Brief Blog: Omada Health Raises $50M, Led byHumana

Omada Health, a leading provider of virtually delivered disease prevention programs, announced a new funding round of $50M on June 14, 2017.  For details, here.   

DPP Programs Validated Internationally
Type 2 diabetes is becoming one of the largest drivers of healthcare costs.   International studies have shown that intensive behavioral modification programs addressed to persons who do not have T2D, but are at elevated risk, have a material impact on better health.   In addition, the CDC has developed a certification program for diabetes prevention program (DPP) providers (here).

Medicare Roles Out New Preventive Services Benefit: DPP
Medicare - the Center for Medicare and Medicaid Innovation - ran a large-scale pilot program and found that DPP's were cost saving in the Medicare population (peer reviewed publication here).  CMS will roll out DPPs as a new Medicare preventive benefit in 2018, and plans to include both "brick and mortar" and virtual providers, since both have been proven similarly effective, including in the Medicare population (report of publication, here).  For CMS updates and more CMS links, see the CMMI DPP website, here.

Omada Health
For its home page, here.   For current news articles on Omada, here.  For an undated, but detailed, interview with founder Sean Duffy, here.  See also an announcement of a three-way partnership between Omada, AMA, and Intermountain Health in 2016, here.

Through 9/2015, Omada had previously raised at least $77M (here).  Besides Cigna, investers include Norwest, Humana and Providence, Oak and Oxeon,  Omada was featured in a WSJ article on chronic disease and virtual health on 6/25/2017 (here).

Reimbursement Processes for DPP at AMA 
AMA has been in the process of creating Category III codes for both "brick and mortar" and virtually delivered DPP services.   For more details of the Medicare program being planned for CY2018, see Medicare's Part B annual public rulemaking, which will be published in the Federal Register circa July 1.  CMS plans to create a new provider category specific to DPP which will be cross-linked to CDC DPP provider certification.

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image from Omada's press release website.

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Glooko, which integrates information from diabetes home glucose testing and other sources, also had a major fund-raising round, garnering $35M for Series C on June 27.  MobiHealth here, MedCityNews here.   MySugr was acquired by Roche; for an interview with the MySugr CEO, here.

Brief Blog: AMP/CAP Comment on MolDX LCDs for Gene Panel Testing of CRC, Melanoma, Ovarian

For a couple years, MolDX has provided coverage of comprehensive gene panel (CGP) testing in lung cancer, but with fairly stringent technical standards.  In December, they announced coverage would be broadened by 3 new LCDs in new topic areas - CGP for colorectal cancer, for metastatic melanoma, and for ovarian cancer.   (Article here).

In March 2017, CAP/AMP sent joint comment letters to MolDX and posted them publicly.  In general, they feel that MolDX sets arcane and inappropriately high technical requirements for coverage tests.   They assert that very, very few US labs could meet the closely fitted technical requirements found in the LCDs.   They are concerned that NY State approval is required even for labs and patients in Midwestern or West Coast states.  More after the break.

Brief Blog; Digital Genomics Panel at Precision Medicine Leaders Summit (San Diego, August 23, 2017)

This year the second annual Precision Medicine Leaders Summit will be held in San Diego, August 21-24, at the Hilton Bayfront next to the Convention Center and Gaslamp District.

I have the privilege of chairing a panel on Digital Genomics - focusing on companies that that focus all their services on data interpretation and clinical utility after the sequencing is complete.      We're still developing the full panel for this panel (we do know the date and time - August 23 at 4 pm).  See the full conference website is here and the agenda page is here.

Brief Blog: ACLA Continues to Weigh In on PAMA Policy with House and CMS

In June, ACLA continues to weigh in on how CMS implements PAMA Section 216, repricing of national Medicare lab fee schedules based on market price surveys.

ACLA and other stakeholders have raised concerns that CMS is using methodology that will result in incorrect and excessively low repricing.

• ACLA's June 1 letter to the House Ways & Means committee is online here.
• ACLA's June 7 letter to Seema Verma, administrator of CMS, is online here.

The House letter has a range of topics - bad execution of PAMA law at CMS; illogical gapfill/crosswalk amounts for obscure rationales; and need to nix the 14 day rule.

The Verma letter asks that PAMA be delayed, and rapid interim final rulemaking should require hospital outreach labs to be part of PAMA, giving them November-January to report.  ACLA anticipates that PAMA repricing could be implemented (with extra hospital lab data) by 7/2018, and the next cycle of data collection should be pushed from 2020 to 2021.

For a March 2017 press release providing an overview of the issues facing ACLA and other lab gruops, here.  A March letter to HHS leader Tom Price was signed by ACLA, AdvaMed, CAP, and other groups (here).

One Washington Hillwatcher noted that academic medical centers, in general, do not like DAIA.

Brief Blog: The Crazy Complicated World of MIPS-MACRA Measures

Update - 2018 MACRA rulemaking was published on June 21, 2017, here.  Trade article here.  26 page summary of 1074 page rule, here.

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Just yesterday I was talking to a European consultant colleague about helping a European company understand how its innovative product might be affected by U.S. MIPS/MACRA measures.   (Answering that question is a substantial deep dive research project, including explaining in clear terms to foreigners what Medicare is and what MIPS/MACRA is, let alone drilling down into a specific subject area and then building out a corporate strategy and then executing it.)

In my inbox today, CMS is holding an annual call for MIPS/MACRA measures, which is open til June 30.   See that and more below after the break.

Trump Administration Should Keep Releasing Annual Part B Medicare Billing Data; Vivid Example (Allergy Skin Testing)

UPDATE: CY2015 DATA RELEASED BY CMS ON JUNE 15, 2017.  HERE.  

Original Article June 5:

Beginning several years ago, after HHS lost lawsuits regarding whether physician billing records to Medicare were private or subject to FOIA, CMS began releasing annual physician and other part B provider billing records online.

Records are available for CY2012, CY2013, CY2014, at this website; click Interactive Dataset.  The full dataset is 2 GB (too large for Excel) but there is a web interface from which you can select and filter data and download it.  For example, all Part B providers of allergy skin testing (95004) make about a 1MB file.  (To use the database yourself, see my instructions here.)

CMS had been releasing annual data after about 16 months, e.g. CY2014 data in April 2016.   CY2015 data has not been released.  Possibly, because physician groups have protested data release, the Trump administration will stop voluntarily releasing data.  (If so, I believe parties could still get the 2 GB file via FOIA).

A Case Study With One HCPCS Code

The data is a valuable tool against abuse.   For example, for a client, I pulled the 4,114 Part B providers who were paid for skin testing 95004 in 2014.  2,307 were allergists.  88 were nurse practitioners, and so on.

What's of interest is your ability to further sort the data.  The facts are pretty shocking.  The highest paid provider for allergy skin testing garnered $1.2M from Medicare - for 95004 alone.  He was paid about $1,500 per patient - at $7 each, that's 180 daily skin tests per patient.  (This was in New York.)   Of the 15 busiest annual providers of 95004 nationwide, by dollars per year (for all patients), only one was an allergist.  All were paid over $200,000 per year by Medicare for allergy testing.  Most of these high billers were in New York or Texas.

About 30 providers were paid by Medicare over $700 dollars per year per Medicare patient, most with over 100 skin tests per patient - on average.   All but 5 of the top 33 providers with that billing pattern were allergists.  Of the top per-patient billers, most were in California.

About 570 of the 4100 providers billed, on average, more than 70 services per patient.    (Several LCDs and BCBS sources cite a maximum of 70 tests per patient, though others have lower suggested limits).  These providers grossed $20M for 95004 out of the $58M total paid for 95004.  In sum, about 33% of Medicare payments went to providers who were billing at above-guideline intensities, sometimes far above guidelines.  

LESSON

CMS should keep releasing Part B data, and public sources should study it to identify the biggest overspending problems in Medicare and keep the executive branch on its toes.  Stay on the lookout for whether CMS releases 2015 data by June or July of 2017.

This column previously discussed the equally or even more wacky world of Medicare BRCA gene test pricing (here), also using only publicly available CMS data.

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Data for 95024, intradermal skin tests, look very similar to the graph above for 95003.

Allergists billed 55%  ($32M) of 95004 billings.  Allergists billed 50 services per patient, on average, SD 19.  32 allergists billed over 100 services per patient (> 2 SD high).  Non allergists had the same average and SD: 52 average, SD 17.

As George Orwell wrote, "To see what is in front of one's nose needs a constant struggle," but the online CMS database is a big help.

United Healthcare May Be Widening "Pre Auth" for Genomic Tests

United Healthcare posts a provider bulletin online each month, and the June 2017 issue has a page describing upgrades and extensions to genomic test pre-authorization requirements.  The PDF is here; the genetic preauthorization policy page is on page 17.  The article adds, "Details will be published in a future bulletin."

Waves of tighter genetic test payment controls have been rolling through the payer industry.  For example, Medicare genomic test payments actually fell from 2014 to 2015, due to tighter controls on CYP (pharmacogenetic) testing that cut out several hundred million dollars of services.  

A mini-industry of standalone companies exist to help payers mediate and control payments to laboratories (BeaconLBS; Anthem AIM; Avalon; Concert Genetics; Evicore; and others.)  These are often called LBM - laboratory benefit managers - in analogy to PBMs, pharmacy benefit managers.

Brief Blog: The Nit-Picky World of CMS Policy Gems

While we hurtle forward in Washington with health insurance reforms, CMS continues to put out little policy corrections on a daily basis.   These are called "Transmittals" - they have a special webpage and there are several hundred per year (here).

• PLA Codes.  In R3783CP, CMS updates some details of hospital outpatient claims processing and includes use of the brand-new AMA CPT "PLA" section of codes, which AMA will produce quarterly.  Here.  (There's a policy mistake in it; here.)
• HIV Screening.  Based on a USPSTF recommendation, Medicare covers HIV screening tests under one set of conditions between ages 18-65 and another set below 18 or over 65.  
• Medicare has 4M beneficiaries below age 65.   
• There are also a set of special rules and specific codes for pregnant Medicare beneficiaries.  
• Here. 
• Oncology Care Model - Includes Cancer Patients Who Need Hospital Care ("Somebody tell the computer.")  With much fanfare, CMS created a monthly special payment for cancer care called the "Oncology Care Model" or OCM.  It was discovered that payments were blocked if a claim for the monthly support was submitted on a day when the patient was in hospital.  CMS fixes this.  Here.
• Mysteries of Drug Q Codes.  CMS normally produces new drug codes on a January 1 basis, based on a year long review process for applications submitted the prior January.   However, it sometimes pulls drugs into rapid code production, called "Q" codes, which are issued quarterly and help the claims processing work until the next January cycle.  When and how CMS decides to upgrade a drug to a rapid temporary Q code is an enigma to me.  
• The drug ustekinumab (Stelara, for psoriasis, iv) gets a Q code right now.  Few other drugs do, they have to wait til January.  Here.
• There is also the mysterious creation of two codes for hydroxyprogesterone caproate, available as Makena, under an orphan drug license that may expire in early 2018. One of the codes is specific to "Makena."  For articles, here and here.  Issues on orphan pricing of Makena and accusations of price gouging date at least to 2011 (here).
• CGM.  In a big breakthrough for diabetes patients, CMS finally approved coverage of continuous glucose monitors earlier in 2017.   This requires codes.  Here come the codes (here).  They are a rarely use class of codes,  "K" codes, which are "temporary DME codes."   
• PILD.  Since 2014, CMS has not covered lumbar spinal stenosis surgery if done by the percutaneous image guided technique (PILD).  After two CED trials, CMS reviewed the topic and decided to wait for more CED trials.  Sounds like the goalposts are not clear.  NCD here, transmittal here.
• Note that open and endoscopic lumbar surgeries are covered without further controls; it is only image-guided lumbar surgery that is restricted.  
• This is a variant from most CMS surgical coverage, which is agnostic to method.  For example, there was never any NCD on the topic of robotic prostate surgery as a technique nor on any other robotically-mediated surgeries.   

CMS Incorporating Use of AMA CPT "PLA" Codes on a Rolling Basis

PAMA law, passed in 2014, requires CMS to create codes for new "advanced diagnostic laboratory tests" (ADLTs) as well as any new FDA cleared or approved tests (FDACOATs) that request a code.

While CMS could create these with the G code system, AMA has initiated rapidly quarterly creation of "PLA" codes based on a simple abbreviated application form.  The abbreviation stands for AMA "Proprietary Laboratory Analysis" codes.

The PLA code system will allow a wider set of tests to be coded than the PAMA requirement, as PLA includes ADLTs, additional sole source tests that don't meet the fine points of ADLT rules, as well as  FDA cleared or approved tests.   I wasn't sure how readily CMS would adopt the PLA code system - especially when PLA codes were created for things that wouldn't have gotten ADLT codes under PAMA.  Verbally, I had heard someone remark that he had heard that someone had said CMS would be using all the PLA codes.

However, solid evidence in a new hospital outpatient policy transmittal suggests that CMS will be adopting all the PLA codes as they come out, on a rolling basis.   Transmittal "R3783CP" includes classification of the two newest PLA codes, 0004U and 0005U.   (For hospital policy purposes, 0004U is separately payable and 0005U is bundled to hospital outpatient services.)

CMS notes that its policy cycles do not necessarily match the AMA CPT PLA publication cycles.  For example, these two codes will be added to the July 2017 editor but with effective dates retrograde to May 1.   These are code files only; CMS coverage and payment would be determined separately.

The CMS publication is here.
The AMA website for PLA codes is here.
The current list of PLA codes is here.
Image, click to enlarge:

This could mean that PLA codes will be put in the annual CMS July crosswalk/gapfill cycle.  The agenda for this year's crosswalk/gapfill cycle has not been announced as of May 31.  Administrative MAAA codes have been incorporated in crosswalk/gapfill meetings as they appeared.

Brief Blog: Simple Way to Organize a Brainstorming Meeting

Brainstorming meetings have their advantages, but can be too disorganized in the pursuit of "blue sky" ideas.   In an SF meeting last week, we used this simple motife to structure what was basically a one hour, three-person brainstorming whiteboard session on a topic that held a lot of uncertainties.

Here's the picture:

Brief Blog: Hidden Gems from the SEC Blasczak Insider Document: How Wheels Turn at CMS

Last week, news broke that the long-simmering story about insider information leaks had reached public filing of an SEC legal document (news links here, SEC document online here.)

One interesting aspect is to actually read the SEC 51-page filing.   Business journalists picked up on the lurid details - how one individual was allegedly dangling future benefits in front of a CMS employee, and embarrassing turns of speech clipped out of emails from 2013 and 2014.

But policy watchers can also read the SEC document for some interesting insights into how the wheels turn at CMS.   For example, in January, I was describing to a client how, if you want to affect June 30 annual rulemaking, you need to back up to publications or communications in January, February and March, because issues at the agency will converge towards final meetings and decisions in April if possible for writing, editing, and troubleshooting sessions in May and final vetting underway by early June.  

The SEC documents contain stories that mirror that timeline - for example, there are emails traded about policy meetings in March and April, and the crafting of CMS debriefing and decision decks on that timeline, all in preparation for rulemaking that must be released around June 30 after vetting by higher levels at CMS and legal counsel and the Office of Management and Budget.

Brief Blog: Incredible Concert Genetics Reports on Genomics Industry and BRCA Industry

Concert Genetics (formerly NextDxGx) is a company that provides services to health plans nationally to help them manage genetic testing.  Home page here.

A Wall Street report on the genomics industry this week cites several deep-dive PDF-format studies available from Concert Genetics (download with simple email registration).

These include:

• "The Current Landscape of Genetic Testing" - 20 pp, here.
• "A Guide to BRCA Testing for Health Plans" - 12 pp, here.
• "Critical Steps to Realizing the Potential of Personalized Medicine" - 24 pp, here.

Many interesting graphics, charts, and tables.

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For a publicly available checklist of process management for an out of network molecular lab, see here.
Publicly available sources suggest Concerto (NextGxDx) has raised about $10M in venture capital, here.

Brief Blog: Unique Scott Gottlieb House Hearing Transcript / May 24, 2017

On Thursday, May 25, 2017, FDA Commissioner Scott Gottlieb testified before the House Committee on Appropriations.    The House webpage is here (includes Youtube archive of the hearing).   Gottlieb's six page prepared testimony is here.

FOR A UNIQUE TRANSCRIPT OF THE HEARING, CLICK HERE.

• Coverage at Endpoints, here.
• WSJ here and here.
• Bloomberg here.  
• This article by Max Nisen pivots off Gottlieb's testimony, but mostly covers drug pricing trends in general.  Several interesting charts.
• Coverage at RAPS, here.

Brief Blog: Breaking The Box in Genomic Research Paradigms: DecipherGRID

An article in this week's New England Journal, written by an international consortium (here), focuses on the global data for widespread data sharing in genomic cancer research.   They summarize the needs and goals, as reflected in programs like Cancer Moonshot.  

An innovative approach to shared genomic research resources appeared as Zhao et al. earlier this month in JAMA Oncology (here).    The authors took the concepts of luminal and basal gene expression or differentiation - as long used in breast cancer - and applied it to prostate cancer, with significant results.  (These panel-based classifications may prove clinically impactful for prognosis-dependent management and in predicting responsiveness to androgen deprivation drugs.)

However, a very interesting aspect is how they did it: with large gene-chip archives of data developed by San Diego's commercial firm GenomeDx through the DecipherGRID program.

GenomeDx has commercialized a prognostic prostate cancer test which has Medicare coverage.  In addition, GenomeDX uses a methodology which has also archived genomic data on 46,000 coding and non coding genes through array technology - the DecipherGRID program (homepage here.)  Researcher can collaboratively test hypotheses on the data - and many dozens of publications have already appeared.

Additional coverage of the Zhao et al. paper at Genomeweb here., and Genomeweb coverage on the DecipherGRID program here.

DecipherGRID data archives have also contributed to a major article on prostate cancer radiation sensitivity (research in Lancet Oncology here, press here.)

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For an article on coverage issues for prostate gene panel tests, see Managed Care, May 2017, here.  For example, a couple years after launch, the Myriad Prolaris test conducted for prognostic classification on biopsy tissue received relatively narrow coverage from Medicare MolDx (October, 2014; here);  which was expanded considerably over 18 months later (May 2017; here).

SF's Genome Medical Raises $12M for Telemedicine Genetic Counseling

One of the challenges with the rapid growth of genetic testing is the shortage of genetic counselors.  Genome Medical, a San Francisco start up, aims to address this by rapid development of high-quality telemedicine services.

The startup has raised $12M in recent months from major investors such as Illumina Ventures, Canaan Partners, and others.   The company is founded by Randy Scott (previously involved in founding both Genomic Health and Invitae, which have a combined market cap of $1.3B), Lisa Alderson, and Harvard Medical School geneticist Dr. Robert Green.

• CNBC story, here.
• Genomeweb, here (brief).  Genomeweb subscription deep dive, here.
• Genome Medical website, here.

In January 2017, Invitae acquired the patient-centered data information company AltaVoice (here).  Invitae also has collaborations centered around the Illumina spinout Helix (here) and Invitae announced a new exome service in March 2017 (here).   (Illumina has a current market cap of $25B).