Very Brief Blog: LA Times Shows Mismatch Between COVID Cases, Vaccinations

In an article February 24, 2021, Los Angeles Times shows a striking mismatch between zip codes rated for vaccination rates and COVID burden.   Below, red arrows highlight Santa Monica, with very high vaccination rates and very low COVID history, and South Central LA, with a completely opposite pattern.  

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Other articles discussed issuance of "vaccine access codes" specially targeted for new distribution sites opening in low-income areas, but "vaccine tourists" from wealthy zip codes show up with the codes (here, here).  

Very Brief Blog: Liz Fowler Tapped to Head Center for Innovation at CMS

As first noted in Politico here, and presented in Fierce Healthcare here, Biden has picked Liz Fowler to head the Center for Innovation (aka CMMI) at CMS.

The Fierce Healthcare article is worth reading and gives a good background on both Fowler and CMMI.  Fowler work in the 00's for Max Baucus in the Senate, and was an advisor to the Obama administration.  Most recently she's been at both Johnson & Johnson and the Commonwealth Fund.

CMMI originated in Section 1115 of the Affordable Care Act, to run "demo projects."  Due to a quirk in the law, there is no limit on the size and duration of "demo projects" or their scope, as they can alter any aspect of CMS law "for the duration of the demo."   For example, the Trump proposal to up-end existing law about drug pricing for injectable (Part B) drugs, pegging prices instead to European prices, was a to be a decade-long nationwide "demo project" (sic).  That is on hold due to court actions (here) and its CMS webpage says it won't be implemented without new rounds of notice and comment rulemaking (here).  There was actually legislation proposed in early 2020 to reign in CMMI by restricting its demo's to be less than unlimited scope and duration.   

See her December 2020 blog on whether the puzzling, Trump-proposed "Medicare Geographic Care Model" is a good idea - if I understand it correctly, essentially depositing Medicare FFS beneficiaries in some zip codes into capitated-budget, Medicare Advantage plans.  Her blog.  See an article on Geographic Model at the trade journal Dark Report on Feb 12, here.

Very Brief Blog: Many Hospitals Still Struggle with Margins, Cash

In the first two COVID months, we heard how hospital revenues often plummeted and the situation was described as dire.   

For an update to February 2021, see a report from Kaufman Hall on hospital finances and margins.   

• See a trade journal summary at HealthCareDive here, 
• See an update by a different HCD journalist on Feb 25, here.
• See the original 30 page PDF online here.

The authors summarize, "The median hospital operating margin was down 46.1% compared to January 2020, and down 34.1% when CARES Act funding is factored in. Smaller hospitals tended to experience smaller drops than larger institutions.  Adjusted discharges were down 17.6%."

Kaufman Hall provides consulting services (strategic, financial) for institutions including healthcare and education.

Very Brief Blog: WSJ Features COVID Sequencing Variants

In a lead article released February 22, 2022, Wall Street Journal features COVID sequencing, and notes that some COVID PCR tests that already exist pick up some sequences in COVID - e.g. render a positive - while not seeing the important mutation that underlies the U.K. Variant.   Brianna Abbott writes,

The highly transmissible Covid-19 virus variant that first emerged in the U.K. can partially evade a commonly used coronavirus test. Some health authorities are using that fact to their advantage.  

As more-transmissible variants emerge as a concern in the fight against the virus, the vast majority of Covid-19 diagnostic tests haven’t been affected. But for a handful, including one from diagnostics giant Thermo Fisher Scientific Inc., TMO -2.25% a section of the test can’t pick up on variants including the U.K. variant that have a specific mutation, the company, laboratories and health officials who have processed its tests said. 

Yet the other parts of the tests still work. So if a test comes up positive for Covid-19 but that portion of the test fails, that could indicate that the samples contain the U.K. variant. Some laboratories are exploiting the bug to more quickly find cases that might be caused by the fast-spreading variant.

• See the full WSJ here.
• See Thermo Fisher's educational page on COVID testing, here.

Some Related Links

WSJ also cites HELIX tests.   COVID SEQ tests with EUA include Helix here, which uses several PCR amplicons detected via NGS reads.  Guardant also has an EUA COVID-SEQ test (N1 gene, P gene), here.   Illumina has a sequence-reporting 98-target COVID SEQ test, EUA here.   

Biden Administration is expected to inject up to $1.6B more funds into COVID testing and sequencing, here.

 

Very Very Brief Blog: Most Unusual Map: COVID in Iowa (Feb 2021)

 Writing as a native Iowan, the most unusual COVID map I've seen all year (new cases):

HARPA: Proposing a Multi-Billion Dollar Applied Medical Research Agency

You may start hearing about the abbreviation HARPA - modeled on DARPA, a "HARPA" would be a large-scale national research agency modeled on applied healthcare research.  The idea is that this big middle area of healthcare is missing out in our current mix of (A) NIH funding, on the one hand, and (B) industrial for-profit funding, on the other.   You'll also see the abbreviation ARPA-H, modeled on ARPA-E, the existing federal energy research agency.

See an article appearing February 12, 2021, in Fast Company online - here.   The summary is, "The Biden administration is contemplating creating a research agency to help fund breakthroughs that aren’t economically viable for big health and pharmaceutical companies. Meet HARPA."  Potentially, tens of billions could flow through "HARPA" as part of Biden's plan to spend as much as $300B on federal research during his administration.

One of the advocates is Mike Stebbins, formerly on the White House Office of Science and Technology Policy (OSTP).  "Innovations in biomedical research are right now largely funded by the private sector or through organizations like the NIH...The problem is you’ve only got a $40 billion budget for the NIH annually, and they fund very little in the way of research on products.”

For back story, see a August 2019 article in WaPo here.  See advocacy on the topic from the Wright Foundation, here, with a 30-minute video and special website here.

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Readers interested in this topic might also enjoy a recent blog on a USC white paper on amped-up federal health technology assessment - here.

A side note, last fall CMS opened a special office to deal with problems and dilemmas in technology coding and pricing in healthcare - under Jason Bennett, here.  I see situations all the time when useful products fall aside from VC's (and aren't funded by NIH) because of illogic, biases, and gaps in the reimbursement system we have now.

Biden Nominates CMS Administrator; MolDx Gets Add'l Medical Director

Brooks-LaSure Nominee for CMS Administrator

On February 17, 2021, it was widely reported that the Biden administration will nominate Chiquita Brooks-LaSure to lead CMS, overseeing the Medicare and Medicaid programs.  See Fierce Healthcare here.  She's worked successively at OMB, on the House Ways and Means Committee, and at HHS during the implementation of the Affordable Care Act.  Most recently, she was a managing direct at Manatt in its consulting and policy group.  She holds a BA from Princeton and an MPP from Georgetown - bio here.

See a follow up article on Brooks-LaSure here.

• Separately, hearings for Xavier Becerra as Secretary of HHS have been scheduled for February 23 (HELP) and February 24 (Finance).

Charnot-Katsikas Joins MolDx as Medical Director

According to Linked In, in December 2020, Dr. Angella Charnot-Katsikas joined MolDx as a medical director.   See Linked In here, U Chicago website here (here).   See the full listing of Palmetto medical directors here.

As of 2/2021, she had 24 publications based on a PubMed search (here).  At Chicago, she served as Assistant Professor and Assistant Director of the Clinical Microbiology and Immunology Laboratories.   She holds a BS from University of Chicago and her MD from Rush.

Brooks-LaSure; Charnot-Katsikas

FDA Publishes Position Paper on Regulation, COVID, in NEJM

FDA has regularly been using forums like Health Affairs and NEJM to share its positioning on diagnostics regulation, especially under the umbrella of COVID.   On February 13, 2021, they posted an article on FDA regulation of COVID serology, but with numerous side comments reflecting goals of FDA leadership for national diagnostics policy.

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On September 2, 2020, I published a blog on recent announcements from FDA (August 18) and HHS (August 19) offering conflicting views on the FDA regulation of diagnostics.  That September 2 blog is updated, to include a September 9 FDA article in NEJM, and a September 15 backstory in Politico.

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On February 13, 2021, FDA's Jeff Shuren (head, devices) and Tim Stenzel (head, diagnostics) offer an NEJM op ed focused on the year's history of FDA regulation of COVID serology.  Here.  (Update: Paginated at 384:592-4, here.)    I would argue it's not just about "COVID serology," however, as the Op Ed has a range of opinions and goals about how diagnostics should be regulated and "lessons learned" the FDA intends to apply moving forward.   For example, there is a lot of emphasis on national planning and central coordination, something the Trump administration had been repeatedly criticized about.   My reading is that the FDA team is saying, if you want more national planning and coordination, we're here and ready to roll.  

USC Health Policy Center Posts White Paper on Health Tech Assessment

USC has an active health policy center (website here) and has just released a white paper on the state of health technology assessment (HTA) in the US.

• See the press release and summary here.
• See the 11-page white paper here.
• See an essay about the project by health expert Jason Shafrin, online here.

Quoting from Shafrin's  summary, the USC white paper has six recommendations - 

1. Continue to encourage private HTA [BQ: e.g. Evidence Street, Hayes, others]
2. Establish a nationally funded Institute for HTA, I-HTA
3. Include economic evaluations in the reports
4. Include new and old devices, both specific tech's and "health policy interventions"
5. Allow stakeholder engagement
6. Have US policies that encourage such HTAs to "impact" policy-making

The new USC paper was issued February 9, by Lakdawalla et al.  

There's more history on the same topic at USC.  See a February 2020 USC policy center article here, which itself included a 45-page 2019 USC white paper on the history of US HTA, here.

There's also an updated, 72-page "Office of Technology Assessment" white paper produced as recently as April 2020 by the Congressional Research Service - find it here.  

Journal articles.  You can also find an open-access 28-page 2014 academic article by Wong at Biotechnology Law Report on the history of HTA in the US, here.   See also a 53-page academic article on "the role of the federal government in comparative effectiveness research," in Annals of Health Law in 2012 by Francis, here, open access here.  Even further back, see a 2003 open access article by Stevens et al. at J Public Health, 2003 (here).

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There's a wealth of information on efforts toward HTA harmonization in Europe; for one entry point, see a 2018 white paper here.

White Paper on PLA Codes: Statistics, Trends, Impact on Genomics Coding

What does "PLA" stand for?  (Proprietary Laboratory Analyses codes.)  How are they impacting the coding for genomic tests?

When was the first PLA code created?   How many are there now?   How many are for human genomics, as opposed to drug tox testing or microbiology?   How often are they crosswalked?  How often are they gapfilled?   What is the timeline for getting one?    

For answers, see a new white paper, "US Reimbursement of Genome Wide Sequencing: A Coding and Pricing Perspective."

• Find the white paper here.

It's PLA-ology!

For example, of 212 PLA codes created as of July 2020, 165 were for human tests, and 47 were for non-human tests (either drugs or pathogens).  Of the 165 human tests, 46 were MAAA tests and 119 were non-MAA A tests.  13 PLA codes were exomic or genomic (including whole transcriptome and joint germline/tumor analyses).  

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Turning from test type to pricing method, of 123 codes in the CMS pricing process by last summer, 63 had been crosswalked, and 24 gapfilled, with 36 more in the active gapfill process.  Only a few PLA codes were priced at CMS by the "ADLT" process (Advanced Diagnostic Laboratory Test pricing rules.)

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The white paper compares existing CPT Category I genomic codes with the growing library of PLA codes.  The paper closes with a "case study" of a real-life lab getting a PLA code and seeing it through the pricing process, and a discussion of some issues and predictions for the future.

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Editorial content and data analysis and any errors are the sole responsibility of Bruce Quinn Associates LLC.  We thank Illumina for support of the research work for this study.

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One thing I didn't mention in the white paper.  Every PLA code gets a short clinical and technical description in each year's edition of AMA CPT CHANGES.  You can buy these as paper books or eBooks (see AMA CPT website or Amazon), and you buy buy them as part of a (fairly expensive) subscription to Optum Encoder Pro plus an add-on Total-CPT services package.

Has Biden Administration Deleted Trump's Prior Authorization Final Rule?

It's no secret that the Biden administration has deleted or delayed several of the later Trump administration CMS policies.

However, I haven't read anywhere else, formally, that the Prior Authorization Final Rule was being deleted, but it seems to have disappeared from the CMS website and even the press release for it on January 15, seems to have been deleted (!!).

See a Becker's Hospital Review article on January 26 that three rules were being deleted while others were moving forward.  Here.  Deletions, per Becker's were Medicare Part A enrollment rules, dialysis rules, oversight of accreditation rules.   However, Becker's said that the prior auth rule was moving forward, and that the MCIT rule (breakthrough coverage plus reasonable and necessary regulations) was going forward.

These can be distinguished.  All the press releases about the MCIT are still up, and the full rule officially appeared in the Federal Register on January 14.  Here.

But check out the links in my January 15 article about the Prior Auth rule.  They're all dead.  If you look at the CMS press release archive for January, the Prior Auth press release seems to have vanished.   And, the prior auth rule never appeared in the Federal Register, either.

This may not be new-news, but I googled it, and I couldn't find any press about the prior auth rule being deep-sixed.   But it seems it's as dead as Marley's ghost.

Since they may now be collector's items, I put the press release and fact sheet and Prior Auth Final Rule in a cloud zip file - here.

"As dead as Marley's ghost"

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Tidbits.

Separately, the Biden administration officially delayed the Trump drug pricing rule ("Most Favored Nation") for a year, but it's tied up in a pile of lawsuits anyway.  

By coincidence, an article in JAMA this week on America's outrageous healthcare administrative costs note that reform of prior auth required by Section 1104 of the ACA, never occurred.  By USC's Robert Kocher - here. 

AMA comments on the prior auth rule - here.

See an article that Biden "probably moving ahead" with prior auth rule - here.  See an article at Bloomberg about delays in rules here.

Very Brief Blog: The Human Genome at 20 (Science, NEJM)

We're getting articles and journal issues commemorating the Human Genome at 20.

See the cover story and a series of open access short essays at Science, here.

See a deep dive essay by Francis Collins and colleagues at NIH, in New England Journal, here.

The 2021 Gapfill Process: Confused? Some Clues Here.

This year, 2021, CMS has assigned roughly 50 new laboratory codes (most but not all PLA codes) to the gapfill process (CMS instruction to MACs is here.)  See my August 2020 white paper on the gapfill process, here.

In this process, MACs are supposed to set proposed prices on each code by February, which CMS posts for public comment in March or April, and final MAC prices are posted around September.   However, in real life, the proposed prices have often not appeared til as late as August, triggering the "initial" 60 day comment period into September and October. 

Here's what's up so far.

MOLDX MAC (Palmetto, WPS, Noridian, CGS)

Go to the MolDx home page and see a link to a spreadsheet which is their gapfill protocol.  I'm glad they structure the process, but I see a few points of confusion.  For one example, labs filling out the form must list financials for "allowable indirect costs," but there's no hint provided as to what "allowable" means.   

No dates are posted, but I urge clients to get their data in "circa" the first week or two of February or as soon as practicable thereafter.  For questions, try     moldx@palmettogba.com  .    

FCSO MAC

They've just posted a website for the gapfill process!  They ask for responses by March 8, 2021.  Find it here:

https://medicare.fcso.com/Clinical_lab/index.asp  for link  https://medicare.fcso.com/Clinical_lab/0456242.asp  

FCSO leads the reader to a "surveymonkey" website for entering basic data required for gapfill by regulation, such as "charges" and "prices of other payers" and "resources required to provide the test."

Novitas MAC

Novitas has newly posted gapfill instructions on its website, asking for response by March 8, 2021.

https://www.novitas-solutions.com/webcenter/portal/MedicareJH/pagebyid?contentId=00246106

(Novitas and FCSO are both owned under the umbrella of Florida BCBS, and both point the reader to a "survey monkey" website.  The rest of the text on the two MAC websites seems to match, too.)

NGS MAC

I emailed NGS MAC policy staff, and they replied "[we] only need to do gapfill on PLA codes for labs based [in our own] states."  

However, CMS policy staff in Baltimore advised me that all MACs will be requested to submit gapfill for all 2021 gapfill codes.  And this is what CMS has always expected in the past several years, that all MACs submit prices for all codes in the annual gapfill channel.    In addition, this is what the public CMS webpage indicates:   For any new test code that will be gapfilled, we request our MACs to develop MAC-specific gapfilled amounts for each test code and report the amount to CMS by April 1 of the following year.  Here.

I think the confusion is a understandable misinterpretation of a remark in CR12080 (here) that "MACs shall only price PLA codes for laboratories within their jurisdiction."  In context, CMS is referring to the rolling, quarter by quarter release of brand new PLA codes, and not to the annual formal gapfill process for designated new codes resulting from the annual summer meeting.  

Here are two summary slides from the information above:

Crosswalk, Gapfill, Flow Chart (click to enlarge)

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MAC Table (see blog for details) (click to enlarge)

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I've archived a cloud copy of the Surveymonkey here.

For footnotes to CMS website, MAC websites, here.

Very Brief Blog: CMS Updates Webpage for MAC COVID Test Pricing

CMS has periodically published MAC prices for the rapidly appearing range of COVID lab test codes.  This will be equally important in 2021, because CMS bumped a number of the codes into the "gapfill" process rather than directly assigning national prices.

Good news for CMS watchers - CMS updated its webpage for MAC COVID prices on January 25, 2021. 

• Find the current CMS price list here.
• I've put a duplicate copy in the cloud here.

I've clipped the table below as well.  The MAC prices are uniform so you really only need the first 3 columns.

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Among the more common tests, the standard AMA CPT PCR test (not high throughput) is 87635 $51.  The antigen test 87426 is $35.   The single step antibody test is 86328 $45, the multi step (e.g. Elisa) is 86769 $42.  The "gold standard" neutralizing antibody tests are screening, 86408 $42, and titer, 86409 $80.  CMS bumps up to $142 for combination tests, e.g. COVID + FLU.  

CMS has fixed prices for U-series codes for high throughput PCR testing, $75, and CMS adds $25 via an add-on code if reported in two days. (Trade article here).  (See also, interview with ACLA, here.)

For an August 2020 blog on COVID test coding, Lennerz, Link In, here.

 

Very Brief Blog: COVID and "Number Needed to Vaccinate" NNV, per Death Avoided

In healthcare, we often talk about "number needed to treat," or NNT, per outcome obtained or event avoided.   (In diagnostics, the equivalent metric is "number needed to test," also NNT.

While I am sure experts vary in their calculations, see a tweet from former biopharma executive Dr. Thomas Wilckens (here), pointing to a new article by Prof. Hermann Brenner of Heidelberg on  number needed to vaccinate per death avoided in COVID - article here.  

He argues that NNV in COVID is as low as 8 in the institutionalized elderly, to 167, in relatively healthy 65-74 year olds, to 12,873 in the low risk population < 65.    He also calculates that 99% of deaths avoided are reached with 33% of population vaccinated (being older or higher risk).  

The paper is open access.