DAB Draws Fence Around Categorical vs R&N Decisions and Appeals Processes

Medicare ALJs are allowed to review LCDs for validity, and prior decisions have held this is true even if the LCD is couched in other formats such as an "article."   DAB has ruled that in some cases the articles are de facto LCDs and therefore they reach legal review channels as LCDs.

However, not every published adverse coverage decision gets to ALJ review under this concept of the broad category of LCD and de facto LCD.

In case 2782 in April 2017, the Department Appeals Board rules that a MAC published viewpoint that CGMs are considered "precautionary and non covered under the DME benefit" could not be reviewed as if it were an LCD. 

Link here.
https://www.hhs.gov/sites/default/files/board-dab-2782.pdf

The risk, of course, is that MACs could be wily and insulate non coverage decisions from review by tactially saying that XYZ, whatever XYZ is, is "precautionary or screening and therefore not a benefit," rather than stating that it is not reasonable and necessary.  For any topic.  Because DME category decisions include findings of fact about medical purpose, the category decision can have areas of conceptual overlap with an R&N decision.  And I agree with the poor over-ruled ALJ that "precautionary" is a weird concept, not found in CMS manuals or regulations.   Even regular  glucose blood tests could be seen as "precautionary" to find out if your insulin dose must be raised or lowered, and things like INR testing in warfarin patients is "precautionary" to find out if the INR level is too high or low.   For a patient with severe unilateral headaches, an MRI is "precautionary" to see if there is a brain tumor.

Brain teaser for the reader.  Since ALJ's are only allowed to review LCDs based on "reasonable and necessary" decisions, can a MAC frame its decisions in an Article and as "investigational and experimental" and thereby evade ALJ review?   In this hypothetical, MACs could stop putting out LCDs that services are "not reasonable and necessary" and instead put out articles that  services are "investigational and experimental," wording that is not reviewable by an ALJ...Perhaps double insulating its decision by stating the service is "not a benefit category" because it is "experimental and investigational."

Consultants Corner: Successful Deck Used in Changing the CMS 14 Day Rule

This deck came from a July 2017 article in AXIOS by Bob Herman, here.  For some additional follow-up, here.  For my cloud copy of the deck in case the original goes away, here.

A group of industry and association stakeholders met with CMS in May 2017 to discuss long-postponed and much-needed changes to the 14 Day Rule.  Below, I use the document's pagination (large numbers on the pages).   This PPT and meeting didn't sway CMS alone; there were many other touchpoints and stakeholders involved over a couple years.   But since this deck was associated with a success, it's probably worth study.

1. The title is "The Impact of the Date of Service 14 Day Rule."  So the "point" is "The Impact" and the "topic" is the 14DR.
• The stakeholders were Biodesix, Boehringer-Ingelheim, Guardant Health, LUNGevity, Myriad Genetics, Veracyte.  
2. Slide 2 is a detailed OVERVIEW with three sections, about ten bullet points, and a concluding signal to the "recommendation" or ask.
• So if you walk out after slide 2, you know everything the meeting was about.
3. Slide 3 is a detailed "history of the problem" from 2001-2017.
4. Slide 4 actually explains the whole 14DR, with a lot of text, but in a friendly "[Question]?" format.
• Note they chose to place "the history of the problem" ahead of "what the 14DR is."  In part, they could be confident the people they were talking to knew what 14DR was.   On the other hand, and we don't know, if this was a meeting with The Administrator, rather than mid level policy staffers, you couldn't assume that content knowledge.
5. Slide 5 is clinical: "Impact on Lung Cancer Outcomes."  ("Delay in treatment can result in worse outcomes, ^tiny journal footnote.")
• "Impact" here echoes the title of the whole deck.
6. Slide 6 is similar, but colorectal cancer.
7. Slide 7 is a fancy flow chart infographic of the whole landscape presented visually and organized L to R by time.
• Is the message "here's how the Swiss watch works" or "This damn thing you've created is more complex than a Swiss watch! It hurts my eyes!"
8. "Consequences of These Billing Policies."  Three bold categories, visual, "Inconsistent billing," "Beneficiary Access Problems," "Reduced Efficacy of Treatment" due to 14DR delay.
• From "Impact" to "Consequences."
9. Slide is titled, "Real World Examples" but consists of a bullet description of the 7 stakeholders.   Possibly this slide was a "backdrop" for a planned discussed segment with a script for each stakeholder.
• Make the problem real.  Tell a story.
10. "Evaluating the DOS Rule Effects."  This is actually a short description of a CMS demo (requested by Congress) in 2012-2014, reported in 2016, that had no conclusions.
• Years go by and you CMS do nothing.  At the least, do the following, next slide:
11. ASK.   Recommend that CMS Solicit Comments on DOS in Proposed Regulation."   Flagged for CMS what points to request comment on.   Stakeholders, in this deck, did not tell CMS what an "edit" or "redline" should be.
12. "Additional Outreach."   Coalition has a broad swatch of Hill meetings and has previously met with CMS at different level, and with groups like OMB.  Notably, the group had already also formally asked in 2016 that CMS take public comment on 2017, the same ask that is already on record and being repeated in this deck.
13. "The Landscape of Precision Diagnostics."  Unclear why this occurs here, but it states that typical precision medicine tests are by a "lab that is unaffiliated with a hospital and specialized in one type of molecular testing."   It states that "some" ADLTs are performed by a "single laboratory" but I think all ADLTs must be sole source.
14. Landing slide; Simple "Thank you" (not an ask or other message.)

How FDA Approved KEYTRUDA for All Solid Tumors based on MSI status

In 2017, FDA approved KEYTRUDA for all solid cancers based on LDT "MSI" status ("locally developed PCR tests for MSI-H").

Labeling here
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s014lbl.pdf


Clinical study table 24, table 25, page 41.  In colorectal cancer, N=90, ORR rises from 36% to 46%.  But Duration of Responses rises from 1.6 months to 22 months.

Other cancers were studied - in total 59, of which 14 endometrial, 11 biliary, 9 gastric, etc.  Many cases were studied N of 1.  There were variable but meaningful increases in ORR but big increases in DOR.

Click to enlarge.

For the Keytruda discussion in a December 2017 article on precision medicine in Nat Rev Clin Onc, by Moscow, Fojo & Schilsky (NCI, Columbia, ASCO), see here and clipping below.

click to enlarge

The December 21, 2017 NEJM has an interesting letter from Yarchoan and colleagues at Johns Hopkins plotting three things together:  ORR, TMB, and Tumor Type in one graphic. 

Foundation Medicine PMA Approval Summary (Product Group PQP)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_template.cfm?id=p170019


DeviceFoundationOne CDxClassification NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemGeneric NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemApplicant

Foundation Medicine, Inc.

150 Second Street, 1st Floor

Cambridge, MA 02141

PMA NumberP170019Date Received06/02/2017Decision Date11/30/2017Product Code

PQP	[ Registered Establishments With PQP ]

Advisory CommitteePathology

Expedited Review Granted?Yes

Combination ProductNo

Approval Order Statement

p170019

FoundationOne CDx™ (F1CDx) is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.

The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

Additionally, F1CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. The F1CDx assay is a single-site assay performed at Foundation Medicine, Inc.

Table 1: Companion diagnostic indications
Indication    Biomarker     Therapy
Non-small cell lung cancer (NSCLC) EGFR exon 19 deletions and EGFR exon 21 L858R alterations Gilotrif® (afatinib),Iressa® (gefitinib), orTarceva® (erlotinib) EGFR exon 20 T790M alterations Tagrisso® (osimertinib) ALK rearrangements Alecensa® (alectinib),Xalkori® (crizotinib), orZykadia® (ceritinib) BRAF V600E Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib)
Melanoma BRAF V600E Tafinlar® (dabrafenib) or Zelboraf® (vemurafenib) BRAF V600E and V600K Mekinist® (trametinib) or Cotellic® (cobimetinib) in combination with Zelboraf® (vemurafenib)
Breast cancer ERBB2 (HER2) amplification Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), orPerjeta® (pertuzumab)
Colorectal cancer KRAS wild-type (absence of mutations in codons 12 and 13) Erbitux® (cetuximab) KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) Vectibix® (panitumumab)
Ovarian cancer BRCA1/2 alterations Rubraca® (rucaparib)

2014 MOLDX Statement of Work (Part of Palmetto JM Contract)

In 2014, Palmetto GBA won a competitive bid for Jurisdiction M, which includes in its statement of work a special section "C.7.38" for the "Molecular Diagnostic Test Project."

The recompete document archive is online at FedBizOpps, here.

The SOW is titled, "JM J.01 AB MAC Statement of Work 07 16 14.doc".  I've put a cloud copy here, and the SOW C.7.38 is clipped below (page 181 forward).

C.7.38.1 Develop Molecular Diagnostic Test Pricing Process

The Contractor will establish/maintain a documented process to detail a pricing for complex gene/mutation panels, new technology based tests, and multi-analyte assays with algorithmic analyses (MAAAs) that are not priced nationally. The process will enable analysis, coverage, and pricing strategy recommendations for these tests.

The Contractor shall compile and maintain a file of established molecular diagnostic tests defined by AMA CPT© Tier I and Tier II molecular pathology codes that are not nationally priced. This file will identify lab developed tests (LDTs) and FDA cleared tests.  The Contractor shall provide file updates on an as needed basis to the CMS COR and/or designee.

In addition to the master file, the Contractor will establish/maintain a documented process to detail a payment methodology for complex gene/mutation panels, new technology based tests, and multi-analyte assays with algorithmic analyses (MAAAs) that are not nationally priced. The process will enable the Contractor to evaluate and provide pricing recommendations for these tests.

The Contractor will append the current MoIDx activity with the following responsibilities:

• ·       Review/update the file on a quarterly basis
• ·       Assist CMS in all efforts to address pricing and coverage challenges

 

C.7.38.2 Maintain Master Test Registry [aka Z codes]

Maintain a Master Test Registry with a user interface that allows test providers an avenue to register individual tests and allow stakeholders a tool to look-up registered tests.  The Master Test Registry will enable the following functions:

• ·       Create and/or adopt, and maintain a unique identifier (code) for each unique test
• ·       Provide an automated registration process that enables submission of all required information in a standardized, electronic format
• ·       Maintain an online test listing resource for registered test look-up
• ·       Safeguard required proprietary data elements

C.7.38.3 Review of Evidence

To support the efficient review of tests in light of the rapid technological advancements in the MoIDx industry, the Contractor will establish a consistent methodology which the Contractor will use for reviewing evidence for requested test indications. The methodology will use an evidence framework that is consistent with the ACCE criteria developed by the Centers for Disease Control and Prevention (CDC) for the evaluation of genetic tests. 

The Contractor shall consider the analyses articulated from 2009 onward in national coverage determinations (NCDs) pertaining to molecular diagnostic tests to be examples of the application of the ACCE criteria to Medicare coverage. The Contractor will establish methods to collect and analyze claims data. As requested, the Contractor will provide recommendations to CMS regarding local coverage variation and system edits.

C.7.38.4 Develop Master Edit File

The Contractor will expand the current file developed through the J1 MoIDx work [California] and prepare this file for shared system (SS) integration. Once the SS edit module is complete and activated, on a quarterly basis the Contractor will produce and submit to CMS a Master Edit File for MAC distribution. This file will include all necessary identifier/CPT/NPI crosswalks, coverage assigned and any non-fee-schedule pricing required. To develop this file the Contractor will perform the following tasks:

• ·       Review all newly registered tests
• ·       Establish price (non-fee schedule)/coverage by ID
• ·       Develop a list of recommended edits including but not limited to the following as appropriate:

o   Frequency

o   ID to procedure code editing

o   ID to ICD-9-CM/ICD-10

o   LCD recommendations

• ·       Assist CMS in the development and maintenance for Shared System (MCS/FISS) edits to utilize the MoIDx Master Edit File.

C.7.38.5 Prescribed Methodology of Evidentiary Review for Complex Molecular Tests, New Test Methodologies

The Contractor, with an established network of technical and clinical experts, will employ recognized and generally accepted technical assessment methods to perform the following tasks:

• ·       Create a complete submission process for all supporting application documentation that includes information needed to make evidence based coverage decisions for each test. Maintain the submitted documentation in a retrievable format that supports evidence based decision making.
• ·       Maintain appropriate evidence/administrative records connected to all coverage policies and make this information readily available to CMS upon request.
• ·       Publish and maintain any LCDs and related articles on the Medicare Coverage Database.
• ·       Maintain the submitted documentation in a test specific retrievable format that supports the medical review process.

• ·       When the available evidence is insufficient to support coverage for routine use in some indications, consider whether the use of the test for beneficiaries enrolled in certain clinical studies will support beneficiary access to covered testing for one or more of those indications. Approved clinical studies would:

o   Be registered on www.clinicaltrials.gov; and

o   Have a methodologically appropriate study protocol to answer the relevant evidence questions regarding beneficiary health outcomes; and

o   Provide assurance that findings are published peer-reviewed clinical literature; and

o   Provide CMS with interim and final data as requested.

·       

• Provide 1^st level of appeals “white papers” that support evidence based decision making for non-covered molecular assays.  [Eg help CMS win the appeal by justifying the non coverage]

C.7.38.6 Ongoing MoIDX Program Education

To support the MoIDX Program, the Contractor will develop a robust educational program to perform the following tasks:

• ·       Develop program launch materials
• ·       Develop MoPath correct coding manual
• ·       Create educational articles for MAC/CMS
• ·       Provide MAC and Provider Community SME POCs

CMS Releases Quality Measures Under Consideration; Hints at New Drug Payment Systems

CMS releases 32 new "measures under consideration" for quality metrics; Healthcare Dive December 4, with further links to CMS, here.

Fierce Healthcare covers Seema Verma remarks on new approaches to drug pricing, Fierce Healthcare December 5, here.

FMI NCD Questions to Address

click to enlarge

CMS Payments to ASSUREX in CY2015, CY2016

CMS has a provider-specific data set for CY2015, and has released state-specific data for CY2016.

CY2015

Using the provider-specific data, NPI 1235363052, Assurex Health, received about $21M for payments from 9,840 services for code 81479 at $2177 per service.  Presumably, this is the CMS volume and payment rate for Genesight.

CY2016

CMS has released only state-level data for 2016 so far.  (Provider level data will be released in about 05/2018).

In Ohio, providers were paid about $28M for 13,067 Genesight services at about $2,170 per service.  This is presumably almost entirely Genesight payments, but final data won't be out until about 05/2018.

See picture below; click to enlarge.

click to enlarge

Foundation Medicine Draft NCD (Operational Text)

https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=290&bc=ACAAAAAACAAAAA%3d%3d& 

A. General

Clinical laboratory diagnostic tests can include tests that, for example, predict the risk associated with one or more genetic variations. In addition, in vitro companion diagnostic laboratory tests provide a report of test results of genetic variations and are essential for the safe and effective use of a corresponding therapeutic product. Next Generation Sequencing (NGS) is one technique that can measure one or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic test.

Patients with advanced cancer can have recurrent, metastatic, and/or stage IV disease. From results of clinical studies it has been shown that genetic variations in a patient’s cancer can, in concert with clinical factors, predict how each individual responds to specific treatments.

In application, a report of results of a diagnostic laboratory test using NGS (i.e., information on the cancer’s genetic variations) can contribute to predicting a patient’s response to a given drug: good, bad, or none at all. Applications of NGS to predict a patient’s response to treatment occurs ideally prior to initiation of the drug.

B. Nationally Covered Indications

Effective for services performed on or after [Month/XX] [Day/XX], [20XX]  CMS proposes that the evidence is sufficient to cover Next Generation Sequencing (NGS) as a diagnostic laboratory test, including the test results, when performed in a CLIA-certified laboratory and when ordered by a treating physician, and when both 1 and 2 are met.

1.  Patient has:

1. recurrent, metastatic, or advanced stage IV cancer; and
2. not been previously tested using the same NGS test; and
3. decided to seek further cancer treatment (e.g., therapeutic chemotherapy)

2.  The diagnostic laboratory test using NGS meets all the following criteria:

1. the test is an FDA-approved companion in vitro diagnostic; and
2. the test is used in a cancer with an FDA-approved companion diagnostic indication; and
3. the test provides an FDA-approved report of test results to the treating physician that specifies FDA-indicated treatment options for their patient’s cancer.

Results from this test must be used in the management of the patient to include guiding selection of treatments proven to improve health outcomes.

CMS proposes coverage with evidence development (CED) for NGS as a diagnostic laboratory test, including the test results, when performed in a CLIA-certified laboratory and when ordered by a treating physician and when both 1 and 2 are met.

1.  Patient has

1. recurrent, metastatic, or advanced cancer; and
2. not been previously tested using the same NGS test; and
3. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

2.  The diagnostic laboratory test using NGS meets the criteria in section a or b below:

1. The test is an FDA cleared or approved in vitro diagnostic, providing a report of test results to the treating physician who is using those results in the management of the patient’s cancer only if all the following requirements are met:
   
   
   1. The diagnostic laboratory test using NGS must be registered in the NIH Genetic Testing Registry (GTR).  All fields in the NIH GTR are required to be completed.
   
   
   2. The patient is enrolled in, and the furnishing laboratory is participating in, a prospective registry that consecutively enrolls patients, adheres to the standards of scientific integrity and relevance to the Medicare population as identified in section (B)(2)(c), and is designed to answer the following CED questions:
      
      
      • How do patient outcomes compare to either the initial clinical validation of the companion diagnostic or a cohort of controls receiving the same treatment?
      • How do the clinical characteristics of registry patients affect the clinical endpoints relative to those in initial clinical studies?
   
   
   3. The registry shall have a written executable analysis plan to address the CED questions (to appropriately address some questions, Medicare claims or other outside data may be necessary).  The registry shall make data available in a form and manner specified by CMS upon request.
   
   
   4. The registry must be able to identify the patient’s cancer type, stage, and extent of invasion and metastasis at baseline. 
   
   
   5. The registry shall track all of the following outcomes evaluated after each intervention:
      • Overall survival
      • Progression free survival
      • Objective response rate, definition must be consistent with the Response Evaluation Criteria in Solid Tumors, including definitions of minimum size of measurable lesions, instructions on how many lesions to follow, and the use of anatomical assessments for overall evaluation of tumor burden. 
      • Patient-reported outcomes using measurement developed to evaluate symptomatic toxicity in patients on cancer clinical trials.


2. The test is providing a report of test results to the treating physician who is using those results in the management of the patient’s cancer.  The diagnostic laboratory test using NGS is covered under CED only when all of the following requirements are met:
   
   
   1. The diagnostic laboratory test using NGS is provided to patients as a diagnostic test within an NIH-NCI National Clinical Trial Network clinical trial.  The trial shall adhere to the CED standards of scientific integrity and relevance to the Medicare population and identified in section (B)(2)(c), collect all data necessary, and have a written executable analysis plan and outcomes available in a form and manner specified by CMS upon request to address all of the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary):
      
      
      • How do patient outcomes compare to either the initial clinical validation of the companion diagnostic or a cohort of controls receiving the same treatment?
      • How do the clinical characteristics of registry patients affect the clinical endpoints relative to those in initial clinical studies?
   2. The diagnostic laboratory test using NGS must be registered in the NIH Genetic Testing Registry (GTR).  All fields in the NIH GTR are required to be completed.


3. All CED studies must adhere to the following standards of scientific integrity and relevance to the Medicare population:
   
   
   1. The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
   2. The research study is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
   3. The research study does not unjustifiably duplicate existing studies.
   4. The research study design is appropriate to answer the research question being asked in the study.
   5. The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
   6. The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the FDA, it also must be in compliance with 21 CFR Parts 50 and 56.
   7. All aspects of the research study are conducted according to the appropriate standards of scientific integrity.
   8. The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.
   9. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life-threatening as defined in 21 CFR § 312.81(a) and the patient has no other viable treatment options.
   10. The clinical research study is registered on the www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.
   11. The research study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors. However, a full report of the outcomes must be made public no later than 3 years after the end of data collection.
   12. The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting of said populations on the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
   13. The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.

Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that meet the above-listed standards and address the above-listed research questions.

C. Nationally Non-Covered Indications

CMS proposes non-coverage of NGS as a diagnostic laboratory test when patients do not have the above-noted indications for cancer or when the test does not meet the above-noted criteria.

D. Other

N/A

The 2017 Biosimilar Rule Revision

This is a sidebar article.  For our main blog, see DiscoveriesInHealthPolicy.com

###

CMS policy for biosimilar pricing had a major revision on November 2, 2017.

For the last several years, CMS had a policy to classify all biosimilars for a particular product under one code, and pay them at the quarter average sales price of the several biosimilars.   Since we don't have many or any categories with multiple biosimilars, this event hadn't really occured yet.

However, in big win for the biosimilar industry, CMS will begin categorizing each new biosimilar under its own HCPCS code from now forward (page 53348ff).

• Under "bucket" coding for biosimilars, CMS would likely have had lower prices, due to drug-on-drug competition to create a profit margin for physicians, by one-upping each other to give the physician more margin under the CMS payment price for the quarter.  
• For example, if a category pays $2000 for the biosimilar drug, each biosimilar would be incented to price for the physician at $1900, then $1800, then $1700, in a race to the bottom driven by competition to raise the physician's margin.
• However, a sufficiently adverse marketplace would mean biosimilars would stand down and not enter the US marketplace at all, a genuine concern.   See RAPS, October 30, here.
• CMS acknowledges that its change to biosimilar-specific coding will "address concerns about a stronger marketplace...encourage innovation to bring more products in the market."
• Note that while CMS sets payment policies only for itself, it also controls all HCPCS codes.  So long as CMS staff had refused to even create unique HCPCS codes, any efforts to get a better market in other payer venues was a non-starter. 
• Two other notes:
• It's unusual that a change this large could be accomplished without a regulatory change.  The requisite regulation, 42 CFR 414.904(j), does require that all biosimilars that are coded together would get an average price.  414.904(j) does not say whether CMS must, or must not, issue codes that group more than 1 biosimilar together.   CMS says, basically, it was discretionary within the regulation to lump biosimilars in one HCPCS code yesterday, and it will be discretionary now to give each biosimilar its own code tomorrow.  
• It's unusual in that the proposed policy discussion was quite short, and the final policy change and discussion was quite long.  Only in the final discussion did CMS reveal intentions and rationales in the final policy that couldn't have been guessed from the July proposal.
• CMS used long term economic incentive thinking and found on balance it needed to encourage market entry and innovation.  
• One might think of the legal economic analyses championed by Judge Richard Posner in many articles and books (here).
• See July proposal, November final, and Regulation bundled together by me into one PDF file here.

These rules help with pricing of biosimilars. 

Note that in the actual market, products will try to differentiate themselves with delivery devices, apps, or other methods.   See the ENBREL special delivery device from Amgen, here.   See Amgen's special NEULASTA delivery timer pod device, here, the ONPRO injector.   The more biosimilars enter for a particular product, the more likely there is to be injector or other differentiation methods in competition to create improvements for physicians and patients.

A MAC Statement of Work

Solicitation documents and elaborate statements of work for CMS MAC's are available online, because these are publicly solicited government bids.

The website for the Jurisdiction J MAC is here, at Federal Biz Opps.gov.

I've extracted the Solicitation here and the SOW here and archived them in the cloud.

Many readers of this blog are familiar with the Palmetto MOLDX program.  It doesn't seem to have a public SOW.   I tried to FOIA it; Palmetto GBA declined to release its SOW through FOIA, and CMS has acknowledged my request but may move in glacial time, if ever.

Nerdy Deep Dive on MSK IMPACT Approval Categories

This is a side bar to the main article, found here.
_______

De Novo Classification

The MSK IMPACT test was approved through a 510(k) De Novo pathway, which is familiar enough.  Classification letter here.

Regulatory Category 866.6080?

The letter classifies IMPACT as Regulatory Category 21 CFR 866.6080. 

Oddly enough, this category appears to be absent at eCFR, which I think of as the categorical reference for Code of Federal Regulations.   (Here, and look for 866.6080: the official CFR stops at 866.6060.)

However, the FDA's own website has a webpage for 866.6080, here.   It says the regulation was created on April 1, 2017.   This was a Saturday, a day when the Federal Register isn't published.  FDA just lists the name of the category, not further detail.

So 21 CFR 866.6080 appears to be a sort of phantom regulatory category --  found on the FDA's "CFR" page but not on the federal CFR page, despite having a claimed creation date of April 2017, plenty of time for the two sites to sync up.

Product Category PQM versus PQZ

Oncomine Target Dx is classed as Product Class PQP, "NGS Oncology Panel, somatic or germline variant detection system."   PQP is always a PMA submission.   See FDA webpage here.    Manufacturers using Class PQM include Illumina, Foundation, Thermo Fisher; see here.

Product Category PQZ has its own webpage also, here.   This is for  "Next generation sequencing based tumor profiling test."   It's classed as 510(k) based on 21 CFR 866.6080.  It is eligible for "Third Party Review," specifically, by the New York State Department of Health.

A PowerPoint that walks through all this with screen shots is here.

Agenda for Frontiers Health Conference, Berlin, November 2017

https://www.frontiershealth.co/agenda

• • DAY ONE
    2 
    Welcome Networking Breakfast
    

    8:15am - 9:15am Nov 16
    Read more
• 9:00am
  • 4 
    Welcome + Performance
    

    9:15am - 9:30am Nov 16
    Read more
    
    

    

    Joe Ferrari
    Designer

    
    

    

    KORINAMI 

    
    

    

    Matteo Penzo
    CEO, Frontiers Conferences
• 9:30am
  • 5 
    Conference Opening
    

    9:30am - 9:45am Nov 16
    Read more
    
    

    

    Roberto Ascione
    CEO, Healthware International
• 10:00am
  • 2 
    Regulatory Awareness by eHealth Hub [Workshop]
    

    10:00am - 12:00pm Nov 16
    The Regulatory Awareness Workshop (RAW) focuses on the medical device regulatory landscape that arises to startups and SMEs in the digital health sector. The RAW helps developers of medical and health-related apps and software to understand the importance of considering the medical device regulatory framework in the digital health sector.
    
    By using case studies, the following issues are explained:
    • when medical software falls under the medical device directive
    • how to classify medical device software
    • which key regulatory standards are mandatory
    • the impact of the new regulation (MDR) on medical device software
    
    The workshop will include a presentation (1 hour) and a Q&A section (1 hour).

    Read more
    
    

    

    Christian Johner
    Founder & CEO, Johner Institut GmbH
  • 2 
    Start-up Discovery I [Company Presentations and Panel]
    

    10:00am - 12:15pm Nov 16
    Meet awesome up-and-coming start-ups, which will make it through our selection process, hear from key investors about their funding strategies and engage with the Experts’ Q&A Panel.
    
    Moderated by: Paolo Borella
    
    Presentations by:
    
    AMICOMED - Giangiacomo Rocco di Torrepadula, CEO & Co-Founder
    
    Binnovate Digital Health Corp - Kirby Binayao, Founder
    
    GAIA - Mario Weiss CEO & Founder
    
    HeartWatch - Guido Magrin CEO & Co-Founder
    
    Kaia - Konstantin Mehl ‎Founder and CEO
    
    Keleya Digital-Health Solutions - Victoria Engelhardt Co-Founder
    
    Oviva - Kai Eberhardt CEO and Co-Founder
    
    QoLware - Ying Huang Finance & Legal
    
    Selfapy - Farina Schurzfeld Co-founder
    
    Sleep.ai - Michiel Allessie CEO and Founder
    
    TOMMI - Valentino Megale CEO and Co-Founder

    Read more
    
    

    

    Paolo Borella
    CEO, Head of Program, Vertical accelerator

    
    

    

    Christian Hein
    Lead, EU Technology Hubs, Amgen Innovation, Amgen

    
    

    

    Clara Leonard
    Associate, Digital Health Ventures

    
    

    

    Steve Seuntjens
    Partner, PHS (Personal Health Solutions)

    
    

    

    Karolina Korth
    Digital Health Scout, Roche Diabetes Care

    
    

    

    Alessio Beverina
    General Partner, Panakès Partners
  • 6 
    Start-up Discovery II [Company Presentations and Panel]
    

    10:00am - 12:30pm Nov 16
    Meet awesome up-and-coming start-ups, which will make it through our selection process, hear from key investors about their funding strategies and engage with the Experts’ Q&A Panel.
    
    Moderated by: Martin Kelly
    
    Presentations by:
    
    Paginemediche - Marina Peluso, Content & Social Media Strategy
    
    Baze - Philipp Schulte, CEO
    
    D-EYE - Alberto Scarpa, CEO
    
    Infermedica - Piotr Orzechowski, Co-Founder
    
    INNOVITAS VITAE - Alessandro Scozzesi, CEO
    
    Med Angel - Amin Zayani CEO & co-founder
    
    Medicinisto - Guido Axmann, CEO & co-founder
    
    MediLad - Lutz Haase, Business angel
    
    Miamed - Benedikt Hochkirchen, co-CEO
    
    Myontec Oy - Janne Pylväs, CEO
    
    Sky Labs - Jack Lee, CEO
    
    SYMPTOMA - Jama Nateqi, CEO
    
    Diagnosia - Lukas Zinnagl, Founder and CEO

    Read more
    
    

    

    Katrin Geyskens
    Partner, Capricorn Venture Partners

    
    

    

    Joachim Rautter
    Co-founder and Managing partner, Peppermint VenturePartners

    
    

    

    Martin Kelly
    CEO, HealthXL

    
    

    

    Shwetank Verma
    AVP & Head of Open Innovation, LumenLab | MetLife Innovation Center

    
    

    

    Frank Antwerpes
    CEO, DocCheck AG

    
    

    

    Lars Buch
    Managing Director, Startupbootcamp Digital Health Berlin
• 12:00pm
  • 3 
    Menarini’s Cardiovascular Innovation Business Meetings [invitation only]
    

    12:00pm - 2:00pm Nov 16
    During the meetings, invited startups will have the opportunity to present ideas on how to solve key challenges that Patients, their Caregivers and Physicians are likely to face when living with Hypertension, Angina, and Coronary Heart Disease (CHD).
    Please contact the Frontiers Team or Menarini delegates in the Community to get considered for invitation.

    Read more
  • 1 
    Crowdfunding for healthcare [Talk]
    

    12:15pm - 12:30pm Nov 16
    aescuvest: a healthy investment

    Read more
    
    

    

    Patrick Pfeffer
    CEO, aescuvest
• 12:30pm
  • 1 
    Networking Lunch Break
    

    12:30pm - 2:00pm Nov 16
    Enjoying awesome food and drinks in excellent company are conducive to great spirits and conversations. This is why you will not want to miss Frontiers Health’s delicious Networking Lunch Break, which informally brings together entrepreneurs, founders, investors, pharma, device makers and insurance executives.

    Read more
• 2:00pm
  • 3 
    Transforming Pharma [Keynotes and Talks]
    

    2:00pm - 3:30pm Nov 16
    Introduced by: Paul Tunnah
    
    Discover how new pharmaceutical companies are re-inventing themselves as ‘digital first’ and how established players are reinventing themselves through Open Innovation, launching Proof of Concept initiatives with clearly defined business roadmaps and goals.

    Read more
    
    

    

    Lana Ghanem
    Managing Director, Hikma Ventures

    
    

    

    Eugene Borukhovich
    Global Head, Digital Health Incubation & Innovation, Bayer

    
    

    

    Francesco Acanfora
    Head of Digital Innovation & Services (DIS), Menarini

    
    

    

    Steffen Kurzawa
    Head Global Communications and Corporate Responsibility, Sandoz International

    
    

    

    Fiona Cook
    Senior Manager, Global Corporate Responsibility Programs, Sandoz International

    
    

    

    Paul Tunnah
    CEO, pharmaphorum media

    
    

    

    John Gordon
    Head of Digital, Internal Medicine, International Developed Markets, Pfizer Ltd, UK
• 3:30pm
  • 3 
    Will M&A be the key to scaling Digital Health? [Panel]
    

    3:30pm - 4:15pm Nov 16
    Moderated by: Marc Sluijs
    
    The current fragmentation of the Digital Health landscape is a barrier to large scale adoption due to a) a lack of end-to-end solutions, b) a lack of large scale evidence and c) the lack of financial bandwidth to fund global Go-To-Market and be a stable long term partner. As digital health consolidation is emerging, we will explore different M&A strategies and their implications for the ecosystem with our panel of investors and (recently acquired) digital health companies. In particular, we will explore the 3 main scenarios for digital health M&A: 1) similar companies merging to create more scale, 2) complementary companies merging to create more complete solutions, and 3) acquisitions of digital health companies by players from other industries.

    Read more
    
    

    

    Francesca Domenech Wuttke
    Managing Director/Investment Principal Europe, MSD Global Health Innovation Fund, LLC

    
    

    

    Marc Sluijs
    Advisor, digitalhealth.network

    
    

    

    Christoph Ruedig
    Partner, Albion Capital

    
    

    

    Marco Mohwinckel
    VP of Strategy, WebMD

    
    

    

    Marc Berrebi
    Founder, eDevice

    
    

    

    Steven Yecies
    Venture Partner, OrbiMed Advisors
  • 1 
    Insurers - the new “B” in B2B2C [Panel]
    

    3:30pm - 4:30pm Nov 16
    Moderated by: Frederic Llordachs
    Payers and health insurers are playing an increasingly important role in the adoption of Health 2.0 solutions and the general development of the digital health industry in Europe and around the world. After all, they have the most to gain from increased prevention, performant disease management and generally speaking improved clinical and financial outcomes. This panel session, convening the most active health insurers in digital health, will discuss solutions that are designed to be implemented “by” or “through a partnership with” health insurers.

    Read more
    
    

    

    Josep Carbo
    CBDO, Mediktor

    
    

    

    Luca De Sanctis
    Manager, Ernst & Young Financial Business Advisors

    
    

    

    Gabriel Enczmann
    Business Development Director, MySugr

    
    

    

    Frederic Llordachs
    Co-founder, partner & Global Business Development Manager, Doctoralia Internet S.L.

    
    

    

    Shwetank Verma
    AVP & Head of Open Innovation, LumenLab | MetLife Innovation Center
• 4:00pm
  • 2 
    Digital Nutrition [Keynote]
    

    4:15pm - 4:35pm Nov 16
    Digital Nutrition: enhancing people’s quality of life through Nutrition, Health and Wellness

    Read more
    
    

    

    Valerio Nannini
    Senior Vice President Head of Strategies and Performance, Nestlé
• 4:30pm
  • 3 
    Start-up / Investors Lounge
    

    4:45pm - 6:30pm Nov 16
    1:1 meetings slot for start-up and accredited investors in dedicated lounge

    Read more
  • 2 
    Innovating Customer Engagement by Healthware + Intouch Solutions [Workshop]
    

    4:45pm - 6:30pm Nov 16
    A customer experience workshop
    
    Over the last 10 years, the healthcare industry has gone through several attempts at transforming itself to keep up with the torrid pace of changes in technology and services happening in other industries. While some “digital first” pharma initiatives have achieved good results, the overall success record across the industry is mixed at best. Today, a convergence of motivated consumers collecting personal health data with medical grade wearables, along with advances in data sciences/AI, and startups launching new healthcare models, present real threats as well as tremendous opportunities to traditional healthcare business stakeholders. Intouch Solutions and Healthware have joined forces to show a way forward that seeks to identify opportunities for engagement with today's health consumers by creating and delivering highly valuable customer experiences that integrate the latest innovations in tech and data.

    Read more
    
    

    

    Gerry Chillè
    Partner, HealthwareLabs

    
    

    

    Justin Chase
    EVP, Head of Digital Innovation, Media, Social, Intouch Solutions
• 5:00pm
  • 3 
    Clinical Trials 2020: Patients and Emerging Technologies drive a Networked Ecosystem [Panel]
    

    5:00pm - 6:00pm Nov 16
    Moderated by: Nana Bit-Avragim
    
    As medicine grows more specialized and data-driven, the need to rethink the current business of clinical trials becomes imperative. The Internet of Things and emerging technologies offer many undeniable advantages to becoming the “new norm”. At the same time, the health industry is moving to a new paradigm, Medical Affairs 2.0, where data mining combined with medical expertise are becoming critical for R&D and commercial counterparts and its role in product launch is getting strategically crucial.
    Now, which challenges clinical trials business are facing today? Who are the new players in the clinical trial ecosystem? Can web reset clinical trials?
    Leading experts in pharma, medicine, technology, digital health and a patients’ representative will search for answers and discuss how to reinvent and accelerate progress towards networked and patient-centric clinical trials ecosystem.

    Read more
    
    

    

    Gerrit Brand
    Co-Founder, Tyche Heart

    
    

    

    Bastian Hauck
    Founder, CEO, #dedoc° Diabetes Online Community

    
    

    

    Erik Sundermann
    Global Project Head Verily Portfolio , Diabetes Development, Sanofi

    
    

    

    Nana Bit-Avragim
    Head of Strategic Relations, Medicinisto AG

    
    

    

    Sarah Kerruish
    Chief Patient Officer, Antidote

    
    

    

    Frank Kramer
    Director Biomarker Strategist, Cardiovascular, Dept. of Experimental Medicine Cardiovascular & Hematology, Bayer Pharma AG

    
    

    

    Ralph Richter
    Head of EMEA Digital Analytics CoE, SAP Deutschland SE & Co. KG
  • 1 
    Pfizer Healthcare Challenge Award Ceremony
    

    5:00pm - 6:30pm Nov 16
    The Pfizer Healthcare Challenge Award Ceremony is open to all Frontiers attendees and Pfizer guests (entry 4:30 pm, program from 5:00 pm to 6.30 pm, closes in an networking aperitif).
    
    Agenda
    16:30 Entry for Pfizer guests and other conference attendees
    17:00 Welcome by Pfizer Healthcare Hub, Moderation by Dr. Karsten Neumann (Roland Berger Spielfeld)
    17:05 Keynote Peter Albiez, Country Manager Germany, Pfizer
    17:15 Presentation of the Pfizer Healthcare Challenge 2017
    17:30 Pitches of the finalists
    17:50 Ceremony
    18:00 Panel discussion with the winners & the jury
    18:30 Ending & Networking Aperitif

    Read more
• 6:30pm
• 2 
  Networking Aperitif + Blues Jam Session
  

  6:30pm - 10:00pm Nov 16
  Conference co-hosts Healthware International and Intouch Solutions are delighted to sponsor the Frontiers Health 2017 Networking Aperitif reception and welcome all speakers and delegates 
• DAY TWO

• • 
    2 
    Day 2 Opening

    9:00am - 9:15am Nov 17
    Welcome + Day 1 recap

    Read more
    

    Joe Ferrari 
    Designer

    

    KORINAMI 

    

    Matteo Penzo 
    CEO, Frontiers Conferences

    

    Roberto Ascione 
    CEO, Healthware International
  • 2 
    FightTheStroke, a story of love and science [Keynote]

    9:15am - 9:35am Nov 17
    Read more
    

    Roberto D'Angelo 
    Co-founder, Fightthestroke

    

    Francesca Fedeli 
    Co-founder, Fightthestroke
• 9:30am
  • 2 
    How is the NHS going Digital? [Keynote]

    9:35am - 9:55am Nov 17
    The NHS is one of the leading health systems in the world. Learn how it is embracing digital health and hear about some of the recent pilots involving cutting edge digital health tools.

    Read more
    

    Indra Joshi 
    Clinical Lead, NHS England
  • 2 
    Digital Ethics to Harness The Value of AI Applications in Healthcare [Keynote]

    9:55am - 10:15am Nov 17
    Data Science provides huge opportunities to improve healthcare, as well as private and public life. Unfortunately, such opportunities are also coupled to significant ethical challenges, involving privacy, trust, transparency, accountability, and responsibility. On the one hand, overlooking ethical issues may prompt negative impact and social rejection. On the other hand, overemphasizing these issues may lead to regulations that are too rigid, and this in turn can cripple the potential of AI in data driven health applications. In this talk, I will focus on Digital Ethics, as the right macroethical framework for harnessing the values of data science in healthcare while respecting human rights and societal values.
    

    Read more
    

    Mariarosaria Taddeo 
    Research Fellow, Oxford Internet Institute
• 10:00am
  •  

    2 
    Meet the Game Changers [Talks and Q&A with Experts ]

    10:15am - 11:45am Nov 17
    Founders and Directors of well established innovative companies talk about their transition from startups to fast-growing businesses. Learn from these game changers’ success stories, discover future strategies and, with the sentiment pointing towards more M&As, will we witness the next major acquisition unfolding before our very eyes? Leading investors will egange the presenters with in-depth conversations to reveal the dynamics of these successful and fast growing companies.
    
    Introduced by: Unity Stoakes
    
    Company Presentations: Antidote, Ayogo Health, HealthLoop, Owlstone Medical, SkinVision. 
    
    Experts: Janke J. Dittmer, Min-Sung Sean Kim, Edward Kliphuis, Mauro Pretolani, Richard Willmot, Francesca Domenech Wuttke.

    Read more
    

    Fredrik Gustafsson 
    CEO and Co-Founder , Arthro

    

    Dick Uyttewaal 
    Chief Executive Officer, SkinVision

    

    Chris Hodkinson 
    VP Business Development, Owlstone Medical

    

    Francesca Domenech Wuttke 
    Managing Director/Investment Principal Europe, MSD Global Health Innovation Fund, LLC

    

    Min-Sung Sean Kim 
    Venture Capitalist, Allianz Ventures, Digital Health

    

    Edward Kliphuis 
    Investment Director, Merck Ventures

    

    Sarah Kerruish 
    Chief Patient Officer, Antidote

    

    Unity Stoakes 
    President, Co-founder, StartUp Health

    

    Richard Wilmot 
    Head of Philips Health Technology Ventures, Philips Ventures

    

    Michael Fergusson 
    CEO, Ayogo Health

    

    Mauro Pretolani 
    Senior Partner, Fondo Italiano d'Investimento SGR SpA 

    

    Janke Dittmer 
    Partner, Gilde Healthcare
• 11:30am
  • 2 
    Roche + MySugr: Health's Digital Future, on Stage, Here and Now!

    11:45am - 12:05pm Nov 17
    Read more
    

    Anton Kittelberger 
    Chief Operating Officer, mySugr

    

    Tim Jürgens 
    VP, Global Head, Roche Diabetes Care New Business Models and Emminens
• 12:00pm
  • Networking Lunch Break

    12:05pm - 1:40pm Nov 17
    Read more
• 1:30pm
  • The Pioppi Protocol + The Mobile Executive

    1:40pm - 2:00pm Nov 17
    Pioppi is a tiny fishing village in the south of Italy that holds the secret to longevity and good health. Local residents often live to over 100 and remain active in their community during their golden and platinum years. In the 1950’s Pioppi became the location of a study on nutrition and longevity by note American Physiologist Ancel Keys, whose work became know worldwide as “The Mediterranean Diet”. Given today's stratospheric rise of metabolic diseases such as diabetes, hypertension and obesity, a team lead by noted British cardiologist Dr. Aseem Malhotra and documentary film maker Donal O’Neill went back to Pioppi to find out what, if anything, might have been missed by Professors Keys in his original assessment. Their work brings us The Pioppi Protocol, an alternative interpretation of the observations from Prof. Keys, and a scientifically informed guide for better nutrition, movement and lifestyle inspired by the habits of the people of Pioppi, and that is already beginning to show promising health results in the people following it. Today the Pioppi Protocol is available in a documentary and book (published by Penguin Books as the Pioppi Diet) and will shortly be launched as a software platform for adoption by insurance companies and wellness programs, along with a clinical study that has been designed to measure its effectiveness.

    Read more
    

    Louise Knoop O’Neill 
    Founder, Prime Movement

    

    Donal O’Neill 
    Documentary Film Maker , The Pioppi Protocol

    

    Aseem Malhorta 
    Cardiologist, The Pioppi Protocol
• 2:00pm
  •  

    3 
    Software as a drug: the dawn of Digital Therapies [Keynote and Panel]

    2:00pm - 3:00pm Nov 17
    More than 150 companies are already working on digital therapeutics, and an increasing number of these are starting to show significant clinical evidence. In addition, several pharma companies have started investing in digital therapeutics companies, and are partnering to distribute digital therapeutics through their sales channels. This is a strong indication that digital therapeutics will be the "3rd wave of medicine". Our panel will discuss the resulting industry transformation, the opportunities for healthcare providers and the pharma industry, and what efforts are underway to define new protocols of care and measures of clinical effectiveness.

    Read more
    

    Pierre Leurent 
    CEO, Voluntis

    

    Anand Iyer 
    Chief Strategy Officer, Welldoc

    

    Marc Sluijs 
    Advisor, digitalhealth.network

    

    Steven Yecies 
    Venture Partner, OrbiMed Advisors

    

    Roberto Ascione 
    CEO, Healthware International

    

    Vincent Hennemand 
    VP of Strategy, Corporate & Business Development, Akili Interactive
• 3:00pm
  • 2 
    Digital Health is a reality. How will Pharma adapt? [Keynote]

    3:00pm - 3:20pm Nov 17
    A new breed of disruptive digital innovators are moving to become the access point for healthcare to millions of patients as health care solutions become more consumer friendly offering convenience, affordability, accessibility, and in many cases better efficacy threatening to undermine the healthcare industry’s decades old model.
    
    Rather than buying a pill, insurers or employers are purchasing entire solutions that embody sensors, mobile phone access, and big data driven intelligent virtual care from companies that have digital competence and the ability to build lasting bonds with consumers.
    
    When upwards of 25% of all health spending including pharmaceuticals are not contributing to positive patient outcomes, how will the pharmaceutical industry move beyond the pill to embrace a “healthware” (healthcare and software) approach to delivering better outcomes, improving access, and lowering costs?

    Read more
    

    Jeff Dachis 
    Founder and CEO, One Drop
  • Privacy and data protection in Digital Health [Keynote]

    3:20pm - 3:40pm Nov 17
    Data about healthcare and biometric data are considered 'sensitive data' under the General Data Protection Regulation of the European Union, which will come into full effect in May 2018. In principle, processing those data is prohibited, though there are exceptions. It is far from sure that smart healthcare applications will be covered by those exceptions. This will have an impact on digital health start-ups and hamper innovation in practice. In addition, the application of the GDPR is determined by the scope of 'personal data', which may include anonymous, aggregated and statistical data - this may have a big impact on the possibility of doing scientific medical research on patient data and biosamples. Although the privacy and data protection framework has not always been adequately enforced, the GDPR will change this - inter alia, it allows for fines running up to 20 million euro's when the rules are not respected. This may happen when there is no explicit informed consent for scientific research using patients health data, not giving patients full control over their own tissues or when there are insufficient safeguards to ensure that the data that are used of patients are correct and up to date. 
    

    Read more
    

    Bart van der Sloot 
    Senior Researcher, Tilburg Institute for Law, Technology and Society (TILT)
• 3:30pm
  • 1 
    E=mc^2 aka Endgame equals MusicMedicine × Convergence squared [Keynote]

    3:40pm - 4:00pm Nov 17
    The rise and adoption of MusicMedicine can be compared to those of Acupuncture, but on a much faster scale! Practitioners of this innovative health practice select specific types of music to address their patients’ different health needs with the same attention as if choosing and prescribing actual medicines. This talk will balance the practical and theoretical aspects of MusicMedicine.

    Read more
    

    Walter Werzowa 
    Founder, MusikVergnuegen, HealthTunes™

    

    Klaus Laczika 
    Doctorate, Medical University of Vienna
• 4:00pm
  • 1 
    Roadmapping the future of Digital Health [Conversation]

    4:00pm - 4:30pm Nov 17
    To wrap-up Frontiers Health 2017 experts from the different corners of the digital health ecosystem will answer fast paced questions to address what a possible roadmap could be for the upcoming year and which priorities are arising on the medium / long term horizon. This will be the final highlight of our program and the seed for the 2018 edition

    Read more
    

    Matthew Holt 
    Co-Chairman, Health 2.0

    

    Min-Sung Sean Kim 
    Venture Capitalist, Allianz Ventures, Digital Health

    

    Marc Sluijs 
    Advisor, digitalhealth.network

    

    Unity Stoakes 
    President, Co-founder, StartUp Health

    

    Kristin Milburn 
    Strategic Partnerships Head, Digital Acceleration Lab, Novartis

    

    Monique Levy 
    SVP, Head of Customer Strategy and Value Delivery, PatientsLikeMe

    

    Roberto Ascione 
    CEO, Healthware International