Thursday, June 7, 2018

Some Heartflow Document Links

With minimal comment, these are some CMS document links regarding Heartflow as of 6/2018.

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Judicial Proceedings 2016-2017
2016
August 12, 2016 Department Appeals  Board here.
    Sustains determination of MAC that Heartflow could not be enrolled as an IDTF; affirmed by judge.

2017
April 5, 2017 Department Appeals Board here.
    Heartflow appealed the 2016 ruling, and a panel of judges sustained the adverse ruling.
  • For my earlier June 2017 blog (from when Heartflow was still "outside the gates") see here.
  • For hospital outpatient purposes, CMS classified Heartflow as a payable service in November 2017.   For my April 2018 blog, here.   
The remainder of this blog provides access to documentation, screen shots, and links relative to the Heartflow service against different aspects of the CMS policy system.


Category III Code Text (4 codes)
The actual January 2018 new AMA codes 0501T-0504T can be read online here or in Appendix C.

Hospital Outpatient Rulemaking

The hospital outpatient rulemaking regarding these codes (determining they are "payable" in principle, and at what APC in the outpatient setting) was 92 FR 52356, November 13, 2017, hereSee Heartflow's issue at pages 52422-5.

Public Comments Influenced Rule Outcome
There were 3333 public comments on the entire rule (loads slowly).  Click on "comments" and then "show all comments" to get a search box where you can search for comments on 0501T or fractional flow reserve.

I identified 5 comments by fractional flow reserve.  Heartflow's own fall 2017 comment letter is here and is critical to understanding why CMS changed the code status to payable.  A zip file with 4 of the 5 public comments is here.  (Regulations.gov asserted there were 5 comments but one was a download error.  The zip file of 4 comments ncludes the Heartflow detailed legal memorandum and also comments by 3 hospital systems.)

Proposed Rule Merely Flagged Unpayable Status in a Table
The above November rule built on the July proposed rule; see 82 FR 33558, July 20, 2017, hereThere was no actual proposed comment on the Heartflow codes in July; CMS simply listed them in an appendix of new codes with the tabulation, "M" = not payable, not billable (p. 52422 of November rule).   The fact the codes were listed as status "M" was enough to allow CMS to consider the range of comments submitted; see prior paragraph. Note that the rule did not specify why the new AMA codes were nonpayable status "M."  Merely reading the AMA code text alone would have given CMS little data to go on for a coding judgement of that type.

Heartflow Worked with CMS From 2015 to Late 2017
But the comment authors clearly have had meetings with CMS that allowed them to make granular rebuttal to specific points and phrases of Medicare law and policy being asserted by CMS.  In fact, you can glean this from the public record: the FR reveals that Heartflow had applied for an outpatient new technology code more than a year earlier, in March 2016, which was denied by CMS because it was packaged image guidance (p.52423, first column).  Negative arguments from CMS at that time would have been the basis for detailed provider comment to CMS (rebutting CMS positioning) in September 2017.

Heartflow has had numerous publications; for an open access review, Kueh et al. 2017, here.  CMS also cited to the FDA De Novo 510(k) review, November 2013, 15pp, here.

Aside: Comparing ALJ Cases and CMS Outpatient Rulemaking
I won't attempt a full analysis, but in a nutshell.
  • The ALJ cases hinged on Noridian's assertion that FFR was not payable, because all digital analysis for a report was included in the base CT code 75574.  And lacking a payable service on offer, Heartflow could not be enrolled as an IDTF with Medicare, although it could get an NPI number classed as IDTF by the NPI enumeration system.
  • The hospital policy case began with the CMS assertion that (whether or not FFR was bundled inside CPT code 75574 in Part B), all digital analysis would be bundled inside one CPT that contained both 75574 and FFR 0501T, and that this must occur due to a written regulation 42 CFR 419.2(b)(13).   See regulation clipped as: Appendix D.


Billing for 0501T-0504T Today?

In regular Part B, these would be contractor priced PCT codes (when not done in the hospital setting, where they are APC priced codes).   Local contractors might or might not view the service as medically necessary and payable even after being classed in a (potentially payable) status in an APC by CMS.   One person familiar with CMS claims rules suggested that if the underlying CT was done in a hospital setting, then any associated claim (such as physician interpretation with a -26 modifier or a standalone supplemental interpretation such as FFR) could be billable with a hospital place of service status, and be a "service of the hospital" billed by the hospital to CMS even if under a subcontractor to an off campus digital service center.   (For these instructions, see Claims Manual, 100-04, Chapter 26:10.5). 

For hospital outpatient centers, CMS's final code statuses (Table 19, page 52425) are "M" not payable for 0501T and 0504T, N not payable for 0502T, and payable directly as APC 1516 for 0503T.  Appendix E.

For regular Part B, CMS classified AMA CPT codes 0501T-0504T as all equally status C, carrier priced, here.  None are status N not payable nor status B bundled.  It's not clear to me if all MACs view all codes as payable (e.g. 0502T data transmission might be considered overhead by some MAC; just speculating.)

Local MAC Documents on the Web

(1) Noridian Non Coverage Code Article Shows Heartflow Codes as of June 2018
As of 6/7/2018, 0501T-0504T are listed as non covered in a Noridian Non Coverage Cat III Code Article, revised 5/24/2018, A55681.  Here.  In this article, see its Group 1 codes for 0501T.

(2) Noridian Guidelines for IDTF Physicians and Staff: Do not provide Heartflow Codes as of June 2018
To my eye, Noridian would list the physician and technician IDTF requirements for the Heartflow Cat III CPT codes online here, but they don't appear to be listed as an IDTF service as of 6/2018.  It's the lack of IDTF instructions for 050XT that are interesting.

(3) Another MAC: NGS MAC (for other states) Lists Heartflow as Covered as of 1/1/2018
A different MAC - NGS - which has some upper midwestern as well as northeastern states - has an LCD for cardiac computed tomography that explicitly DOES cover the Heartflow codes.
As of 6/7/2018, 0501T is listed as COVERED in Cardiac Computed Tomography NGS LCD L33559, revised 1/1/2018. Here "Rev3: LCD revised to add coverage for CPT codes 0501T-0504T (Fractional Flow Reserve) effective for dates of service on or after January 1, 2018. Sources reviewed for this coverage were added to Sources of Information."

This NGS LCD L33559 would not apparently govern the geography where the Heartflow enbtity is located, in the SF Bay Area.   However, as a digital company it might be able to set up multiple sites of service (I don't know.)  For example, Irhythm has locations in California, Illinois, and Texas.

Fun With FDA (LOL)

I had a fun moment looking through Heartflow's 510(k) update, K161772.   They changed their indication in a minor way, from being "post processing software" (which CMS doesn't pay for!) to being "coronary physiologic simulation" software.  Wild!  Here.




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Expired Heartflow Job Application (Health Economics & IDTF Management) here.
    Text archived below as Appendix A.

Heartflow NPI Listing (npidb.org) here.
    Text archived below as Appendix B.
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Appendix A

Job Detail for Director of Health Economics and Reimbursement
Job Location: HeartFlow, Redwood City, CA, 94061, USA

Job Description: The Director of Health Economics and Reimbursement is responsible for all strategic and tactical elements of the process to acquire coding, coverage, and payment for HeartFlow's products and services in the U.S. This includes direct interactions with payors, providers, professional societies, and other advocates. The Director of Health Economics and Reimbursement will also help manage ongoing reimbursement efforts outside of the U.S., including Europe, Australia, and Asia. Job Responsibilities: Design and execute strategies with professional society / CMS / AMA to secure coding for HeartFlow's products. Work with senior leadership and other appropriate individuals from private and government payers and providers, in the US, to secure coverage and payment. Design and deliver communication vehicles for the economic value proposition for HeartFlow's products. Tasks may include refining economic models and value dossiers that can be used in discussions with payers. Create health economic analyses that can be translated into useful tools to be used by the commercial organization. Educate cross-functional teams including sales, marketing and technology groups on health economic and reimbursement related items that pertain specifically to HeartFlow objectives. Execute approval process for establishing HeartFlow as an IDTF. Advise product development teams on design and clinical attributes seen through a reimbursement lens. Estimated global travel of 20%

Skills Requirements Outstanding communication skills with demonstrated success in leading a cross-functional team in the development and execution of strategies for acquiring coding, coverage, and payment for new healthcare technologies. Strong team leadership skills for cross functional project groups. Ability to work with product development teams with demonstrated success in identifying features and evidence requirements to support eventual reimbursement for products in development. Ability to lead development and presentation of models that demonstrate the clinical and economic impact of adopting and/or reimbursing new medical technologies. Educational

Requirements & Work Experience: 5+ years demonstrated success in the area of health economics and reimbursement for medical devices, diagnostics, or pharmaceuticals, with strong connections to decision-making individuals and stakeholders in U.S. private and government payer organizations.

Prior experience establishing / managing IDTFs is a plus as well as experience in outcomes research.

Bachelor's degree required. Master's preferred Additional experience in non-US markets preferred.

About HeartFlow HeartFlow is an exciting, revolutionary, VC-backed, medical device software start-up in Redwood City that has received international recognition for reaching exceptional strides in healthcare innovation. We are dedicated to changing cardiovascular healthcare through improvement in the accuracy of non-invasive diagnostic imaging. HeartFlow operates a service business that processes Computed Tomographic (CT) imaging to generate 3D models of patients' coronary arteries for physicians' use. HeartFlow is a Pre-IPO company and received FDA clearance in 2014.

www.heartflow.com      HeartFlow, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.


Appendix B

HEARTFLOW, INC.
Physiological Laboratory, (Independent Physiological Lab)
A laboratory that operates independently of a hospital and physician's office to furnish physiological diagnostic services (e.g. EEG?s , EKG?s, scans, etc.).





The above screenshots show that Heartflow (June 2018) is identified with an NPI number which is classified as IDTF for the purposes of issuing an NPI.  It does not additionally say that Heartflow is currently enrolled in Medicare or not.  (For example, as a doctor, I could have an IDTF as a physician but not be enrolled as a Medicare provider).   I have no information whether Heartflow is enrolled in Medicare (or not) and I just don't currently know where to find out.  (Medicare enrollment status is easier to find out for an MD or for a Hospital). 

An Independent Diagnostic Testing Facility is an entity that can enroll in Medicare, provide services to patients, and get paid. (To enroll in Medicare you have to be an entity legally recognized by it, such as "hospital" or "doctor" or "ambulance service" or "IDTF.")  The rules are pretty complicated (for samples see here and here and here).




Appendix C


The new HeartFlow FFRct CPT codes will become effective on January 1, 2018. They include:

0501T — Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to assess the severity of coronary artery disease;
     data preparation and transmission, analysis of fluid dynamics and simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report

0502T — Data preparation and transmission

0503T — Analysis of fluid dynamics and simulated maximal coronary hyperemia, and generation of estimated FFR model

0504T — Anatomical data review in comparison with estimated FFR model to reconcile discordant data, interpretation and report

For more detail about the CPT codeset, see here.

Appendix D

https://ecfr.io/Title-42/se42.3.419_12
42 CFR 419.12(b)
(b) Determination of hospital outpatient prospective payment rates: Packaged costs. The prospective payment system establishes a national payment rate, standardized for geographic wage differences, that includes operating and capital-related costs that are integral, ancillary, supportive, dependent, or adjunctive to performing a procedure or furnishing a service on an outpatient basis. In general, these packaged costs may include, but are not limited to, the following items and services, the payment for which are packaged or conditionally packaged into the payment for the related procedures or services.
(13) Image guidance, processing, supervision, and interpretation services.


Appendix E
CMS OPPS Rule, November 2017, Table 19


click to enlarge

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Author local files as
2017 CMS 0405 Heartflow DAB Denial 25pp.pdf
2016 CMS 0812 Heartflow DAB Denial 4p.pdf
2018 Noridian 0607 Heartflow Code Explanation re CAT III LCD.pdf


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