My 2021 Book and Film List

If of interest, the seventh annual edition of my book and film list - 

https://bqwebpage.blogspot.com/2021/12/books-and-films-cy2021.html

BUSINESS STRATEGY

Conflicted (Ian Leslie)

HISTORY - POLITICS

The Lost Cafe Schindler (Meriel Schindler); Republican Rescue (Chris Christie).

BIOGRAPHY

A Reason for the Dark (on Edgar Allan Poe; John Tresch), 

and In and Of Itself (book & film; Derek DelGaudio)

ESSAYS

Everything in its Place (Oliver Sacks); Joan Didion

SCIENCE & TECHNOLOGY

A History of the Index (Dennis Duncan), and A Place for Everything (Judith Flanders).

And related to these, works by or about Eugene Garfield (see below).

FILM AND TELEVISION  

Very Brief Blog: Genomeweb Annual Survey of Precision Oncology (Subscription)

On December 20, 2021, Genomeweb released its annual survey on the practice of oncology and oncology genomics.  Find the report here (subscription) at the Precision Oncology News website.

The survey topics include the following:

• Trends on insourcing and outsourcing (e.g. from single gene to exome to LBx)
• Tests used for immunotherapy choices (PLD1, MSI, TMB, etc)
• Stage at which CGP is a good idea
• Trends on utilization of germline oncology testing (BRCA, Lynch, more)
• Use of institutional molecular review boards
• Why biomarker testing is underutilized (barriers)
• Use of clinical trials
• Biggest challenges for precision oncology

Related

See also recent reports by the consultancy Decibio on use of CDx and use of multiomics and digital pathology.  

See also the March 2021 survey by Health Advances LLC and the Personalized Medicine Coalition on institutional readiness for precision oncology - here.

Very Brief Blog: McDermott Will & Emery Issues 18 Page Report on "Telehealth Post Pandemic"

McDermott Will and Emery has issued a timely 18 page update on "Medicare Reimbursement of Telehealth" after the pandemic - after the public health emergency (PHE).

Access the new report with email registration here.  Most of the report is in a three-column tabular format, specifying a topic (such as direct supervision rules, or audio-only visit rules), the current state under PHE, and potential changes after the PHE.  Several dozen policy topics like these are summarized.

For those primarily interested in lab industry issues, note that telehealth potentially makes large alterations in the channels and pathways for both routine and specialized lab tests.  E;g. a current article in JAMA by Scott Gottlieb notes,, "Home diagnostic tests will be increasingly coupled with telemedicine visits...This ability to connect at-home diagnostic tests with telemedicine and rapid turnaround of definitive laboratory testing will change infectious disease management." 

See McDermott's home page for digital health law and policy here:

https://www.ofdigitalinterest.com/

Along a related theme, see the FDA's new guidance on digital health, remote technologies, and clinical trials - here.    

And pair that with Morning Consult's new poll on the final arrival of digital technologies in clinical trials, here, something also stressed by Verily's Amy Abernethy here.  These themes highly relevant to the diagnostics industry; see for example Labcorp acquisition of Covance here and IQVIA-Quest collaborations and separations in the clinical trial space here (and here) and the new Thermo Fisher acquisition of PPD clinical research organization here.

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See also an article on Surprise Billing and surprise impact on telemedicine here.

 

Very Brief Blog: CMS Publishes Final Special DME Rule, With Benefit Category Rules, Other Bells and Whistles

Every year, CMS publishes rulemaking about Durable Medical Equipment policies, often fairly inconsequential and often annexed to some passing major rule, like the annual ESRD rule.

In 2020, CMS made a more elaborate proposal (as well as as rolling up some DME topics in interim final rulemakings related to COVID last year).  See 85 FR 70358, November 4, 2020, 57pp.  CMS publishes new ways of making fee schedule adjustments outside of competitive bidding areas; CMS provides adjustments for rural areas; CMS provides rules for benefit category determinations for DME (and prosthetics etc, DMEPOS).   Determining a benefit category sets whether something is payable at all, but the specific benefit category choosing will invoke different payments rules specific to that benefit.

As a side note, this benefit category thinking built into HCPCS decisions isn't brand new; many products for years and years have gotten a turn-down with the comment, "We do not believe there is a benefit category."  And other items are assigned a code and a pricing method (such as an E-code and pricing as rental DME) meaning a benefit category choice was implicit.

Find The Stuff

Find the home page for the final rule here.   Find the pre-publication or typescript inspection copy of the rule, 167 pp, here.  On December 28, Fed Reg will release the final paginated and typeset version.

HCPCS "Theory and Goals" Simply Dropped from Final Rule; Bookmark the Proposed Rule

CMS is dropping some proposals such as regulations that HCPCS codes would follow CMS determining a service has a Medicare "claims processing need."   CMS already utilizes this type of consideration (E.g. we read something was rejected because "we did not identify a claims processing need") but CMS won't be memorializing this and other concepts in permanent and formal regulations at this time.  

To understand some of the nuances of CMS's thinking about HCPCS coding, one should definitely continue to bookmark the many pages written in November 2020 about "claims processing need" and coding theory and goals (e.g. 85 FR 70385), since all those pages were deleted from the final rule.  But savvy HCPCS applicants will keep all those statements of policy and frameworks in mind.    

Submit a Standalone Benefit Category Analysis; Timetable Matches HCPCS Requests

CMS will allow parties to submit benefit category requests  without requesting a HCPCS code.  These requests will be dovetailed with the existing twice-a-year HCPCS review and public comment process.  (E.g. imagine a day with agenda items 1-10 = DME, agenda items 11-15 = Prosthetics, and then agenda items 16-18 are benefit category requests only).  

If parties request a less formal benefit category decision off-cycle from HCPCS meetings, CMS seems to say it will in the future channel such requests into the biannual process rather than giving one-off replies.

I'm not sure how this new process fits with or replaces an existing, but very very rare process, called a National Benefit Category Determination (e.g. here, for IBOT here.)   These resembled NCDs, for 40-page public analyses being publishes, as opposed to implicit or informal benefit category decisions made during coding, or stated in a sentence or two during the issuance of a new HCPCS code.  

Lots About CGM - Continuous Glucose Meters

There are many pages covering precise and hotly debated nuances about the details of CGM policy, which I leave as an exercise to the reader.

OIG Issues Report on Massive Medicare Genetics Spending Growth, Highlights Fraud

The Office of the Inspector General has issued an overdue report on the massive growth in genetic spending & alleged fraud since 2018.   Find the 21 page report here or here.  I say the report is overdue because it's based on data ending in December 2019, and it's nearly 2022.

The report officially highlights what I vigorously pointed out in Fall 2020 based on  CY2019 data - that anomalous spending in genetic testing had skyrocketed.  The OIG report also builds on a July 2020 white paper (24pp) by the Healthcare Fraud Prevention Partnership - here.

The December 16 HHS OIG report documents (page 19) that the highest-spending genetic code in 2019 (and nearly the highest in 2020) was 81408, a code for a grabbag of very rare genes with full sequence reported.  

• The usage of this code was essentially zero in 2016 and 2017, and popped to $121M and $284M in 2018 and 2019, respectively.  
•  The genes inside 81408 are so rare, AMA expects they will have very little usage (less than 1000 per year nationally), or else they would be elevated to regular genetic Tier 1 codes.  

81408 Massively Incompetently Handled by CMS

See my five-blog series in December 2021 - here.

For a shorter five-part trail of horrors, here:

#1 Which labs?  Billing for 81408 for Medicare patients by familiar labs like Labcorp, Quest, Invitae, Bioreference, Ambry, and others?   Zero.   Look for billing by pop-up places with names like "ABC Lab" and no website.

#2 Which MACs?  As I've documented in the past, billing for 81408 was essentially zero in the MolDx MACs and the NGS MACs, and was concentrated only in the Novitas and FCSO MACs, and briefly in the now-defunct Cahaba MAC.    

#3 Complete Incompetence at CMS Office of Program Integrity.  In an ongoing scandal that it would be charitable to call "complete incompetence," the Medical Unlikely Edit, or payment cap, for 81408 is 2, allowing fraudulent labs to bill every case in a multiple of 2 ($4000!).   It would have taken only seconds in 2018 or 2019 or 2020 or 2021 to change this edit to 1, saving Medicare about $150M a year, pretty good return on 30 seconds effort by an administrator.  It's even more bizarre because nearly all genetic codes, including Tier 2 codes, have an MUE of 1.   

#4 Problem Understood in Mid 2019; Few Actions by End-2020.   The problems were fully understand by mid 2019, as evidenced in public press releases about Operation Double Helix (here).   Yet spending only dipped slightly for 81408 from CY2019 to the end of CY2020, which is crazy.   Spending should have gone back to near zero, by putting place controls in January 2020 based on findings in 1H2019.   Should have bone back to near zero, as it was in 2016, 2017, 2018.   

Hundreds of millions of dollars gushed out long after the torrent of cash had been fully identified.  

#5 PAMA Paid a Role.   PAMA played a role when PAMA prices were introduced in CY2018.   In 2016-2017, the higher Tier 2 codes including 81408 had minimal utilization, and had no prices set (because they had no Medicare usage!!!!) and had to be manually reviewed and individually paid.  On January 1, 2018, 81408 was assigned a price of $2000 per test and began to autopay, slowly at first, and then madly.   And often in pairs, following the MUE limit of 2.

OIG report (page 14) highlights several categories of fraudulent billing.  (1) Billing for services not performed at all.   (2)  Unbundling of claims or repeat billing.  (3) Blanket ordering of costly panels of rare genes on a series of patients by unscrupulous providers which are then autopaid by the insurer.

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See comprehensive year-by-year spending tables pn pages 19-20.  

Note that OIG treats all spending the same, so that $300M spent on Cologuard (under FDA approval and an NCD) is treated the same as $300M spent on 81408 (to pop up labs with no website cited as allegedly fraudulent by DOJ in press releases).   It's all the same in this report. As Becky Winslow remarked on Linked In, "Labs who don't even have the technical ability to perform 81408 have billed and been paid for 81408."

See concise coverage of the OIG report at Genomeweb here.

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In Point 2, I noted that the alleged fraudulent claims never occurred MolDx MACs, which devote great resources to genomic payment controls.  However, no payments occurred in the NGS MACs either, which devote de minimis controls (but firm ones) on genetics.

Very Brief Blog: PGDx ELIO FDA Review Documents (32pp, 108pp)

From time to time I get questions about what FDA review is like for a next generation sequencing test, or why the FDA review takes so long.

Not new-new, but still of interest.  In spring 2020, Personal Genome Diagnostics (PGDx) got FDA clearance for a several-hundred-gene tumor test.   It's 510(k) clearance, the predicate being the Memorial Sloan Kettering IMPACT test, which was de novo 510(k).   

For Medicare types, the ELIO test isn't automatically covered under CMS Next Gen Sequencing NCD 90.2, because it isn't a "companion diagnostic" test.  However, it can be covered by local MACs.   It went through a separate post-FDA review process at MolDx until September 2020 (here).  MolDx apparently assigned the test to code 81479 (other molecular test) rather than 81455 (tumor gene panel > 50 genes).  In 2021, the saga continued, with PGDx ELIO getting a PLA code in the spring, 0250U, which was crosswalked to the price of 81455 (about $2900) in November 2021.  The test includes mutations, small indels, 1 amplification, 4 translocations, and also MSI and TMB.

Here are links to the key FDA pages:

FDA Home Page for the test, links, and updates:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192063

FDA authorization letter, 32pp:

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192063.pdf

FDA safety and effectiveness review, 108pp:

https://www.accessdata.fda.gov/cdrh_docs/reviews/K192063.pdf

(In contrast, the PMA review of the original Foundation Medicine CDx panel, was only about 50 pp).

The test is classified as FDA product code "PZM" and falls under 510(k) regulatory classification 21 CFR 866.6080.   

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For the Foundation One "Liquid" CDx approval, here.  it's product type PQP, but doesn't have a regulatory classification at 21 CFR since it's PMA not 510(k).  

The PAIGE AI software system for prostate biopsies got FDA De Novo in September 2021; its full evaluation documents are not yet posted by FDA but will appear here (DEN 200080, 21 CFR 864.3750, code QPN.)

AMA Releases 18 Page White Paper from July Workshop on Precision Medicine and Coding

 In July, AMA held a public all day town hall meeting on whether CPT could be improved to better serve the needs of precision medicine.

At the time, I listened all day and I was very happy they were holding the session, but I found it difficult to describe any home-run take home lessons as materializing during the day.

Now you can read for yourself.  AMA has issued an 18 page white paper summarizing the meeting.

Find it here:

https://drive.google.com/file/d/1aUbqIXUld-YhEXIDK6Rvx_3lH7QuXaS3/view?usp=sharing

The AMA and the CPT Editorial Panel thank stakeholders who participated and contributed their perspectives and insights.  Attendees and other interested parties can download a copy of the meeting summary at the following link:    **AMA CPT Diagnostic Precision Medicine Virtual Meeting Summary**

Best regards and happy holidays,  AMA and CPT Editorial Panel

CMS Officially Recognizes: PAMA Delayed by Another Year

Update: Release of 2022 fee schedule circa December 30 - here.

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Under the original PAMA Schedule, prices for tests paid in 1H2019 were to be reported in 1H2020 for the 2021 fee schedule.  It was delayed by two years.

Newly, on December 10, the Protecting Medicare act  added another year's delay.  Now, prices for tests paid in 1H2019 will be reported in 1H2023 for pricing in 1H2024.   Presumably, that will be a three year fee schedule for 24, 25, 26, so that prices in 1H2025 will be reported in 1H2026 for a new three year schedule commencing 2027.

Which Means...

Another way of saying that, median prices observed 1H2019 will be applied until December 31, 2026.

There will be no payment reductions as we leave 2021 and enter 2022.  CMS has delayed issuing the CY2022 CLFS fee schedule, which will soon appear here.  On that webpage, wait for the appearance of a file titled, "22CLFSQ1."

PLA Codes in PAMA Limbo

The highest PLA code in the six months of 1H2019 was 0061U (a 5-biomarker tissue oxygenation code which had 378 payments in CY2020 at $25 each).  AMA is already up to 305U (RBC morphology biochip).  That means all the codes from 0062U forward will have missed the last PAMA data capture cycle in 1H2019 and won't be surveyed until the next PAMA data capture cycle way out in 1H2025.  As I read the regulation for pricing (though it's a bit mind-bending), tests sit at their new crosswalk/gapfill prices until the next PAMA cycle they are eligible for.  

(Alternatively, if codes higher than 0062U are considered "codes with no applicable PAMA information" when they reach the PAMA pricing process of summer 2026, hundreds of such PLA codes would enter the crosswalk/gapfill process all at once.)  

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https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2021-12-16-mlnc#_Toc90391085

CMS writes,

Medicare Clinical Laboratory Fee Schedule Private Payor Data Reporting – Delayed until 2023

On December 10, the Protecting Medicare and American Farmers from Sequester Cuts Act delayed the Clinical Laboratory Fee Schedule private payor reporting requirement:

• Next data reporting period is January 1 – March 31, 2023
• Reporting is based on the original data collection period, January 1 – June 30, 2019

The Act also extended the statutory phase-in of payment reductions resulting from private payor rate implementation:

• No payment reductions for Calendar Years (CYs) 2021 and 2022
• Payment won’t be reduced by more than 15% for CYs 2023 through 2025

Visit the PAMA Regulations webpage for more information on what data you need to collect and how to report it.

Novitas Finalizes Cardio Genetics LCD I Warned About; No Genes Covered

 In mid-August, I published an alarmed blog about a newly proposed cardiovascular LCD from Novitas (and First Coast) MACs.   My concern was that the LCD simply proposed generalistic comments about what cardio genes might or might not be covered (with no specifics).   In addition, the LCD provided rules for medical review that could be applied arbitrarily in such a way that virtually no medical record would support any testing.  See my blog here.

The final LCD has been released, with essentially zero changes despite extensive comments.  (L39084).  Moreover, the LCD remains generalistic - you could word search and replace "cardiovascular" with any other disease area and the rules could be applied.   

But when you get to the billing and coding article, A58797 (here), there's the real surprise.  It consists of nothing but a list of cardiovascular related genes (and the list of all Tier 2 genes) and a summary statement that nothing is covered.  The ICD-10 section is concise: "Due to non coverage, there are no ICD 10 codes that support medical necessity."

In case it's not clear, my issue was and is, that the LCD body is that it contains generalistic coverage rules, and one medical director might write an article that covers 20 or 30 genes per those rules, and the next medical director might cover "zero" of them per exactly the same generalistic rules.   You can't tell until you open the billing and coding article, which isn't subject to public comment and can be revised at any moment at the whim of the current medical director.  (See similarly high level and generalistic rules for covering germline testing in MolDx DL38966, blog here).

I've put the whole set of draft and final versions, public comments, and billing article in a cloud zip file here.

The Novitas and First Coast MACs were ground zero for massive genetics Medicare fraud in recent years, according to allegations from Department of Justice.  Much of those hundreds of millions of dollars flowed out freely under uncontrolled (and unwatched?) use of Tier 2 codes.  As I've pointed out, payments for 81408 - very rare full sequence genes - went from almost 0 in 2017 to the highest paid Medicare code in 2019 and almost the highest in 2020 (crazy !!!!!).   They put out a highly atypically written genetics billing and coding article this fall related to that effort, here.  

Frankly Bizarre Reasoning and Misuse of Citations

Below, click to enlarge and see one example of Q&A along the path to the noncoverage LCD. I am stunned and unable to draw any line at all between the actual 2020 Musunuru AHA guidance article cited (here) and the Novitas flat noncoverage billing article that was created.   To me this is a gross example of mis-citation without any associated mental reasoning.   It's like citing an article that the moon rotates around the earth to justify a conclusion that the moon doesn't exist.

click to enlarge

Brief Blog: FDA Headlines: 5 Issues for FDA; Califf at Congress; "Chaos" in Checkpoint Inhibitors

Flurry of headlines about the FDA.

• At Endpoints, Zachary Brennan highlights five issues for  FDA, as it prepares for a new leader after a year without one.  Here.
• Accelerated approvals - are they too low a bar?
• Real world evidence - how to really use it? (e.g. for just 1 resource, here).
• COVID - from boosters to medications to backlog
• Hiring and retention
• Opioid epidemic; ongoing issues
• Robert Califf MD, who led the FDA under Obama, and most recently had a leadership role at Veriliy, on the Hill for confirmation hearings.  
• Story at Government Executive, here.
• Cancer leadership at FDA, including Richard Pazdur, describe a chaotic world of me-too checkpoint inhibitor drugs.
• See a news story at Endpoints here.
• See the new op ed "Wild West" at NEJM here.

Everyone who works at the intersection of diagnostics and oncology knows that better checkpoint inhibitor biomarkers are badly needed.  Some markers appear to work well in large meta-analyses yet have little clinical traction (here).

  

Very Brief Blog: DeciBio Consultancy Launches Venture Fund

Interesting headline from the press releases wire services - pairing deep content knowledge with investment plans.

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DeciBio Consulting Announces Debut Venture Fund, 

DeciBio Ventures, 

to Support Ground-Breaking Precision Medicine Companies

Press release here.

 LOS ANGELES, Dec. 15, 2021 /PRNewswire/ -- DeciBio Consulting, LLC, a precision medicine-focused strategy consulting and market intelligence firm, has launched DeciBio Ventures. This venture capital and creation firm invests in and supports ground-breaking companies in the precision medicine space.

"We believe that technological improvements will drive the precision medicine revolution. Funding the most innovative companies in precision medicine is another step for us to help accelerate burgeoning advancements to improve human health," stated DeciBio Consulting's Co-Founder Stephane Budel, Ph.D."At DeciBio, we have always differentiated ourselves by our depth of expertise and close ties with industry players. With consulting services, data analytics and products, software products, and now venture capital, DeciBio is poised to support various stages in the commercialization journey.   

In line with DeciBio Consulting's mission to accelerate precision medicine advancements, DeciBio Ventures aims to invest in start-ups across both tools and therapeutics. Portfolio companies will be able to leverage DeciBio Analytics' novel products, solutions, and services to gain differentiated, market-level insights. 

"We continue to look for ways to support early-stage companies that are advancing precision medicine. DeciBio Ventures is the next step in that pursuit and represents another layer of support to help these companies commercialize the technologies that will drive future waves of innovation," added Miguel Edwards, Ph.D.

"DeciBio Ventures codifies our engagement and collaboration with pioneering early-stage companies transforming precision medicine and provides a strategic edge to these companies to ask bolder questions and seize on fertile, untapped science to tackle the most critical challenges in healthcare for patients," added Carl Schoellhammer, Ph.D.

About DeciBio 

DeciBio Consulting (www.decibio.com) is the leading strategy consulting, market intelligence, and SaaS firm dedicated to accelerating the adoption and impact of technologies enabling precision medicine.

Headquartered in Los Angeles, California, DeciBio serves a global base of clients and customers, ranging from startups to Fortune 500 healthcare corporations. DeciBio offers advisory services for growth planning, market and opportunity assessment, product and portfolio strategy, voice-of-customer feedback, technology assessment, and commercial due diligence.

Contact:

Carl Schoellhammer

Ventures@DeciBio.com

310.451.4510

Tidbit: What Did Unicorn Founders Study at University?

Tidbit from LinkedIn.   

What did Unicorn Founders study at University?  There's a "Big 3" = computer sciences, engineering, and business.  After that, it's a long tail, from poli sci to accounting to sociology.

Find it here:

https://www.linkedin.com/posts/ilyavcandpe_unicorns-venturecapital-startups-activity-6876923312635695104-sCJU

Click to enlarge:

Very Brief Blog: 600,000 Medicare Beneficiaries Died of COVID

On December 13, 2021, NYT runs an article focusing on the age distribution of COVID deaths.  600,000 of 800,000 deaths so far, or 3/4, have been in the 65 and over population. For perspective, laid end-to-end, the caskets of Medicare beneficiaries would stretch about 700 miles.  

See the link -

https://www.nytimes.com/2021/12/13/us/covid-deaths-elderly-americans.html

As shown in the graphic, in the first 12 pandemic months, the over-65 death proportion was always 75% or above.  It fell to about 60% during the Delta surge last summer and early fall.  Today it's running about 75% again.

In 2020, 63M people were enrolled in Medicare, 54M age 65 or older.  Medicare Advantage is about 26M (26M/63M = 40% are in Medicare Advantage).

With 600K deaths / 60M beneficiaries, about 1% of Medicare beneficiaries have died of COVID.  Only about 1/4 of 1% of the total US population (800K/350M) have died of COVID.

In the first pandemic year, through February 2021, about 500K died of COVID.  It's still several months to the end of February 2022, and the death toll March 2021 to Feb 2022 will likely be fairly close to 500K again, since it's already over 300K and rises faster in Jan/Feb.  

Very Brief Blog: Review All Code Applications for February 2022 CPT Meeting

I noted on November 19, 2021, that AMA had posted early notice of the new lab codes for the February 2022 CPT meeting. 

Since then, AMA has posted all the code applications for the February meeting.  

See the meeting home page (and registration info) here.

See the full agenda here.  Interested stakeholders can request and review applications up to January 13.

There are about 9 pathology applications and about 29 other applications.

Very Brief Blog: Abbott Highlights Lack of Racial Equity in CGM Glucose Meter Usage; Meeting with OMB

On November 4, 2020, CMS issued a proposed rule change for DME, HCPCS coding, and benefit category determinations - 85 FR 70358ff, here.  The rule is not finaled, and groups may meet with the Office of Management and Budget (OMB) about the rule.  See OMB page here, meeting page here (aka Executive Order/EO-12866 page).  This shows a meeting with Abbott and OMB on 11/19, with Medtronic and OMB on 11/23.  The decks are here and here, respectively.

The Abbott deck includes a slide that shows a marked disparity between white population states and black population states in the utilization of CGM per 100 individuals with diabetes.  This rate ranged from 160/1000 for states with the highest white population, and down to 20/1000 for states with the highest black population, close to a ten-fold difference.

Separately, see a very powerful recent story in the LA Times about the impact of diabetes and amputations in minority communities - here.  By journalist Joe Mozingo and photographer Francine Orr.

For the Abbott slide, click to enlarge:

AHA and AMA Sue Government over Surprise Billing Law

Last December's surprise billing law goes into effect in January 2022, and HHS has been rolling out regulations and guidance documents.  Generally, it caps payments to out of network providers at the median of a payer's in-network rates.  360Dx had an August subscription article on implications for labs (here).

New news.  AMA and AHA file a lawsuit against HHS regarding misguided implementation of the law.

• Press release here.
• AMA says No Surprises Act bad, here.
• Kaiser Health News here.
• Fierce Healthcare here.
• Healthcare Finance News here.

One of my takes on this is that it changes the "game theory" of contracting.  Let's say a health plan contracts with one hospital at $100, another at $125, another at $150.  Health plan could drop the top two hospitals from network, and contract with only the $100 hospital.  Then the second and third hospital will get paid by law at the $100 median in network rate, without bothering to contract with them.   Just an example.  The actual rules are complex.  Labs have faced contracting network strategy games for years - do you want to bill $100 out of network, hoping to get paid 50% or $50, but maybe zero, or do you want to contract in network for $45 you can count on reliably?  

See a mid-November article at NPR, "Doctors mad at surprise billing rules," with strong comment from Secr. Becerra that the law is good and will stop over-billing by certain providers.

Surprise Billing Law

Telemedicine surprise can get unexpectedly caught in the Surprise Billing Law.   What if you're an out of network telemedicine provider and charge $100 for 30 minutes, but the payer's in-network rate is $15 for 30 minutes?   See an article at HealthcareFinance here.  See an earlier note from McDermott here.

Congress Delays PAMA Cuts

For the third time in two years, Congress has delayed PAMA implementation.  The first delay was in a December 2019 budget bill (just before COVID), and the second delay was in one of the spring 2020 COVID acts.

December 2021, Bill #3, the Protecting Medicare and American Farmers from Sequester Cuts Act.  

I had a brief blog on this December 8, see more detail at an open access article at 360Dx. It's not just about labs, various sequesters and other cutbacks affected hospitals and physicians in multiple ways.

• 360Dx here.
• Legislation, in legalese, here.

Very Brief Blog: House Passes Bill to Delay Medicare Cuts, Including Lab Cuts

The House has passed a bill that will delay a wide range of Medicare spending cuts, including PAMA.  PAMA rate cuts will be delayed for an additional year (out to January 2023).  In addition, I understand that PAMA reporting may be moved from 1Q2022 to 1Q2023, indicating that it would apply to a 1Q2024 new fee schedule.

See press release on December 7 from ACLA, here.  See a letter from numerous groups on December 2 asking the PAMA cuts be delayed here.  

See an article at Fierce Healthcare that talks about the range of the cuts and the delays here.  I've read that physicians, in general, faced up to 10% cuts due to multiple reasons and hospitals, 6% cuts.

See a copy of the 7-page bill (in legalese, adding bits of phrases and insertions to various laws) here.

WHO Boosts Molecular Classification in Brain Tumors: Headaches From 14 Day Rule

The November 2021 issue of CAP TODAY includes a cover story by Karin Titus on the sharply growing role of molecular classification in the diagnosis of brain tumors.   Molecular testing has become critical for major decisions both in tumor classification (tumor type) as well as in tumor grading.

See the article here.

Genomics are used for classifying types of brain cancer (e.g. two major and different lines of astrocytomas) as well as tumor grading.  Methylation patterns are also rising in importance for tumor classification.   Great news for molecular pathology and for better patient diagnostics.

14 Day Rule Collides with Inpatient DRGs

If the specimens were outpatient specimens, the 14 day rule now has an exception for human (but not microbial) molecular testing.  However, there is no exception for any kind of testing, or molecular testing, on inpatient specimens.  The molecular tests are bundled to the fixed DRG price, and most brain tumor specimens will be inpatient specimens.  That means the lab has to incur hundreds of dollars of new, and bundled, costs unless the physician's order for molecular testing is made at least14 days after the patient's discharge.

Worth thinking about the policy and patient care implications.  The article, which features comments from Arie Perry of UCSF and Daniel Brat of Northwestern, notes that a new CAP guideline for brain tumor testing will appear shortly in Arch Pathol Lab Med.  The article is based primarily on the recently completed 2021 WHO guidelines for brain tumor diagnosis and classification.

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Brings back some memories for me; I'm a board certified neuropathologist and served on the Northwestern faculty 1997-2001 before moving into business positions.

AMA Scope of Practice Email (Click to Enlarge)

 

click to enlarge

Video and transcript

https://www.ama-assn.org/practice-management/scope-practice/scope-practice-and-patient-safety-michaela-sternstein-jd

AMA CPT Update: Clinical Pathology Consultation - Complexified !

For years, we've had two approaches to pathologist consultations.   Codes 80500 and 80502 were clinical pathology consultations, valued at $22 with 22,000 uses and $73 with 13,000 uses.

Turning to anatomic pathology, for review of outside slides, or if needed making new slides, we had codes 88321, 88323, 88325 ($99, $115, $167, with utilization 182,000, 35,000, 11,000).

2022

Now for 2022 we have several new codes for pathology clinical consultation.  Although they seem geared to clinical pathology (and one might think especially genomics), each includes a valuation for microscope use as a practice expense for the whole service (at 15, 30, or 54 minutes).  Note that AP slide review codes 88321 etc. continue unchanged in 2022.

More notably, the instructions for 80503-80506, replacing 80500,80502, are vastly more complex.  Instead of a sentence or two, the instructions now run several pages.  I've clipped screen shots below although they are not legible, to avoid interfering with AMA copyright.

80503 accounts for 5-20 minutes of total time, 80504 for 21-40 minutes, and 80505 for 41-60 minutes.  Additional half-hours bill as 80506.  Billing can be for time alone, or, for complexity levels elaborately defined (rather like E/M visits have elaborate decision levels).  The CMS RVU valuation, published 11/2021, is here.  86 FR 56101-2.

The total non facility RVUs, per the November 18 final rule, are below.  I've used a simple placeholder conversion factor of $36.  Recall the old code pair was $22 simple and $73 complex.

80503  .77 or $28

80504  1.54  or $55

80505  2.79   or $100

80506  1.25  or $45

AMA Posts Registration (Til Jan 21) for Feb 3-5, 2022 / ZOOM ONLY MEETING (Not in SF)

Update.  On January 7, 2022, AMA canceled the in person component.  Zoom only.

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The AMA has posted information for in person and/or virtual registration to the February 3-5, 2022, CPT Editorial Meeting in San Francisco.

This February 2022 meeting will be the first 'live" meeting since February 2020.

In person capacity is limited to 250 people, and may "sell out."  Open till January 21, if not sold out.  Virtual attendance open til January 28.

See the registration information here:

https://web.cvent.com/event/8b43311f-72d8-4e4c-87e8-d7a10ae05d08/summary

I believe at some point a link (another entry point) will also be posted from this website:

https://www.ama-assn.org/about/cpt-editorial-panel/cpt-february-2022-editorial-panel-meeting

Medicare Corner: Part B Physician Spending Fell $14B in Pandemic Year

We've seen headlines that telehealth went up 60X during the pandemic year relative to 2019 - here.

Here's another one.  Despite Medicare notoriously raising Part B premiums by 15% for 2022 - and blaming half the rise of "Aduhelm," the Alzheimer biological with nearly no sales so far - actual Part B payments fell 14% or $14B in CY2020.

Here's an article on the drop at AMA.  Here's the AMA policy report. (PDF, 24pp).

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In a quirky and obscure corny of the Medicare fee schedule, I noted that glaucoma screening tests fell 50% in 2020 - from 100 in 2019 to 50 in 2020.  Here.   Spinal taps (62270) fell by 2/3 (from about 80,000 to about 25,000).   

Pathology Corner: Surg Path Volumes That Disappear Due to Hospital Bundling

CPT codes 88302-88309 are the codes for a pathologist's work (before special stains) with anatomical specimens.   They're paid differently based on the size and complexity of the specimen, and the larger payments include more technical resources for blocks and slides.

The codes run from 88302 to 88309, skipping 88303 and 88306 and 88308, for historical reasons.  The numbers used, are titled from "Level II" to "Level VI".   For example, 88302 Level II includes "appendix, incidental," and 88309 Level VI includes total resection of the colon or pancreas.

Non-hospital specimens are paid "global" fees, if processed at one time and place.   Hospital specimens generally have the technical component bundled to the surgical center or hospitalization fee, and the only fee charged separately in Part B is the pathologist's interpretation fee on the prepared slides.  

As specimens become more complex, they are more and more likely to be inpatient specimens, so the global fee tends to disappear and the professional-fee-alone billing pattern becomes more common.  Let's see how it plays out.   

Click to enlarge

Interestingly, it's a sort of inverted-U curve, with both 88302 and 88307-88309 being mostly professional fees and few global or technical fees.

Looking at total volume, the surg path codes are dominated by 88305, with few cases billed as lower or higher levels of service:

click to enlarge

GRAIL Announces GALLERI Adoption by Medicare Advantage Plan, Alignment Health

On December 6, 2021, GRAIL announced that a Medicare Advantage plan, Alignment Health, had adopting coverage for the GALLERI test.   The plan has members in California and North Carolina.  See press release at link:

https://www.biospace.com/article/releases/grail-announces-partnership-with-alignment-health-plan-as-first-medicare-advantage-plan-to-offer-galleri-multi-cancer-early-detection-blood-test/

The GALLERI test is a sensitive oncology biomarker test for early detection of occult cancers.  

Medicare Trivia: Why Is Medicare Glaucoma Screening Only 50-100 Cases Per Year?

I got an interesting email this week from a graduate student in health policy working on Medicare preventive benefits.  He was asking, "Why is the Medicare usage of glaucoma screening so low?  Only 50-100 cases per year?"

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The glaucoma screening benefit was created by legislation in 2000 (BIPA 2000).  (See Foote & Blewett, footnote.)   It's memorialized at 42 CFR 410.23.   It's a subpopulation-guided preventive benefit, for Medicare beneficiaries who have diabetes, a family history of glaucoma, or are African-Americans or Hispanic-Americans.  Using recent data files for annual Part B payment volumes, usage was about #100 cases in 2019, and about #50 cases in 2020 (Covid year).

The codes are G0117, G0118:

• G0117 (Glaucoma screening for high-risk patients furnished by an optometrist or ophthalmologist)

• G0118 (Glaucoma screening for high-risk patients furnished under the direct supervision of an optometrist or ophthalmologist).

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See a JAMA article this month on Medicare & Prevention & Health Equity, Niforatos et al. here.

I'm not sure how many cases I expected - 1,000?  10,000?  Other?  But not #50.   If anyone has a clue, let me know.

Someone suggested to me that most patients eligible for this benefit also have other reasons for seeing an optometrist or ophthalmologist that result in a covered office visit rather than a unique code for a stand-alone glaucoma screening test and no other service that day.  Generally, office visits aren't very tightly edited for ICD10 codes since office visits can be associated with any human disorder or condition.

For more on the glaucoma benefit:

See a standalone version of the glaucoma screening act, 2000, here.

See a coding reference site about the benefit here.  Hispanics were added in 2006.

See a 2002 ophthalmology trade journal here and a 2002 optometry trade journal here.

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Foote & Blewett, 2003.  Politics of prevention: expanding prevention benefits in the Medicare program. J Public Health Policy,  https://pubmed.ncbi.nlm.nih.gov/12760242/ .

click to enlarge

Foote and Blewett, 2003, Politics of Prevention: (Benefits in Medicare).

https://pubmed.ncbi.nlm.nih.gov/12760242/

Very Brief Blog: Telepharmacy regulations proposed; relationship to "tele-laboratory"

 We hear a great deal in the laboratory field about telemedicine and its impact on channels and processes for laboratory testing.   

Just for a perspective, one might look at new regulations proposed by the DEA regarding telepharmacy (86 Fed Reg 64096, November 17, 2021, 4 pp).   Here.  DEA seeks public responses to 39 questions.  See a discussion of the proposal by Valiente et al. of Foley Lardner, here.  By Murray of Dinsmore LLP here.  DEA accepting comments to January 18, 2022.

On the one hand, telemedicine and genetic testing will be critical to the treatment of some patients and a pillar of proper care for them.  On the other hand, Department of Justice has asserted (here) that many allegedly improper DME and genetic test orders are made by telemedicine (typically in cases where the physician had no patient contact).   Similarly, use of a "clinical care network" of contracted doctors ordered UBiome direct to consumer tests (see e.g. here), ending up in high-profile court filings.

Very Brief Blog: Authors at FIRST DATABANK review FDA PGx Resources

 See a new article in MedCityNews, by Christine Cheng, highlighting FDA and other resources for the uses and effectiveness of pharmacogenetics. 

The new trade journal articles points to a research article by Cheng and colleagues in Annals of Pharmacotherapy.   That academic article appeared online 12/2020 and in print (that is still a thing?) in 10/2021.

Trade:

https://medcitynews.com/2021/11/fda-study-offers-new-tool-to-make-sense-out-of-pharmacogenetics-data/

Academic:

https://journals.sagepub.com/doi/full/10.1177/1060028020983049

Direct PDF link:

https://journals.sagepub.com/doi/pdf/10.1177/1060028020983049

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See a streamed talk by Kristine Ashcraft, Invitae Pharmacogenomics, November 30, here:

https://precision-medicine-institute.com/live-briefings

(Scroll down for on-demand library).

Very Brief Blog: CMS Publishes Transmittals for PFS CY2022 Final Rule

 CMS published its physician fee schedule and hospital outpatient annual rules back around November 1, effective CY2022.   CMS has published transmittals implementing new instructions to its MACs.   Occasionally, these transmittals include some newly written prose communicating CMS staff "thinking" or "rationale" (this was true last year), but I don't see any unexpected new insights from the current implementation instructions.

CR12519, November 16, 2021

https://www.cms.gov/files/document/r11115cp.pdf

Parallel Medline Matters here, MM12519

https://www.cms.gov/files/document/mm12519-summary-policies-calendar-year-cy-2022-medicare-physician-fee-schedule-mpfs-final-rule.pdf

Topics include continuing tweaks to the nuances of colorectal screening copay policy, for example.  

Very Brief Blog: Q1 Diagnostics Hosts Boston Conference, December 6-7, 2021 (Plus notes on PMC and TriCon)

We've had two years of mostly canceled conferences, or live conferences converted to Zoom-only events.   

Here's an annual live meeting that's back on track.  On December 6-7, 2021, Q1 Productions will host "Diagnostics Coverage and Reimbursement Conference," at the Boston Marriott Renaissance Hotel.  See the website and registration info here:

https://www.q1productions.com/dx-reimbursement/

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Molecular TRI-CON is scheduled for February 21-23, 2022, in San Diego ("and online.")  Here.

Personalized Medicine Coalition will hold its next (deferred) annual meeting in Southern California, Laguna Niguel, May 19-20, 2022.  Here.   

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It's the opposite of a live meeting, but you can still log into a wide range of free precision medicine videocasts from November 2021, at Partners in Precision Medicine, here.

First Look: CMS Payments for COVID Tests in CY2020

On November 23, 2021, CMS released payment files for CY2020 for Part B services, by CPT code.  See my blog here.

I've pulled out the COVID lab tests payments for a separate headline.

COVID Code Usage CY2020

Here's a table of the COVID lab code usage.  Use of neutralizing antibody tests was almost nil, and use of antibody and antigen tests were only 5% and 2% of payments, respectively.  Almost all PCR testing went through the "high throughput" codes for platforms with > 200 tests per day.

CMS spent about $1B in total on COVID testing, and $900M on high volume PCR testing.

click to enlarge

CMS Publishes National Data File for Part B CY2020

Every fall CMS publishes Part B utilization data, by CPT code, for the prior year, on this page:

https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Part-B-National-Summary-Data-File/Overview

This year, the data for CY2020 is a month or two later than normal, but it's out.

Enjoy!  I've put a copy of the lab spending alone in the cloud here.

Note that CMS releases the CY2020 data in numerous successive XLS files.   There is no file for the 80,000 series, the lab codes.  These are because they are in the file labeled labeled as starting with 0001U, which is actual a complete laboratory and pathology code file, including e.g. PLA ("end with a U") codes.  Note the "Begin with U" codes (special CMS COVID codes) are in a separate file, titled  "Miscellaneous."  For most of the data below, I manually pulled out U0003 U0004 and added them to the CMS lab file starting with "0001U" and including the 80,000 series.  Whew.

CMS has not yet released the state-level data files (they will appear here) but they're very tedious to work with since there are 50-plus separate Excel files.  

A few tidbits.

Concentration of Category III Codes

In a recent webinar presented at Stanford, AMA staff emphasized that Category III codes were doing well, with several hundred million dollars of annual payments.  Yes, but.  The payments are highly concentrated.  In this CMS data, there are $275M dollars allowed.  But out of several hundred Category III codes, the top 2 had 77% of all payments and the top 10 had 95% of all payments.  Only about 25 codes were paid more than even $100,000 nationwide in Part B.  

Why a pretty old Category III code, 0191T, with >80,000 uses year after year, is not a Cat I code is a mystery to me.

click to enlarge

Part B Lab Spending 

Simplifying by leaving out lines for interpretation or tech component only, I see $6.9B in Part B lab code spending (without COVID) and $7.8B (with COVID PCR).  

The largest dollars allowed was U0003/U0004, high throughput COVID testing, at $900M.   

Turning to the "regular" CPT codes, the highest path/lab code was 88305 - a surgical pathology code - at 17M services for $860M.  Next is molecular unlisted code 81479, with 138,000 services  at $290M.  (This code is used almost exclusively by MolDx).  

For CY2020, code 81408 - rare full length genes nearly never used in the Medicare population before 2018 - was code #9 at $207M (or #8, not counting COVID).  Labs cited in alleged-fraud investigation Operation Double Helix almost always billed high amounts of 81408. 

Among all lab spending, including COVID, the top 10 codes were 46%.

Top Path/Lab Codes (incl COVID) - Click to enlarge

Part B Molecular Spending

I quickly sorted for molecular codes 81170-81599 and U-codes (PLA codes).  I tally $1.4B in spending (about the same as CY2019) for general codes, and $2.3B when we add COVID PCR as codes U0003-U0004.

Amazingly, given the profusion of hundreds of new molecular codes, the top 8 codes (excluding COVID) take 70% of the spending.  

And even more amazingly, 5 of the top 8 codes (excluding COVID) are non specific codes. (!!!)

Among the specific codes, excluding COVID,  #1 is Cologuard 81528 at $210M, followed by Oncotype (81519) and Foundation Medicine (0037U) at about $77M each.

Just two nonspecific codes, 81479 and 81408, grossed $400M.

Note, the table below is missing 81162 (BRCA 1&2) at $85M spend and 46,788 services, because I cut the data rows below at 81170 lower bound.  (Discovered 5/27/2022).  It should be the fourth-highest coce after 81479, 81528, 81408.   

MoPath w/o COVID - click to enlarge

MoPath Data With COVID

Here is the data including the $900M of spending for COVID PCR (U0003, U0004).  At $900M, COVID is about 39% of all molecular spending, not far from half.

MoPath "with" COVID U0003-4 (39%, $900M) - click to enlarge

PLA Codes Incredibly Concentrated

In another blog today, I noted that Cat III codes were incredibly concentrated in the top couple codes among hundreds of codes, and the huge majority of Cat III codes paid little or nothing.  (Here).

Same for PLA codes.

In total, PLA codes were paid $127M, however, $90M of that went to the top two codes (FMI CDx and Oncotype Prostate), and of the top two codes, $77M/90M went to FMI CDx.   

Only about 20 PLA codes were paid more than even $100,000 (say, the salary of a single sales worker).  95% of PLA spending went to the top ten of over 200 codes, while even that is misleading, since 75% went to the top 2 alone.

click to enlarge

COVID Code Usage CY2020

Here's a table of the COVID lab code usage.  Use of neutralizing antibody tests was almost nil, and use of antibody and antigen tests were only 5% and 2% of payments, respectively.  Almost all PCR testing went through the "high throughput" codes for platforms with > 200 tests per day.

CMS spent about $1B in total on COVID testing, and $900M on high volume PCR testing.

click to enlarge

HCPCS Code Trivia

The files include data for all alphanumeric HCPCS codes (e.g. drugs, wheelchairs, full tables here).  "S" codes are supposed to be for private payers (on request to CMS for a code) and "T" codes for Medicaid or other federal agencies, not for Medicare.  In fact, payments for S and T codes were "zero" at Medicare Part B.