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.  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

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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/

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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.   

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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.

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).

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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.   

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[*] 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).  

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.

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

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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."

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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).

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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.  

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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.

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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.

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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

INSPECTION COPY OF FINAL DECISION (FEDERAL REGISTER)

https://public-inspection.federalregister.gov/2021-24916.pdf

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.

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