Tuesday, September 21, 2021

New Review: How Fuzzy and Confusing are FDA Drug Decisions?

See a paper from Stanford with several FDA authors on how FDA makes decisions when the evidence is close.   The paper screens drug applications from 2013 to 2018, finding 912, of which 22 faced multiple review cycles including a flat-out initial denial.  

 The authors conclude that "the FDA has no mechanism to find, or tradition to cite, similar cases when weighing evidence."   They argue that FDA decision pathways and evidence standards were "highly variable."   

The authors argue that a better tradition of "case studies" and systematic approaches would enhance the transparency and reliability of these decisions.

Find the Janiaud paper here.  Find the op ed here.





Dr. Janiaud is at the Meta-Research Innovation Center at Stanford; Dr. Goodman is professor of epidemiology there.   Goodman and John Ioannidis co-led the MRIC.  Dr. Russek-Cohen is retired FDA; Dr. Irony is former FDA, now with Janssen.

Although it's a 2021 decision, outside their scope of 2013-2018 decisions, the authors make several references to the 2021 approval of aducanumab (Aduhelm).  There is also an op ed from Washington University's Joel Perlmutter, who resigned in June from the FDA neurology committee.


Very Brief Blog: Comment by October 15 on the Cancellation of Medicare "Breakthrough Coverage"

In January 2021, the Trump administration finalized regulations that would provide 4 years of Medicare coverage to new devices if they were approved by the FDA Breakthrough Pathway - here.  The title is, "Medicare Coverage for Innovative Technology," or MCIT.

After several intermediate steps, the Biden administration announced on September 13 it intends to entirely cancel the Breakthrough coverage regulations - here.

       (See a listing of all the regulatory steps - here.)

In order to comment the MCIT cancellation, go to this webpage:

Click in the blue box "COMMENT" in the upper left to register your comment.  Final date is October 15, 2021.


___

Note, the box in the upper right, "SUPPORT," is for technical support, not a button for making a PayPal donation to CMS or regulations.gov.


Monday, September 20, 2021

In Memoriam: Dr. Charles Root, Founder of CodeMap

On September 15, 2021, Dr. Charles Root passed away.  He was well-known throughout the laboratory community for his wisdom and expertise.   

Dr. Root, whose original training was in nuclear physics, was a founder of CodeMap, which provides policy guidance, analytics, and consulting for the laboratory industry.

See the In Memorium announcement at CodeMap, here.   See the CodeMap home page, here.



Saturday, September 18, 2021

Very Brief Blog: Dr. Paul Gerrard Joins Veracyte as Medical Director, Managed Care

In an announcement posted on Link In (here), we learn that Dr. Paul Gerrard has joined Veracyte as the Medical Director for Managed Care.  

Dr. Gerrard previously served as a medical director for the MolDx program (here), and most recently, as a Vice President in the McDermott Plus consulting group affiliated with the McDermott Will & Emery law firm.

Online bio here.   Linked In here.  


In other news, Veracyte appointed Joshua Klopper MD as medical director of Endocrinology; he's been with both University of Colorado and Kaiser Permanente.  The executive medical director at Veracyte is Richard Klopper MD.

Friday, September 17, 2021

Very Very Brief Blog: Browse Comments on PFS Rule

Medicare published the proposed Physician Fee Schedule rule in July, with comments running to September 13.  Hot topics including valuation of AI services.

See the original rule here.

See and search the 35,000 comments receive  - here.  

CMS will publish the final rule circa November 1, effective January 1, 2022.

__

AdvaMed always has strong comment letters that explain the problem before providing alternative solutions.  That's true again this year. See the 25-page AdvaMed general comment on codes and valuations here, and the special 14-page comment on issues like self-referral, here.





Very Brief Blog: Harvard Course on Molecular Diagnostics in Cancer

This past week, Harvard Medical School and partners ran a four-day course on molecular diagnostics in cancer.   I haven't researched this extensively, but it appears the full syllabi (in numerous powerpoints) are posted, along with a video archive which states it's online for two weeks.

See the home page here:

https://www.cmeinfo.com/harvard-molecular-diagnostics-syllabus/

click to enlarge

Click on each date row to unwind a listing of 8-10 powerpoints in PDF.  

Close to my heart, for example, on the fourth day, is a 20-slide deck by MGH's Dr Jochen Lennerz on reimbursement and regulatory issues.

https://www.cmeinfo.com/wp-content/uploads/2021/08/28.-Billing-and-Regulatory-Issues-Jochen-K.-Lennerz-MD-PhD.pdf

Lennerz and team have just released an article on insights from COVID policy towards regulation of LDTs in the future (trade press here, article here.)   

Click on the "video library" bar to open a calendar of the video files.  The website remarks, "Access to the Video Library is available for 2 weeks after the end of the conference and will expire at 5:00pm Central on October 1, 2021."




___

For a 19-page,  2021 review of "clinical cancer genomic profiling," see Chackravarty & Solit, Nat Rev Genet, here.  The authors are at Memorial Sloan Kettering.

Very Brief Blog; HHS Releases Round 2 of Regulations on "Surprise Billing"

Last winter, Congress abruptly passed a Surprise Billing law, that will substantially regulate payments between insurers, patients, and out-of-network providers beginning in CY2022.  (Overview here.)

CMS issued the first round of implementing regulations for comment in July (here).  Article about the July rule here.  AHA letter on the initial surprise billing rule here.

On September 10, HHS released a second round of regulations, which appear to focus on topics like air ambulance, and ways that CMS itself can enforce surprise billing payment rules if states do not do so adequately.   It also addresses another corner of the law, in which consumers get transparency about how insurance brokers are compensated.

Press release here.

Regulation home page here.  Comment to October 18.

   (30 days comment; the earlier rule had 60 days.)

   PDF here (86 FR 71530, 9/16/21).

Air Ambulance fact sheet here.

___

In September 2020, CMS announced a program that was controlling payments for air ambulance billing and had saved $650M in 4 years (acronym RSNAT).  Here.

In the new press release, HHS notes that the air ambulance industry is highly consolidated.  You would expect that; you wouldn't expect multiple competing firms to each have little market shares and high costs while maintaining aircraft and pilots on-call 24/7.   


Thursday, September 16, 2021

Center for Medical Technology Policy to Close

 In a listserve marked, Update / For Immediate Release, the Center for Medical Technology Policy (CMPT) announces it will be closing in the near future.   


The change was announced by Donna Messner, PhD, the President and CEO of CMTP.  Advances in medical technology policy was a rarefied space 10-20 years ago, but now is "an active and vibrant space," including the federal PCORI (Patient-Centered Outcomes Research Institue), ICER (a high-visibility health outcomes institute), and others.  Messner holds a PhD in science and technology studies.

CMTP was founded by Dr. Sean Tunis 12 years ago.  Tunis had been Chief Medical Officer of CMS (2000-2005).   Tunis  has been a thought leader in evidence-based medicine and a prolific author (PubMed).

Find the CMTP website here.

Wednesday, September 15, 2021

Nerd Note: Lab Wins Legal Argument that LCDs Violate Statute; But Loses in Federal Appeals Court

 

Agendia Vs Azar; LCDs Ruled Invalid without notice & comment under APA; but Reversed at Appeals Court

Agendia, a molecular lab in California, has disputed denials of claims in 2012 and 2013 under an early MOLDX LCD and in a period when California was directly under Palmetto MAC LCDs.  

Agendia used constitutional arguments against LCDs.   They won at the federal court level in 2019 but the decision in their favor was reversed at the appeals level in July 2021.

Note - I am not an attorney and I am providing my best "English language" summary of the cases.

______

The case was delayed due to ALJ backlog from 2014 to 2018.  An ALJ supported payment in 2018, finding the claims were "reasonable and necessary" despite the position of the MAC and QIC.   But it didn't end there. 

The Department Appeals Council overruled, saying the ALJ in this case had not clearly explained why he was overriding the LCD. (The judge is supposed to "grant deference" to LCDs and MAC medical directors, although he has the right to do overrule them, with justification.)

Agendia appealed to federal district course.  HERE.   Agendia v Azar, 10/29/2019.   Agendia argued that 

  1. LCDs are an illegal delegation of responsibility from CMS to a private entity.  This is a constitutional issue, what the federal government can delegate.
  2. LCDs violate the Administrative Procedures Act.  This is a statutory issue.
  3. LCDs were arbitrary and capricious.  (Arbitrary is a judicial concept related to implementation of APA and other issues).
The district court ruled:

  1. LCDs are not an illegal delegation, as CMS continues to supervise MACs and LCD claim decisions can be overturned (even if "deference" is paid to the LCD) and LCDs can be invalidated under a beneficiary's LCD challenge.
  2. LCDs do violate the administrative procedures act.  They set operational CMS policy.  They may set CMS's initial policy.  Regardless of whether LCDs have a public comment period of sorts, there is no statutory basis for this to be different than APA notice and comment rulemaking.  (There IS, however, a separate statutory comment provided for NCDs.*)  
  3. The judge need not address #3 because he has decided the case on #2.
For a discussion of the above district court ruling, Baker Donelson, here.

The judge remanded back to CMS for Department Appeals Board review, but instead, CMS appealed the case in federal appeals court.  

A video hearing is online from January 16, 2021.   YouTube, HERE.  (Autotranscript, here.) The appeals case was decided on July 16, 2021.   It determined that the federal court decision was incorrect, e.g. LCDs do not violate the APA.   HERE.  The decision was that the LCDs "do not establish or change a substantive legal standard" and therefore did not implicate APA.  One judge dissented.


##

As discussed several times in the appellate case, the 21st Century Cures Act, which was passed in December 2016 before these cases, does create an explicit comment period framework for LCDs, so the 2019 judge's argument that there was no such explicit pathway, granted by Congress, separate from APA, would be moot today.

##

For a Reuters article on the Appeals court case, July 2021, here.   
See back story on a similar, but prior, legal case supported by California Clinical Lab Association - May 2015 here (and see links to prior stories in April 2014, July 2014).  The prior case was eventually halted for "lack of standing," so a judgement on the issues was not reached.  There was no question in the current case that Agendia, having submitted claims, had standing.

##

Separately, Agendia was involved in a corporate integrity agreement related to the 14 day rule - here.

##

There are indexes for ALJ decisions, MAC (Medicare Appeals Council) decisions, and DAB (Departmental Appeals Board) decisions (here), but I wasn't able to find either the original 2018 ALJ decision for Agendia nor the 2019 MAC decision rescinding it.  What are linked above are, the federal district court case and the subsequent federal appeals case. Along the way I found a new 2018 guideline for appointing ALJ judges (here).

___
* Since it is Congress that created the APA, it is Congress which can create alternatives to the APA for certain federal procedures, here, the NCD.

Tuesday, September 14, 2021

Very Brief Blog: CMS Blog on Plans for the MCIT, and Other Essays

 CMS has had several publications about innovation and new directions in the past few weeks.

MCIT #1

There's yesterday's announcement CMS plans to cancel the MCIT, Medicare Coverage for New Technologies, which was developed under the Trump administration last fall.  Here.

MCIT #2

On September 13, CMS revisited the MCIT topic in a long blog that parallels the release of the rulemaking.  Here.  Penned by Dr. Lee Fleischer, Chief Medical Officer.  

CMMI in Review

In August, CMS published a long blog at Health Affairs on CMMI, The First Ten Years.  Here.

CMS Administrator: Looking Ahead

September 9: Administrator Chiquita Brooks-LaSure pens an essay on her first several months and her outlook.  Here.

Monday, September 13, 2021

Flash: CMS Proposes to Cancel the MCIT Breakthrough Device Coverage Rule

CMS, under Biden, has now officially proposed cancellation of a suspended Trump administration rule.  The rule would have granted unconditional 4 year coverage to FDA breakthrough devices.  

See my four minute video on Youtube - Here:

https://www.youtube.com/watch?v=uFfHjfYXMWU

### 

In September 2020, CMS proposed to create immediate and unconditional automatic coverage, for four years, for all FDA breakthrough devices.  This is the "Medicare Coverage of Innovative Devices" or MCIT rule.

The FDA BT pathway is a review pathway for devices that do not have an FDA predicate or are novel in some other promising way.  It is issued early in the review process for promising devices, and is not contingent on the actual final performance of the device after clinical studies and FDA final review.

At least several hundred devices have entered the FDA BT pathway in the past several years.

In January 2021, CMS under President Trump finalized the MCIT regulation.  However, in March 2021, the Biden administration delayed it til May.  In May, they delayed it again, until December.

On September 13, 2021, after market close, CMS released a proposed rule that would exist simply to reverse the prior finalized rule, and would cancel the MCIT regulation.   CMS explains that public comment led it to reconsider problems with the MCIT rule.  For example, CMS now believes the MCIT rule would have resulted in erroneous coverage of devices even if they had no evidence specifically in the Medicare population, or coverage of devices whose manufacturers fail to complete post-marketing studies.   

Rather than unilaterally "cancelling" the rule, CMS must administratively "propose to cancel" the rule, take public comment for 30 days, and then issue its final position.   But the net policy is simply to retract the prior MCIT regulation.  

CMS published a "typescript" or inspection copy on September 13, and a full typeset publication will appear in Federal Register on September 15.  Comment runs until about October 11.

The rule can be read at the link:

https://public-inspection.federalregister.gov/2021-20016.pdf

Update:

CMS also released an essay on the MCIT topic which is penned by Dr. Lee Fleischer, Chief Medical Officer.  The main point is that MCIT is being canceled, but the general topic of adequate and timely coverage remains a priority of CMS administrators.


___

Coverage at Healthcare Dive here.  MHealthintelligence here.  AuntMinnie (radiology) here.  Fierce Healthcare here. Healthcare Finance News here.  RevCycleIntelligence here.

 AdvaMed press release here.  AdvaMed notes a favorable OpEd by Dr Anand Shah, who has worked at both CMS and FDA, here.   Others, like Tuft University's health policy expert Peter Neumann, opposed MCIT, here.  Some payers were critical - here.
___

A Senate bill, S. 2416, introduced in 2019 and reintroduced in July 2021, asks CMS to accelerate coding and payment and coordinate better with FDA - here.  Senator Burr's press release here. Titled, "New Opportunities for Value to Extend Lives ("NOVEL") Act."  A different bill, HR4033, would specifically enforce coverage of breakthrough devices for 4 years through law, much as MCIT would have done (here).









Sunday, September 12, 2021

Very Brief Blog: Medicare Coverage Database Will be "Down" 9-17 to 9-19.

Next weekend, you might as well go to the beach or the hills.   The Medicare Coverage Database, a national library of MAC coverage articles and LCDs, plus NCDs, will be out for the weekend of September 17-19.   They will migrate to a new hosting environment, hopefully, one that is more amenable to covering innovative new technologies.

https://www.cms.gov/medicare-coverage-database/search.aspx



Friday, September 10, 2021

MolDx Posts Advisory Committee for Upper GI Cancer, October 12, 2021

MolDx has posted an announcement that it will hold a Contractor Advisory Committee on October 12, 2021 (2-4 ET, 11-2 PT).  Registration is open until October 11.  The conference is listen-only mode for the audience.

The meeting will discuss the clinical literature related to MolDX: Molecular Testing for Risk Stratification of Upper Gastrointestinal Cancer and rate their confidence in a series of key questions.

What they mean is, tests that risk-classify Barrett's Esophagus (dysplasia).  The key question is, "Is there sufficient data to use molecular testing to risk stratify patients with BE to low or high grade dysplasia?"  Historically, this was done by tiny biopsy samples and simply rating the tissue on H&E slide for dysplasia.

They also ask, does the test preclude the need for more invasive procedures?  And/or, can biomarkers be sampled by less invasive means than traditional endoscopic biopsy?

  • There's a recent open access review article by Grady et al., 2020, here.   
  • There's an open-access article on managing Barrett's by Kamboj , 2021, here.  (One author, Iyer, is also featured on the Cernostics web site here.)
  • There's a non-open-access review by Souza and Spechler, 2021, here.

The MolDx website is linked below, and the website includes additional documents like agenda and the complete text of key questions.  As well as registration.

https://www.palmettogba.com/palmetto/moldxv2.nsf/DID/9TXCRWTLD4

___

Endnotes

I don't have a comprehensive roster of labs in this space but two with a focus on biomarkers in Barrett's would include Cernostics ("Tissue Cyper") and CDX ("WATS3D" testing).   Cernostics is backed by Pittsburgh/ UPMC (here).  

Unrelated to Barrett's, but also in the field of advanced pathology/immunohistochemistry, is ImmunoScore slide-based testing for colon cancer from HalioDx, recently acquired by Veracyte, in a circa $300M deal.  Their code 0X70U/0261U, was presented at the June 2021 CMS new test pricing meeting, with a request to crosswalk to 0108Ux1.2 (at $3015).   CMS will release pricing this fall.

For a July 2021 article by Liang et al. on digital pathology, here from the boutique consultancy Bionext.

The journal with the Grady review article mentioned above, published a long list of symposium articles on early detection of cancer with molecular testing in 2020 - here.  The articles spring from the 20 year NCI effort, Early Detection Research Network or NCI-EDRN. Overview of that, by Bast and Srivastava here.

Thursday, September 9, 2021

Very Brief Blog: Last Two Days to Comment on Novitas Cardiology Genetics LCD

 There are numerous indications to test for genetic causes of cardiac diseases, including arrhythmias and cardiac hypertrophy.   Medicare coverage policies have sometimes been quite limited.

The NOVITAS MAC has had a draft LCD under comment from July 29 to September 11.  I think it has some good features, but it may be pretty quirky in other ways.   For example, it asks the risk of any gene testing to be 40% or more, which seems to high for normal medical practice.  They also seem a little unaware of the overlap of syndromes and thus, the use of panel based gene testing.  

Those with stronger content knowledge in cardiology genetics will want to comment by September 11 (yes, that's technically a Saturday.)  I've put the draft LCD DL39082 and article DA58795 in a zip file in the cloud here.   Comments are directed to, ProposedLCDComments@novitas-solutions.com .

I discussed some pro's and con's of this approach to writing LCDs - more vague LCDs - back on August 17 here.

###

Core rules [partially quoted] include - 

Genetic testing for hereditary cardiovascular disease will be considered medically reasonable and necessary if:

1. The patient has rigorous disease-appropriate phenotyping to establish clinical diagnosis or suspected diagnosis for which the test results would directly impact the management of the patient’s condition, prior to ordering the test 

AND

2. The evidence for the gene-disease association is evaluated by the evidence-based, transparent, peer- reviewed process of the National Institutes of Health (NIH) sponsored Clinical Genome Resource (ClinGen) and is determined to demonstrate actionability in clinical decision making, meeting all bulleted metrics:

  • Disease severity of sudden death, possible death or major morbidity, modest morbidity
  • Substantial or moderate evidence of a >40% likelihood of disease
  • Substantial or moderate evidence of a highly effective or moderately effective intervention
  • The nature of intervention is either low risk/medically acceptable/low intensity intervention or moderately acceptable/risk/intensive interventions, 

AND

3. Clinical validity and qualitative descriptors from Moderate, Strong & Definitive with contradictory evidence NOT being reported as disputed or refuted.

Wednesday, September 1, 2021

Very Brief Vlog: Using Medicare's Physician & CPT Code Data, A Brief Video

This week, CMS released another year's worth of incredible granular data for how physicians and labs use CPT codes for all Part B patients.  There's 10M lines of data from CY2019.

My blog on the data release - find it here.   Would you like to explore the data yourself?  I've made a simple 5 minute video to help get you started.  Find the video here.


The Data Set in Use:

Who got paid for Category III codes in 2019?  Here.

Who got paid for PLA lab codes in 2019?  Here.

Who got paid for Unlisted Genomics code 81479, and where did it happen, in 2019? Here.

Who got paid for 81408, the "very unusual" and highest-paid lab code in 2019?  Here.

Use of the Category III Codes in CY2019 - Who Got Paid for Them?

Earlier I posted that on August 31, 2021, CMS released CY2019 utilization data by provider (or lab or IDTF), and by CPT code.

Here, I culled the data for all Category III codes (searched as all codes containing "T.")

There were 11,000 unique lines where a provider was paid for a Category III code.  Total payments were about $240M.  

The largest was iRhythm, paid $57M for code 0297T, followed by Cardionet, paid $8.9M for 0297T.   While the 3rd-largest line was code 0379T at $4M (remote visual field assessment), the 4th and 5th lines were again 0297T, about about $3M each.  Thus, by line five, 31% of all Cat III payments were accounted for, and most were for cardiac patch-based monitoring, 0297T. 

After that, the next ten or fifteen top payments went to code 0191T, an ophthalmic surgery code (anterior chamber drainage device).

See my extracted cloud database here.   I've sorted one page by "dollars" and one page by "CPT code" in order.



More About Category III Codes - 90% Never Paid by Medicare

In another analysis, only 26 unique Category III codes were reported in the database.  While there were 785,797 total services, 95% of all services went to the top 7 CPT codes.  (And 70% of all services went to the "iRhythm" codes, 0296-97-98T.)   

I'm not sure the total Category III codes active in CY2019, but now in CY2019, there are about 350.   This suggests that in a year, CMS makes a payment only on about 10% of all Category III codes, and never pays for about 90% of them.   

click to enlarge

In addition to "tail" here, ~300 codes had 0 pmts (not shown)


___

The Penny Puzzle

I noticed there were a number of payments of 1 penny per patient, and I first guessed that this was a nasty MAC paying 1 penny to just clear the claim out of its computers and move on.   All the penny claims were in New Jersey (Novitas MAC).  

However, these penny claims turn out to reflect CHARGES of one penny - the doctors billed one penny, so Medicare paid them one penny.   This involved about 700 claims for 0296T (an Irhythm code) in New Jersey, most of the penny-billing docs being in Morristown or Mendham or New Arlington NJ.  No idea what this means.  

__
That's penny billing for Cat III codes.  I went back to the CMS data source and searched paid claims for one penny services.  About 90 CPT codes received payments (for some docs) of one penny, totalling 25,000 payments of one penny.   0296T, the main T code on the list, is not even very high up at #741 payments of one penny.   J7613, albuterol, inhalation, had 2803 payments of one penny, and g0444, annual depression screening, had 2553 payments of one penny.   Ipratropium inhalation J7644 and denosumab injection J0897, had 1986 and 1506 payments of one penny, respectively.   The 90 CPT codes getting 25,000 payments of one penny were distributed across some 700 docs.  

Half of all these 700 docs getting a penny payment (for any of those 90 CPT codes) were in just five states, PA, RI, WV, FL, NJ (with percentages PA 14%, RI 11%, WV 7%, FL 7%, and NJ 7%).   

Use of the PLA Codes in CY2019 - Who Got Paid for Them?

In a previous blog, I noted that on August 31, 2019, CMS released data for CY2019 utilization by physician or lab and by CPT code.

I searched the data for all codes containing "U" - PLA codes.  129 entities billed for PLA codes.  Total payments under PLA codes were $115M.   

Use of PLA codes was HIGHLY concentrated.  Foundation Medicine had $78M for 0037U, the Foundation Medicine FDA test (used 22,954 times).   That's almost 70% of all PLA code use from ONE code in ONE lab.

Next up was Genomic Health with $21M for 0047U and $2M for 0045U - that's Genomic Health Prostate and Genomic Health DCIS, respectively.  Those three codes so far were 88% of all use of PLA codes.  When someone was paid for a PLA code, about 70% of the time it was less than $100K.

I've put a cloud spreadsheet here.  

I've clipped the top lines of the database below. Click to enlarge.



Use of Genomic Code 81479 in CY2019 - Who Got Paid for It?

In a prior blog, I noted that CMS has just released data by provider (physician or lab) and CPT code for CY2019.  I also discussed usage of the largest code in genomics, 81408, billed only by labs in the Novitas and FCSO jurisdiction.

In this blog, I provide a link to a cloud excel file of labs billing CMS for molecular unlisted code 81479 in CY2019.  Virtually all the billing of 81479 (96%) was in MolDx states.  The other 20-some states had almost no payments at all under 81479 (almost zero).  

Total 81479 allowed charges were $197M, of which 59% was paid in California.

The cloud data file is here. A summary by states is in the table below.






Medicare Releases Physician- and Lab-Specific Payments by Codes for CY2019

CMS has been releasing physician and laboratory payments by year and by CPT code dating back to 2014.  The CY2019 data has just been released.

The 3 GB 10M line database can be searched online by using filters and queries in a cloud database.  

For the lab industry:

I've put a condensed version of 47MB and 888,000 lines in the cloud, including all 80,000 series (lab & pathology) CPT codes.  Excel can usually open 1M lines, so this should open in Excel. Across the 888,000 lines of charges for lab & pathology codes, total allowed charges were $7,374,664,794, or $7.4B.

How to Find the CMS Data for CY2019

  • I've made a simple a five-minute video on how to do this - YouTube here.
  • Finding the data:
  • The home page for all data resources at CMS is here.
    • Interesting data pages include "Medicare Fee for Service Parts A&B" and "Part B Carrier Summary Data File" and "Part B National Summary Data File."
  • For the new 3GB of data, the data page for Physicians and Other Practitioners is here.
  • Data is by geography (e.g. all uses of a CPT code in a state), by provider (with detailed summary data by provider such as ages and races of patients seen), and the most granular, "by provider and service."  That's where the new 3GB data of physician & CPT usage is found.



  • Cut to the chase: You'll get to this webpage:


  • Where you want to click on the white box, left side, for VIEW DATA.
  • How you see the data in the cloud.  Between last spring and now, CMS has revised the data layout and I think it is worse, but the data is still there.  Note there is a small drop down box in the upper left where you can select year (2019, 2018, 2017, etc).

  • Note that the data view, before any filtering, has 10M rows.  
  • You will want to filter it by "managing columns" and "filtering" (e.g. for only code 81445), and then use the EXPORT button to export data to your hard drive in Excel.  My simple video guide here.

  • I say the data set is worse because, for example, you used to be able to filter CODE by "Starts with" or "range" and now, you can only filter it by standard number equations like "equal to" or "less than."  The visual user interface also used to be better, and the column names used to be reader-friendly.
Using the Data - Quick Examples
  • I believe that the genetic test fraud situation called "Operation Double Helix" was at its peak in 2018 and 2019 - press here.  
  • For example, a person with an interest in doing so, could look up every lab that was named publicly by DOJ in "Operation Double Helix" and see how much each lab was paid, and by what MACs, and for exactly which CPT codes.  (See more at the end of this blog.)
Using the Data - Who Got Paid for 81445, 5-50 Tumor Genes?
  • Here I show a table (click to enlarge) of payments for code 81445, tumor, 5-50 genes, with 7,325 services going to 24 labs for a total of $4.2M in 2019.   The point is: You can do this kind of data for any CPT code, or range of codes.   You could look up all the urologists who used a particular prostate surgery code.  And so on.



  • DOWNLOAD ALL LAB PAYMENTS.
  • If you'd like to ask any question about lab codes, labs, and payments, but you don't want to mess with the CMS cloud data, I've tried to help.
  • I've put in the cloud a shortened, downloadable 47MB, 888,000 line file of all physicians and labs who used any 80,000 series CPT codes in CY2019.  >>  Here.  <<
81408: The "Fraudomatic" Code
  • For a couple years, I've tracked CPT code 81408 (rare long genes, $2000).  This code was virtually unknown before 2018, and use exploded in 2018 and 2019.  
  • Intense users of this code were disproportionately mentioned in Operation Double Helix, and almost all use in 2019 was in two MACs, Novitas and First Coast.  These MACs had "no edits" on this $2000 code, meaning it would autopay if billed and in units up to 2 per day.   Blog here.
  • 81408 came out of nowhere with lightning speed to be the top billing genetic code in Medicare in 2019 ($283,634,684).  I mean, wow - an unbelievable story.
  • There's essentially no billing of code 81408 by familiar national genetic labs like Invitae, Ambry, Labcorp, Quest, Bioreference, and etc. Click to enlarge.


  • Medicare Part B pending by state for 81408 in CY2019 was as follows:


  • That's 81408. For data on CY2019 users of code 81479, see the next blog.
_____

Watching the Annual CMS Calendar of Data Releases

The next big CMS data events in Part B will be release of national- and state-level data for CY2020 in about October 2021.   CMS will release provider-level data for CY2020 around August 2022.

Very Brief Blog; Medicare's Breakthrough Technology Rule (MCIT): Expect Another Version Soon

Medicare and others have been talking about special status for FDA Breakthrough Review devices (BT) for several years, with the Trump administration finalizing a major regulation in mid-January 2021.  The Biden administration delayed the regulation on Mach 17, and issued further plans on May 18, including a delay until December 2021.

Expect some news in September 2021.   

A new version of the rule is now being reviewed by the Office of Management and Budget (OMB) - link here, and update paragraph (8/27) here.  This usually means that a Federal Register publication is due within a few weeks.

As proposed in January, the Medicare Coverage for Interim Technology or MCIT rule would have granted four years of automatic Medicare coverage to any BT device, effective for four years from the date of FDA approval.  For links to the various stages of initial and interim rulemaking, see the OMB link above. 

The tracking page also links to several official  government and stakeholder meetings about the rule - here.

Saturday, August 28, 2021

Solid Data: One in Four COVID Cases are in Fully Vax People, in Highly Vaccinated Regions

1 in 4 COVID cases in Southern California occur in the majority-share of the population which is fully vaccinated, according to CDC. While limited to one region, the report gives access to results of 43,000 documented infections in a population of 10M in Los Angeles County. The time period is May 1-July 25, so it include the ramp-up of COVID Delta, but most of the period studied was before the full-blown surge. 

I’ve seen claims that fully-vaccinated people are less than 10% of new cases, or as high as 60% of the test-positive population (data from Cambridge, MA, in July). Fully vaccinated people remain hugely protected from hospital-grade illness, although some will have at-home illness that is fairly severe. 
 
The CDC report is here:
https://lnkd.in/gEXTEV9S
 
See a news summary by Allie Hogen:
https://lnkd.in/gpK8uimU
 
In my view, news sources reported HIGHLY misleading data on the rate of infections in fully-vaccinated people right up to the end of July – less than 4 weeks ago! I shot down misleading rate data published in the LA Times on July 23:
https://lnkd.in/ghYF3hcv






Illumina Announces 2021 Americas Genomic Payer Summit (September 21-24)

Illumina has announced a 4-day calendar of events for its 2021 "Americas Genomic Payer Summit."  

Described as:

Hear genomics leaders from North and South America discuss the coverage landscape, identify strategies to evaluate clinical utility and economic value, and improve access and reduce burdens for patients. Explore the virtual conference and engage with coverage and reimbursement leaders, labs, and patient advocates about the current and future state of genomics in medicine.

Find the Event Registration here.   Find the agenda here.

 


Thursday, August 19, 2021

Two Resources for Medicaid Coverage: Screening Services, Lung Cancer Services

It's notorious that Medicaid is fifty separate programs, with their own websites, quirks, and rules.   In this blog, we point to papers on (1) biomarker coverage and (2) preventive services coverage.

####

It's notorious that Medicaid is fifty separate programs, with their own websites, quirks, and rules.  Or even more than that, when a state has multiple competing Medicaid Managed Care organizations.  (And Managed Medicaid, as opposed to a state-operated fee for service program, is well more than half of Medicaid).

I ran across two useful references that both demonstrate, and attempt to summarize, the diversity of Medicaid programs.

Medicaid and Lung Cancer Coverage

The first is a 20 page white paper from the lung cancer association, Lungevity, a "state scorecard" for cancer-related coverage.   Find it here.  The report was undertaken by the consultancy ADVI.

For example, only 39% of states cover full-panel biomarker testing (code 81455):


The report includes epidemiological data as well, such as lung cancer rates and survival rates.  

Medicaid and Preventive Services

The second is a peer-reviewed paper on Medicaid coverage for preventive services.  A wide range of preventive services are now baked into Medicare, and commercial plans are required to cover USPSTF endorsed preventive services.  [*] However, Medicaid coverage is at state discretion.

See Bloodworth et al, 2018, Variation of preventive service utilization by state Medicaid coverage, cost-sharing, and Medicaid expansion status.  Pubmed here, journal Preventive Medicine here. (Pay per view, $36).


___

For more on the ACA and preventive services, see e.g. Chait & Glied (2018) Ann Rev Public Health, Prevention under the Affordable Care Act, here (open access).



Very Brief Blog: Boston Healthcare Associates Becomes Part of "Veranex" Business

For many years, biopharma and medtech consultancy Boston Healthcare Associates has been a leader in precision medicine consulting, leveraging their expertise in the diagnostics industry.

See a new press release that BHA is now part of the VERANEX consulting solutions group.   Graphic here:


Veranex promises a pathway of solutions from design to regulatory to clinical trials to market access:


Consolidations are a regular feature of the specialty consulting industry.  

See, for example, an April 2021 announcement when Vachette Pathology, a pathology/laboratory revenue consulting firm, was acquired by Lighthouse.   Deals for specialty consultancies can be quite large, such as when Inovalon acquired Avalere for $140M in 2015 (here).

In 2017, Quorum Consulting was acquired by Navigant (here.).

Tuesday, August 17, 2021

J Molec Dx: Press Release: COVID Viral Load Correlates Poorly with Transmission

 We regu\larly hear about viral loads in COVID (for example, Delta variant is 1000X higher).  Passing along a J Molec Diagnostics press release for a new article that directly looks at cycle-time viral loads and transmission, with a warning not to equate the two.  The authors were seeking high viral load index cases to identify the highest-risk persons for contact tracing.   However, the correlation between (Ct) and observed infectivity of contacts did not support such a policy.  In a college environment, half of index cases with COVID did not have any identified transmission to others.  Of persons in quarantine, about 18% tested positive.

Direct link to Tian et al. here.  I saw the press release today; the article dateline is June 5, however.



###


New study: 

Viral load is not a true indicator of SARS-CoV-2 transmission risk

 

Cycle threshold (Ct) has limited utility in guiding decisions regarding isolation and quarantine of COVID-19 patients, report researchers in The Journal of Molecular Diagnostics

 

Philadelphia, August 16, 2021 – The transmission of SARS-CoV-2 virus is dependent on many factors. Although some in vitro studies indicate that the amount of virus isolated from infected individuals affects the successful rate of virus transmission, whether the viral load carried at the individual level can determine transmissibility was unknown. A study of college students who underwent regular testing and contact tracing after positive tests, found significant overlap in cycle thresholds (Ct) between spreaders and nonspreaders. This makes Ct values questionable in determining transmission rates. Even those with low viral loads can pass on the virus, researchers report in The Journal of Molecular Diagnostics, published by Elsevier.

 

“We wanted to find whether there was a scientifically sound way to quickly triage students with potential high-risk exposure to COVID-19 positive students for quarantine,” explain co-lead authors Patrice Delafontaine, MD, Department of Medicine, and Xiao-Ming Yin, MD, PhD, Departments of Pathology and Laboratory Medicine, Tulane University School of Medicine, New Orleans, LA, USA. “Some studies have found that the Ct value of the RT-PCR assay is a surrogate for infectivity, and cutoff Ct values have been proposed as a way to guide isolation practices. Through testing and contact tracing, we found that Ct value could not predict transmissibility. We should not overlook positive patients with low viral load, and all positive patients should be quarantined.

 

Tulane University maintained on-campus educational activities in the fall semester of 2020. A high-throughput SARS-CoV-2 surveillance testing program was established to support contact tracing, isolation, and quarantine efforts needed to restrict viral transmission throughout the campus. All students were tested twice a week. At the time of testing, students were asked about symptoms they may be experiencing. Contact tracers spoke to all positive case subjects to identify close contacts.

 

The study looked at 7,440 patients who were screened between September 1, 2020 and October 31, 2020. 602 positive cases were identified. From this group, 195 index cases were identified with one or more reported close contacts, who were then tested during their mandated 14-day quarantine period for evidence of transmission from the associated index cases. Of these index cases, 48.2% had at least one contact who became SARS-CoV-2 positive, whereas 51.8% of the index cases were nonspreaders with no contacts who subsequently tested positive. Mean Ct values of the spreaders and the nonspreaders were nearly identical.

 

The investigators then took a reverse approach, in which index cases were traced for 481 students undergoing quarantine due to known exposure to the disease. Eighteen percent of the students became positive during their quarantine. Index cases for the 481 quarantined students were considered spreaders if they were linked to one or more quarantine students with a positive test result, or nonspreaders if they were associated only with students with negative test results. The mean Ct values of the spreader and the nonspreader groups were similar. 

 


Caption The cycle threshold (Ct) values of the spreaders and the nonspreaders are largely overlapping. A: Separation of index cases into spreader and nonspreader groups. The n of the cases in each population is indicated. Scatter plots of Ct values expressed as means ± SEM (B) or median ± interquartile intervals (C). D: Histogram of the distribution of Ct values. E: Cumulative frequency of Ct values. Dashed lines indicate the cumulated percentage of each population at the designated Ct value (24 or 32). At the indicated Ct value of  24, there is a higher percentage of spreader cases than nonspreader cases, although the differences are small. Ct values of the indicated populations are compared. Mann-Whitney U test (P > 0.05). (Credit: The Journal of Molecular Diagnostics).

 

Next the investigators identified and evaluated 375 positive COVID-19 cases to assess the relationship between symptom presentation and Ct values. Reported symptoms included lethargy, fever, headache, cough, runny nose, and gastrointestinal symptoms. The mean and median Ct values were significantly lower in symptomatic cases than in asymptomatic cases, indicating a higher viral load. These findings suggest that infections with a higher viral load may be more likely to lead to symptom development, or that symptomatic individuals tend to have higher viral loads or maintain their viral loads for a longer period of time. Ct levels may be useful at a population level, in association with symptomatic presentation, to indicate the likelihood of transmission. These values may thus have epidemiologic or surveillance importance.

 

“Taken together, these index cases suggest that Ct values alone do not predict transmission risk, and reporting of Ct values at the individual level, such as by setting a cutoff value of 32, would provide little diagnostic value for case management,” note Dr. Delafontaine and Dr. Yin. “A sensitive and robust SARS-CoV-2 diagnostic testing method is needed to effectively control viral transmission by maximizing the ability to identify and quarantine even those with a low level of virus.”

 

---

 

Notes for editors

The article is Ct Values Do Not Predict Severe Acute Respiratory Syndrome Coronavirus 2 (SARD-CoV-2) Transmissibility in College Students,” by Di Tian, Zhen Lin, Ellie M. Kriner, Dalton J. Esneault, Jonathan Tran, Julia C. DeVoto, Naima Okami, Rachel M. Greenberg, Sarah Yanofsky, Swarnamala Ratnayaka, Nicholas Tran, Maeghan Livaccari, Marla L. Lampp, Noel Wang, Scott Tim, Patrick Norton, John Scott, Tony Y. Hu, Robert Garry, Lee Hamm, Patrice Delafontaine, and Xiao-Ming Yin (https://doi.org/10.1016/j.jmoldx.2021.05.012). It appears online in advance of The Journal of Molecular Diagnostics, volume 23, issue 9 (September 2021) published by Elsevier.

 

This article is openly available at https://www.jmdjournal.org/article/S1525-1578(21)00163-X/fulltext.

 

This study is based on the internal support from Tulane University.

 

Full text of this study is also available to credentialed journalists upon request; contact Eileen Leahy at +1 732 238 3628 or jmdmedia@elsevier.com. Journalists wishing to interview the authors should contact Keith Brannon, Director, Tulane University Public Relations, at +1 504 862 8789, +1 504 621 2724 (mobile), or kbrannon@tulane.edu.

 

Elsevier’s Novel Coronavirus Information Center provides expert-curated information for researchers, healthcare professionals and public health officials, including clinical guidance and a portal to access all of Elsevier’s COVID-19 research. All resources are freely available. We also have dedicated hubs for healthcare professionals; health educators and students; librarians; and R&D professionals. You can find these in our Coronavirus Resource Directorywww.elsevier.com/connect/coronavirus-information-center.

 

About The Journal of Molecular Diagnostics

The Journal of Molecular Diagnostics, the official publication of the Association for Molecular Pathology, co-owned by the American Society for Investigative Pathology, and published by Elsevier, seeks to publish high quality original papers on scientific advances in the translation and validation of molecular discoveries in medicine into the clinical diagnostic setting, and the description and application of technological advances in the field of molecular diagnostic medicine. The editors welcome review articles that contain: novel discoveries or clinicopathologic correlations, including studies in oncology, infectious diseases, inherited diseases, predisposition to disease, or the description of polymorphisms linked to disease states or normal variations; the application of diagnostic methodologies in clinical trials; or the development of new or improved molecular methods for diagnosis or monitoring of disease or disease predisposition. www.jmdjournal.org