Saturday, August 4, 2018

CMS Releases SEP-1 Data - A Sepsis Management Performance Measure for Hospitals

Summary
  • Sepsis is a major public health issue, and international guidelines urge rapid interventions.  
  • After several years, CMS has just released data on how well hospitals perform to its sepsis rapid intervention metric.   
  • About half of US hospitals failed Medicare's sepsis management measure for over half of their patients.
    • Academic centers ranged from 23% compliance (Yale) to 71% (Stanford).
    • Even Republican health leadership doesn't help - Indiana is near the bottom of national rankings.
    • Henry Ford Hospital - the "owner" of the national NQF500 Sepsis Metric - scores below the median of US hospitals at only 43%.
    • Update.  Data in this essay is 7/2018 date for Q1-Q3-2017.  In 10/2018, CMS released full CY2017 data.  I've put the CY17 raw data here.   This would only cause very minor changes in the essay below.   
      • In CY2017, 461,523 CMS patients were logged into the urgent care SEP-1 protocols of which just 229,093 completed the protocol successfully.

Sepsis as a Public Health Crisis
In the past decade, sepsis has increasingly been recognized as a major public health problem.   According to Sepsis Alliance, the cost of sepsis is over $24B and steadily growing, here.  See also a table and links here.   Accordingly, the CDC has a major public health effort on sepsis (home page here).

Surviving Sepsis Guidelines
One aspect of sepsis management is early recognition and intervention.   A global sepsis alliance regularly updates an overall guide to sepsis management, with special focus on activities in the first 1-3 hours of sepsis management, such as rapid fluid resuscitation and rapid blood draw for organism culture.    See links for the Surviving Sepsis Campaign Guidelines here.  There is an increasing focus on actions right in the first hour, here.   There are also concerns that sepsis guidelines (including CMS SEP-1) lead to overuse of antibiotics, with attendant patient harms (e.g. C. diff) and public harms (resistance), here.

NQF Sepsis Measure - NQF-500
As often occurs, guidelines designed by clinical experts can also be reflected in administrative quality measures and metrics.   NQF, the main U.S. body for endorsing measures, manages NQF-500, a 3-hour sepsis measure.  See here and here.  For a 2018 article on the measure, see Pepper et al., here.

State Mandates for Sepsis Interventions
Some states have mandates for quality tracking and reporting on early sepsis intervention, of which the first was New York State.  For entry points see here and here.

CMS Quality Measure "SEP-1"
For its part, CMS adopted the NQF Sepsis Measure 0500 in 2015, but modifies it with additional instructions for CMS hospital reporting.   While closely based on NQF 0500, CMS calls its measure, "SEP-1."  One issue is that while the intervention actions can be described in 50 words or less, providing exhaustive instructions, rules, and exceptions analysis takes >100 pages (for one entry point, here).

See over twenty papers on SEP-1 at PubMed, with a range of pro & con viewpoints, here.    For stakeholder group comments, here.  For, "Why IDSA Didn't Endorse SEP-1," here; for two blogs here, here.  For a recent hospital trade journal essay, see here.  For a June 2018 publication analyzing early actual SEP-1 data, see Rhee et al., 2018, here.  For ins-and-outs of administratively defining sepsis, see Rhee et al., 2017, here.

In August 2018, for Inpatient FY2019 final rulemaking, CMS determined it would drop chart-abstracted (and labor-intensive) metrics except for SEP-1.  In the final rule, CMS made a point to remark that it remained interested in SEP-1 and would continue to track SEP-1.

CMS SEP-1 DATA NOW RELEASED

CMS Just Released The First Hospital-Level and State-Level SEP-1 Performance Data

In late July 2018, CMS released hospital-level and state-level SEP-1 data for the first time.  (See an article at Boston STAT, here.) There are two different routes to this data.   For consumers, CMS provides a brief summary of what SEP-1 is (here) - one of several hospital indexes for "timely and effective care."  You can search for hospitals by name or zip code and among other measures, you'll see their SEP-1 performance (here).

The professional method gives you Excel spreadsheets of hospital performance data.  Go to this professional's page (here) and click on Download Flat Files.  You'll get about 50 Excel files totalling 250MB of unzipped data.  See the ones titled "Timely and Effective Care" for data from the hospital, state, and national levels.

I've Done the Database Work For You (As .XLS)

I've created a 1 mb file of about 8 tabs of SEP1 data - hospitals, hospitals sorted by score, hospitals sorted by number of cases per year.  I've also included tabs for state level data and national data.  It's in the cloud HERE.  (Click the down-arrow to download as XLS.)

A Snapshot of SEP-1 Data

Of about 4800 hospitals listed, about 1700 don't report SEP-1 data. 

Of those that do, about 6 hospitals had a perfect 100% SEP-1 compliance score - but these hospitals had just 15-90 cases in the year.   A handful of hospitals had >700 SEP-1 category cases in the year.   About 190 hospitals had >80% SEP-1 score.

About half of hospitals had <50% score.   500 hospitals had only 30% compliance or worse with SEP-1.  The median hospital scored about 80 relevant patients per year, or about 1.5 per week.

State Level Data
In state data, Hawaii ranked highest at 68%, Puerto Rico lowest at 11% and DC second-lowest at 35%.  Indiana ranked in the lowest ten-percentile, in the bottom 4 of 50 states, at 43%.  (Indiana is the home state of Secretary of Health Azar, CMS Administrator Verma, and Vice President Pence).

SEP-1 Rules Are Complex
Note that the complex SEP-1 rules allow many patients to be excluded from counting, such as patients with sepsis but with DNR or other palliative-care-only status for whom rapid invasive interventions would be inappropriate.  Since SEP-1 is calculated manually through detailed chart review, some hospitals may be better or worse at applying the complicated appropriate or allowable exclusions.

Hospital Touts SEP-1 Score
I've seen one hospital already issue a press release on its high SEP-1 score (here).

Famous Academic Centers As Low as 23% Score
Academic centers had high variance.  Samples include Stanford (71), Johns Hopkins (53), Brigham Women's (42), and Yale (23).

click to enlarge

Charts

The chart below showed state or territory average scores.  Hawaii has a 68, at top left.  Puerto Rico has 11, at bottom right.  Most states fall between 40 and 60.


click to enlarge

In the next chart, below, 3000 hospitals are distributed across the possible scores from 0 (left) to 100 (right).   About 100 U.S. hospitals report SEP-1 scores between 0 and 15 (the three bars to the far left).  About 60 hospitals have scores about 90 (the three bars on the far right.)   
Hospitals are pretty broadly distributed for scores between 25 and 75 (about the middle twelve bars). 
click to enlarge




About 80% of hospitals fall between 25 and 75, and about 10% each are either above 75 or below 25.

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Deep Dives Possible
Hawaii had the highest average score, at 68.  Of 23 hospitals in Hawaii, only half (12) reported, the others did not.  Hawaii hospital scores ranged from 41 to 82.  Scores were (41, 44, 51, 52, 53, 62, 68, 70, 71, 78, 80, 82).   Hawaii reporting is based on 2,778 total patients, about 230 average per hospital (range, 58-652, from Kona Community Hospital in Kealakekua [Big Island] to Straub Hospital in Honolulu, respectively).

Puerto Rico had the lowest regional score.  In Puerto Rico, of 51 hospitals, 29 did not report.  Of reporting hospitals, 11 reported between 1% and 88% compliance, with six below 10%.  I'm uncertain if 9 additional PR hospitals reported with a dash as their score, represent "0".

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Footnote.
I was stumped that a category with $24B costs could be the largest health care driver for hospitals.  See data here.   20 categories, with 1%-6% each, tallied just 47% of costs at $181M (2013).   The link just provided is a quite interesting view into hospital cost categories for all payers, Medicare, Medicaid, etc.

For an August 2018 article on use of "big data" to map patient physiology to sepsis, here.  For sepsis in claims vs EHR data, here.

Friday, August 3, 2018

Very Brief Blog: Caris' Website Comparison of Caris and FMI

A month ago, I was struck by a back cover advertisement by Caris on the ASCO POST trade journal, Caris positioning as "The Independent and Unbiased Molecular Information Company."

I noticed today the same logo appears on their website here (as of August 3, 2018) - https://www.carismolecularintelligence.com/info/

The website includes a comparison of Caris and Foundation Medicine - Caris launched in 2009, FMI in 2012; Caris test has 592 genes at 750X depth, FMI just 324 genes at 500X, and so on. 

No take home message - just found the marekting or positioning approach and table interesting. Rather than quote it further or use screenshots, I'd direct you to the link above.


Very Brief Blog; McKinsey Publishes Trifecta of Life Sciences Strategy Articles

McKinsey & Co. is a leading global strategy consultancy.  Their Pharma & Life Sciences strategy group regularly publishes detailed open access articles on trends in pharma or, less often, medical devices.

This summer, for airplane or beach reading, see a trifecta of articles at their division website (both web and PDF versions are available; email registration may be required).  Start here.

  • Designing a Healthy Future for Medical Devices (6pp)
  • Real World Evidence: Driving a New Drug Development Paradigm in Oncology (8 pp)
  • Launches in Oncology: Elements of Success (16 pp)
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Also in early August.  On a separate note Endpoints blog has an entry here on a new 15 page PDF report here from IMAK on overpricing in the drug industry based on patent thickets. Press release here.  IMAK is a 503(c) originally titled, Institute for Medicines, Access, Knowledge.  They have a lengthy news item page here.   Secretary of Health Alex Azar has made remarks about "patent gaming."  Trade journal article at MedCity about IMAK, here.

Also in early August, Politico had a piece on drug prices in the and shadow-boxing over price hikes and cuts, here.




Thursday, August 2, 2018

Very Brief Blog: CMS Releases Final Inpatient Rule for FY2019

On August 2, 2018, CMS released the final hospital inpatient rulemaking for FY2019, effective 10/1/2018.

The home page for the final rule is here.   CMS has released a "unpublished" early version (typescript); the final typeset version will be released August 17.   The rapid version PDF is here.  It tallies a hefty 2,593 pages.

The most newsworthy item is that CMS will pay for CART therapies (Kymriah, Yescarta) under standard "new tech" payment rules, which pay hospitals 50% of the extra cost - CMS will pay the hospital e.g. $80,000 of an extra $160,000 cost.

Overall, CMS had 15 new tech products under review, and while 4 dropped out for various reasons, it covered 10 of the remaining 11 candidates.   Typically, CMS raises a lot of objections of variable cogency against the products' novelty or value in preliminary rulemaking but is less stringent in final decisions.  However, I believe the win rate for industry is higher this year than usual.[*]  CMS now liberally creates new tech ICD-10 procedure codes as needed to implement new tech payment rules.


CMS produced the final rule only 35 days after the comment period closed (June 25).

Biorobotic Medtech Wins NTAP for Prostate Surgical Treatment

A Bay Area medtech company, PROCEPT Biorobotics, won a New Technology Add-On Payment (NTAP) for its Aquablation procedure for treatment of BPH.   (See pp. 752-782).  The procedure is also up for a Category I CPT code in the 9/2018 AMA CPT meeting.   Procept successfully raised $118M in February 2018.

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[*]  In August 2015, there were only six applicants and four were rejected.  Some organizations complained that CMS standards were unreasonably high (here).

Comment on (Non Lab) CPT Codes Proposed for September AMA CPT Meeting

AMA CPT provides a brief listing of new code applications and accepts public comment a motnh or two before each CPT Editorial Panel meeting.   

Lab codes run on an earlier schedule than non-lab codes.

Go to the home page for the September 27-29, 2018, CPT editorial panel meeting, here.

Scroll down to"Panel Meeting Public Agenda" and download the PDF file (currently here.)

  • For lab codes, AMA expected you to request a packet on a code of interest by August 1, and deliver comments to them by August 7.
  • For non-lab codes, AMA will accept requests to review an application packet until September 7, and will accept your comments until September 14.


62 Agenda Items

The September 2018 meeting is the last meeting for which new (non lab) codes will enter the CY2020 CPT manual.   Therefore, September meetings tend to be bigger than average.

There are a range of code deletions and new code proposals for "Online Digital Evaluation Services, or E-Visits."   There are new or revised codes for self-measured blood pressure monitoring and other remote physiologic monitoring.  There is a Cat III code for addiction management (tab 58) and for biomechanical computed tomography (tab 57). 

I tally 18 tabs for Category III codes (some of which are agenda items with multiple codes within them; and several are requests to revise codes up from Cat III to Cat I.)




Very Brief Blog: Concert Genetics' Free Website Search of Labs and Charges

This month, I was working on a project to help stakeholders comment on the bizarrely low CMS gapfill price for clinical whole genome sequencing (CPT 81425, CMS proposal $349 [!]). 

One helpful resource was the Concert Genetics open public database of labs, test names, and often charges [email registration required.]. 

Go to https://www.concertgenetics.com/ and in the upper right see "Search Genetic Tests."   For first time users, you'll be guided to open-access registration.   A few screen shots below.  Typical charges for whole genome sequencing are circa $7500.

click to enlarge


Brief Blog: Imminent Lab Comment Deadlines for CMS Gapfill and for AMA CPT September Mtg

Comment Deadlines:

COMMENT ON CMS GAPFILL BY AUGUST 7, 2018

CMS has 18 lab codes under the gapfill pricing method and under public comment.   Go to the CMS lab public meeting home page here, and scroll down to Gapfill.   Submit comments to Mr. Glenn McGuirk by Tuesday afternoon, August 7, eastern time (see email on page).   Scroll to the hot link 2018 CLFS Gapfill Preliminary Determinations - Updated 06/13/2018 [ZIP, 17KB]  to see the proposed prices under comment.
Probably the most bizarre price is for whole genome clinical sequencing (81425) for which CMS MACs propose $349 payment, although whole exome clinical sequencing (81415) is priced at about $4800.   The only thing close to $349 I could find was a price offered by Dante Labs on Amazon.com, and I couldn't find an NPI or CLIA registration for Dante.   Concert Genetics has a public website* of lab offerings, many with charges, and typical whole genome pricing was about $7500 per proband or in one case about $18,000 for a trio (infant, two parents, the typical scenario).  WGS clearly has some high-profile and impactful use cases now (see Faernes et al., 2018, from Rady Children's Hospital in San Diego; here.).
COMMENT ON AMA CPT LAB CODES BY AUGUST 6, 2018

AMA CPT posts brief titles of pending CPT applications a couple months ahead of each meeting, and you can request a full application (about 20 pages), review it, and comment.   The schedule for lab codes runs earlier than all other codes.  AMA wanted you to request the applications by August 1, and comments are due August 6.  Home page here, PDF of lab codes here.  Note that links may change, in which case start from the page I've just listed as "home page."

COMMENT ON AMA CPT "Non-LAB" CODES for SEPTEMBER

AMA CPT has posted the brief titles of all non-lab codes on the same home page for the September 27-29 meeting.  For links see here.

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* You can get into the Concert Genetics website and see labs, offerings by test name, and often charges, but you have to do a free email registration (here).




Wednesday, August 1, 2018

Brief Blog: California Legislature Approves $2M for Whole Genome Sequencing in Rare Diseases

Not "new news" but here's a link to a June 22, 2018, article that the California legislature had approved a $2M pilot program to provide whole genome sequencing (WGS) to patients with rare diseases in the MediCal program (California Medicaid). 

The program is summarized as:  "The pilot project will serve a minimum of 100 Medi-Cal neonatal and pediatric patients with undiagnosed diseases that have either remained undiagnosed, or had multiple incorrect diagnoses. These patients will be tested using cWGS as a first line diagnostic test. Regular reports to the Legislature and the state Department of Health Services will be required to provide tight oversight on the project’s progress and patient treatment adjustments. The goal of this proof of concept project is to demonstrate both the clinical benefits for Medi-Cal patients and financial benefits for the program as a whole."



Similarly, an incubating House propose in D.C. would providing optional funding for states that wanted to provide WGS to children in their Medicaid programs; see H.R. 5062 sponsored by Rep. Swallwell (here, here).

The California genomics industry is split between the SF and San Diego areas; for example, Thermo Fisher and Illumina have larger centers in both locations.   A recent report attributed the genomics industry as having a $5.6B impact on the San Diego area (here). 

Brief Blog: McDermott Produces Detailed Guide to Medicare Digital Health Progress

McDermott Will & Emery has produced a detailed guide to recent updates, changes, and proposals with regard to how Medicare will pay for, or could pay for, digital health in the coming year. 

See the article here, posted on JDSUPRA open access (email registration might be required).  The article tallies about 4000 words and 11 pages as a Word document.  Authors are posted as Marshall Jackson Jr, Lisa Schmitz Mazur, Michael Ryan, and Dale Van Demark.



See some additional links to Dhealth/Telehealth changes at CMS in my link to the new PFS proposed rule here, one particularly good essay by Foley Lardner here.





Thursday, July 26, 2018

July 25, 2018: CMS Releases Annual Outpatient Rule Proposals

On July 25 - almost a month later than normal - CMS released outpatient rulemaking for CY2019.    Public comment is open for 60 days (September 24, 2018).

The CMS homepage for the rulemaking is here.  The CMS press release is here.  For a deeper dive see the "Fact Sheet" here.

The Federal Register home page (includes comment link) is here and the actual rule is here (83 Fed Reg 37046-37240, 195pp, July 31, 2018).

Bonus:
Read a speech presented on the same day by Seema Verma to the California Commonwealth Club, here.

Wednesday, July 18, 2018

OIG Posts Report on How CMS Collected PAMA Data

OIG has posted a public report on how CMS collected national PAMA data for laboratory rate-setting, and how the process could be improved.   The 20 page report is available here.  Unusually, it is written in a "powerpoint" format.



Key conclusions are:
  • CMS performed limited quality assurance checks and relied on labs' self-certification of their reported data. CMS's quality assurance activities that identified outliers or excluded data affected new rates for a few low-volume tests. Labs experienced some one-time challenges in complying with a new policy, but CMS's limited quality-assurance efforts present an ongoing risk.
  • WHAT WE CONCLUDE
  • Complete and accurate data are essential to setting payment rates for lab tests, and CMS should address challenges from 2017 to ensure data quality in the future. Effective outreach can help ensure that all labs required to report data comply during future data reporting periods. CMS can help ensure data quality by assessing quality assurance efforts and compliance activities. 
  • OIG will continue to issue an annual analysis of the top 25 lab tests, based on Medicare Part B payments, and other analyses that OIG determines appropriate regarding the implementation and effect of the new payment system.
ACLA and others have strongly complained the CMS process improperly excluded hospital lab payments.   See ACLA's home page for the topic, here.   CMS discussed and/or welcomed public input on its process in July 2018 PFS rulemaking; entry point here.    See an August 2018 Genomeweb article about industry complaints about PAMA to the Hill, here.

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OIG issues elaborate reports each fall on top CMS lab tests; they mention above they will continue to do so.  Entry point here.

For an article on ADLT price gaming, here.

Separately:  Affecting PFS services (including PFS lab tests), in PFS rulemaking in July 2018, CMS also released a truly massive database of new RUC/Supply/Equipment values for RVU-based services.   This will affect RVU-based pathology tests.  Entry point here.

Tuesday, July 17, 2018

July 16-17, 2018: CMS Panel Debates New Test Pricing; Value of R&D?; Transcripts

CMS is pricing almost 100 new CPT codes (including PLA codes) for CY2019.  After a public comment meeting on June 25, 2018, on July 16-17, CMS is holding two all day sessions of its laboratory advisory panel to debate the crosswalk/gapfill issues.
  • For the CMS new test price webpage see here.
  • For the CMS youtube channel (both streaming) see here.

  • Unofficial Transcripts:
  • Monday Morning HERE
  • Monday Afternoon HERE
  • Tuesday Morning & Afternoon HERE.
In 2016 and 2017, CMS both streamed and archived video of these lab policy sessions.  This year in 2018, CMS has not posted archive video of the June 25 session and it is to-be-seen if they will archive post the current live-stream advisory sessions.

Crosswalk Valuation and R&D?

CMS's statute for crosswalk and gapfill of new tests is at SSA 1834A, as created by the PAMA law of 2014.  

Payment for the test shall be determined—
(A) using cross-walking (as described in section 414.508(a) of title 42, Code of Federal Regulations, or any successor regulation) to the most appropriate existing test under the fee schedule under this section during that period; or
(B) if no existing test is comparable to the new test, according to the gapfilling process described in paragraph (2).
(2) Gapfilling process described.— The gapfilling process described in this paragraph shall take into account the following sources of information to determine gapfill amounts, if available:
(A) Charges for the test and routine discounts to charges.
(B) Resources required to perform the test.
(C) Payment amounts determined by other payors.
(D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant.
(E) Other criteria the Secretary determines appropriate.

42 CFR 414.508 states that crosswalking is used "if it is determined that a new CDLT is comparable to an existing test, multiple existing test codes, or a portion of an existing test code."   

Neither statute nor regulation, then, describe what "comparable" means.   (For example, is one new car the most comparable to any one of ten existing cars when they are the same brand; or the same color; or the same body style; etc.  Which of these things is most like the other?)

At 81 FR 41039, CMS remarked that crosswalking "is used when a new test is comparable in terms of test methods and resources."  Elsewhere, CMS has also stated to the public what information CMS requires from the public to make a crosswalk decision, which is fairly detailed and broader (clinical purpose of the test, etc.; see 71 FR 69703) and it wouldn't make sense to request and require that type of information if it were not germane to its crosswalk decision.  [I believe this was in prior but fairly recent rulemaking on the crosswalk/gapfill processes].

Resources to Perform a Test Include Marketing and R&D 

In regard to ADLT pricing (81FR41-56), CMS writes that "we view the statute as intending to award special payment status to the one laboratory that is expending the resources for all aspects of the test - developing it, marketing it to the public, performing it, and selling it."   Even without this confirmation, it would be clear to me in plain English that for any test "resources required to perform a test" included having a lab to put it in (some amount of overhead) and having developed it (you have a test to do in the first place, whether protocol and reagents assembled and developed to implementation by one lab or by the kit manufacturer.)

CMS is obligated to provide an explanation of how it chooses either crosswalk or gapfill rates (81FR41086).  However, this explanation is sometimes telegraphic ("We determined that Code A is most similar to Code B.")   

Footnote 1

PLA codes are easily created and sometimes the lab is not even around by the next summer when the crosswalk meetings arise.  For examlpe, Armune Bioscience got PLA code 0021U in October 2017, but the lab closed in January 2018.  Expert panelists carefully debated how to price this no longer existing test.

Footnote 2

Statute requires crosswalking to "the most" appropriate test.  This suggests that if CMS chooses B of choices A,B,C, you could argue that A is "the most" appropriate.   Regulation only requires CMS to crosswalk to "an" appropriate test.  Here's the difference.  This suggests that if A, B, C are all potentially appropriate, and if CMS chooses "B", it has chosen "an" appropriate test of several, and you can't argue that A or C was most appropriate.   (If push came to shove, the statute should overrule the regulation.)

Footnote 3

Audio transcript from Youtube streaming conference, commissioned from REV.COM by Bruce Quinn Associates LLC

Friday, July 13, 2018

Statement of Work for Michael Cohen's $1.2M Consulting Contract with Novartis

In articles on July 13, 2018, Boston STAT discussed Michael Cohen's work as a consultant for Novartis, including the release of 249pp of related Hill documents.  Here, here, here.

The statement of work for the Novartis contract paying "One Million, Two Hundred Thousand Dollars" is clipped below.

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For November 2018 follow up, interview with Novartis here, Senate document re Novartis here and pdf here.

Thursday, July 12, 2018

Brief Blog: CMS Releases Physician Proposed Rules for CY2019

On July 12, 2018, CMS released the "inspection copy" or typescript of the CY2019 physician fee schedule proposed rules.  Comments are open for about 60 days (about September 10, 2018).

The Federal Register home page is here; access the typeset 665 page PDF directly here (83 Fed Reg 35704-36386, published 7/27/2018).  CMS fact sheet here.  The CMS rule home page with twenty links, attachments, and zip files is here.

  • Nerd tip: For me, the 665 page PDF downloads as a frozen or "locked" version.  In my PDF editor, I can "extract" all pages and save as "new" 665 page .PDF file which is no longer locked, so I can highlight, annotate, etc. 

Coverage at MedPageToday here; MobiHealthNews re telehealth, here; also here.  More on telehealth rules from Foley Lardner, here; Drinker Biddle, here.

Coverage focusing on E&M changes here, here, here, here. Here, here.  WSJ CFO page, here.

In a press release, CMS framed the rulemaking as "historical changes that increase the amount of time doctors and other clinicians can spend with their patients by reducing the burden of paperwork" (here).   The changes are part of the CMS "Patients over Paperwork" initiative.  CMS's goals to reduce regulatory burden and paperwork are not limited to physician paperwork: in April, CMS proposed to kill dozens of reporting requirements for hospitals as well.

Overview

CMS proposes to streamline E&M documentation, reduce some physician staff supervision requirements (in radiology), and pay clinicians for telehealth services like short calls that avoid an office visit and review of patient-submitted photos.  For the latter, see p. 63ff, especially pp. 66ff, and early coverage at Forbes here.

Regarding telehealth  policy, CMS takes a new spin on its statute.  CMS has generally only covered "face to face physician services," with a few exceptions like a monthly fee for care management.  However, the statute allows coverage of "physician services" per se - without restriction.  CMS takes the position that the restriction on limited telehealth for office visits (from rural areas only) is actually a creation of the telehealth section of statute.   Where the legacy telehealth statute for office visits doesn't apply, CMS can create more flexible telehealth on its own (!), as it does in this rule.  This is most especially true where the "physician services" are new and not inherently face to face.  Intriguing viewpoint.

In more detail, I discuss below mass re-indexing of equipment and supply prices, and rulemaking re PAMA lab definitions.

Streamline Measures & E&M Rules

MIPS reporting of quality measures will be pared down by axing what CMS calls low-value measures.  34 topped out process measures will go away.

There will be a mass simplification of rules for E&M visit pricing (details here, here).


Roll Over, RUC: ReIndexing Supply and Capital Equipment Pricing

On page 50ff, there is discussion of better approaches to market-based supply pricing (for RVUs);

PAMA Section 220 gave CMS wide new authorities in this regard (as I discussed in 2015 here).

Interestingly, a large contracted research project found "there was no statistically significant difference between estimated commercial prices and current CMS prices for both equipment and supplies."

But individual prices will change under a proposed shift over 4 years to new input prices.   Bringing a smile to my face, they elected to  illustrate this four-year phase-in with a hypothetical product that is paid $100 now but will get a new price of $200.  See figure at bottom.

See Zip file at CMS here.  This includes a 57-page report by consultancy StrategyGen.  This includes new prices for 1300 supplies and 740 equipment items (capitalized items).

While total average prices won't changes, shifts will be large.  The tables list CMS supply codes, not product types, so they're a bit cryptic by themselves.  But for example, the price of ED004 (6MP camera) will drop from $946 down to $152 (16%), and the price of ED017 (brachytherapy workstation) will rise from $105,403 to $281.580 (267%).   Supply SA051 (pelvic exam pack) will rise from $1.17 to $20.16 (1720%) while SA046 (laparotomy drapes) drops from $26.12 down to $7.26 (28%).  While CMS plans to use these "market prices" rather than GSA product acquisition prices, but where available, GSA prices are listed in a separate table for comparison.  For example, Angiography Room EL011 has a CMS price of $1.4M, and new target of $1.1M, and a GSA price of $229,145.  (There are some cases where GSA prices are higher than CMS, though).

Article on "rethinking the RUC," here.

As a tidbit of digital health, there is a discussion of the input price for Breast Biopsy Software EQ370 (p 57).   (They declined to add software as a line item cost input, but because there is already a global entry for "MR room equipment package EL008").  In current equipment tables, EQ370 is "Breast MRI computer aided detection and biopsy guidance software" but has no dollar value.  For very elaborate debates in Fall 2017 on OPPS APC handling of Heartflow software services, see here.


Lab Industry: PAMA Revisited At Length

Minimal rules directly affect the lab industry.  CMS proposed to reduce the minimum lab volume for PAMA reporting from $12,500 to $6,250 and requests comment.

Notably, on page 405ff, CMS proposed to consider new definitions of a PAMA reporting laboratory that might include more hospital-based labs.  For example, CMS opines whether the law requires them to include Medicare Advantage (Part C) revenues when making certain PAMA determinations for eligible labs.  Discussions of how to define laboratories by TIN run from 410ff; CMS recognizes there is a debate (not to mention a lawsuit, and the lawsuit is not mentioned) on this topic.  Net-net, CMS lands on "no change" but invites comment at 413ff.  Absent the ACLA lawsuit about PAMA, it's unlikely we would have seen 20 pages of discussion of these policies today.

In summary, CMS proposes to exclude Part C revenues from eligible lab definition, but only proposes to consider alternatives to how it handles hospital lab eligibility otherwise.

CAP prepared a table of revisions to PFS pathology prices, here.  Big gains for computer assisted tumor IHC.

"No News is Good News?" Department

No use of the words genetic or genomic in the rule.

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CMS picked cheerful illustrative hypothetical of price change






MolDX Posts Final LCD For Guardant G360 Gene Panel Liquid Biopsy Test

MolDx has posted the final version of a positive coverage LCD for the Guardant G360 gene panel liquid biopsy test, with coverage for advanced lung cancer patients.

Proposed coverage was initially posted in May 2017 (see here).   Finalization was likely delayed due to the CMS NCD for next generation sequencing in cancer patients, which was under public comment and CMS decision-making from November to March.

A live link to the LCD is here for L37699.  The public notice period started July 12 and the LCD is effective on August 27, 2018.


Coverage

Coverage falls under two scenarios:

  • At Diagnosis - when results for EGFR, ALK/ROS1, BRAF are not available AND tissue testing is infeasible (e.g. biopsy contraindicated or insufficient tissue);
  • At Progression - for progression on or after chemotherapy or immunotherapy for patients who lack tumor typing for EGFR, ALK/ROS1, BRAF or for patients progressing on TKIs.
For full details see LCD.   Recent NCCN guidelines for use of LBx are cited explicitly.  

The LCD has 21 literature citations.   MolDx also published a lengthy document responding to public comments over the past year.   See A56038, here.

Guardant Health

Guardant Health has announced clinical trial collaborations with BMS, AstraZeneca, Merck, Merck KGaA, and Pfizer (here), and is being used in an important basket trial in Japan (here).  The company had 29 abstracts at ASCO (here) and recently published the large accuracy comparison between tissue and liquid biopsy (here).  For a press release on the new LCD, here.

In the Cloud

I've also put the PDF LCD and PDF Article in the cloud in a zip file, here.  

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Nerd Note

For the last several years, most MolDx LCDs have featured an increasingly detailed analytical validity table and discussion within the LCD body.  See for example last fall's AlloSure LCD.   Although the G360 test underwent detailed technical analysis by MolDx, this LCD doesn't include the detailed analytical performance data that MolDx has been including in LCDs.  Possibly this is a new pivot in the LCD template used by MolDx.