, two molecular labs focusing on women's health raised collectively $205M.

Counsyl raised $80M (here).  Progenity raised $125M (here). 

In other news, on November 7, a publicly held company in germline genetics, Invitae, had a stock pop of 13% based on growing revenues (here.)   Invitae announced a $73M private placement offering a couple months ago (here).  Germline genetics company Ambry recently sold to Konica Minolta in a deal valued up to $1B (here).

Tuesday, November 7, 2017

FDA Announces "Pre-Certification Route" to Genetic Test Approvals for Germline Risk Tests

On November 6, 2017, FDA announced a new rout to review of "genetic health risk" germline tests.

Detailed article at MedCityNews, here.  Genomeweb here.  The FDA's press release, here.

Flagged Online at FDA on September 26

Gottlieb actually flagged this Pre-Cert approach clearly in late September, but few picked up on it.  See my blog entry on September 26, here.  In a speech at Advamed, which was reported by MedCityNews and others at the time, Gottlieb said that "we need some legislation" on LDTs. 

However, if you dug around on the FDA website at the time, you could see the "official prepared remarks" -- which were a little different from the actual speech.  Here's what we found at the time.

In the "official prepared remarks," online at FDA.gov, Gottlieb had a script for talking about the newly released "pre cert" process for digital health software, and was to have remarked verbally that this would be a "basis for a modern legislative approach" to LDTs.  However, this sentence didn't appear to occur in his verbal remarks from the Advamed podium.

For an FDA press release on the Digital Health Software Pre Certification Program, see here.

FDA's Key Text Released November 6

Returning to the new genetic health risk (GHR) framework, here's a quote from the new FDA press release:
Today, the FDA is taking steps to implement a novel regulatory approach for the regulation of GHR tests that applies proper oversight in a flexible, new way. It builds on the important lessons we learned from the FDA’s authorization of the first GHR and carrier screening tests sold directly to consumers. Specifically, today the agency issued a notice of its intent to allow GHR tests to be exempted from premarket review under certain conditions. If and when finalized, manufacturers of these types of tests would have to come to FDA for a one-time review to ensure that they meet the FDA’s requirements, after which they may enter the market with new GHR tests without further review. The agency also established special controls for these tests in a separate de novo classification order, which outline requirements for assuring the tests’ accuracy, reliability and clinical relevance and describe the type of studies and data required to demonstrate performance of certain types of genetic tests. This approach is similar to the proposed firm-based, pre-certification model that we developed for digital health technologies.

These Important Wheels Starting Turning in February 2015

Note that this process builds on groundbreaking approaches to genetic test policy created for 23andMe a couple years ago.   We described this as a sea-change in the FDA's approach to molecular approvals in a deep dive essay back in February 2015.