Very Brief Blog: CMS Responds to Hill re Medicare Program's Sepsis Policies

Just a week ago, there were several big-data articles, supported by CMS and BARDA, on the scope and morbidity of sepsis in the Medicare population (entry point here).

Separately, one of the controversies in the academic literature has been around CMS's mandatory measurement of a measure called SEP-1, which has had a conflicting range of positive and negative articles (entry point here; see also PubMed for SEP-1 here.)

In 2020, the House asked HHS to report on its interventions for sepsis and its management of the SEP-1 quality measure.  CMS has now responded.

See the Fiscal Year 2021 CMS Justification of Budget, 346pp, online here.  (This is the mandatory 300 page bedtime reading for Medicare-ologists until the Hospital Rule comes out in April 2020 and the Physician and Outpatient rules come out in June 2020).   CMS's response flags that it may prefer to replace SEP-1 (a complex process measure) with a simpler and more direct outcome measure (such as % survival in sepsis.)

Scrolling head to page 260, here is the House request of CMS, issued last summer:

Sepsis.—The Committee is concerned that sepsis and antibiotic resistant bacteria continue to be leading public health threats that are responsible for a significant number of deaths, as well as rising costs within the healthcare system. According to the most recent data, the national average compliance rate for CMS’s sepsis treatment measure, known as SEP–1, is only 49 percent. The Committee urges CMS to issue a Request for Information to gather views on proposals to modernize and optimize CMS’s current SEP– 1 measure.

The Committee requests an update on these activities in the fiscal year 2021 Congressional Budget Justification.

CMS responds:

CMS agrees that ensuring proper sepsis treatment and antibiotic stewardship is crucial to protecting patients in healthcare facilities and in the community at large.

As stated in CMS’Measure Inventory Tool
(https://cmit.cms.gov/CMIT_public/ReportMeasure?measureRevisionId=300 ),
a principle of sepsis care is that clinicians must rapidly treat patients with an unknown causative organism and unknown antibiotic susceptibility. Since patients with severe sepsis have little margin for error regarding antimicrobial therapy, initial treatment should be broad spectrum to cover all likely pathogens. CMS continues to work closely with the Sepsis (SEP-1) quality measure stewards and stakeholders on measure updates.

Since measure inception in 2015, the stewards have made many updates to the measure to improve abstraction, reduce burden, and address concerns raised by clinicians and stakeholders. Measure updates have taken into account evolving clinical practice and current measure specifications align with the Surviving Sepsis Campaign guidelines. The SEP-1 measure is up for National Quality Forum re-endorsement next year and CMS plans to continue close collaboration with the measure
stewards and stakeholders on potential updates and/or changes to the SEP-1 measure.

Additionally, CMS expects to begin working on a sepsis outcome measure and has formed a Technical Expert Panel that will help inform development of this new measure

CMS shares the Committee’s concern about antibiotic resistance. The consequences resulting from misuse of antibiotics are severe, leading to life-threatening infections, adverse drug events, and increasing the prevalence of drug-resistant bacteria. In recognition of the importance of proper antibiotic stewardship, on September 30, 2019, CMS finalized requirements that will ensure that all participating hospitals and critical access hospitals implement antibiotic stewardship programs following nationally recognized guidelines (84 FR 51732). Specifically, the final rule includes important requirements for the implementation of antibiotic stewardship programs as part of the Conditions of Participation for hospitals and critical access hospitals in the Medicare and Medicaid programs. We believe that these antibiotic stewardship programs will provide a critical tool for hospitals and critical access hospitals to use in the fight against the emergence of new strains of antibiotic-resistant bacteria and in the defense of our currently effective antimicrobials.

Jeff Bezos Says: Give Strategic Decisions Time, and Don't Overuse PowerPoint

While both PowerPoint and Word memoranda can be the right way to deliver a message, I've seen that sometime PowerPoint is more likely to hide flaws and gaps in the reasoning or the argument.

It's been said for many years that "Amazon Bans PowerPoint" and that they start meetings off with written memos and a five minute reading session. 

In his 2018 letter to shareholders, Bezos devoted some additional thinking to these topics.   He begins by using the example of someone who wants to do free handstands (no wall).  Experts say this takes six months to do perfectly, not a week or two.  Bezos says if you think it takes a week, the project is dramatically under-resourced.   He refers to handstands in the following section.  See the full letter online at SEC (here).

Bezos: 

Unrealistic beliefs on scope – often hidden and undiscussed – kill high standards. To achieve high standards yourself or as part of a team, you need to form and proactively communicate realistic beliefs about how hard something is going to be – something the [gymnastics] coach understood well. 

Six-Page Narratives 

We don’t do PowerPoint (or any other slide-oriented) presentations at Amazon. Instead, we write narratively structured six-page memos. We silently read one at the beginning of each meeting in a kind of “study hall.” Not surprisingly, the quality of these memos varies widely. Some have the clarity of angels singing. They are brilliant and thoughtful and set up the meeting for high-quality discussion. Sometimes they come in at the other end of the spectrum. 

In the handstand example, it’s pretty straightforward to recognize high standards. It wouldn’t be difficult to lay out in detail the requirements of a well-executed handstand, and then you’re either doing it or you’re not. The writing example is very different. The difference between a great memo and an average one is much squishier. It would be extremely hard to write down the detailed requirements that make up a great memo. Nevertheless, I find that much of the time, readers react to great memos very similarly. They know it when they see it. The standard is there, and it is real, even if it’s not easily describable. 

Here’s what we’ve figured out. Often, when a memo isn’t great, it’s not the writer’s inability to recognize the high standard, but instead a wrong expectation on scope: they mistakenly believe a high-standards, six-page memo can be written in one or two days or even a few hours, when really it might take a week or more! They’re trying to perfect a handstand in just two weeks, and we’re not coaching them right. The great memos are written and re-written, shared with colleagues who are asked to improve the work, set aside for a couple of days, and then edited again with a fresh mind. They simply can’t be done in a day or two. The key point here is that you can improve results through the simple act of teaching scope – that a great memo probably should take a week or more.

Bezos summarizes, great work "simply can't be done in a day or two."  Years ago, in a quote I've forgotten, one of the famous 20th century judges, like Cardozo or Brandeis, made the same point in an essay about hard judicial opinions.  His strong point was, after hearing the case, after reading the briefs, the final decision ...just...took...time.  Pretty much the same point Bezos is making in a business context above.

Karius Raises $165M for Microbial NGS Sequencing

From Reuters and other newswires, Bay Area molecular diagnostics startup KARIUS raises $165M in a Series B funding round.   Karius provides overnight assessment of the complete blood microbiome (1200 pathogens).    

Reuters here.
TechCrunch here.
Fierce Biotech here.
The company's website is here - https://www.kariusdx.com/

See a detailed 2019 paper on analytical and clinical validation in Nature Microbiology, open access, Blauwkamp et al., here.

Excerpt from Tech Crunch:

“What Karius is good at is identifying those novel microbes before they become an outbreak like coronavirus,” says Mickey Kertesz, a chief executive whose life sciences startup just hauled in $165 million in new funding.

While the new money may have been raised under the looming threat of Covid 19, the company’s technology is already being used to test for infection-causing pathogens in immunocompromised pediatric patients, and for potential causes of complex pneumonia, fungal infections and endocarditis, according to a statement from the company. 

Liquid biopsy technology has been widely embraced in cancer treatments as a way to identify which therapies may work best for patients based on the presence of trace amounts of genetic material in a patient’s bloodstream that are shed by cancer cells.

Karius applies the same principles to the detection of pathogens in the blood — developing hardware and software that applies DNA sequencing and machine learning techniques to identify the genetic material that’s present in a blood sample.
As the company explains, microbes infecting the human body leave traces of their DNA in blood, which are called microbial cell-free DNA (mcfDNA). The company’s test can measure the cell-free DNA of more than 1,000 clinically relevant samples from things like bacteria, DNA viruses, fungi and parasites. These tests indicate the types of quantities of those pathogens that are likely affecting a patient. 

“We’re through the early stages of adoption and clinical studies show that the technology literally saves lives,” says Kertesz.

click to enlarge.  OGrady/Nature here.

Very Brief Blog: Proposed Pathology CPT Codes Reviewable - on Whirlwind Schedule

The AMA CPT editorial panel meets three times a year - roughly February, May, October - and posts abbreviated descriptions of each proposed code some six weeks in advance (March 13, 2020), allowing stakeholders to request code application packets and submit comments.

(Commenters must have a direct relationship to the code in question, however, which AMA reviews before sending the packet out to the stakeholder.  For example, my status as a consultant interested in CPT trends doesn't qualify me to get copies of new digital health codes.  However, if I was a digital health company with a product or service that would likely use the code, that would qualify as a stakeholder.)

However, pathology codes are on a whirlwind schedule.  Path/Lab codes, which were due at AMA around February 12, have been posted already and if you want to comment, you must state your intent in an email to AMA by Wednesday February 26 at the latest.

AMA will send you materials, which you can comment on by March 2.

The PDF agenda (and comment instructions) for the May 2020 CPT meeting are online here.  Again, you must respond to AMA by Feb 26 if you want your input considered.  If you are interested in non-path non-lab codes, check back with AMA around March 15 when those codes will appear online.

Codes include:

• Carbamazepine drug assay
• Felbamate drug assay
• Drug assays for flecainide, itraconazole, leflunomide, methotrexate, rufuinamde.
• MAAA code for adrenal cortex malignancy risk
• MAAA code for 70 gene breast cancer risk panel by microarray OR by NGS
• MAAA for bladder cancer subtyping
• MAAA for bacterial vaginosis
• MAAA for allograft rejection
• GSP (genomic sequencing eg NGS) code for solid tumors editing coding and placement of RNA analysis
• Cat III code 0500T HPV genotyping elevate to Cat I
• Campylobacter antigen
• Free estradiol test (multiple revisions)

Comments will be circulated  to the Pathology Coding Caucus, a group that includes CAP, AMP, ACLA, Advamed, and other major organizations.  They will also become part of the file available to the CPT committee of the whole.

___

Some CPT dates (here).  Applications were due Feb. 12 for CPT Chicago May 14-16, 2020.  Applications will be due June 30 for CPT New Orleans October 1-3, 2020.   Applications will be due November 4, 2020, for the AMA CPT in Phoenix February 4-6, 2021.   In each case, Path/Lab codes open for comment about 7-10 days after they are due, while other codes open for comment about 60 days prior to the CPT meeting.

____

The results of panel actions are posted at:
https://www.ama-assn.org/about/cpt-editorial-panel/summary-panel-actions

The September 2019 Seattle meeting has been posted, but not yet the February 2020 SF meeting.
https://www.ama-assn.org/system/files/2019-11/september-2019-summary-panel-actions.pdf

FDA Creates New Pharmacogenetics Websites, More

It's notorious that in November 2018 and in first-half 2019, the FDA had a number of aggressive tactics against pharmacogenetics laboratories.   (E.g. see background facts inside a recent February 14 report in Genomeweb, here.)  See also a Citizen's Petition filed against the FDA and its regulatory actions in mid-January, here and 19-page PDF document here.  (See similarly a deck about FDA at CPIC, the PGx consortium, here.)

On February 20, 2020, FDA released a long press release about new websites and initiatives at FDA regarding pharmacogenetic testing and reporting.

• See FDA press release here.
• See new FDA webpage for PGx associations - here.
• See the public comment docket here.
• FDA has been discussing whether or how it might joint a multi-stakeholder "collaborative community" on PGx - here.
• Article about FDA at RAPS, here.
• Article about FDA at Genomeweb, here.
• Article about FDA at Endpoints (echoes RAPS), here.
• 
  
• See separately a January 2020 article at Genomeweb about Translational Software, a vender of advanced PGx software, entering into the 510K process at FDA, here.
• Separately, CAP TODAY features PGX for February 2020 - here.

Very Brief Blog: Center for Connected Medicine's 2020 "Top of Mind" Healthcare Innovation Report

I saw several press releases recently that pointed back to the same source, a 26-page survey report of how hospitals and providers are thinking about innovation, released by the Pittsburgh-based Center for Connected Medicine (CCM).

Some quick links:

• Read about the CCM here.
• See their blog/news page here.
• See their view on the fits-and-starts roll-out of digital health here.
• See their summary of precision medicine findings in the 26-page report here.
• Download the 26-page Top of Mind report here.

___

By the way, in Southern California, where I'm based, this month both UC-Irvine and UCLA hold interesting health innovation conferences.   See the the 2020 Health Forecast conference at Irvine here (Feb. 20-21) and the UCLA medtech/digital health conference here (March 3).

CMS, BARDA, Support Deep-Dive Study of Sepsis Prevalence in Medicare

Sepsis is a major cause of death nationally and world-wide, and threatens to rise even higher because of the rise in highly antibiotic-resistant pathogens.

In a series of six papers appearing this week in the journal Critical Care Medicine, we have one of the largest-ever real-world evidence studies using diverse Medicare fee-for-service and Medicare Advantage data.  Sepsis-related admissions rose 40% during a period when the Medicare program grew 22%. 

Costs per year are in the $50B range while six-month mortality is 60% for septic shock and 36% for severe sepsis.  Comorbidities like cancer market elevate the mortality statistics.  (Medicare benefit payments in 2018 were $730B).

The articles appear in the March 2020 issues of Critical Care Medicine, timed with the 49th Annual Critical Care Conference being held in Orlando.  In addition, the set of articles triggered a lengthy press release from the Department of Health and Human Services, including comments from BARDA head and study co-author Dr. Rick Bright.

(For those who track Washington and infectious disease, note that the President's Advisory Council on antibiotic resistances, PAC-CARB, is meeting later this month - here.)

The Six Papers

All three of the main data analysis papers, clocking in at 13, 13, and 17 pages, are first-authored by Dr. Timothy Buchman, a prolific academic who is also professor of anesthesiology and professor of surgery at Emory.   Several BARDA staff are also co-authors, along with staff at the Bay Area consultancy ACUMEN.

The three main papers are titled:

Sepsis Among Medicare Beneficiaries:
   1.  The Burdens of Sepsis (48:276)
   2.  The Trajectories of Sepsis (48:289)
   3.  The Methods, Models, and Forecasts of Sepsis (48:302)

Note that the same issue of the journal also includes two adjacent articles on the mortality and trajectory of pediatric septic shock, Zimmerman et al. (48:319, 48:329). 

On the Buchman et al. Medicare publications, see also a set of three Op Eds.   The first is by Rhee et al. on the "eye popping costs of sepsis" (48:420); the second by Levy on the use of big data (48:422); and the third by Busch et al. on the amount of data coaxed out of Medicare claims from diverse data sets (48:424).

On a special visualization page, click down the left headers for data views.  See toggle settings on the right.

click to enlarge

Trade Press and HHS's Press Release
h
The HHS press release brings together CMS and HHS/BARDA voices, is fairly lengthy at 1300 words.  The press release uses the data as a springboard for noting CMS efforts in quality of care improvement, CMS payment advances for antibiotics, BARDA investments in sepsis, and CDC investments in antibiotic and sepsis issues.   The press release also links through to DRIVE, a BARDA biotechnology investment program that includes diagnostics for sepsis (here).

For example, the press release states: "CMS continues to clear away regulatory obstacles and financial disincentives that have long inhibited the development of life-saving antibiotics capable of treating sepsis patients. Patients suffering from sepsis deserve to see America’s full innovative potential mobilized to address this devastating condition.” 

Another quote:  "Most patients with sepsis arrived at the hospital with the condition, rather than developing sepsis in the hospital, a possible indicator of success for CMS efforts to reduce hospital-based cases of sepsis [iatrogenic infection]."

HHS Assistant Secretary for Preparedness and Response Dr. Robert Kadlec states, “Any infection can lead to sepsis, including infections caused by influenza or emerging diseases like coronaviruses, which makes sepsis a significant concern in public health emergencies.”

For a trade press story at Fierce Healthcare, here.

Since the papers are all open-access, I've also bundled them in a cloud zip file, here.





 

Offbeat: NEJM, CAP Weigh In on CMS Autopsy Policy; CAP on MolDx Unlisted Codes

I trained in pathology at UCLA in the 1990s (I was doing an elective at the coroner's office during the 1994 LA earthquake), and was intrigued by the policy and process around autopsies.

Here's a letter in today's NEJM that leads to CAP viewpoints on CMS policy.   The letter highlights for NEJM readers that CMS recently deleted its autopsy rule.   U Vermont's Dr. Rueckert notes that in a new 1,037 case series, autopsies found major actionable missed findings in 2%.

Back story -

On September 30, 2019, CMS removed a historical hospital condition of participation requiring autopsies.  (It was the same rulemaking that creating a new condition of participation for antibiotic stewardship programs.)  CAP highlighted the issue in its November 2019 policy report to members (here).

CAP had protested the issue a year earlier, in November 2018, in a CAP letter to CMS which is online here.

The  now-deceased regulation, 42 CFR 482.22(d), recommended hospital staff secure autopsies in cases of "unusual deaths, medical legal, and educational interest."   It's expunged as of September 30, 2019.  CAP argued that CMS's regulation was redundant in medico-legal cases - those follow a legal pathway with or with a CMS rule.  But CAP liked the encouragement from CMS to hospital management to perform autopsies for unusual cases and educational interest.

The dearly departed regulation looked like this before it expired:

Side Story - Autopsies and Precision Medicine?  Yes!

There's also a side story connecting autopsies in cancer patients with precision medicine, since the autopsy provides a chance for unlimited sampling of widespread tissue mets, or parts of one tumor mass, that's not possible with FNA, LBx, or other low-invasiveness measures.  Turna Ray at Genomeweb discussed this in an article in September 2019 - here.   See a representative research article based on rapid-autopsy genomics here.  The rapid autopsy can also provide unlimited tissue for research such as ex vivo explant tumor models.

Side Story - Shortage of Autopsy Pathologists (Medical Examiners)

Around the same time, February 25, 2020, NYT ran a health policy article on the severe national shortage of autopsy pathologists (e.g. forensic medical examiners) - by Jordan Kisner; here.

Other CAP Priorities - LCDs and Unlisted Codes

CAP suggested some priorities where it DID want CMS to pursue regulatory relief.  CAP complained about the LCD process (page 2-3 of its letter.) 

CAP also complained about burdensome use of unlisted codes (topic 7 and page 5 of its letter.)

When You Say Unlisted Codes, You Mean MolDx

Nationally the use of a few pathology (anatomic pathology) unlisted codes is almost nil.   In the wetlab, use of molecular unlisted code 81479 is about 12% of MoPath payments at $135M in 2018 (here).

But those payments for 81479 are almost entirely (>95%) from MolDx MACs.  81479 is virtually unused by MACs outside of MolDx.

Insight from FOIA

Based on additional data via FOIA, MolDx has edits on about 13,000 Z codes, of which 38% or 4,937 track to the unlisted code 81479. 

Among all 13,000 Z codes in the MolDx inventory, 8,545 or 66% were listed as nonpayable.

Nature Publishes Bonanza of Open-Access Papers on Advanced Genomics of Tumors

Genomeweb currently has a headline article on a new publication regarding advanced genomics of tumors - here.  The trackback is to an article by Paczkowska et al. on multiomic-genomics of tumors and advanced bioinformatics insights - here.

But the bigger story for me is that the Paczkowska article was just one of a set of 21 similar articles, all published open access by Nature on February 5, 2020.   View the full set of articles here.

The project is supported by the International Cancer Genome Consortium, where you can find the Pan Cancer Analysis of Whole Genomes data portal (ICGC/PCAWG).

Very Brief Blog: FDA Pushes AI in Radiology; Will Hold Two Day Conference

Pathology, Radiology, and AI

We think of radiology and pathology as the two diagnostic specialities.  We talk about AI in both (on the pathology side, see e.g. Sloan Kettering's spinout PAIGE-AI which raised $45M this winter.  Not to be out-done, New York's nearby Mt Sinai also has a lab AI spinout, Renalytics_AI.) 

On the radiology side, literally, hardly a single issue of Journal of American College of Radiology (JACR) gets published without an article on AI-related policy and science issues for its industry and its physician membership.

FDA Produces De Novo Ultrasound/AI Clearance; Issues White Papers; Will Hold Public Meeting Feb 25-26, 2020

FDA has produced a De Novo clearance of a novel ultrasound-AI device for cardiology.   See MedCityNews here, see Healthcare Dive here.  The product comes from Caption Health here, and the FDA press release is here.   The FDA 5-page DN approval is here; DN190040.

The FDA has a whole new regulatory category for these devices, AI in Imaging - Product code QJU, category 891.2100, here, and FDA produced a major white paper on the topic last year.

FDA Conference: AI in Imaging, February 25-26, 2020

See the FDA's web page, with extensive agenda, for a February 25-26, 2020, conference on AI in imaging - here.

___

Separate from AI in radiology, see an article about non-radiologists interpreting advanced imaging; here.

CMS Innovation: Innovation Officer Leaves; Congress Proposes Fences for CMMI

Innovation Officer Dr. Anand Shah Leaves CMS, Joins FDA

In January 2019, CMS created a new position of Senior Medical Advisor for Innovation.  The first holder of this position was Dr. Anand Shah, a Columbia University-trained radiation oncologist with NIH and FDA background.

In January 2020, Dr. Shah departed CMS for the FDA, taking the position of Deputy Commissioner for Medical and Scientific Affairs.   I've clipped the FDA's description of Dr. Shah's background as a footnote.

Track his FDA/Twitter account here.  For example, from his FDA position, he endorsed the NGS NCD expansion at CMS which occurred about the time he left.


Congress Proposes Legislative Guardrails for CMMI

The Affordable Care Act created the CMMI, the Center for Medicare and Medicaid Innovation, through Section 1115A of the Social Security Act (here).    Previously, demo projects at CMS were created one legislated project at a time, and could represent either good ideas or some pork belly shenanigan snuck into the bottom of a long bill.

Section 1115A allows the CMMI to create any demo project it wants, waive any law it needs to, to do so, and the demo can be as large as it wants and run as long as it wants.   (Yup - you think, "Woah?!") 

In fact, Republicans in 2016, before the election, were quite agitated about CMMI as it was expanding under the Obama administration (here).  Riding that wave, CMS under the new administration called a temporary halt to CMMI initiatives.  And the value and quality of CMMI's work was criticized by GAO.

Seems like a long time ago.  In fact, the administration recognized that CMMI's broad powers could allow it do to major initiatives, like block grants for Medicaid, drug pricing reform, etc.    There's also a complicated section that allows CMMI to put in play processes that permanently replace existing laws with new ones developed by CMMI projects.

As noted in Healthcare Dive here, and in a press release from Congr. Sewell here, at least some lawmakers on the Hill don't want CMS to have the authority to suspend any legislated rule in the name of a demo that could run nationwide and be of unlimited duration.   While it seems like a long and awkward bill, read H.R. 5741 to see what they came up with.   It deals both with (A) how demo programs can be established (guardrails) and (B) how the results of demo projects can interact permanently with Congressional laws (very complicated.)

There's a lot of health policy media about H.R. 5741; rather than list a lot of links, see for yourself by going to Google and search Sewell and CMMI together; such as here.

See a detailed blog at Health Affairs on February 12 by Micklos, Pierce-Wobel, and Traylor, about reforms needed to make CMMI more useful and viable - here.

____

Schrodinger AI (supports biopharma)

Although not directly related to CMS innovation or FDA-AI-diagnostics, in today's IPO news, Schrodinger, a software company that assists drug discovery, had a $230M IPO this past week; for its market cap check Yahoo Finance here.  (Google gives its market cap as $1.2B.)    The prospectus I found listed the share price as $17 but as of today it traded at $26 (over several days, it rose to $32 and slipped back down to $26).  What's interesting about the IPO is that it generates a 262 page prospectus about its business model, IP, and business plans - here.  Its revenue is running about $70M a year.

See a Nature Reviews Drug Discovery article by Schneider et al. here; see Nature Reviews collection for AI and digital health here.  See an article calling for FDA regulation of AI in pharma R&D; here.

_____

Footnote - FDA Describes Dr. Anand Shah's Background

Dr Shah co-led and scaled Information Exchange and Data Transformation (INFORMED), a science and technology incubator designed to harness the power of big data and advanced analytics to improve disease outcomes.

Dr. Shah developed organizational and technical infrastructure for modern approaches to evidence generation in support of regulatory decisions.

He is a widely recognized authority on how innovative medical products are developed, regulated, financed, and delivered. Dr. Shah’s efforts have focused on the development and implementation of innovative approaches to value-based health care delivery and expanding competition and consumer choice. He recently served in two senior leadership roles at the Centers for Medicare & Medicaid Services (CMS).


####

I'm not an attorney, but note that on February 14, 2020, CMS lost a case that would have authorized work as a requirement for some Medicaid enrollees in Arkansas (article here, ruling here).  (The court notes it was applying the same reasoning as a prior ruling on the same topic in Kentucky.)  As far as I can tell, CMS attempted to allow the work waiver under the CMS "Medicaid waiver" authority, which Court rejected.   But if CMS had created the work demo program instead under its CMMI authority, it might have worked, since "any" program can be created there under current law.   

####

See an article on Medicare Advantage plans that could be designed as "special needs" plans for homeless people - here.

Very Brief Blog: Trump Administration Posts "Budget in Brief" For HHS for FY2021

With much fanfare, the Trump administration released its government-wide budget plans on February 10, 2020, WaPo here.

As part of this, HHS released a 188-page FY2021 budget in brief.   Find it here.  See also the HHS budget home page here.

Example: Kidney Disease

The budget reflects priorities that President Trump launched in July 2019 with a coordinated roll-out of initiates in kidney disease and transplant care. 

Writing:

The Budget includes $39 million across multiple HHS
agencies and requests new legislative authority in
support of the initiative’s three goals:
   * Reduce the number of Americans developing
End-Stage Renal Disease (ESRD) by 25 percent
by 2030.
   * Have 80 percent of new ESRD patients in 2025
receive dialysis at home or a transplant.
   * Double the number of kidneys available for
transplant by 2030.

Adding, "The Budget invests $31 million in HRSA for the Organ Transplantation program, including $18.3 million for the Organ Procurement Transplantation Network, Scientific Registry of Transplant Recipients, and public and professional education efforts to increase public awareness about the need for organ donation...The Budget also advances legislative proposals to revolutionize the way patients with chronic kidney disease and kidney failure are diagnosed, treated, and supported."  The plan also includes efforts to keep kidney transplant patients on anti-rejection drugs, which currently terminate (along with the rest of their Medicare) 36 months after transplant (unless the patient is otherwise Medicare-eligible.)

I've used renal care as an example; many other proposals are found in the 188-page document.


Example: Medicare Coverage Policy & Processes

In October 2020, President Trump issued an executive order for improving coverage and processes at Medicare.  This was echoed in a pair of December 18, 2019, long blogs in Health Affairs on improving Medicare coverage rules and processes (entry point here).

Several paragraphs in the FY2021 plan also address Medicare:

Provide Price and Quality Transparency -  

Improve Clarity and Transparency of the Medicare
Coverage Process
Many stakeholders find the process and standards for the Medicare coverage determination process lack clarity. This proposal requires CMS to issue additional
guidance around the Medicare coverage process, including sub-regulatory guidance on the evidence standards that CMS utilizes in assessing coverage and the process to appeal coverage determinations, in an effort to improve clarity around Medicare coverage.
[Budget Neutral] 

Strengthen the Parallel Review Process to Streamline Medicare CoverageThe Parallel Review program is a collaborative effort between the Food and Drug Administration (FDA) and CMS that reduces the time between FDA approval of a device and Medicare coverage of that item. This proposal strengthens the existing parallel review process to improve device manufacturer participation and increase transparency. [Budget Neutral]

Thanks to a former senior CMS official who pointed out to me, these FY2021 paragraphs, while echoing the recent October 2019 Executive Order, are also very close to improvements captured in a 2012 Obama "Bioeconomy Blueprint" which is still online - here.


___

While not directly related to healthcare, Trump also proposes raising spending on AI and quantum computing to $2B per year within 2 years (WSJ here).


 

Very Brief Blog: Teaching in Dx Reimbursement Intro Course; Tuesday March 3, SF

I'm looking forward to participating in #TRICON in San Francisco the first week of March - I am one of the instructors in the "Coverage and Reimbursement for Advanced Diagnostics" workshop organized for Tuesday March 3, 6.30-9.30PM.

Learn about things to know - and mistakes to avoid

Webpage here.

SC25: Coverage and Reimbursement for Advanced Diagnostics

TUESDAY, MARCH 3 | 6:30 - 9:30 PM  

ABOUT THIS COURSE:

Market access for diagnostics developers is more complex and challenging than ever. New compliance requirements and payer demands for more detailed information compel companies/laboratories to be as good at communicating the value of their products as they are at developing them. We will discuss some of the intricacies and realities of proving long-term value to stakeholders including clinical data and real-world evidence on the benefits of testing.

TOPICS TO BE COVERED:

• Investigating the Background, Implications and Future Outlook of Medicare Reforms to the Clinical Laboratory Fee Schedule
• Development of the value proposition for commercial payers: Key evidence requirements
• Trends in laboratory benefits
• The role of national guidelines in establishing commercial payer coverage
• Know key decision points for optimization of your revenue cycle operations
• Strategically meet industry billing requirements head-on, while minimizing your costs and boosting your bottom-line

COURSE AGENDA:

6:00 pm Dinner Buffet

6:30 Course Welcome and Introductions

6:40 Latest Updates on Medicare Coverage: Local and National

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates

7:10 How Do I Get a CPT Code and What are My Options?

Victoria Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Medical and Molecular Genetics, Indiana University School of Medicine; President, Association of Molecular Pathology


7:45 Dessert Break

8:00 Payer Presentation Prep: Successful Strategies

Lon Castle, MD, CMO, Lab and Specialty Drug Services, eviCore healthcare

8:30 Healthcare Storytelling for Clinical Diagnostics – How to Do It…

Katherine Tynan, PhD, CEO, President, Tynan Consulting LLC

9:00 Q&A with Attendees and Speakers

9:30 Course Ends

Very Brief Blog: Myriad Describes Reimbursement Challenges

In October, Health Affairs published a major article on the growing power of Laboratory Benefit Managers, and I used it as an opportunity to link back to August investor calls at Myriad, such as their August investor call, describing growing impact of claims processing edits, prior authorization, and LBMs - entry point here.

Here, I'm flagging their February 6, 2020 investor call, where they continue to describe challenges with edits, prior authorizations, inappropriate denials, and other barriers to revenue.   (Open access tp transcript here). 

In something called after-hours trading (which I don't fully understand) share price was reported as falling from circa $30 to circa $20.   More information when Friday's markets open.

Here's a remarkable paragraph:

Reductions in average selling price are largely unrelated to lower contract prices or ineligible patients. Instead, they are a result of shifting preauthorization rules, inappropriate denials, new documentation requirements and fluctuating coding directions. 

To address these challenges, we have made significant organizational changes, including establishing a new department, which we have called revenue operations. This organization has the responsibility to develop new approaches and to coordinate resources across the enterprise to attack the highest priority opportunities.

For example, in the second quarter, we developed and deployed an early warning system powered by artificial intelligence to detect billing anomalies earlier so we can act on them immediately. 

Amazing stuff. Reimbursement matters, and requires increasing agility and resourcing.

In other news, the CEO resigned and they are awaiting a potential improved coverage policy for Genesight from MolDx.   (Private payer edits have been slowing Genesight revenue, possibly due to edits on CYP gene codes). 

They also remark, "Prenatal cash collections were negatively impacted by issues in billing operations that occurred during the transition of the homegrown Counsyl billing system to an industry standard system used by Myriad. While the issues will be resolved this quarter, the disruption in cash collections necessitated a negative adjustment..."

For an intro-to-reimbursement course I'm teaching in early March in SF, here.

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One of the bugaboos for Myriad and other labs is "improper prior authorization."  There's an article in the February 3, 2020, JAMA on improper authorization, which is based on pharma, but probably has learnings relevant for the diagnostics industry too.  Here.