Thursday, April 9, 2020

Covid Tidbit: Shorage of Ventilator Drugs?

We had the first warnings of a rapidly impending shortage of RNA extraction kits weeks ago.  One problem - production can increase linearly (e.g. 24/7 is 3X output) while demand can increase exponentially (e.g. 100X).

Here's a story from the trade website IDSE (Infectious Disease Special Edition) - Could the next rate limiting factor be a shortage of drugs critical to the deployment of ventilators?

See the article by Bruce Buckley, byline April 8, here.

I've clipped the first paragraphs below the break.


MAC Track: 99% of Noridian Staff Can Work From Home

Getting ready for a client call today, I went to the Noridian JF/Part B website here.  I searched for COVID - search yourself or try here.   There were 32 hits.  Many were copies of CMS instructions and updates regarding COVID.  

But here's an interesting one, dated March 23.  Noridan says normally, half of their employees telecommute, and by now, with COVID, 99% do.   Copied below.

A message from Noridian on COVID-19 and business continuity 

Noridian Healthcare Solutions, LLC remains committed to its role in supporting essential functions for the Medicare FFS and Medicaid programs during the COVID-19 pandemic. Last week we moved 900 employees to temporary work from home. With nearly half of our employee base telecommuting already, we were very prepared for that move. Our process was organized, controlled, and phased to provide for continuity of business operations and the safety of our employees. Today 99 percent of our employees are work-from-home. Each of our office locations is closed, and access to those is restricted to a handful of employees with an approved business need. Those employees are operating under CDC recommended social distancing. We will continue to perform our work with quality and care.    Last Updated Mar 23, 2020

Very Brief Blog: Roger Klein MD JD Becomes Chief Medical Officer at Omniseq

Roger Klein, MD JD, has been appointed Chief Medical Officer of Omniseq, a lab company spun out from Roswell Park Cancer Center in Buffalo and funded in part by investments from Labcorp.  Omniseq focuses on advanced sequencing technologies in oncology.  Press release here.

See his website Rogerdklein.com here.  Follow him on Twitter here.  See a STAT article by Klein here.   Dr. Klein has been a very active member of AMP at AMA CPT, CMS, and other forums.   See his 16-page declaration in the ACLU/AMP/Myriad BRCA Supreme Court patent case here.






Offbeat Lesson: Hospital Chargemasters and Medicare Inpatient Billing 101

Let's talk about Part A hospital billing and Chargemasters!  Pull up a chair and a mug of hot chocolate.


The Wacky World of Chargemasters, DRGs, and Charges for Lab Tests

Not too much of my consulting work is for procedures and tests specifically offered to inpatients, and inpatient billing has always been a step beyond my comfort zone.  I spent some time this week with real-live Chargemasters, and I'm offering some learnings.

DRG 101

Medicare pays for inpatients by Diagnosis Related Groups, or DRGs, of which there are hundreds.

They are broadly classed as Medical or Surgical.  Medical DRGs are driven by primary diagnoses, and surgical DRGs are driven by the main surgical procedure. 

Generally, DRGs come in clusters, with a basic rate (say, $10,000) which may be raised by the presence of minor or major complications (such as appendetomy + sepsis, or valve replacement + stroke).

A base DRG may be $10,000 and the minor complications rate rises to $14,000 and the major complications rate could be $20,000. 

Outlier Payments Basic Math 
There's such a thing as outlier payments, but they are rare (1% of all inpatient payments.)  Medicare takes the charges, multiplies by that hospital's cost to charge ratio (say .33),  subtracts around $25,000, and then pays the remaining at 80 cents on the dollar.    
Here's a whiteboard example of the math.   For a $15,000 DRG for Aunt Jane, say that a hospital bills $150,000 of chargemaster-charges. Since the cost to charge  ratio of this hospital is.33, the costs are imputed to be $50,000.   OK.  Medicare subtracts $25,000 from the costs, then compares what's left ($25,000) to the DRG payment already made, in this case $15,000.   The gap is $10,000, which Medicare pays at the outlier rate of 80 cents per dollar, or $8000.  
So hospital had $50,000 in costs (charged at $150,000) and got paid $18,000 ($10,000 DRG + $8000 outlier) and seems to have lost $32,000.   Remember, though, that outlier payments are only about 1% of total payments by Medicare Part A.
How DRGs are Assigned

I know how Part B services are billed by doctors and labs to Medicare.  It's the 1500 claim form, and after background info like your name and the patient's data, there's a series of lines, each one of which holds a date, a CPT code, an ICD10 diagnosis code, and a charge.  Got it.

OK, so how do hospitals submit inpatient charges to Medicare Part A?

First, they use the same 1450 form as outpatient hospital services.  (Quiz question, though - outpatient services are driven byAMA CPT procedure codes and inpatient by ICD-10 procedures codes.)

The inpatient DRG is driven by a DRG grouper which looks at (1) ICD-10 procedure codes and (2) diagnosis codes and assigns a DRG.  Next, a Medicare Part A Pricer assigns a locality-adjusted final price.

The scale of DRG pricing.  Basic medical DRGs like pneumonia might be in the $10,000 range, basic surgical DRGs $20,000.  Prices can double with complications like sepsis.  The most expensive DRG, heart transplant, was in the $100,000 range a couple years ago when I checked.

Overview of Part A Hospital Bills to CMS

How detailed are the hospital bills to Medicare Part A MACs?

I'm told, by a kind Part A CMD who took me under wing, that most of the charges tallied by the hospital are rolled up to Revenue Codes (aka Cost Centers) and this is what CMS sees when it processes the inpatient 1450 form.

For example, in lab medicine, 030X is the revenue code family, such as 0301 chemistry, 0302 immunology, 0306 microbiology, etc. 

So while the hospital may rack up 100 lines lab tests for $20,000 in line-by-lineChargemaster charges, day by day, what Medicare sees on the 1450 claim after discharge is, "0306 Microbiology $5000" and "0301 Chemistry $15,000" as part of that $150,000 Chargemaster submission for Aunt Jane in her $10,000 DRG for pneumonia.

What Chargemasters Look Like (Enter If You Dare)

What does a Chargemaster look like?   State of California provides very easy access.
The link is:
 https://oshpd.ca.gov/data-and-reports/cost-transparency/hospital-chargemasters/2019-chargemasters/

I pulled down two Chargemasters, one for for Cedars Sinai 2019 and one for California Pacific Medical Center.  They're big Excel spreadsheets with over 7000 lines.

Cedars Sinai

Cedars has 7500 lines.  Here, each line has a Cedars code and, if possible, a CPT/HCPCS code.  (No ICD-10 procedure codes are seen here). 

The Cedars codes seem to match the 4-digit CMS revenue categories plus four digits specific to Cedars.  For example, 03010001 = CMS center 0301 labs + Cedars item 0001.

Lab tests plus pathology tests total 2280 lines. 

For example, at line 54, we have "basic metabolite panel" which is Cedars code 03010001 (the 0301 = CMS lab revenue center), we see also  the CPT code 80047, and the Chargemaster price $791.  The CMS lab fee schedule price is $13.73.   (In case you aren't doing the math in your head, 791/13 = 60X).

Immunoassay, not specified, Cedars code 83011268, CPT 83520, is $350.  (CLFS is $13.73).

The short text on the Chargemaster does not appear to be the same as the CPT short text.

While the Cedars Chargemaster is arranged by Cedars item number (0301-1286 followed by 0301-1287 followed by 0301-1288), these don't match the CPT codes, being  neither in CPT order nor in descriptor alphabetic order.  I have no idea how Cedars created the serial order of the tests.

On a lark, I sorted the Cedars lab codes Chargemaster by charge, from high to low.  

HLA Class I&II, High Res, is 81378, $55,578

81445 is defined by AMA as tumor genes, 5-50.  CMS pays $600.   It is used several times for targeted genomic sequence analysis, with charges from $33,842 to $31,072.

HCV genotyping, 87902, is $3,959.   

87633, viral panel, 12-15 targets, is $5,258.  KRAS gene analysis, 81275, is $3647 (CMS CLFS, $193.) 

Many genetic tests match CLFS, though.  Many other genetic tests, however, more or match the CLFS schedule.  81162, BRCA 1 & 2, is $2074, and 81225, CYP2C19, is $168.   Altogether, 196 codes in the genetic series are included on the Cedars Chargemaster (81162-81503).

Unlisted codes on Chargemaster.  A few Cedars codes map to unlisted codes (e.g. Cedars 0309-1651, Trofile (an HIV sequencing test) mapped to 87999*, other microbiology code, charge $1960.

In Pathology, there is a distinct Cedars number 0310-0364, Urovysion (a patented FISH test from Abbott), mapped to CPT 88121 and charge $1960.

In Pathology, 88344, multiplex immunohistochemistry, is $929.  IHC estrogen receptor is 88361, $969.  Screening PSA, G0103, is $343.  (CMS CLFS, PSA, $19).

Cedars lists inpatient and outpatient prices; outside lab medicine, in some examples I looked up, like radiology, the inpatient price was 30% higher. 

When You've Seen One Chargemaster, You've Seen One Chargemaster

For Cedars, many codes didn't list a separate inpatient price, and I believe this means it is the same as the outpatient price.  Below, we turn to CPMC, where every code has both an inpatient and outpatient price, though some are the same, and no lines list the CPT code.

California Pacific Medical Center

This one has more lines than Cedars Sinai (9600 vs 7500).  Each line lists a CPMC item number, but these codes (unlike Cedars) don't appear to be built on top of CMS revenue codes.   Each line shows the CPMC code number, a text descriptor, and then the CMS revenue code (e.g. 0301 chemistry).  Then the inpatient price, and outpatient price.  For many services, the inpatient and outpatient prices are the same.

In order to scope out the CPMC chargemaster for labs, I had to sort by Revenue Code.  Including pathology codes (310, 311, 312) this included only 1040 total codes, about half as many as Cedars.

CPMC doesn't offer CPT code crosswalks, but I compared a few lines by text name.

PSA (CPMC 40900103) was $153 outpatient, $188 inpatient.   Recall it was $343 at Cedars and $19 at CMS.

Basic Metabolic Panel was $123 outpatient, $259 inpatient.  (Note that at CPMC, from code to code, the ratios inpatient/outpatient aren't the same).   Procalcitonin, a biomarker for infection, was CPMC code 40900473, $344 outpatient, $476 inpatient.  (CMS CLFS is circa $30).

Sorting CPMC by high price, the highest was HLA 1&II typing, $1640 inpatient, $1451 outpatient.  Fetal fibronectin, an immunoassay, tallied $821 outpatient, $1010 inpatient.  In situ hybridization per probe was $437 ouitpatient, $794 inpatient.  Trichomonas direct probe was $299 outpatient, $790 inpatient (the delta near to 3X).   CMS is circa $30.

___

PS. Hope this blog is helpful.  I probably spent 8 hours figuring this out.

Nothing fancy, but the Excel Chargemasters and derivative worksheets (like sort-by-price) that I used today are in the cloud here.

In issuing reports on outlier payment overpayments, OIG also explains the system; see outlier payment OIG reports from 2017 and 2019 and one in progress here.

Inpatient ICD-10 procedure codes can be longer than 5 digits.  For example, the new technology inpatient code for the T2 microbial test is ICD-10 XXE5XM5, 7 places.

Dark Report, March 3, had an article that United Health Care and other papers are "cracking down" on hospital lab payment rates.  Recall that in the commercial lab world, payers often contract for chemistry tests at below the CMS CLFS rates, whereas hospital charges may be 20X higher.

Further Reading

See an online article, "Intro to Chargemasters," here.

Venders create and manage Chargemasters for hospitals, here.

There's a Chargemaster Alternatives alliance organized by HFMA and Leavitt Partners and cooperating hospital groups - here.

See an HFMA letter to CMS, 09/2019, on Chargemaster problems - 19 pages, one more exciting than the next - here.   Seriously, this is the graduate course in cost-to-charge.  For example, they write that cost-to-chart has gone from .33 in 2009 to .25 in 2020 - so the reported charges for a $10,000 inpatient stay are now $39,000, instead of $29,000.   They propose a novel DCM, or Direct Cost Model, to rebase CMS payments and calculations.  These include CMS weighting of DRG, weighting of outpatient APCs, and calculation of outlier payments for DRGs.

*For inpatients, all lab tests are bundled.  In general, for Medicare hospital-related outpatients, all lab tests are also bundled (clin chem, microbiology) except for human genetics.   People watching CMS with a magnifying glass may have noticed that CMS made an exception recently, unbundling COVID testing in the hospital outpatient setting and allowed its reimbursement ($50) to be made separately from other hospital care on that outpatient day.  Generally, other microbiology outpatient hospital related tests are bundled to the office visit or procedure.   So is clin chem, etc.  For example, the Cedars Chargemaster is also an outpatient chargemaster, and the Trofile code 87999 is a code nonpayable by CMS in outpatient setting and bundled in an inpatient setting..   


















MolDx Requires New Appproach to Gapfill Pricing; Posts Rules

This year, about half of 90 PLA codes were sent to the MAC Gapfill process for pricing.  During the first months of the year (ideally Jan-Feb, in practice Jan-April) each MAC prices each code that is sent to the gapfill process. 

The rules are in bare-bones text and are found in a federal regulation at 42 CFR 414.508:   Consider the charges for the test, the resources required, the payments of other payers, and charges/payments/resources for similar tests - then the MAC sets a price. 

The prices are collated by CMS, which sets the test price at the median of the MAC prices (after a comment period).   The prices stay the same until the next three-year PAMA data cycle.

MolDx now provides more guidance and more detail. 

See the "MolDx Pricing Worksheet" as a splash screen on their home page:


I've put a screen shot below, click to enlarge.  I've put an archival cloud copy here.


Answer these questions:

5-year expectations for:
 - Test volume
 - Test capacity
 - Cost of Goods
 - Labor
 - Indirect costs
 - Total capital equipment cost
 - R&D cost

For R&D, "if already in production, put all current R&D in Year 1."

Then list the list price of test, and any discounts.

The list any tests that are similar for comparison (e.g. crosswalk is a good match).

Finally, list any prices from other MACs and state whether the test is FDA approved.

That's it.


Margolis Center, Gottlieb Release "National Testing Plan" for Serology, Back to Work

I mentioned in an April 7 blog that the American Enterprise Institute had released a 20 page "back to work plan" for reopening the US economy - entry point here.

New to me, on April 7, Gottlieb and a mix of same-and-different co-authors also released a 17 page "National COVID Surveillance System" under the auspices of the Duke Margolis Center for Health Policy.  See the 17 page white paper here.



Wednesday, April 8, 2020

AMA Has Briefly Posted 2nd Quarter PLA Codes for Comment

Each quarter, AMA takes PLA codes applications, and about ten days later, it briefly posts them for comment, prior (in this case) an April 22 workgroup meeting.

See the AMA PLA page here, see the (temporary) posting of PLA codes for this quarter, PDF currently here.   You can request a copy of a PLA application relevant to you, in order to comment by writing ahead of the April 22 workgroup.  Follow instructions on the website and PDF.  Based on another calendar webpage for PLA, the comment request deadline is April 17, but I recommend moving quickly if you want to comment.

There are 26 code applications.   2 are from Veracyte (AFIRMA brand), 4 are related to the DISCERN brand of Alzheimer fibroblast tests.  6 are high intensity sequencing (like exome/genome), but of those, four are branded Genomic Unity (the Variantyx company, Framingham, MA.) 

VelaDx applies for a code for its "Sentosa" HIV NGS test, there are two blood-group related tests, and the test Melody (see website, "Identify breast cancer through tears;" lacrimal fluid; here.)


Tuesday, April 7, 2020

Very Brief Blog: Amgen, Adaptive Biotechnologies Offer Genomics/Covid Webinar Thursday 8 PT

I realize this is the third time in a month I've mentioned Adaptive Biotechnologies, but they keep having headlines at the critical intersection of precision medicine, high intensity genomics, and the COVID pandemic.

New new Tuesday evening: Adaptive and Amgen announce a webinar on Thursday, April 9 (8 PT, 11 ET) on their COVID collaboration.

See a press release below, which directs its readers to the Amgen or Adaptive investor websites for sign-up information.   The press conference will also be archived.  Full text after the break.


Very Brief Blog: Finding CMS MAC Medical Directors

Periodically one wants to contact a CMS "MAC" medical director.  Here are some links.

  • At CMS, a web listing of all MACs and medical directors, but without emails (note there are multiple web pages), here.
  • At CMS, a PDF listing (tiny print) of all MAC medical directors, with emails, here.
    • Updated to 02/2020.
    • A reader of this blog was kind enough to provider a conversion of the CMS PDF listing in Excel, which I've put in the cloud here.


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Footnote.

If you google "PDF to Excel conversion" you'll get a number of cloud websites that claim to do this well and for free; I didn't try any.

Very Brief Blog: Off Topic: Upgrading Your Background in Zoom

Off topic of federal health policy, I was feeling increasingly guilty to have awful Zoom backgrounds for business meetings, when more and more participants on calls with me had blue skies and waterfalls. 

To make a Zoom virtual background for yourself, I believe this is easiest on the Zoom app on a laptop (not on a phone*). 

If you've only joined Zoom meetings by anonymously clicking a link, you also have to have a free registration in Zoom (email required).    OK.   At that point, you can quickly click Settings and Virtual Background, and either pick a pre-fab background or upload a favorite photo. 

I put this off for a month, and it took 15 seconds to do it.  (My landscape is currently Runyon Canyon in the Hollywood Hills near my house). 

Quick screen shot of the steps in Windows, below.  If my pic below isn't clear enough, you can also find many sources of free instructions on Google or YouTube.

click to enlarge
__

*One source says Virtual Backgrounds may work on iPhone 8 or later and iPad Pro or 5th gen iPad. It definitely works, quick and easy, on the laptop apps.

COVID "GOOD" NEWS - When to Reopen the Economy (Scott Gottlieb et al); Other COVID Headlines

Scott Gottlieb and coauthors have released an American Enterprise Institute white paper on when and how to open the US economy as fast as possible.

  • See coverage at Politico here.
  • See coverage at NYT here.
  • See the AEI 20-page white paper online here.
    • SEPARATELY, Gottlieb et al. released a COVID surveillance plan, 17pp, via Duke Margolis Center, here.
They suggest loosening and reopening should occur when
  1. Hospitals can treat all patients, without crisis mode.
  2. State can test everyone who is symptomatic.
    1. This could require 750K-1M tests per week nationwide.
  3. The state can monitor confirmed cases and their contacts.
  4. There must be a preceding sustained reduction across 14 days.
Co-authors of the white paper include Lauren Silvis, who is on both the AEI and the Margolis white papers.  She is a former FDA attorney who is now on the team at TEMPUS.


McKinsey also has a new white paper on rebooting post COVID economies - here.


Precision Medicine News

WSJ has an article on a theme I've considered important, taking a genetic, genomic, precision medicine approach to who gets sick and not call it solely a "roulette wheel" if you die at 30, or "a higher statistically change" if you're in the 10% who die at 65.   Genetic factors (in HLA, in cytokines, in T-cell receptors, etc) could be a driver we don't understand yet, multiplied by factors like age or respiratory reserve.  In this article, 23andMe is featured.  Other approaches are coming online, such as an open-access collaboration for samples by Adaptive Biotechnologies and Microsoft (here).  Adaptive is also partnered with Amgen working on monoclonal drugs with genomics support (here).

Digital Health News

Rockhealth reported $3B investments in digital health (broadly conceived) in 1Q2020.

For Somewhat Less Cheerful News...

NYT ran an article on the "real epidemic map" we'd be seeeing on maps if testing were fully up to speed - here.

NYT ran an article (as did WSJ this week) on ongoing shortages of testing supplies, staff, equipment.  Here.

Test Shortages

Some of the test shortage news shouldn't be surprising, even if we were making estimates a few weeks ago.  DNA probes seem to be the fastest thing to produce.   However, RNA extraction kits, RNA swab kits, and platforms/lab staff are limited resources that increase slowly.   An RNA probe factor could go from normal shifts to 24/7, so production rises 3X.  Good.  Linear.   But demand could rise 100X, exponential, leaving a 97% gap that will rear its head quickly.  Shortages of staff and platforms emerge as 7-10 day wait times.   (This paragraph thanks to my Operations class professor, when I took that class in MBA school 20 years ago.)    

Monday, April 6, 2020

HHS OIG Releases Report on COVID Problems

It's not hard to find distressing COVID-19 news.*

But in addition, HHS OIG has released a new 41 page report on problems US hospitals were experiencing based on an interview period of March 23-26.

  • The OIG report is here.
  • Trade press coverage April 6 at MedCityNews, here.  Endpoints here.

In other news April 6, the open-access British newspaper The Guardian ran an article on impending closures of small US rural hospitals that simply run out of funds (to buy supplies or pay staff) under pandemic stress.  Here.
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*One website for national and international COVID epidemiology is:
https://www.worldometers.info/coronavirus/country/us/



Friday, April 3, 2020

Brief Blog; Where to Find It: CARES Legislation, CMS Interim Final Rules

It's easy to find articles about the CARES legislation and the $2 trillion stimulus package.  It's a little harder to find the actual law.  Here, I discuss CARES Act in first half of the blog, further down I discuss CMS interim rules.

If you'd like one more original document, not further discussed, the FDA's March 31 8-page guidance on COVID LDT testing - here.


CARES ACT

Find the CARES Act, HR 748, original text here (335pp):
https://www.congress.gov/bill/116th-congress/house-bill/748/text

Congress.gov provided a locked version of the bill you can't highlight.  I've put an unlocked version in the cloud here.

See sections on PAMA delays at S. 3718.  PAMA round 1, year 3, is proceeding as normal, as always expected, with 10% payment cuts on those tests that had a greater than 20% payment drop from PAMA 1 data (2017/2018).

Next year, in 2021, there will be a fixed fee schedule (same as 2020) with 0% cuts.

In 2022, there will be reporting of PAMA, reporting 1H2019 claims.  In 2022, there will be 15% fee cuts on any tests that still have such a steep cut remaining based on 2017/2018 data, that is, PAMA round 1.

In 2023-2024-2025, there will be a new Round 2 PAMA three year fee schedule.  In its first two years, 2023, 2024, cuts of up to 15% are allowed.  Unlimited cuts in 2025 and forward.  I've tried to capture this with the following chart (click to enlarge):

click to enlarge

But wait, there's more, about commercial insurance and COVID.

In the next section, I'm summarizing in general terms, for the exact terms see the law itself.

Sections 3201, 3202, 3203 cover private insurance and COVID testing. 

  • 3201 defines a COVID 19 as one cleared or authorized by the FDA (including emergency use) or one for which the LDT intends to apply for emergency use.   
  • Section 3202 says that for group health plans or health insurance, the health plan will reimburse the lab a pre-existing negotiated rate OR ELSE, the cash pay rate the lab has on public internet.  Section (b) requires the lab to post a cash price on the internet.   
  • Section 3203 is interesting and deems COVID preventive services and vaccines to be covered services, at such future data as vaccines are invented.   


CMS INTERIM FINAL RULEMAKING re COVID EMERGENCY

CMS announced in rule CMS 1744 IFC that it was making multiple interim changes in federal rules to help deal rapidly and efficiently with the COVID crisis.  Interim final rulemaking means that comments are accepted, but, the rule itself is effective quickly, before the normal run of a comment and revision period.

See the CMS interim rule online here, at 221 pages, March 30.  Update: See the Federal Register publication, 85 Fed Reg 19230-19292 (63pp), April 6, 2020, here.   An "unlocked" copy you can highlight, is in the cloud here.

CMS has an infographic (March 30) of emergency waivers and rules, here.

See the full press release and summary from CMS here.  For example, CMS has emergency "hospitals without walls" rules to cover tent-setups, use of empty college dorms, etc.  

See article about the changes from Hayes and Boone law firm, online here.
A rule summary focusing on telehealth is here and deeper dive on that here.

There's a lot of rulemaking here in the Interim Final Rules, including for example a range of Stark emergency COVID waivers analyzes on the Faegre Drinker website here.   Basically, CMS marches in 63 pages through a whole host of CMS rules and regulations.  Diabetes Prevention Services could only be given in brick and mortar classes; now they can be telehealth.   DME NCDs and LCDs required face to face encounters; now they don't.   Opioid Treatment Programs could have audiovisual counseling sessions; now they can be telephonic only; etc. 

You can comment on the Interim Final Rules, which were issued and effective March 31, until June 1, 2020.


CMS INFORMATIONAL ALERT - MEDICAID, TELEHEALTH

CMS also has a multi-section press release webpage and summary dated April 3, 2020 here.  See, for example, a 23 page letter on rural Medicaid, CHIP, and telehealth policy updates here.  See also a 19 page Medicaid FAQ here.

____

CMS's own summary of topics in the Interim Final Rule is as follows.  The CLFS section is about the coding and pricing for COVID specimen collections.



[This rule covers:]

...issues related to telehealth services, and 
communication technology-based 
services; frequency limits on subsequent 
care services in inpatient and non- 
facility settings, critical care 
consultations, required ‘‘hands-on’’ 
visits for ESRD monthly capitation 
payments; removal of restrictions on 
technology, and supervision of 
interactive telecommunications 
technology; clinical laboratory fee 
schedule; services furnished by opioid 
treatment programs; payment under 
Medicare Part B for teaching physician 
services and resident moonlighting; 
remote physiologic monitoring; 
physician supervision flexibility for 
outpatient hospital services; payment 
for office/outpatient evaluation and 
management visits; counting of resident 
time at alternate locations; Ambulance 
Fee Schedule; rural health clinic 
services; federally qualified health 
center services; and inpatient hospital 
services furnished under arrangements 
outside of the hospital.

##


  


Thursday, April 2, 2020

AMA Releases Newest PLA Codes (Submitted Jan 1, Released Apr 1) - Next Comment Period April 8

AMA produces PLA codes at lightning speed - applications are due quarterly (circa Jan 1, April 1, July 1, October 1).    There is a very brief public comment period thereafter.   The PLA subcommittee revised and votes on the codes soon (this month, April 22) and the codes will be voted on (somewhat pro-forma) by CPT editorial committee a few weeks after that.

  • Heads up: The second quarter PLA applicants (submitted in the last couple days) will be posted for public comment on April 8, and this is a very brief window (after that, the cohort of codes submitted April 1 will be taken down and hidden until posted as final around July 1).


Read the New PLA Codes Online

The big news is that on April 1, AMA posted the PLA codes voted on and completed during the first quarter.   You can read the codes now; they will be "active" for example for Medicare claims, on July 1, 2020.    This cohort of codes will also be on the agenda of the summer CMS lab test pricing meetings ("crosswalk-gapfill meetings.") 

The home page for PLA codes is here.
The PDF of brand new April 1 codes is >>>  here.
   (Link for PDF at bottom of the PLA home page.

AMA has deleted 5 codes but added 30, and revised one (0068U).  Note that AMA has been touchy about when a PLA code can be "revised" and when a revision represents "a new test therefore a new code."  For 0068U, it looks like the brand name (not the code text itself) changed.

The deleted codes were mostly represented by deleted prenatal biochemistry screening tests held by Eurofins.

In reading the PDF, which is 12 pages, note that it lists (old) new codes for October 1 and January 1 prior to new-new codes for April 1.   This is because this PDF is a listing of all PLA codes that have not been otherwise previously published in the yearly AMA CPT manual.  Thus, the new-new April 1 codes are on page 9-12 of this PDF.

What Hath PLA Wrought?

Grifols has codes 0180U-0201U for RBC typing singly or in panels.

Other new codes run from 0172U to 0179U and include a number of oncology gene panels and also psychiatry panels.

Myriad MyChoice is here 0172U, which is also an ADLT (see CMS ADLT webpage.)  CMS has priced it at $4040 here.







Adaptive Biotechnologies Partners with AMGEN for COVID Therapies

A few weeks ago, I was impressed that Adaptive Biotechnologies had forged a new alliance with Microsoft (super-powered cloud technologies) and was openly seeking COVID-19 patient blood samples for research on immune system responses in an extremely complex, NGS-based way.   This was news on March 20 (entry point here).

Today, on April 2, Genomeweb runs and article that Adaptive has also forged an agreement with Amgen, to develop human antibody-based treatments (for example, neutralizing antibodies) - Genomeweb article open access here.

I've done some consulting for Adaptive from time to time, which raises my awareness of them.  But the big point here is, they started as a lab (send them a blood sample, they'll send you a ClonoSEQ report), also providing RUO reagents to researchers.    Here, now, Adaptive's state-of-the art sequencing core capabilities are deeply embedded in in the heart of therapeutics development, and not just as a companion diagnostic (which has become commonplace) but bringing the molecular biotechnology sequencing lab directly into the middle of the drug development process with one of the world's major biopharma firms.  (Adaptive also inked a deal a year ago with Genentech). 

It's a horrifying time, with the pandemic COVID, but it is a very exciting time to watch the evolution and brand new roles of NGS at the cutting edge of responses to the crisis.


Saturday, March 28, 2020

Article in SCIENCE Highlights Precision Medicine Aspects of COVID-19

Most discussion of COVID-19 highlights increasing severity with age and comorbid conditions (see article in WSJ currently, here. Which is true, but may not be the whole story.  Consider, for example, your risk of heart attack always rises from 40 to 50 to 60, but a lot more if you have familial hypercholesterolemia.

We should also look for risk factors that pile on top of age and comorbidity, risk facts like immune system genetics, that might raise the odds of a cytokine storm caused by COVID. 

  • Jocelyn Kaiser at SCIENCE provides an article, dateline March 27, on this theme, here.    

The journalist includes quotes from CEO Kari Stefansson of Icelandic "DeCode Genetics," from the Finnish FinnGen initiative, the UK Biobank effort, and others.   Targets include scanning the whole genome for currently unguessable risk factors, balanced by looking at obvious genomic candidates, like variations in the ACE2 receptor (angiotensin converting enzyme receptor) that COVID must bind to before entering a cell.

Searching for co-pathogens that spike the risk of a patient's deterioration could also be fruitful and could be undertaken by NGS pathogen metagenomics, given that end stage patients are often on high dose antibiotics that can interfere with culture (e.g. Karius and others).   There's some preliminary journal publications that a patient's early procalcitonin bioresponse to infection (more commonly tested in US and Asia than USA) may flag early cases that are likely to deteriorate (Pubmed here).  The point is that answers could come from many different directions and help us better than "aging or comorbidity."

Adaptive Biotechnologies in Seattle, partnering with Microsoft's massive data systems,  has started an open call for samples in an initiative to seek immune system variations that develop during, or predispose to, the COVID response (entry point here).

I had an early blog on this theme March 1 - here.

Tuesday, March 24, 2020

Reminder: CMS Accepting Comments on Colorectal Screening NCD til March 29, 2020

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.



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.


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.


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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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.


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* 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

Codes Not Priced

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.

  • 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
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.


click to enlarge

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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:
  • 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.

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).

  • See the AdvaMed "Center for Digital Health" here.
  • See the conference website here.
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.
  • 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:
"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:


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