At that time, CMS wrote, "...AI applications are emerging, we recognize that issues involving the use of AI are complex. While we agree that the costs for AI applications should be accounted for in payment, AI applications are not well accounted for in our PE methodology."
Saturday, April 10, 2021
Friday, April 9, 2021
According to a blog by Diana Richard on the XIFIN website, dated April 7, United Healthcare (UHC) will require Medicare Advantage claims to include Z-codes, effective June 1, 2021. Read it at XIFIN - here.
There have been news stories about UHC requiring various types of registry codes for lab tests dating back to mid-2020 (see a subscription story at Dark Report here.)
This is the first major sale of DEX Z-codes to a commercial payer that I've read about, although it appears to apply only to United's Medicare Advantage contracts and not its overall book of business as a payer. According to Kaiser, Medicare Advantage has 24M enrollees in 2020, about 40% of Medicare. According to United, they have 6.5M Medicare Advantage patients in 2020. That gives United about 27% of the MA beneficiaries (or about 10% of all Medicare benes, including the FFS ones.)
Palmetto GBA (which is related via holding companies to South Carolina BCBS) took over the DEX or Z-Code assets last summer, as was announced at the time when the DEX website was rebranded. (Here, here). There are currently about ~14,000 entries in the online DEX test library - here. Some locally-set prices (prices that are not on a national fee schedule) are newly available in DEX (here).
The Z-code system was originated by McKesson circa 2010, prior to the modernization of the CPT genomic coding system. It was spun off independent of McKesson as Change Healthcare, which in turn is now owned by United, but along the way the Z-code business silo was acquired by Palmetto. In March 2021, AHA opposed the union of Change and United/Optum in a filing with the Department of Justice (here).
It's been over a month since Chiquita Brooks-Lasure was announced as the expected nominee for head of CMS. Since then, Secretary of Health Becerra has had hearings, and has been confirmed. (Entry point here.)
Senate Finance Committee has now set the Brooks-Lasure hearing for Thursday, April 15, and set up the web page for it.
Wednesday, April 7, 2021
On April 2, 2021, MedPAC gave a half-hour presentation on PAMA policy and its recommendations for potential changes. The full report will appear in a June 2021 as a report to Congress.
Stakeholders have complained that in 2017, CMS used rules that selectively under-reported test payments to hospital-based outreach labs and to physician office labs. In fairness to CMS, the agency was navigating rules from Congress about a lab's revenue sources (Part A vs Part B), and had instructions from Congress (and advice from AMA) not to overburden small physician labs with reporting. Since then, likely in response to legal actions, CMS has broadened the basket of hospital labs required to report in the next PAMA cycle.
MedPAC used an outside contractor, RTI, to review two topics. One, could one selectively sample labs and get equally accurate pricing? The answer is obviously "yes," you don't have to count each one of billions of claims to pin down what the median is, within a percent or so. And, if you sampled more hospital and physician claims, the median price which sets the next CMS fee schedule, would go up.
- Key data showed that independent labs (and mostly big ones) contributed 90% of PAMA data, while hospital and physicians labs were 51% of the market (29%+22%).
- Hospital and physician lab payments were 45% and 53% higher, respectively, than independent lab prices.
They also considered just going straight to commercial claims databases and not bothering labs directly for data at all, but they seemed lukewarm to this idea.
In discussion, one panelist wondered if other pricing methods like "competitive bidding" would be better. That, of course, would be a wholly different legal and policy approach with a lot of complexities (see footnote). A panelist noted that point of care (local) tests had values, like rapid care and avoided return visit, that may justify marginally higher costs and prices. A MedPAC staffer noted that the MedPAC was thinking about how to handle all sorts of high priced items with new approaches, whether drugs, DME, or genomics.
- Web page for the meeting here.
- Deck presented, here.
- By mid-April, MedPAC should post a full transcript as well.
- Genomeweb coverage here.
- Inside Health Policy here (Subscription).
- I posted a 3 minute video about the meeting at YouTube - here.
- I discussed some of the background issues in a blog in March, here.
Tuesday, April 6, 2021
CMS has updated its 17 page data sheet on characteristics of COVID patients in Medicare.
See PDF here:
Webpage for project, here:
So far, 700,000 Medicare patients have been severe enough to hospitalize, of which 18% expired (126,000):
For inpatients, about half had less than 8 day stay, about half, longer than that. 1 in 3 admitted patients, 30% ,were 11 days or longer. As shown above, only 36% were discharged to home.
Prior blog here:
From time to time I need to research CMS data files on hospital performance, and it's usually a bit of a trick to find it again. A brief outline here.
- First, CMS has a simple consumer facing website for quickly looking up data at a local hospital or two. It's called Hospital Compare - here and here.
- If you want to navigate big Excel files, you'll go the professional site, data.cms.gov. This gives you categorical entry points like doctors, home health, hospitals, etc. Find it here.
- I clicked on the Hospital data website and I went to the bottom of the page to show 50 (rather than 5) sources once. Here.
For example, if you're interested in hospital acquired infection (HAI) data, scroll down till you find "Healthcare Associated Infections - Hospital" as a title. This gives you a 175,000 line Excel dataset.
The 32 megabyte 175,000 line Excel looks like this:
For example, for Southeast Alabama Medical Center in Dothan, AL, their MRSA data is no different than national and their CDIFF data is "better than national."
For more info on "hospital acquired conditions" (HAC) rules and metrics or specifically a subset which are "hospital acquired infections" (HAI), some websites are here:
If you enter the website a certain way, it allows you to go to a "beta" new version of cms.data.gov, but when I tried that, it terrified me and it seemed like data categories and files would become much harder to find that the current hierarchy. The system they have now is kind of boring and tedious, but the new system "beta" seemed like a confusing form of modernization.
Sunday, April 4, 2021
For anyone planning to get in a Spring Quarter PLA code, the deadline is Thursday, April 8. See AMA here.
For those who submitted PLA codes in early January 2021, AMA released the results on April 2, 2021. Find the PDF of code names here.
Codes 0248U through 0254U were released - a fairly small crop (7 codes). 3 of the 7 are from one applicant.
- 0248U, "3D Predict Glioma" cell culture test from Kiyatec;
- 0249U, Theralink 32 phosphoprotein test in breast cancer;
- 0250U, PGDx elio(TM) 505 gene tumor test, I assume the same as the FDA-cleared test in spring 2020;
- 0251U, Hepcidin ELISAm "IntrinsicDx;"
- 0252U, Products of conception aneuploidy test, Igenomix;
- 0253U, ERA endometrial receptivity test, Igenomix;
- 0254U, SMART-PGT-A preimplanation cytogenomics test, Igenomix.
Flurry of conferences going by...
McDermott Plus; Diagnostics Forum (April 6)
McDermott Plus Consulting holds its sixth annual Diagnostics Forum, Tuesday, April 6, 12-330 ET.
Website here, four-page PDF agenda here. There are a wide range of top speakers both from industry and government; CMS speakers including Tamara Syrek-Jensen, head of coverage at CMS, and Dr Gabriel Bien-Wilner, senior medical director for MolDx. If I'm reading it right, this virtual meeting may be complimentary.
Cambridge Healthtech - AI and Digital Pathology (Sept 30-Oct 1)
This conference will run September 30-October 1, "a comprehensive program for all aspects of digital pathology and AI." See the website here. Early bird registration as low as $399 academic, $899 commercial.
ISPOR - Numerous 4 Hour Short Courses (Monthly)
ISPOR, the international society for pharmacoeconomics and outcomes research, has a bonanza of short courses which are virtually available. Typically, they are two, two-hour sessions, giving you a lot more depth than an hour's overview but not requiring a full day invested.
For short courses, here. March 31-April 1 was Value Assessment of Medical Devices; April 28-29 is Intro to Patient Reported Outcomes (PROs); May 24-25 is Tools for Real World Analysis, and so on. I sampled one and registration (as a member) was $255.
For all ISPOR events, here.
Just Past: Medtech, Diagnostics, Value & Access (Just Past)
While this European-focused conference on value and market access just went by, March 30-31, you might find the speakers and topics of interest. See more conferences from this sponsor here.
Thursday, April 1, 2021
Everyone knows that there has been an explosion in telemedicine over the past year and there is much speculation on how it will continue and in what form. (E.g. for one entry point see Paul Sonnier's essay in The Hill in early March.)
There's an interesting essay on economic and industry-structure repercussions which appeared last fall in Medical Economics under the title, "Will Telemedicine Create Perfect Competition?" It's by economist Adam Block and health policy expert Michael Adelberg, who heads the health strategy practice at Faegre Drinker. (Bios here and here).
The article is newly complemented by a podcast at Health Assurance, a new podcast series. See the 30-minute podcast here.
(See index of interesting podcasts. The December 6 podcast authors have a 2020 book, Taneja, Klasko, Maney: Unhealthcare. Good podcasts also with Caroline Savello of COLOR, Toyin Ajayi of CityBlock, and Jenny Schneider of Livongo.)
Perfect competition is an abstraction in economics where there is no friction between buyers and sellers and the exchange of goods, and profits rapid fall to minimal levels as prices approach marginal cost. The absence of perfect competition gives profits, which formally are called economic rents or monopoly (oligopoly) power.
Businesses tend to want to avoid perfect competition; creating barriers to entry of all types, whether brand loyalty, difficult credentialing rules, etc.
There's a book that was influential on me a decade ago, In Defense of Monopoly (U Mich, McKenzie, Lee). Without foreseeable profits, there won't be future cash flow to pay for today's risk and investments, and innovation is badly impaired. It's hard to invest for innovation (and risk) if your product will also and quickly be sold at the marginal cost of production.
But there are also a lot of natural ways for prices to exceed marginal cost. Let's say a dry cleaned shirt costs $5, and in my city there's enough business for a dry cleaner every 2 miles. Let's say it costs $1 for me to drive 2 miles. My dry cleaner can charge $5.99 for a shirt (with 99 cents profit) before it makes sense for me to drive 2 miles to get a shirt cleaned for $5.00. It's these inherent frictions that we may rarely think about, that give even a near-commodity business some return on investment. Take them away, and the economics go into alternate paradigms we aren't used to. This in turn affects industry structure and vertical integration (see. e.g. Coase's work on "the nature of the firm.")
Early in the Trump administration, there were hearings for the initial Secretary of Health, Tom Price, and for the CMS administrator, Seema Verma. The Price hearings weren't particular informative of future policy but I found the Verma hearings extremely interesting and worthy of study, at the time (here, here.)
We've now had the HHS Secretary Becerra confirmation hearings - I don't know how telling they will prove to be, but I provide links below. In the near future, we'll have hearings for proposed CMS Administrator Chiquita Brooks-LaSure (here) and I'll provide links when they occur.
For Your File; Some Resources for Becerra Hearings
Becerra had hearings at the Senate Finance Committee, and at the Senate HELP Committee (Health, Education, Labor, Pensions).
See the HELP webpage here - February 23, 2021.
There is a 3h 20m video streaming here. There is a link to a simple two-page opening statement here.
See the SFC webpage here - February 24, 2021.
There is a 3h 18m video streaming here.
There are more document links.
- Sen. Wyden's 2-page opening statement here.
- Sen. Crapo's 3-page opening statement here.
- Becerra's 2-page opening statement here.
- Of more interest, a 95-page PDF of "questions for the record," here.
The saga of prior authorization continues - a colleague pointed out that United Healthcare has a number of open-access webpages that describe its evolving rules for providers.
See UHC "Genetic and molecular lab testing updates" - here:
See UHC "Genetic and molecular lab testing Notification/Prior authorization" - here:
The College of American Pathologists (CAP) has a webpage dedicated to upcoming and recently finished CAP guidelines - here.
One of the newest is an in-progress guideline for PD-L1 testing - here. The PD-L1 webpage states, "The primary goal of this guideline is to develop evidence-based recommendations for the testing of immunotherapy/immunomodulatory biomarkers including PD-L1 and TMB in patients with non-small cell lung cancer (NSCLC)."
The webpage provides you with 8 "key pre analytical questions" and creates an open comment period on proposed guideline conclusions which is open to April 23. There's a link to a 7-page bibliography, and a link to a PDF of 6 proposed summary recommendations. You can click on a comment box which collects basic information on the commenter (e.g. profession, such as pathologist) and allows step by step comment on each of the recommendations.
Comments are open until April 23.
At the work in progress webpage here, ten topics are listed: MSI testing, glioma evaluation, monoclonal gammopathies workup, HPV lesion terminology (ano genital), PDL1, whole slide imaging, IHC validation (in general), amyloidosis protocols, HPV testing rules for H&N cancer, TKI testing in lung cancer.
Tuesday, March 30, 2021
In brief, a New York Times story today describes elite Manhattan hospitals - like Lenox Hill - charging $3000 for single COVID tests. They note that Congress requires COVID tests to be covered without a fee to the patient, but assert there is price gouging by some suppliers.
Very Brief Blog: JAMA: After Vaccination, Strong Real-Life Neutralizing Antibodies for COVID Variants
An interesting short open-access article in JAMA this week by Edara et al:
There are two types of COVID antibody tests, simpler tests for the presence of anti-COVID antibodies, and more complex tests that actually use cell culture to detect whether there are toxic "neutralizing antibodies." In this report, the authors set up not one, but four types of cell culture systems for neutralizing antibodies, against four major variants.
Two findings. One, vaccinated persons (Moderna version) produced stronger neutralizing antibodies than either new or recent COVID patients. Second, the antibodies performed well regardless which of the four viruses was used in the cell culture system. Click to enlarge.
Note that in the left panel, a few hospital patients 10 days into their illness still had minimal detectable neutralizing antibodies (their dots sit at bottom in each column.) Note also that the convalescing patients (middle panel) were several months post infection, and expected to have gradually falling antibodies, whereas the Moderna patients (right panel) were exactly 2 weeks after their second injection, which might be the natural "peak antibody" timepoint.
As AMA prepares for its May 2021 CPT meeting, it has released the agenda of code proposals. Interested stakeholders can obtain a copy of the application packets by requested by April 15, and then, responding by April 22. AMA screens the requests to comment for being a validly involved stakeholder (e.g. not a journalist, not just curious, etc). For example, a competitor company is a valid stakeholder.
See the code proposal list here:
There are circa 54 total agenda topics. It looks like 17 are for Category III codes. The codes range from Tab 6, Revise Non Face to Face Inter-Professional Consultation (99451), to Tab 60, a proposal to create a code for cytogenomic (genomic wide) analysis by the low-pass sequencing method (styled as an addition to the 81228/81229 cytogenomics code family). This technique has been reported to have less adverse racial bias that some other methods (here).
It might be a bit scary for owners of Cat III codes that there are ~17 new applications for these codes, but I only counted 1 application to elevate a Cat III to a Cat I code and 17 applications for simple deletion of Cat III codes.
Lab test items had an earlier comment cycle in the beginning of March (entry point here) to allow the comments be available for pre-May subgroups for lab tests (Molecular Pathology Advisory Group MPAG, Pathology Coding Caucus PCC.)