Saturday, December 15, 2018

Very Brief Blog: ObamaCare "Struck Down;" Actual Ruling Here; Judge Tosses CMMI in Trash

Every news website today leads with news that "ObamaCare has been struck down."   Rarely, an article provides a link to the actual 55 page ruling.
  • NPR article summarizes ruling here.
  • Actual 55 page judge's ruling here.
    • The judge opens by writing, "A court must determine whether the Constitution grants Congress the power it asserts."
    • The ruling has a whole has a number of instances of clever writing.
Washington Post notes that the ruling was not unexpected as the judge was highly critical of Democratic state attorneys-general pro-Obamacare arguments in an earlier hearing (cited here).  Not helping would be the Administration's determination in June not to defend the ACA against this court action to terminate it.

The Jenga Game

Recall that several years ago, Supreme Court ruled that ObamaCare was constitutional under Congress's taxation authority.  A mandatory tax element (for having no insurance) has been later discontinued by the Tax Cuts and Jobs Act of 2017.   The theory here is that with a razor thin majority in the Senate, the Congress couldn't repeal ObamaCare, but they could repeal one sliver of it, which might lead the rest to topple via a subsequent judicial ruling.   (See Jenga game, here.  Judge writes, the 2010 Congress enacted the ACA, the 2017 Congress sawed off the last leg it stood on (p.54).)

Nothing is Severable:
ACA as Consumer Insurance vs ACA for Medicaid & for CMMI 

WaPo writes that the judge concluded that the insurance requirement was "essential to and inseparable from the remainder of the ACA," while adding that by contrast, in June, US DOJ itself asserted that other than some insurance industry consumer protections, "many other parts of the law could be considered legally distinct and thus can continue."
  • For example, Congress has passed many laws on Medicaid and part of ACA expands Medicaid.  
  • The Patient Center Outcomes research institute is a creation of ACA.
  • ACA created CMS Center for Innovation, which has been a showpiece of several 2018 Trump administration efforts, including a bold recent one to potentially benchmark US Medicare drug prices to European average prices.   
    • That high-visibility Trump proposal stands on top of the CMMI authority, which is inside the ACA, which is axed by this ruling.  
Judge C'Connor does not parse the diverse parts of the ACA, but writes simply that "the Court adheres to Congress's textually expressed intent and binding Supreme Court precedent to find the Individual Mandate is inseparable from the ACA's remaining provisions."  

The judge continues that: "the ACA includes many other integral regulations," but cites by name only those related to conventional insurance, e.g. children remaining on parents' plans to age 26.  He simply describes the ACA's "hundreds of minor provisions [in] 900 plus pages of legislative text" as "complement[ing] the above mentioned major provisions."  After citing an 1879 case about the limits of judicial construction (e.g. to limit a part of a statute), and remarking that "federal courts lack a roving license to flip through the US Code with a red pencil," judge concludes that ACA, Public Law 111-148, as a whole, is invalid.

See here:



___

Severability - More.

Judge acknowledges that defendants do make arguments that, "by eliminating the shared-responsibility payment [AND] leaving the rest of ACA intact, Court should infer that Congress intended to preserve the balance of the ACA." (see page 52-54). 

In addition to citing an 1879 case about the limits of judicial construction [court not competent to pick and choose among parts of ACA], see lengthy footnote 34 about arguments in favor of more severability within the ruling.  Arguments to 1928 case, Frost.  Quotation that "Frost's bite is not available [here.]"  Adds:  Frost is not a license for courts to reach out and hold unchallenged constitutional acts unconstitutional as a remedial safety valve...Because of how Texas structured its challenge, the district court [e.g. the writing judge]  is presented with a narrower menu of options with respect to severability. No one—not the Plaintiffs, not the Intervenors—has challenged the constitutionality of the TCJA. Federal courts lack a roving license to flip through the U.S. Code with a red pencil to void one statute in order to save another."

____

Jenga - More.

I wrote above that the Congressional act of 2017 foreseeably led to the 2018 court ruling.  The judge acknowledges that, as written above.  He notes that Congress did not strike down the Individual Mandate but rather the tax based on the individual mandate.  But the Individual Mandate, solo, had been ruled unconstitutional, at which point we only have the ACA since it was saved by the existence of the tax, since Congress has tax authority.  But now, Congress has deleted the tax-text.

He also doubles down on the message:

"The 2010 Congress memorialized that it knew the Individual Mandate was the ACA keystone; Supreme Court stated repeatedly that it knew Congress knew, and knowing the Supreme Court knew what Congress had known...."

Thursday, December 13, 2018

Very Brief Blog: AMA Posts Agenda for February 2019 Mtg; Dullsville for Lab Tests

The next AMA CPT meeting will be February 7-9 at the Westin La Paloma in Tucson (overall agenda here). 

Thursday February 7 is the CPT annual meeting, mostly policy updates and discussions.  February 8-9 is the Editorial Panel session for new codes.

The new codes have been posted.   If you were interested in commenting on lab codes, the public posting was November 19 and comments to November 30.   If you are interested in seeing and perhaps commenting on other codes, they are posted December 7 and comment open to January 17.  See the code level agenda here.

For the lab industry, not much.  Tab 13 deletes administrative MAAA code 0009M.  Stay awake, there's more.  Tabs 14 and 15 elevate Tier 2 codes to Tier 1, which is good news for fans of Palb2 or PIK3CA.   Tab 24 would create a Category III code for a stem cell cytotoxicity assay (my guess is this could have been proposed either as Cat III or PLA). 

About 50 Category III codes (as old as 0058T and as new as 0405T) are scheduled for a sundown discussion (more like sunset, I'd say).   

Wednesday, December 12, 2018

Very Brief Blog: My Brief Adventure with DTC Testing

Having worked in genomics policy for years, I have never explored DTC testing.  I ordered panel testing from Color and microbiome testing from Ubiome. 


Ubiome 

Ubiome testing was easier than I thought (you tap the paper with a swab).  A report took several weeks.  (A) I had no "pathogens," (B) my normal flora was "normal," and a range of I guess (C) particularly healthy bacilli (various lactobacilli) were reported separately.

Color

Kit. Color sent a simple kit with an empty vial to spit into.   After about 30 days, it provided a hereditary cancer panel, a heart health panel, and so far at 6 weeks has reported 2 of about 14 CYP genes. 

Cancer & Cardio.  I had no hits on the cancer panel (recall that the general prevalence of e.g. BRCA is well below 1%).

This wasn't surprising; Color "warns" you, so to speak, that most people will be negative in their tests.  And my extended maternal/paternal history is unusually negative for any cancers. 

I also had no hits on the cardio panel either (and I have no family history for A-Fib, for sudden death, or for familial hypercholesterolemia). 

CYP.  The first two available CYP genes came with strong click-through warnings not to change any meds without talking to a physician.   I was normal (intermediate) for CYP2C19 and CYP2D6. 

Color tells me that twelve more pharmacogenetic genes will be reported, but in up to six months.  I'm curious if I'm slow for CYP1A2, since I'm hypersensitive to caffeine.

Caveats.  I assume these tests look for the more common variants and if they aren't there, the default is "normal."

Glitches.
  • Despite clicking around, I couldn't find a list of the 12 (yet to be reported) CYP genes.
  • Despite clicking on a cardio link that promised "learn more about these genes," I didn't learn anything.  
    • So I'd be left googling Wikipedia to figure out what cardio gene MYH7 was.   
    • (I can guess that KCN and SCN are K+ and Na+ channels, but maybe my PhD in neuroscience helps there.)
  • The "learn more" click for cancer was more helpful; for example, I learned if my APC gene was positive I'd have a very high risk of CRC. 
  • Based on the various direct-to-consumer email traffic to me from each company, I believe each test was "ordered by a physician," somewhere, based on my age/sex/and very basic clinical checkboxes during enrollment.


___

Cardio genes were:  ACTA2, ACTC1, APOB, COL3A1, DSC2, DSG2, DSP, FBN1, GLA, KCNH2, KCNQ1, LDLR, LMNA, MYBPC3, MYH11, MYH7, MYL2, MYL3, PCSK9, PKP2, PRKAG2, RYR2, SCN5A, SMAD3, TGFBR1, TGFBR2, TMEM43, TNNI3, TNNT2, TPM1.

Cancer genes were:  APC, ATM, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A (p14ARF), CDKN2A (p16INK4a), CHEK2, EPCAM, GREM1, MITF, MLH1, MSH2, MSH6, MUTYH, NBN, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, SMAD4, STK11, TP53

___


Aside.  While my Color cardio panel was negative, I do have strong maternal/paternal loading for common hypertension of aging, both parents having had poorly controlled hypertension and dying of cardiovascular causes (father 60, mother 80). 

Accordingly, from my early 50s to late 50s my blood pressure switched from around 90/60 to around 150/100, and it seemed completely unrelated to sodium.  A daily generic tablet keeps my BP around 115 instead of 150, so I'm lucky.  I confirm BP control periodically with a Qardio bluetooth arm monitor linked to my iPhone.   But none of this issue is flagged by the Color cardio panel, which looks for rare things like potassium channel mutations.

At the podcast Tech Tonics, Harvard professor Sek Kathiresan recently discussed polygenic modeling of cardiac risk (here).  I might have that; but my hypertension-of-aging isn't something picked up by single disease genes like SCN5A.

Very Brief Blog: Gottlieb TweetWatch: Tweetorial on IVD, Happy-Tweets with CMS

In the past week, Washington news on IVD/LDT policy has included:

  • December 6, Policy outlook/overview by Gottleib and Shuren at FDA, preceding new legislative draft. Here.
  • December 10, Hill releases new 200 page model for FDA legislation.  Here.
    • I've heard that Hill is taking comments til early February.
Perhaps lost in the whirlwind events - today, December 12 Gottleib announced biosimilar policy for insulin - does this guy ever sleep? - were some equally interesting but less high profile Gottleib tweets.  

First, he issued an extended TWEETORIAL on FDA and diagnostic tests, and the differences between IVD/LDT.   See PDF in cloud here.

Second, he traded happy back-patting tweets back and forth with Seema Verma of CMS:



Third, and this went viral, he conveyed a Dr Seuss style poem after CDC warned about hazards of unbaked cookie dough (making CDC the Debbie Downer of the federal twitter landscape):



Monday, December 10, 2018

Very Brief Blog: SUPPORT Act is Federal Legislation Affecting Lab Sales Practices to All Payers

In October 2018, Congress passed the SUPPORT Act, an omnibus opioid abuse legislative package.  An "11th hour" addition, Section 8122, could affect lab practices to all payers, not just Medicare and Medicaid.   Practices include compensation for blood draws, on-site phlebotomists, sales force compensation, etc.
  • Legislation here (Section 8122).
  • Covered in Dark Report, December 3, 2018 (subscription)
  • Open-access discussion at Epstein Becker Green, here.
  • Open-access discussion at Mintz law firm, here.
  • Memo on the ACLA website from Alston & Bird, November 26, 2018, here.
  • Letter from ACLA to HHS re: anti-kickback improvements; letter mentions Section 8122.  Here.
  • Washington Post here.  
At a glance, to me, I would have thought the law applied to relationships between opioid treatment centers and tox labs serving opioid treatment centers.  But it applies to opioid treatment centers OR labs, regardless of whom the lab is dealing with.

(According to Dark Report, p. 9, this is scope is "open to debate" in view of the legislative history and intent, or, "applies to all laboratories and to all services.")   Everyone agrees it's a criminal provision.



____

The law develops out of an earlier bill, HR6878, Eliminating Kickbacks in Recovery Act, EKRA, but the SUPPORT Section 8122 is not exactly the same.

____

Pop Quiz.

What is LEIE?  The HHS OIG list of excluded individuals and entities.  When was it last updated?  Today!     How many entities are on it?  70,847.  How many are entities (clinics, pharmacies, DME suppliers)? 3087.  How many are people?  67,760.  How many are labs?  45.  How many are hospice owners/employees?  35.  Related to infusion centers?  40.  Government employees related to the Health Resources Services Administration (HRSA/HHS)?  3.  Government employee of Substance Abuse and Mental Health Administration?  1.

By the way, if you want someone's name, address, and birthday, without breaking into Target's computers, they're here.  Youngest birthday seems to be April 29, 1990 (28).  There appear to be a couple dozen earlier than 1910, predominantly classed general practitioners. 
____

December 10, 2018: Legislators Release New 200-page Draft Diagnostics Legislation

Last Thursday, December 6, FDA released a rather quirky statement on its intention to encourage innovative diagnostics while regulating LDTs.  LDTs would be regulated by new methods, risk-based, and including "pre-certification" aka self-certification.   The statement, released in a series called "FDA Voices," opened with a statement by Commissioner Scott Gottlieb, then a statement by CDRH leader Jeff Shuren, then a statement from the legal team, Lauren Silvis, focusing on hazards and risks of unregulated LDTs (bad cop?).

December 7, as publicized by Genomeweb here, the Hill has released a new 200-page version of legislation that would greatly reform the FDA's approach to clinical diagnostic tests.

  • See the 200 page legislative online here.
  • It's now called VALID - "Verifying Accurate Leading-Edge IVCT Development Act of 2018."
  • This legislative version follows a prior draft legislative proposal in May 2017, and a 60-page FDA version of a better idea released in August 2018.
    • It includes pre-certification as law, something that FDA has been proposing in speeches and pilot programs.
  • Biocentury here, AACC here.  Sen. Hatch here.
  • I've heard from DC experts that legislators are welcoming comments until early February, and that the 200 page bill has some holes in it, as it was put together quickly.

Can such an act possibly pass in this section?  You can assume not (a couple legislative days left.)  Sen. Hatch (retiring) regrets he will not be around, in 2019, to see the possible future action on the bill.

Stay tuned for CY2019 and a new Congress.


____





Sunday, December 9, 2018

Steeply Falling Valuations: HLI, Nanthealth, Vermillion

Wall Street Journal has posted a story that Human Longevity Inc (HLI) is raising funds under the strictures of a "down round," which has lowered the valuation from $1.6B  eighteen months ago, to $310M today (negative 80%).   The round would raise $25M under rules (WSJ uses the word "onerous") that would protect new investors.   WSJ story here.  MedCity here.   (MedCity links to a cloud term sheet which I don't believe WSJ did (here).)

According to the Journal, employee headcount has fallen from 300 to 150, and "its chief executive officer, chief medical officer and chief operating officer all departed in 2017, according to their LinkedIn profiles."   Google suggests that Chief Technology Officer has also been a rapidly passed-along title.

Other Declining Valuations

Other declining valuations include NantHealth, which was valued at $18.54 on 5/28/2016 and 79 cents per share today (4.2%).   



Another example of downward valuation would be Vermillion, which markets ovarian cancer laboratory tests.  VRML started at $310, on 11/1/2000, during the original internet/biotech bubble.  However, after slipping to $30 in the 2002 selloff, it later rose to $123 in September 2003, falling to 30 cents in December 2008, and rising to $32 in February 2010, related to FDA and CMS approvals.   On December 7, 2018, it closed at 52 cents.  Over the past four years, sales in 2014-2017 at Vermillion are about $2-3M per year, GAAP losses around $10-20M per year.  If you roll back to quarterly investor calls around the time of FDA approval (9/2009) and Medicare LCD coverage (3/2010), I believe (from memory) the company's management forecast was for revenue very near term in $millions, then $10s of millions within a few years.




Tuesday, December 4, 2018

Very Brief Blog: FDA Recognizes ClinGen Database for FDA Genetic Tests

Continuing its effort to smooth new pathways for FDA review of genetic tests of all types, FDA announced it has recognized ClinGen / Expert Curated Human Genetic Data as a database that may be referenced in submissions.

FDA press release (December 4, 2018) here.
For a Twitter message chain, see #fdarecognizesclingen here.



FDA cites its April 2018 guidance on use of databases in genetic test submissions.

Journals and Trade Journals 

Genomeweb covers the December 4 ClinGen story here, and cites back to a recent article in Genomeweb here about a special issue of the journal Human Mutation, here.   Volume 39, Issue 11, November 2018, had a series of open-access articles on ClinGen and Clin Var.



Very Brief Blog: FDA Releases 20-page Device De Novo 510K Proposal

As FDA promised in recent weeks, it has released new policymaking that would update and codify the existing de novo classification process.  De novo requests have risen from 22 in 2012 to 100 in 2017.
  • The published copy of the rulemaking is online here.  83 FR 63127-46, 12/7/2018.  
    • Comment is open for 90 days (March 7).
  • See a detailed pre-release discussion by MedTech Dive here.
  • Press at Genomeweb here.  News at RAPS, here.   
  • Nice review at Forbes by Yiannis Mouratidis, here.
Rules will be placed at 21 CFR 860.1, and under a new Subpart D to Section 860 when finalized.

In part, FDA states that the new rulemaking will increase the clarity and efficiency of the process, and (my reading) place into formal regulations some rules that may be similar to various prior guidances (some of which which FDA cites).  Regulations also have the force of law, which guidance documents do not have.

The de novo process dates to 1997 and was "streamlined" in 2012 by allowing direct classification of some new devices into the de novo process, no longer requiring a rejected 510(k) application.   My sense is that FDA has proceeded for years by policymaking by "guidance" and "process" and has not kept 510(k) or "de novo" regulations up to date.  (See here; for more background here and here).  Here, FDA dusts off 1998 regulations lost to the sands of time at 21 CFR 860 and updates them to reflect current statute and processes.

See the 17 page October 2017 De Novo guidebook here.

Context

Class II Exempt-from-Review Changes

In other 510(k) news this year, FDA published rules regarding when Class II devices would be exempted from review in June 2018 (final rule 83 FR 25910), here

This includes some direct to consumer genetic risk tests used for wellness purposes, for example.   See FDA's regulatory classification for genetic risk tests at 21 CFR 866.5950 (issued November 7, 2017, revised June 5, 2018), here.  FDA received at least one comment that it was making genetic test review too easy.

Last Week's News: Making 510(k) More Rigorous

Today's FDA regulation on 510(k) de novo is separate from a press announcement on November 26 that FDA would seek to toughen up 510(k) predicate usage, here.   Takeaway: To the extent that 510(k) predicate usage is made more rigorous, more tests would be shunted into the 510(k) de novo pathway.   So they are trying to oil the path for de novo before those new devices are shunted into it.

___

Forbes author Mouratidis recently reviewed AI in pharma trials, here.

Friday, November 30, 2018

Very Brief Blog: GAO Releases Report on CMS Lab Overpayments and Risks



GAO has issued an unusual report that implementation of PAMA lab pricing "May Lead to Billions in Excess Payments."   This will probably be a head-spinning conclusion, to anyone watching lab payment rates fall annually under PAMA.
  • The GAO report home page is here.
  • The one page summary is here.
  • The full 47 page report is here.
    • See comments in response, from HHS to GAO, page 38-40.
    • Footnote 67 on page 30 references a House report language request to CMS that I cited in a blog on August 31.

I think I was one of the first to report in 11/2017 on the potential implications of CMS dropping its longstand practice not to pay more for clinical chemistry panel components than it would pay for the clinical chemistry panel.  GAO picks up this same issue in its summary now in 11/2018. In addition, their Figure 6 page 29 almost exactly replicates the figure I published in the bottom of my blog in 11/2017.
CMS stopped paying a bundled payment rate for certain panel tests (groups of laboratory tests generally performed together), as was its practice prior to 2018, because CMS had not yet clarified its authority to do so under PAMA, according to officials. CMS is currently reviewing whether it has the authority to bundle payment rates for panel tests to reflect the efficiency of conducting a group of tests. GAO estimated that if the payment rate for each panel test were unbundled, Medicare expenditures could increase by as much as $10.3 billion from 2018 through 2020 compared to estimated Medicare expenditures using lower bundled payment rates for panel tests.

Very Brief Blog: CMS Releases First Transmittal on NCD for Cancer Tumor Testing

In March 2018, CMS released its ground-breaking National Coverage Determination for next generation sequencing tests used in oncology. 

CMS has released its first official "transmittal to contractors" (MACs) on how they should implement the NCD.   This transmittal primarily replicates the effective coverage text of the NCD, and includes a long list of oncology codes that support payment under the NCD.   (The ICD-10 codes must be associated with patient qualifications, such as having advanced/metastatic cancer.)
  • Download the November 30 transmittal here
    • The PDF was very slightly updated after its initial release to clarify that one long set of ICD10 codes in the back (all solid tumor oncology codes) are for FMI CDx, and a one page set of lung codes is for Thermo Oncomine 0022U.
  • Since the NCD does almost nothing except cut/paste/replicate the NCD text, along with the full cut/paste of the ICD-10 oncology code list, it's unclear why it took eight months to be issued.

Workload and task instructions in the transmittal at 10878.4, 10878.5, request MACs to work collaboratively to ensure consistent editing and attend "up to 4 one hour calls" to discuss implementation of the NCD and to provide consensus recommendations on implementation in a "final report to CMS" (10878.5).


What This Is Not

This is not detailed claims processing instructions.  CMS states those will be released in the first as amendments to the CMS "Claims Processing Manual."   CMS says point blank in the introductory paragraph that "A subsequent CR will be released at a later date" with more claims processing instructions.

The NCD has a number of implications that are subject to interpretation, or on which experts disagree.  My best guess is that the Claims Processing Manual rules, when they come out, will generally quote from the existing NCD and may not resolve alot of the remaining fuzzy issues.

What It Says Re LCDs

Regarding coverage by LCDs, the transmittal says that:
Medicare Administrative Contractors may determine coverage of other diagnostic laboratory tests using NGS for patients with cancer only - 
when the test is performed in a CLIA-certified laboratory, ordered by the treating physician and the patient has: 
either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,• either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and,• decided to seek further cancer treatment (e.g. therapeutic chemotherapy).
A diagnostic laboratory test using NGS is non-covered when cancer patients do not have the above-noted indications for cancer. 

MACs have covered NGS tests in women with breast cancer & and high family history, and Lynch testing in colorectal cancer, including when the cancer is not metastatic, so MACs will have to decide how to apply the above text in those situations.  (To not cover BRCA panel or Lynch panel in non metastatic patients can't possibly be an intention of the NCD authors, though, since they reviewed only CDx issues in cancer patients and didn't even touch the literature on BRCA panels or Lynch testing, so the effect of the NCD shouldn't pertain to those areas.) 

There are also puzzles such as a new first presentation of advanced leukemia, which isn't literally "recurrent" or "metastatic" or not known to be "refractory" since it hasn't had first-therapy yet, the words found in the bullet-points of the NCD.  But is surely "advanced cancer," the heading of the NCD as a whole.

The NCD covers gene panel testing in some situations that might seem surprising, such as if you have a very small, but recurrent, squamous skin cancer of the trunk (code C44.509).

CMS classifies some high-cost NCDs as payable by Part A/B rather than Medicare Advantage.  I haven't seen a statement that CMS has classified this NCD that way.

Tuesday, November 27, 2018

Very Brief Blog: HHS Floats New Part D Pricing & Policy

Briefly, on November 26, 2018, CMS released proposed new rules that would somewhat raise competitive pricing pressure among Part D plans, and shift some existing policies such as those surrounding protected drug classes like HIV drugs.
  • Trade press on new Part D policy here.
    • Pharma stakeholders argue:
    • Part D already handles protected drug classes economically, here.  (Study by Avalere).
    • However, DOJ continues to act against Part D suppliers for illegal patient supports and rebates, here, here.  $360M settlement regarding Tracleer and other oral drugs.
  • CMS announcement on new Part D policy here.
  • Proposed rule in full, here.
    • Comment open to January 25, 2019.
    • Final rulemaking in spring 2019 for CY2020.
    • Rules apply to direct Part D plans as well as the many beneficiaries who get "Part D" benefits through Part C - Medicare Advantage.
    • For separate Part C rules for physician-administered drugs (aka Part B drugs) under step therapy see HHS proposals in August 2018, here.
Recall that on October 25, President Trump gave a press conference in person at HHS discussing potential, and more speculative, possible future changes to Medicare Part B drug pricing such as indexing US Medicare prices to European prices; entry point here.  

The proposed rule, like the October announcement, are keyed back to the May 2018 "Trump Administration Blueprint to Lower Drug Prices."  Here, here, here.






Monday, November 26, 2018

Very Brief Blog: National Academy of Medicine Report on Genomic Disparities

The National Academy of Medicine runs an ongoing roundtable of events on "Genomics and Precision Health" - home page here.

On November 14, 2018, they released the proceedings of a June conference on "Understanding Disparities in Access to Genomic Medicine."   (I had the chance to chair one of the panels).

  • The conference webpage is here, including video archive and presentations.
  • The conference report is here.
    • Download PDF ebook for free.

___


In other news, in recent weeks, NAM released a new ebook on "Harnessing Mobile Devices for Nervous System Disorders" - here - and one on "Economics of Microbial Threats," here



FDA Will Soon Float New 510(k) Guidance; Positions on Drug/Software Pairs and Bayesian Designs

Over the Thanksgiving weekend, FDA Commissioner Dr. Scott Gottlieb tweeted that FDA was about to launch new initiatives to "modernize" the 510(k) process.  

This process is a pillar of the 1976 medical devices law, which generally grandfathered preexisting devices and required review or approval for new devices unless they had pre 1976 "predicates."    An important modernization was the introduction of "de novo 510(k)," a regulatory process that is much faster than a PMA device approval.

The Monday, November 26, 2018, press release from FDA (both Dr. Gottleib and Dr. Shuren of CDRH) is here.   The modernization will focus on shifting manufacturers away from use of "old predicates" and toward use of predicates less than ten years old.  They indicate they will issue a plan for public feedback, meaning either a draft guidance or draft regulation.  No specific date is offered.  FDA notes that some of its "goals" may require "additional guidance from Congress."
  • Although not directly related to 510(k) changes, this article also includes sections further below on:
  • FDA's recent announcements about software directly tied to pharma, and 
  • FDA's recent announcements about Bayesian and other complex trial designs (CITD).  

Insight

The FDA seems to be responding to years of criticism of the FDA 510(k) system as too lax, including a burst of new documentaries and books in 2017/2018, e.g. here.   One smoking gun, hitting the public media several years ago, was fatal cancers caused by use of tissue morcellators in minimally invasive uterine fibroid treatments (here; press here on GAO report here).  Another class of issue was manufacturers who viewed existing regulations as endorsing an abilityto get by with 1976-equivalent technology.  (Let's say, as a made-up example, if 1976 glucose meters were plus/minus 20% accurate, and modern ones 5%, you could merely meet the 1976 predicate today).

Links re 510(k) 
  • New Detailed November 26 FDA press release here.  
    • 3400 words.  At 200 wpm, about a 20 minute read.  
      • The current FDA regime uses these "press releases" as substantive and detailed reviews of the agency's plans and next direction, and how it views its own process and goals.  Ignore reading the whole thing, at your peril.
    • Early open access coverage at MedTech Dive, here.  
    • WSJ here.  
    • Genomeweb here.
  • The FDA also issued an 8-page "performance report" on recent achievements and improvements in the 510(k) policy system, here.
  • Last week's November 20 FDA press release on updated device post market surveillance efforts, here.
    • Much of this document describes NEST (see next).
  • November 26, FDA seeks $46M for national health surveillance system NEST, here.
    • FDA home page for NEST, here.
    • NEST involves funding from FDA to the MDIC (Medical Device Innovation Consortium) to set up another body, NEST Coordinating Center or NESTcc.
    • See 8 pilot test cases of NEST projects, here.  
      • The scope would be greatly expanded with $46M instead of several $M.
  • FDA current medical device predicate home page here.
    • Current 2014 PDF guidance on finding and using predicates (42 pp) here.
    • FDA sets the new 510(k) ideas firmly in context of its Medical Device Safety Action Plan, floated in Spring 2018, here.
  • Gottlieb's November 25 "FDA Sunday Tweetorial" on device improvements
  • In separate messaging, such as in December 2017, FDA discussed wanted to ensure that devices could enter the market with "acceptable uncertainty" and not be overly delayed by regulatory review, here.



FDA Sports Metaphor

The November 26 press release gives Gottleib and Shuren a chance to use the (overused?) hockey metaphor "skate to where the puck will be."   "We not only have to skate to where the puck will be, we also need to drive the puck to where it should be."  Both of these risk being obvious; of course you are supposed to skate toward where the puck is going, in order to hit it; and when you do hit it, you are supposed to hit it to where you need it to be next. 

_____


Footnote 01: FDA and Software Directly Related to New Drugs

A year back, in November 2017, I was at a digital health conference where Amgen was discussing its plan to develop drugs closely linked to software packages.   FDA has been pushing forward on that front, too.
  • See a November 19, 2018, press release on FDA proposals to link digital tools with drug approvals, here.
    • See the FDA's corresponding official Request for Public Comment on the proposal (comment open until January 22), here.
    • Trade press on the above, Medtech Dive, here. At RAPS, here.
  • Earlier, May 2018 trade press on FDA and digital devices (Covington), here.
    • Gottleib comments on digital health at Datapalooza April 2018, here.
  • Trade press on digital therapeutics, June 2018, here.  Trade press (RAPS) on FDA and Dhealth and "paradigm shift," April 2018, here.
  • FDA report on how 21st Century Cures impacts FDA medical software policy, here (December 2017, 14 pp).
  • FDA draft guidance on clinical decision support (CDS) software, here (December 2017, 13 pp).
Pre-Certification.  Separately, FDA has been crafting a "pre-certification" system for some types of health related software, with pilot announcements in 2018 and more detail to come by early 2019.   In October 2018, Sen. Warren issued a 12-page letter to FDA requesting more detail about risks of this adventure (PDF from here, trade press here, here.)



Footnote 02:  FDA and Complex Innovative Trial Designs

The 21st Century Cures Act asked FDA to provide guidance and look closely at innovative trial designs (e.g. Bayesian designs).   Some argued that Congress was trying to lower the rigor of FDA design standards, but to my eye, Congress was only asking FDA to "provide guidance" - for example, it could provide guidance it hated Bayesian designs and it would meet the Congressional direction to provide guidance.

In any case, the FDA has latched onto "CITD" - Complex Innovative Trial Designs.  FDA held a full day workshop in March 2018; webpage here.   (See decks, transcripts, video; public comment docket with 12 comments).  See post meeting comments by BIO, PHRMA, Friends of Cancer Research (totalling 44pp); here.

See the FDA homepage for CITD Pilot Program here.

Press release here (August 29, 2018).   Corresponding FDA Fed Reg announcement here.  (83 FR 44274).   Trade press here, here.  RAPS here.

RAPS on September 2018 draft guidances, a pair of them, here.  See #1 Adaptive Designs draft guidance here.  See #2 "Efficient Master Protocol Design to Expedite Development..." draft guidance here.




Wednesday, November 21, 2018

CMS Posts CY2019 New Molecular Coding Rules! Envisions More, Not Less, Use of 81479

Every November CMS updates a national coding rulebook called "National Correct Coding Initiative Edits."   This include massive excel spreadsheets, but also a zip file of PDF coding instructions.

The new files for CY2019 are now posted here and have some big changes for genetic coding.   NCCI edits and rules may be used by private payers as well.

CORRECT CODING PDF HANDBOOK FOR LAB TESTS

At the CMS website here, click on the download for "NCCI Policy Manual...January 1, 2019...Zip".

Inside that Zip, the file for laboratory (codes 80000-89999) is Chapter X (10).  Inside that, Section F is Molecular Pathology (p9 ff).  I've also put up a cloud copy of Chapter X here, as it was on November 21.

Revisions in Chapter X, Labs, Section F, Paragraphs 7, 8, 9

The three revisions are new section 7, section 8, section 9. 

Section 7 states that individual Tier 1 or Tier 2 CPT codes (e.g. "EGFR") shall not be reported with a genomic sequencing procedure, when the CPT descriptor for GSP procedure includes a descriptor for the Tier 1, Tier 2 analyte.   E.g. don't report BRCA testing (81162) along with a Hereditary Breast Cancer gene panel (81432).   Don't report individual Lynch genes along with a Lynch panel (81435).

Section 8 states that if a lab analyzes multiple genes by "a next generation sequencing procedure," report only one unit of service of GSP, MAA, or PLA code.  "If no CPT code accurately describes the procedure performed, report CPT 81479 x 1."   And:  "The laboratory shall not report multiple CPT codes describing the component results."   


  • My joint reading of the two rules above, if you bill the 10 or more genes for an AMA CPT breast cancer or colon cancer panel, bill the panel codes (81432 or 81435) not individual CPT codes.   If you bill some subset, like 8 of the 10 breast panel codes, do not code stack them, but bill 81479.  Presumably, a MAC would not pay more for the subset panel as 81479 than it would pay for the whole panel (81432).  This fits recent Congressional instructions for CMS to handle panel unbundling (here).


Section 9 states that the NCCI Excel tables, or procedure-to-procedure edits, describes CPT codes that "should not be routinely reported together."   They give the example of 91292 MLH1 gene and 81292 MLH1 dup/del analysis, adding, "it may be appropriate to perform dup/del testing if the disease variant is not identified by full gene sequencing."

These are summaries and for this article I'll ignore some probably very esoteric or obscure or likely unintentional readings of the text.   Readers should refer to the full CMS text.


Molecular section F, new points 7,8,9.




They also include a similar paragraph, not in the molecular section, but in the introductory section "A" on page 4:







INSIGHTS AND ANALYSIS


Section 7:  Don't report CPT codes that are found inside GSP (gene panel) codes  This seems like commonsensical coding advice.   I've been puzzled in the past by CMS data that MAC payments didn't seem to follow this rule.   There is a general principle to use the best-fit CPT code rather than components that add up to the same CPT code.    However, particularly MolDx may have given lab-specific instructions in the past in unpredictable combinations. 

Section 8:  Use of 81479 rather than code stacking Here, I think the key sentence is: "The laboratory shall not report multiple individual CPT codes describing the component-test results."   The most obvious fact here is that CMS seems to be nationalizing a MolDx rule called "Genetic Test Panel Alert" that multiple CPT codes (e.g. EGFR gene + KRAS gene + BRAF gene) should not be added up one by one, but coded as 81479 (unlisted procedure, unpriced procedure).   The MolDx rule is here (and cloud archive 11/21/18, here.)

  • Nationalizing a Quirky MolDx Coding Rule.  In the past, I felt the MolDx rule (that flipped every group of several genes into 81479 coding) violated the normal national correct coding rules and concepts, but now, the NCCI CMS manual appears to be updated to more or less match the MolDx multi-gene rule.
  • Labs May Complain There Isn't Time to Do This.   Labs may complain that this rule comes out near December 1, for implementation January 1, and there isn't enough time to recode LIS and billing systems to conform.  
  • I Predict Payment Chaos Without Further Instructions.  Without a payment rule, this creates huge opportunities for unfairness.  
    • What if one lab bills EGFR+KRAS+BRAF, let's pretend they historically add up to $200+$200+$200 =$600, and gets paid $100 for this use of 81479 and the lab across the street under the same MAC gets paid $500 for the same use of 81479?  
    • Remember that 81479 is unpriced and there is no pricing rule for it.  
    • Or different MACs across state lines might bundle and reprice genes under 81479 in very different ways.  This is inconsistent with the new nationwide fee schedules, which were deliberately meant to reduce state-to-state variation in lab test pricing.
    • Plus, there is a huge manual activity burden when 81479 is used, a burden on the MACs that process the claim.
    • Plus, if all payers follow this rule, PAMA genetic pricing surveys(which is based on individual genes for lab tests and ignores 81479) go haywire.
    • Auditors can't audit.  Let's say an OIG auditor finds a lab was billing for and getting paid for three CPT gene codes in 2019, and this instruction says to use 81479.  What overpayment would OIG assign?  It's undefined.  Would they just guess?  Spin a wheel?
    • In October 2017, CMS issued an instructions to MACs to "report to CMS" those labs that were using 81479.  Here.  At the time, my best guess is that CMS wanted to centrally track those labs doing a lot of 81479 billing, perhaps to encourage them to use specific codes or get a PLA code.   (Of course, CMS could always track labs billing 81479 anyway, since CMS has access to its own claims data.)  This November 2018 instruction would boost, not reduce, claims with 81479.   
    • Data dive:  CMS CY2016 data for 81479 billing by lab can be obtained here.   Total 81479 Part B payments were about $108M.  All but about 7% went through MolDx states.  The largest 81479 biller in CY2016 was (Assurex + Myriad) at $39M (36%; Myriad acquired Assurex in mid-year CY2016).  See screenshot of the top 18 81479 billers in CY2016, here.  8 labs provided 90% of 81479 billing.  Excel in cloud here.
    • Claims for some CPT codes that might have autopaid without further editing might be slowed down (requests for records, orders, physician notes) through the 81479 process.
  • Perverse Incentive to Tilt Away from NGS Sequencing.  These rules could be an incentive to do Sanger or PCR hotspot testing, as the bundling and down-payment applies only if an NGS method is used.  
    • The same incentive to Sanger or PCR  methods  is found in the CMS national NCD for NGS testing in cancer, which makes some types of genetic testing literally unpayable unless if performed by methods other than NGS, since the NCD applies only to NGS.
Section 9:  Dup Del analysis can be a reflex test, but don't report routinely with sequencing.  This is the only new rule that doesn't cite NGS as a method.   This is actually an improvement in some ways, because until recently MolDx had a published rule against paying for dup del testing such as 81433 (breast cancer panel dup del) at all; it was on a list of MolDx unpayable codes.   Here, NCCN says that Dup Del should be a reflex test, however, in most cases -- such as BRCA syndrome testing or Lynch/Colon syndrome testing -- the sequencing code will be negative >95% of the time so you will indeed reach the Dup Del code almost all the time. 

What I'm saying is that a new rule paying Dup Del 95% of the time on reflex is better than an old rule paying it never.   I've been told that some private payers paid Dup Del coding irregularly, but this confirms a payable role for Dup Del code use and payment. 

Since the sequencing code is typically negative 95% of the time, there will be a lot of endorsed use of modifiers to pay the second code, the dup del code, in those 95% of instances, at least when no other rule like use of a comprehensive code (e.g. 81162 or 81455) is available.

While Dup Del is sometimes reflected by a separate code (whether a separate single gene Dup Del code like 81294 or a separate gene panel Dup Del code like 81436) there are other times when Dup Del is already part of the CPT code (e.g. Dup Del is already inside the sequencing codes 81162 or 81455).