Thursday, July 29, 2021

CMS Prematurely Proposed Pricing for Colon Cancer LBx Screening Tests; Likely to Back Down

In January 2021, CMS established a creative national policy for coverage of FDA-approved, liquid biopsy colon cancer screening tests.  They will be covered every 3 years for patients 50-85 years old, if the test is 74% sensitive and 90% specific.  The quirk is, no such FDA-approved test exists yet. 

In May 2021, surprising many stakeholders, CMS created a new G-code, G0327, to describe liquid biopsy tests under the NCD.   (See CR12280, 5/20/2021, here.)  In late June 2021, CMS surprised stakeholders even more by suddenly adding the code to the summer lab test pricing process as a revised, 100th agenda item (agenda here).  At the June 24 public meeting, there were verbal comments that trying to price this code (for hypothetical future tests) was a bad idea, and after the meeting, many stakeholders submitted their written concerns to CMS.

At the July 29 meeting of CMS's professional advisory panel for lab tests, CMS introduced G0327 as an agenda item, but also stated, G0327 was likely to be removed from consideration this year, as there is no predicate or index test to be used to evaluated crosswalks or required resources. CMS used this slide during the webinar:

click to enlarge
Problems include:
  • G0327 was introduced to the agenda just before the June 24 meeting, but regulations require 30 days public notice.
  • CMS has no information to set the rate.
  • There may be substantial variability among future tests.
  • Some of the future tests, when created, may be priced by ADLT methods.
  • There's lack of clarity as to the scope of G0327.
  • CMS crosswalks tests to "comparable" tests but here, there's no index test against which to match a "comparable" test.  No FDA-approved test with the future required labeling exists.
  • CMS can't gapfill the code either, as MACs will have no comparable tests, no resources, no methods, no prices or charges to use in the gapfill pricing process.
Commenting groups included AdvaMed, AMP, BloodPac, 21st Century Coalition, Guardant, POC Test Association, Bruce Quinn Associates LLC, and others.

I've uploaded an auto-transcript of today's CMS comments on G0327 - here.   I would add, I would think, CMS would set this code as status "N" not payable since no tests are yet authorized under the NCD the code applies to.

CMS has created codes for NCDs before, that weren't actually used.  In creating an NCD for amyloid PET scans in September 2013, and created a generic A9599 code for amyloid PET scan tracers.  However, it deleted this generic code, which was never priced, when specific codes for specific tracers began to appear (e.g. A9586, florbetapir, Amyvid.)  


Tuesday, July 27, 2021

Very Brief Blog: Lawsuits, Associations Go After "Gouging" on COVID Test Prices

Update August 25.  While continuing to emphasized I have no "right" or "wrong" in this story, and just providing links, two updates.

NYT covers the topic on September 25 - here.   

GS Labs countersues Blues plan, August 5, here.

Update, GS Labs sues MN plan, November 1, here.

Original July 27 blog...


In legislation in spring 2020, Congress required COVID testing to be covered without a copay, and set the price as the lab's public price on its website.   HHS reminded payors of their obligations in a June 9 announcement - here.

But from the payor side, incoming missiles.  See an article July 26 at MedCityNews about a BCBS plan suing a test provider over "price gouging."  Here.  They also posted the 29-page legal document here.  BCBS press release here.

See also AHIP, the payors' trade association.   See their price release about COVID test pricing and exceptional (high) pricing - here.  It's paired with a 3-page infographic, here.

News stories about the lab date back to 12/2020 (here).

Friday, July 23, 2021

Fun Fact: Medicare Coverage Excluded If Act of War

 Someone was asking about Medicare exclusions from coverage (eyeglasses: excluded; dental: excluded). 

Another one is exclusion of Medicare payment for medical services required "as a result of war or act of war."

So it seems if we had a continental war here, and there were 2 million Medicare age people injured, they wouldn't have health insurance.   Whether this type of exclusion might be found in commercial plans; I don't know.

SSA 1862(a)(5)

Very Brief Blog; CMS Posts Agenda for July 28-29 Lab Expert Pricing Meeting

Find an unofficial 140-page transcript of the two-day meeting here.

I apologize that Hour 2 and Hour 3 of Morning 1 are missing from the transcript.

CMS should post voting scores by mid-August, I think.


Every summer, CMS has meetings to assist the agency in pricing new lab codes for the subsequent January.   CMS held a public comment meeting in June, and will hold an expert panel advisory meeting on July 28-29, 2021, which will be viewable by Zoom.

The agenda has been posted here:

The meeting is scheduled to run from 9 am to 430 pm on Wednesday, July 28 and Thursday, July 29.  Based on past experience, the time alloted to any given code can very unpredictably and by large amounts.  CMS posts a planned agenda in 2-hour increments and published a panel item list of 101 items.

The panel has about a dozen members and is divided into four subgroups A,B,C,D, each of which reports on detail on about 25 codes, although all the panelists vote on all the codes.  I am guessing that each panels understands his/her set of 25 codes and the pricing alternatives quite well, but deals with the other 75 codes mostly by the agenda-item presentation of each code and recommendation by its workgroup.  The public doesn't have any comment rights but panelists may ask a code sponsor for a clarifying answer.

CMS often takes the panel decision, or at least considers it, but the panel is only "advisory" to CMS.  CNS has been classifying nearly half the codes as "gapfill" in the past couple years, meaning the pricing decision is left to MACs in the following calendar year.


On a personal note, a code I am involved with as a consultant was in the first ten items in June, but is in the last ten items this time around.

Very Brief Blog: AMA Releases New Cat III Codes

 AMA releases the text of new Category III codes six months before the codes are active.  

Accordingly, AMA releases text of codes approved in May 2021 and active January 2022.   Find the Cat III descriptors here:

AMA home page for the topic here.

AMA Posts Home Page for Fall CPT Meeting; Release Lab Codes for Comment (JULY 23)

AMA holds CPT meetings in February, May, and October, and for each meeting it creates a new home page which holds agendas and other key documents, as well as a registration link. 

  • Virtual registration is open to 9/24.  
  • In person registration requires proof of vaccination and closes 9/13.  
  • This fall, on site registration will not be possible.*

The webpage for the September 30-October meeting has been created.  It will be a virtual & in-person meeting (hybrid).  For 18 months, all meetings have been virtual-only.

AMA releases lab codes earlier than other codes, to get a head start on public comments prior to the internal workgroup meetings for lab codes.   The Lab public agenda has been released:

A cloud archive copy of the July 16 agenda with 8 lab codes, is here.

There are 8 code agenda items.  You must request a code change review packet by July 23 (sorry, today), and submit it by July 30.

The 8 lab code topics are cutaneous melanoma; macular degeneration; Coenzyme Q test; gadolinium test; GSP code for bone marrow failure (814XX, separate from 81450, hematopoietic cancer), codes related to in vivo embryo culture; GSP code for drug metabolism (possibly a large panel of PGx codes?), and code for TPMT enzyme activity.


AMA also released the July crop of PLA code applications for comment a week or two ago, here.


* I believe at past in person meetings, registration "closed" several days ahead of the meeting, but on site registration was also possible.

Very Brief Blog: New ACMG Guidance for Gene Lists in Carrier Screening

A few weeks ago, I highlighted new guidelines from ACMG on exome/genome screening in pediatrics (here).  

This week, ACMG has updated carrier screening guidelines for recessive- and X-linked conditions.   

  • See the open-access guideline (practice resource) from ACMG here.
    • Gregg et al, 2021: "Screening for autosomal recessive and X-linked conditions during pregnancy and preconception: a practice resource of the American College of Medical Genetics and Genomics" 
    • "ACMG has now created a set of 113 genes, both autosomal recessive and X-linked, that should be considered as a standard offering to preconception and prenatal patients."
  • See coverage at Genomeweb here.
  • See press release here.

While googling this, I ran across a publicly available "Clinical Appropriateness Guideline" (22p) for "Genetic Testing for Reproductive Carrier Screening," here, from AIM Specialty Health.  It has an effective date of 9/6/2021.  For example, it lists 9 genes for Ashkenazi screening (p. 4).  

Monday, July 19, 2021

CMS Releases Hospital Outpatient Proposed Rule for CY2022; Proposes $2M Fines

On July 19, 2021, after market close, CMS released the annual proposed Outpatient Rule (OPPS Rule) for CY2022.  Comment period will run for 60 days.

  • See press release here.
  • See Fact Sheet here.
  • See the Federal Register page here.
  • See the early or "typescript" version here.
    • Clocks in at 863 pages.
  • Importantly, see the Related Files page (Excel spreadsheets of prices, etc), here.
  • Early trade press at Healthcare Dive here.
  • Deep dive by Thomas Sullivan at "Policy & Medicine," here.
$2M Penalty Linked to Price Transparency

Consonant with recent reports that only a few percent of hospitals are following January 2021 price transparency regulations from the Trump Administration (here), the Biden administration is proposing to raise penalties to between $100,000 and $2M dollars per year, depending on hospital size by bed-count.  The price transparency rule has triggered lawsuits (here) and confusion (here).

There's a humorous section around 751-752 on ways some hospitals have hidden or blocked access to the required machine-readable pricing files.  See an article on hospitals in the 5% who complied, here.

Re-use CY2019 Data

Generally, CMS uses (re-uses) CY2019 claims data for CY2022 prices, due to the abnormal nature of the CY2020 Covid year.

Two Trump-Biden Reversals (Inpatient Only List, ASC List)

The Trump administration had proposed to drop an inpatient-only list of procedures (e.g. nonpayable in hospital outpatient setting), but the Biden administration wants to keep it for "patient safety."   Along the same Trump/Biden vein, CMS  had recently revised criteria for ASC (ambulatory surgical center) procedures, but will flip back to the older criteria.  "CMS proposes to remove 258 of the 269 ASC procedures" that were added last year under DJT.

Special Payment for Non-Opioid Analgesics 

Two non-opioid analgesics, Exparel and Omidria, are paid for separately in the ASC setting rather than packaged, due to SUPPORT Act 6082(a), see 1833(5)(22)(A) (text here).   There's a fairly complex discussion of this topic that I haven't fully absorbed yet.   Typescript version of rule, see p 64-84.


Although not directly related to the price transparency rules discussed here, there's another topic on transparency and access.  Beginning April 5, 2021, providers are supposed to open EMR information so that "patients [have] access without charge to all the health information in their electronic medical records 'without delay.'  "    Obviously this creates tension between providing access "without delay" and the need for elaborate controls to prevent hoaxing or phishing, even more complex when patients have limited computer literacy, have conservators or guardians, etc.   One entry point here, another here.  This is called the "Information Blocking Rule" (hence the verbal connection to the outpatient price transparency issue noted earlier) but it is actually an "information UN-blocking" rule.

Calendar Watch: MolDx LCDs for LBx MRD, and Hereditary Risk Genes


MolDx has had several very high-visibility LCDs recently, and I'll summarize quickly here.

Transplant Liquid Biopsy - Finalized in June

MoLDx brought out a general purpose LCD for the use of liquid biopsy (e.g. circulating donor DNA) in transplant management.  LCD L38568 was finalized in April, and became effective on June 5, 2021. Here.

Tumor Liquid Biopsy for Recurrence, Response - Waiting for September 23

MoLDx has a very important draft LCD for minimal disease detection, by liquid biopsy, in cancer.  It will cover both solid tumors and hematopoietic tumors, and use cases for both recurrence monitoring and for treatment response monitoring.  The comment period opened on September 24, 2020, so I believe the final must be issued online by September 23, 2021.  Read the draft DL38779 here.

Note this is a separate LCD from the one for detection of oncogene, driver genes, CDx genes by Lbx.

Hereditary Risk Genetic Testing - Comment Period Extended to July 31

This summer, MolDx proposed an unusual and far-reaching LCD for all types of inherited cancer syndrome genetic testing.   Coverage for specific genes and diseases would be specified by later articles released by the MAC on a rolling basis at its discretion.  The comment period has been EXTENDED by popular demand and runs to July 31, 2021.  Here.  DL38966.  MolDx remarks, "The extension is at the request of the provider community to allow additional time to gather and submit comments."

The MolDx (Palmetto) LCD home page is here.

Very Brief Blog: AMA Releases New Crop of PLA Code Applications

Every quarter, AMA accepts PLA code applications and posts them for public comment.  

Find the AMA PLA home page here.  Find the code candidates submitted for this quarter's review, here.

According to a separate AMA  calendar, codes were posted July 15 and parties can request permission to comment til July 22.

I tally about 30 code applications.  One is an edit, transferring ownership of a melanoma test from Myriad to Castle Biosciences.  There is a deletion request for the Veracyte Afirma MTC classifier for thyroid cancer.

Praxis Genomics applies for some elaborate CGP tumor codes, such as genomic analysis of tumor vs germline, plus optical genome mapping, plus other testing. 

Sunday, July 18, 2021

In the News Again: Part B Drug Pricing and Drug Packaging, Wastage

For many years CMS has paid for "drug wastage," for example, if a physician opens a one-time-use 20 mg vial, gives a patient 17 mg, then the other 3 mg can be billed as wastage (Parman, 2016 here).   For a 2016 review by Bach and colleagues in BMJ, here.

In a new article in Health Affairs, July 9, 2021, Peter Bach revisits this while reviewing a recent report by the National Academy of Medicine on drug wastage (here).   

His main reference point is a 173-page report released by National Academies in February 2021 which got less attention at that time (Capitol riots, COVID third wave, inauguration) - here, here.  

CMS had posted its own review of drug wastage 2017-2019 a few weeks earlier, in December 2020 here.   


AMA Publishes Report on Legacy of "White Men," Need for Racial Equity

Update 11/2021.  In the fall, AMA released "Guide to Language, Narrative, and Concepts."

Blog discusses here (n.b., takes contrary stance)

See also 10/2021:

And 10/2021, "How color-blind policies exacerbate black-white inequities," Ann. Intern. Med.

See a cluster of articles in JAMA in November 2021:

AHRQ: Racism methods report, Lin et al., here.  USPSTF racism overview report here.  (See also, social risk AHRQ report, Davidson, here.  AHRQ gender report here.)  Esslen, pharmacoequity here. Lyles, digital health equity here.  


This [July 2021] weekend, the Los Angeles Times carries feature articles on the "medical cartel," including a lead Sunday front page story here and a document archive to go with it, here.

Meanwhile, AMA releases an 86-page report as an "organization strategic plan" for Racial Justice.  Find the PDF report here.   Press release here.  See also op ed by AMA President Dr Harmon here.  Update - the August 17 issue of JAMA was dedicated entirely to racial equity issues (here).

The AMA report notes that both race and ethnicity have been categories based on "financial and self-interests of white men."  It notes that while these white-men driven categories have included "races," in contrast there is not "enough genetic variability among its populations to justify either the identification of geographically based races."  Rather, references to race in healthcare have been "used to legitimize the preferential treatment of whites over others"   Particularly, "definitions of race differ depending on context, but they always operate in the service and self-interests of social-dominance hierarchies, thus benefitting white individuals."  The system normalizes white, hetero, Christian people at the expense of others (p. 11).  Adding that the "direction forward requires us to gain the knowledge...[acknowledging structures] rooted in white patriarchy."  And adding by quotation, "Our nation’s investment in racism, capitalism, and white supremacy shredded our safety net."   

From page 25, the document turns to specific racist activities of the AMA from the 1800's forward through the 1960s and 1970s.  In the Native American section, the report notes that as recently as 1990, the AMA urged state medical associations to protect the "medical interests" of patients against harm by "inappropriate religious treatment,"  which could "undermine the legitimacy" of "native healers."  The AMA derided Asian health practices as "barbaric and cruel."  AMA insistence on Western medical practices "furthered the overall goal of eliminating indigenous cultures."  

Many of the themes echo those of Dr. Camara Jones in her 2018 essay describing issues arising as president of the American Public Health Association (2015-2016; article here; Jones is cited 22 times in the AMA review).


For an AMA review of a new book written "by physicians" about problems with care provided by nurse practitioners and physician assistants, here.


See also in precision medicine; Genomeweb article June 8, 2021, on "systemic rational inequities in lung cancer biomarker testing; here.  In addition to gene testing, clinical trial participation was 2X higher in the white population (though only reaching 4%).  

See also:  Goodman & Brett (2021) Race and Pharmacogenomics - personalized medicine or misguided practice?  JAMA 325:625-6.   Comment at Wolters-Kluwer by Streetman, here.



Wednesday, July 14, 2021

How to Comment on the CURES 2.0 Bill - Through July 16

 In mid-June, legislators released a draft version of 21st CENTURY CURES VERSION 2.0, for public comment.

See the original blog here, with multiple links:

Here's a late update - how to comment on the legislation:   

Please send feedback/comments 

to by July 16. 

Tuesday, July 13, 2021

CMS Issues Physician Policy Rule Proposals for 2022 (PFS), Sets Dr. Meena Seshamani as Center for Medicare Director

Dr. Meena Seshamani

First, let me catch up on a CMS press release from a few days ago.  CMS is the Centers for Medicare and Medicaid; thus, it has internal directors for Medicare and for Medicaid.  CMS has announced the new Director of the Center for Medicare is Dr. Meena Seshamani.   Press release here.   She has an MD/PhD, the PhD being in Health Economics from Oxford.  She's an otolaryngologist trained at Hopkins.

PFS Rule for CY2022

With a triplet of press releases, CMS releases proposed Physician Fee Schedule and other outpatient proposals for CY2022.  This kicks off a 60 day comment period.   

  • Press release here.
  • Fact sheet here.
    • The fact sheet weighs in at 6500 words, which may be a record.
    • For me it prints as 17pp.
  • Special fact sheet about Diabetes Prevention Model (MDPP) here.
  • There's also a separate 21-page PDF fact sheet for quality measurement program changes, here.
  • Rulemaking permalink here.
  • Published version July 23, 2021, 86 FR 39104, 804pp.
    • Link here.  It's an awesome 60mb this year.  And locked (no highlighting)
    • I've made a version which is 30mb and unlocked (allows notes and highlighting), in the cloud here.
  • Inspection copy aka typescript version here.
    • It's an imposing 1747 pages long.

Telemed Liberalization

See early coverage of telemed liberalization proposals, here.   See the Center for Connected Health Policy (CCHP) 7-page fact sheet here and 13-page slide deck here and 19-minute YouTube here.

See a full review of virtual medicine provisions by McDermott Will & Emery, here. See an update on finicky RPM rules through 12/2021, by Foley Lardner, here.  

Extensive Discussion of AI Pricing, e.g. AI-retina or Heartflow

Extensive discussion of RVU pricing for software and AI/ML, such as for AI-retinal diagnostics or for the Heartflow fractional flow reserve Category III code.  P. 39123-6. version.  References RAND studies of how to update the RVU/PE system.  Note that CMS held a workshop on this topic earlier this summer

In contrast, there's no proposed national price for iRhythm. Discussion at 39178. (However at 39169ff they do tweak RVUs for similar remote cardio codes code 93228/29).  

See new codes for "remote therapeutic monitoring" RTM page 30183ff (989X1 ff).  This is a new code set different than, but echoing, "remote physiological monitoring" RPM.

Quite interesting, they propose new regulations for IDTFs that perform computer analysis primarily, rather than patient facing services like x-rays.   IDTF regulations require patient friendly signage, perhaps even bathrooms, things irrelevant to companies like Heartflow or iRhythm.  CMS proposes to update IDTF rules for for computer-modeling-focused IDTFs.   39313.

Ejection from Program

CMS has regulations allowing it to revoke participation from abusive-billing providers.  They want to revise the rules that even a short period of severe abuse could result in revocation.  (For example, a lab submits $1000 of normal claims January-June and submits $10M of fraudulent claims in July).  P. 39311ff.

Regulations for Documentation During Review - MACs, RACs, Etc.

CMS has authority to collect medical records for payment review at 1833(e) but proposed a set of regulations to implement this historical authority.  Page 39314ff.  Revising 42 CFR 424.535ff.  They don't say very much; they just say MACs and others can do this, can use certain dates, can allow certain exceptions.

Lab Note

CMS has varied lab blood specimen collection fees between $3 and $25 (COVID), and asks what long-term policy should be.  Submit your comments.

AMA has replaced longstanding codes for pathology consultations (80500, 80502) with four codes.  CMS carefully reviews pricing issues to set RVU units.  39167ff.  Also, the RUC included microscope time, but CMS doubtful that is part of clinical pathology consultations.  (See, in contrast, a different code range for consultation on slides prepared elsewhere, 88321, 88323).  

In quality measures, CMS will delete C.7, Myelodysplastic syndrome & leukemia, cytogenetic testing performed on bone marrow.  39786.   It's listed as "no longer maintained" by the measure steward, American Society of Hematology.  I haven't looked up the affiliated CPT codes, but would just note this has been a huge area of technological innovation, from conventional cytogenetics (light microscope) in the 1970s/80s, to FISH, to microarrays, to low-coverage NGS (new CPT code created), to optical genome mapping (see Genomeweb this week here and Mendelspod this week here.)

NCD Death Watch

CMS has a process for deleting outdated and obsolete NCDs.  Circa 10 were on the list last year, although a number of those weren't actually deleted due to public comment.   

This year 2 are proposed for deleted, a DME NCD for parenteral nutrition and an NCD that controls use of PET scans outside of oncology.  39255ff.  Oncologic PET scans would continue under fairly broad NCDs, but a historical ban on local LCDs for non-oncologic indications will be lifted.  Some miscellaneous one-off specified non-oncology PET NCDs will remain, if they've already been written, like one that blocks brain amyloid PET scans except in approved clinical trials, and one that blocks sodium fluoride PET scans.


CMS established a Medicare benefit for diabetes prevention programs several years ago, based on a demo project by the YMCA that was cost-saving in the Medicare population.  The program has never really taken off and was probably really torpedoed by the COVID epidemic.  CMS proposed some changes to make it more friendly to those who would fund and provide the programs.

Remote Therapeutic Monitoring

I understand the Remote Physiological Monitoring codes well enough, but there are new codes for "Remote Therapeutic Monitoring" and CMS explains these are intended, in part, to allow billing by non-physicians, e.g. physical therapists.  See code text here.   

However, CMS is concerned this is a contradiction in terms, because the practice expenses for RTM involve "incident to" expenses which is a concept used only for physician services.  

An expert explained the difference between "remote physiological monitoring" (several years old) and "remote therapeutic monitoring" of respiratory or musculoskeletal function.  The RTM codes are intended for things like monitoring inhaled drug usage or musculoskeletal range of motion. 

Colon Cancer Screening Copays

Screening services generally don't have copays, like screening colonoscopy, but CMS has long converted this to a "copay" medical service if there is a biopsy event during the colonoscopy.  Legislation recently aimed to remedy this (Consolidated Appropriations Act, 2021, section 122); CMS has a section on implementing the legislation.  39218ff.   (In a true nerdy twist, they mention that the ACA dealt with this regarding deductibles but not regarding copays.)  There is a footnote to the CY2022 OPPS rule - not released as early as the PFS rule - that there will be changes stemming from CAA-122 there, also.
The financial changes will dribble in; status quo CMS pays 80% in 2022.   CMS pays 85% in 2023-2026 (thanks!).  CMS pays 90% in 2027-2029, then 100% from 2030 forward.   

This change in Medicare payment (from 80% now to 100% per CAA 122) is described over 3 pages.

Colon cancer copays have been bouncing around since 2014; see Howard et al. here



AMA has created different code sets for "remote physiological monitoring" (e.g. blood pressure), "remote therapeutic monitoring" (e.g. range of motion), and (remote) "cognitive behavioral therapy" by devices per 30 days.   (The latter will be January 2022 Cat III codes).   So these are RPM, RTM, and CBT.   Note that you also see the abbreviation RPM = Remote Patient Monitoring, rather than "p=physiological" monitoring.

Historical Note: Incident-To Evolves (I Think)

The code for remote physiological monitoring was created by AMA some years ago, but not accepted by CMS until about 3 years ago.  (As of 2019, it still had quite limited utilization).  I believe this is because CMS felt that the physician providing (for example) a home blood pressure monitoring device, exceeded the concept of "incident to" which historically covered things purchased and used in the office suite. (This including disposable surgical supplies, even expensive ones, and chemotherapy, things that were used "in the office" or literally "furnished in the office.")   

Validation of this comes from the fact there is a special section of statute for allergists to compound and supply the patient with take-home allergy shot antigens (at 1861(s)(2)(G), so take-home antigens were not considered included in the prior definition of incident-to services (furnished IN the office per statute) at 1861(s)(2)(A)).  SSA here.  See 2002 OIG report and 2006 OIG report.

With the RPM (and now RTM and we expect CBT) codes, CMS has opened up its view of what is "furnished in the office" and "incident to" (it now includes the take-home monitors), but this is still contingent on the physician "incident to" benefit which doesn't apply to psychologists or physical therapists.

For a vender's listing of the RPM CPT codes, here.  99454, 30 days RPM service, is priced for a $1000 "heart failure patient physiol monitoring equipment (EQ392)" (table 16 here; see also here) with a 5 year life, prorated at $49 value per month in the AMA RVU tables (subscription).  After various obscure calculations for practice expense, the CMS payment for 99454 is circa $63.  

Nerdy Blog: MolDx Updates Billing and Coding Guidance for Multiple Genes

With an effective date of July 22, 2021, Noridian has posted some text updates to its billing and coding article for multiple genes.   It looks likes it's branded "R1" - Revision 1.

I've copied the Noridian article in brown text below, and further down, I show an update online at from another MolDx MAC (WPS MAC).   

What's The Point?

MolDx is clearly trying to make "code stacking" of genes very difficult, either by ensuring that labs use panel codes (e.g. 81432 BRCA panel) or else, using 81479 which can be freehand priced by MolDx during claims processing, or more likely, priced in advance by a Z code category.



Billing and Coding: MolDX: Testing of Multiple Genes - R1 - Effective July 22, 2021

This coverage article has been revised and published for notice under contract numbers: 02101 (AK), 02201 (ID), 02301(OR), 02401 (WA), 03101 (AZ), 03201 (MT), 03301 (ND), 03401 (SD), 03501 (UT), and 03601.

Effective Date: July 22, 2021

Summary of Article Changes:

Under Article Text-Multiple Distinct Procedural Services 

Example revised the fourth paragraph to read, “In general 2 or more codes describing a genetic test billed on the same beneficiary on the same date may constitute a panel, and if so the service must be billed as a single procedural service. We would generally expect that a provider or supplier would not bill for more than 1 distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service. If providers or suppliers do bill for more than 1 distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service, the provider or supplier must attest that each additional service billed is a distinct procedural service using the 59 modifier”.

Under CPT/HCPCS Codes Group 1: Paragraph revised the verbiage to read, “When 2 or more codes from this list are submitted for the same beneficiary on the same date of service, the claims processing system will reject every code submitted after the first service. However, if a lab runs more than 1 distinct procedural service from this list on a single date of service, then the lab must use the 59 modifier with each additional service billed as an attestation that it is a distinct procedural service”.

 Formatting, punctuation, and typographical errors were corrected throughout the article.

Visit the Molecular Diagnostic Services (MolDX) webpage to access the locally hosted MolDX Medicare Coverage Article from the “Covered Tests” or the “Excluded Tests” webpage.

To view the complete listing of locally hosted coverage articles and/or access the Active, Future, or Retired articles available in the CMS MCD, visit the Medicare Coverage Articles webpage.


I couldn't easily find the corresponding Noridian Article on, but I could find a matching WPS MolDx MAC article on, where it is A57880, and is stamped with a Future Effective Revision on the same day, July 22.

FUTURE Local Coverage Article:

Billing and Coding: 

MolDX: Testing of Multiple Genes (A57880)

Wisconsin Physicians Service Insurance Corporation

Original Effective Date


Revision Effective Date


Article Text:

The following information will be effective 10/21/2019 for dates of service on or after 10/15/2019.

A panel of genes is a distinct procedural service from a series of individual genes. All services billed to Medicare must be reasonable and necessary. As such, if a provider or supplier submits a claim for a panel, then the patient’s medical record must reflect that the panel was reasonable and necessary. Alternatively, if a provider or supplier bills for a number of individual genes, then the patient’s medical record must reflect that each individual gene is reasonable and necessary.

For ease of reading the term “gene” when used in this document will be used to indicate a gene, region of a gene, and / or variant(s) of a gene.

Genes can be assayed serially or in parallel. Genes assayed on the same date of service are considered to be assayed in parallel if the result of 1 assay does not affect the decision to complete the assay on another gene, and the 2 genes are being tested for the same indication. Genes assayed on the same date of service are considered to be assayed serially when there is a reflexive decision component where the results of the analysis of 1 or more genes determines whether the results of additional analyses are reasonable and necessary.

If a laboratory assays 2 or more genes in a patient in parallel, then those 2 or more genes will be considered part of the same panel. A panel constitutes a single procedural service, so 1 HCPCS codes must be submitted for the panel. If the laboratory assays genes in serial, then the laboratory must submit claims for genes individually. The order by the treating clinician must reflect whether the treating clinician is ordering a panel or single genes, and additionally, the patient’s medical record must reflect that the service billed was reasonable and necessary.

Two examples:

Single Service Example: A clinician orders 5 specific genes associated with breast cancer. The laboratory analyzes the 5 genes for common mutations using polymerase chain reaction. All 5 PCR procedures are started prior to the results of any 1 PCR procedure being known. The results are signed off on simultaneously, and all 5 results are sent to a clinician.

This would be considered a single procedural service, a single 5 gene panel, and it must be billed as such. This single panel must be reasonable and necessary to be billed to Medicare.

Multiple Distinct Procedural Services Example: A clinician requests that genes associated with early onset colorectal cancer be analyzed in a patient. The clinician orders stepwise reflex testing where a negative or positive result in 1 gene determines whether additional analysis on other genes will be performed or what that will be.

Each gene assayed represents 1 procedural service, so if more than 1 gene is analyzed, then multiple procedural services may be billed in some patients for whom reflex testing goes beyond the first gene. Each gene billed to Medicare must be individually reasonable and necessary. A clinician’s order is not by itself sufficient to indicate that a test was reasonable and necessary. The record must reflect that the test is used in the management of the beneficiary's specific medical problem in accordance with CFR §410.32.

Labs must register a test with the Diagnostics Exchange as it reflected on the order form and is run in the laboratory. If a gene / variant is tested as part of a panel, then the lab must register the panel and must submit the correct z-code and CPT code for the panel. If a lab has a panel but sometimes also analyzes individual genes from the panel, the lab must register both the panel and the individual genes that are analyzed.

In general 2 or more codes describing a genetic test billed on the same beneficiary on the same date may constitute a panel, and if so the service must be billed as a single procedural service. We would generally expect that a provider or supplier would not bill for more than 1 distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service. If providers or suppliers do bill for more than 1 distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service, the provider or supplier must attest that each additional service billed is a distinct procedural service using the 59 modifier.

The use of the 59 modifier will be considered an attestation that distinct procedural services are being performed rather than a panel. Providers and suppliers must use the 59 modifier in conjunction with other modifiers where appropriate. When providers and suppliers bill for multiple distinct procedural services, each service must be reasonable and necessary.

Laboratories that are billing for many individual genes using the 59 modifier rather than panels may be subject to medical review as outliers.


Group 1 Paragraph:

When 2 or more codes from this list are submitted for the same beneficiary on the same date of service, the claims processing system will reject every code submitted after the first service. However, if a lab runs more than 1 distinct procedural services from this list on a single date of service, then the lab must use the 59 modifier with each additional service billed as an attestation that it is a distinct procedural service.

[Numerous CPT codes follow]

WPS Revision Explanation:

07/01/2021-Under Article Text-Multiple Distinct Procedural Services Example revised the fourth paragraph to read, “In general 2 or more codes describing a genetic test billed on the same beneficiary on the same date may constitute a panel, and if so the service must be billed as a single procedural service. We would generally expect that a provider or supplier would not bill for more than 1 distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service. If providers or suppliers do bill for more than 1 distinct laboratory genetic testing procedural services on a single beneficiary on a single date of service, the provider or supplier must attest that each additional service billed is a distinct procedural service using the 59 modifier”. 

Under CPT/HCPCS Codes Group 1: Paragraph revised the verbiage to read, “When 2 or more codes from this list are submitted for the same beneficiary on the same date of service, the claims processing system will reject every code submitted after the first service. However, if a lab runs more than 1 distinct procedural service from this list on a single date of service, then the lab must use the 59 modifier with each additional service billed as an attestation that it is a distinct procedural service”.

 Formatting, punctuation and typographical errors were corrected throughout the article. 

Under CPT/HCPCS Codes Group 1: Codes added CPT® codes 81307, 81308, and 81309. The code description was revised for CPT® code 81350. 

Monday, July 12, 2021

Aduhelm: CMS Announces National Coverage Decision Process (July 2021-April 2022)

 On July 12, 2021, after market close, CMS posted an announcement that it will carry out a national coverage determination and analysis for aducanumab (Aduhelm).  See the CMS website here:

The request was "internally generated" meeting CMS doesn't have to meet any particulars that might have been initiated by an extramural request letter.

The protocol is multi-stage and the key dates are as follows:

  • July 12, 2021: Announcement
  • July 12-August 11: Initial Public Comment Period 
  • January 12, 2022: Proposed Decision Memo Due Date
  • This will trigger a second comment period, circa Jan. 12-Feb 11
  • April 12, 2022:  Final Decision Memo Posted
CMS could run faster than the timeline, but that's quite unusual.  From time to time, CMS has exceeded its posted times.  If CMS convenes a public advisory board (acronym MedCAC) that could occur in the fall and extend the analysis time by 6 months.

  • For a four-minute video, see me on YouTube, here.  

For the CMS press release, here.  For a rapid statement from the Alzheimer's Association, here.  Barron's here.   WSJ here.  Stat Plus here. Fierce Healthcare here.  A neurologist at Johns Hopkins discusses innovative clinical trial designs and innovative uses of biomarkers, Dr. Thambisetty, here.  Thambisetty in turn refers to an online copy of a MS. by Dr. Glymour of UCSF.  See also a February 2021 review in BMJ on amyloid as a surrogate for Alzheimer therapies here.


CMS will hold two national stakeholder calls, July 22 (9-11 am ET) and July 27 (2-4 pm ET).   CMS also posted the stakeholders for several recent meetings in commitment to transparency.  (Biogen, Alzheimer's Association, Duke Margolis Center, Johns Hopkins).   See the Transcript from the July 22 call posted on August 18 here.

The NCD will be generic - "[present and future] monoclonal antibodies directed against amyloid," not specific to aducanumab.

Coverage at Reuters here.

I've cut/pasted the CMS body of text below the break.

Sunday, July 11, 2021

Very Brief Blog: Interesting Headline: Telehealth Plateaus, at 38X Pre Pandemic Levels

 Interesting headline - 

From MedCity News:

Based on a McKinsey report:

Very Brief Blog: NYT Features 1-800-Autopsy

In February 2020, I highlighted changes in CMS quality measures regarding autopsies (with comments from CAP).   This week, New York Times features a deep-dive feature article on fee-for-service autopsies, such as may be conducted at families' request after a death that occurs in police custody and after a county autopsy.

See the article by Erika Hayasaki here.

Aduhelm: Some BCBS Plans Post Non-Coverage; AHIP, Alz Assoc Ask for NCD

One of the bigger healthcare stories of the past month has been the FDA's accelerated approval of aducanumab (Aduhelm).   See the FDA's page for data, decision analysis, and labeling here.  Aduhelm was shown to reduce beta-amyloid levels in Alzheimer patients, which was also statistically associated with better cognitive function in the trial data.    

However, over the past several days, several BCBS plans have posted noncoverage positions (see one here).  (July 13: Update here.)  Concurrently, to quote an alert published by the group Washington Analysis LLC in a new bulletin, the health insurance organization AHIP has requested that CMS develop a National Coverage Determination for Aduhelm (here).  (Note that the most recent major NCD for drugs/biologicals was for CAR-T therapies, following an external request from United Healthcare.)  

Alzheimer Association has also issued a press release asking for CED, here.

A recent blog at Health Affairs by Chambers, Lin, Tunis, and Neumann suggested that a Medicare NCD with "coverage with evidence development" might be possible - here.  CMS has a website for pending NCDs (aka "NCD Wait List") here, but hasn't updated it since September 2020, approaching a year.

According to BioPharmaDive, quoting the FDA calendar, Peter Stein and Jacqueline Curay of FDA met with Alfred Sandrock and Michael Vounatsos of Biogen on June 14. BioPharmaDive also notes the AHIP letter to CMS.


CED was also raised by authors at Pink Sheet and Forbes.  It is mentioned in the AHIP letter (p.3).

Wednesday, July 7, 2021

Very Brief Blog: ACMG Publishes Guideline for Exome, Genome Sequencing in Pediatrics

The American College of Medical Genetics and Genomics (ACMG) has released its first evidence-based guideline for clinical practice using exome/genome testing.  The guideline focuses on (1) congenital anomalies and (2) intellectual disability.

  • See the press release here.
  • See the 9-page guideline Manickam et al. here.
  • See coverage at Genomeweb, July 1, here.
The new guideline summarizes,
"The literature supports the clinical utility and desirable effects of ES/GS [exome, genome sequencing] on active and long-term clinical management of patients with CA/DD/ID, and on family-focused and reproductive outcomes with relatively few harms. Compared with standard genetic testing, ES/GS has a higher diagnostic yield and may be more cost-effective when ordered early in the diagnostic evaluation."
The report notes that exome sequencing does not capture certain types of variants including copy number variants, while stating that "genome sequencing provides coverage of both array and exome targets."  I have always been puzzled by payers who happily cover exome + microarray together, but decline to cover one test for sequence and copy number ouput (genome) even when it is the same or lower cost.

Previously, ACMG had had a "microarray" guideline for constitutional analysis in congenital anomalies and intellectual disability (here).  A March 2020 Ontario Health Technology Assessment recommended exome testing as a second-tier test, that is, to be positioned as a reflex test after a full microarray test had come back negative (here).

See also a new Avalere paper on the tortuous "diagnostic journey" for new rare disease patients, here.

Tuesday, July 6, 2021

Very Brief Blog: Bioinformatics for Genomics: Sophia Genetics Files for $100M IPO

More than a few companies in the genomics space describe themselves as "data companies," from Sema4 to Syapse to Tempus - but that's the only way to describe Sophia Genetics.  After raising $100M just last fall, it has newly filed for a $100M IPO.  In 2020, Sophia Genetics had $28M revenue and $39M net loss.

  • See F-1 document here (340pp)
    • Foreign-based company equivalent of S-1
  • See article at Endpoints about IPO here
  • Inks deal with GE Healthcare; 360Dx, here
  • See article at Endpoints about $100M raised last fall here
  • See a panel presentation this spring including co-founder Lars Steinmetz, YouTube, here
  • See company home page here
From Sophia's "What We Do" - "We offer a cloud-based Software-as-a-Service platform — the SOPHiA DDM™ platform — that enables healthcare institutions to get quick, robust insights from their data. We apply our technology to diseases such as cancer and inherited disorders, where combining genomic and phenotypic information is vital to support discoveries, treatment decisions, and drug development efforts."

From 360 Dx, "Sophia also announced Tuesday that it has signed a letter of intent with GE Healthcare to codevelop new artificial intelligence-driven analytics and workflow technologies to improve the matching of treatments based on genetic and tumor profiles of cancer patients."

Sophia is based in Lausanne with offices in Boston and France.

The company had $28M in gross revenue in CY2020, with a gross profit (over COGS) of $18M.   That is, COGS was only $10M.

R&D and Selling/Marketing and Other Administration each cost about $18M, with a net loss of $39M.  The accumulated deficit to date is $150M.  Cash on hand is $57M.

click to enlarge

Material Weakness in Financial Reporting

Every IPO proposal catalogs a litany of woes and risks - "We may not be able to compete; We may lose key staff; Our patents may lose in court," etc.   The Sophia risks include one that caught my eye, "We have identified material weaknesses in our internal control over financial reporting...if to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition..."    

There's also a familiar remark about genomics reimbursement, "The insurance coverage and reimbursement status of newly developed products, such as data analytics platforms and related solutions, products and services, particularly in a new category of diagnostics and therapeutics, is uncertain. An inability to obtain or maintain adequate coverage and reimbursement could limit the commercial potential of our SOPHiA platform and related solutions, products and services."

Monday, July 5, 2021

Very Brief Blog: Endpoints Says Duke-Margolis Center, Closed-Door Meeting, "Evidence and Coverage" for A-Beta Alzheimer Drugs


"Duke to host private meeting with payers and biopharma on how to pay for Alzheimer's drugs"

Endpoints reports on July 2, 2021, that "at the request of the FDA" the Duke-Margolis Center for Health Policy will hold a "closed door meeting" which will "convene public and private payers, clinicians, academics, patient groups, and industry" to discuss "coverage and evidence challenges" for beta-amyloid Alzheimer drugs as a class.   Article here.

It's unusual for FDA to go very far in convening meetings on "coverage" and they usually take themselves to be their own gold standard for "evidence."  

New White Paper Addresses "Emerging Market Solutions" For Highest-Cost Gene Therapies

We've heard much in the CAR-T era of how payers might handle extremely expensive therapies (e.g. $250K-$1M).   Here's a new entry point and white paper review.

The consultancy Real Endpoints has a news announcement that links one of its work productgs to a white paper at the MIT "NEWDIGS" program.   See Real Endpoints here.  See the MIT program, "New Drug Development Paradigms" (NEWDIGS) - here.   See their peer-reviewed publications here.  See their white papers and research briefs here.

And find the new 14-page white paper here.  

  • It's branded FOCUS - Financing and Reimbursement of Cures in the US.   
  • See also the webpage for the MIT "Paying For Cures" program, here.  
  • See also the MIT "Center for Biological Innovation" - here, which is co-branded with the white paper.

For the FOCUS White Paper, the MIT program surveyed 12 companies (payers, PBMs, etc) with a basket of 16 drug services, answering 32 questions for MIT.   

Products fell in 4 categories - (1) payer stop loss or carve-out solutions; (2) contract negotiation and data services; (3) contract negotiation services, and finally (4) "financial warranty services."

click to enlarge

See partial screenshot of their taxonomy of risk, cost, administration, and provider-facing services:

White paper, page 9


See also an open access 2021 paper by Latimer et al., Challenges in valuing and paying for combination regimens in oncology: Multi-stakeholder international workshop, here.  (Also open access is Ronco et al., 2021, here.)  See an earlier 2018 report on new horizons for CAR-T financing by ICER, here.

For Medicare and CAR-T therapy, see Avalere in September 2020 here, with an update in March 2021, here.  

In the same vein, see also an open access trade journal article, "Medicare braces for expanded use of high cost CAR-T therapy," March 2021, Lewis, here.  See a June 2021 article, Anderson, "Payers create CAR-T approval systems as adoption increases," (email registration required), here.

Friday, July 2, 2021

CMS Proposes Strongest Effort Yet to Directly Penalize Providers with Health Equity Disparities

Much has been written about socioeconomic and racial disparities in healthcare for decades.   Most Medicare policies did not address these directly.  Now, in the ESRD space, CMS is proposing measures that would directly penalize providers with ongoing disparities.   CMS notes that the effort is a direct collaboration between the regular ESRD policy makers and the Innovation Center (CMMI), which can waive certain laws for its own demo projects.


On July 1, CMS proposed annual ESRD rulemaking, and includes measures more directly targeting at health disparities than ever before.  Disparities in renal care include lower access to home dialysis and to transplants in low-economic and minority groups.

Historically, CMS has been highly aware of these and other disparities, but reluctant to address them directly.   For example - a hypothetical - CMS would be reluctant to require a white suburban hospital to have a 95% survival rate after a procedure, but an inner city hospital to have only an 85% survival rate.  However, by providing uniform reward and penalty benchmarks to such measures, inner-city hospitals might be perpetually penalized ad infinitum, further worsening their economic crisis year by year.

In the new ESRD rules, CMS writes, "[these] policies would aim to encourage dialysis providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model the agency’s first CMS Innovation Center model to directly address health equity."

  • See press release here.
  • Fact sheet here.
  • Proposed rulemaking here.
  • See early coverage at Health Care Dive here.
The public has 60 days to comment, until circa September 1.

I've clipped part of the Fact Sheet below the break.  The model being adapted is the ETC, ESRD Treatment Choices model, which can inflict penalties or bonuses on providers based on home dialysis and transplant rates in their populations.

CMS Releases First Round of Rulemaking on Surprise Billing; Important for Lab Industry

On Thursday, July 1, 2021, CMS released its first round of rulemaking to implement the national Surprise Billing law passed by Congress in December.   It matters a lot to the lab industry, due to the significant ratio of out-of-network to in-network claims for many labs.


There were multiple press briefings, Hill hearings, and news articles about surprise billing in the middle of the Trump administration, but to most people it was unexpected when Surprise Billing legislation suddenly zipped through House and Senate last December.   Now, in mid-summer, HHS is releasing rulemaking to implement the complex law.

  • See the main CMS press release here.
  • See not one, but two CMS fact sheets about the regulations, here and here.
  • See the inspection copy (typescript) regulation at 410 pages here.
    • The typeset version in Federal Register will appear later.
    • Comment period is 60 days, to circa September 1.
  • See early trade press in Healthcare Dive here.

See also:
  • HealthPayer Intelligence here.
  • Yahoo News (Washington Examiner) here.
  • Axios here (leads with a potential unexpected unintended consequence of the law).
  • Becker's Hospital News here.
  •      Becker's ASC News here.
  • Bloomberg Law here.
  • Health Affairs here.
  • General AMA page on the law (predates the new rule) here.
  • Meanwhile, WSJ publishes on July 6 a deep-dive article on sky-high prices charged to those out of network or uninsured, here.

ADLT Clause in Statute

New to me - it's mentioned in the June 21 CAP letter on the No Surprises Act and elsewhere (eg here), there is a clause that potentially carves out ADLT tests from other ancillary services in laboratory medicine.  See 2799B-2, Balance billing, (b)(3), "The secretary may, through rulemaking, establish a list of ADLTs which shall not be included in "ancillary services" [like other lab and radiology services]."

From the proposed rule:


I noted the press release leads with "Biden-Harris Administration," although they are simply implementing law passed and signed in the previous Congress and Administration.   It's still a step down from the last administration's press releases, which often opened with: "Thanks to the leadership and vision of President Trump..." a new DME rule or other policy was announced.