Very Brief Blog: Telepharmacy regulations proposed; relationship to "tele-laboratory"

 We hear a great deal in the laboratory field about telemedicine and its impact on channels and processes for laboratory testing.   

Just for a perspective, one might look at new regulations proposed by the DEA regarding telepharmacy (86 Fed Reg 64096, November 17, 2021, 4 pp).   Here.  DEA seeks public responses to 39 questions.  See a discussion of the proposal by Valiente et al. of Foley Lardner, here.  By Murray of Dinsmore LLP here.  DEA accepting comments to January 18, 2022.

On the one hand, telemedicine and genetic testing will be critical to the treatment of some patients and a pillar of proper care for them.  On the other hand, Department of Justice has asserted (here) that many allegedly improper DME and genetic test orders are made by telemedicine (typically in cases where the physician had no patient contact).   Similarly, use of a "clinical care network" of contracted doctors ordered UBiome direct to consumer tests (see e.g. here), ending up in high-profile court filings.

Very Brief Blog: Authors at FIRST DATABANK review FDA PGx Resources

 See a new article in MedCityNews, by Christine Cheng, highlighting FDA and other resources for the uses and effectiveness of pharmacogenetics. 

The new trade journal articles points to a research article by Cheng and colleagues in Annals of Pharmacotherapy.   That academic article appeared online 12/2020 and in print (that is still a thing?) in 10/2021.

Trade:

https://medcitynews.com/2021/11/fda-study-offers-new-tool-to-make-sense-out-of-pharmacogenetics-data/

Academic:

https://journals.sagepub.com/doi/full/10.1177/1060028020983049

Direct PDF link:

https://journals.sagepub.com/doi/pdf/10.1177/1060028020983049

###

See a streamed talk by Kristine Ashcraft, Invitae Pharmacogenomics, November 30, here:

https://precision-medicine-institute.com/live-briefings

(Scroll down for on-demand library).

Very Brief Blog: CMS Publishes Transmittals for PFS CY2022 Final Rule

 CMS published its physician fee schedule and hospital outpatient annual rules back around November 1, effective CY2022.   CMS has published transmittals implementing new instructions to its MACs.   Occasionally, these transmittals include some newly written prose communicating CMS staff "thinking" or "rationale" (this was true last year), but I don't see any unexpected new insights from the current implementation instructions.

CR12519, November 16, 2021

https://www.cms.gov/files/document/r11115cp.pdf

Parallel Medline Matters here, MM12519

https://www.cms.gov/files/document/mm12519-summary-policies-calendar-year-cy-2022-medicare-physician-fee-schedule-mpfs-final-rule.pdf

Topics include continuing tweaks to the nuances of colorectal screening copay policy, for example.  

Very Brief Blog: Q1 Diagnostics Hosts Boston Conference, December 6-7, 2021 (Plus notes on PMC and TriCon)

We've had two years of mostly canceled conferences, or live conferences converted to Zoom-only events.   

Here's an annual live meeting that's back on track.  On December 6-7, 2021, Q1 Productions will host "Diagnostics Coverage and Reimbursement Conference," at the Boston Marriott Renaissance Hotel.  See the website and registration info here:

https://www.q1productions.com/dx-reimbursement/

++

Molecular TRI-CON is scheduled for February 21-23, 2022, in San Diego ("and online.")  Here.

Personalized Medicine Coalition will hold its next (deferred) annual meeting in Southern California, Laguna Niguel, May 19-20, 2022.  Here.   

++

It's the opposite of a live meeting, but you can still log into a wide range of free precision medicine videocasts from November 2021, at Partners in Precision Medicine, here.

First Look: CMS Payments for COVID Tests in CY2020

On November 23, 2021, CMS released payment files for CY2020 for Part B services, by CPT code.  See my blog here.

I've pulled out the COVID lab tests payments for a separate headline.

COVID Code Usage CY2020

Here's a table of the COVID lab code usage.  Use of neutralizing antibody tests was almost nil, and use of antibody and antigen tests were only 5% and 2% of payments, respectively.  Almost all PCR testing went through the "high throughput" codes for platforms with > 200 tests per day.

CMS spent about $1B in total on COVID testing, and $900M on high volume PCR testing.

click to enlarge

CMS Publishes National Data File for Part B CY2020

Every fall CMS publishes Part B utilization data, by CPT code, for the prior year, on this page:

https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Part-B-National-Summary-Data-File/Overview

This year, the data for CY2020 is a month or two later than normal, but it's out.

Enjoy!  I've put a copy of the lab spending alone in the cloud here.

Note that CMS releases the CY2020 data in numerous successive XLS files.   There is no file for the 80,000 series, the lab codes.  These are because they are in the file labeled labeled as starting with 0001U, which is actual a complete laboratory and pathology code file, including e.g. PLA ("end with a U") codes.  Note the "Begin with U" codes (special CMS COVID codes) are in a separate file, titled  "Miscellaneous."  For most of the data below, I manually pulled out U0003 U0004 and added them to the CMS lab file starting with "0001U" and including the 80,000 series.  Whew.

CMS has not yet released the state-level data files (they will appear here) but they're very tedious to work with since there are 50-plus separate Excel files.  

A few tidbits.

Concentration of Category III Codes

In a recent webinar presented at Stanford, AMA staff emphasized that Category III codes were doing well, with several hundred million dollars of annual payments.  Yes, but.  The payments are highly concentrated.  In this CMS data, there are $275M dollars allowed.  But out of several hundred Category III codes, the top 2 had 77% of all payments and the top 10 had 95% of all payments.  Only about 25 codes were paid more than even $100,000 nationwide in Part B.  

Why a pretty old Category III code, 0191T, with >80,000 uses year after year, is not a Cat I code is a mystery to me.

click to enlarge

Part B Lab Spending 

Simplifying by leaving out lines for interpretation or tech component only, I see $6.9B in Part B lab code spending (without COVID) and $7.8B (with COVID PCR).  

The largest dollars allowed was U0003/U0004, high throughput COVID testing, at $900M.   

Turning to the "regular" CPT codes, the highest path/lab code was 88305 - a surgical pathology code - at 17M services for $860M.  Next is molecular unlisted code 81479, with 138,000 services  at $290M.  (This code is used almost exclusively by MolDx).  

For CY2020, code 81408 - rare full length genes nearly never used in the Medicare population before 2018 - was code #9 at $207M (or #8, not counting COVID).  Labs cited in alleged-fraud investigation Operation Double Helix almost always billed high amounts of 81408. 

Among all lab spending, including COVID, the top 10 codes were 46%.

Top Path/Lab Codes (incl COVID) - Click to enlarge

Part B Molecular Spending

I quickly sorted for molecular codes 81170-81599 and U-codes (PLA codes).  I tally $1.4B in spending (about the same as CY2019) for general codes, and $2.3B when we add COVID PCR as codes U0003-U0004.

Amazingly, given the profusion of hundreds of new molecular codes, the top 8 codes (excluding COVID) take 70% of the spending.  

And even more amazingly, 5 of the top 8 codes (excluding COVID) are non specific codes. (!!!)

Among the specific codes, excluding COVID,  #1 is Cologuard 81528 at $210M, followed by Oncotype (81519) and Foundation Medicine (0037U) at about $77M each.

Just two nonspecific codes, 81479 and 81408, grossed $400M.

Note, the table below is missing 81162 (BRCA 1&2) at $85M spend and 46,788 services, because I cut the data rows below at 81170 lower bound.  (Discovered 5/27/2022).  It should be the fourth-highest coce after 81479, 81528, 81408.   

MoPath w/o COVID - click to enlarge

MoPath Data With COVID

Here is the data including the $900M of spending for COVID PCR (U0003, U0004).  At $900M, COVID is about 39% of all molecular spending, not far from half.

MoPath "with" COVID U0003-4 (39%, $900M) - click to enlarge

PLA Codes Incredibly Concentrated

In another blog today, I noted that Cat III codes were incredibly concentrated in the top couple codes among hundreds of codes, and the huge majority of Cat III codes paid little or nothing.  (Here).

Same for PLA codes.

In total, PLA codes were paid $127M, however, $90M of that went to the top two codes (FMI CDx and Oncotype Prostate), and of the top two codes, $77M/90M went to FMI CDx.   

Only about 20 PLA codes were paid more than even $100,000 (say, the salary of a single sales worker).  95% of PLA spending went to the top ten of over 200 codes, while even that is misleading, since 75% went to the top 2 alone.

click to enlarge

COVID Code Usage CY2020

Here's a table of the COVID lab code usage.  Use of neutralizing antibody tests was almost nil, and use of antibody and antigen tests were only 5% and 2% of payments, respectively.  Almost all PCR testing went through the "high throughput" codes for platforms with > 200 tests per day.

CMS spent about $1B in total on COVID testing, and $900M on high volume PCR testing.

click to enlarge

HCPCS Code Trivia

The files include data for all alphanumeric HCPCS codes (e.g. drugs, wheelchairs, full tables here).  "S" codes are supposed to be for private payers (on request to CMS for a code) and "T" codes for Medicaid or other federal agencies, not for Medicare.  In fact, payments for S and T codes were "zero" at Medicare Part B.

CMS Publishes Final Decisions on New Lab Codes for CY2022

Each summer, CMS has public meetings on how to price new lab codes.  CMS publishes proposed prices in September and final prices in November.  The final prices are out.

Go to this web page at CMS and scroll down for CY2022, Final Payment Determinations:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings

I've also put a cloud copy here.

Statistics

98 codes were in play.  This is about the same as last year.  But before coding reform, before 2011, there were only 5-10 new lab codes per year.

See my blog on the proposed codes in September here. CMS disagree with its advisors 57 of 99 times, which I'm pretty sure is a record.  As you'll see below, it almost never changed its mind, either.

How many PLA codes?

I tallied 60 of them as PLA codes (ending in ---U).  

How many were gapfilled?

35 of the 98 are gapfilled.  This is a bit less than this year, but it's still alot.  Before coding reform, often 0 codes per year were gapfilled. 

What does "Comment Period" do?  Does CMS change its mind?

CMS made almost no changes in its proposed decisions this year.  Usually CMS changes its mind a dozen or more times; this year, only 3 times.  

• Most noteworthy: 0261U, HalioDx, 4-slide colorectal cancer test, with AI, crosswalk to 0108U, a multi-slide Barrett's test, for $2513.  [*] HalioDx acquired by Veracyte in mid-year; here

This lack of changes could mean that CMS made its proposals very carefully (even though it disagreed with the expert panel the majority of the time), and was unlikely to hear any really "new" information during the comment period.  Or, it could mean that CMS doesn't listen to the comment period.  (I think the former).

  __

Besides 0261U conversion to crosswalk, two other codes changed (always by conversion to crosswalk.   These included 0247U (CW 0063U, $750).  It is a 2-immunoassay test with algorithm for preterm birth risk.   And 87428, antigen immunoassay for COVID and FLU, priced to a simple crosswalk (87430&87400) rather than the 2X crosswalk panelists recommended.   O

___

[*] Not mentioned on this crosswalk report, since it was a summer 2021 gapfill code that did not change price, readers interested in the $2513 pricing for 0261U and 0108U shown above, might want to keep track of 0220U, image analysis of breast cancer slides, $706 (priced this year during gapfill).  

In December, it was announced that Castle Biosciences closed its acquisition of Cernostics (AI slide imaging) for $30M - here.  Although not associated with coding, see also the FDA de novo authorization for slide-based AI imaging for Paige AI in September 2021.

Rarity: Federal Register Mishandles CMS Physician Fee Schedule Final Rule

Here's extreme Medicare nerdism, but it's one I've never seen before.  

CMS released a "typescript" or "inspection copy" of the Physician Fee Schedule annual rule on November 2, and the fully printed and typeset version appeared today November 19 in the Federal Register.

They've badly mispaginated it, which I assume they'll eventually correct.

If you go to the home page for this publication, the PFS rule, today, it's here:

https://www.federalregister.gov/documents/2021/11/19/2021-23972/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part

And it gives a link to the PDF rule, and lists the pagination as 508 pages from page 65524-66031.

This pagination, and the document offered for download, are incorrect.  They have posted a document that starts in the middle of the CY2022 PFS rule.

https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf

I tracked back and downloaded the entire Federal Register issue.   The correct pagination is not 65524-66031, but 64996-66091 (about 1095 pages).   Another observation is that, at 1095 pages, the PFS rule is almost the entire Federal Register for today (the whole issue is 1364 pages).  The PFS weighs in at 165MB of a total of 174 MB.

##

See a discussion of the PFS rule CY2022 by Suzanne Michelle Joy at Holland & Knight, here.

##

400 Pages of Quality Measure Appendix

Up to Secretary Becerra's signature, on page 65686, it's 691 pages.  After that, 400 pages of Appendix regarding quality measure rulemaking.

Anti-Racism Plan For Quality Measure Activities

On Page 65384, discussion of a quality measure anti-racism plan.  The goal is to help "clinicians move beyond analyzing data, to taking real steps to naming and eliminating the causes of the racial disparities identified [65969]."  It includes "an organization's plan to prevent and address racism and/or improve language access and accessibility."

__

In Appendix 2: Improvement 

Activities of this final rule, we 

discussed an improvement activity 

titled ‘‘create and implement an anti- 

racism plan’’. This improvement 

activity acknowledges it is insufficient 

to gather and analyze data by race, and 

document disparities by different 

population groups. Rather, it 

emphasizes systemic racism is the root 

cause for differences in health outcomes 

between socially defined racial groups. 

Further, we also proposed to modify 

five existing improvement activities to 

address health equity. We note that 

some improvement activities within our 

current Inventory already aim to 

improve equity. We believe further 

modifying them can more explicitly link 

the activity to health equity without 

changing the core activity. In other 

cases, our proposals to modify an 

activity fundamentally shifts the activity 

to focus on health equity specifically.

See tables, page 65969.  A quality measure for anti-racism actions and activities in the healthcare setting implements Executive Order 13985, January 20, 2021.

For a 20p PDF of equity & quality measures discussions, see here.

AMA Posts Webpage for February Meeting; Early Rapid Comment on Lab Codes is Open

Three times a year, AMA opens a new webpage for the upcoming CPT meeting.  AMA has just opened the webpage for 

For any meeting, check this home page for CPT and see if the next meeting is posted yet:

https://www.ama-assn.org/about/cpt-editorial-panel

For the February 3-5 2022 meeting, find it here:

https://www.ama-assn.org/about/cpt-editorial-panel/cpt-february-2022-editorial-panel-meeting

Find the PDF for the lab agenda here:

https://www.ama-assn.org/system/files/cpt-panel-feb-2022-agenda.pdf

If you want to comment on a lab code, you must follow a prescribed application process (in the PDF) and request materials for review by December 2, and submit written comments by December 9.  This is because AMA wants your comments to be available to lab policy subcommittee meetings.  For "regular" proposed CPT codes, the review period is later and much longer, from early December to mid January.

There are a number of tumor genome codes in play, including revisions for Comprehensive Genomic Profiling regarding DNA vs RNA analysis.  This one is a puzzle, since this topic was raised and "passed" (according to the AMA posted results) in September.  Should be exciting.

Agenda items in brief are below.  See full PDF for full description.

1. Revise 0016M, bladder test.
2. 81401 code revision for ARMS2 gene.
3. 81401 revision for CHF gene.
4. Chemistry code for gadolinium.
5. Revision to CGP codes (e.g. 814XX) for RNA, DNA, etc.  Seems to revisit a 9/2021 change.
6. WGS specifically for use in oncology (current WGS is for germline).
7. MAAA code 815xx for tumor methylation.
8. MAAA code 815xx for modified HPV in tumor tissue.
9. Obstetric panel, delete 81055 and create 80081.

click to enlarge

AMA hasn't posted registration for the meeting yet.  The last meeting (October) was planned as real/virtual but then switched to virtual.  I believe the next one (February) is again planned as real/virtual.  Since it's not posted, the city is unknown to be, but I noticed that RUC will meet about the same time in San Diego.

Stanford Biodesign Hosts Deep-Dive AMA CPT Webinar; And Another on FDA & Innovation

Not brand new, but new to me, on September 27, 2021, Stanford Biodesign hosted a webinar with several AMA CPT executives on the present and future scope of AMA CPT.  (See also my link to their FDA webinar, below).

___

Definitely worth tracking, and the run time of 1 hr 50 minutes - longer than many movies - suggests how much material there is to cover.  Speakers included Laurie McGraw, Kenyetta Jackson, Leslie Prellwitz, and Jay Ahlman of AMA, as well as Josh Makower, head of the Byers Biodesign center, and Andrew Cleeland, CEO of the Fogarty Institute (also for medtech innovation.)  Find the webinar at YouTube here.

Overall, it's a very important webinar.  It gives you a lot of insight into how AMA thinks and its vision for improvements to the AMA CPT.  

I could quarrel with some of the AMA "spin" for example, they rebut the impression that Category III codes are very hard to get paid for, noting over $200M of payments in a recent year.  Yes, but.  I did a recent analysis showing that of several hundred Category III codes, 95% of all services went to just 7, and of that, 70% went to only 3 iRhythm codes, CPT codes that are not longer in Category III by 2021.   Thus, it remains true that, at least in CMS data, the great majority of the Cat III codes get paid either nothing or very little.  Blog with data tables here.  Updated in brief for CY2020 here.

Also of High Interest - Scott Gottlieb Webinar on "FDA and Innovation"

Also of interest, see a Scott Gottlieb webinar at Stanford Biodesign on FDA & innovation; recorded January 2021.  Here.  Also an excellent presentation.

Gottlieb was strongly in favor of "Medicare Coverage for Innovative Technologies," MCIT, and discusses that at some length.  Also, the role of FDA in sending important signals that lead to the most effective R&D investments.  

__

See the homepage for Stanford Biodesign at YouTube here.  More detail on the CPT webinar here.

Very Brief Blog: "Bridging the Gap" - Regulatory Affairs, Reimbursement, Product Life Cycle - Focus on Digital Pathology

There have been a number of interesting lab industry policy articles originating from, or associated with, MGH in the last few months.  See an article on the costs of implementing VALID Act, Huang et al., here.  See an article on FDA, regulatory innovation, COVID regulation, and insights for the NEXT era of FDA lab regulation, Marble et al., here.

Add a third one.  This one is on the interface and interaction between regulatory affairs, reimbursement, and product life cycle management -- with a focus on the rapidly progressing digital pathology industry.  

Find Kearney et al, "Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software," open access, here.

By the way, their Figure 2, showing "regular LDT" and "FDA approved LDT at one site" and "IVD" is a nice one:

Kearney 2021 Fig 2

Enjoy - 

Below the break: Abstract and first paragraph.

HHS Legally Withdraws Policy Keeping FDA Away from LDTs; and FDA EUA Updates

In August 2020, the Trump administration issued a policy restricting FDA from reviewing LDTs.   (The August policy was based in part in a lengthy internal legal memo on FDA review of LDTs a few months earlier).

On November 15, HHS officially withdrew the August 2020 policy.

LDTs IN GENERAL

Coverage at CNN here. HHS statement here.  

The HHS statement might have been accelerated in part by a recent October position at PEW on the dangers of unregulated LDTs (my blog here).

FDA & COVID & EUA

FDA statement about COVID test review, focus on mass-produced POCT, here.  Genomeweb covers the story, here.   And also, FDA "revised guidance on FDA COVID test review, November 2021" here.

HHS COVID & $$$

From a few days ago, HHS to invest $650M for POCT/PCR/COVID.  

HHS here, Healthcare Finance News here.

___

Background

Backstory.

See my August 20, 2020 story on the original HHS decision here.  Also in 2020: See a September 2 story here at DIHP about "dueling FDA and HHS announcements," here.  See an October 7 story here at DIHP about Congressional kickback regarding the need to reign in LDTs here.  The August 20, 2020 HHS notice blocking LDT review was based on an earlier, June 22 17 page legal memo on the topic, here.

FDA and CMS "high throughput" rules differ.

I noticed that FDA defines "high throughput technologies" in the guidance above, differently than CMS defines "high throughput technologies" for the purpose of increased COVID payment under CMS codes U0003, U0004.   In the FDA guidance, here, they focus on high throughput technologies defined as 2, 384-well plates per 8 hours.  (768 per 8 hours or 2304 per 24 hours).   In the CMS guidance in April 2020, introducing new codes priced at 2X of conventional PCR Covid ($100 instead of $50), CMS defined "high throughput" as 200 cases per day.  Here.

21st Century Cures Version 2.0 Legislative Draft Released; Includes Reboot of "MCIT" Section 404

After a year of discussion, and the circulation of draft versions, they've released a legislative draft of 21st Century Cures version 2.0.

• PASTEUR ACT, special funding for special antibiotics, is section 105.  See a brand-new article on this policy issue here (Outterson, head of CARB-X, funded by BARDA).
• See another recent article on the antibiotic crisis by Andre Hudson here.  See a law firm overview of 21CC-2, here.
• Something similar to the recently canceled Medicare Coverage for Innovative Technologies (MCIT), meaning Medicare coverage for Breakthrough Devices, is included at Section 404. 
• Duke Margolis Center had an 11 page review of the draft MCIT inside 21CC-2, here.  They also submitted a comment letter to CMS on the original MCIT here.  

See a copy of the 173 page 21CC-2 bill here:

   https://degette.house.gov/sites/degette.house.gov/files/CURES%202.0%20Text.pdf

See a 5-page summary here:

   https://degette.house.gov/sites/degette.house.gov/files/Cures%202.0%20Section%20by%20Section%20Summary.pdf

See 2 pages of pre-boxed favorable quotes from groups like AMA and Friends of Cancer Research:

   https://degette.house.gov/sites/degette.house.gov/files/Cures%202%20Quotes.pdf

See coverage at ENDPOINTS (including proposals for real world evidence in FDA trials) here.

Title IV focuses on Medicare including:

• 401, GAO study
• 402, Access to telehealth in Medicaid
• 403, Medicare telehealth
• 404, Breakthrough device coverage.   
• 405, HHS to report on its coverage for innovative technology
• 406, HHS to report on CMS computer systems
• 407, Precision Medicine for Kids
• 408, Medicare coverage for "consultations" (PGx)
• 409, Geographic tracking prohibitions
• 410, Electronic prescribing
• 411, Federal health plan claims data
• The next title, Section V, 501ff, creates a new "Advanced Research Projects Agency for Health," e.g. DARPA for Health, to focus on translational medicine and clinical trials

401, GAO reports on changes needed to improve coverage and reimbursement under Medicare for innovation.  improve interagency communication.

404, regarding BT coverage, it's complicated text and legalistic, inserting phrases here and there into existing laws (Bill, pp 87-109).  In October 2021, Duke Margolis reviewed the proposal in detail in its earlier draft from spring - Duke PDF here.  (I haven't redlined whether the final text in this legislation as #404 varies from what Duke reviewed.)  See also a trade article at HealthCare Dive here.

405, CMS to report on digital alternatives to treatment, including wearables and digital platforms.  Determine coverage processes for such technologies, including payment innovations.

407, CMS to issue guidance to health plans regarding coverage for genomic testing including WES/WGS and gene panels for pediatric patients, if for example there is a positive result from newborn screening or there are developmental anomalies or they have seizures or are referred to pediatric ICU. A pilot program is proposed, along with a report thereupon by the National Academy of Medicine, as well as a CMS report on genetic coverage in Medicaid in the 50 including WGS, WES, microarrays, FISH, etc.   

408 adds a benefit category for pharmacogenetic (PGx) consultations by a pharmacist, genetic counselor, or pathologist.

MCIT Final Rule Includes Odd Treatment of "Diagnostic Tests"

Today CMS issued a rule permanently canceling the MCIT program for breakthrough devices.  I wrote an adjacent blog about this - here.

There's a really odd treatment of "diagnostic test" and I felt it was worth calling out as its own short article with its own headline.

____

CMS View of "Diagnostic Test" vs "Device"

In the original September 2020 proposal, CMS said it would cover breakthrough devices for four years.  Then, CMS also asked the public, if it should "also" cover breakthrough diagnostic tests or drugs.   This made no sense, because FDA views IVDs as devices, so diagnostic tests are already included in the regulation for breakthrough devices.   In the January 2021 final rule, CMS clarified that "diagnostic tests" were naturally part of the covered range of breakthrough devices.

There's an odd flip flop in today's final rule.  In discussing how many BT devices either were already covered or were irrelevant for Medicare coverage, CMS states,  "The majority of BT that would have been eligible for the MCIT were already paid by an existing mechanism, (or) were directed to a pediatric population, (or) were a diagnostic lab test, or were subject to an NCD or had no benefit category."   

Why on earth diagnostic tests under BT review are put together with "pediatric devices" and "devices with no benefit category" is cryptic.  Many BT devices are diagnostic tests and would have greatly benefited from accelerated MCIT coverage.

Medicare Officially Cancels "MCIT" Rule

 On November 12, 2021, CMS officially and finally announced it was *canceling* the "MCIT" rule, which had been finalized in the closing weeks of the Trump administration in January. 

The Medical Coverage for Innovation Technology rule would have automatically covered new FDA-approved "Breakthrough" devices for four years, under Medicare. 

The policy had previously been put on hold and then proposed for cancellation. The Biden administration promises two stakeholder workshops in CY2022 on other ways to improve Medicare coverage.

BACKGROUND

A few weeks ago I posted a cloud zip file of some of the most interesting public comments in favor of MCIT (here).   I also flagged a blog that was pro-MCIT by Joe Grogan, who was one of the leaders for health policy in the White House in 2019/2020.   Scott Gottlieb and Grogan discussed reasons why MCIT was good in a recent webinar here.

CMS PRESS RELEASE

https://www.cms.gov/newsroom/press-releases/cms-repeals-mcitrn-rule-will-consider-other-coverage-pathways-enhance-access-innovative-medical

FINAL DECISION (FEDERAL REGISTER)

November 15, 2021.  86 FR 62944-58.  Here.

_______

Coverage at MedCity here.  Coverage at Genomeweb here.

Legislation has been introduced to recreate the MCIT coverage by lawmaking, but it's too early to judge whether it's likely to pass (here). HR 4043. See also HR 5333 in 2019.  HR 5009 in 2016.

Update:  Said legislation, or similar, is Section 404, the MCIT section of 21st Century Cures Version 2, released November 17, HealthCareDive here.   

Nerd Note.  CMS View of "Diagnostic Test" vs "Device"

In the original September 2020 proposal, CMS said it would cover breakthrough devices for four years.  Then, CMS also asked the public, if it should "also" cover breakthrough diagnostic tests or drugs.   This made no sense, because FDA views IVDs as devices, so diagnostic tests are already included in the regulation for breakthrough devices.   In the January 2021 final rule, CMS clarified that "diagnostic tests" were naturally part of the covered range of breakthrough devices.

     There's an odd flip flop in today's final rule.  

In discussing that many BT devices either were already covered, or were irrelevant for Medicare coverage, CMS states,  "The majority of BT that would have been eligible for the MCIT were already paid by an existing mechanism, (or) were directed to a pediatric population, (or) were a diagnostic lab test, or were subject to an NCD or had no benefit category."   

Why on earth diagnostic tests under FDA BT review are put together in this sentence with "pediatric devices" and "devices with no benefit category" is cryptic.  Many BT devices are diagnostic tests and would have greatly benefited from accelerated MCIT coverage.

Second Nerd Note - Repetitive

I'll go out on a limb and say I usually find most CMS rules to be pretty well written.  (Of course, when you hit an ambiguous sentence that affects you directly, that's memorable.) 

In the case of the MCIT final rule, produced very quickly, I can't say that.  It's unusually meandering and circuitous and repetitive.  

Third Nerd Note - Med Advantage

There were comments that Medicare Advantage plans may fail to match Medicare Fee for Service coverage (as they should) or impose reasonable barriers to access.  CMS made a short neutral remark in response.

###

Scott Gottlieb discussed the role of MCIT in a detailed webinar he gave to Stanford Biodesign earlier this year, here.

Dramatic Day for Precision Oncology: MolDx Releases "Minimal Residual Disease" LCD

On November 11, 2021, three MolDx MACs released final LCDs for Minimal Residual Disease testing in cancer, coverage that will be effective on December 25, 2021.  The decision had been awaited since the release of a draft policy back in September 2020.

Here are the links.  I also provide all the files in one Cloud Zip File - here.  

I've also made a three minute video that explains the LCD - here.

• Final LCD here.
• Final billing article here.
• Final Q&A on public comments here.
• (Original draft LCD online here).
• See a rapid press release from Natera - here.
• See Adaptive Technologies press release here.
• See coverage at Genomeweb/Precision Oncology, here.

In the Zip file, find also a Redline comparison of the draft and final documents.   The LCD has almost doubled in length, from 4026 words to 7708 words (and from 40 references to 89).   The public comments article is probably the longest I've ever seen, at  68 PDF pages, and the billing article (mostly ICD10 codes) runs to 91 pages.

Both Recurrence and Therapeutic Response

The LCD covers BOTH testing for minimal residual disease recurrence (e.g. relapse after colon cancer surgery) as well as changes in circulating tumor DNA reflective of response-or-failure of chemotherapy.

click to enlarge

MolDx Plans a Consistently Updated Coverage Article Naming Tests

The billing article includes instructions, at this time, for the Natera SIGNATERA test and the Adaptive technologies CLONOSEQ test.  MolDx has not always regularly updated its billing articles to reflect the most current coverage.  However, THIS billing article A58376 states that "Tests not listed in this table have not been established that they meet the coverage criteria...This table will be updated to reflect revisions or additions of newly covered tests."

Natera Signatera Coverage for Immune Checkpoint Therapeutic Monitoring

On page 50 of the Billing Article A38779 (my PDF version) there is coverage for "Signatera tests used to monitor response to immune checkpoint inhibitor therapy for use with any solid tumor cancer."  This type of molecular test coverage should help compensate for the difficulty of predicting ICI response in advance (e.g. via PDL1 staining) or early in therapy (due to the lag time for imaging response or due to ICI pseudoprogression.)

Tech Assessment Forms

The Billing Article states that MolDx may, to implement the LCD, issue special tech assessment forms specific to this MRD LCD.   When you apply for coverage, check for the most recent version of the MRD LCD (if in fact there is one).

NOTE: NOV 18:
NORIDIAN IN FACT POSTED THE LCD ONE WEEK LATER (Nov 18 not Nov 11)

ORIGINAL TEXT:

Noridian Lags

Three of four MolDx MACs released the LCD concurrently and effective on 12/25 (L38779 Palmetto, L38835 WPS, L38822 CGS).  The Noridian MAC did not release an LCD today, as far as I saw, but this lag for Noridian is not uncommon in the MolDx MAC system.   To see all CMS LCDs in the "notice of final" period, go to this link and for the dropdown box "all statuses" select "in  notice."

 

Quoting the MolDx Coverage in Full

Since it is fairly lengthy and defies a simple summary, I am quoting the "coverage rules" in full below.  I have provided some underscoring and a single comment to aid the reader of this blog.  There is no highlighting in the original LCD.  

The LCD covers both hematopoeitic cancers (e.g. leukemia relapse) and solid cancers.

NEW LCD TEXT:

This Medicare contractor will provide limited coverage for minimally invasive molecular deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) tests that detect minimal residual disease (MRD) in patients with a personal history of cancer.

This Contractor provides limited coverage for MRD testing in cancer when ALL of the following are true:

1. If Next-Generation Sequencing (NGS) methodology is used in testing, the conditions set by NCD 90.2 are fulfilled (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously tested with the same test for the same genetic content) or are not applicable (the patient does not have cancer as defined below);

2. The patient has a personal history of cancer, the type and staging of which is within the intended use of the MRD test;

3. The identification of recurrence or progression of disease within the intended use population of the test is identified in the National Comprehensive Cancer Network (NCCN) or other established guidelines as a condition that requires a definitive change in patient management;

4. The test is demonstrated to identify molecular recurrence or progression before there is clinical, biological or radiographical evidence of recurrence or progression AND demonstrates sensitivity and specificity of subsequent recurrence or progression comparable with or superior to radiographical or other evidence (as per the standard-of-care for monitoring a given cancer type) of recurrence or progression;

5. To be reasonable and necessary, it must also be medically acceptable that the test being utilized precludes other surveillance or monitoring tests intended to provide the same or similar information, unless they either (a) are required to follow-up or confirm the findings of this test or (b) are medically required for further assessment and management of the patient;

6. If the test is to be used for monitoring a specific therapeutic response, it must demonstrate the clinical validity of its results in published literature for the explicit management or therapy indication (allowing for the use of different drugs within the same therapeutic class, so long as they are considered ‘equivalent and interchangeable’ for the purpose of MRD testing, as determined by national or society guidelines);

7. Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population;

8. The test is being used (a) in a patient who is part of the population in which the test was analytically validated and (b) according to the intended use of the test;

9. The MRD test    [unless it is a Food and Drug Administration (FDA) approved and established standard-of-care single-gene polymerase chain reaction (PCR)]     satisfactorily completes a technical assessment (TA) that will evaluate and confirm that the analytical validity, clinical validity, and clinical utility criteria set in this policy are met to establish the test as Reasonable and Necessary;

10. Tests utilizing      a similar methodology or evaluating a similar molecular analyte to a test for which there is a generally accepted testing standard or for which existing coverage exists        must demonstrate equivalent or superior test performance (i.e., sensitivity and/or specificity) when used for the same indication in the same intended-use population.

MRD testing often requires 2 types of assays to be performed as part of the service. First, a sample is taken from tumor diagnostic material to establish a baseline (solid and/or liquid) tumor signature as defined by the test methodology. This is followed by a series of assays run on a minimally invasive specimen (i.e., liquid biopsy or bone marrow aspirate) to detect the presence or recurrence of tumor, based on the measured biomarkers, expression, or other analytes over various timepoints. 

Other approaches are also acceptable, based on the validity established for the individual test comprising the service. This series of assays comprises a single test when the patient is known to have cancer.

When the patient is NOT known to have cancer (specifically when there is no clinical, radiographical, or other biological evidence that tumor cells remain post treatment and subsequently the patient is no longer being subjected to therapeutic interventions for cancer), a second kind of test may exist wherein a single timepoint may constitute a single test. In such patients, the frequency of MRD testing is in accordance with national or society guidelines or recommendations.

[BQ - the above section navigates repeat testing for a patient "with cancer" which is otherwise affected by NCD 90.2; if a patient had a full resection (e.g. mastectomy, colectomy, nephrectomy) they may become a patient without current evidence of cancer at present.]

For patients with or without cancer (as defined above), established standard-of-care MRD tests using single-gene PCR (i.e., BCR-ABL1) are covered under this policy according to testing schedules outlined in national (i.e., NCCN) or society guidelines.

MRD testing in accordance with this policy can be performed using PCR and/or sequencing-based technologies and is not restricted to a single type of biological material or defined number of genes.

___

New articles on MRD appear constantly; here's one from Nov. 19 on use of MRD in postsurgical lung cancer. 

Very Brief Blog: Short Deck and Video about CMS Pricing Artificial Intelligence Medical Services

 You might be surprised to find out how many reimbursement decisions Medicare has recently made regarding AI-based services.   

• See a short deck here.
• Over on YouTube, I walk through the deck (5 minutes), here.

First, I walk through New Technology Add-on Payment (NTAP) services in the inpatient rules for FY2021 and newly for FY2022.   This include Viz.AI ContaCT (yes $1040), AI DOc Briefcase for PE (no), Rapid ASPECTS (no), and Caption Health Guidance (yes $1868).

Next, I walk through three examples from this fall's PFS final rule.  These include retinal AI (92229),  Heartflow (0503T), and iRhythm-and-similars (93241ff).   Finally, I mentioned 0219U (a histopathology-AI lab service for breast cancer).  

See more links about the fall final rules here.  Though it doesn't have coding and reimbursement to address here, see my recent blog on PAIGE and its FDA AI approval, here, and Harry Glorikian's interview with the CEO of PAIGE, here.

click to enlarge

click to enlarge

Video title

Lung Cancer Screening NCD Under Review: Proposal Expected November 18, 2021

Takeaway:  CMS is reviewing its 2015 NCD for low dose CT lung cancer screening, and will issue a draft revised NCD by November 18, 2021.

_______

I believe I missed this first time around.  CMS created a national Medicare benefit for low-dose CT lung cancer screening in February 2015 (here).  At the time, CMS seemed to view the issue as relatively delicate, because RCTs had found a clinical benefit for LDCT screening, but the rate of discovering worrisome nodules, repeat CT testing, or having biopsy adventures was high.   

Another issue is that USPSTF, though operating slowly, can issue revisions to its endorsements at least year or two faster than CMS can update its NCDs, following such a USPSTF revision.

So, long story short, in May 2021, CMS opened an NCD review of its 2015 LDCT NCD.   The draft NCD revision should appear by November 18, 2021.  The reopening was based on a written 17-page request, filed on March 9 by GO2 Foundation, STS, and ACR.    The public stakeholders ask CMS to update the NCD to match the most recent USPSTF position, and make some other changes to details of the NCD.

Very Brief Blog: Revenue Headlines at Genomeweb Today

 Revenue headlines online at Genomeweb, morning of November 5, 2021.

click to enlarge

• Natera revenues up 61%
• Illumina revenues up 40%
• 10X Genomics up 74%
• Adaptive Biotech up 50%
• Qiagen up 11%
• Personalis up 12%
• Bionano over 50%
• Guardant up 27%
• Quidel up 7%
• Exact "busy for 2022," revenue up 31%

Very Brief Blog: Interim Final Rule, Vaccinations for Healthcare Workers (Links)

Much press today about an Interim Final Rule affecting vaccination status of healthcare workers in entities serving Medicare and Medicaid patients.  Some links here.

• Announcement that this was coming, September 9, here.
• Press release November 4, here.
• Federal Register page (publication 11/5) here.
• Preliminary publication (typescript) here.
• Trade press at "Rev Cycle" here.
• While the interim final regulation promises to be effective January 4, regardless of comments, comments are accepted for 60 days (circa Jan 4).
• Separately, the interim final rule from OSHA regarding large-employer vaccinations is online here.  This was quickly put on hold by a federal appeals court.

Quoting Rev Cycle, 

"CMS has issued the interim final rule with comment period requiring all healthcare workers to get a COVID-19 vaccine. The rule mandates vaccinations of eligible staff at healthcare facilities participating in Medicare and Medicaid programs by January 4, 2022.  

CMS said the emergency regulation will apply to approximately 76,000 providers and cover over 17 million healthcare workers across the US."

The rules apply "regardless of clinical responsibility or patient contact" to staff who provide "services for the center or its patients."  Telehealth employees who do not come on site (have contact with neither patients nor staff) are exempt.  Students and volunteers are included.  Employees and contractors are included.

___

Page 18 of the typescript recites 5 previous interim final rules (April 6, May 8, September 2, November 6), all 2020, and also May 13, 2021. 

A substantial part of the rulemaking is the actual regulations, running from p. 169 to page 214.   However, this is in part because they have to plug the Vax rules into multiple regulations, ASC regulations, hospital regulations, hospice regulations, and so on. The regulations are generally inserted into existing regulations mandating "infection control."  

Very Brief Blog: CMS Publishes Final Rules for Physicians, and Hospital Outpatient Services, CY2022

Every summer, CMS does extensive rulemaking and policy tweaks, as well as setting new prices, in the hospital outpatient setting and physician fee schedule (independent) setting.  After a comment period, the final rules appear around November 1, 60 days before the January 1 calendar year.

Here we go!  The rules appear first in "typescript" form (PFS 2414 pp, OPPS 1394pp), later in the Federal Register.

Find the physician fee schedule final rule here.  Fed Reg version on November 19.

Find the hospital outpatient final rule here.  Fed Reg version on November 16.

Press Releases and Fact Sheets

PFS Press release here, fact sheet here

OPPS Press release here, fact sheet here. 

Trade Press

Trade press at Fierce Healthcare here.   Becker's here.  Press release by Digital Diagnostics on CMS's AI pricing moves, here.  Many cancer hospital's don't comply with price transparency law, here. RevCycle on PFS here.  Fierce Healthcare on PFS here.  ASTRO (Radiation Oncology) "deeply concerned," here.   See a discussion November 12 by Shatzkes & Borha of the Sheppard law firm here.

Draft Rules

My notes last summer on the draft PFS rule here.  My notes on draft OPPS rule here.  (Also from summer, the final inpatient rule here.)

For me, topics of interest in the PFS rule this year including telemedicine liberalization, extensive discussion of AI reimbursement, new rules for AI-focused IDTFs, new principles for remote therapeutic monitoring and remote physiologic monitoring (RTM, RPM), regulations for document review, and rules to eject "abusive billing" providers from the program.  Several NCDs were proposed for deletion.  There were few surprises in the finalization of any of these initiatives.

In an unusual move, CMS priced the Heartflow cardiac image analysis code, which is very rare for a Category III code.  CMS did so by referring to the hospital outpatient charge-based rate and then mimicking it in the RVU valuation (see "Nerd Note.")   However, according to a late evening iRhythm press release, CMS did not nationally price the extended cardiac monitoring code that iRhythm uses (here, citing  93241, 93243, 93245 and 93247.)  New article on Heartflow here.

CMS discusses the impact of infectious disease on ratesetting at p. 385ff, and pain management at 389ff.

___

Nerd Note.

CMS proposed to crosswalk the main Heartflow code to the price of the corresponding hospital patient APC (ambulatory payment category), which is set by calculations based on hospital charges.  AMA RUC objected that PFS prices must be set by practice expense data such as the RUC provides, related to Balanced Budget Act 1997 Section 4005 and the corresponding CFR regulation.  (I cover this RUC objection in a September blog here, see "AMA RUC strongly opposed...")   However, I was aware that PAMA 2014 gave CMS broader authority to set RVUs by data inputs it finds appropriate.  In the final rule (typescript p. 106ff) CMS notes  its PAMA Section 220 authority to set prices with all sorts of data sources under SSA 1848(c)(2)(N).  Score one for CMS.  However, CMS actually set the price not by direct reverence to the APC dollar value, but by finding a crosswalk code (in the $900 range) that mimicked the OPPS APC value for the code.  

In another quite odd twist, (typescript p. 385) CMS after long debated finalized the stockroom price of a Zio patch at $200.15 (SD339) yet declined to finalize the national RVU price that this missing supply code would have established.

Very very brief blog: Webinar on Whole Genome Sequencing, EHR, Novel Paradigms

Today's email brought an interesting invitation to a webinar on December 6 on:

"Whole genome sequencing and

 electronic health record machine learning for 

hospital outbreak detection: A novel paradigm."

It's a Genomeweb-based webinar, sponsored by Tecan, which is involved in software and lab automation.  It's December 6, 2021, at 1 pm ET.   I've clipped the text below.  The speaker is Dr. Lee Harrison of University of Pittsburgh.

https://event.on24.com/wcc/r/3421020/1EB97F541D72A30D7089D36F74C48FFE

Text clipped as:

Approaches for hospital outbreak detection have remained unchanged for years. When an outbreak is suspected, a method to establish genetic relatedness such as whole-genome sequencing (WGS) may be performed. This approach can miss outbreaks and falsely identify suspected outbreaks that are refuted by WGS.

In late 2016, University of Pittsburgh Professor of Medicine and Epidemiology, Dr. Lee Harrison and colleagues began developing the Enhanced Detection System for Healthcare-Associated Transmission (EDS-HAT), which combines WGS surveillance with data mining and machine learning of the electronic health record (EHR) to detect outbreaks and correctly identify their routes of transmission, respectively. The team found EHR machine learning useful for transmission routes that cannot be identified by traditional means. The purpose of this talk is to describe the results of using this novel approach for detecting hospital outbreaks. 

For a listing of Genomeweb webinars,

https://www.genomeweb.com/events

For a November 9 interview between healthcare expert and future Harry Glorikian and the CEO fo PAIGE, here.

Very Very Brief Blog: HHS to rescind Trump rule that would "sunset" all health regulations

To quote Zach Brennan at Endpoints News (here):

"HHS is proposing to withdraw a Trump-era final rule that would have sunset thousands of FDA and other public health agency rules based on how long they’ve been in place."

It was a use it or lose it proposal, sort of like zero-base budgeting; if you haven't reviewed a regulation in 10 years, it's gone.   Read the rescission regulation here (October 29, 2021, 86 FR 59906).  Comments to December 28.

The original rule was finalized right at the very end of the Trump administration, on January 19, 2021 (find it at 86FR5694).   SUNSET - Securing Updated (and) Necessary Statutory Evaluations Timely.  

The original draft was November 4, 2020, and HHS held a hearing on the topic November 23, 2020.  A transcript (145pp) of the November public hearing is available (here).  The public meeting opened with an un-footnoted citation to Harvard's Prof. Cass Sunstein on the importance of reviewing all regulations, since at the time of issuance their benefits are necessarily speculative.  HHS remarks, "Professor Sunstein described this as one of the most important steps imaginable for regulatory reform, not least because it can reduce cumulative burdens and promote the goal of simplification. He has noted that agency's failure, until very recently, to gather, let alone act on retrospective reviews is an astonishing fact."

See Sunstein's books, Simpler: Future of Government (Simon & Schuster. 2013). The Cost-Benefit Revolution (Penguin, 2018), Too Much Information (MIT, 2020), Law and Leviathan: Redeeming the Administrative State (Harvard, 2020). Sunstein worked for the Obama White House, 2009-2012.