Negative PGx Real World Study

Mayo Clinic did a study whether patients with more atypical PGx genes (which presumably weren't being managed) had more hospital or ER visits than "normal" PGx profiles.

The answer was no.

Takahashi et al

https://www.dovepress.com/no-association-between-pharmacogenomics-variants-and-hospital-and-emer-peer-reviewed-article-PGPM

No Association Between Pharmacogenomics Variants and Hospital and Emergency Department Utilization: A Mayo Clinic Biobank Retrospective Study

There was a response from Youssef Roman at VCU noting the study was observational and not decisive.

https://www.dovepress.com/pathway-to-ascertain-the-role-of-pharmacogenomics-in-healthcare-utiliz-peer-reviewed-article-PGPM

Pathway to Ascertain the Role of Pharmacogenomics in Healthcare Utilization Outcomes [Letter]

Fooled by Randomness, NYT, and COVID

In 2005, the now-well-known Nicholas Tasib published a book, "FOOLED BY RANDOMNESS," asserting that in many situations human beings assume causability or patterns that don't exist.  ("If we put a chicken on this rock at dawn, it will cause it to rain.")

This week, the NYT had two articles that could potentially fall into the Fooled by Randomness paradigm, or at least, have to be considered in that end.   

The first, on strokes with the AstraZeneca COVID vaccination, makes the point explicitly.

https://www.nytimes.com/2021/03/22/opinion/astrazeneca-vaccine-trust.html?action=click&module=Opinion&pgtype=Homepage

Among the 20 million people who have received the AstraZeneca vaccine in Europe, 25 people developed blood clots following vaccination. 

The rate of blood clots that would normally occur among unvaccinated people is in fact much higher. 

But given the newness of the vaccine, every reported side effect is being carefully considered. This is a good thing. Instead of being scared, we should be reassured that the safety system is working.

That isn’t how last week’s developments were received, though.

Clearly, this example could open a chapter in "Fooled by Randomness."

On the same day, however, there was another article that while certainly, possibly, real, also could raise the base-rate question again.

https://www.nytimes.com/2021/03/22/health/covid-psychosis.html?action=click&module=Top%20Stories&pgtype=Homepage

The article describes very rare individuals developing psychotic episodes after COVID, and if many millions of Americans have had COVID (30M confirmed tests, perhaps 60M, 90M actual cases?), some would have psychotic episodes anyway, including more than a few would have a history of prior psychotic episodes, out of 90M.

iRhythm also prced at PALMETTO

 Of interest - MolDx began newly putting prices on its DEX website.  Notoriously, Novitas a few weeks before put on its website local prices for iRhythm (at a huge discount to the longstanding and just-prior local price).    Here, Palmetto puts iRhythm prices on its website.   I've seen where FCSO is putting Cat III or other local prices on ITS website.    

Is there a CMS push behind this, or is it magically all happening by concidence?

 

###### iRhythm (IRTC):  Palmetto Rate Read-Through

John Leppard, 202-756-7703 jleppard@washingtonanalysis.com

The move by Medicare Administrative Contractor (MAC) Palmetto last night to establish global payments of $160 for the 2-7 day wear time code for electrocardiographic (ECG) monitoring [CPT 93241], while positive relative to Novitas payment levels, provides us with an incrementally negative read-through for iRhythm (IRTC), and to a lesser extent Hill-Rom (HRC) and Boston Scientific (BSX).   Although Palmetto has yet to set rates for the scanning & analysis portion of the service [CPT 93243], nor the 7-15 day wear global [CPT 93245] / scanning & analysis [CPT 93247] components, both of which are more material for these companies: 1) a $160 global rate would imply Palmetto payments of ~$122 for IRTC’s scanning / analysis portion [explanation below], in line with our long-held base case;  2) this is likely a setback for hopes that payments might return to pre-2021 levels [$311], even in the unlikely event Palmetto [0.83% of legacy volumes] ascribes a 2x+ multiplier to 7-15 day rates; and  3) the already questionable prospect of companies funneling volumes through alternative MACs, should Novitas [97.74% of legacy volumes] not adjust its current rates upward [$43], now has more negligible upside.  We continue to believe that Novitas is likely to revise its Jan. 29 reimbursement, likely within the next few weeks, but would view a best-case scenario as ~$170. For our full thoughts on the matter, please click here.

Prognostic Model Research

  Prognosis Research Strategy (PROGRESS) 3: prognostic model research - PubMed

2013

Review PLoS Med

. 2013;10(2):e1001381. doi: 10.1371/journal.pmed.1001381. Epub 2013 Feb 5.

Prognosis Research Strategy (PROGRESS) 3: prognostic model research

https://pubmed.ncbi.nlm.nih.gov/23393430/

Prognostic models are abundant in the medical literature yet their use in practice seems limited. In this article, the third in the PROGRESS...

###

https://pubmed.ncbi.nlm.nih.gov/23386361/

BMJ

. 2013 Feb 5;346:e5793. doi: 10.1136/bmj.e5793.

Prognosis research strategy (PROGRESS) 4: stratified medicine research

From Twitter  Maarten van Smeden

https://twitter.com/MaartenvSmeden/status/1371829584249905152

https://www.slideshare.net/MaartenvanSmeden/development-and-evaluation-of-prediction-models-pitfalls-and-solutions

March 2021

#####

114 slide deck

Similar 100 slide deck by Ben Van Calster  March 2021

https://www.slideshare.net/BenVanCalster/development-and-evaluation-of-prediction-models-pitfalls-and-solutions-part-ii?qid=3f3d5590-2402-4ddf-8803-b119e965a9b9&v=&b=&from_search=1

(from TWITTER)

"08 PREDICTIVE 04 PREDICTIVE"

Clipped from: https://twitter.com/maartenvsmeden/status/1372111094815277060?s=12

Above slide is #51 in his deck 2021 03 Van Smelden....pdf

tiny print says 'courtesy (someone) no further ref'  LAURE WYNANTS

https://twitter.com/laure_wynants?lang=en

https://www.linkedin.com/in/laure-wynants/?originalSubdomain=be

https://twitter.com/maartenvsmeden/status/1372106090108837890

####

ALLELICA wants polygenic risk scores

https://www.genomeweb.com/informatics/allelica-wants-polygenic-risk-scores-become-routine-heart-disease-care#.YFfow69KhPY

CONSERVATIVE RE MAAA

Molecular Biomarker Testing in Localized Prostate Cancer

Baraban et al

APLM 145_264

https://meridian.allenpress.com/aplm/article/145/3/264/449935/Molecular-Biomarker-Testing-in-Localized-Prostate

POSITIVE RE MAAA

https://jamanetwork.com/journals/jamaoncology/fullarticle/2776221

Invited Commentary

February 11, 2021

Deciphering Genomic Risk in Prostate Cancer—Ready for Prime Time

Sean E. McGuire, MD, PhD1,2

https://jamanetwork.com/journals/jamaoncology/fullarticle/2776225

Original Investigation

February 11, 2021

Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer

An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial

Felix Y. Feng, MD1,2,3; Huei-Chung Huang, MA4; Daniel E. Spratt, MD5; et al

MEDPAGE

https://www.medpagetoday.com/hematologyoncology/prostatecancer/91156

PRESS Feb 11 2021

https://www.prnewswire.com/news-releases/decipher-test-clinically-validated-as-a-predictor-of-overall-survival-in-men-with-prostate-cancer-301227328.html

presS may 2024

https://www.prnewswire.com/news-releases/nccn-guidelines-designate-decipher-prostate-as-recommended-for-men-with-adverse-pathology-after-radical-prostatectomy-301028637.html#:~:text=About%20Decipher%20Prostate%20RP%20and%20Decipher%20GRID&text=The%20Decipher%20score%20is%20intended,and%20can%20reduce%20treatment%20intensity.

NCCN Guidelines Designate Decipher Prostate as "Recommended" for Men with Adverse Pathology after Radical Prostatectomy

The first and only genomic test to achieve "Recommended" status for the management of prostate cancer patients

 Decipher Biosciences (PRNewsfoto/Decipher Biosciences )

NEWS PROVIDED BY

Decipher Biosciences 

Mar 24, 2020, 07:00 ET

A few Links About CPT and its Fees

Overview article at Pubmed

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3865623/

open access Dotson 2013.

Google search might be:
ama cpt codes royalties  (no parentheses)

https://www.google.com/search?q=ama+cpt+codes+royalties

###

I don't know how much BCBS, or CMS, or Medicaid, or other payers pay for CPT.

It may be available somewhere on Google, but I couldn't find.

We do know top line, AMA FEES total $337M relative to budget of $400M.

##

Just looking at some google results physician fees are $20 per head, so with 1M physicians, that would be the first $20M.   If that's correct, you would infer by the math that payer fees are most of their revenue.

By the way, easily found publicly, CAP has revenue of like $250M (not that much less than AMA at 400M) and CAP revenue is 95% clia fees.

##

No prices of PAYERS but some public links at the national AMA ASSN itself

https://www.ama-assn.org/practice-management/cpt/ama-cpt-licensing-overview

https://www.ama-assn.org/topics/cpt-royalties-licenses

Some outside links

https://microwize.com/why-do-i-have-to-pay-a-fee-to-use-cpt-code/

https://help.practicefusion.com/s/article/CPT-License-FAQ

https://www.epstudiossoftware.com/the-evils-of-cpt/

https://www.verywellhealth.com/what-are-cpt-codes-2614950

https://www.medpagetoday.com/primarycare/generalprimarycare/89592#:~:text=AMA%20says%20the%20cost%20to,despite%20being%20in%20solo%20practice.

https://www.healthleadersmedia.com/welcome-ad?toURL=/strategy/sermo-wars-ama-over-cpt-codes

https://www.medpagetoday.com/blogs/campbells-scoop/80583?vpass=1

"AMA membership declines"

Publications

Dotson P (2013) Adv Wound Care 2:583-7.  CPT Codes, What are they, why are they necessary, how are they developed?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3865623/   Open access

Hirsch JA et al. (2015) J Neurointerv Surg 7:309-12 [A BMJ journal]  Current procedural terminology: A primer.  $37.

https://pubmed.ncbi.nlm.nih.gov/24589819/

Deeken-Draisey A et al. (2018) Arch path lab med 142:1524-32.   Current Procedural Terminology Coding for Surgical Pathology: A Review and One Academic Center's Experience With Pathologist-Verified Coding.  [may be open access]

https://pubmed.ncbi.nlm.nih.gov/29582674/

(Note to self, file names as:

2013 AWC 2_583 CPT Codes Where when Dotson zcpt 5p.pdf

2018 APLM 142_1524 CPT for Surg Path Verified Coding 8pp zCPT.pdf

2015 CPT A PRIMER Hirsch zcpt.pdf)

Forbes 2011

https://www.forbes.com/sites/theapothecary/2011/11/28/why-the-american-medical-association-had-72-million-reasons-to-help-shrink-doctors-pay

    

March 2021 rule delays

 In addition to MCIT rule delay...

HHS Continues Rule Effective Date Delays

Ongoing litigation, COVID-19, and a January executive order continue to impact agency actions regarding several major regulations finalized in the last several months of the Trump administration. This week saw the delay of effective dates for three major HHS rules which are under legal challenges. First, pursuant to a March 15 court order, HHS-Office of Inspector General delayed the effective date of all amendments to the anti-kickback statute rebate safe harbor rule until January 1, 2023. Second, HHS issued an administrative delay of the so-called “SUNSET” rule which generally requires thousands of Department regulations to be reviewed within five years or else expire if the regulation has not been reviewed in the last 10 years. The effective date for the SUNSET rule is now delayed for one year, to March 22, 2022. HHS explains that the delay will allow them to review the rule in light of a lawsuit filed March 9 by a diverse set of stakeholders alleging the rule is contrary to law, arbitrary and capricious, and in violation of the APA’s notice-and-comment requirements. Lastly, on Friday, HHS’ Health Resources and Services Administration (HRSA) delayed until July 20 a final rule requiring HRSA-funded community health centers to pass through rebates for insulin and epinephrine to patients. HRSA explained the delay would allow the agency to assess whether enforcing the rule is appropriate given the focus on the pandemic.

 

More broadly, as the 60-day effective dates for so-called “midnight” regulations by the Trump administration arrive this week and next week, HHS may delay the effective dates to allow the agency more time to review the rule in light of the administration’s priorities. A January executive order called for review of any published final rule whose effective dates had not passed by President Biden’s inauguration to allow the new administration’s appointed officials (or designees) to review the rule and consider the merits of moving forward with the rule or delay the effective date and solicit comment on areas where the administration is considering changes.

Articles & Resources

Link to SUNSET rule delay

 

Link to HHS-OIG rebate rule delay

 

Link to HRSA drug discount rule delay

Becerra Hearing

 CSPAN logs video and provides "all capital" transcript, in small chunks.

https://www.c-span.org/video/?c4947801/hhs-secretary-nominee-becerra-delivers-opening-statement-confirmation-hearing#

Senate.gov has 3:20 hearing (no apparent transcript).

HELP - Health, Education

https://www.help.senate.gov/hearings/nomination-of-xavier-becerra-to-serve-as-secretary-of-health-and-human-services

SENATE FINANCE (Starts with 8 minutes silence) (In 2 recording attempts, stops at recording point 28m).

https://www.finance.senate.gov/hearings/hearing-to-consider-the-nomination-of-xavier-becerra-of-california-to-be-secretary-of-health-and-human-services

SFC has 95 pages of questions for the record

https://www.finance.senate.gov/imo/media/doc/Becerra%20SFC%20QFRs%20MASTER_FINAL.pdf

File copy as:

2021 HILL 0324 Senate HELP Becerra Questions for Record QFR 95pp.pdf

NGS MAC Article re Spring 2021 Gapfill Rules

 https://www.ngsmedicare.com/ngs/portal/ngsmedicare/newngs/home-lob/news-alerts/news-articles/news-detail/ab%202021%20gap_fill%20request/!ut/p/z1/tVNdk5owFP0r9mEfM_kgIDxGdLE6i_2iSl52AgQ3LUTFVLr99Y2zu7NtGcWOLQ_M3Ms5587h3As5XEGuxUGthVEbLSpbp9y7p-ztBOMQzRf-FCE2HzPK4sjxEwyXfwCchY8YvR2Nx-_fOdGIQP7b53mCLZ9MnDgKCUqGz3x04mHoMv4rIJwwO38cezG7xQvk9vE_Qw75NlcFTAvqYg8XFNi3C2hJAxC4GQalF8iiIEMaeOSIzrXZmgeY6vW-loXKRSPzjTZSGy3bG_RL-6mW7R4IXQBRycbsXxqNUXklbfnMvUEiGxBE8GAttvelqqpBI3ff5N50PHZM8L_LqAPg5yNYHl33pNyncV4hph1AJ8jUuhiechFNHbg8KNnCRG-a2m7ux9dgRUaoS2QAShJkgOaUApEjBPJhgUvpeIWDKZyingkBuXJCjzy6Un7Wt-r2ltWX3Y4zu8LHnftu4Oqf7PB5Zz7Gp51ddHM98s6V8rO--_lvP-6S47fDSXMX3q2tJ2EegNLlBq5Owrd1kiS17zwq8PXD9McoBlGY-e2nsl6CdHY4Nnj22L75Cd4SVAo!/dz/d5/L2dBISEvZ0FBIS9nQSEh/

As posted by NGS MAC in March 2021:

2021 GAP-FILL REQUEST

National Government Services , the MAC for Jurisdictions JK and J6 is in receipt of the new laboratory test codes identified by CMS to be gap-fill priced for 2021. The Protecting Access to Medicare Act (PAMA) regulations instruct the MACs to establish local payment amounts for the new laboratory test codes using the following sources of information, if available:

• • Charges for the test and routine discounts to charges
  • Resources required to perform the test
  • Payment amounts determined by other payors
  • Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant

NGS seeks your input on establishing pricing under the Medicare program for new laboratory test codes 86328, 86769, 87635, 0101U, 0102U, 0103U, 0129U, 0139U, 0140U, 0141U, 0142U, 0143U, 0144U, 0151U, 0152U, 0153U, 0156U, 0157U, 0158U, 0159U, 0160U, 0161U, 0162U, 0163U, 0164U, 0165U, 0171U, 0173U, 0174U, 0175U, 0178U, 0179U, 0180U, 0206U, 0207U, 0208U, 0209U, 0212U, 0213U, 0214U, 0215U, 0216U, 0217U, 0219U, 0220U, 0221U, 0222U, 0015M, 0016M, U0001, U0002, U0003, and U0004. NGS kindly requests that you submit your responses to ngscmd@anthem.com by 3/19/2021.

Please note that your answers will be kept to the greatest degree of confidentiality and will not be disclosed, except as may be necessary to share with others under confidentiality agreements with CMS for the sole purpose of establishing Medicare clinical laboratory fee schedule gap filling pricing.

Your responses will be reviewed and evaluated by NGS and if proper, set forth in its recommendations to CMS of the appropriate fees for these tests. If no response is received, the fee will be determined by evaluating the charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.

MolDx Advertises 3 Staff Positions circa March 01, 2021

 From AMP LIST SERVE

This is your opportunity to help direct policy and direct the future of molecular diagnostics.

 

Current Open Positions:

 

MD and PhD level Medical Director positions (require MGP training and experience for MDs, or ABMG training and experience for PhDs):

 

https://ourhrconnect.wd5.myworkdayjobs.com/PalmettoGBA/job/Columbia-South-Carolina/Medicare-Medical-Director---Palmetto-GBA_R1012763

 

Clinical Lab Scientists (expertise in lab methodologies and test menus required, experience/knowledge of billing/coding highly desired)

 

https://ourhrconnect.wd5.myworkdayjobs.com/PalmettoGBA/job/Columbia-South-Carolina/Clinical-Lab-Scientist---Palmetto-GBA_R1012767

 

Medical Affairs Coordinators (RN and payor experience required, experience with/knowledge of molecular testing highly desired)

 

 https://ourhrconnect.wd5.myworkdayjobs.com/PalmettoGBA/job/Columbia-South-Carolina/RN-Medical-Affairs-Coordinator---Palmetto-GBA_R1012770

 

Please follow the links and apply!

 

Cheers,

 

Gabriel Bien-Willner, MD, PhD

Chief Medical Officer, Palmetto GBA

MolDX Program Director

How to find page for next pending CPT editorial meeting

 Go to this fixed AMA CPT page, About CPT:

https://www.ama-assn.org/about/cpt-editorial-panel

Scroll down past all the image boxes near the top, and you'll eventually hit a chronological listing of articles, new webpages, or links.   Here, and today is March 3, I see a listing that takes me to MAY CPT MEETING which is found at entry #2, below "COVID CPT Coding" updated March, and "CPT Codes for new Coronovirus vaccines" which is entry #3 Feb 2.   The next one is AMA announces additional...Dec 17.   See pic below.

For SUMMARY OF PANEL ACTIONS, 

here:  https://www.ama-assn.org/about/cpt-editorial-panel/summary-panel-actions