Very Brief Blog x 2: Genetics Firm Agrees to $1.9M Repayment; And Case Where Repayments Are Stayed

Lab Pays Recoupment After Court Case

According to a February 11, 2019, press release from the Department of Justic, GenomDx Biosciencs Corporation agree to a $1.99 million repayment "to resolve allegations that it violated the false claims act...".  GenomeDx is based in San Diego.   Press release here. 

The press release states that whistleblowers (aka qui tam case) will receive $348,316.  Docketed as United States ex rel. La Fleur et al. v. GenomeDX Biosciences Corp., No. 17-CV-1959 (S.D. Cal.) (e.g. at Pacer here.) 

DOJ states, "The United States alleged that GenomeDx knowingly submitted claims for the Decipher test to Medicare between September 2015 and June 2017 that were not medically reasonable and necessary because the prostate cancer patients did not have risk factors necessitating the test, including pathological stage T2 disease with a positive surgical margin, pathological stage T3 disease or rising Prostate-Specific Antigen (PSA”) levels after an initial PSA nadir."  

This suggests very close application of terminology in a Medicare LCD (L36345).   In other cases, MolDx provides brief coverage parameters in an "article," rather than an LCD, or sets up arrangements with providers that are not necessarily memorialized in a public LCD or article.
 
Qui tam actions are common in the lab industry.  In a January 2019 article, the SF Chronicle describe qui tam employee actions against CardioDx, here.

Case Where Program Integrity Recoupments Are Stayed by Judge Due to CMS Delays

Not new-news, but I ran across a July 2018 article about cases in which recoupments have been stayed by federal judges based on intolerable CMS delays in the appeals process.  Worth being aware of.

Trade journal article here.   If you are issued a recoupment, it is delayed while you are at the first level of appeal (MAC) and second level of appeal (Hearing).   However, if you lose at that point, you're expected to repay the money while you separately pursue an ALJ hearing to get the money back.

In a case involving a $7.5M recoupment against Family Rehab Inc, a federal district court judge ruled that the recoupment had to be "stayed" or put on hold, because CMS was running an egregious backlog and had far exceeded the 90 statutory timeline for an ALJ hearing.   The case sites a 3-5 year backlog, egregiously exceeding 90 days. 

The party was represented by Foley Lardner attorneys Zaitlin, Waltz, and Donovan.

Docketed as Civil Action No. 3:17-CV-3008-K; originating with a ZPIC (Zone Program Integrity Contractor) extrapolation from a $124,000 penalty on 43 manually reviewed claims to a universe of $8M imputed faulty claims.

Read the June 4 temporary restraining order here and the June 28 injunction (against recoupment) here.

Very Brief Blog: Medicare Releases NCD On CAR-T Therapy in Medicare Patients

A few weeks ago, I posted some background and links on Medicare's decision on CAR-T therapy (here).    In September and November 2017, I had posted there were obvious holes and gaps in press articles about supposed value based pricing for this class of drugs (here, here).

On Friday morning, February 15, 2019, CMS released its proposed national coverage determination on CAR-T therapies.   Therapies (whether inpatient or outpatient), are covered, but there are some (commonsensical) requirements on the hospital and the patient must be in a CAR-T outcomes registry.

There is also a clause for coverage that is not necessarily on-label, but endorsed in a compendium.

Early press from Reuters here. 

The full NCD is online at CMS, here.

Full text of the decision is clipped below the break.   For full NCD, which prints at 56 PDF pages, see online.  Comment is open for 30 days (to 3/17/2019).

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Brief Blog: Scripps Calendars "Future of Individualized Medicine" Conference, March 14-15, 2019

Scripps has scheduled its 2019 "Future of Individualized Medicine Conference (FOIM)," which will be Thursday/Friday, March 14-15, 2019, in La Jolla.  It's the 11th annual event.

See the agenda here.  Registration through March 4 is $450 (on site, $550). 

On the third day, Saturday, March 16, there will be a separate workshop on implementing precision medicine.  For the extra workshop, registration is $450, or for $500, if you also would like PGX testing from OneOme.

Eric Topol chairs the conference; he just supervised a 50-page "Topol Report" for digital medicine in the UK NHS (here).

Conference text clipped below:

Future of Individualized Medicine

March 14-15, 2019 | La Jolla, California

After 11 annual conferences exploring genomic medicine, we’re broadening our scope.

In 2019, the newly renamed Future of Individualized Medicine (formerly Future of Genomic Medicine) conference will expand to include additional perspectives on how to tailor medicine to the individual. Individualized medicine takes into account a person’s genes—and genomics will remain a core topic for exploration and discussion—but it also considers the full spectrum of a person’s uniqueness from their biologic, physiologic, anatomic, lifestyle and environmental information.

The Future of Individualized Medicine conference will thus incorporate perspectives from the emerging fields of digital medicine, artificial intelligence and machine learning, behavioral science and others.

This is truly a multidisciplinary forum designed to accelerate the transformation of medicine.

Very Brief Blog: UK NHS Releases 50-page Digital Health Report; Sanofi Joins the Wave

In trade news today, UK NHS releases a 50-page digital health report, aka The Topol Report.

Download it here.

In other news, Sanofi appoints a Digital Health Officer here.   Ameet Nathwani MD, is also Sanofi's chief medical officer.  Heather Bell, a McKinsey grad with a PhD from Oxford, holds a similar global digital health title at Sandoz, here.

Nature launches a new Digital Medicine Journal; article here, website here.   See a summary of these topics at Endpoints, here.

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For a fifty-minute November 2018 Rock Health panel, Digital Health: Where's the Exit?, YouTube here.  Text here.

For a February 12, 2019, article in NYT about artificial intelligence in physician decision-making, here, based on a Nature Medicine article on a pediatrics AI system here.

Very Brief Blog: It's Official, HBO Theranos Documentary is March 18

It's official, the Theranos documentary on HBO will premiere on Monday, March 18, 2019.

From Endgadget, here.  From HBO, here and here.

The "Discoveries in Health Policy" archive of a couple hundred Theranos links from 2006 forward, here.  My blog on what-are-usually-very-scarce FDA confidentiality leaks, here.

Very Brief Blog: McKinsey Publishes 80 Page Monograph on Precision Medicine "Opening the Aperture"

McKinsey has published an 80-page monograph on precision medicine, "Opening the Aperture" (28 mb). 

See the landing page for an introductory article here.  Click near the bottom to download the full length PDF version.  Authors are Aptekar et al., most in the Silicon Valley office of McKinsey.

Brief Blog: Trapelo and Astrazeneca Launch New Approaches to the "Last Mile" in Successful Precision Oncology

This week, an article in Genomeweb highlighted the continuing gaps in clinician knowledge and testing penetration which inhibits precision oncology.  Genomeweb Premium article here.  (Open access at AP, here.)

Around the first of the year, there were a flurry of announcements in the clinical bioinformatics space, such as Illumina announcing a partnership with PierianDx, Qiagen buying Nof1, and Sophia Genetics raising $77M for expansion.   This week, DNAnexus in Mountain View announced a $68M funding round, to deploy Apollo, "platform for multi omics and clinical data science," here.  It had also raised $58M just twelve months ago.

Two more topics in the field, this week.

Trapelo

Genomeweb runs an article on Trapelo, a newly packaged and integrated service from Intervention Insights.   The article describes a partnership with City of Hope, and describes the service as follows:

...An evidence-based clinical decision support system that links healthcare providers, testing laboratories, and payors, giving them access to current, molecular testing information and results interpretation in order to optimize utilization of molecular testing services and offer the most appropriate care to patients.

Company website here.  See a video on the home page.

CEO is Clyde Taylor (here), who recently wrote a Linked In blog on his vision for precision medicine (here).  He previously held a high position with clinical decision support at NantHealth.

click to enlarge

AZ and AZ Oncology ID

This week brought both direct mail, internet advertisements, and a paste-on oncology journal cover about Astrazeneca Oncology ID.  Pitch:  "AZ Oncology ID is your resource for biomarker testing to help patients receive the most appropriate, personalized treatment."  See the website here:    https://www.azoncologyid.com/    

Another pharma adventure in this space is Navify, from Roche, "a cloud-based workflow product that securely integrates and displays relevant aggregated data into a single, holistic patient dashboard for oncology care teams to review, align and decide on the optimal treatment for the patient."

Myriad Highlights Best-of-Breed Clinical Integration

On the same theme of the last mile in oncology genomics, Myriad's investor call deck includes a slide highlighting their "best of breed" integration with patient costs, E.M.R. integration, availability of consult sessions, tele-education, and results-management provider portal.  Branded as Myriad Complete.  Pic:

Footnote.

On the same informatics vein, a recent article in Dark Report (12/24/2018) focused on how labs like Quest are strengthening their data analytics and patient management game to provide more integrated and useful information to large payers. 

(And today Google Verily announces it is taking on clinical care in the opioid epidemic with big data, here; similarly here, here.)

Brief Blog: Medicare Still Defines High Risk Colon Cancer Syndromes Without Genetics (Party Like It's 1897...)

One of the most important, frequent, and best understood cancer risk syndromes is Lynch Syndrome, which causes elevated risk of colon cancer (here, here, here).  Adequate screening for Lynch Syndrome is considered a public health issue.

Medicare defines inheritance of high risk for colon cancer, however, without any reference to genetics or Lynch syndrome. 

That means, for example, in a family with Lynch syndrome or familial polyposis and four offspring, Medicare blindly classes all four offspring as high risk for colon cancer, regardless of the fact that genetics will "de-select" two of them as not having inherited the relevant dominant gene.

Medicare's benefit system for colon cancer screening (ranging from FIT to colonoscopy to Cologuard) is here.   The regulations, from 1997, defining "high risk Medicare beneficiaries" are here.  Given the lack of genetics, they could as well date from 1897.

It's like they never heard of Gregor Mendel, or Watson & Crick.

Medicare defines High Risk for colon cancer screening as:

• A close relative has had colorectal cancer OR an adenomatous polyp;
• A family history of FAP (familial adenomatous polyposis);
• A family history of hereditary nonpolyposis colorectal cancer;
• A personal history of adenomatous polyp or colorectal cancer;
• IBD (Crohn's or ulcerative colitis).

Note that Medicare considers a personal history of Stage 1 or 2 colorectal cancer a justification for annual colonscopy ($1000 plus each year) but (in a current scandal) not a justification for one time only Lynch panel screening (about $700).

Very Brief Blog; Stanford Holds Annual Big Data in Health Mtg; May 22-23, 2019

Stanford has registration up for its annual Big Data in Health meeting, which will be May 22-23, 2019.

Find the home page here:  https://bigdata.stanford.edu/ 

2019 speakers are being posted here.  They include Jeff Dean PhD, Senior VP at Google, and Taha Kass-Hout MD, Senior Leader, Healthcare, Amazon, and Don Rucker MD, the National Coordinator for Health Information Technology, HHS.

Early bird pricing to March 22 is $750.  After that, it rises to $1400 (academic discounts available).

Brief Blog: Illumina Trusight Panel at FDA; Breakthrough Status; Pan Cancer + TMB

In lat January 2019, Illumina announced that a version of its Trusight NGS tumor panel is under review at FDA, and further, that FDA had granted it "breakthrough status." 

The test is aiming for "pan cancer" labeling - the same status that the Foundation Medicine FDA CDx test has.  In addition, the test is planned to report tumor mutational burden (TMB). 

So far, there is no FDA-approved pan cancer IVD to compete with Foundation Medicine in both FDA status and pan-cancer profiling.   A pan cancer IVD would be available at large hospitals, academic medical centers, regional reference labs.   If it can be run profitably, it could be a significant competitor to FMI, or at least, shake up the marketplace.

Read More:

Coverage at Med Tech Dive here.  Press release here.  Illumina's most recent quarterly investor call transcript, January 30, 2019, here.  Illumina had 4Q revenue of $876M and free cash flow circa $200M.  Revenue for the year was $3.4B.

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In related news, the VA set up a $111M contract (cumulative; 5 years) with Foundation Medicine to provide services to its patients, including F1 CDx, F1 Liquid, F1 Heme - here.

Very Brief News Flash: ACLA and 60 Groups Oppose CMS Interpretation That Blocks Germline Testing for Cancer Management

Lead news on February 1, 2019, at the ACLA website:

Over 60 groups sign letter to CMS administrator Seema Verma, asking to halt an "interpretation" of the 2018 CMS NCD that would now act to block germline testing in cancer patients (with stage 1,2 cancers).  This is likely over half of BRCA testing, as breast cancers are usually detected before stage 3 and 4.  However, I think for multiple reasons the NCD is itself clearly ambiguous or, taken as a whole, self-contradictory, and that will eventually surface.  The very fact that it took nine months for this issue to arise suggests the position is hardly clear.

See the ACLA press release here.
See the Collective Sign-On Letter online at AMP, here.

For additional background:

• March 2018
• I discussed application to germline testing as a possible, but likely ill-conceived, interpretation of NCD - here.
• January 2, 2019
• I noted that MolDx LCDs on germline testing were now, after nine months, being revised to refer readers to the NCD for limits of coverage - here.
• January 22, 2019
• Genomeweb publishes an article about growing unrest in the oncology community, here.  I discussed further in blog here.
• January 31, 2019
• Washington Analysis Group publishes investor article with headline, "Myriad Genetics (MYGN) & Invitae (NVTA): Medicare Germline BRCA Coverage Halted?" 
• February 1, 2019
• Noridian amends its BRCA LCD for its jurisdictions (e.g. mountain states, west coast) - here.  (See also discussion of NCD effective date, here.)

ACLA press release clipped below the break.

The crux of the matter is that, while the NCD could be squinted-at and considered ambiguous (for many reasons, read as a whole, and interpreted to avoid absurdity, I don't think it is ambiguous)...in November CMS issued a transmittal on the NCD that contains the wholly new sentence, "A diagnostic laboratory test using NGS is non-covered when cancer patients do not have the above-noted indications for cancer under either national or local coverage criteria." And CMS gave this new sentence an effective date retroactive to March 2018, which raises problematic issues under the statutory voluntary repayment law (here).

Very Brief Blog: Grassley Asks CMS to Follow Up GAO Report on Panel Unbundling in Lab Tests

360Dx, the sister publication of Genomeweb, reports that Senator Grassley's office has issued CMS a detailed letter asking CMS to follow up on weaknesses in the Clinical Laboratory Fee Schedule triggered by panel unbundling.  360Dx here, Grassley January 2019 PDF here. 

In part, the Grassley letter to CMS follows up on a November 2018 GAO report on the same topic, here.  In January 2019, ACLA characterized the GAO's report as "fundamentally flawed" - here.

I wrote about the pending issue in November 2017, here.

The GAO report in November 2018 used some graphics very similar to those I had used in November 2017.

In July 2018, the House, but not the Senate, issued a request to CMS to report on the lab test unbundling issue, here.

See timeline here (click to enlarge):

Very Brief Blog: Reviewing ACA Rules on Voluntary Overpayments from Medicare Part A & B

From time to time I get questions about Medicare's voluntary overpayments rule.  

If you think you have such a situation, you want to talk to compliance experts or e.g. a Medicare/healthcare attorney.  I can give some general layman's background to where the policies are.

Section 1128J of the Social Security Act was added by the Affordable Care Act of 2010 (ACA).   Online here.  (See also 42 CFR 401.305 here).  Stating in part,

In general.—If a person has received an overpayment, the person shall—
(A) report and return the overpayment to the Secretary, the State, an intermediary, a carrier, or a contractor, as appropriate, at the correct address; and
(B) notify the Secretary, State, intermediary, carrier, or contractor to whom the overpayment was returned in writing of the reason for the overpayment.
(2) Deadline for reporting and returning overpayments.—An overpayment must be reported and returned under paragraph (1) by the later of—
(A) the date which is 60 days after the date on which the overpayment was identified; or
(B) the date any corresponding cost report is due, if applicable.

CMS has a fact sheet about this from 2016, here.   The full February 12, 2016 rule is here (81 FR 7654, 32pp).  A law firm 3-page white paper is here.  The section referring to MAC edits of LCDs, NCDs, is here.

Very Brief Blog: Noridian Updates Germline BRCA NCD to Incorporate Restrictions under CMS NGS NCD

On January 22, 2019, Genomeweb published an article that Palmetto MolDx germline BRCA testing LCDs were being updated to include references to CMS NCD 90.2, on NGS testing in cancer, which could be interpreted to block germline testing in Stage 1/2 cancer patients.   I had pointed out this issue related to a Palmetto MolDx LCD revision on January 1, 2019 (here).

This week, the Noridian MAC contractor, which handles Mountain and West Coast states, published the same revision to a mirror LCD.   See revision to LCD L36163 here.

The revision includes a header section reference to the NCD ( ^ "National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS), which describes the criteria under which contractors may cover NGS laboratory tests for patients with cancer."   Under panel testing, there are some new sentences of text that say that in addition to LCD criteria (e.g. a personal history of cancer), all NCD criteria apply as well.  The NCD directed coverage to advanced (e.g. stage 3/4 cancer) when NGS method testing is used.

Personally, I think the NCD is materially ambiguous as to whether, taken as a whole, germline tested is described as out of scope (here). 

Very Brief Blog: AMA Launches 100-page Digital Health Innovation Playbook

For several years, AMA has had committees and workgroups closely involved with digital health issues.   AMA now has released a 102-page "Playbook" as a magazine-style white paper, presenting key questions and choices for bringing digital health technologies to patient care.

See the home page here.   Register with email to get a link to the 102-page PDF.

On Monday, January 28, 2019, FDA commissioner Scott Gottlieb gave a speech at the Bipartisan Policy Center in DC on FDA's next moves in real world data, real world evidence, much of which may involve mobile health data collection.   See review at Endpoints, here.  The speech extends the FDA viewpoint for a RWE framework as released in December.