CMS Posts Agendas for July 31 and August 1 Lab Meetings

Each July CMS holds a public meeting regarding pricing and payment policies for upcoming new laboratory codes.   In mid June, CMS announced the dates for this meeting as July 31/August 1 and posted the list of new and appealed codes (there are 61).  See here.

This week, CMS published the Agenda for the July 31 meeting, as well as the Agenda for the subsequent PAMA Laboratory Advisory Panel Discussion.

• July 31 agenda here - mostly public stakeholder presentations, including individual companies as well as large associations like CAP and AMA.
• August 1 agenda here - mostly the Advisory Panel on view as they discuss the same codes.  In addition, the Advisory Panel has an afternoon agenda on panel test payments.  
• The agenda notes these are "routine chemistry" panels, not genomic panels.

Brief Blog: The MEDICAIDIZATION of Healthcare - A trend?

The term "Medicaidization" dates back to at least 1990 (here in JAMA) but is still used pretty infrequently.  See a 2012 article about Medicaidization of social services (here) and an article on "Medicaid for All" at Frenkel Benefits, here.   I think the term is a useful concept - narrow networks, lots of downward pressure on pricing - and have used it in this blog a few times (here).

In May 2017 at Health Affairs, Margaret Murray and Mike Adelberg produce a well crafted and insightful article on Medicaidization - find it here.  They note, for example, that Exchange marketplace plans may likely also provide Medicaid managed care plans, suggesting shared expertise.

As of today, the term only has 2 hits on Pubmed - from 1990 and 1991 - but I think its use will pick up.

Brief Blog: Informa to hold annual FDA/CMS SUMMIT (Washington, December 5-6, 2017)

Informa has posted the agenda and discounted registration for the annual FDA/CMS SUMMIT, to be held on Tuesday/Wednesday, December 5/6, 2017.

The home page is here.   Agenda Day 1 is here, Agenda Day 2 is here.

Speakers include Scott Gottlieb, head of the agency, and Janet Woodcock, head of CDER.    

Topics include updates on post market studies and surveillance, FDA's use of patient reported outcomes, precision medicine, accelerated approval, expanded access issues (eg right to try), value and price transparency, Medicaid update, biosimilars in US versus globally, and rare diseases and pandemics.

Brief Blog: Getting This Blog in a Blog Reader or by Daily Email

We've set up a basic FEEDBURNER page for Discoveries in Health Policy.  

This facilitates signing up for DIHP via a blog reader (such as FEEDLY).  
There is also a simple sign-up box for a daily email update.

Click HERE.

You should see this page:

http://feeds.feedburner.com/discoveriesinhealthpolicy/tmVH

We're working on a more advanced system that will include an option for once-a-week updates.

Brief Blog: What Medicare Paid HDL Lab, And How

This summer, I was describing to a client the "shell shock" that US payers experienced in 2013/2014 with an explosion of claims for cardiac biomarkers and pharmacogenetic testing.

In the case of cardiac biomarkers, this resulted in large Department of Justice settlements with labs in March 2015 (here).  As described in Forbes in April 2015, one lab rapidly skyrocketed to $400M revenue, $100M profit, but was bankrupt within a year (here).

Medicare has comprehensive online data for Part B payments from 2012-2015.   In CY2014, the Medicare MAC for Virginia paid $116M to HDL Laboratories (NPI 1629209853).  The top 20 codes garnered over 75% of the payments, click to enlarge:

About 25% of payments to this lab, totalling $30M, were for the nonspecific chromatography/mass spec codes 82541, '542, '545.  Some of these codes were deleted by 2016 (here).

Most tests were $15-50, the only outlier being 81225, CYP-P450, at $289.   Full data is available at the CMS 2014 database, here.

In CY2015, payments to this lab were still nearly $40M.   News stories evolved rapidly from the WSJ's first article in September 2014 (here) to discussion of the lab's bankruptcy filing in June 2015 (here).  See also a 2015 story at Dark Daily (here).

Today, both private payers like Aetna and Medicare payers like Noridian (MolDX) have much stricter controls against payment for cardiac biomarker tests (here, here).
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Another lab that found itself in difficult times in the same 2014-2015 period was a New Orleans-based genetics lab (see NYT here); UTC Laboratories NPI 1720342884 did business as Renaissance Rx (here).  It appeared to do about $168M of business with one Medicare MAC in CY2014, based on data in the same CMS database.   For example, its billing of $34M for 81225 (CYP) was 32% of Medicare's nationwide CY2014 payments of $108M for that code.

AGENDA: Precision Medicine Leadership Summit, San Diego, August 21-24, 2017

The Agenda is out for the Second Annual Precision Medicine Leaders Summit, to be held in San Diego, August 21-24, 2017.

Monday August 21 will be workshops; the main conferences runs Tuesday-Thursday, August 22-24.

Full agenda is online here.

CLINVAR Lists Ten Labs Meeting "Data Sharing Criteria"

CLINVAR has published its initial list of ten labs meeting data sharing criteria which it describes as "essential for supporting genomic medicine and a critical part of quality assurance."

The CLINVAR lab listing page is here.  The American College of Medical Genetics has very strongly supported open-access genomic data sharing, as reiterated in early 2017 (here, here).   Additional subscription coverage at Genomeweb, here.

(Image captured 2017/7/19)

Chief Medical Officer of NHS Advocates for More Genomic Testing in Healthcare

In an annual report released last week, the Chief Medical Officer of the National Health Service in England advocates for more genomic testing for "an era of precision medicine."

Coverage at The Guardian here.   Home page for the report, by Dame Sally Davies, here.  The actual PDF report, here.  The report is an eight-chapter, 256-page review of clinical genomics by policy topic, such as the UK 100,000 Genome Project, rare disease, prevention, diagnosis, and precision therapeutics.

Med-C Program Rebranded as Cure-One

Among the openings, mergers, closures of the genomics industry, rebranding is an occasional activity.  For example, in recent months Omicia became Fabric Genomics and NextDxGx, a laboratory benefit manager, became Concert Genetics.

In June 2017, the Molecular Evidence Development Consortium (MED-C) rebranded as Cure-One.  See the press release here and the new website here.   Dane Dickson MD remains founder and CEO  (Linked In here).

Cure-One announced a registry-based partnership Guardant Health in June, here.

Press release quoted below the break.  In related news, CLINVAR recently endorsed a set of major national genomics labs that follow recommended data-sharing guidelines (here).

FDA Documentation for Illumina PMA Extended RAS Panel by NGS

On June 29, 2017, FDA announced PMA approval of the Illumina Extended RAS panel by next generation sequencing, along with on-label use in patients with colorectal cancer receiving Amgen's Vectibix (panitumumab).  Open access news at Genomeweb, here.

FDA documentation is now coming online (here).  

• See the FDA page about the panel (here), 
• the PMA160038 technical home page (here), 
• 46-page instructions for use (here),
• 43-page summary of safety and effectiveness (here).   

For FDA documentation on the Thermo Fisher Oncomine 23-gene NGS test, approved June 22, see links here.

Cancer Drug Development Continues to Swamp-Out Other Areas

See the open access blog ENDPOINTS NEWS here for several charts on biopharma development pipelines.  The blog aggregates summary data recently reported by EvaluatePharma and Analysis Group.  

From Preclinical and Phase I forward, Oncology dominates other areas of biopharma, with 8,651 projects tallied (for comparison, neurology has 2,517 and diabetes 749).   Thumbnail below; full graphics at the original blog.

For details see original blog as cited.

CMS Opens National Dialog on a More Effective, Less Complex Medicare

In physician fee rulemaking released July 13, 2017, CMS included a Request for Information (RFI) soliciting wide-ranging suggestions on how to make Medicare and our healthcare system more effective and less complex.

The goal is described best in the PFS Fact Sheet (here).   CMS states that it will not respond to comments on this topic in the final November rule, but rather, will keep them under advice for new initiatives and new ways to improve Medicare in the future.  The RFI comment box is open until September 11, 2017.

In addition to the payment and policy proposals, CMS is releasing a Request for Information (RFI) to welcome feedback on positive solutions to better achieve transparency, flexibility, program simplification, and innovation. This will inform the discussion on future regulatory action related to the PFS.  The agency writes:

We would like to start a national conversation about improving the healthcare delivery system; how Medicare can contribute to making the delivery system less bureaucratic and complex; and how we can reduce burden for clinicians, providers, and patients in a way that increases quality of care and decreases costs, thereby making the healthcare system more effective, simple, and accessible while maintaining program integrity and preventing fraud. 

CMS is soliciting ideas for regulatory, sub-regulatory, policy, practice, and procedural changes to better accomplish these goals. Ideas could include recommendations regarding payment system re-design; elimination or streamlining of reporting; monitoring and documentation requirements; operational flexibility; and feedback mechanisms and data sharing that would enhance patient care, support the doctor-patient relationship in care delivery, and facilitate patient-centered care. Ideas could also include recommendations regarding when and how CMS issues regulations and policies and how CMS can simplify rules and policies for beneficiaries, clinicians, providers, and suppliers.

In responding to the RFI, CMS should be provided with clear and concise proposals that include data and specific examples. If the proposals involve novel legal questions, analysis regarding CMS’ authority is welcome. 

CMS will not respond to RFI comment submissions in the final rule, but rather will actively consider all input in developing future regulatory proposals or future sub-regulatory guidance. 

CMS also solicits open-ended comments on how it might expand its telehealth program, but within existing statutory authority, which generally limits the site of origin (aka site of patient) to rural areas.

CMS includes the same offer for comments on innovation in its outpatient rulemaking published the same day.

2017 Digital Health Funding is High: $3.5B in First Six Months of 2017

Rock Health has released a report on digital health funding in 1H2017, which tallies $3.5B in new investments.  It follows a report by StartUp Health, tallying $6.5B in the same period.

RockHealth: $3.5B in Six Months

• The report is summarized by RockHealth here.  
• They sell the full 24 page report sells $99.  
• See a news summary on Healthcare Dive, here.

StartUp Health: $6.5B in Six Months

The RockHealth report follows a report by StartUp Health just a few days earlier.

• See the StartUp Health Powerpoint online here.  
• See the respective Healthcare Dive story, here.  
• StartUp uses different definitions of DHealth and tallies $6.5B in investments in 1H2017. For example, they include Grail (about $1B for genomics). 
• Startup Health found that most activity was located in the SF Bay Area, with a 4:1 ratio between SF:NY.

Philips 2017 Report
Separately,  Philips runs an elaborate website, www.futurehealthindex.com, which provides a 100 page 2017 report on digital health.

Contrasting Perspective
For a contrasting note, see an interesting article this week on Reuters on Jawbone's attempt to compete with Fitbit, titled, "Death by Overfunding" - here.

Views on Validation and Valuation
See also an article at Forbes by Fahad Aziz on the valuation of digital health startups and how they require V&V - valuation AND validation.  Here.   And a CNBC article by Christina Farr picks up on Aziz and adds further comment, here.

CMS Posts CY2018 Proposed Rules for Physician and Hospital Outpatient Settings

After markets closed on Thursday, July 13, 2017, CMS released "inspection" or typescript copies of the Annual Rulemaking for both the Physician Office and Hospital Outpatient settings.   Comments due September 11.

• Home page for new CMS rules, here.
• Outpatient rule, here. 82 Fed Reg 33558-724 (167 pp).  CMS fact sheet, here.  
• Physician office rule, here.  82 Fed Reg 33950-203 (254 pp).   CMS fact sheet, here.

Outpatient Rule

The outpatient rule includes proposed changes to the infamous CMS Laboratory Date of Service rule aka 14 Day Rule (page 33650ff).  CMS might allow labs to bill either only for ADLTs, or, for all genomic tests that are not otherwise bundled.  Other changes a proposal to cut 340B drug payments (see also a July 18 Hill hearing on 340B, here.)

• Summaries at Beckers (here), American Pharmacists Assoc (here), Radiology Business (here), RevCycle (here), and National Law Review (here).

Physician Rule

The physician rule includes more specifications for the novel Diabetes Prevention Program (DPP; page 34129ff.)   CMS proposes it may consider reviewing "100% virtual" services under a new demonstration project (page 34171ff), which would "run in parallel with" the rest of the DPP Expanded Model.[*]   The DPP section runs almost 50 pages; payment would be tracked via 19 G-codes.

Other PFS topics include altering physician payments at "off campus" hospital affiliated sites (33978ff).  Note that physician quality reporting rulemaking is mixed between this rule and the June 20 MACRA rule (here).   There is a discussion of the new, Congressional mandated Appropriate Use Criteria (AUC) that must be consulted (preferably via EHRs) in the ordering of advanced imaging (34091ff).  Finally, CMS seeks comments on how to improve its criteria for E&M coding and grading (34078ff).

• Summaries at Beckers (here), Medscape (here), Fierce Healthcare (here), Healthcare IT News (here), Healthcare Dive (here).

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[*]  CMS gives the DPP its own separately titled press release, but the so-titled press release just describes the overall PFS rule with only a bland sentence that it includes DPP.
Informal aggregated web clippings, online here.

Unwrapping Medicare Advantage Provider Payment Levels: New Study

This week, JAMA Internal Medicine publishes a new study by Trish et al. which researches Medicare Advantage payments to providers and compares them to payments made on various fee schedules under Traditional Medicare.

The article is online here; an editorial on the article, by Berkeley's James Robinson, is here; and coverage the Healthcare Dive is here.

The take-home lesson is that physician payments are about the same under Medicare Advantage and under Traditional Medicare.  However, Medicare Advantage plans are able to negotiate payments circa 70% of Medicare fee schedule rates for some lab tests and some DME.

Tidbits follow the break.    Pm a separate note, for an interesting current overview of ways to make Medicare Advantage more innovative, by Broome & Mostashari of Aledade, see their July 2017  Health Affairs blog here.