Evidera Publishes Set of Open Access RWE Articles

Evidera, which is part of a CRO, publishes set of articles on Real World Evidence.

https://www.evidera.com/thought-leadership/our-publication-the-evidence-forum/

Evidera's biannual publication addresses the scientific, strategic, and operational challenges of today's healthcare environment, providing a forum for the exchange of thoughts and ideas focused on evidence and value. In this issue you can read content related to the relevant issues facing companies along the path to approval and access. In This Issue

Advancing Healthcare through Innovation and Collaboration: An Interview with Gigi Hirsch, MD, from MIT's NEWDIGS Program Research Operations for Secondary Use of Clinical Sites’ EMR Increase Study Awareness and Patient Engagement with the Use of Branded Study Materials Virtual Trials and Real-World Evidence Data Collection: Identifying Core Needs and Defining “Virtual Trials" Pragmatic Randomized Trials: Considerations for Design and Implementation Protocol Design in Real-World Evidence: The Indispensable Link Between Strategic Need and Study Execution The Role of Integrated Scientific Advice for the Early Determination of RWE Requirements in HTA and Payer Assessments Enhancing Patient Centricity of HTA: Opportunities in Europe Patient Preferences in Health Technology Assessment in Europe: Recent Advances and Future Potential The Growing Influence of the Institute of Clinical and Economic Review on Payer Decisions in the US Health Economics in China: Changing Pharmaceutical Pricing and Reimbursement The Growing Need for Real-World Evidence in Medical Devices

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OIG Annual Report on CLFS is Late (Fall 2019)

PAMA requires OIG to produce an annual report on CLFS payments.  This typically appear in September for the prior year (September 2018 for CY2017, etc.)

For example, "Medicare Payments for Clinical Diagnostic Laboratory Tests in 2017: Year 4 of Baseline Data" is here.

As of October 22, 2019, we are still waiting for the CY2018 report.

How Much Space Does We Work Have?

According to an Wikipedia, WeWork currently managed 47 million square feet at end-2018; according to an informational video at WSJ and a public blog, they had 528 locations as of summer 2019.

With 43,500 square feet to an acre, that is 1080 acres.

With 640 acres to the square mile, that is 1.7 square miles.

___

According to a website, they have raised around $8B in capital and according to 10/21/2019 news reports, have a valuation of about $8B.    Reportedly around summer 2019 they were losing about $200,000 an hour.

MolDx Test Panel Alert M101 (Cloud Copy; 10/2019)

Parent article here:  http://www.discoveriesinhealthpolicy.com/2019/10/hold-on-to-your-hats-moldx-publishes.html

Cloud copy in 10/2019 of M00101:

https://palmettogba.com/palmetto/MolDX.nsf/docsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~General~Molecular%20Test%20Panel%20Edit%20Alert%20(M00101%20V4)?OpenDocument&Click=

Molecular Test Panel Edit Alert (M00101, V4)

    

 

MolDX CPT code range affected: 81161-81408

Test Panel Definition: A predetermined set of medical tests composed of individual laboratory tests, related by medical condition, specimen type, frequency ordered, methodology or types of components to aid in the diagnosis/treatment of disease.

Palmetto considers the performance of multiple molecular biomarkers, regardless of whether the test requisition lists the tests as a panel or individually, and completed on a single sample to be a 'panel' of tests. Therefore, each panel should be registered and billed with a single CPT code and a unique MolDX identifier. Based on data analysis of MolDX claims, labs are submitting multiple biomarker 'panels' as individual tests similar to the submission of the previous stacking codes.

Example: A lab receives a patient specimen and performs the following tests:

• CPT code 81225-CYP2C19, cv
• CPT code 81240-F2, 20210G>A
• CPT code 81241-F5, Leiden

The panel of three tests listed above should be registered and claims submitted with CPT code 81479 and a single MolDX ID. If the lab also performs one of the three panel’s biomarkers on patient specimens, each biomarker must also be registered and receive a unique ID to submit on claims when only that biomarker is performed. Again, a single CPT code should be billed with a unique ID.

To correct this example, the lab must register four tests and receive identifiers for MolDX claim submission:

Test #	Test Name	Biomarkers	ID	CPT Code
1	Clotting Test Panel	CYP2C19, cv F2, 20210G>A F5, Leiden	Z1234	81479
2	CYP2C19	CYP2C19, cv	Z5678	81225
3	F2, 20210G>A	F2, 20210G>A	ZA234	81240
4	F5, Leiden	F5, Leiden	ZA567	81241

Labs should register all panels and obtain a unique MolDX identifier for each panel. If a lab does NOT perform single biomarker tests, they must notify the registry of this registration error.

Updated 12 31 2015.

Brook Byers 2019 Speech at Stanford

For blog and link to YouTube, here:
http://www.discoveriesinhealthpolicy.com/2019/10/noted-life-sciences-investor-brook.html


Cloud transcript here.

MolDx LCD Release Time Watch

As of October 14, 2019, Palmetto MOLDX has 13 LCDs in comment period (which runs to Novemer 15, 2019).

From its May 2019 LCDs, Palmetto has 7 LCDs still in review and not released to final, after a comment period that closed June 20, 2019.   This is 116 days, or 3.9 months.

An 8th LCD, L38039, TruGraf renal rejection test, was released to final on October 4, 2019, which was 106 days or 3.5 months after its June 20 close-comments date.

Note that MolDx probably does not finalize LCDs until all comments are in, in all MoLDx MACs.   This could have been a few weeks later than June 20 for the various MACs (Noridian, CGS, WPS).

I've put a very simple Excel in the cloud here.

50 Slide Deck from NHGRI 2016: The Methods for NGS

Mardis of Wash Univ/McDonnell Center presented a 53-slide deck at NHGRI in 2016 on the various main methods for WGS - Illumina, Thermo Fisher, Pac Bio, etc., and key considerations.   Online here:

https://www.genome.gov/sites/default/files/media/files/2019-03/Next-Generation%20Sequencing%20Technologies_052516.pdf