Friday, January 28, 2022

"Discoveries" Blog Reaches 1M Views, 1800 Articles

This week, this blog, Discoveries in Health Policy, reached 1M hits as it crossed to more than 1800 articles.  The blog began on February 16, 2014.   

The 1M views are counted directly on the website.  Several hundred subscribers see the blog by media readers or email subscription.

Beginning in 2020, I feature one or two articles per month as short videos (here).

7 articles have had more than 1,000 views, with the highest being my 2006-2016 library of Theranos links.  It's had 11,000 views; I began it in 2014.  (The famed WSJ article was October 15, 2015).


Thursday, January 27, 2022

From December 2021: Opko 4Kscore Gets FDA PMA Approval as Sole-Source Test

Update from December 2021.  On December 7, 2021, FDA issued a PMA approval for the Opko 4Kscore test.   This is one of very few lab-based (sole source) tests that has a PMA, rather than 510(k), approval.  The approval remarks, performed solely at Bioreference.

The 4Kscore Test measures four proteins, three are forms of PSA (tPSA, fPSA, iPSA), and kallikrein-2.  If I am reading the FDA approval correctly, the test incorporates age, previous biopsy, and digital rectal exam results.

Find the FDA home page for 4Kscore here. It's P190022.

Find the summary of safety and effectiveness here (36 pp).  

Find the labeling here (aka package insert; 16pp).

Medicare Policy

For reasons that are lost on me (aka above my pay grade), the Noridian MAC has an LCD (non coverage) of 4KScore, even though the test is not performed in California.  The LCD is titled as a MolDx LCD and appears to be currently active (L37120, effective January 2019, revised November 2019).  See also billing article A57336 and "response to comments" A56191.

The active coverage is via Novitas MAC, under LCD L37792, active since March 2019.

CPT code 81539 for the Opko 4Kscore test in CY2020 had about 13,000 Part B FFS uses for about $10M at about $760 per test.   This makes it about the 20th-highest-paid MAAA or molecular code in 2020.

Intended Use

The FDA intended use is pretty long:

The 4Kscore Test is an in vitro serum or plasma test that combines the results from four

immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA,

intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the

following information: a patient’s age, previous biopsy and digital rectal exam (DRE). The

4Kscore Test is indicated for use with other patient information as an aid in the decision for

prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA

and/or abnormal DRE. The 4Kscore Test is intended to aid in detection of aggressive prostate

cancer (Gleason Score >= 7/Gleason Grade Group >= 2) for whom a biopsy would be

recommended by a urologist, based on current standards of care before consideration of the

4Kscore Test.

A 4Kscore < 5.0 is associated with decreased likelihood of a Gleason score • 7 on biopsy.

Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than

once every 6 months.

The test is intended for professional use only, and is performed at a single-site BioReference

Laboratories, Inc.  [Warnings include: "Prescription Use Only.")

Tracking S&E FDA Reports

The PAIGE PROSTATE AI software was de novo approved by FDA in September 2021, but as of yet, January 2022, the safety and effectiveness report isn't posted by FDA.   Here.  You can also track the appearance of the S&E summary for DEN200080 here on the de novo index page.

Wednesday, January 26, 2022

Xifin Acquires OmniSYS for Closer Integration with Retail Pharmacy

In December 2021, XIFIN expanded into the pharmacy market with the acquisition of informatics firm OmniSYS.  XIFIN is a leading consultancy for lab revenue cycle improvement.

  • See press release here.
  • See coverage at HIT Consultant here.
  • The story was featured in the January 10, 2022, Dark Report (subscription).
  • In other news, XIFIN expanded 54% in CY2021 to 800 employees, with both East and West coast offices.  Here.

I've clipped the press release descriptions of both XIFIN and OmniSYS below the break.

Very Brief Blog: AI in Radiology News & AI in Pathology Headlines - PANDA Challenge

In pathology and laboratory medicine, in 2021, we had the FDA approval of AI-assisted prostate cancer interpretation.    Here, here.  (For PaigeAI, see the September 2021 classification order on this index page but the FDA decision summary is not up yet as of late January 2022).

I tend to think that in this area, radiology is just running a couple years ahead of pathology.   Quoting an article January 24, 2022, in AuntMinnie, a radiology news web site.

Imaging services provider RadNet has acquired Dutch artificial intelligence (AI) software developers Aidence and Quantib in deals that the company hopes will enable wide-scale screening programs for lung and prostate cancer....RadNet's acquisitions of Quantib and Aidence reflect a strong trend toward the need to establish one platform for AI, informatics expert Dr. Erik Ranschaert, PhD, told  "Also, U.S. companies appear to have a keen interest in buying European AI developers at the moment," said Ranschaert, a radiologist from St. Nikolaus Hospital in Eupen, Belgium, and a visiting professor at Ghent University.

See the full article (might require free registration):


Footnote - today 360Dx has an article on AI in Pathology (subscription):

Quoting in brief, "German artificial intelligence-based software company Mindpeak has developed a proprietary machine learning method to fully automate the process of digital pathology that can also be integrated with other laboratory software to help clinical laboratories streamline their processes.  As its base technology, Hamburg-based Mindpeak uses a proprietary hybrid deep learning method and combines that with its AI pre-trained with pathology data that doesn't have annotations from pathologists."   

2022 Pathology - AI Headlines

See also new Pathology/AI headlines, such as "AI Holds Its Own Against Pathologists," (MDEdge, 1/18/2022) and "PANDA Challenge: AI for Gleason Grading," (ESMO, 1/24/2022).  

  • Regarding FDA and Pathology AI, there's the de novo approval for PAIGE last September (DEN200080, for which the Summary of Effectiveness is not yet posted) and Verily is still percolating on its 2019 Breakthrough Status for Pathology AI (here).

The PANDA challenge is available at Nature Medicine as Bulten et al., open access:

Abstract of Bulten et al. here:

Artificial intelligence (AI) has shown promise for diagnosing prostate cancer in biopsies. However, results have been limited to individual studies, lacking validation in multinational settings. Competitions have been shown to be accelerators for medical imaging innovations, but their impact is hindered by lack of reproducibility and independent validation. 

With this in mind, we organized the PANDA challenge-the largest histopathology competition to date, joined by 1,290 developers-to catalyze development of reproducible AI algorithms for Gleason grading using 10,616 digitized prostate biopsies. We validated that a diverse set of submitted algorithms reached pathologist-level performance on independent cross-continental cohorts, fully blinded to the algorithm developers. On United States and European external validation sets, the algorithms achieved agreements of 0.862 (quadratically weighted κ, 95% confidence interval (CI), 0.840-0.884) and 0.868 (95% CI, 0.835-0.900) with expert uropathologists. 

Successful generalization across different patient populations, laboratories and reference standards, achieved by a variety of algorithmic approaches, warrants evaluating AI-based Gleason grading in prospective clinical trials.

Could CMMI Survive Challenge at the "Gorsuch Court?"

I'm not an attorney but I'm writing as a full time expert in health policy.   I think that if you put together three things - (1) the law that created CMMI, Medicare's Center for Innovation, and (2) legal arguments made in the case against the Trump "Most Favored Nation" drug pricing rule from CMMI, and (3) writings from the "Gorsuch Court" in the current OSHA case, the outlook for CMMI would not be good.

This Blog Also Available in Video

See the seven-minute video based on this blog - HERE.


Let's take the three main points in sequence.

1.  SSA 1115A - Creates CMMI

The Center for Medicare & Medicaid Innovation - CMMI,  or CMI, [FN1], also called CMS Innovation Center - was created as part of the original Affordable Care Act in 2010.  It's located at SSA 1115A, and CMS treated the statute as self-implementing (they didn't undertake rulemaking before setting up CMMI.)   

There's a lot of webpages for CMMI at CMS - here.   It's authorized to create and run any number of "models."  The statute describes no limits on the size or duration of models, but shields them from judicial review at 1515A(d)(2).   The statute also allows CMS to waive any law in Medicare or Medicaid for the purpose of carrying out a model at (d)(1).

As I covered in this blog at the time, in 2016, Republicans on the Hill were highly distressed about CMMI (under Obama) and held hearings with a very negative bent, and Trump's first Secretary of Health was anti-CMMI.    In their first years, both the Trump and then the Biden administration have offered major "reboots" of CMMI.  However, the "unlimited" powers of CMMI are tempting.  The Obama administration offered a national drug repricing law under CMMI - discontinued in the last days of the Obama administration.  In its last months, the Trump administration offered an even bigger "most favored nation" (MFN) drug repricing law created suddenly by the CMMI.   MFN was fast thrown out in court and slowly, in the ensuring year, formally withdrawn by the Biden administration.   

(Tidbit - CMMI, at SSA 1115A, sites adjacent to historical law for Medicaid waivers, SSA 1115.)

2.  MFN CMMI Demonstration - What Court Records Show

The Trump administration had Rose Garden speeches and executive memos about drug repricing, but the actual achievement was Interim Final Rulemaking - essentially, emergency rulemaking - introducing "most favored nation" pricing, where Medicare drug prices would be pegged to international benchmarks (in the lame-duck phase, November 27, 2020).   This was rapidly challenged in court, and implementation was stopped by the courts.   After implementation was stopped by the courts, the Biden administration withdrew  the ruling rather than fighting for it in higher courts.   The final CMS action in the MFN withdrawal process was December 29, 2021 at 86 FR 73986.  

But let's go back to the court cases along the way.  See the Blake ruling, December 2020 on MFN.  There were three legal arguments against MFN:

1.  CMMI inappropriately created MFN emergency "IFR" rulemaking.
2.  CMMI, the authority, acted outside its scope of abilities in making the MFN model.
3.  CMMI should not exist in the first place, it is an inappropriate delegation of Congressional authority.

Each of these points was argued articulately in the court cases in the effort to throw out MFN.  However, in the pivotal judicial decision, MFN was thrown out on the basis of #1 only.   This follows the legal principal that you don't reach to statutory or constitutional arguments unless you have to.   The judge ruled that MFN was not legitimately justified as reasonable emergency rulemaking.   (For example, if you are going to change drug prices for 8 years, it's not feasible that's an emergency which compels you to skip 30 days of public comment at the beginning.)

Therefore, the court recited, but did not address, arguments 2 and 3. (Remarks quoted at FN2)    Argument 2 in the MFN cases was that Congress could not have intended "model" to mean a sudden massive change in drug pricing law,  nationwide.  While Congress did not precisely define the word "model," it couldn't have meant something so broad.   Argument 3 was that Congress could not, in the first place, have authorized CMMI to issue models unlimited in size and scope and waiving "any" CMS law in the process of doing the model.  (For example, I've joked, CMMI could lower the Medicare age to 55 and call it a twenty-year nationwide "model.")

I've included some of the MFN court filings and the 2020/12/23 Judge Blake ruling in a cloud file here.

3.  SCOTUS Opinions in the OSHA Case

Here's an important what-if.  What if Argument #3 above - that CMMI is an unconstitutional level of delegation - got to the "Gorsuch" Supreme Court?   

We have some clues in the current OSHA vaccination case, where the Biden administration used emergency (IFN) rulemaking to require all businesses over 100 employees to either have vaccinated workers or daily masking and weekly testing.   Note that this case didn't reach a final decision, rather, SCOTUS allowed the OHSA implementation to be immediately stopped pending a final decision.  There won't be a final decision, since the Biden administration is withdrawing the rule.

I don't like the term "conservative justices" because they are often in favor of states' rights.   So if a state wants to restriction abortion, they may allow that, as states' rights.  But if a state requires vaccination, they may also allow that, for the same reason, states' rights.  For example, in the current HHS hospital workers vaccination case, Justice Thomas in his dissent was against HHS requiring vaccinations, but noted pointedly that states have the right to require vaccinations under SCOTUS precedents (both being  historical smallpox vax cases).  

There are three  conservative opinions in the recent HHS VAX and OHSA VAX cases:

If you go past the headlines, and if you read all three opinions shown in red, you get the viewpoint of what's usually the SCOTUS majority, up to date to January 2022.   It's about constitutional limits, about states' rights, about the original 1788 delegation of powers held by the states (the 13 colonies) to the federal entities, and case law on limits of delegation of authority from the Congress to federal agencies (FN3).   From these readings, it's hard to imagine the majority justices agreeing that (A) it's OK for CMMI to have unlimited abilities in the size, scope, nature, and duration of models, and that (B) CMMI crowns that with the ability of CMS to waive any aspect of CMS law for the purpose of the models.   

(See my earlier blog on the OHSA and HHS VAX cases here).

Interestingly, exactly as occurred in the MFN case, SCOTUS would only reach arguments about the constitutionality of CMMI in a case where the issue could not be decided on a lesser point, such as a process violation of notice and comment rulemaking.   (See again FN2).

But if CMMI does reach Judge Gorsuch, would he not repeat what he's already said about OSHA?   "Under OHSA's reading, the law affords it almost unlimited discretion, and imposes no meaningful restrictions that meaningfully constrain the agency" [Cite to TOUBY case, 1991].  

My point has been, he could lift this quotation word for word and apply it to the seemingly unlimited authorities asserted for CMMI.

How Could CMMI Find Itself In Front of Gorsuch? 

There's no single answer but one possibility might be the "CMMI Medicare Direct Contracting" system, created by Trump and altered and continued forward by Biden.  It's unpopular in some circles - here.



FN1.  The statute calls the center, "Center for Medicare and Medicaid Innovation," and you see it abbreviated often as CMMI.  However, the statute at 1115A immediately describes the abbreviation as "CMI."   You also see "Innovation Center" or "CMS Innovation Center" (which would be CIC, but you never see that choice of abbreviation, since it offers the pronunciation "sick.") 

FN2.  In the Judge Black ruling, 12/23/2020, the 3 arguments against MFN are recited.  The court agrees with Argument 1 - MFN was bad due to its IFN emergency rulemaking.  QED.

However, her footnote 9 carefully writes, "The court does not today reach the plaintiffs' arguments concerning the statutory authority of CMS [scope too broad] or the constitutionality of the rule [excess delegation by Congress to CMMI].    

See also her footnote 17, "The court reiterates that it is expressing  no opinion on the merits of teh plaintiffs' statutory or constitutional challenges to the rule."

FN3.  In 2009, law professor Cass Sunstein wrote an article, Is OSHA Constitutional?  (Cited inside one of the judicial opinions I read above, the BUSH dissent in appellate court filings on the path to the OSHA SCOTUS case).  One could imagine Sunstein revisiting the same  themes under the new title, "Is CMMI Constitutional?"


I have some informal personal links and notes on Direct Contracting here.

Tuesday, January 25, 2022

Brief Blog: Noridian Issues Plasma-Based Genomic Profiling LCD, Will Eventually Match the Rest of MolDx

The MolDx system for genomic policies includes four MACs, Palmetto (where full time MolDx staff are found), Noridian, WPS, and CGS.  

Generally, the four MACs release LCDs in lockstep.  However, back around 2020, Noridian began releasing some coverage decisions as "articles" which quoted the key coverage text found in "LCDs" in the other three MACs.   

  • For example, Palmetto, WPS, and CGS would each have an LCD covering "Gene ABC" and Noridian, instead, would have a matching article covering "Gene ABC."

With the release of DL39230 and DL39232 on January 20, 2022, Noridian starts the path to having an LCD for "plasma based genomic profiling in solid tumors" that will match already-existing and similar LCDs in the other MolDx MACs.

MRD and other forms of early detection are getting a good response at ASCO, per a January 26, 2022 article in Precision Oncology News by Molika Ashford - here.

Find LCD DL39230 and LCD DL39232 .   Comment period is open to March 5, 2022.  See the Noridian website to look for a promised public meeting (teleconference) on January 24.

The current master LCD, the Palmetto LCD, is L38043.  The Noridian drafts match the current master Palmetto LCD.

Nerdy Detail - Noridian releases one LCD for Jurisdiction E (CA/NV/HI) and one LCD for Jurisdiction F (mountain states), which is why we see LCD '230 and also its twin '232.

The Ever-Confusing Gapfill Season is Underway

Update: Novitas and First Coast published data templates and a due date of Feb 28 - here.


The Gapfill information season is Medicare at its most confusing.  

In Fall 2021, CMS priced about 65 of 100 new lab codes, and sent the other 35 into the "gapfill process."  In this process, all the MACs are supposed to gather information on the 35 gapfill tests, recommend prices, and submit the prices to CMS (ideally by March).  By about May, CMS publishes a list of all the MACs, all the codes, and all the proposed prices, for public comment.  In about September CMS publishes a list of "final gapfill prices" (the comments having been considered over the summer).

  • However, there's no central list of gapfill codes or central instructions on what to do, but you can hunt and peck and find the gapfill codes among the 100 codes priced on November 23.   
  • See my blog about the February 2021 process a year ago because eventually the 2022 process will probably lurch its way to the same configuration.

Although gapfill info is due in Jan/Feb, I couldn't find any MACs with information yet on how they wanted info submitted.   I tried search word "gapfill" at several different MACs and came up with nothing.   MolDx has a gapfill Excel spreadsheet to organize inbound information (you can find it at MolDx, and then hover over Forms, and then look for Gapfill.)   But they don't have any specific advice yet or a specific mailbox or portal to upload the info into.   I've been in calls where MolDx staff say verbally they'd also need a formal and more detailed cost breakdown than is requested on their form, but I've never found a place on the website that says they want that.  

In the past, Novitas and First Coast have set up a sort of "doodle poll" online where you can type in requested info into formatted web form pages.   I haven't seen any news about those for 2022, either.

MolDx Updates FAQ's and Forms for Tech Assessments

MolDx has updated some of its technology assessment spreadsheets (January 6, 2022) and updated some of its Frequently Asked Questions/FAQs, today on January 25.

Find the home page here.

Find the tech assessments here.

Find the FAQ web page here.   Also as preprinted PDF here.


Updated forms for "Checklist" and "Hereditary Cancer Testing" and especially see AV/CV for MRD (NEW), minimal residual disease.  They have two types of forms for "solid organ allograft rejection" which aren't labeled new, but are new to me.


Unfortunately, MolDx does not highlight revisions in its FAQs, so you have to read all of them and guess what's new.   

The PDF version offered does not exactly match the online Q&A version.  The online version starts with a question, "What Can I Do to Facilitate Review?"   

Some of the advice includes "detailed information on orthogonal methods" and "clear description of Intended Use" and one comment I particularly enjoyed (just about LOL.)  That last was, "We recommend someone familiar with the validation complete the documentation." 

Proposed: Center for Neuroscience at FDA

FDA already has set up a Center for Oncology Excellence and there's now interest in creating a Center for Neuroscience Excellence.

One interested party is Lundbeck, a biopharma focused on neurologic drugs - products here.

See Lundbeck's webpage about why a "Center for Neuroscience" at FDA is a good idea - here.

See a detailed December 2021 page at AgencyIQ about the "Neuroscience Center of Excellence Act" sponsored by Senators Collins (R-ME) and Lujan (D-NM).  Here.

The Senate press release about the bill is hereNote, a link to "text of the bill" at that webpage was not active for me today.  However, I found the full text of the legislation online at S.3427 here.


Wednesday, January 19, 2022

Brief Blog: My Comment on JAMA Article on Aducanumab Expected Costs

On January 11, 2022, CMS announced a plan to cover the Alzheimer drug aducanumab (Aduhelm) and other Alzheimer amyloid drugs, only in randomized controlled trials, for which Medicare would pay direct drug costs.  Entry point here.

On January 14, 2022, JAMA Health Forum published an article, Mafi et al, on "Estimated annual spending on Aducanumab in the US Medicare Program" - here.

I believe the authors make an error.  The authors discuss the potential Medicare market that might be available to aducanumab - from 1M to 6M patients.  This is likely correct and is the focus of the authors' expertise.  The concept of "potential market" will be familiar in business terms as the "total addressable market" or TAM.

However, and this  went by the editors of JAMA, the authors pivot directly to expected Medicare expenditures, and state an "upper bound limit" (which is correct) and what they call "a lower bound limit" (sic) which is absolutely not correct.   They describe their results as "Medicare spending estimates" which they are not.  Among "limitations" they mention a few, such as misclassification of dementia, but do not mention they project dollar values for expected Medicare costs without allowing any variable for market penetration.   

They open by stating that aducanumab "could threaten Medicare's solvency."  This is unlikely; it is a high multi hundred billion dollar program.  New therapies, such as aggregated checkpoint inhibitors, are larger dollar volumes that aducanumab would be.   Whether aducanumab was $100M or $1B in sales, it would not singlehandedly threaten the larger program's solvency, any more than Provenge for prostate cancer did (it reached $300M in sales).   Even worse, the "minimum lower bound of Medicare cost" for aducanumab is presented as $7B with narrow plus/minus error bars.

I submitted a public comment which I clip below the break.

Monday, January 17, 2022

Catching Up With MolDx: December Meeting on Rheumatoid Arthritis Therapy Selection

On December 7, 2021, MOLDX held a multi-jurisdictional advisory meeting on the topic, "Predictive Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis."

The webpage is here:

This is framed as a MolDx meeting, but many of the questions were directly on the drug therapies themselves (for example, different tolerance profiles of different TNF inhibitors), and only a few questions focused on targeted diagnostics.  The "PrismRA" test was mentioned a few times.  See the company EXAGEN in a recent Genomeweb article.

The questions, panel ratings of the questions, and transcript are posted online, as well as links to videos.  See link above or see the cut/paste below the break.

The transcript is worth reviewing for insights into the way MolDx medical directors think and the experts they were interviewing were focused and articulate.

Sunday, January 16, 2022

The Government *Can* Require Vaccinations: Supreme Court History

We often hear conservative politicians emphasizes to audiences that the government can't make you get a vaccine.   That's misleading, based on Supreme Court precedents that were touched upon last week's vaccination cases.

Last week, there were two highly discussed Supreme Court decisions (links below).  Both were, technically, temporary decisions (to postpone or allow an implementation, not to decide a case in a final way).   

  • The Supreme Court put on hold an OHSA regulation that would have required vaccination (or weekly testing) at large employers.   
  • The Supreme Court did NOT put a hold on an HHS regulation that requires nearly all health care workers at institutions to be vaccinated.   

Although I don't like the "conservative" and "liberal" nomenclature at all, the "conservative" justices lost the HHS healthcare institution decision, and left behind a dissenting opinion by Justice Thomas.   Here, they brought up an argument they didn't need to voice in the OSHA case, since they had already won that one.    They noted that our federal constitution was created by the states in 1788 and retained all governing powers to the states, that weren't transferred to the federal government.  For example, raising an Army, declaring war, international treaties, and regulation of disputes between the states are some of the enumerated federal powers in the various Branches and Articles of the Constitution.

Thomas noted that vaccinations belonged to the legitimate authority of the state level, and not the federal level.   Thomas cited to Zucht v King 1922.   Zucht is a short dismissal of a state vaccination case, the point of which is to refer back to the prior and authoritative case, Jacobson v Massachusetts, 1905.   Both cases support the authority of states to create and enforce vaccination laws.   Opponents of state-based vaccination mandates lost in the Supreme Court.

So if a state governor, say, in Florida, says, "The government has no legal right to require vaccination!" that's not really true, unless the Constitution of Florida specifically governs that.  In general, Supreme Court precedents allow state legislatures to create vaccination mandate laws.  A governor can give a speech and promise not to do vaccination laws, but he and the assembly could do them, absent a local state constitution saying otherwise.  


Jacobson v Massachusetts, cited in briefing documents multiple times but cited just once in the 65pp of final opinions and dissents, remains an interesting read.  Basically, Jacobson argued first that vaccination violated the preamble of the Constitution (promote the general welfare and secure the blessings of liberty.)  Judge Harlan said that was not controlling law and too vague a standard to apply.   Jacobson argued that vaccination violated "the spirit of the constitution," which Harlan also dismissed quickly.   Jacobson argued a range of findings of fact, points which had been lost at lower trial courts and were not re-ligitated.   Finally, Jacobson argued that vaccination violated the 14th amendment (not to deprive of liberty and property without due process), which Harlan dealt with more carefully but found unavailing.   

Harlan 1905 attributes vaccination authority to the "police power" of the several states, which sounds grim, but I believe it's a term of art that means the general governing power of the state.  See a contemporary 1907 article in Columbia Law Review, by Cook, "What is Police Power?," writing, "no phrase is more frequently used and at the same time less understood."  

Zucht in 1922 was a girl wanting to attend Texas public schools; the vaccination was smallpox.


AMA attorney on the new cases here.  Discussion at MedPageToday here.  At HealthCareDive here.

OSHA Case (no vaccination per SCOTUS) here.  (Prior documents here.)

HHS health system case (vaccination can proceed per SCOTUS) here.  (Additional docket PDFs here).

Zucht 1922 here.  Justice Brandeis.

Jacobson 1905 here. on Jacobson, here.

Deeper dive, 2021, at National Constitution Center, here.


The Jacobson case reminds me again that SCOTUS opinions of the mid 1800s and early 1900s, like this one, are often clearer and more easily read than novels of the day, say Edith Wharton or Henry James from 1905.

The OSHA prior documents include remarkable dissents by Sutton (pdf p. 65) and Bush (pdf p. 92), the latter tracking policy back to 1822 for originalists.  He also cites Cass Sunstein, 2008, "Is OSHA Unconstitutional?" (here).  

Saturday, January 15, 2022

AMA Publishes January Applicants for New PLA Codes

 The AMA takes applications for new PLA codes quarterly and handles them within several weeks.  For the January 2022 quarter, the submitted PLA applications have been posted.   Interested parties can follow instructions on the linked PDF to review particular applications; apply to AMA by January 20, the comment request deadline.  If that is the request deadline, you have to turnaround a comment promptly as the PLA committee meets January 25.   Final voting occurs in conjunction with the February 3-5 general CPT meeting.

Find the agenda PDF listing the codes HERE.   The PLA home page is here.   Find the dates deadline here.

Quick Tally

I tally about 12 codes, a couple of which are minor revisions.  Two are microbiology - a metagenomic test from Hopkins and a sexually transmitted infection test from Bridge Diagnostics.   There is a cancer optical genome mapping test.  Among publicly held companies, Guardant applies for a Guardant360 code.  There is also a very complex cancer test "OncoMap Extra" which brings together the DNA exome, the RNA transcriptome,  and markers like TMB and MSI.   

Nerd Note 

At one time, AMA required exact gene numbers for multi-gene tests, but now they allow more flexible nomenclature like "83 genes or more."   

Thursday, January 13, 2022

Hearings on the Hill: House, New Med Tech (Dec 8), Senate, Covid Omicron (Jan 11). Bonus: Amy Abernethy Futurism.

Two interesting Congressional hearings in the past weeks.


On December 8, 2021, House Energy & Commerce held a 3.5 hour hearing on "Future of Biomedicine: Translating Biomedical Research into Personalized Health Care."   Speakers including Amy Abernethy (Verily), Atul Butte (UCSF), Leroy Hood (Institute for Systems Biology), Lloyd Minor (Dean, Stanford).   

  • Find the Congressional website here.
    • This includes links to streaming video plus links to PDF prepared testimony.
    • Bonus!  I provide an auto-transcript of the hearing.  Here.  58 pp.
    • Bonus!  I provide the PDFs in one zip file here.


If you're a fan of Amy Abernethy, see a 26 minute interview with her, January 13, 2022, at Health Care Blog, link to video here.  

Title is: Futurecasting with Amy Abernethy: Verily, Real-World Data, Clinical Trials & Health Policy in 2022.



See the website for the Senate HELP committee hearings on January 11, 2022, on the Administration's response to COVID Omicron.  Speaking? The usual top level leadership, Rochelle Walensky of CDC, Anthony Fauci of NIH, Janet Woodcock of FDA, Dawn O'Connell (Assistant Secretary, HHS). 

  • Find the Congressional website here.
    • This includes links to streaming video plus links to PDF prepared testimony.
    • Find an autotrascript of the four hour hearing here.  66p.
    • Find a zip file of the 4 prepared PDFs here.
    • See coverage of the sometimes fiery hearing at Bloomberg here.

Amy Abernethy at House Hearing, 12/2021


Some crude page numbers for topics in Dec 8 hearing, here.

Nerd note.  I rarely see the term PHENOME, used several times by Dr. Hood.  However, it appears in a new JAMA headline in Bastarache et al. here.  JAMA Cardiol headlined the term in an A-Fib and genetics article in 2019, Salem et al., here.

Phenome use frequency at PubMed. 2021 usage count was #917.  Shown.  Used as title word, #60 times.

Revisiting the Stormy and Controversial Legal Path to "Coverage with Evidence Development"

On January 11, 2022, CMS released a proposed decision on the class of present and future anti-amyloid Alzheimer drugs, allowing them to be covered only in a randomized clinical trial (entry point here).

This is called "CED" or "Coverage with Evidence Development."  Payment for services under CED, and the rules for when it is OK or not OK, are predicated on an obscure phrase in the Medicare statute that has become controversial from time to time.  

In fact, the Trump administration issued an order in January 2021 that CED, as currently used, was not legal under the statute.   This blog revisits some of the links.

  • See the five minute YouTube version of this article, here.


Typical Medicare Statute: Benefit at 1861, Restriction at 1862

Early in the Medicare statute, there is a phrase that says Medicare is a program for medical and other health services.   Then, further along, at SSA 1861, we find definitions (such as "physician") and this section includes a definition of what Congress means by "Medical and Other Health Services," placed at SSA 1861(s).  

The term means "physician services" (see definition of a physician!), "services incident to a physician," "diagnostic tests," and so on.   This goes on for 2000 words, and while some benefits are 3 words and some are 50 words, let's say the average is 15 words - that's 130 benefits, more or less.  For example, "physician services" are a two-word benefit, while an "oral drug used as anti cancer drug" is a 65 word benefit.  

OK, that defines benefits.  

What are the restrictions?  These are found at SSA 1862.   Most famously, see 1862(a)(1)(A), medical may not pay for services that are not reasonable and necessary to diagnose or treat disease.   So 1861 tells us that physician services, and diagnostic tests, and oral anti-cancer drugs (among many things) are Medicare program benefits, while 1862 tells us that payment is impossible if they are not reasonable and necessary.   

CED Justification Actually Found at 1862 - As a Restriction to Medicare

The justification to CED is actually found, not at 1861 (where clinical studies of AHRQ might have become a defined benefit) but at 1862 (where services not reasonable and necessary for AHRQ studies, are NOT a benefit.)

At 1862, we find the odd phrasing:

  • No payment may be made under Part A or B for any expenses for items and services {necessary for treatment of illness} {except for...}
  • (E) in the case of research conducted pursuant to SSA 1142, which not reasonable and necessary to carry out the purposes of that section.  

SSA 1842 is AHRQ law.

So when CMS says CED is justified by SSA 1862(a)(1)(E), what they are pointing to is a law that CMS cannot pay for services not fulfilling the goals of SSA 1142.  It never says that CMS "can" pay for services fulfilling the goals of SSA 1142.

So we can summarize how Section 1861 and 1862 work in this table:

Click to enlarge

But Wait, There's More: Confusing Adjacent Uses of "Reasonable and Necessary" Phrase

Notice that the term "reasonable and necessary" is being used in completely different ways.   In 1862(a)(1)(A), "reasonable and necessary" is in regard to human medical care for patients with diseases.   OK, we know what that means.   In 1862(a)(1)(E), "reasonable and necessary" is used in regard to "purposes of AHRQ research" which is a completely different domain or concept.  

While SSA 1142 is long, 1700 words, and the word "support" occurs 11 times, the top line purpose of AHRQ in this section of law is to "conduct and support research with respect to outcomes, effectiveness, and appropriateness of health care procedures."

What CMS Thinks (2014)

CMS, as an agency, believes it has broad authority through National Coverage Determinations, to issue coverage restricted to clinical trials, or registries, or other research pathways, as it sees fit.   CMS last elaborated on the legal status and implementation policy for CED in a long web article on the CMS website in 2014 - here.

What General Counsel at HHS Thought in January 2021

There have been multiple cycles of legal debates regarding what the CED law (e.g. the phrasing at 1861(a)(1)(E) pointing to SSA 1142) means.   Note that this section is phrased in the negative; CMS an't cover services not reasonable and necessary to treat disease, and can't cover services not necessary to support SSA 1142 aka AHRQ.  

January 2021.  In January 2021, the outgoing Trump administration posted a legal Advisory Opinion of General Counsel of HHS, at that time led by attorney and HHS Secretary Alex Azar.  While later deleted online by the Biden administration, a cloud copy is here.     This memo provides some behind-the-scenes insights.  For example, it says in the agency file (internal file) for each NCD with CED, there is an email or letter from AHRQ saying it "supports" the NCD.  

The key point is: Then-HHS General Counsel Robert Charrow opined that such a "note to file" is insufficient to meet the standards of "support" in its reasonable meaning in place in the legislation.   

(I would put it this way.  If we hear that, "NIH supports the Johns Hopkins Cancer Institute," you wouldn't expect that to mean solely that someone at NIH sent an email to Johns Hopkins, "Fine cancer center - keep it up" and thus "supporting" the cancer center.)

Lilly's Arguments Against CED - February 2022

In comments regarding the Aduhelm NCD in February 2022, Lilly provides several paragraphs of arguments on why CED is not legal, at page 5-6-7 of this comment document (here).  

Understanding New NCDs that Point to 1861(a)(1)(E)

This provides some background why all the CED NCDs, such as the Amyloid Drug NCD just proposed, carefully refer to 1861(a)(1)(E), and carefully cite AHRQ as an cooperating agency.   

The first point of this article is that CED is so debated, and requires pages of justification by CMS, because the statutory background is so weird and implicit.   Look: CMS never write a 20-page memo justifying if it can provide hospice benefits, because statute at 1861(dd) point-blank creates hospice benefits.  No such section at 1861 affirmatively creates AHRQ support.

My second contribution would be to point out that judging whether a service - like this pill here for John with this disease - is "reasonable" and is "necessary" to treat a disease is very different than asking whether something like "a clinical trial" is "reasonable" and "necessary" to support a goal of an abstract entity like an agency.  (Or at least, what an agency "wants" and "needs" and how it has a "goal" or "purpose" is abstract, in a way John on a certain day and in a certain medical office, and his cancer, and his pill are not.)


Other Notes

Book.  Twenty years ago, in 2000, National Academies of Science released a book on "Extending Medicare Reimbursement in Clinical Trials."  It's still online as a free PDF here.

Little-Known Payment Law.  MIPPA 2008 law added a clause to Medicare payment policy, at SSA 1833(w), allowing Medicare to alter payment rules in the context of clinical trials.  This has no implementing regulations or policies, and I'm not sure if it's ever been used (as a self implementing regulation) but the idea would be to adjust or change copays and payments to preservice blinding (masking) in RCTs that have double blinding.

"Reasonable and Necessary."  AT 1862, the phrase is used first in regard to health care and immediately later, in regard to goals of AHRQ.   Yet there must be a sea change in meaning between one phrase and the other of the identical twin usage.  For example, CMS defines "reasonable and necessary" as "not investigational," but everyone would define an RCT as "investigational."   CMS would never define a placebo as "necessary" to treat disease, but a placebo might be "necessary" toward a trial that is a research goal of AHRQ.  

CMS phrase, "Trials supported by NIH."  Charrow wanted to define "support" narrowly and CMS defines "support" broadly (e.g. AHRQ note to file stating "support.")   This broad definition at CMS becomes very helpful when we turn to CMS supporting (in CED) trials "supported" by NIH, since NIH wouldn't need to fund the trial, or mostly fund it, but only "support" the trial.  Charrow wanted to define "support" narrowly and CMS defines "support" broadly (e.g. AQRQ note to file stating "support.")   This broad definition is helpful when we turn to CMS paying for (in CED) trials "supported" by NIH, since NIH wouldn't need to fund the trial, or to mostly fund it, but only to  "support" the trial.   

What I think it all meant.  Clearly, Congress meant "something" by 1862(a)(1)(E).  I think they intended that AHRQ would plan trials that included routine clinical costs, experimental clinical costs, and administrative costs (which can be large).   CMS would pay routine clinical costs anyway.   1861+1862 allows CMS to pay necessary clinical costs that were beyond routine clinical costs.  AHRQ would still pay for administrative costs or other costs (e.g. AHRQ plans and "supports" the trial.)  As it is, CMS has pretty much unfettered CED at scale.   A CED trial with 10,000 patients and a $30,000 drug would involve $300M dollars (or $150M if discounted for half placebo).   An NIH trial at that scale would never exist but other large NIH trials would have enormous amount of vetting before NIH spent even $10M or $20M.   

1862(a)(1)(E) was Drafted to be Confusing.  The more times I re read 1862(a), the more the piled-up clauses and "except for's" and double negatives are confusing.  It would be simpler if 1861(s) had a written benefit for support of AHRQ trials, and then regulations and rulemaking as to what that means.

CMS Coverage in Clinical Trials - Dates to 1980.   See a fascinating 2017 paper by Roger Evans, who was involved in 1980 decisions about heart transplant policy.   I wrote about the era, informally, in a 2015 blog.

SCOTUS: Legislators Do Not Hide Major Principles.  I argue here that the CED law is, at best, murky.   There are long CMS arguments about if, when, or how it can do CED at all.  In contrast, there are no long murky arguments if CMS can offer hospice benefits, you just point at 1861(dd), or physician benefits (1861(s)(1)), or diagnostics (1861(s)(3)).   The current SCOTUS case about CMS requiring health system personnel vaccinations notes "We presume Congress does not hide fundamental details of a regulatory scheme in vague or ancillary provisions," Whitman v American Trucking, SCOTUS, 2001.


Charrow also wrote a book, Law in the Laboratory, 2010, here.

Wednesday, January 12, 2022

CMS NCD Proposal for ADUHELM; Will CMS Cover Larger Registry Trials if "Supported" by NIH?

On January 11, 2022, CMS released the proposed version of its much-debated NCD on amyloid-directed monoclonal drugs in Alzheimer's disease.

The event got widespread rapid news coverage as well as a CMS press release.  In short, both ADUHELM and future in-development Alzheimer monoclonals will be covered by CMS only in the limited and controlled setting of RCTs, and, "trials supported by NIH."  The latter may be an important clause, as I discuss below.   Comment is open 30 days and final decision (which may vary from this proposal) is expected April 11.

CMS press release here.

CMS NCD proposal and entry to comment portal, here.

Read the book, see the movie.  I've produced a brief two minute video about the decision, at YouTube, here.

Key Points of the Proposal

Trials under Coverage with Evidence Development must be randomized controlled trials reviewed and endorsed by CMS as meeting quality criteria, or, trials supported by NIH.   Trials must be hospital-based and must have populations similar to the  national demographics of Alzheimer's disease (in particular, adequate minority populations.)   Nothing written here limits the number or size of trials.   Each patient can get one amyloid PET scan (something which is not otherwise covered by CMS.)   After an RCT is run, the patients may continue on drug, with drug payment, in a long-term registry.  As written, the conditions apply to future Alzheimer monoclonals in the amyloid class, even if they might have stronger primary trial outcomes than existing drugs.   

At least some of the supported trials will overlap with FDA trials required by the accelerated approval.

Whether CMS can do "Coverage with Evidence Development" NCD's has sometimes been controversial; here.

"Supported by NIH" - Possibly, Potentially, Maybe Broader?

Here's one small twist, and it is ONLY hypothetical.  The language covers trials reviewed and endorsed by CMS, and, trials supported by NIH.   If you read the grammar carefully, it sounds like trials "supported by NIH" do not have to be entered into separate review by Medicare.   

Here's a theory, and it's only a theory, based on a close reading of the grammar.  There are over two dozen NIH supported Alzheimer Disease Research Centers, or ADRCs.   They often conduct trials partially supported by the core NIH grant funds (for management, databases, etc) and funded additionally by other sources (pharma, foundations, donors, etc).   Let's say a pharma runs a registry study at one of these centers, funding 90% of it, with part of the management funding attributed to the NIH grant.  This is a study supported (in part) by NIH, but might be more of the high-quality registry type, and since it is in part NIH supported, it seems to fall into a separate track from the RCT studies discussed in the NCD.  

Lots of Press

Within hours, there were countless articles about the policy proposal. 

  • NYT here
  • NPR here.
  • USA Today here.
  • AP here.   Fox here.
  • Axios here.
  • The Hill here.
  • Website "Being Patient," titled, "Why Everyone's Mad" here.
  • Flurry of coverage at STAT open access - here, here.  Subscription here, here, here.
  • Rachel Sachs covers the decision for Health Affairs here.
  • Excellent subscription article on trial design at Endpoints, here.
  • For more on Biogen's response, on January 13 at Endpoints, here.  BioPharmaDive here.

It's only a hypothetical, quote above, but to my eye, the grammar above separates trials "reviewed by CMS" and "meeting CMS criteria" from other trials - "or trials" supported by NIH.   


Nerd Note.

Billing, blinding.  As if this is the first "nerd note" in this blog.   CMS proposes randomized controlled trials, which are often blinded (doctor & patient), but how do you bill them?   Coverage with Evidence Development pays for "the drug."  It pays for "the treatment" under CED.   Do just half the patients get a copay?  How does the hospital bill for "the drug" in half the patients don't get the drug, but placebo?   Does CMS pay $14,000 for all patients, knowing that 50% got a $28,000 drug?  I think CMS has wrestled this bear to the ground before, but it's a gnarly one.   And the doctor's office, if an infusion, can't bill for the drug unless he buys and takes ownership of the drug, which may be true for the hospital as well.   And CMS isn't paying Biogen for the drug, presumably, it pays doctors and hospitals for drugs.   CMS has rarely done any placebo RCTs on drugs and even rarer, or never, so there are some pitfalls here to figure out.   CMS has the authority to alter payment systems used within clinical trials (with an eye to blinding etc), SSA 1833(w), but it still has to figure out HOW to do so.   This provision came from the MIPPA 2008 Section 184.  

CED policy.  Long 2014 CMS essay about the topic, here.   Short HHS Advisory Opinion in January 2021 (Trump Admin) that CED was illegal - later deleted by Biden - here.  Full article by me here.

Equity.  Even without considering the copay difference and "blinding," for the many minority or very poor patients, even $50 copays are too high, let alone the 20% or over $5000 copay for Aduhelm.  That is another barrier to entry for CED-based equitable enrollment.  STAT interviews experts on equity issues here.

Last Summer's Public Comments.  CMS took public comment on the plan to do an NCD of some kind, last summer.  CMS also hosted two audio sessions.  The transcript of one of the audio sessions is online at CMS here.   The other listening session seems to have resulted in no transcript.

Friday, January 7, 2022

Very Brief Blog: Yes, CMS Does Plan to Revisit "MCIT" Breakthrough Technology Policy

From August 2020 to December 2021, the Trump then Biden administrations put out successive comment rounds and rulemaking announcements about "MCIT," Medicare Coverage for Innovative Technology," which provided 4 years of coverage at Medicare after a device was cleared through the breakthrough pathway (whether specifically de novo, 510(k), or PMA).   The rule was finally canceled in November, see back story and links here.

However, the concept lives on as a section of the omnibus legislative package 21st Century Cures "Version 2022."   

Meanwhile, the Office of Regulatory Affairs in the White House has posted a notice of future (eventual) rulemaking on the topic.  The new policy, when it is finally crafted and proposed, will be retitled, "Transitional Coverage for Emerging Technologies."  We read, "This proposed rule would establish the criteria for an expedited coverage pathway to provide Medicare beneficiaries with faster access to innovative and beneficial technologies."  To be continued.

  • See the placeholder webpage here.  

This page will also list (via the "12866" link) any meetings held between public stakeholders (e.g. AdvaMed, etc) and the OMB.

click to enlarge

Thursday, January 6, 2022

Very Brief Blog: CMMI Grapples with "Direct Contracting" Messaging

Very early in the Biden Administration, HHS appointed long time Washington policy expert Liz Fowler as head of the Center for Innovation (CMMI) - here, here.   The potentially powerful CMMI program regularly announces a new strategic direction, most recently in October 2021 (here).   Current themes include "health equity," and "streamlining the number of CMMI models," and "encourage care delivery transformation."  They'd like to "use tools to support transformation" and achieve "high qualify, affordable, person-centered care."


I'm sensitive to whether in the lab industry we underestimate some of the underlying secular trends, such as telemedicine (Where do blood draws get taken?  Where do the samples go?) and surprise billing (new laws; but how do they change contracting for non-surprise-billing by shifting the landscape?)    While it's only a proposed model, it's seemed to me that the CMMI "Direct Contracting" models could also have rolling impacts on the lab industry.   

Despite all the other events - "January 6" and "Omicron" - direct contracting surfaces in the news this week.   See a detailed discussion at MedPageToday on January 4 by Joyce Frieden - here.  See long interview extracts online on January 3 at Advisory Board - here.   

Personalized Medicine at CMMI?

In its ten years, CMMI has generally not promoted particular technologies (like genetics) unless very broad (like telemedicine).   However, of note, the current Chief Medical Officer at CMMI is Dora Hughes MD - announcement from last summer, here.  Dr. Hughes worked for Senator Obama before 2012, and under Obama Secretary of Health Kathleen Sebelius.   She later had positions at the Sidley Austin law firm in its policy group, and then on the faculty at George Washington University. Recall that Obama had been interested in personalized medicine as early as his Senate career, and genomic medicine was a focus of then-VP Biden.

Very Brief Blog: Brookings Report on "Precision Medicine Through Agile Governance"

New report from Brookings to kick off January 2022, "Advancing precision medicine through agile governance."  Find it here:

There are three authors, Kevin Doxzen, Landry Signe', and Diana Bowman.  While applied to precision medicine, the work by Doxzen et al. tees off from previous writings by Landry Signe' on economics and agile governance in general - here.

If you like the topic of regulatory reform and agile governance, see also this paper:

  • Bridging the Gap: The critical role of regulatory affairs and clinical affairs in total product life in pathology imaging devices and software.  Kearney et al. (open accss) here.
  • Laboratory-developed tests in the new European Union 2017/746 regulation: opportunities and risks.  Vogeser et al. here.
  • Temporary regulatory deviations and the COVID PCR Labeling Update Study indicate what LDT regualtion by FDA could look like.   Marble et al. (open access) here.
  • National maintenance cost for precision diagnostics under VALID ACT of 2020.  Huang et al. here.

Very Brief Blog: Flagging a Great Article by Matthew Holt: Simple Bills Aren't Simple

Journalist and health policy expert Matthew Holt offers a detailed and well-researched blog on the theme,, "Simple Billing is Not So Simple."  

I regularly get YouTube ads for One Medical and similar organizations, "new medicine," "simple bills," "no confusion," and so on.   Holt tracked down all the paperwork (multiple levels and layers) behind his annual One Medical visit.  

  • It turns out that behind the scenes, there are still mountains of paperwork, obscure stacks of CPT codes, charge-to-payment ratios, allowed and disallowed costs, going on between One Medical and his BCBS insurer.

Loved it.

Find the article here:


If this is of interest, see my article about Medicare Advantage denial rates, especially for lab tests, yesterday, here.


See an interview with Liz Fowler, head of CMS Center for Innovation, "We are committed to moving away from fee for service."  But One Medical's interactions with BCBS have a completely old-school FFS infrastructure, as Holt shows.   See another interview where Fowler more or less agrees with real-world comments than a non-FFS, value-only system is still far in the future.   

Precision Diagnostics for Drug Selection: Context Counts

In one of my favorite articles of 2021, Adashek et al. pointed out that even with modern expansive genomic testing, most cancer patients do not have a precision-guided option (article here, Nature Cancer 2:369, 2021).   They don't have EGFR, don't have BRAF, don't have KRAS, etc.  Across the field of oncology, we need more precision medicine tests, and good ones, for more patients.  

Is it decisional?

Another topic is whether a precision diagnostic to guide therapy selection is strong enough to be decisional.  The classic example would be a population where 50% of patients respond to Drug A.  A company comes along with a new test, which effectively divides the population, by survival, on Kaplan-Meier curves, into a group with 40% response and 60% response (and p<.0001).   

The issue is, oncologists tell you that they will give drug A to any patient with a 40% or better chance of response.   So while Test A is a precision diagnostic, and has p<.0001, whether the patient is positive or negative on our Test A, he will still get Drug A just the same.  

A payor would say that Test A lacks clinical utility.  Investors upstream may have been impressed enough that the test segregates the Kaplan-Meier curve at p <.0001. 

Story so far: click to enlarge the figure below.

click to enlarge

There are two important points we can add, and pretty easily, to make the picture less grim for Company A.   Here they come.

#1 Context Matters

Let's introduce two drugs.   Drug A has an overall response rate of 50%, and Test A gives us populations with 40% or 60% response.  So far, an oncologist will give every patient Drug A, due to the 40% rule.

But now let's introduce Drug B.   Drug B is for the same patients, has a 50% response rate, and has no test.   In a world with no test for either drug, Drug A and Drug B are a toss-up, with 50% response rate for each.   In a world with Test A in use, some patients have a 60% chance of response with Drug A, so that's now better than Drug B.   And some other patients have only a 40% chance of response with Drug A, so now, for those patients, Drug B becomes the better choice.

So the value of "Test A" depends entirely on the context and the choice between Drug A and Drug B.

#2 Setting a Set Point:  Decision Theory; Vickers Papers

How do we make decisions which balance probabilistic pro's and con's?   For example, if it takes two negative breast or prostate biopsies to find one cancer, we will go ahead with the plan of care (triggered by mammography or PSA, for example).   But what if it takes 10 biopsies to find one cancer?   Or 25?  Or 50?   Or what if an intervening test (say, a multi-kallikrein test) lets us do 4 biopsies to find 1 cancer, but, by letting more men just go home, we catch a few less total cancers.   How do we draw the line? 

There are better ways than hunches, hand-waving, or guessing.

Clearly, it's a form of the number-need-to-treat problem, or here, the number-needed-to-test.  For me, I keep going back each year to a 2006 paper by Vickers and Elkin; Vickers is a statistician at Memorial Sloan-Kettering with a large body of work.   See, "Decision Curve Analysis: A Novel Method for Evaluating Prediction Models," Med Decis Making 26:565, 2006 - here.   The article models the outcomes with Treatment A with Treatment B (which might be no treatment) but can be adjusted for the expected results with and without Test A (meaning, does Test A move the needle enough to be better and different than not using Test A).

For more from Vickers, see also, "Method for evaluating prediction models," Trials 8:14, 2007 - here.  See also the MSKCC website for decision curve analysis resources - here.

MSKCC interactive website

Tuesday, January 4, 2022

New Study Documents Medicare Advantage Denial Rates, Causes of Denials

In the January 2022 issue of Health Affairs, Schwartz et al. study the rate of denials in Medicare Advantage, using Aetna data (most authors from CVS which acquired Aetna in November 2018).  Denial rates were only about 1% and 85% of Medicare Advantage denials were rooted in Medicare fee for service policies.  (Aetna can deny additional claims, when there is no Medicare policy to the contrary and when the service is deemed not beneficial by Aetna).   Here

Of additional interest, Exhibit 2 in Schwartz et al. shows that 80% of denials were due to "experimental" or "no proven efficacy" while 10% were denied due to lack of medical records.  Most of the remaining 10% were denied relative to some primary denial (e.g. if a surgery fee is not necessary, the anesthesia fee is not necessary).   

Exhibit 3 shows that laboratory service denials swamp out all other medical service areas, which are miniscule in comparison.  

Another interesting fact is that when there are Medicare Advantage denials for oncology or drugs or surgery, they are usually caused by Medicare Advantage rules.  (Gold bar longer than the very short green bar).  This is because FFS Medicare has few LCDs (or NCDs) on cancer care, or on other drugs, or surgeries.  

Click to enlarge.
For an article on rough-and-tumble  contracting amongst MA plans, here.