Saturday, August 28, 2021

Solid Data: One in Four COVID Cases are in Fully Vax People, in Highly Vaccinated Regions

1 in 4 COVID cases in Southern California occur in the majority-share of the population which is fully vaccinated, according to CDC. While limited to one region, the report gives access to results of 43,000 documented infections in a population of 10M in Los Angeles County. The time period is May 1-July 25, so it include the ramp-up of COVID Delta, but most of the period studied was before the full-blown surge. 

I’ve seen claims that fully-vaccinated people are less than 10% of new cases, or as high as 60% of the test-positive population (data from Cambridge, MA, in July). Fully vaccinated people remain hugely protected from hospital-grade illness, although some will have at-home illness that is fairly severe. 
The CDC report is here:
See a news summary by Allie Hogen:
In my view, news sources reported HIGHLY misleading data on the rate of infections in fully-vaccinated people right up to the end of July – less than 4 weeks ago! I shot down misleading rate data published in the LA Times on July 23:

Illumina Announces 2021 Americas Genomic Payer Summit (September 21-24)

Illumina has announced a 4-day calendar of events for its 2021 "Americas Genomic Payer Summit."  

Described as:

Hear genomics leaders from North and South America discuss the coverage landscape, identify strategies to evaluate clinical utility and economic value, and improve access and reduce burdens for patients. Explore the virtual conference and engage with coverage and reimbursement leaders, labs, and patient advocates about the current and future state of genomics in medicine.

Find the Event Registration here.   Find the agenda here.


Thursday, August 19, 2021

Two Resources for Medicaid Coverage: Screening Services, Lung Cancer Services

It's notorious that Medicaid is fifty separate programs, with their own websites, quirks, and rules.   In this blog, we point to papers on (1) biomarker coverage and (2) preventive services coverage.


It's notorious that Medicaid is fifty separate programs, with their own websites, quirks, and rules.  Or even more than that, when a state has multiple competing Medicaid Managed Care organizations.  (And Managed Medicaid, as opposed to a state-operated fee for service program, is well more than half of Medicaid).

I ran across two useful references that both demonstrate, and attempt to summarize, the diversity of Medicaid programs.

Medicaid and Lung Cancer Coverage

The first is a 20 page white paper from the lung cancer association, Lungevity, a "state scorecard" for cancer-related coverage.   Find it here.  The report was undertaken by the consultancy ADVI.

For example, only 39% of states cover full-panel biomarker testing (code 81455):

The report includes epidemiological data as well, such as lung cancer rates and survival rates.  

Medicaid and Preventive Services

The second is a peer-reviewed paper on Medicaid coverage for preventive services.  A wide range of preventive services are now baked into Medicare, and commercial plans are required to cover USPSTF endorsed preventive services.  [*] However, Medicaid coverage is at state discretion.

See Bloodworth et al, 2018, Variation of preventive service utilization by state Medicaid coverage, cost-sharing, and Medicaid expansion status.  Pubmed here, journal Preventive Medicine here. (Pay per view, $36).


For more on the ACA and preventive services, see e.g. Chait & Glied (2018) Ann Rev Public Health, Prevention under the Affordable Care Act, here (open access).

Very Brief Blog: Boston Healthcare Associates Becomes Part of "Veranex" Business

For many years, biopharma and medtech consultancy Boston Healthcare Associates has been a leader in precision medicine consulting, leveraging their expertise in the diagnostics industry.

See a new press release that BHA is now part of the VERANEX consulting solutions group.   Graphic here:

Veranex promises a pathway of solutions from design to regulatory to clinical trials to market access:

Consolidations are a regular feature of the specialty consulting industry.  

See, for example, an April 2021 announcement when Vachette Pathology, a pathology/laboratory revenue consulting firm, was acquired by Lighthouse.   Deals for specialty consultancies can be quite large, such as when Inovalon acquired Avalere for $140M in 2015 (here).

In 2017, Quorum Consulting was acquired by Navigant (here.).

Tuesday, August 17, 2021

J Molec Dx: Press Release: COVID Viral Load Correlates Poorly with Transmission

 We regu\larly hear about viral loads in COVID (for example, Delta variant is 1000X higher).  Passing along a J Molec Diagnostics press release for a new article that directly looks at cycle-time viral loads and transmission, with a warning not to equate the two.  The authors were seeking high viral load index cases to identify the highest-risk persons for contact tracing.   However, the correlation between (Ct) and observed infectivity of contacts did not support such a policy.  In a college environment, half of index cases with COVID did not have any identified transmission to others.  Of persons in quarantine, about 18% tested positive.

Direct link to Tian et al. here.  I saw the press release today; the article dateline is June 5, however.


New study: 

Viral load is not a true indicator of SARS-CoV-2 transmission risk


Cycle threshold (Ct) has limited utility in guiding decisions regarding isolation and quarantine of COVID-19 patients, report researchers in The Journal of Molecular Diagnostics


Philadelphia, August 16, 2021 – The transmission of SARS-CoV-2 virus is dependent on many factors. Although some in vitro studies indicate that the amount of virus isolated from infected individuals affects the successful rate of virus transmission, whether the viral load carried at the individual level can determine transmissibility was unknown. A study of college students who underwent regular testing and contact tracing after positive tests, found significant overlap in cycle thresholds (Ct) between spreaders and nonspreaders. This makes Ct values questionable in determining transmission rates. Even those with low viral loads can pass on the virus, researchers report in The Journal of Molecular Diagnostics, published by Elsevier.


“We wanted to find whether there was a scientifically sound way to quickly triage students with potential high-risk exposure to COVID-19 positive students for quarantine,” explain co-lead authors Patrice Delafontaine, MD, Department of Medicine, and Xiao-Ming Yin, MD, PhD, Departments of Pathology and Laboratory Medicine, Tulane University School of Medicine, New Orleans, LA, USA. “Some studies have found that the Ct value of the RT-PCR assay is a surrogate for infectivity, and cutoff Ct values have been proposed as a way to guide isolation practices. Through testing and contact tracing, we found that Ct value could not predict transmissibility. We should not overlook positive patients with low viral load, and all positive patients should be quarantined.


Tulane University maintained on-campus educational activities in the fall semester of 2020. A high-throughput SARS-CoV-2 surveillance testing program was established to support contact tracing, isolation, and quarantine efforts needed to restrict viral transmission throughout the campus. All students were tested twice a week. At the time of testing, students were asked about symptoms they may be experiencing. Contact tracers spoke to all positive case subjects to identify close contacts.


The study looked at 7,440 patients who were screened between September 1, 2020 and October 31, 2020. 602 positive cases were identified. From this group, 195 index cases were identified with one or more reported close contacts, who were then tested during their mandated 14-day quarantine period for evidence of transmission from the associated index cases. Of these index cases, 48.2% had at least one contact who became SARS-CoV-2 positive, whereas 51.8% of the index cases were nonspreaders with no contacts who subsequently tested positive. Mean Ct values of the spreaders and the nonspreaders were nearly identical.


The investigators then took a reverse approach, in which index cases were traced for 481 students undergoing quarantine due to known exposure to the disease. Eighteen percent of the students became positive during their quarantine. Index cases for the 481 quarantined students were considered spreaders if they were linked to one or more quarantine students with a positive test result, or nonspreaders if they were associated only with students with negative test results. The mean Ct values of the spreader and the nonspreader groups were similar. 


Caption The cycle threshold (Ct) values of the spreaders and the nonspreaders are largely overlapping. A: Separation of index cases into spreader and nonspreader groups. The n of the cases in each population is indicated. Scatter plots of Ct values expressed as means ± SEM (B) or median ± interquartile intervals (C). D: Histogram of the distribution of Ct values. E: Cumulative frequency of Ct values. Dashed lines indicate the cumulated percentage of each population at the designated Ct value (24 or 32). At the indicated Ct value of  24, there is a higher percentage of spreader cases than nonspreader cases, although the differences are small. Ct values of the indicated populations are compared. Mann-Whitney U test (P > 0.05). (Credit: The Journal of Molecular Diagnostics).


Next the investigators identified and evaluated 375 positive COVID-19 cases to assess the relationship between symptom presentation and Ct values. Reported symptoms included lethargy, fever, headache, cough, runny nose, and gastrointestinal symptoms. The mean and median Ct values were significantly lower in symptomatic cases than in asymptomatic cases, indicating a higher viral load. These findings suggest that infections with a higher viral load may be more likely to lead to symptom development, or that symptomatic individuals tend to have higher viral loads or maintain their viral loads for a longer period of time. Ct levels may be useful at a population level, in association with symptomatic presentation, to indicate the likelihood of transmission. These values may thus have epidemiologic or surveillance importance.


“Taken together, these index cases suggest that Ct values alone do not predict transmission risk, and reporting of Ct values at the individual level, such as by setting a cutoff value of 32, would provide little diagnostic value for case management,” note Dr. Delafontaine and Dr. Yin. “A sensitive and robust SARS-CoV-2 diagnostic testing method is needed to effectively control viral transmission by maximizing the ability to identify and quarantine even those with a low level of virus.”




Notes for editors

The article is Ct Values Do Not Predict Severe Acute Respiratory Syndrome Coronavirus 2 (SARD-CoV-2) Transmissibility in College Students,” by Di Tian, Zhen Lin, Ellie M. Kriner, Dalton J. Esneault, Jonathan Tran, Julia C. DeVoto, Naima Okami, Rachel M. Greenberg, Sarah Yanofsky, Swarnamala Ratnayaka, Nicholas Tran, Maeghan Livaccari, Marla L. Lampp, Noel Wang, Scott Tim, Patrick Norton, John Scott, Tony Y. Hu, Robert Garry, Lee Hamm, Patrice Delafontaine, and Xiao-Ming Yin ( It appears online in advance of The Journal of Molecular Diagnostics, volume 23, issue 9 (September 2021) published by Elsevier.


This article is openly available at


This study is based on the internal support from Tulane University.


Full text of this study is also available to credentialed journalists upon request; contact Eileen Leahy at +1 732 238 3628 or Journalists wishing to interview the authors should contact Keith Brannon, Director, Tulane University Public Relations, at +1 504 862 8789, +1 504 621 2724 (mobile), or


Elsevier’s Novel Coronavirus Information Center provides expert-curated information for researchers, healthcare professionals and public health officials, including clinical guidance and a portal to access all of Elsevier’s COVID-19 research. All resources are freely available. We also have dedicated hubs for healthcare professionals; health educators and students; librarians; and R&D professionals. You can find these in our Coronavirus Resource


About The Journal of Molecular Diagnostics

The Journal of Molecular Diagnostics, the official publication of the Association for Molecular Pathology, co-owned by the American Society for Investigative Pathology, and published by Elsevier, seeks to publish high quality original papers on scientific advances in the translation and validation of molecular discoveries in medicine into the clinical diagnostic setting, and the description and application of technological advances in the field of molecular diagnostic medicine. The editors welcome review articles that contain: novel discoveries or clinicopathologic correlations, including studies in oncology, infectious diseases, inherited diseases, predisposition to disease, or the description of polymorphisms linked to disease states or normal variations; the application of diagnostic methodologies in clinical trials; or the development of new or improved molecular methods for diagnosis or monitoring of disease or disease predisposition.


Novitas: Proposal for New Approach to Cardiology Genetic Testing

After oncology, cardiology is a significant clinical area for genetic testing.  Medicare programs have traditionally said fairly little about this.  The Novitas MAC proposed a new LCD dedicated solely to cardiology testing.   Stakeholders may want to comment.

The LCD exemplifies an important new trend - also seen in a currently proposed MolDx LCD for cancer inherited risk testing - of stating some generalities and principles of coverage but not stating any particular diseases, conditions, or genes covered.  Those might be stated, or updated, in greater or lesser detail in accompanying articles, or, the LCD could be viewed as "self-implementing" when the generalities are complied with.  

What's the Problem?

The difficulty is that the physicians and patients can't look up what is covered, or denied, in the viewpoint of the medical director or nursing staff later implementing the policy.

Further, it's difficult or impossible for Medicare Advantage plans to know what they must, or need not, comply with.   

A few months ago Novitas issued a policy for molecular infectious disease testing that simply stated such testing was covered when it was timely and likely to influence care.  Well, yes, but those are generalities that might lead into hostile arguments in event of an audit or recoupment.

More Detail - See Links & Comment

See the Novitas webpage for new LCDs here.  The LCD for cardiovascular genetic testing is DL39082, and is paired with a billing article DA58795.   Comment period is open July 29-September 11, 2021.



I've clipped the body of the LCD, as proposed, below the break.

Friday, August 13, 2021

Where is CMMI Going? Health Affairs Video and Article (Brooks-LaSure)

One key question for the future of CMS is where it will go with the Center for Innovation (CMMI).  On Thursday, August 12, 2021, Health Affairs posted a detailed article on the future of CMMI, by CMS authors, and held a one-hour webinar, archived on YouTube.

See the article here:

See the video at YouTube here:

There are a few strange things about CMMI.   In the Obama administration, Republican senators were eager to kill it entirely, believing it was too powerful.   The Trump administration put CMMI on hold at first, but then realized it was a very powerful tool.  For example, the Trump administration, in its last quarter, proposed resetting US drug prices to European drug prices as a "demonstration project" nationwide for years, under CMMI's authority.  That authority allows CMMI to hold a "demonstration project" of unlimited scope and scale and waiving any part of Medicare law for the duration of the project.   (Yowza!)   Numerous Medicare waivers occur under CMMI authority, but are simply referred to as 1115A waivers, as if it was part of Medicaid protocols rather than the referring to CMMI's blanket authority.

CMS has never conducted regulatory rulemaking under 1115A, so it has been treated was "self-implementing," giving CMS even more "flexibility."   

CMS Article

In the article, CMS highlights six goals for CMMI.

  1. Every Model should include health equity factors.
  2. Don't make too many models.
  3. Design meaningful financial incentives.
    1. They may want to downplay voluntary models, as providers will opt in for profit and opt out to avoid loss, making the model pointless.
  4. "Providers find it challenging to accept downside risk."  
    1. With thin margins, obviously.  "Show strong consistent signals of where CMS is heading for value based care."
    2. I would add, there is also a significant problem with 'rich get richer, poor get poorer' outcomes.
  5. Effectiveness have been limited by faulty benchmarks.
    1. For example, national benchmarks may be out of whack for some systems, but local (individualized) benchmarks may create the wrong incentives.
  6. Success means: lasting transformation of the health system.

Another example of "self implementing" CMS authority has been its authority to conduct medical reviews and audit or recoup from providers. In this summer's PFS rulemaking, CMS proposed to convert some of that statutory authority into regulations for medical review functions, even though those functions have been carried out under "self implementing" authority for decades.


An unofficial auto-transcript from the YouTube link is here.

Sunday, August 8, 2021

Very Brief Blog: CMS Nixes "Most Favored Nation" Rule for Drug Pricing, But Still Seeking New Ideas for Drug Pricing

What happened:

The Trump administration made headlines when it released a proposal to re-set Medicare Part B drug prices to the level of European countries.  The Biden administration has nixed the idea, but promises to keep revisiting drug pricing.


The Trump administration made headlines in December 2020 when it suddenly released a go-live proposal ready to re-set Medicare Part B drug prices to the level of European countries.  Trump aimed to implement the rule as quickly as it could be carried out by policymakers. (My December blog here).  

The December final rule quickly collided with the courts, in part, because CMS asserted it needed to release the rule as final rulemaking (so-called "interim final" rulemaking) due to the "drug pricing crisis." 

That point aside, the Most Favored Nations escapade is conceptually interesting because it was an extreme application of the powers of the Center for Medicare Innovation (CMMI).  CMMI was created by the Affordable Care Act with the authority to waive any CMS law for the purpose of a demonstration model, that model being potentially of any length or scope.   

Uses of CMMI to waive Medicaid rules are widely used and are routinely classed as "Section 1115A" waivers, which means, CMMI demonstration projects allowing the waiver of any existing CMS law.

See the inspection copy of the Biden rule here.   The typeset Federal Register version will appear August 10.  

While the Trump rule was scheduled to go into effect, as if it were a final rule, it also triggered 1166 comments.  We propose to "address the November 2020 interim final rule's procedural deficiencies by rescinding it."  LOL.  But HHS will continue to "explore all options" for drug pricing and to encourage "value based payments."

Technically, it is a "proposal to rescind" to which public comment is taken now and for 60 days.  

Friday Night Special

I believe it was released Friday after market close, which is a typical way to "dump" announcements as far outside the news cycle as possible.

Te recission rule was dropped without any press release.

But See July Biden Executive Order

See also a July executive order that was reviewed as follows.   "The focus of the executive order’s directives for the healthcare industry are designed to address drug‑pricing concerns.....President Biden also commits his administration to lowering prescription drug prices through 'aggressive legislative reforms' such as allowing Medicare to negotiate drug prices, imposing inflation caps, and supporting a public health insurance option."

As stated in Endpoints August 9, "What President Biden ultimately intends to do to lower drug prices may become more clear in the near future as Biden in mid-July ordered HHS to 'issue a comprehensive plan within 45 days to combat high prescription drug prices and price gouging.' "

On August 12, Biden released a "Fact Sheet" of ways Congress could lower drug prices.

With rapid coverage at Endpoints, here.

Insight to MCIT Machinations

The flip-flops between Trump and Biden administrations, and the technical means and tactics for carrying them out by the Biden team, is interesting for anyone watching the MCIT rule (Medicare Coverage of Innovation Technologies), Like the MFN rule, the MCIT rule which was "finalized" by Trump, then "put on hold" by Biden. In the case of the MCIT rule, it's on hold until December 2021.

Other Coverage

  • At Endpoints here. Medcity here.
  • "Citizens Against Government Waste" (CAGW) notes that aspects of MFN drug pricing are in HR3 here.  
  • Pink Sheet, subscription, here.

Appearing a few weeks earlier than the rule rescission, see recent review articles on Medicare and drug pricing at Commonwealth Fund here and at Kaiser Family Foundation news here.

Friday, August 6, 2021

Novitas MAC Wins Jurisdiction "L" Renewal

In July 2021, CMS announced it had renewed the competitive contract for the Novitas MAC to manage Jurisdiction L.   Jurisdiction L includes Delaware, DC, Maryland, New Jersey, and Pennsylvania.  

The CMS web page with some additional links is here:

While the Novitas  MAC proposal is not public, the final award in total is $669M.  Contracts are for 7 years and JL is 11% of US Medicare.   The prior award of the same geography to Novitas was in September 2012.

You can access the September 2020 website where CMS posted all the work requirements and tasks for managing Jurisdiction L - here.   It's these documents that Novitas responded to, to win the award.  SOW etc are posted at SAM, the System for Award Management.  

The JL fact sheet is here:


THe prior MAC win was Noridian, winning to continue Jurisdiction E, back in December 2020.  Here, here.

Thursday, August 5, 2021

AMA Revamping Genomic Tumor Codes (CGP Codes): Special Deadline August 16

AMA released its plan to revamp the genomic tumor codes (81445, 81450, 81455) on July 30.   While the normal lab test comment deadline was July 29, AMA will take comments on a later schedule for these proposals.  You can request permission to comment til August 16 and must finalize your comments by August 23.

These codes are usually referred to as "comprehensive genomic profiling" of tumors; see the website for the multi-stakeholder Access to CGP coalition here.

Your main entry point is to follow instructions at this PDF document, page 1, for how to request the ability to comment (via a portal called ZenDesk).

From today's AMA email:

My earlier blog on August 2 here.

Tuesday, August 3, 2021

CMS Releases Final Inpatient Rule for FY2022

CMS released its proposed Inpatient Rule FY2022 in April (here) and has now released the final version.

  • Press release here.
  • FAQ sheet here.
  • Inspection copy (typescript) rule here.
    • 2295 pages, up from 1914 pages in the proposed rule.
    • 86 FR 44774 PUBLICATION HERE.
    • August 13, 2021, 842 pp.  
  • Early coverage at MedCity here.  RevCycle here.  Becker's here.
19 of 22 NTAP (add on payment) devices were approved.  It used to be half or less.

Monday, August 2, 2021

AMA Reviewing Changes to the Tumor Gene Panel Codes (81445-81455; CGP)



Original August 2 blog below.

AMA has 3 codes for tumor genes panels, 81445 (5-50 genes), 81450 (5-50 genes, if hematopoietic cancer), and 81455 (51 genes or more.)   The MolDx program, which processes the lion's share of CPT molecular pathology codes, does not recognize 81455 and uses 81479 (other test) instead.

After many months of rumors, AMA CPT has announced it is planning revisions to the tumor panel 81445-81450-81455.  See the agenda here.


Process for 81455 Revisions Has Been Atypical

Normally, AMA releases lab CPT code proposals in mid July, with an early comment period such as July 23-29.  Then, AMA releases all the other codes in late July, with a different comment period, until mid-September.

As I documented in mid-July, AMA released a list of 8 lab codes for the fall CPT meeting.  My blog here, cloud 8-code agenda here.   When AMA updated the agenda on July 30, it added dozens of codes on other topics, AND IT ALSO ADDED THE 81455 AGENDA ITEM.  That means there are now "9" lab code agenda items. See the July 30 version here.

Normally, AMA would want lab-code comments by July 29, but that hardly seems fair for 81455 revisions, since they weren't posted until July 30.  See the Agenda (previous link) for instructions on page 1 for how to request a code packet and how to comment on it.  Members of the CPT panel will be able to review your comments in a private cloud library.


Additional Aspects

There's been concern that CGP is too often unavailable to cancer patients; see the Access to CGP Coalition here.  

On July 22, 2021, AMA held a day-long virtual meeting on molecular coding policy, problems, and solutions, pic below.  AMA promised to release an article or white paper summarizing the conference.



CMS Announces Advisory Panel (MEDCAC) on Cerebrovascular Disease, 9/22/2021

 Medicare can convene a standing committee of experts called the MedCAC - Medicare Coverage Advisory Committee.   The roster has about 100 members and about 8 are flown in for any particular meeting.

In the Federal Register, CMS announces a MedCAC on "cerebro-vascular disease" on September 22.  Within the next days, CMS will post more detail about the agenda such as a list of "key questions" for the public to comment on and for the panelists to discuss.  The agenda will appear at some point on the "Index of Meetings" which can be accessed via the MedCAC home page here.

Find the CMS meeting announcement here.  86 Fed Reg 41040-42, July 30, 2021.

While CMS didn't provide details beyond the generic topic "cerebrovascular" yet, my guess is, this is related to the perpetually revised NCD on cerebrovascular stents.   

AMA Expands Seats on CPT Panel, Solicits Nominations

Recently, the AMA announced it was expanded the CPT Editorial Panel from 17 to 21 seats.  The expansion will support the need for panelists who can support "content advances to reflect the emergence of digital health, diagnostic precision medicine and augmented intelligence."

The AMA is soliciting nominations for new members on the panel.  Submit nominations by September 24, 2021.  Panelists will be chosen in time to be observers at the February 2022 meeting and to be seated as panelists for the May 2022 meeting.  Terms are usually four years.  Nomination details:

The four new panelists will include 2 nominated by AMA member societies, one from the payor sphere or a specialty medical society, and one from an "at large organizational member."

At the same link, the second one, see information about a different but related panel, CPT Advisory Committee, CPTAC, which also seeks nominations from time to time.  They mention that they look for CPT panel members who have previous, less-high-pressure experience serving on the CPTAC.


Most of the panelists are nominated by specialist medical organizations but "do not represent the interests of the organization that nominated them." OK...  

AMA Publishes Agenda (Code Requests) for September 30 CPT Meeting; Revise Tumor CGP

In the past couple weeks, AMA set up a webpage for its September 30-October 1 CPT meeting, and as usual posted the lab codes early (July 23).   Now, AMA has posted all the code proposals for the meeting.  

See my July 23 blog  here regarding the early posting of lab codes.

See the new full 10-page CPT code agenda here.  

Looks like about 39 agenda items (outside of the dozen lab items released in mid-July).  Review the code proposals, request a code packet of interest by September 9, and submit your code comment by September 16.  Quite a few in digital health.

There is a code set revision for comprehensive genomic profiling of tumors 81445-50-55.   Interested stakeholders should have requested code packets to review by July 23.

There is also a proposal to make an appendix/dictionary of AI related terms.