Friday, December 15, 2017

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.

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."

Monday, December 11, 2017

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.)

Friday, December 8, 2017

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

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. 

Wednesday, December 6, 2017

Foundation Medicine PMA Approval Summary (Product Group PQP)

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
PQPRegistered Establishments With PQP ]

Advisory CommitteePathology

Expedited Review Granted?Yes

Combination ProductNo

Approval Order Statement


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)

Tuesday, December 5, 2017

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; 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 1st 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.

Friday, December 1, 2017

CMS Payments to ASSUREX in CY2015, CY2016

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

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.

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

Thursday, November 30, 2017

Foundation Medicine Draft NCD (Operational Text) 

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 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

Wednesday, November 22, 2017

The 2017 Biosimilar Rule Revision

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


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.

Monday, November 20, 2017

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

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.

Friday, November 17, 2017

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.

Thursday, November 16, 2017

Agenda for Frontiers Health Conference, Berlin, November 2017