Which Two Things Are Enough Like the Other? NTAP and Product Similarity

CMS sometimes issues product-specific policies (e.g. the NCD on Provenge, the NCD on the Exact Sciences Cologuard test) and sometimes categorical policies (the NCD on transvascular valve implants, TAVR, which applies on a rolling basis to all similar valves the FDA approves).

Today at MedCityNews, Niall Brennan, former Chief Data Officer at CMS, has an interesting article on the definition of "similar" in New Technology Add-on Payments, the DRG supplement program (NTAP).  Essay here.  Brennan is CEO of the Health Care Cost Institute, HCCI.

I've always thought of these as product specific.  And usually that's an easy one: either there was only one product of the type being reviewed, or the product was a drug which by definition is usually unique.   I have a memory that CMS may have once or twice considered two products closely together, in parallel and consciously crosswalked to each other, but they were still two products with both being reviewed.

Brennan lays out the vision of some NTAP categories where they may be a profusion of products, besides the index product studied by CMS, or there may be disputes about whether some new product is similar enough to a benchmark product to be under the same NTAP.   

Can new products not reviewed by CMS tag along with an NTAP-eligible ICD10 procedure code that fits them?   I wouldn't be sure they could - but this is the point that Brennan's essay is about.  He writes;

Traditionally, a substantial similarity determination has been applied via new NTAP applications, and CMS has determined whether products are substantially similar and have told applicants whether they are eligible for coverage under the initial NTAP. Where things start to get problematic is if, instead of CMS determining substantial similarity, other vendors unilaterally assert substantial similarity in order to “piggyback” on an existing NTAP.

It's true that normally coding decisions are made by the hospital or other provider, if the real-world service is close enough to a CPT or ICD10 procedure code to fit.  It's a new viewpoint to note that the ICD10 procedure code could be locked to a special payment rule designed for one product, although the ICD10 procedure code itself is applicable to more than one product.

CMS Part B Data: Profiling Code 81479 Billing in CY2018

Summary:  This article briefly highlights use of unlisted molecular pathology code 81479 in 2018 versus 2019, with a deep dive into recently-released granular data for 2018.  CMS data is easy to find and review; this blog took less than an hour "A to Z" including finding the cloud data, arranging it in small Excel tables, and writing.  

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National Data for 81479

From data released nationally by CMS in Excel spreadsheets (here), we know that CY2017 use of code 81479 (unlisted molecular test) was $116M, CY2018 use was $135M and CY2019 use was $202M.   The growth rate more than doubled from +16% to +50%, and the two-year growth in 81479 was +75%.

• In CY2019, 81479 the third-highest MoPath code (behind 81408, #1 at $290M, and 81528 Cologuard, #2 at $245M).   
• 81479 is an "unlisted" code that falls outside of PAMA pricing rules, both regarding data collection and regarding price setting.

By going through state-by-state Excel spreadsheets for CY2019, I ascertained that nearly all CY2019 use of 81479 was in MolDx states, with a few percent of use by Novitas in Pennsylvania.   For example, from 2018 to 2019, MolDx shifted its coding instructions for about 7000 cases of 81455 to 81479, adding to the 2019 growth in 81479 (see article on 81455 here). 

Here, I focus on detailed and easily-manipulated cloud databases released by CMS for CY2018 (here). This data is older than 2019 data, but far easier to use, since it's in cloud databases.

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State Level Data for 81479 for 2018

CMS's state level data for CY2018 has 260,000 rows (each use of a CPT code in each state can be a row), but filtering for 81479, only 22 rows are left.  That is, 81479 was used in only 22 states.  

58% of the dollarized use was in California, 28% in Ohio (for Myriad Assurex Health, Genesight).  That's 86% of the 81479 use in 2 states out of our 50 states.  See table below (click to enlarge).

Nearly all 81479 billing in 2018 was in MolDx states - easily discovered in the CMS cloud database for 2018.   This is the same result I got by manually going through each one of the newer 2019 state level Excel files one by one for code 81479.  

Lab Level Data for 81479 for 2018

CMS's provider (lab) level data has a robust 10M lines of cloud data.  Filtering for 81479 gives only 58 rows, e.g. 58 labs billed at least 10 uses of 81479. (FN1)

• The top payee for 81479 in CY2018 was Assurex Health, Ohio, 17,341 services, $38M (average allowed, $2,178).  
• The next highest was CareDx, California, 7,571 services at $2841 for $22M.  
• The third highest was Genomic Health, California, 5,184 services at $3121 for 416M.  
• These three of the 58 lines total 56% of the 81479 payments.  

Below, I chart all of the labs paid at least $100,000 in CY2018 in this Part B data.  Like in the prior table, the few labs outside MolDx states are shown in red.  Click to enlarge.

Note that in "state" data for Ohio, there were 17,529 uses of 81479 among 5 providers.  While in "Assurex" data for Ohio, there are 17,341 uses of 81479. at $2178.  Some other 4 providers apparently divided 188 other uses of 81479 in Ohio.  Further down in the lab-level table, we find that Labcorp was paid for 178 uses of 81479 for $321 via its Dublin, OH location.  

Dublin wasn't the only place where Labcorp billed 81479.  Labcorp has two Research Triangle Park entries for 81479, under two different NPIs ('6001 and '8700), getting 3,563 81479 services at one, and 223 81479 services at the other.

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The original spreadsheet data I used is in the cloud here. (FN2)

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Caris - Mix of Molecular and Pathology Codes in 2018

Caris, which raised $310M in growth capital in fall 2020 (here) and ranked highly in recent data I studied for CY2018 use of CGP (tumor profiling) code 81455 (here).  

By pulling Caris lab data for CY2018 from the cloud, we find that 81455 (tumor, 51 or more genes) constituted 71% of its CY2018 payments from CMS; total CMS dollars allowed were $28M in 2018.  

Note that a significant percentage of Caris's CMS payments were 88-series codes, or tissue pathology codes rather than 81-series codes for genomics.

81479 Charge/Payment Ratios

Charge to payment ratios are pretty meaningless in Medicare, but sometimes fun to look at.  I sorted for the labs with Charge/Payment ratios at 5 or over (range, 5-12).  Most had less than $10,000 in Medicare payments.  The average payment was  $177.  All were in non-MolDx states.  (E.g., use of 81479 in non-MolDx states is rare, and pays poorly.)   

Though not a high-ratio case, Labcorp in NC was paid for 3,563 cases of 81479 for $1.2M, but that's only $327 a case.

   

Tennessee  switched from the Cahaba MAC to Palmetto MAC in 2018, but I don't believe MolDx rules were applied until mid-year or later.

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FN1

109 providers billing 81479 are shown in the state data, but only 58 in the national data of labs.  The difference is that providers must be paid for 10 or more uses to show in the national data, providers paid for 9 or less uses are not shown.   Apparently, 51 providers were paid for 9 or less uses of 81479, and 58 were paid for 10 or more uses of 81479.

FN2

This week, Google Drive appears to convert uploaded Excel workbooks into Google Sheets automatically, although my settings tell it not to do that.  (?!)  I believe that if you click Download it will give the option of back-converting to Excel.   

CMS Part B Data: Profiling Tumor-Genomic-Profiling Billing in CY2018

I noted earlier this month that CMS had (finally) released provider-specific CPT code utilization data for CY2018 - here.   

In this blog, I look at the billing patterns for comprehensive genomic profiling (CGP; codes 81445, 81450, 81455) in CY2018.   One middle-ranked biller is Tempus, which caught my attention, and I pulled Tempus's billing for CY2018 also.

A major reason that the CGP codes caught my attention is the recent formation of a coalition to improve access to testing, the Access to CGP group - find it here, https://accesstocgp.com/

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I went to the 2018 Part B cloud database (here) and searched on the following codes:

• 81445, 5-50 tumor genes.  About $600.
• 81450, 5-50 tumor genes, hematopoietic cancers,  About $600.
• 81455, 51+ tumor genes.  About $3000.
• 0037U, Foundation Medicine F1 (FDA) Test.  About $3500.

Here's the Medicare utilization for 2018:

• For 81445, there were 3,173 uses totaling $1.9M, and the highest biller was Interpace (Pittsburgh) with 627 cases.
• For 81450, there were 4,889 uses, for $3.7M, and the highest biller was Genoptix with 2,949 uses for $2.2M.
• For 81455, there were 7,476, but from only 8 labs, totalling $22M.  The highest biller was Caris in Phoenix with 6,872 uses for $20M.  
• Finally, Foundation Medicine 0037U received $33M for 9,884 FMI F1 cases.

In 2019, where we have national but not provider level data, these codes were used as follows: 81445, 7,424 cases for $4.4M; 81450, 12,196 cases for $9.2M, and 81455, only 847 cases for $2.3M.  (That's just about what would happen if you pulled out Caris's 6872 cases in 2018).   And 0037U rises in 2019 to 22,914 cases for $80M.

Understanding the Changes from 2018 to 2019

81445 and 81450, the 5-50 gene codes, both grew considerably from 2018 to 2019 (they're the blue and orange bars below), while the FMI code 0037U towers above the other codes in 2019.    Adding all four codes studied, usage grew from 25,422 in 2018 to 44,381 in 2019.

Curiously, the standard AMA CPT high-complexity tumor code, 81455, actually fell from 2018 to 2019. in fact, it fell by over 80% (gray bar).  What gives?   I think the answer is that most MACs don't pay for 81455 in 2019, while MolDx does pay for it, but under unlisted code 81479.  Thus, the drop in 81455 (51+ tumor genes) from 7476 uses to 847 uses in CMS 2019 data reflects the "shunting" of this service to unlisted code 81479 in 2019, at MolDx, about the only MAC that was paying for 81455 in 2018.  See my parallel blog on 81479 here.

MolDx and 81455, 51+ Genes

Note that the MolDx program (which paid the 7,476 cases of 81455 to Caris in CY2018) normally does not use code 81455, for reasons I've never understood, and probably pays most genomic profiling venders under unlisted code 81479 plus Z codes.  

In 2019, 2020 public meetings, I've heard MolDx staff say they've now stopped paying 81455 in the few cases where they might have paid it in 2017 or 2018.  Their LCD for large tumor gene panels clearly instructs labs to use 81479 (molecular unlisted) not 81455 (tumor genes 51+) when you study 51+ tumor genes.

Tempus 2018

Tempus shows up in the list for billers of 81445, with 39 cases for $23,000.   This goes along with something I noticed earlier this year, MoPath payments in any NGS MAC states are very tiny, with the sole exception of Cologuard, which is paid in NGS MAC state Wisconsin, but via an NCD, not local coverage.  

Turning to billing by Tempus in CY2018, in this Part B database, they were paid $1.9M, of which 47% or $905K was paid for code 81211, BRCA testing.  They billed in total two dozen codes, many paying less in total than $25,000.   

Tempus raised an additional $200M in 4Q2020, bringing net funding to $1B (here).

Find the Data By Individual Lab for 2018

See my Excel spreadsheet in the cloud here.  

I've also put screen shots below (click to enlarge), but it's going to be easier to read the cloud spreadsheet.

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Readers interested in the tumor genome consortium A-CGP cited above may also be interested in a New York-based effort to document the clinical utility of whole genome sequencing - January 2015 Genomeweb article here.

Very Brief Blog: McKinsey Issues Report on COVID, IVD Dynamics

The consultancy McKinsey has released a new report summarizing market trends in diagnostics stimulated by the COVID crisis and the associated boom in molecular testing.   

The trends cited aren't all earth shattering - more use of molecular testing, more use of point of care testing - but it's nicely collated in one place.  

There's a web version, and a typeset PDF is free with email registration.

Here.

CMS and Some Digital Health Codes, 2018, 2019

Entry points to the discussion on Medicare and digital health are too numerous to cite.   In this blog, I look at some actual digital-health-related codes in CY2019 and, for a few codes, 2018 data which is more granular.  Bottom line?  Some codes like remote physiological monitoring and a new type of e-consult based on electronic records, saw remarkably little use in CY2019.

In a December 1 blog on the final PFS rule, I discussed how Medicare bumps and collides against some payment concepts that will be needed in digital health (here).  In today's blog, I just lay out some plain-jane data and numbers from 2018 and 2019.

CMS Data Sources

CMS has released 2019 data as national Part B utilization and payment files at the level of CPT codes.  See my original blog here.   If you go back to 2018, CMS recently released cloud data file for CPT code utilization and payment level at the national, state, and even the provider level (e.g. Dr Jones used CPT 92011 30 times).   These latter cloud databases are easier to use than Excel files, for but 2019, Excel is all we have.  

I've cherry-picked a few groups of codes:

E-Consults between physicians - Codes

Historically,  physicians got "consult codes" for seeing a patient at the recommendation of another physician, primarily to report back their judgment rather than to take over a new patient.  New CPT codes allow non-face-to-face interprofessional communications.  These are codes 99446-99449, for up to 10, 20, 30, or >31 minutes of time.

Remote Physiological Monitoring - Codes

These were exciting new codes in 2019, and I got a lot of questions on them from d-health startups.  99453 provides the device, 99454 compensates for 30 days of use (e.g. as if rented from physician).  99091 is collection and interpretation of data (minimum 30 minutes of time).  (If I read correctly, 99091 will continue to exist in 2020, 2021, but largely replaced by 99457, 99458.  I'm not looking at 2020 data, so I haven't studied this).

iRhythm - Codes 

In 2021, iRhythm will graduate from its longstanding Category III codes to Category I codes, an issue that required extensive discussion by CMS regarding RVU valuations (CMS ended up declining to assign national RVUs for some of the codes for CY2021; see iRhythm transcript here).  But we do have access to CMS payment data for the Cat III codes in CY2018 (by provider) and CY2019 (at the national level).   Codes are 0296T for recording including connection, 0297T for analysis and report, and 0298T for final physician interpretation.  0295T also exists, a comprehensive code for each component together. So, 0295T-0297T.  I'll shorthand these as iRhythm codes, but they apply to any comparable technology coded the same way.

- - - - Data - - - - 

E-Consults 2019 - Data

Despite the excitement about physician-to-physician electronic consults (consults based on provided EHR records),  national use was very low, relative to the tens of millions of Medicare Part B patients.  The entire budget for this services in 2019 was less than $400K and only several thousand uses of this service were filed by clinicians.

Remote Monitoring 2019 - Data

This is pretty similar data.  Despite all the interest in remote physiological monitoring codes newly launched by CMS in 2019, the payments for these codes were only a couple million dollars.  The months of monitoring used were about 60,000, which is about one month of remote monitoring for every 800 Medicare patients (it's not terribly far from 1:1000).  

IRhythm (or similar technologies) - Data

2019 National Data

The comprehensive code was used in less than 10% of patients, and paid an average of $264.  The partial code 0297T, in contrast, was used 240,000 times, and paid an average of $311.  Physician interpretation paid an average of $27.  In 2021, the RVU prices for the successors to 0295T, 0298T, will not be priced by CMS, while the successors to 0296T, 0298T, will be priced by CMS in RVU values at about the same value as shown in the carrier pricing (local pricing) above.

2018 Line Item (Physician) Data

Note that you can get extremely granular summary data, such as the age distribution, race distribution, state distribution, of payments for 0295-0298T, in CY2018 here.  See aggregate cloud data links in the lower part of the webpage.  For example, at your fingertips you can get the number of 0298T patients that were African-American, or Medicare-Medical patients, or >age 85 patients.

• I've put an excel spreadsheet of provider information (5000 lines of Excel) in the cloud here. 
• It's sorted by CPT code then dollar volume per line. 

In 2018, 0295T, the comprehensive code, was billed by 150 doctors, the highest being a North Carolina physician with 299 services paid $67,806.   The payment level varied greatly, from $88 to $315. One doctor in California, Palm Springs, billed CMS for $4800 per use (he was paid $68).

In 2018, 0296T, the provision code, was billed by about 1850 doctors.  Payments ran from the single digits to the mid-$20's.  The highest volume was an Illinois doctor with 566 provisions of the device netting $18,061 or $24 per device (he billed $142).  

In 2018, 0297T, the analysis code, was billed 130,486 times by an IDTF in Illinois, charging $397, paid on average $238 (allowable $307) totaling $40M.  The next-highest IDTF was in Malvern PA, with 17,224 cases for $261 (charge $2784, allowed $335).  The two top IDTFs had 97% of the market for 0297T.  Several other IDTFs billed far smaller amounts in Texas and Maryland.  

But there's more for 0297T.  About 70 clinicians also billed for "analysis" 0297T.  Cases were typically 100 or less, and payments $300 or less, sometimes as little as $25.  3,116 cases of 0297T were paid to physicians, for about $1M.  One doc with a Cedars Sinai office building address in LA charged $500 per 0297T service (allowed by Noridian for 0297T, $43.)

In 2018, 0298T, the physician interpretation code, was billed by about clinicians.  The highest billed 783 services for $20 each.  Three other clinicians billed >500 cases each.  About 2800 clinicians billed for interpretations, whereas only 1850 billed for provision of the device.  

In the table below, I pull only the IDTF-based billings for 0297T in 2018.  Interestingly, PA TX MD are under one MAC Novitas, but appear to pay different rates, and IL, where iRhythm is shown as billing, pays the lowest average allowable rate ($307) of the 8 IDTFs listed.  

For an update on iRhythm pricing in January 2020, here.

 

CMS Part B Drug Pricing Proposal Dynamites Existing Law; PhRMA Protests in Court; Hidden Backstory

Overview

On November 20, 2020, CMS released a blockbuster proposal to national reprice Part B drugs according to international price metrics (aka Most Favored Nation Status, or MFN).   Response from the biopharma industry was swift and resulted in a major legal filing by December 4.   The Medicare policy facts are pretty bizarre and I'll both lay out the key facts and provide some fascinating backstory in this blog.

Update 12/15

• CMS Files motion to dismiss.  46pp.  Here.
• See Navathe et al. on Future of CMMI, Health Affairs.  Here.

Update 01/17

• There will be numerous ongoing legal motions and injunctions.  CMS home page for this project should give the latest status.  Here.
• January 21:  Personalized Medicine Coalition comment here.
• February 19:  Liz Fowler tapped to head CMMI here.
• (Retro to December): See an excellent review at McDermott on MFN, here.
• This is a comprehensive review that includes comparisons to Eurozone policies.
• See a March 2, 2021 article in JAMA, Kesselheim et al., here.

What CMS Did on November 20

CMS used its authority (from SSA 1115A, part of the Affordable Care Act) to create new demonstration products.  It's used this authority dozens or hundreds of times.  In this case, CMS asserts it can rapidly create a nationwide demonstration program that will last for years, and totally reconfigure drug pricing policy under Part B (e.g. intravenous drugs, chemotherapy, etc).   In fact, SSA 1115A does create the Center for Innovation (aka CMMI) and allows it waive any part of Medicare law for the purpose of demonstration projects.   The law is brief and doesn't state any limits on the duration of a demo (e.g. 6 months versus 999 years) or the scope (3 metropolitan areas versus all 50 states) or the project content (e.g. tweaking a small rule as a pilot versus raising the Medicare age to 75).  

• See the CMS fact sheet here.
• CMS calls this the PDPM, Prescription Drug Payment Model, which doesn't capture the fact it is Part B drugs only.
• However, the CMMI webpage it titled Most Favored Nation - here.
• See the CMS press release here.
• The proposal was released in tandem with an HHS report on drug price inflation here.
• See the November 27 Federal Register web page here. 
• See the 80 page PDF here.  85 Fed Reg 76180-259, November 27, 2020.
• Yes, somebody was working the day after Thanksgiving.  
• My understanding the rule doesn't change what manufacturers charge, just what CMS pays in compensation to hospitals or doctors for those patients who are fee for service Medicare patients.
• It doesn't affect Medicare Advantage except in that overall per-patient capitation for MA will slip downward as FFS payments are reduced.  

What Happened Next?

A number of major stakeholders, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Association of Community Cancer Centers (ACCC), the Global Colon Cancer Association (GCCA) and National Infusion Center Association (NICA), filed a law suite against the CMS pilot on December 4.

The 65-page lawsuit argues first, that the pilot program is illegal.  That is, the pilot program is too big and exceeds the concept of a "demo" or "pilot" program under SSA 1115A.

In the alternative, if the project was legal under the text of SSA 1115A, it's not legal under the constitution, because it is too big a delegation of authority from Congress to the Agency.

• See ACCC press release here.
• See PhRMA here.
• You can download a legal one pager or the full case from the prior link.  
• Full complaint PDF here.
• There are collateral motions like injunctions and restraining orders.
• See trade press:
• PolicyMed here, here.
• National Law Review / K&L Gates - here.  And / Polsinelli, here.
• Healthcare Finance here.  "Would cut drug reimbursements to hospitals by an average of 65% when fully phased in, the AHA says."

What's All This About a Backstory?

There's a lot of fascinating backstory here.

Before 1115A, No Demo Projects without Specific Legislation

Before SSA 1115A in the ACA of 2010, CMS had no authority to do demonstration projects.  This allegedly impaired innovation in our health system.   From time to time, a little demo for this or that would squeak by Congress in a paragraph of law, and CMS would dutifully carry out the little demo, and issue a report on it, and close it down.

In fact, the SSA itself contains some line-item demo projects.  For example, ACA 3113 created a short demo project that provided an escape valve from the date of service rule, which bundled reference tests to being billed only by the hospital where the sample was obtained.  For example, if a patient in 2009 had a breast biopsy in Florida, and 7 days later had a genomic test report from the Genomic Health (Oncotype) lab in California, only the Florida hospital could bill for it.  But the Florida MAC might not know Genomic Health from a hole in the ground, and claims wouldn't get paid.   

Demo 3113, Complex Tests, Date of Service 

As of 12/2020, HHS still has a guidance webpage for Pilot 3113, one dated January 28, 2011, one dated March 10, 2011.  It refers to transmittal CR7278, Publication 100-19, Demonstrations, Transmittal 70.  Here.   CMS excluded tests that didn't have specific CPT codes, which left the advocates for this demo in the lurch, since proprietary codes (MAAA codes) or PLA codes...hadn't been invented yet.

See the CMS home page for Demo 3113 here.  See a Fact Sheet about the demo, July 2011, here. See a "request for G code" document here.   See the legislative language here.  See a Report to Congress, 2015, here, and a final report, 2016, here.   

1115A:  CMS Now Can Make Demo Projects On Its Own Volition

Section 1115A of the Social Security Act is brief and creates the Center for Innovation at CMS.  Read 1115A here.

The key issue with CMMI is what we introduced early in the blog:  it can create demo projects of variable length, geographic scope, and policy scope, but there is no remark anywhere in the law about how big or little, how long or short, how trivial or massive, the pilots can be.   So, hypothetically, you could waive Medicare law for a pilot project excluding women from Medicare enrollment for 100 years in all 50 states.   

Admittedly, the projects are supposed to be expected to not reduce health quality and not raise costs, which produces some scope limitations, but those are just guidelines for what the agency says it hopes to achieve in a demo.   

The law also lets CMS make permanent successful demos if they are shown (objectively, by actuarial review and endorsement) to maintain quality while not raising costs.  

However, there's a quirk in that the law says CMS may suspend or change (waive) any aspect of Medicare law "solely for purposes of carrying out this section with respect to testing models described in subsection (b)" where (b) refers to Pilots, not Extensions.  I've seen CMS argue, somewhere in the Federal Register, that the law giving ability to waive law for pilot projects (b) implies it can also waive law for resulting permanent programs.  However, as a non attorney, I find that reading hard to believe, see the law specifically says waivers can be SOLELY for the purpose of the section on pilot models "b."  Expansion of models is law section "c".  To me, a law that is "solely for [b] " is a law that does not include  the adjacent "c."   Of course, CMS could escape this problem by making the demo "b" phase 99 years long instead of a year or two, so the demo never faces finalization as expansion phase "c."

Obama Administration Proposed Part B Drug Pricing Demo!

The Obama administration proposed a less drastic Part B pricing model in 2016.  This was proposed on March 11, 2016, 81 Fed Reg 13229-13261, here.

Here's how the 2016 Obama administration described its fairly modest proposal:

This proposed rule discusses the implementation of a new Medicare payment model under section 1115A of the Social Security Act (the Act). We propose the Part B Drug Payment Model as a two-phase model that would test whether alternative drug payment designs will lead to a reduction in Medicare expenditures, while preserving or enhancing the quality of care provided to Medicare beneficiaries. The first phase would involve changing the 6 percent add-on to Average Sales Price (ASP) that we use to make drug payments under Part B to 2.5 percent plus a flat fee (in a budget neutral manner). The second phase would implement value-based purchasing tools similar to those employed by commercial health plans, pharmacy benefit managers, hospitals, and other entities that manage health benefits and drug utilization. We believe this model will further our goals of smarter, that is, more efficient spending on quality care for Medicare beneficiaries.

Republicans Hated CMMI and its Models and Trashed It

Republicans were quite hostile to CMMI, in 2016 and before, climaxing in 2016 after the drug model was proposed.    There were hearings on the Hill very toxic to the CMMI.  The group Citizens Against Government Waste wrote op eds against CMMI repeatedly (entry point here).  Some groups like AARP supported CMMI by writing letters to Tom Price, chair of the House budget committee (here).  

A House hearing lambasted the CMMI, see links at my blog of 9/24/2016, here.  Note that at that time, Republicans were basically taking positions against the constitutionality of CMMI that PhRMA is taking in 2020.

Moratorium on CMMI by New Trump Administration

I recall that Trump's first Secretary of Health, surgeon Tom Price, diss'ed the CMMI in his confirmation hearings (and see FN1). I believe in 2017 the Trump administration under Price went so far as to declare a CMMI moratorium.

However, by September of 2017, CMS was realizing that despite previous objections to the legality of CMMI, it could be a powerful tool for doing....well, for doing about anything.  Seema Verma had a Op Ed in WSJ on September 19, 2017, touting the possibility of a re-envisioned CMMI (here).  CMS held an open call for comments about how it could reboot and re-use CMMI.   Verma wrote, "This administration plans to lead the Innovation Center in a new direction. On Wednesday we are issuing a “request for information” to collect ideas on the path forward."  The 9/2017 RFI is still online here.

By 2020, the tenth anniversary of CMMI brought much praise via a symposium (see links here, anniversary video at YouTube here, and a subsequent 10/2020 article about "lies and revisionism" at CMMI, at MedCityNews, here.)  See a review article about the first decade of CMMI at Health Affairs here.

Trump Administration Touted International Pricing Model in 2018

Trump Administration touted the IPI, International Pricing Model in 2018, schema in May here, notice of future rulemaking in Ocober here, proposing it would launch in 2019 or 2020.  (The date in the brand new rulemaking is 1/1/2021).  See contemporary article at Modern Healthcare, 10/25/2018, here.   PhRMA did not like the IPI (e.g. here).

Early 2020 Legislation Would Have Reigned In the Scope of CMMI

See coverage in February 2020 at Healthcare Dive here.  Legislators (both "D" and "R") introduced HR 5741 to rein and CMMI and introduce more accountability to it.   See press here.   See House legislative text here.  The bill promises to "clarify parameters" under which CMMI operates.

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FN1

See the House Concurrent Budget Resolution of 7/2017, here.

"H.Con.Res.71."

The Centers for Medicare and Medicaid Innovation [CMMI] 

presents another example [of why ACA is bad]: CMMI 

was designed to test new payment models in Medicare and 

Medicaid, but the Obama Administration interpreted its 

authority beyond the ability to ``test'' payment models and 

announced it will ``mandate'' untested payment models that may 

adversely affect quality of care for Medicare and Medicaid 

patients. In the new administration, HHS Secretary Price has 

signaled his intent to restore the CMMI program to its original 

intent.

Price resigned from HHS related to air travel expenses, in 9/2017.

CMS said in 7/2019 it would only use mandatory payment models when it couldn't get enough participation in voluntary models - here (see several links and quotes related to both Seema Verma and Alec Azar, and some callbacks to Tom Price.)

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The MEDPAC policy commission submitted a 13-page comment to CMS on 1/25/2021, stating it had "significant concerns about the structure and potential effects of the MFN model."  Here.  They add the MFN "manifests a number of serious flaws."  They also note that basing the MFN on per-drug sales (for top drugs) could unfairly bias providers toward lower-volume drugs.  For example, drugs A,B,C are in the same class and about the same price.  Drug A is large enough in sales to trigger MFN, so its price is cut in half, but drugs B and C are not, and remain at the same high price.

Noridian Hosts January Expert Panel on Pathogen Panels / Infectious Disease

Noridian has announced it will host a public panel of experts in a four hour meeting on January 11.  The topic will be "Molecular Diagnostic Testing for Pathogens."  In this blog, we make some guesses what the backstory might be.

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Find the Noridian home page for public policy meetings here.  Based on a December 8 update, there's a pending meeting on January 11, 2-6 pm CST, and registration is open.  The topic?  "Molecular Diagnostic Testing for Pathogens."  (PDF here.)  

The moderator will be Anitra Graves MD.  See her Linked In as a medical director at Noridian here.  In her earlier resume, she is listed as a pulmonologist or intensivist in Georgia. She's been associated with Medicare since 2018.  Her Linked In lists her as a Palmetto general medical director from 2018 to March 2020, and as a Noridian DME medical director since September 2020.

The registration page gives a bit of additional information, cut pasted here:

A multi-jurisdictional Contractor Advisory Committee (CAC) Meeting to discuss clinical literature related to Molecular Diagnostic Testing for Pathogens is being hosted by:

• Noridian Healthcare Solutions

• CGS Administrators 

• Palmetto GBA

• WPS Government Health Administrators

The purpose of the CAC meeting is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing the Local Coverage Determination (LCD) and promote communications between the Medicare Administrative Contractors (MAC) and the healthcare community. 

The CAC panel will be asked to discuss the clinical literature related to "Molecular Diagnostic Testing for Pathogens" and rate their confidence in a series of Key Questions. Discussions will occur between the CAC panelists and MAC Contractor Medical Directors. The public may attend; however, questions from the public will not be entertained. 

How will the agenda be filled in?

I can only offer some guesses.  Noridian (and other MolDx MACs) have quite restrictive LCDs regarding the use of viral or pathogen panels in respiratory and GI disease.   Coverage focuses on only the minimal CPT code set, that for 3-5 pathogens, and higher-count pathogen tests are generally not covered.    See: here. 

Recently, of course, there's much more interest in picking up co-pathogens in COVID pneumonia, and such patients are often hospitalized, on antibiotics, and difficult to culture, bringing the focus to molecular testing.  FDA has granted EUAs for some large pathogen panels (e.g. 20-21 pathogens) to which COVID testing has newly been added.    For example, read about Biofire panels under EUA "plus COVID" -- here.

My bet is that the main topic will be the use of these large panels in COVID patients, especially outpatients, since testing for inpatients would be under a DRG anyway and not paid separately.

I do know that when MolDx initially promulgated narrow LCDs on pathogen test panels, there was public pushback from AMP, CAP, IDSA, ASM, perhaps others.  See Medicare document A56251 here.  

IDSA, CAP, AMP (April 2020)

Newer and more specific to COVID patients, see a letter from AMP, CAP, IDSA, others, to Seema Verma on 4/28/20 here, and a Genomeweb article on the topic on 4/30/20, here.

Other possible topics include COVID antigen and antibody testing, but I'm not sure if this will be an added focus or not.  

CMS Posting: All Tests With COVID Inside Get Special Ordering Rules, But Not Necessary "Coverage"

There's a pretty bizarre situation where CMS issued special emergency rules and exceptions regarding the ordering (and ordering documentation) for tests containing COVID.  These ordering rules apply equally to a test that is solely COVID (e.g. U0004), or a test that contains COVID (e.g. a large Biofire 22-pathogen test, one of which is COVID.)   However, CMS announced publicly in June 2020 that is ordering rules don't extend to coverage.  See FN1.

Additional Background on Molecular Clinical Utility

In 2019, American Society for Microbiology published a position paper on Clinical Utility of Advanced Microbiology Testing Tools, by Miller et al.  It's an important publication and worth checking out for anyone interested in clinical utility of diagnostics.  Here.  

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FN1

CMS COVID ordering rules are not equal to CMS coverage of COVID testing.  

CMS says its table of COVID-containing tests is a comprehensive listing of all tests that contain COVID, and any of them may qualify for special emergency rules regarding a physician's order.   However, CMS adds the table ONLY concerns tests that fall under its physician-order-policy, and this is not a table regarding COVERAGE.    

See the CMS clarification at its (currently 165-page) guidance of COVID special rules, here:

 https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

I'm quoted from the 12/8 online version, but the particular question in the FAQ is dated back to 6/19.

11. Question: Does the CMS table “COVID-19, Influenza, and RSV Clinical Diagnostic Laboratory

Tests for which Medicare Does Not Require a Practitioner Order during the PHE” list Clinical Diagnostic Laboratory Test codes that Medicare will cover during the PHE? 

Answer: This table lists codes that, if otherwise covered by Medicare, do not require a treating practitioner’s order as a condition of Medicare payment. The table should not be interpreted as a statement of coverage for the listed codes. There may be some codes for which there are local coverage determinations that non-cover or limit coverage of certain tests. 

Practitioners and laboratories should check with their local Medicare Administrative Contractor regarding specific questions of coverage. New 6/19/20

ASU Diagnostics Resources; New George Poste Deck on COVID Science/Policy Intersection

ASU offers a unique Master's program in Biomedical Diagnostics - here.  Oriented to COVID, they also offer some "Diagnostic Commons" websites, developing one for the workplace (Workplace Commons here) and one for testing (Testing Commons here).  They also run a good webinar series with an archive of presentations (here).  And a blog site here.

On December 8, the ASU team held a fifty-person diagnostics workshop devoted to COVID policy.   ASU's national thought leader on diagnostics, Regents Professor George Poste, runs an extensive website of his frequent talks, here, part of the CASI or Complex Adaptive Systems Initiative.   Poste has posted his 34-slide deck from the December 8 workshop here.  Recommended.

Aside -

While on the topic 

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House Introduces PASTEUR Act for Antibiotic Innovation; Follow-up to Senate Bill in September

\In September 2020, Senators Bennet and Young introduced the PASTEUR Act to promote antibiotic innovation.  See favorable discussion at Pew Foundation here, from IDSA here.  

Now, in December, in the House, Doyle and Ferguson introduce the sister bill - here.

There have been several bills to help ameliorate the crisis in new antibiotics development.  The DISARM bill would provide payment for fee for service patients outside the DRG - a helpful but relatively limited response to a national problem for all patients.  The PASTEUR Act  (also here) would set up essentially a trust fund to buy large amounts of novel next-generation antibiotics.  It also has some requirements around use of diagnostics and use of antibiotic stewardship.  

One concern with novel antibiotics for special purpose is that they may be used so rarely for obscure "killer bacteria" that the manufacturers go under, or such that investment is not made in the first place.  A large private-public investment partnership, CARB-X, funds antibiotic development, as does BARDA.  There is a federal panel for policy on antibiotic resistance (PAC-CARB) and in October 2020, HHS released a new five-year plan for antibiotic resistance policy and actions.

For a few articles on the antibiotics innovation crisis, see PBS here, Nature here, MedCity here.

 

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Medicare Fix: Colorectal Screening Act to Remove Copays from Colonoscopy Biopsies

Update: I understand that the Colonoscopy Copay bill HR 1570 is expected to pass House & Senate in the year-end omnibus budget bill, 12/21.  That bill is also expected to contain out of network legislation.

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A few days ago, I discussed the introduction of H.R. 8845, a bill that would require Medicare to cover multi-cancer liquid biopsy screening tests upon FDA approval (here).  Here's another Medicare fix, H.R. 1570, a bill which would remove copays from colonoscopy biopsies.  It actually passed the House this week (but so did dozens of other tiny bills).

• See the bill text here as a House.gov PDF.
• Note that this version confounds a colorectal section (pp 1-5) with a drug pricing section (pp 5-11).
• See the CBO score here.
• See the GOV webpage for the bill here.
• For some new trade press see here.   It sounds like HR 1570 'passed' the House in 12/2019 "inside of" HR3, but it is now re-introduced on its own two feet as HR 1570 for a direct vote on Dec 9 (here)
• See an Amer J Managed Care sponsored article on colorectal cancer screening policy here. PDF here.

I haven't tracked this issue in detail.  I know for years, there were Medicare policy (theological) debates like these.  (1) A screening colonoscopy that finds nothing is billed as a screening test, no copay, but if you find and remove a polyp, does it become a diagnostic surgical procedure (copay)?  (2)  If you go direct to a screening colonoscopy, it's a no-copay screening service.  But if the same screening colonoscopy is triggered by a positive screening fecal test, is it now a diagnostic workup of the positive screening result?     See American Cancer Society here.[*]  See 2018 article in Stat here.  See  ...And so on.   

Similar issues arise in other screening services.  For example screening mammography finds a shadow, and the biopsy is considered a diagnostic surgical procedure.  Similarly for low dose screening CT for smokers - find a mass and it's a copay biopsy.  Ironically, in the lab test industry, this can be a good thing, because the original LDCT service had to go through oneous USPTF and NCD review, whereas a blood test to "work up" the mass or shadow becomes "diagnostic" and therefore requires only a quick LCD.   

Tricky

This is a tricky area because the current "Congress.gov" online version is very short (here) and a PDF version online elsewhere at House.gov is pretty complex and convoluted legalese (here).  The PDF version, while titled the Colorectal Screening Act, switches on page 5 to a lengthy discussion of drug pricing reporting rules.  

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[*]

Per American Cancer Society, "But if you have a screening test other than colonoscopy and the result is positive (abnormal), you will need to have a colonoscopy. Some insurers consider this to be a diagnostic (not screening) colonoscopy, so you may have to pay the usual deductible and co-pay."  And CMS says, "If a polyp...is found and removed...you may pay 20% [copay]...".  Here.

Regarding a family history and BRCA screening, Kaiser Family Foundation notes that due to a transmittal from HHS, under preventive services in ACA, both genetic counseling and BRCA testing are covered without copay (here).  At this webpage, see "FAQ Set 12 Q6."   This is good because the USPSTF benefit is really focused on genetic counseling.  However, if you have Medicare, it doesn't cover genetic counseling ever and it doesn't cover a BRCA test unless you have a personal history of cancer. 

To see the diversity of floor actions in the House, here.  Go to Dec 8 and HR 1570.

An Extra Way to Boost DRG Payments: the NCTAP, New Covid Add-On Payments

It's November news, but I just ran across a new way to get extra payments above a DRG from CMS.  It's called the New COVID Therapy Add On Payments, or NCTAP, and it was created by CMS in November under its longstanding general authority to tweak DRG pricing rules.  What happens: FDA EUA drugs such as remdesivir are paid separately, up to 65% of cost, for COVID inpatients.

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Classically, DRGs are "hard rules" - you have an inpatient admission, you get paid for a DRG rate, and that's it, regardless of higher or lower costs and charges.   

For many years, there are only two exceptions to DRG bundling.

• One is the NTAP - the New Technology Add On Payment for DRGs.   There is an elaborate (arduous) application process for new technologies, and if they both provide a meaningful novel health benefit AND are a substantial cost outside the DRG, there is a temporary add on payment (historically 50%, currently 65%).   In 2019, CMS made it a little easier to fast track breakthrough FDA technologies into the NTAP.    
• The second longstanding method is the "outlier" DRG payment.  It's a limited benefit.  CMS reduces hospital charges to costs (e.g. charge deflation), then subtracts the DRG payment, then subtracts $30,000, then pays 80% of what's left.  
• If the DRG pays $20,000 and the hospital's charges are $200,000, and the cost to charge ratio is 4, CMS assumes the costs for that admission were $50,000 costs, subtracts $30,000 factor, subtracts $20,000 already paid in the DRG, and so in this case the outlier payment is 80% times ...zero.

20% DRG Bump for COVID (Old News Early 2020)

The CARES Act added a 20% supplement to every DRG payment for a COVID patient.  That is, the supplement comes direct from Congress, via legislation. 

This summer, CMS added a rule that the COVID patient must have a specific, positive COVID test for the DRG supplement to apply.    

Here Comes NCTAP (New News)

In policymaking released October 28, published November 6 (85 FR 71142), CMS created a 65% supplemental payment for COVID drugs, on its own initiative using existing legal powers.*  That's it.

• See Fed Reg home page here, see Fed Reg publication here, see a trade journal article here.  

The 20% add-on payment is reviewed at 85 FR 71155, as is the existing inpatient NTAP, and the FDA COVID drug program is reviewed on p. 71156 as is the existing outlier payment system.  

Proceeding briskly, CMS introduces the NCTAP for new FDA COVID drugs, on page 71157.  

One of the most interesting tidbits for me is that CMS is creating the new +65% drug payment for COVID drugs, using existing authority to tweak DRG rules as it sees fit (at SSA 1886(d)(5)(I).)  Stating: "The Secretary shall provide by regulation for such other exceptions and adjustments to such payment amounts [of DRGs] under this subsection as the Secretary deems appropriate."

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There isn't a lot of trade press about NCTAP, though of course everyone who summarized the Fourth Interim Final Rulemaking for COVID Public Health Emergency, noted it.   See e.g. a page in the AABB summary here.  See another summary at RevCycle here.and HealthLeaders here.

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* In the diagnostics community, this rule was best known for adding some regulations around how public posting of COVID test prices are defined; 45 CFR 182.40,  p. 71204.  It also placed into regulations prior law covering COVID vaccines at no charge to the patient.