February 28 seems like a long time ago - four weeks in the COVID era seems like four years in regular time.
Recall that on February 28, 2020, CMS announced it would be undertaking an NCD this year on the Epigenomics Epi proColon blood-based colon cancer screening test. The test was FDA PMA approved in 2016, and the NCD opening request letter was filed by Epigenomics in April 2019. (However, investor calls of the publicly-held company show it was negotiating with CMS well before 2019).
The NCD opening followed fairly quickly after a favorable health economics study in December 2020 - press here, article by D'Andrea et al. here.
My original blog is here. The CMS webpage is here. The CMS comments page is here - see the orange box that says, "COMMENT." There were 38 comments through March 24. Often, commenters show up on the last day - submit your comment by March 29.
Epigenomics has the first FDA-approved blood test for colorectal cancer screening. Multiple other companies have announced they are developing tests in this category.
Note that CMS views colorectal cancer screen by stool or blood as an intermediate test is is concerned whether the patient is "lost to followup" when positive and never gets a colonoscopy. (An earlier lost-to-followup step is never turning in the blood or fecal test material itself). The D'Andrea modeling study focuses on this.
In other news, in 2019, recall a CMS-sponsored study was highly critical of the covered stool nucleic acid test Cologuard, which is circa $500 per test (Naber et al., PLOS, 2019). Exact Sciences has market cap of about $9B, 2019 revenue around $800M, 2019 operating loss around $200M. In 2018, The Exact Sciences Cologuard test was about 20% of Medicare's $1B in molecular spending, the highest paid single test.
Tuesday, March 24, 2020
Monday, March 23, 2020
MolDx Medical Director Dr Paul Gerrard Joins Consulting Group
Catching up on March news, on March 4, 2020, it was announced that Dr. Paul Gerrard of Palmetto MolDx had taken a new position as Vice President at McDermott Plus Consulting.
See his corporate web page here. See his Linked-In here. According to his Linked-In page, he was a medical director and MolDx Director of Clinical Science from February 2018 to February 2020. Previosuly, he had been associate medical director at the New England Rehabiliation Center in Portland, ME. He holds a BS in economics and an MD from the University of South Carolina; his residency was in the Harvard system.
I noted that a few weeks ago on the AMP listserv, MolDx circulated an open position for a molecular pathologist Palmetto MAC medical director, via the BCBS South Carolina job openings website.
See his corporate web page here. See his Linked-In here. According to his Linked-In page, he was a medical director and MolDx Director of Clinical Science from February 2018 to February 2020. Previosuly, he had been associate medical director at the New England Rehabiliation Center in Portland, ME. He holds a BS in economics and an MD from the University of South Carolina; his residency was in the Harvard system.
I noted that a few weeks ago on the AMP listserv, MolDx circulated an open position for a molecular pathologist Palmetto MAC medical director, via the BCBS South Carolina job openings website.
AMA Makes May 2020 CPT Meeting Virtual - And Posts Full Code Agenda for Comment
Recall that AMA posts lab codes for public comment during a very brief window a couple weeks after the code applications are due, and months before the relevant CPT Editorial Meeting. See lab codes for comment in February 2020 for the May 2020 meeting (here).
New news. AMA has announced the May 14-16 CPT Editorial Panel Meeting will be virtual, so your trip to Chicago can be cancelled. AMA page here.
Separately, AMA has posted all the CPT codes proposed for the May meeting. See PDF online here.
There are 54 agenda items, including a number of lab codes that had been rapidly posted for early comment in February. To comment on a non-pathology code, submit a request-to-comment by April 23 and comment back to AMA by April 30.
New news. AMA has announced the May 14-16 CPT Editorial Panel Meeting will be virtual, so your trip to Chicago can be cancelled. AMA page here.
Separately, AMA has posted all the CPT codes proposed for the May meeting. See PDF online here.
There are 54 agenda items, including a number of lab codes that had been rapidly posted for early comment in February. To comment on a non-pathology code, submit a request-to-comment by April 23 and comment back to AMA by April 30.
Friday, March 20, 2020
Adaptive Biotech, Microsoft Commit to Rapid Deep Dive Research on Coronavirus Immune Response
On March 1, I wrote a blog that the erratic, unpredictably lethal attack of COVID-19 on the body shouldn't be attributed to random chance nor aging except as a last resort. Before that, triggering factors must be searched with molecular methods - maybe it is something with HLA type, maybe it is the inflammatory response profile of cytokines driven by host genetics, maybe it is a co-pathogen.
Other than age and comorbid frailty, we don't know much yet. Maybe ibruprofen contributes. Maybe blood type A vs O contributes. We need to be learning fast.
In an announcement March 20, Adaptive Technologies and Microsoft commit to rapid research and investments in the host immune signature among COVID patients. They also commit to an open access portal for the bioinformatics.
See the full press release here and clipped in this blog below the break. Labcorp participates.
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Other than age and comorbid frailty, we don't know much yet. Maybe ibruprofen contributes. Maybe blood type A vs O contributes. We need to be learning fast.
In an announcement March 20, Adaptive Technologies and Microsoft commit to rapid research and investments in the host immune signature among COVID patients. They also commit to an open access portal for the bioinformatics.
See the full press release here and clipped in this blog below the break. Labcorp participates.
##
Tuesday, March 17, 2020
AMA Creates COVID Code; AMP Warns about Legislative Error; CMS Prices Its Two COVID Codes; More
In brief updates, AMA creates a COVID code (CMS had already rushed out a pair of COVID codes). AMP warns on March 16 about a "legislative error" relative to legislation about COVID test coverage. CMS issued pricing for its two "U-codes" for COVID.
1 AMA Creates COVID Code
2. CMS Prices its own COVID Codes $36, $53
3. AMP and COVID Payment Legislation
4. Congress Introduces VALID Act for Lab Reform
5. Sidebar: Economist article on COVID biology and virology
6. Sidebar: Trump's Remark re Obama Rules
1. AMA CREATES COVID CODE 86735
AMA rapidly drafted a new single code for COVID-19 testing and made it immediately available for us, if payers can load it that fast.
See the AMA CPT COVID webpage here. AMA also popped out a 4 page fact guide for the code, PDF here. For example AMA coding advice states that if separate samples for nasal and pharyx are run, and reported separately, bill 87635 on two lines with modifier 59 on the second line.
This is a standard CPT Category I code in the molecular microbiology section, at code 87635. The text is:
Infectious agent detection by nucleic acid (DNA or RNA);severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique
AMA does not set fee schedule prices.
2. CMS PRICES ITS COVID CODES 0001U, 0002U, $36, $53
On around March 6, CMS released two new CPT codes 0001U and 0002U for use by Medicare or other payers effective April 1 (but dates of service retroactive to February).
CMS did not set a national price but asked each MAC to set a price and tell CMS. MACs set prices of $36 for CDC Test Kit Based Test, and $53 for other tests. I believe the rationale is that CMS assumes labs running CDC Test Kit get it for free and only incur additional operating costs. See the CMS pricing PDF here. Or equivalently, CMS MACs think the cost of running the tests are $36 and the costs of COVID reagents is $17 ($53-36). I saw a notice today that California Medicaid (Medi-Cal) adopted the same pricing as Medicare.
CMS has a consolidated webpage for transcripts of its COVID calls here.
NERD NOTE: PAYABLE IN MEDICARE OUTPATIENT SETTING
In the vast, vast majority of cases*, CMS bundles hospital clinic outpatient microbiology tests (like clinical chemistry) to underlying ER or clinic visit fees. This is called Status Q4 for hospital outpatient billing. Human genetic tests are billed separate (called Status A). CMS classed U0001 and U0002 as Status A, meaning they are separately payable (unless patient is admitted).
3. AMP CONCERNED ABOUT LEGISLATIVE FLAW
Congress is in the midst of passing legislation mandating payment for COVID testing but AMP believes there is a technical flaw in the legislation. The concern hinges on the placement of wording about FDA emergency use approval (EUA), which some labs have and some labs don't (for example, it might be pending). Also, requirements for EUA may change rapidly.
See the AMP press release online here.
4. VALID ACT ON THE HILL
Lost in the pandemic news, on March 5, 2020, House and Senate introduced matching versions of the VALID ACT, which would heavily reform and change the entire FDA process around diagnostic lab tests (see open access article at 360DX here.)
Sen. Rand Paul introduced A DIFFERENT BILL (!!) on March 18, AMP press release here.
See lengthy, and I believe open access, article by Turna Ray at Genomeweb on March 16, here. She weaves together a deep dive on VALID with a deep dive on COVID.
5. SIDEBAR:
Economist Open Access Article on Science of COVID
The ECONOMIST published a nice Scientific-American level article on COVID biology and virology - email registration - here.
6. SIDEBAR:
President Trump's Remark about Obama Rule Delaying COVID Testing
A few days ago, there was a spat that involved President Trump remarking on March 4 than "an Obama rule" had delayed COVID testing. There were responses that this was not true (or stronger language). Molecular pathologist and policy expert Roger Klein MD PhD was featured in an article on the topic in the conservative paper Epoch Times March 12 (readable with email registration, here.)
Propublica wrote a detailed article on the FDA policy steps here.
? RNA Extraction Supplies
Around March 12, there were a flurry of stories that US would run out of RNA extraction kits, which are more difficult and constrained to manufacture than any particular set of viral test probes (see e.g. here). My MBA-school math was that you could bravely or even heroically ramp up RNA kit production 24/7 (e.g. 3-fold) but maybe demand was going up 100X or 1000X, a different order of magnitude. We haven't particularly heard more about this.
I've read that typical tests use 4 wells in a 96 well plate (about 24 patients per plate), and that some forms of test run in 3-4 hours. Running 1M tests at 24 per plate at 4 hours turnaround per set would be about 7000 days of 24/7 plate time (for one plate reader). If 1M tests took 2 minutes of tech time each (handling, records, etc) that would be 2,000,000 minutes of tech time or 33,000 hours of tech time or about 16 2000-hour work-years of tech time. To do the 1M tests and 2M minutes of labor in one month would require 208 160-hour work-months or 208 techs for a month.
___
* I discovered scattered molecular microbiology codes that are Status A payable, while nearly identical codes are always Status Q4 not payable separately. As far as I could tell, the rare erratic assignment of a few molecular microbiology codes as "A" amongst the long CPT code lists of molecular microbiology codes was simply erratic.
1 AMA Creates COVID Code
2. CMS Prices its own COVID Codes $36, $53
3. AMP and COVID Payment Legislation
4. Congress Introduces VALID Act for Lab Reform
5. Sidebar: Economist article on COVID biology and virology
6. Sidebar: Trump's Remark re Obama Rules
1. AMA CREATES COVID CODE 86735
AMA rapidly drafted a new single code for COVID-19 testing and made it immediately available for us, if payers can load it that fast.
See the AMA CPT COVID webpage here. AMA also popped out a 4 page fact guide for the code, PDF here. For example AMA coding advice states that if separate samples for nasal and pharyx are run, and reported separately, bill 87635 on two lines with modifier 59 on the second line.
This is a standard CPT Category I code in the molecular microbiology section, at code 87635. The text is:
Infectious agent detection by nucleic acid (DNA or RNA);severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique
AMA does not set fee schedule prices.
2. CMS PRICES ITS COVID CODES 0001U, 0002U, $36, $53
On around March 6, CMS released two new CPT codes 0001U and 0002U for use by Medicare or other payers effective April 1 (but dates of service retroactive to February).
CMS did not set a national price but asked each MAC to set a price and tell CMS. MACs set prices of $36 for CDC Test Kit Based Test, and $53 for other tests. I believe the rationale is that CMS assumes labs running CDC Test Kit get it for free and only incur additional operating costs. See the CMS pricing PDF here. Or equivalently, CMS MACs think the cost of running the tests are $36 and the costs of COVID reagents is $17 ($53-36). I saw a notice today that California Medicaid (Medi-Cal) adopted the same pricing as Medicare.
CMS has a consolidated webpage for transcripts of its COVID calls here.
NERD NOTE: PAYABLE IN MEDICARE OUTPATIENT SETTING
In the vast, vast majority of cases*, CMS bundles hospital clinic outpatient microbiology tests (like clinical chemistry) to underlying ER or clinic visit fees. This is called Status Q4 for hospital outpatient billing. Human genetic tests are billed separate (called Status A). CMS classed U0001 and U0002 as Status A, meaning they are separately payable (unless patient is admitted).
3. AMP CONCERNED ABOUT LEGISLATIVE FLAW
Congress is in the midst of passing legislation mandating payment for COVID testing but AMP believes there is a technical flaw in the legislation. The concern hinges on the placement of wording about FDA emergency use approval (EUA), which some labs have and some labs don't (for example, it might be pending). Also, requirements for EUA may change rapidly.
See the AMP press release online here.
4. VALID ACT ON THE HILL
Lost in the pandemic news, on March 5, 2020, House and Senate introduced matching versions of the VALID ACT, which would heavily reform and change the entire FDA process around diagnostic lab tests (see open access article at 360DX here.)
Sen. Rand Paul introduced A DIFFERENT BILL (!!) on March 18, AMP press release here.
See lengthy, and I believe open access, article by Turna Ray at Genomeweb on March 16, here. She weaves together a deep dive on VALID with a deep dive on COVID.
5. SIDEBAR:
Economist Open Access Article on Science of COVID
The ECONOMIST published a nice Scientific-American level article on COVID biology and virology - email registration - here.
6. SIDEBAR:
President Trump's Remark about Obama Rule Delaying COVID Testing
A few days ago, there was a spat that involved President Trump remarking on March 4 than "an Obama rule" had delayed COVID testing. There were responses that this was not true (or stronger language). Molecular pathologist and policy expert Roger Klein MD PhD was featured in an article on the topic in the conservative paper Epoch Times March 12 (readable with email registration, here.)
Propublica wrote a detailed article on the FDA policy steps here.
? RNA Extraction Supplies
Around March 12, there were a flurry of stories that US would run out of RNA extraction kits, which are more difficult and constrained to manufacture than any particular set of viral test probes (see e.g. here). My MBA-school math was that you could bravely or even heroically ramp up RNA kit production 24/7 (e.g. 3-fold) but maybe demand was going up 100X or 1000X, a different order of magnitude. We haven't particularly heard more about this.
I've read that typical tests use 4 wells in a 96 well plate (about 24 patients per plate), and that some forms of test run in 3-4 hours. Running 1M tests at 24 per plate at 4 hours turnaround per set would be about 7000 days of 24/7 plate time (for one plate reader). If 1M tests took 2 minutes of tech time each (handling, records, etc) that would be 2,000,000 minutes of tech time or 33,000 hours of tech time or about 16 2000-hour work-years of tech time. To do the 1M tests and 2M minutes of labor in one month would require 208 160-hour work-months or 208 techs for a month.
___
* I discovered scattered molecular microbiology codes that are Status A payable, while nearly identical codes are always Status Q4 not payable separately. As far as I could tell, the rare erratic assignment of a few molecular microbiology codes as "A" amongst the long CPT code lists of molecular microbiology codes was simply erratic.
Friday, March 6, 2020
CMS Announces Special New Codes for Coronavirus Testing
On March 13, CMS announced national pricing for COVID at $36 for the CDC kit test (which doesn't require internal development and might even start with a free CDC kit - not positive) and $51 for the local LDT test of various types. PDF here.
This is comparable to my forecast March 1, when I noted the general price for multiplex viral pathogen is $43. To avoid federal rulemaking, CMS lists the price in the above PDF as being a reflection of the price that was set by each individual contractor (MAC).
###
CMS has announced two special codes for Coronavirus testing, both effective April 1, 2020. U0001 will represent CDC-kit testing, and U0002 will represent other testing.
See the March 5, 2020 CMS press release here:
https://www.cms.gov/newsroom/press-releases/cms-develops-additional-code-coronavirus-lab-tests
"CMS developed the first HCPCS code (U0001) to bill for tests and track new cases of the virus. This code is used specifically for CDC testing laboratories to test patients for SARS-CoV-2. The second HCPCS billing code (U0002) announced today allows laboratories to bill for non-CDC laboratory tests for SARS-CoV-2/2019-nCoV (COVID-19)."
In transmittals on the Clin Lab Fee Schedule here and outpatient fee schedule here:
Code: U0001
Short Descriptor: 2019 –nCoV diagnostic P
Long Descriptor: CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel
Code: U0002
Short Descriptor: COVID-19 lab test non-CDC
Long Descriptor: 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC
CMS adds, "Local Medicare Administrative Contractors (MACs) are responsible for developing the payment amount for claims they receive for these newly created HCPCS codes in their respective jurisdictions until Medicare establishes national payment rates. Laboratories may seek guidance from their MAC on payment for these tests prior to billing for them."
Medicare MACs will simply set a price they pay, reagardless of the inbound charge. Options may include Options include 87797 (direct probe, per organism), 87798 (amplified probe, per organism), and 87799 (quantitative DNA/RNA probe, per organism.) CMS pays $30, $35, and $43 respectively.
Retroactive
The codes can be billed retroactive to February 4, but do not submit the claim until April 1 or later.
Hospital Outpatient Bundling?
In general, virology tests are "bundled" in the ER or hospital clinic outpatient setting.
In Transmittal T4544, CR11691, CMS states that the new U-codes for coronavirus are NOT BUNDLED but are PAID SEPARATELY (status "A"). This is an exception to the usually bundling of hospital outpatient chemistry and virology codes. (Actually, if you look at outpatient virology codes/pathogen codes, most molecular ones are bundled "Q4" but very erratically and scattershot, some are "A" not bundled. That's a topic for another day.)
Would CPT Panel Codes Override Special U Codes? And Re-trigger Bundling?
I don't think CMS has addressed whether coronavirus on the same day as several other molecular viruses triggers the multi layer Respiratory Panel code set (which starts at n=3), which are ER- and clinic-bundled (Q4) and paid at fixed rates. I suspect CMS wants coronavirus coded separately, but it's not in print. Those panels do allow for DNA and RNA viruses and do mention coronavirus in parentheticals; recall it's also a long-familiar regular cold virus. These are 3-5 respiratory viruses, any combo (87631 $142), (98632, 5-11 $128), (87633, 12+ $417). These apply when multiplex probe techniques are used and while technically COVID assays are. well, multiplex, it's unlikely the whole set of a half dozen or more pathogens are "one multiplex" at this point.
CDC Issues ICD-10 Coding
CDC issued a news release March 5 on Coronavirus COVID-19 coding. Frankly, it's exactly what I think any coding expert would come up with. There is a code for coronavirus with another disease classification (B97.29). This is the usual correct coding, J12.89 viral pneumonia + B97.29, a coronavirus. CDC says do not use B34.2, coronavirus infection unspecificed, since you know it's respiratory, not unspecified. See press release at CDC here.
Very Brief Blog: No, Virginia, Medicare Might Not Pay for COVID-19 Testing Separately (See Outpatient Billing/Bundling Rules)
Note, Update March 6: CMS announced on March 5 it would pay for new U-codes U-0001, U-0002, separately in the hospital outpatient setting details here.
In a March 1 blog, I reviewed existing Medicare LCDs and coding rules for viral testing (here). On March 5, Vice President Pence defined COVID-19 tests as an "essential health benefit" paid under Medicaid, Medicare, and private plans (here).
Here's the conventional coding for services that don't have a CMS or AMA code yet. Infectious agent DNA/RNA probe detection runs generally from 87471 forward. In a nutshell, for tests for viruses not yet codified by name, payment per test is low and inadequate.
All three of these codes are BUNDLED in the hospital outpatient setting such as hospital outpatient clinics and emergency rooms. (They are also bundled if they are tested by a hospital within 3 days before an inpatient admission). So in most settings, for Medicare patients being seen in an ER or hospital outpatient clinic, there is no separate or add-on payment for COVID-19 testing (under a simple reading of existing rules). The hospital eats the testing cost.
CMS represents this "bundled" status by giving the infectious disease codes classification "Q4" in the hospital outpatient coding system:
2017 Utilization of 87797, '98, '99 in CY2017 Part B Data
In a cloud database, CMS provides information on all labs and physicians paid in Part B for these codes in CY2017 (here). Searching for 87797, 98, 99, yields 467 data lines.
For all these codes together, there were 844,400 services for $35,069,906.
For 87797, there were 3,549 services for $96,556.
For 87798, amplified probe, there were 683,151 services for $25,822,643.
For 87799, quantitative, there were 157,710 services for $9,150,707.
To Amplify on Payments for 87798 (ha ha inside joke)
Interestingly, the the highest paid labs for 87798 (amplified probe) in Part Bwere not the top several highest-paid labs overall. The highest-volume labs for 87798 were CAP Dx (Irvine, CA) at 26%, Bakotic Pathology (Alpharetta, CA) at 13%; Genova Dx ((Duluth GA) at 9%, and Labcorp (Burlington NC) at 6%. Excel in cloud here.
___
Nerd note. In the first chart, where most virology codes are "bundled, Q4," I have no idea why code 87800 is not bundled (is status A) and I've asked different staff at CMS if there is any explanation.
In a March 1 blog, I reviewed existing Medicare LCDs and coding rules for viral testing (here). On March 5, Vice President Pence defined COVID-19 tests as an "essential health benefit" paid under Medicaid, Medicare, and private plans (here).
Here's the conventional coding for services that don't have a CMS or AMA code yet. Infectious agent DNA/RNA probe detection runs generally from 87471 forward. In a nutshell, for tests for viruses not yet codified by name, payment per test is low and inadequate.
- Options include 87797 (direct probe, per organism), 87798 (amplified probe, per organism), and 87799 (quantitative DNA/RNA probe, per organism.)
- CMS pays $30, $35, and $43 respectively.
All three of these codes are BUNDLED in the hospital outpatient setting such as hospital outpatient clinics and emergency rooms. (They are also bundled if they are tested by a hospital within 3 days before an inpatient admission). So in most settings, for Medicare patients being seen in an ER or hospital outpatient clinic, there is no separate or add-on payment for COVID-19 testing (under a simple reading of existing rules). The hospital eats the testing cost.
CMS represents this "bundled" status by giving the infectious disease codes classification "Q4" in the hospital outpatient coding system:
 |
| Hospital outpatient codes: Q4 = bundled |
In a cloud database, CMS provides information on all labs and physicians paid in Part B for these codes in CY2017 (here). Searching for 87797, 98, 99, yields 467 data lines.
For all these codes together, there were 844,400 services for $35,069,906.
For 87797, there were 3,549 services for $96,556.
For 87798, amplified probe, there were 683,151 services for $25,822,643.
For 87799, quantitative, there were 157,710 services for $9,150,707.
To Amplify on Payments for 87798 (ha ha inside joke)
Interestingly, the the highest paid labs for 87798 (amplified probe) in Part Bwere not the top several highest-paid labs overall. The highest-volume labs for 87798 were CAP Dx (Irvine, CA) at 26%, Bakotic Pathology (Alpharetta, CA) at 13%; Genova Dx ((Duluth GA) at 9%, and Labcorp (Burlington NC) at 6%. Excel in cloud here.
 |
| click to enlarge |
___
Nerd note. In the first chart, where most virology codes are "bundled, Q4," I have no idea why code 87800 is not bundled (is status A) and I've asked different staff at CMS if there is any explanation.
Source Documentation: $8B Coronavirus Budget Documentation Here
Numerous headlines have flagged that House and Senate passed an $8.4B coronavirus emergency funding bill. President Trump signed the bill on March 6 in DC, canceling an announced trip to CDC.
Not many link to the source documents. Find them here:
Not many link to the source documents. Find them here:
- House.gov press release on passage, here.
- Full text of H.R. 6074 (28pp) here.
- Official summary of H.R. 6074 4pp) here.
- Law firm summary at Faegre Drinker here.
Via the CDC, $2.2B "to support federal, state, local health agencies." Mostly via BARDA and in part NIH, $3B for research and development of diagnostics, therapeutics, and vaccines. $1B goes for stockpiling emergency supplies of different types.
Division B, Section 102, provides the Secretary of HHS the authority to waive or modify Medicare restrictions on telemedicine services. This applies in "emergency areas" as declared by the President or the Secretary. This budget item is stated as exempt from pay-as-you-go standards.
Thursday, March 5, 2020
Very Brief Blog: VALID ACT to be unveiled soon on Hill
Brief reports in Bloomberg Law News and Politico Pulse state that the long-debated VALID ACT, for regulatory reform of FDA vis-a-vis lab tests, will be unveiled soon.
Politico Pulse here.
Bloomberg Law here.
Sponsors include Rep. Bucshon (R-IN) and DeGette (D-CO) and Sen. Burr (R-NC) and Bennet (D-CO).
Politico writes in part:
BIPARTISAN BILL WOULD OVERHAUL LAB TESTS — A bipartisan, bicameral group will soon unveil legislation to overhaul how the FDA regulates laboratory developed tests and in vitro diagnostics, putting them under one framework as "in vitro clinical tests," POLITICO's David Lim scoops.... major revamp of an FDA proposal for a precertification program — now deemed "technology certification." It also creates a breakthrough program similar to medical devices to speed development and prioritize review of certain tests, as well as a user fee program to support test review.
It's an armful: a 245-page version of the bill has begun circulating.
Politico Pulse here.
Bloomberg Law here.
Sponsors include Rep. Bucshon (R-IN) and DeGette (D-CO) and Sen. Burr (R-NC) and Bennet (D-CO).
Politico writes in part:
BIPARTISAN BILL WOULD OVERHAUL LAB TESTS — A bipartisan, bicameral group will soon unveil legislation to overhaul how the FDA regulates laboratory developed tests and in vitro diagnostics, putting them under one framework as "in vitro clinical tests," POLITICO's David Lim scoops.... major revamp of an FDA proposal for a precertification program — now deemed "technology certification." It also creates a breakthrough program similar to medical devices to speed development and prioritize review of certain tests, as well as a user fee program to support test review.
It's an armful: a 245-page version of the bill has begun circulating.
Very Brief Blog: AdvaMed Digital Health Conference Comes to Los Angeles (May 19-20, 2020)
Last spring, I was sorry to miss the AdvaMed Digital Health Conference, held in 2019 in San Francisco.
This year, I'm tracking the 2020 conference. It's called "The Digital Medtech Conference / Digital Health Revolution," and is jointly sponsored by AdvaMed and Biocom. Look for it Tuesday/Wednesday, May 19-20, 2020 at the Millenium Biltmore hotel in downtown Los Angeles (DTLA).
This year, I'm tracking the 2020 conference. It's called "The Digital Medtech Conference / Digital Health Revolution," and is jointly sponsored by AdvaMed and Biocom. Look for it Tuesday/Wednesday, May 19-20, 2020 at the Millenium Biltmore hotel in downtown Los Angeles (DTLA).
Registration is $550 for non-members ($500 before 4/17). For more about the booming districts that comprise DTLA, here.
Very Brief Blog: VP Pence Defines Coronavirus test as "Essential Health Benefit"
On March 4, 2020, Vice President Pence defined coronavirus testing as an "essential health benefit." Essential health benefit is a term of art that applies to health plans in the U.S. under the Affordable Care Act.
___
Nerd note.
Experts discuss what Pence meant - at AP, here.
See the HHS page for Essential Health Benefits at CCIIO here. CCIIO is, " Center for Consumer Information & Insurance Oversight."
The main categories are very broad - "ambulatory healthcare, emergency services, hospitalization, maternal care," etc.
- CNBC here.
- Fox News here.
- At WhiteHouse.gov, see transcript of Pence speech to Diagnostics CEO's - here.
Separately, CMS issued a press release on how coronavirus prioritization would affect other issues, like hospital and nursing home inspections (here).
My earlier blog on how coronavirus fit into existing LCDs for molecular virus testing is here. My earlier blog on precision-medicine frameworks for understanding vulnerability to coronavirus is here.
From WhiteHouse.gov:
From WhiteHouse.gov:
"HHS has already denominated a test for coronavirus to be an essential health benefit, which — which is a — which ensures that it will be covered by people’s private health insurance. It’ll be covered by Medicare and Medicaid. And we’ll — we’ll continue to work in that way."
___
Nerd note.
Experts discuss what Pence meant - at AP, here.
See the HHS page for Essential Health Benefits at CCIIO here. CCIIO is, " Center for Consumer Information & Insurance Oversight."
The main categories are very broad - "ambulatory healthcare, emergency services, hospitalization, maternal care," etc.
Wednesday, March 4, 2020
Very Brief Blog: CMS Faces Coronavirus (Press Release Here)
https://www.cms.gov/newsroom/press-releases/cms-announces-actions-address-spread-coronavirus
Coverage of this press release, at The Hill, here.
For Bill Gates' op ed on coronavirus in the NEJM - here.
In a news article today, Scott Gottlieb urges widespread coronavirus testing, naming Labcorp and Quest - here.
MedCityNews has an interesting article about innovative ways of handling coronavirus patients or using technology to management them at home - here.
##
CMS Announces Actions to Address Spread of Coronavirus
CMS calls on all health care providers to activate infection control practices and issues guidance to inspectors as they inspect facilities affected by Coronavirus
Today, the Centers for Medicare & Medicaid Services (CMS) is announcing several actions aimed at limiting the spread of the Novel Coronavirus 2019 (COVID-19).
Specifically, CMS is issuing a call to action to health care providers across the country to ensure they are implementing their infection control procedures, which they are required to maintain at all times.
Additionally, CMS is announcing that, effective immediately and, until further notice, State Survey Agencies and Accrediting Organizations will focus their facility inspections exclusively on issues related to infection control and other serious health and safety threats, like allegations of abuse – beginning with nursing homes and hospitals.
Critically, this shift in approach, first announced yesterday by Vice President Pence, will allow inspectors to focus their energies on addressing the spread of COVID-19.
As the agency responsible for Medicare and Medicaid, CMS requires facilities to maintain infection control and prevention policies as a condition for participation in the programs. CMS is also issuing three memoranda to State Survey Agencies, State Survey Agency directors and Accrediting Organizations – to inspect thousands of Medicare-participating health care providers across the country, including nursing homes and hospitals.
“Today’s actions, taken together, represent a call to action across the health care system,” said CMS Administrator Seema Verma. “All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention (CDC). We sincerely appreciate the proactive efforts of the nursing home and hospital associations that have already galvanized to provide up-to-the-minute information to their members. We must continue working together to keep American patients and residents safe and healthy and prevent the spread of COVID-19.”
The first memorandum released today provides important detail with respect to the temporary focus of surveys on infection control and other emergent issues. Importantly, it notes that, in addition to the focused inspections, statutorily-required inspections will also continue in the 15,000 nursing homes across the country using the approximately 8,200 state survey agency surveyors. Surveys will be conducted according to the following regime:
- All immediate jeopardy complaints (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death or harm) and allegations of abuse and neglect;
- Complaints alleging infection control concerns, including facilities with potential COVID-19 or other respiratory illnesses;
- Statutorily required recertification surveys (Nursing Home, Home Health, Hospice, and ICF/IID facilities);
- Any re-visits necessary to resolve current enforcement actions;
- Initial certifications;
- Surveys of facilities/hospitals that have a history of infection control deficiencies at the immediate jeopardy level in the last three years;
- Surveys of facilities/hospitals/dialysis centers that have a history of infection control deficiencies at lower levels than immediate jeopardy.
The memorandum also includes protocols for the inspection process in situations in which COVID-19 is identified or suspected. These protocols include working closely with CMS regional offices, coordinating with CDC, and other relevant agencies at all levels of government. The agency is also providing key guidance related to inspectors’ usage of adequate personal protective equipment.
The other two memoranda provide critical answers to common questions that nursing homes and hospitals may have with respect to addressing cases of COVID-19.
For example, the memoranda discuss concerns like screening staff and visitors with questions about recent travel to countries with known cases and the severity of infection that would warrant hospitalization instead of self-isolation.
They detail the process for transferring patients between nursing homes and hospitals in cases for which COVID-19 is suspected or diagnosed. They also describe the circumstances under which providers should take precautionary measures (like isolation and mask wearing) for patients and residents diagnosed with COVID-19, or showing signs and symptoms of COVID-19.
Finally, the agency is announcing that it has deployed an infection prevention specialist to CDC’s Atlanta headquarters to assist with real-time in guidance development.
Today’s actions from CMS are focused on protecting American patients and residents by ensuring health care facilities have up-to-date information to adequately respond to COVID-19 concerns while also making it clear to providers that as always, CMS will hold them accountable for effective infection control standards. The agency is also supplying inspectors with necessary and timely information to safely and accurately inspect facilities.
To view each memo, please visit the below links:
Suspension of Survey Activities: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/suspension-survey-activities
Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/guidance-infection-control-and-prevention-concerning-coronavirus-disease-covid-19-faqs-and
Guidance for Infection Control and Prevention of Coronavirus Disease (COVID-19) in nursing homes: https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/guidance-infection-control-and-prevention-coronavirus-disease-2019-covid-19-nursing-homes
Tuesday, March 3, 2020
Very Brief Blog: Decibio updates trends in immuno-oncology biomarkers
Los Angeles-based consultancy Decibio (here) maintains and constantly updates a large database for immuno-onology (their "I/O BioMAP;" here).
See an open-access update from Decibio on three new trends in the I/O biomarker field - online here, released March 2, 2020. They review data on trends beyond PD-L1, like gene expression profiling and NGS.
See an open-access update from Decibio on three new trends in the I/O biomarker field - online here, released March 2, 2020. They review data on trends beyond PD-L1, like gene expression profiling and NGS.
Sunday, March 1, 2020
February 29: FDA Emergency Guidance on COVID-19 Testing under CLIA
On February 29, 2019, FDA issued an emergency bulletin allowing high complexity CLIA labs to performed locally developed testing for COVID-19. The bulletin is here; open access coverage at Genomeweb is here. See also coverage at MedTechDive, here. For rapid FDA clearance of a New York State test, Genomeweb here. For an update at WSJ through March 3, here.
For a March 4 update at Genomeweb, here; for a March 5 update at Genomeweb, here.
Large amounts of LDT high complexity CLIA lab testing is already routine in microbiology, and nationwide, without special permission. With this bulletin the FDA, I think, is being sure to stay ahead of the policy skirmishes on this one. AACC provides some backstory.
AACC has a webpage dedicated to coronavirus issues, here. AACC specifically notes in a February 28 open letter to the FDA that an FDA Emergency Edict had not only allowed certain urgent new rules for approved emergency use [good], but proactively barred any other labs from doing tests outside that rule (here) [bad]. I believe AACC wanted CLIA-regulated LDTs and FDA emergency use tests to proceed in parallel in this urgent period.
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On Genomeweb, I noted a COVID-19 qPCR webinar scheduled for March 23, sponsored by Co-Diagnostics (Featherstone & Satterfield), here.
For a March 4 update at Genomeweb, here; for a March 5 update at Genomeweb, here.
Large amounts of LDT high complexity CLIA lab testing is already routine in microbiology, and nationwide, without special permission. With this bulletin the FDA, I think, is being sure to stay ahead of the policy skirmishes on this one. AACC provides some backstory.
AACC has a webpage dedicated to coronavirus issues, here. AACC specifically notes in a February 28 open letter to the FDA that an FDA Emergency Edict had not only allowed certain urgent new rules for approved emergency use [good], but proactively barred any other labs from doing tests outside that rule (here) [bad]. I believe AACC wanted CLIA-regulated LDTs and FDA emergency use tests to proceed in parallel in this urgent period.
____
On Genomeweb, I noted a COVID-19 qPCR webinar scheduled for March 23, sponsored by Co-Diagnostics (Featherstone & Satterfield), here.
Brief Blog: Discordant Ratio of Private and Medicare Payments, for Hospital versus Lab Services
The March 2, 2020, issue of Business Week has an article by John Tozzi and Emma Court that compares statewide hospital prices for commercial payers versus the benchmark of Medicare prices for the same inpatient or outpatient services.
For example, in Michigan, commercial inpatient and outpatient prices are about the same as CMS prices. Everywhere else, they're higher. They're 80% higher in NY, but they're more like 300% higher in Indiana. See graphic (attributed to Rand).
Why? Well, from an armchair, you might guess that in Michigan, hospitals are fragmented and their is one highly consolidated payer, so the payer gets hospitals to bend to low prices. You might think that in Indiana, hospitals are highly consolidated, and payers are fragmented, so hospitals can contract to high prices and make it stick. Of course, any real-world conclusions would require a lot of analysis.
Labs and PAMA
The interesting for labs, under PAMA surveys of commercial payer prices, at least for freestanding labs, often commercial prices were lower than CMS prices, at least in CY2017.
That is, the PAMA data points would be displaced off the left-hand side of the graphic and below the 100% line which is the bottom of the chart.
Suggesting the payer-provider dynamics were very different for labs than for hospitals in most states, vis-a-vis the payer industry segment.
___
From the March 2, 2020, paper issue. The online version has the same text but not the same graphic I've shown above. Here. I suspect the underlying source is RAND, 2019, here.
For example, in Michigan, commercial inpatient and outpatient prices are about the same as CMS prices. Everywhere else, they're higher. They're 80% higher in NY, but they're more like 300% higher in Indiana. See graphic (attributed to Rand).
Labs and PAMA
The interesting for labs, under PAMA surveys of commercial payer prices, at least for freestanding labs, often commercial prices were lower than CMS prices, at least in CY2017.
That is, the PAMA data points would be displaced off the left-hand side of the graphic and below the 100% line which is the bottom of the chart.
Suggesting the payer-provider dynamics were very different for labs than for hospitals in most states, vis-a-vis the payer industry segment.
___
From the March 2, 2020, paper issue. The online version has the same text but not the same graphic I've shown above. Here. I suspect the underlying source is RAND, 2019, here.
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