Thursday, September 30, 2021

Very Brief Blog: Finding Locally-Set Part B Prices; Noridian as Example

CMS sets national fee schedules for most drugs, DME, and physician services.   However, there are numerous codes that are "Status C" or "Contractor Priced."   

In my experience, for years, these locally prices often weren't published anywhere.  Now, they frequently are published.  Here are two examples.  

  • When the new Category I codes for the service provided by iRhythm were released in January 2021, they didn't have RVU values, meaning, they didn't have national prices.  
    • However, Wall Street analysts quickly tracked what their local prices were, because MACs (in this case Novitas) released them.   And then you'll find investor calls where iRhythm management talk about how they're working with Novitas, how Novitas might revise the locally-set payment, and so on.  (Entry point to the trade press, here.)
  • Beginning this year, the MolDx program places its locally-set prices on a special website called "DEX" Diagnostics Exchange, here.  Story here.  (This followed some policy debates whether locally-set fee schedules product prices for Medicare providers were available under FOIA or were a business secret of a MAC).   
Noridian as an Example

If you go to the Noridian MAC website, they've got a dedicated page for fee schedules, hre:

And they've got a special page for "contractor status" codes:

It looks like they provide one annual excel spreadsheet - by County in California - and PDF updates monthly or quarterly.  They include a range of Category III codes (which are almost never priced by CMS) and those Category I or numeric-series codes which aren't priced by CMS.

In the current CMS Part B code schedule, I see about 8000 priced codes (CMS status A) and 1000 unpriced codes (Status C), although that's an overcount because some of the C-codes are in pairs (technical, professional components).   

HeartFlow & Local Prices

Heartflow has CPT codes 0501T (comprehensive service), 0502T (data preparation), 0503T analysis with sophisticated mathematical model, 0504T (physician interpretation.)   In the hospital outpatient OPPS system, CMS does not assign OPPS prices (called APCs) for 0501T and 0504T because they contain, in part or in whole, a physician Part B service.  However, CMS assigned pricing to 0502T and 0503T in the OPPS system.  0503T, for 2022, is proposed in OPPS APC as APC 1511 and price $950.  0502T was reviewed for OPPS APC pricing but assigned status N.  (Final for CY2022 expected around November 1; proposed policies online here and at 86 FR 42018-42360 (August 4, 2021).

  • When the Heartflow code was new to the APC system, CMS initially priced it higher, $1500, based on some invoice data available at that time, prior to CMS access to hospital outpatient claims data.   

CMS nearly never assigns prices in Part B RVU units to Category III codes, and that's true for the national prices of the series (or lack of prices) for 501T-504T.   However, if you look at the Noridian files above, 0504T is assigned a price of $17 - physician's interpretation of Heartflow service.  At least so far, Noridian has not published any Part B prices for the other Heartflow codes 0501T-0503T.  

But the CMS PFS CY2022 rule does propose to deal with Heartflow codes in RVU's despite their Category III status.  See website here and at 86 FR 39104-39907 (July 23, 2021).   Therein, CMS proposed to create 2022 prices for Heartflow codes based on 2022 OPPS prices.   The comments website is here; 35,000 comments received.  

Regarding the use of APC pricing to set Part B RVUs, AMA RUC strongly opposed use of the Heartflow APC price in the Part B realm (with conversion to RVUs).   RUC cites to the Balanced Budget Act of 1997, requiring some simple rules for setting RVUs (must use generally accepted accounting principles for staff, equipment, supplies, etc).   "Use of the relatively of hospital charge data to determine the relativity of practice costs is not consistent with statutory provisions...".   But RUC does not mention, that a later law, PAMA Section 220 in 2014, gave CMS wide new authorities for where it could source data for setting RVUs.  Here, here.

In its comment, Heartflow did not object to APC pricing but used several facts to argue for a higher APC/PFS price ($1100 not $950).  Here.  Heartflow appears to have also submitted a data analysis by the consultancy Braid-Forbes on the nuances of this pricing.


Very Brief Blog; NGS MAC Releases New Draft Policy for Solid Tumors (DL37810)

See an update with link to a public meeting here.


The NGS MAC, which manages New York/New England as well as MN/WI/IL, has proposed a new LCD for "genomic sequence panels in the treatment of solid neoplasms."  It's policy DL37810 and under comment September 30-November 13.

Find the LCD here: 

The LCD  provides GSP coverage for advanced lung cancer and advanced colon cancer patients.  I find the policy a little confusing, since it seems to cover both codes 81445 (5-50 genes) and 81455 (51+genes) in the billing article.  But it predicates "medical necessity" on only 4-5 precisely named genes in each cancer (lung and colon) so it's unclear to me from the text when the patient's medical necessity (under the wording of the text) would require 51+ genes.  To be continued.


The NGS MAC is interesting from a genomics perspective.   They pay for a lot of national genomics services, but only under 2 codes, codes which are controlled by national NCDs (Foundation Medicine in Massachusetts and Exact Sciences Cologuard in Wisconsin).   Except for those two nationally controlled and very highly utilized molecular codes, billing for the rest of the whole range of molecular tests (e.g. codes 81162 to 81599) are far less utilized in NGS MAC states than the other states.  This doesn't mean NGS MAC patients get any less molecular testing, since genomic tests are often processed across state lines and they are billed where the lab is.  In addition, possibly more labs in these regions are hospital-based and don't show up in routine CMS Part B claims data.

Wednesday, September 29, 2021

Very Brief Blog; FDA Releases New Guidance for Risk/Benefit and for Real World Evidence

Endpoint news has an article noting that FDA just released 5 new guidance documents.  

Two are of major interest.   The first is a 23 page draft guidance on how FDA will frame its approach to risk/benefit assessments for drugs and biologicals.  Here.    The second is a 39 page draft guidance on how FDA will assess real world evidence, particularly, EHR data and payor medical claims data.  Here.

Both will have Federal Register announcements that give a specific 60-day time frame for comments and a comment channel (portal).   They'll come out September 30.   Risk Benefit here.  RWE here

Risk-benefit frameworks, of course, are also relevant to FDA approval of medical devices and diagnostics, and have analogies to medical benefit (risk/benefit) decisions at payors.

The risk benefit can be summed up in a short table (in an almost comically simple and short table...), although the point of the 23-page document is providing background to what this table really means.

Very Brief Blog: NYU Launches Master's in Health, Law, Strategy

Twenty years ago, for a master's degree related to healthcare, you largely had the choice of an MPH on the one hand, or an MBA with a healthcare (probably hospital) concentration on the other hand.  NYU has launched an innovative one-year Master's of Science in Health Law and Strategy.


In 2001, when I was doing a night school MBA  Northwestern, they had recently launch an innovative master's in biotechnology which including courses cross-listed with the B-School.  See today's collateral for the NWU program here.  (Similar programs in Boston at Northeastern and at Brandeis.)  Today ASU has a master's program tailored to the diagnostics branch of biotech, here.

NYU, where I was a med school professor 1994-1997, has just launched an innovative approach to a one-year master's degree for healthcare and life sciences. It's called Health Law and Strategy - home page here.  The goal is summed up in a quote from William Bernstein, 

“Healthcare today is like a Rubik's Cube—its aspects seemingly impossible to align. To imagine a future that isn't bound by conflicting financial incentives and regulatory schemes, tomorrow's leaders must not only study the past but master the strategy, law, policy, and technology that will enable them to innovate a different path.”

NYU's Wagner School of Public Affairs is rated #2 nationally for health policy and their law and business schools are also very strong, so they bring a lot of resources to the table.  See more about the interdisciplinary nature of the new program here.

The three semester program is summarized by titles as:

  • Semester 1: Analyzing Health Law, Strategy, and Economics
  • Semester 2: Navigating the Healthcare Landscape: Regulation, Policy, and Financing
  • Semester 3: Leading Technology, Innovation, and Integrated Solutions

Crossreference:  Gilfallin & Berwick's 2021 articles on business strategy, profit methods, and Medicare Advantage.  Follow up at Bloomberg, here.

New Health Policy institute at Stanford. Here.

FTI, a global economics consultancy, launches a new Health Policy vertical for applied economics.  Here.  The website leads to a 21 page capabilities brochure.

Sunday, September 26, 2021

Very Brief Blog: NYT Runs Several Articles on Payer Issues

 Briefly noted - 

  • On September 25, 2021, NYT runs a lead article on COVID test pricing, headline, "How a Law Allows Labs to Charge Any Price."  Here.
    • Many of the issue's in today NYT were in play in the media last summer.  
      • See my July 2021 blog collating articles and links on COVID test pricing, here.
    • For a March 7, 2021, NYT article also on COVID test pricing, here.
    • UPDATE:  After the September 25 NYT article, see also a September 30 article in KHN on "A Covid Test Costs More Than a Tesla."  Here.
  • On the issue of extreme surprise billing, NYT runs an article September 21 on a couple charged $257,000 for infant hospital fees as part of a dispute between the hospital and two insurers.  Here.

Friday, September 24, 2021

Michigan Medicaid Proposes Rules to Reimburse Whole Genome Sequencing

Tucked inside a presentation on September 13, 2021, by Illumina's CEO Francis deSouza, a remark that points to new genomic test coverage at Michigan MedicaidHere's the speech (at Morgan Stanley).

"We have teams that now have deep expertise and experience and tools in getting reimbursement.We saw that even recently where last week Michigan became the first state in the US to have Medicaid coverage for critically-ill children in the NICU for rapid whole genome sequencing. That work on a project called Project Baby Bear [a California Medicaid project for pediatric genomics] was something that we'd worked on for a couple of years to make that happen."

There's a story about Michigan Project Baby Deer (pediatric genomics) at the Rady Children's Institute Genomic Medicine website, here:

"On September 1, 2021, Michigan became the first state to make rapid Whole Genome Sequencing™ a covered benefit for eligible infants enrolled in Medicaid (contingent upon approval of a State Plan Amendment [SPA] by the Centers for Medicare & Medicaid Services).  Michigan Medicaid will reimburse hospitals for the cost of rWGS testing separate from inpatient DRG payments."

See the original Michigan policy document PDF, dated August 17, 2021, here:

See the PDF for inclusion and exclusion rules.  

See an NPR story on infant WGS, October 2019, here.  See a long-form story by Michele Marrill in Wired, March 2020, here.  See a story in MedPageToday, June 2021, here.

For more about the California "Baby Bear" clinical whole genome sequencing project, website at Rady, here.   For a peer-reviewed article on Project Baby Bear, July 2021, Amer J Hum Genet (Dimmock et al), here.  (I noticed this article is online at SciHub).  See also Rady authors at Franck et al., 2021, adoption barriers, here.    (But see Lantos op ed, here.)   For an archive of Grand Rounds videos from Rady, here.

In the U.S. Senate, S.2022 is one of several pieces of legislation in the past year to address increased coverage of urgent pediatric genomic tests in Medicaid.


On biomarkers more generally.  I'm not versed in the details, and legislation can be variably easy or hard to read, but this year Illinois passed a biomarker coverage law (see Genomeweb, August 2021, Turna Ray, here) and so did Louisiana.  In California a Biomarker Bill, SB-535, passed the assembly September 2 and the Senate September 7 - here.


See Rady's webpage for pediatric genomic projects by state.  California has had Baby Bear; Michigan, Baby Deer; Florida, Baby Manatee, and so on.

The Other Side of the 14 Day Rule: The 3 Day Rule (72 Hour, PreAdmission Rule)

There's a "14 Day Rule" that bundles genomic lab tests to inpatient stays for 14 days after discharge.  

Did you know there is also a "3 Day Window" Rule, that bundles lab tests to a DRG, for 3 days in advance of admission?


I wrote a blog explaining the 14 Day Rule for outpatient lab tests in 2015, which is still up - here.  The major update since then was a Fall 2017 rule, supposed to be effective January 2018, actually effective January 2020, that genomic tests should be billed by the lab that performed them for outpatient specifics in a 14 day window.  See CMS home page for 14 Day Rule here.

I'm gearing up to speak on a panel about the 14 Day Rule and lung cancer patients on October 14, 2021.  This is the Foundation for Lung Cancer, Go-2 Summit, CEnters of Excellence Summit.  Home page, agenda, and registration here.

14 Day Rule - Background

See 2015 blog for illustrations.  The starting point is that the date of service is the date of specimen collection (whether for hospital inpatient or hospital outpatient).  This remains the date of service UNLESS a test is ordered by the treating physician more than 14 days after discharge.   For an outpatient, the date of specimen collection and "date of discharge" are probably the same.   For an inpatient, the date of discharge might even be after the 14th day after the specimen collection.  

(For example, a patient is admitted for lung cancer surgery on July 1, has actual surgery on July 2, and is discharged on July 30.  The physician orders the genomic test on August 3.  The triggering date is a physician order 14 days after discharge (not 14 days after surgery), so the physician order must be August 14 or later to reassign the Date of Service, even though the surgery was July 2.)

New News: There's Also  3-Day, or 72-Hour Rule

Diagnostic test bundling also applies for 3 days PRIOR to a hospital admission.  I was aware of this but had never looked up the laws and regulations.   This "3-Day" or "72-hour" rule is complex in its own way.  The CMS term CMS to usually be, "3 Day Payment Window" which implicates this policy applied 3 days before a hospital admission and the start of a DRG payment.

(It's actually a "3 Day Non Payment Window"...)

72-hour bundling dates of pre-admission lab tests dates back decades, and was probably meant to cover routine pre-op tests (blood clotting, urinalysis, CBC).   The Claims Manual (link below) gives rules for claims processing era by era ("For Claims prior to January 1, 1990," we read.) 

But: The 3 Day Window was most recently adjusted by a 2010 law.  Not the ACA, but rather the “Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010,” Pub. L. 111-192.   This requires bundling of all diagnostic services provided 72 hours prior to admission, AND generally requires bundling of all non-diagnostic services EXCEPT IF the hospital can make an affirmative argument that the non-diagnostic services aren't related to the admission.   At the time, the rule was expected to save $4B over ten years (here).

However, this applies to the admitting hospital and any wholly-owned entity under it.  If I've read some explanatory articles correctly, if Entity A owns Hospital Y and MRI Center Z, then MRI's done at Center Z don't require bundling, because Z is not "wholly owned" by the admitting Hospital Y.   (That's my understanding from what I've read, but I'm not an attorney).

Rarely, 3-Day Window Could Make Genomic Tests Bundled?

One could imagine a setting where a hospital runs an on-site 300-gene tumor test on an outpatient July 1, and there'd admitted for a sudden worsening of their cancer on July 3, in which case the 72-hour rule might apply.   Interesting to know.   

Resources on the 3 Day Payment Window
  • The 2010 law is here, the bundling rule is at Section 102.  
  • The law is codified at SSA 1886(a)(4).  Here.
  • CMS isn't given much discretion, because the 72-hour pre-bundling is baked into the hospital payment statute.
  • Regulations are 42 CFR 412.2, here.
  • Manual instructions are at Inpatient Claims Manual, Ch 3, Section 40.3, here.
Further handy explanatory resources include:
  1. CMS FAQ on 72 Hour Rule here.
  2. CMS Home Page for 72 Hour Rule here.
  3. Original Implementing Memorandum here.
  4. Consulting firm Conduent discusses (Andrew Townsend) here.
  5. OIG report, 2020, claiming that CMS pays in appropriately for services that should be in the 72 hour bundle, here.

The MolDx "Minimal Residual Disease" LCD - Will It Appear Imminently?

In July, I published a blog on the progress and publication timelines of some major MolDx LCDs (blog here.)

One of the most highly-watched is the LCD for coverage of minimal residual disease testing in cancer - policy DL38779.   It was posted on the Medicare coverage database on September 24, 2020, and CMS instructions for LCDs require they be completed "within a rolling year of the posting date."   Hopefully, the final LCD will appear any day now.

It turns out, the "one year deadline" for LCDs is not to publish them (according to a MAC) but to finish them ("complete them") internally.   So for example, an LCD finished on September 15 might actually appear or be unveiled to the public on October 10 or 20.   Also, the instruction to complete "within a rolling year" is a guideline, and CMS can allow the MAC extra time upon request.  

Find the draft MRD LCD here:

Find the 365-day finalization rule here:


Nerd note.

The MolDx/Palmetto version of the draft LCD (DL38779) does not have an associated draft billing article.  However, the MolDx/Noridian version of the draft LCD (DL38814) does have a draft billing article which is (DA58454).

The draft article has just a few remarks, being:

MolDX may make available specific forms to assist with test Technical Assessments (TAs). Please follow the instructions on the MolDX website to assist with this process. If such forms are available that pertain to the test type in question, these forms are required for successful coverage determinations.

For patients with cancer, the unit of service for this type of test is 1.

For patients without cancer, testing may not be performed more than once in a month; schedules are set based on the validity established of the individual test.

Billable codes are 81445, 81450, and 81479; not 81455, because MolDx never uses 81455.

Thursday, September 23, 2021

An Early Application for AI: Flagging Slides for Priority Review

Even as AI moves ahead quickly, both in radiology and in pathology, the exact applications or use cases have been under development.  Do we use AI to confirm if a diagnosis is correct?  To provide a "second reading" of benign slides, as a backup?  Other uses?

One general use case that has emerged both in radiology and in pathology is pre-reading large numbers of tests (whether CT of the head or digital prostate slides) and flagging slides for priority review.  A couple of these applications in radiology have not only been FDA-approved, but have garnered extra Medicare inpatient payments (under the 3-year New Technology Add-on Payment rules).  See CMS NTAP for Avicenna.AI's CINA HEAD software for stroke (here).

Here we have the use case brought through FDA approval, and for pathology.  

PAIGE-AI garners FDA clearance for a tool to flag likely positives among prostate cancer biopsies, assuming the data is available as digital files.   The use case is clever because it provides clinical value (faster diagnosis for positive cases) while not directly affecting the pathologist's (or radiologist's) diagnosis, so it shouldn't create false negatives or false positives in actual sign-outs.  However, collateral data for PAIGE.AI suggested it increased actual (true positive) cancer diagnoses by 7%.

See the FDA press release here.  This was a De Novo clearance.  Typically, FDA posts clearance paperwork and reviews within a few weeks of a device approval.

See an article by Elise Reuter at MedCityNews here.

See home page for Paige.AI here.


Paige previously had FDA clearance for its full-slide imaging system, prior to the addition of the AI software.  Here; K201005, using 21 CFR 864.3700.

Wednesday, September 22, 2021

CMS Posts Final Gapfill Rates for CY2021 Codes Under Gapfill

CMS has published the final MAC Gapfill rates for CY2021, finalizing the MAC gapfill rates initially proposed in May 2021.

Find the rates on this webpage:

Scroll down to the header, GAPFILLING DETERMINATIONS, and see the file, "2021 CLFS Gapfill Final Determinations."   (I had to reload my screen a couple times for this to appear.)

To read about today's proposed CLFS prices for NEW codes, to be used in 2022, see here.

Initial Findings

There were 53 codes in the gapfill process.  By reference to tab 2, "Rationales," 20 of the 53 codes received pricing comments over the summer, because they have some kind of rationale remark in response.  

  • Four codes were revised at enough MACs to change the median rate calculation (0156U, 0165U, 0178U, 0219U).   
  • That's it.
  • All the other codes were not revised, suggesting that gapfill prices are pretty "locked in" when first published in May.
  • Most codes had no changes anywhere, despite CMS having logged comments.
  • One code had changes "at some MACs" but not enough to change the median.
CMS notes that two codes were transposed (0206U, 0207U). These are quite different, 206U being $2215 and 207U being $511.  However, both of them belong to the same lab and are closely related processes.

The 4 revised codes were...

0156U - SMASH, NY Genome Center, NGS cytogenomics, $1740.  Up from $597.
0165U - Verimap peanut allergy, $463.   Up from $218.
0178U - Other Verimap peanut allergy test, $459.   Up from $218.
0219U - Gene analysis of HIV, $725. Sentosa, Vela Dx.   Up from $386.  

Codes 0152U (Karius Test) had a price elevation in the NGS MAC states from $2126 to $2919, but because other states didn't change, the national median remained $2126. 

Gapfill Appeals

CMS states, "Once we post the final MAC-specific gapfilled amounts to our website, we accept reconsideration requests on the final gapfilled payment amounts for new and substantially revised test codes for 30 days."  

There isn't much published on this; you just write up your complaint and submit it to CMS promptly.  

Does CMS really change gapfill prices in October based on this "final gapfill price appeal?"  Yes, it happens maybe once a year.   But there's no public data for how many companies submit appeals, so there's no way to estimate the odds of success.

Can CMS lower your price, when you appeal for an increase at this point?  I can't think of a case where a gapfill price has dropped between the "final" September price and the end of the year, that can be attributed to a stakeholder appeal of the September price.  But I'm not sure that it's impossible, so one might consider losing ground during the final gapfill appeal as a low but nonzero risk.   

CMS initially said in the "comment rationales" that 0016U was priced as it was, because it was similar to "81452," a non-existent code (a typo), later revised to "81542," a prostate gene expression test.

Change Tally.

  12 codes - no change is warranted.
  1 code - "Similar to 81452" - and no change.  
13 codes - no change was warranted.
2 codes - transposed, but belonged to same owner (0206U, 0207U)
1 code - some MACs changes, but no median change (0152U)
4 codes - price changed.

13+2+1+4 = 13+7 = 20.

Meaningful changes = 4/20 commented = 20%.

Meaningful changes = 4/53 codes under gapfill = 8%.

Very Brief Blog: IQVIA Issues 71 Page 2021 Report on Digital Medicine

The consultancy IQVIA has released a 71-page new report on digital medicine trends in 2021 and outlook for 2022.  Find the report online here;

The online webpage also provides graphics and data for several of the key findings.

Earlier today, September 22, IQVIA held a one hour webinar which first summarized the report and then hosted a panel of experts.   It may be available on replay.   Try here.  Experts this morning included Meg Barron, VP of Digital Health Strategy for AMA, Jennifer Goldsack, CEO, Digital Medicine Society, Andy Molnar, CEO, Digital Therapeutics Alliance, Marc Sluijs, Digital Health Network.

Big News: CMS Posts Proposed Lab Prices for CY2022 New Codes

Update, for final November prices, here:




Every summer, CMS holds meetings on "how to price" new laboratory codes, and each September, CMS releases its actual proposed prices.  Those proposed prices are posted today.

CMS also issued final gapfill prices today, which I handle in a separate blog here.

How To Find the Prices

Here's the web page for lab pricing policy:

Scroll down to PAYMENT DETERMINATIONS and find, CY 2022 - Preliminary Payment Determinations.  CMS's excel spreadsheet will come inside a Zip file.

I've also put a Google Sheets version of the spreadsheet in an open access cloud file here.

Separately, on the web page for the lab pricing expert panel - the PAMA Advisory Panel on Clinical Diagnostic Laboratory Tests - CMS has posted the Panel recommendations they voted on July 28-29, 2021.  

Just scroll down for "Panel Recommendations"and find "Recommendations...July 28-29, 2021".  It's a fine-print 9-page PDF.  Highlights of the panel votes are also within column G of the proposed pricing spreadsheet.

"CMS Disagrees"

99 codes are being priced.  CMS flags where its pricing disagrees with the majority vote of the PAMA panel.  Using a quick tally with the "search word" function, I see 39 + 16 or 57 disagreements between CMS and the panel.  This is higher than typical.  Note that 39 are filed as "disagrees with panel" entirely, and 16 are filed as "agrees with MINORITY recommendation" of panel.  (Glass half full...)

In some cases CMS changes the crosswalk. For example, 860X2 (aquaphorin) was panel voted to 86146 $25, but CMS chose 83516 $11.   

Comment to October 21

The top line of the CMS excel spreadsheet informs us that comments will be accepted through October 21, 2021.   It's not unusual for a substantial number of codes to change prices between the September proposal and the November final listing.


Of 58 crosswalked codes, all but three were to single target  crosswalks.  Three were to a sum of 2 codes.  No fractions were used.

Only 3 of the 58 crosswalked codes was crosswalked to a PLA code target.  Two of these were crosswalked to 0001U, RBC epitope analysis by DNA (for rare blood group typing).  The third was crosswalked to 0120U, a Mayo RNA panel lymphoma test.

I tallied 40 gapfill codes; that's on par with last year (not far from half).

CMS lists only crosswalk code targets, not their prices or the proposed price.  You have to hunt and peck between this spreadsheet and the price list spreadsheet to dollarize the amounts.


Occasionally CMS posts updates and numeric error corrections so always check the original CMS websites.

G0327 - CMS had proposed to price G0327, a placeholder code for future tests screening colon cancer by liquid biopsy of blood.   CMS has simply deleted this code without comment.  Stakeholders had objected that the code had missed regulatory deadlines for inclusion and was no appropriate to crosswalk or gapfill, because no such tests have yet been released.

For the September 2019 release event, 9/27/2019, here.

For the September 2020 release event, 9/22/2020, here.  There were 132 agenda items.

Tuesday, September 21, 2021

New Review: How Fuzzy and Confusing are FDA Drug Decisions?

See a paper from Stanford with several FDA authors on how FDA makes decisions when the evidence is close.   The paper screens drug applications from 2013 to 2018, finding 912, of which 22 faced multiple review cycles including a flat-out initial denial.  

 The authors conclude that "the FDA has no mechanism to find, or tradition to cite, similar cases when weighing evidence."   They argue that FDA decision pathways and evidence standards were "highly variable."   

The authors argue that a better tradition of "case studies" and systematic approaches would enhance the transparency and reliability of these decisions.

Find the Janiaud paper here.  Find the op ed here.

Dr. Janiaud is at the Meta-Research Innovation Center at Stanford; Dr. Goodman is professor of epidemiology there.   Goodman and John Ioannidis co-led the MRIC.  Dr. Russek-Cohen is retired FDA; Dr. Irony is former FDA, now with Janssen.

Although it's a 2021 decision, outside their scope of 2013-2018 decisions, the authors make several references to the 2021 approval of aducanumab (Aduhelm).  There is also an op ed from Washington University's Joel Perlmutter, who resigned in June from the FDA neurology committee.

Very Brief Blog: Comment by October 15 on the Cancellation of Medicare "Breakthrough Coverage"

In January 2021, the Trump administration finalized regulations that would provide 4 years of Medicare coverage to new devices if they were approved by the FDA Breakthrough Pathway - here.  The title is, "Medicare Coverage for Innovative Technology," or MCIT.

After several intermediate steps, the Biden administration announced on September 13 it intends to entirely cancel the Breakthrough coverage regulations - here.

       (See a listing of all the regulatory steps - here.)

In order to comment the MCIT cancellation, go to this webpage:

Click in the blue box "COMMENT" in the upper left to register your comment.  Final date is October 15, 2021.


Note, the box in the upper right, "SUPPORT," is for technical support, not a button for making a PayPal donation to CMS or

Monday, September 20, 2021

In Memoriam: Dr. Charles Root, Founder of CodeMap

On September 15, 2021, Dr. Charles Root passed away.  He was well-known throughout the laboratory community for his wisdom and expertise.   

Dr. Root, whose original training was in nuclear physics, was a founder of CodeMap, which provides policy guidance, analytics, and consulting for the laboratory industry.

See the In Memorium announcement at CodeMap, here.   See the CodeMap home page, here.

Saturday, September 18, 2021

Very Brief Blog: Dr. Paul Gerrard Joins Veracyte as Medical Director, Managed Care

In an announcement posted on Link In (here), we learn that Dr. Paul Gerrard has joined Veracyte as the Medical Director for Managed Care.  

Dr. Gerrard previously served as a medical director for the MolDx program (here), and most recently, as a Vice President in the McDermott Plus consulting group affiliated with the McDermott Will & Emery law firm.

Online bio here.   Linked In here.  

In other news, Veracyte appointed Joshua Klopper MD as medical director of Endocrinology; he's been with both University of Colorado and Kaiser Permanente.  The executive medical director at Veracyte is Richard Klopper MD.

Friday, September 17, 2021

Very Very Brief Blog: Browse Comments on PFS Rule

Medicare published the proposed Physician Fee Schedule rule in July, with comments running to September 13.  Hot topics including valuation of AI services.

See the original rule here.

See and search the 35,000 comments receive  - here.  

CMS will publish the final rule circa November 1, effective January 1, 2022.


AdvaMed always has strong comment letters that explain the problem before providing alternative solutions.  That's true again this year. See the 25-page AdvaMed general comment on codes and valuations here, and the special 14-page comment on issues like self-referral, here.

See AMA RUC committee, here.  The AMA's 109-page letter is here.

See College of American Pathologists here.

Very Brief Blog: Harvard Course on Molecular Diagnostics in Cancer

This past week, Harvard Medical School and partners ran a four-day course on molecular diagnostics in cancer.   I haven't researched this extensively, but it appears the full syllabi (in numerous powerpoints) are posted, along with a video archive which states it's online for two weeks.

See the home page here:

click to enlarge

Click on each date row to unwind a listing of 8-10 powerpoints in PDF.  

Close to my heart, for example, on the fourth day, is a 20-slide deck by MGH's Dr Jochen Lennerz on reimbursement and regulatory issues.

Lennerz and team have just released an article on insights from COVID policy towards regulation of LDTs in the future (trade press here, article here.)   

Click on the "video library" bar to open a calendar of the video files.  The website remarks, "Access to the Video Library is available for 2 weeks after the end of the conference and will expire at 5:00pm Central on October 1, 2021."


For a 19-page,  2021 review of "clinical cancer genomic profiling," see Chackravarty & Solit, Nat Rev Genet, here.  The authors are at Memorial Sloan Kettering.

Very Brief Blog; HHS Releases Round 2 of Regulations on "Surprise Billing"

Last winter, Congress abruptly passed a Surprise Billing law, that will substantially regulate payments between insurers, patients, and out-of-network providers beginning in CY2022.  (Overview here.)

CMS issued the first round of implementing regulations for comment in July (here).  Article about the July rule here.  AHA letter on the initial surprise billing rule here.

On September 10, HHS released a second round of regulations, which appear to focus on topics like air ambulance, and ways that CMS itself can enforce surprise billing payment rules if states do not do so adequately.   It also addresses another corner of the law, in which consumers get transparency about how insurance brokers are compensated.

Press release here.

Regulation home page here.  Comment to October 18.

   (30 days comment; the earlier rule had 60 days.)

   PDF here (86 FR 71530, 9/16/21).

Air Ambulance fact sheet here.


In September 2020, CMS announced a program that was controlling payments for air ambulance billing and had saved $650M in 4 years (acronym RSNAT).  Here.

In the new press release, HHS notes that the air ambulance industry is highly consolidated.  You would expect that; you wouldn't expect multiple competing firms to each have little market shares and high costs while maintaining aircraft and pilots on-call 24/7.   

Thursday, September 16, 2021

Center for Medical Technology Policy to Close

 In a listserve marked, Update / For Immediate Release, the Center for Medical Technology Policy (CMPT) announces it will be closing in the near future.   

The change was announced by Donna Messner, PhD, the President and CEO of CMTP.  Advances in medical technology policy was a rarefied space 10-20 years ago, but now is "an active and vibrant space," including the federal PCORI (Patient-Centered Outcomes Research Institue), ICER (a high-visibility health outcomes institute), and others.  Messner holds a PhD in science and technology studies.

CMTP was founded by Dr. Sean Tunis 12 years ago.  Tunis had been Chief Medical Officer of CMS (2000-2005).   Tunis  has been a thought leader in evidence-based medicine and a prolific author (PubMed).

Find the CMTP website here.

Wednesday, September 15, 2021

Nerd Note: Lab Wins Legal Argument that LCDs Violate Statute; But Loses in Federal Appeals Court


Agendia Vs Azar; LCDs Ruled Invalid without notice & comment under APA; but Reversed at Appeals Court

Agendia, a molecular lab in California, has disputed denials of claims in 2012 and 2013 under an early MOLDX LCD and in a period when California was directly under Palmetto MAC LCDs.  

Agendia used constitutional arguments against LCDs.   They won at the federal court level in 2019 but the decision in their favor was reversed at the appeals level in July 2021.

Note - I am not an attorney and I am providing my best "English language" summary of the cases.


The case was delayed due to ALJ backlog from 2014 to 2018.  An ALJ supported payment in 2018, finding the claims were "reasonable and necessary" despite the position of the MAC and QIC.   But it didn't end there. 

The Department Appeals Council overruled, saying the ALJ in this case had not clearly explained why he was overriding the LCD. (The judge is supposed to "grant deference" to LCDs and MAC medical directors, although he has the right to do overrule them, with justification.)

Agendia appealed to federal district course.  HERE.   Agendia v Azar, 10/29/2019.   Agendia argued that 

  1. LCDs are an illegal delegation of responsibility from CMS to a private entity.  This is a constitutional issue, what the federal government can delegate.
  2. LCDs violate the Administrative Procedures Act.  This is a statutory issue.
  3. LCDs were arbitrary and capricious.  (Arbitrary is a judicial concept related to implementation of APA and other issues).
The district court ruled:

  1. LCDs are not an illegal delegation, as CMS continues to supervise MACs and LCD claim decisions can be overturned (even if "deference" is paid to the LCD) and LCDs can be invalidated under a beneficiary's LCD challenge.
  2. LCDs do violate the administrative procedures act.  They set operational CMS policy.  They may set CMS's initial policy.  Regardless of whether LCDs have a public comment period of sorts, there is no statutory basis for this to be different than APA notice and comment rulemaking.  (There IS, however, a separate statutory comment provided for NCDs.*)  
  3. The judge need not address #3 because he has decided the case on #2.
For a discussion of the above district court ruling, Baker Donelson, here.

The judge remanded back to CMS for Department Appeals Board review, but instead, CMS appealed the case in federal appeals court.  

A video hearing is online from January 16, 2021.   YouTube, HERE.  (Autotranscript, here.) The appeals case was decided on July 16, 2021.   It determined that the federal court decision was incorrect, e.g. LCDs do not violate the APA.   HERE.  The decision was that the LCDs "do not establish or change a substantive legal standard" and therefore did not implicate APA.  One judge dissented.


As discussed several times in the appellate case, the 21st Century Cures Act, which was passed in December 2016 before these cases, does create an explicit comment period framework for LCDs, so the 2019 judge's argument that there was no such explicit pathway, granted by Congress, separate from APA, would be moot today.


For a Reuters article on the Appeals court case, July 2021, here.   
See back story on a similar, but prior, legal case supported by California Clinical Lab Association - May 2015 here (and see links to prior stories in April 2014, July 2014).  The prior case was eventually halted for "lack of standing," so a judgement on the issues was not reached.  There was no question in the current case that Agendia, having submitted claims, had standing.


Separately, Agendia was involved in a corporate integrity agreement related to the 14 day rule - here.


There are indexes for ALJ decisions, MAC (Medicare Appeals Council) decisions, and DAB (Departmental Appeals Board) decisions (here), but I wasn't able to find either the original 2018 ALJ decision for Agendia nor the 2019 MAC decision rescinding it.  What are linked above are, the federal district court case and the subsequent federal appeals case. Along the way I found a new 2018 guideline for appointing ALJ judges (here).

* Since it is Congress that created the APA, it is Congress which can create alternatives to the APA for certain federal procedures, here, the NCD.

Tuesday, September 14, 2021

Very Brief Blog: CMS Blog on Plans for the MCIT, and Other Essays

 CMS has had several publications about innovation and new directions in the past few weeks.


There's yesterday's announcement CMS plans to cancel the MCIT, Medicare Coverage for New Technologies, which was developed under the Trump administration last fall.  Here.


On September 13, CMS revisited the MCIT topic in a long blog that parallels the release of the rulemaking.  Here.  Penned by Dr. Lee Fleischer, Chief Medical Officer.  

CMMI in Review

In August, CMS published a long blog at Health Affairs on CMMI, The First Ten Years.  Here.

CMS Administrator: Looking Ahead

September 9: Administrator Chiquita Brooks-LaSure pens an essay on her first several months and her outlook.  Here.

Monday, September 13, 2021

Flash: CMS Proposes to Cancel the MCIT Breakthrough Device Coverage Rule

CMS, under Biden, has now officially proposed cancellation of a suspended Trump administration rule.  The rule would have granted unconditional 4 year coverage to FDA breakthrough devices.  

See my four minute video on Youtube - Here:

See a November 2021 update here.


In September 2020, CMS proposed to create immediate and unconditional automatic coverage, for four years, for all FDA breakthrough devices.  This is the "Medicare Coverage of Innovative Devices" or MCIT rule.

The FDA BT pathway is a review pathway for devices that do not have an FDA predicate or are novel in some other promising way.  It is issued early in the review process for promising devices, and is not contingent on the actual final performance of the device after clinical studies and FDA final review.

At least several hundred devices have entered the FDA BT pathway in the past several years.

In January 2021, CMS under President Trump finalized the MCIT regulation.  However, in March 2021, the Biden administration delayed it til May.  In May, they delayed it again, until December.

On September 13, 2021, after market close, CMS released a proposed rule that would exist simply to reverse the prior finalized rule, and would cancel the MCIT regulation.   CMS explains that public comment led it to reconsider problems with the MCIT rule.  For example, CMS now believes the MCIT rule would have resulted in erroneous coverage of devices even if they had no evidence specifically in the Medicare population, or coverage of devices whose manufacturers fail to complete post-marketing studies.   

Rather than unilaterally "cancelling" the rule, CMS must administratively "propose to cancel" the rule, take public comment for 30 days, and then issue its final position.   But the net policy is simply to retract the prior MCIT regulation.  

CMS published a "typescript" or inspection copy on September 13, and a full typeset publication will appear in Federal Register on September 15.  Comment runs until about October 15.

The rule can be read at the link, see also commetns box til October 15.


CMS also released an essay on the MCIT topic which is penned by Dr. Lee Fleischer, Chief Medical Officer.  The main point is that MCIT is being canceled, but the general topic of adequate and timely coverage remains a priority of CMS administrators.


Coverage at Healthcare Dive here.  MHealthintelligence here.  AuntMinnie (radiology) here.  Fierce Healthcare here. Healthcare Finance News here.  RevCycleIntelligence here.  Update:  MedCity here.

 AdvaMed press release here.  AdvaMed notes a favorable OpEd by Dr Anand Shah, who has worked at both CMS and FDA, here.   Others, like Tuft University's health policy expert Peter Neumann, opposed MCIT, here.  Some payers were critical - here.

A Senate bill, S. 2416, introduced in 2019 and reintroduced in July 2021, asks CMS to accelerate coding and payment and coordinate better with FDA - here.  Senator Burr's press release here. Titled, "New Opportunities for Value to Extend Lives ("NOVEL") Act."  A different bill, HR4033, would specifically enforce coverage of breakthrough devices for 4 years through law, much as MCIT would have done (here).

Note, if you look up for example the definition of "reasonable and necessary" at 42 CFR 405.201, on October 15, 2021, at, it will show the legacy section, and it has three headers to the insertion, and postponement, of various pieces of text by the Biden and Trump administrations.  A bit comical but there it is.

See a news article, October 13, FDA gives breakthrough status to a Quanterix blood test for Alzheimer's and a Nonagen Bioscience test for bladder cancer.

Sunday, September 12, 2021

Very Brief Blog: Medicare Coverage Database Will be "Down" 9-17 to 9-19.

Next weekend, you might as well go to the beach or the hills.   The Medicare Coverage Database, a national library of MAC coverage articles and LCDs, plus NCDs, will be out for the weekend of September 17-19.   They will migrate to a new hosting environment, hopefully, one that is more amenable to covering innovative new technologies.

Friday, September 10, 2021

MolDx Posts Advisory Committee for Upper GI Cancer, October 12, 2021

MolDx has posted an announcement that it will hold a Contractor Advisory Committee on October 12, 2021 (2-4 ET, 11-2 PT).  Registration is open until October 11.  The conference is listen-only mode for the audience.

The meeting will discuss the clinical literature related to MolDX: Molecular Testing for Risk Stratification of Upper Gastrointestinal Cancer and rate their confidence in a series of key questions.

What they mean is, tests that risk-classify Barrett's Esophagus (dysplasia).  The key question is, "Is there sufficient data to use molecular testing to risk stratify patients with BE to low or high grade dysplasia?"  Historically, this was done by tiny biopsy samples and simply rating the tissue on H&E slide for dysplasia.

They also ask, does the test preclude the need for more invasive procedures?  And/or, can biomarkers be sampled by less invasive means than traditional endoscopic biopsy?

  • There's a recent open access review article by Grady et al., 2020, here.   
  • There's an open-access article on managing Barrett's by Kamboj , 2021, here.  (One author, Iyer, is also featured on the Cernostics web site here.)
  • There's a non-open-access review by Souza and Spechler, 2021, here.

The MolDx website is linked below, and the website includes additional documents like agenda and the complete text of key questions.  As well as registration.



I don't have a comprehensive roster of labs in this space but two with a focus on biomarkers in Barrett's would include Cernostics ("Tissue Cyper") and CDX ("WATS3D" testing).   Cernostics is backed by Pittsburgh/ UPMC (here).  

Unrelated to Barrett's, but also in the field of advanced pathology/immunohistochemistry, is ImmunoScore slide-based testing for colon cancer from HalioDx, recently acquired by Veracyte, in a circa $300M deal.  Their code 0X70U/0261U, was presented at the June 2021 CMS new test pricing meeting, with a request to crosswalk to 0108Ux1.2 (at $3015).   CMS will release pricing this fall.

For a July 2021 article by Liang et al. on digital pathology, here from the boutique consultancy Bionext.

The journal with the Grady review article mentioned above, published a long list of symposium articles on early detection of cancer with molecular testing in 2020 - here.  The articles spring from the 20 year NCI effort, Early Detection Research Network or NCI-EDRN. Overview of that, by Bast and Srivastava here.

On October 14, 2021, LUCID Diagnostics had an IPO raising $70M, trading on Nasdaq.  Lucid makes the "EsoGuard Esophageal DNA Test" and "EsoCheck" collection device.   EsoGuard DNA Test is an LDT.  A detailed S-1 financial plan is here.  I've clipped a few paragraphs from S-1 as a "Footnote."

On October 18, 2021, Castle Bioscience acquires Cernostics ("Barrett TissueCypher") for $80M.

The meeting was originally posted at least as early as September 10; I note on September 27 the webpage says "Updated September 27" but it's unclear what the update is.


Footnote - From LUCID S-1, IPO prospectus

We are a commercial-stage medical diagnostics technology company focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (EAC).

We believe that our lead products, the EsoGuard® Esophageal DNA Test performed on samples collected with the EsoCheck® Esophageal Cell Collection Device, constitute the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent EAC deaths, through early detection of esophageal precancer in at-risk GERD patients. The technologies were highlighted in the NCI’s Annual Plan and Budget Proposal for FY2020 to Congress as one of the year’s significant advances in cancer prevention. We believe EsoGuard could have as great an impact in preventing EAC deaths as widespread Pap test screening has had in preventing cervical cancer deaths.

We were formed in May 2018 as a subsidiary of our parent company, PAVmed Inc. (Nasdaq: PAVM), to license the technologies underlying EsoGuard and EsoCheck from Case Western Reserve University (CWRU). [....]

In just over three years since our inception, we have advanced the technologies underlying EsoGuard and EsoCheck from the academic research laboratory to commercial products within scalable business model. EsoGuard is commercialized in the U.S. as a Laboratory Developed Test (LDT) and was granted final Medicare payment determination of $1,938.01, effective January 1, 2021. EsoCheck is commercialized in the U.S. as a 510(k)-cleared esophageal cell collection device. EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device designation and is the subject of two large, actively enrolling, international multicenter PMA clinical trials.

We are proceeding with this offering and transitioning to a public company to drive a growth strategy focused on expanding commercialization across multiple channels, including expanding the number of our own testing centers, and expanding the clinical evidence of our products’ efficacy to support our ongoing regulatory, reimbursement and commercial efforts, as well as recommendation of our products in clinical practice guidelines.