Wednesday, June 13, 2018

A Few Resources on Antibiotic Incentives Policy

Referring blog here, based on a policy release by Gottlieb/FDA.


Undated

DRIVE AB: Incentives...23pp...here. See also:   http://drive-ab.eu/ 

2014
Innovation of novel antibiotics: Economic perspective.  McKellar & Fendrick, Clin Infect Dis (open access), here.

2015
Time for a change...addressing R&D and commercialization challenges... Phil Trans Roy Soc Lond (open access), Payne et al., here.
Novel approaches are needed...Am J Resp Crit Care Med, Spellberg et al., (open access) here.
Antibiotic R&D: Business as usual?  J Antimic Chemother, Harbarth, here.

2016
For a 2016 G7 incentives declaration, Ise-Shima Summit, 32pp, here.

Book:
Superbugs, Harvard Univ Press, here, authors: Hall, McDonnell, O'Neill.
   Review, Jerome Groopman MD, at NY Rev Books, June 2018here.

Funding antibiotic innovation with vouchers... Outterson & McDonnell, Health Affairs, here.
   Outterson directs CARB-X, funded by BARDA.

Critical review of (European/British Infectious Disease Financing Facility, IDFF)...Global Health, Brogan & Mossialos, here.

Systems, not pills: Options market...pipeline.   Soc Sci Med, Brogan & Mossialos, here.

Systematic review and critical assessment...J Antibiot (Tok), Renwick et al., (open access), here.

Economic incentives...Transatlantic task force (TATFAR)...Clin Infect Dis, Sciarretta et al., open access, here.

2017
Incentivising innovation in antibiotic drug discovery...Simpkin, J Antibiotics (open access), here.

The antibiotic pipeline: Revising R&D...Exp Rev Anti Infect Ther, Luepke & Mohr, here.

Past, present future of antibacterial economics...Pharmacotherapy, Luepke et al., here.

Antibiotic innovation for future public health needs...Clin Micro Infect, Theuretzbacher, here.

September 2017 
PAC CARB report on incentives including antibiotics, vaccines. 80pp,  here.

2018
January 2018
New study, specter of more bugs resistant to last-line antibiotics, WSJ, here.

February 2018
"Drug Makers Lobby for Antibiotic Incentives," STAT PLUS, here.

For a 23 page FDA white paperhere.
  Required by FDASIA 2012, S. 805.  (See Title VIII, S. 801-806)).
  February 2018:  https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm595264.htm

April 2018
Vital Signs: Containment of novel multi drug resistant organisms.  (CDC) Morbidity Mortality Weekly, 67(13), April 6, 2018.  Here.

June 2018
FDA on:  new paradigms for antibiotic payments. Here.

Medicare's June 11, 2018 Posting on Smartphones & CGS

https://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center.html


Posted June 11, 2018, captured June 13, 2018.


Durable Medical Equipment (DME) Center

Announcement of Important Changes Impacting Medicare Coverage of Continuous Glucose Monitors

Based on input from patients and other stakeholders, The Centers for Medicare & Medicaid Services (CMS) is announcing important changes in its written policies regarding how Medicare covers continuous glucose monitors (CGMs). These changes are consistent with the Agency’s approach of putting patients first and incentivizing innovation and use of e-technology.
CGMs are items of durable medical equipment (DME) that provide critical information on blood glucose levels to help patients with diabetes manage their disease. In January 2017, CMS issued a ruling providing for Medicare coverage of therapeutic CGMs. The ruling was followed by a policy article issued by the Durable Medical Equipment Medicare Administrative Contractors on March 23, 2017 to provide coverage guidance for these devices.
CMS heard from numerous stakeholders who shared their concerns that Medicare’s CGM coverage policy limited their use of CGMs in conjunction with their smartphones, preventing them from sharing data with family members, physicians, and caregivers.
After a thorough review of the law and our regulations, CMS is announcing that Medicare’s published coverage policy for CGMs will be modified to support the use of CGMs in conjunction with a smartphone, including the important data sharing function they provide for patients and their families.
The Durable Medical Equipment Medicare Administrative Contractors will issue a revised policy article in the near future, at which time the published change will be effective.

Establishment of Medicare Fees for Newly Covered Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)

For newly covered items of DMEPOS paid on a fee schedule basis where a Medicare fee does not exist, the Centers for Medicare & Medicaid Services (CMS) uses a process to establish fees called gap-filling. This allows Medicare to establish a price that aligns with the statutory requirements for the DMEPOS fee schedule..........

Medicare's March 2017 Article on Smartphone Use with CGM

https://med.noridianmedicare.com/web/jadme/policies/dmd-articles/coding-and-coverage-therapeutic-continuous-glucose-monitors


Coding and Coverage - Therapeutic Continuous Glucose Monitors (CGM)

Joint DME MAC Article
Posted on March 23, 2017
On December 20, 2016 the Food & Drug Administration (FDA) granted premarket approval to Dexcom, Inc. for an expanded indication for their Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System.  The Dexcom G5® Mobile CGM System is now indicated to replace fingerstick blood glucose monitor (BGM) testing for diabetes treatment decisions, referred to by the FDA as "non-adjunctive" use. The Dexcom G5® Mobile CGM System is currently the only FDA-approved device with a "non-adjunctive" indication.
On January 12, 2017 the Centers for Medicare & Medicaid Services (CMS) issued CMS Ruling 1682R addressing the benefit category for non-adjunctive CGM systems.  CMS Ruling 1682R classified CGM systems into therapeutic and non-therapeutic systems.  Therapeutic CGM are defined as CGM used as a replacement for fingerstick blood glucose testing for diabetes treatment decisions i.e., non-adjunctive use.  Non-therapeutic CGM are devices used as an adjunct to BGM testing (i.e., primary therapeutic decisions regarding diabetes treatment must be made with a standard home BGM, not the CGM).
The Ruling does not directly establish Social Security Act §1862(a)(1)(A) "reasonable and necessary" (medical necessity) or HCPCS coding requirements for therapeutic CGM but instructs the DME MAC contractors to make payment determinations on a claim-by-claim basis.  This article provides interim instructions for individual claim adjudication, effective for claims with dates of service on or after January 12, 2017.
Benefit Category
CMS Ruling 1862R recognizes that therapeutic CGMs are durable medical equipment (DME) under section 1861(n) of the Act; therefore, they fall within the scope of Medicare Part B benefits. As of the publication date of this article, the Dexcom G5® Mobile CGM System is the only device which meets the therapeutic CGM device classification established by CMS Ruling 1862R.  Refer to the Pricing, Data Analysis, and Coding (PDAC) contractor for information concerning which other devices may qualify under this ruling.
Interim Instructions for Individual Claim Adjudication
HCPCS Coding
For purposes of Medicare billing, the Ruling outlines therapeutic CGM as comprising two elements: (1) a DMEcomponent and, (2) an all-inclusive supply allowance.   The DME component for the Dexcom G5® Mobile CGM system is the receiver.  The receiver must be billed using the following code:
  • E1399 - DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS
When billing this code, suppliers must enter "Dexcom G5® Receiver" in the narrative field of the claim.
The supply allowance for supplies used with the Dexcom G5® Mobile CGM System encompasses all itemsnecessary for the use of the device and includes, but is not limited to:  CGM sensor, CGM transmitter, home blood glucose monitor and related BGM supplies (test strips, lancets, lancing device, and calibration solutions) and all batteries. The supply allowance must be billed using the following code:
  • A9999 – DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS SUPPLY
Claims for A9999 must be billed as one (1) unit of service per month.  When billing this code, suppliers must enter "Supplies used with Dexcom G5® Receiver" in the narrative field on the claim.
Smart Device Usage
The Medicare DME Benefit excludes coverage for non-medical items, even when the items may be used to serve a medical purpose.  As a result, smart devices (smart phones, tablets, personal computers, etc.) are non-covered by Medicare under this exclusion.  Likewise, medical supplies used with non-covered equipment are not eligible for Medicare reimbursement.
In addition to the DME receiver included in the Dexcom G5® Mobile CGM System, an alternative option for displaying the received data is with a smart device using the Dexcom G5® app and a beneficiary-owned smart device such as a smart phone or tablet.   Medicare does not cover a beneficiary-owned smart device.  Claims for beneficiary-owned smart devices submitted to Medicare must be coded:
  • A9270 - NONCOVERED ITEM OR SERVICE
Miscellaneous
Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers who provide the Dexcom G5®Mobile CGM System are reminded of the following Medicare coverage policies:
  • Coverage of the CGM system supply allowance is limited to those therapeutic CGM systems where the beneficiary ONLY uses a receiver classified as DME to display glucose data.  
  • If a beneficiary uses a non-DMEdevice (smart phone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the supply allowance is non-covered by Medicare. 
  • Therapeutic CGM devices replace a standard home blood glucose monitor (HCPCS codes E0607, E2100, E2101) and related supplies (HCPCS codes A4233-A4236, A4244-A4247, A4250, A4253, A4255-A4259).  Claims for standard home glucose monitors and all related supplies, billed in addition to a CGM system and associated supply allowance, will be denied as unbundling.
All non-therapeutic CGM systems must be billed with the existing CGM-related HCPCS codes.  At this time, all CGM systems except the Dexcom G5® Mobile CGM System are classified by CMS as non-therapeutic CGM systems. All non-therapeutic CGM systems must be billed using the following codes: 
  • A9276 - SENSOR; INVASIVE (E.G., SUBCUTANEOUS), DISPOSABLE, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM, ONE UNIT = 1 DAY SUPPLY
  • A9277 - TRANSMITTER; EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM
  • A9278 - RECEIVER (MONITOR); EXTERNAL, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM
These codes are non-covered by Medicare (no benefit).
Beneficiary-owned Equipment Retained From a Prior Payer
There is no "grandfathering" of equipment or supplies/accessories for CGM systems obtained prior to Medicare eligibility.  When a beneficiary receiving a DMEPOS item from another payer (including a Medicare Advantage plan) becomes eligible for the Medicare Fee-For-Service program, the first Medicare claim for that item or service is considered a new initial Medicare claim. Even if there is no change in the beneficiary's medical condition, the beneficiary must meet all coverage, coding and documentation requirements for the DMEPOS item in effect on the date of service of the initial Medicare claim. 
Medicare requires that supplies and accessories only be provided for equipment that meets the existing coverage criteria for the base item. In addition, should the supply or accessory have additional, separate criteria, these must also be met.  For beneficiaries that have a Dexcom G5® Mobile CGM System who meet the coverage requirements outlined in this article, Medicare will provide reimbursement for the monthly supply allowance. 
In the event of a Medicare contractor claim review, suppliers must provide information justifying the medical necessity for the base item and the supplies and/or accessories. Refer to the coverage guidance in this article for additional information.
Patient Selection Criteria
A framework for basic medical indications is set out in the "Conclusion" section of CMS Ruling 1682R which states (in relevant part):
CONCLUSION
For CGM products that are used in the home and approved by the FDA for use in place of a blood glucose monitor for making diabetes treatment decisions, these therapeutic CGMs are primarily and customarily used to serve a medical purpose because they are used by Medicare beneficiaries with diabetes who must measure their glucose level frequently and check trends in their glucose measurements for the purpose of adjusting their diet and insulin in the treatment of their diabetes.  ...  A receiver (or type of monitor) for a therapeutic CGM that has an expected life of at least 3 years and is the component performing the medically necessary function of accurately monitoring the trends of the patients' blood glucose levels so that he or she can make necessary diabetes treatment decisions meets the 3-year MLR [minimum lifetime requirements].  [Emphasis added]
These statements provide a framework for determining which Medicare beneficiaries may receive a CGM device.  A therapeutic CGM may be covered by Medicare when all of the following criteria are met:
  • The beneficiary has diabetes mellitus; and,
  • The beneficiary has been using a home blood glucose monitor (BGM) and performing frequent (four or more times a day) BGM testing; and,
  • The beneficiary is insulin-treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
  • The beneficiary's insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results.
Glucose Monitors LCD and related PA Revision
The Glucose Monitors Local Coverage Determination (LCD) and related Policy Article (PA) will be updated in a future revision to incorporate the criteria outlined above.  Policy-Specific Documentation Requirements and Coding Guidelines addressing CGM systems will also be added to the Glucose Monitors LCD-related PA.  Because CMS did not provide coverage for CGM prior to the Ruling, the Glucose Monitors LCD and related PA represents a liberalization of coverage.  Therefore, when the revised LCD is published, per the CMS Program Integrity Manual(Internet-Only Manual 100-08), Chapter 13, §13.7.3, no formal comment and notice period or public meeting is required. 
The Program Integrity Manual section states, in relevant part:
13.7.3 - LCDs That Do Not Require a Comment and Notice Period
When a comment and notice period is unnecessary, contractors may immediately publish a revised LCDelectronically (e.g., Medicare coverage database, contractor Web site, email).  In the following situations, the comment and notice processes are unnecessary:
  • Revised LCD that Liberalizes an Existing LCD - For example, a revised LCD expands the list of covered indications/diagnoses. The revision effective date may be retroactive.
  • Revised LCD that Makes a Non-discretionary Coverage/Payment/Coding Updates - Contractors shall update LCDs to reflect changes in NCDs, coverage provisions in interpretive manuals, payment systems, HCPCSICD-9 or other standard coding systems within the timeframes listed in §13.4C. The revision effective date may be retroactive depending on the effective date of the NCD, etc.
The Glucose Monitors LCD and related PA revisions will be retroactive to the effective date of the CMS Ruling (January 12, 2017). 
For questions about correct coding, contact the Pricing, Data Analysis and Coding (PDAC) contractor Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail questions to the PDAC by completing the DME PDAC Contact Form.
Last Updated Mar 22, 2017

Thursday, June 7, 2018

Some Heartflow Document Links

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

___

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.




___

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.
__


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

__
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


Sunday, May 27, 2018

Elizabeth Holmes July 2015 WSJ Op Ed Supporting FDA Review of All Lab Tests

https://www.wsj.com/articles/how-to-usher-in-a-new-era-of-preventive-health-care-1438125343


How to Usher In a New Era of Preventive Health Care
People should be able to get any lab test on their own. Waiting for symptoms and a doctor’s order may be too late.



Laboratory tests drive 70% of all clinical decisions in health care. They’re used to determine whether a patient should start taking medication and, if so, which one. They help doctors decide whether a patient should undergo medical procedures or be admitted to the hospital. And they’re used to identify an individual’s risk of developing health conditions such as diabetes or heart disease.

Yet many of us get lab tests only when we’re showing symptoms, which means we may already be sick. And too many of us find out we’re sick when it’s too late to change the course of these conditions.

It’s time to move away from reactive health care. Individuals instead need to be empowered to be proactive, take control of their own health, and work with physicians to detect diseases early or before they take hold. This empowerment will usher in a new era of preventive health care. There are several steps that can help us get there:

All lab tests should undergo review by the Food and Drug Administration. Given the pivotal role of labs in medicine, consumers need to trust the quality and accuracy of the tests they get. The FDA sets the gold standard for quality assurance. Its review is data-driven, objective and uniquely rigorous.

I know this firsthand because Theranos, the company I founded, voluntarily committed to submit all of its lab tests for review starting in 2013. On July 2, the FDA cleared the first of those tests, for herpes simplex virus 1, and the associated finger-stick blood-test technology and underlying system on which our tests are run.

The review included an examination of the company’s systems, methods, chemistry, hardware and software. The FDA scrutinized everything from our collection devices to our analytics. It analyzed study data from more than 800 subjects and assessed our test and test system’s performance outside of clinical laboratories when subjected to a broad range of environmental influences.

This oversight should be the norm. It isn’t. Traditional medical-device manufacturers must submit their lab tests to FDA for review before selling their products. Laboratories that make their own tests aren't required to do so.

The FDA recently proposed requiring laboratories to submit their tests for review. The proposal should be adopted. And Congress should provide the agency with the funds to exercise this oversight.

Innovation needs to be unleashed. The improvements that technology and innovation could bring to health care are limited only by the imagination. But the technological progress that brought us the personal computer, the smartphone, the car was powered by consumer choice and free access to information in the market. That will be true in health care as well.

Our data shows that at least 40% of people today don’t get a lab test when a physician orders it for them, often because the patient can’t afford it. No one should have to forgo care because he can’t afford to get a lab test or can’t figure out how much it costs ahead of time.

Empowering individuals to engage in their own health, including through ordering their own lab tests, means the prices of these services will increasingly become transparent. Transparent pricing and consumer engagement allow markets to function, driving competition and innovation for higher-quality and lower-cost services.

This isn’t just an issue for consumers. Federal and state governments pay tens of billions for lab tests through Medicare and Medicaid. Reducing their costs through competition and innovation will pay big benefits for taxpayers. Accessible testing including at lower cost will also help shift the health-care paradigm to early detection and prevention.

Diagnostic information needs to be more accessible. Getting lab tests today typically requires a doctor’s order, determining insurance eligibility, sometimes multiple appointments, time off from work, and waiting for the results to come back.

Technological breakthroughs can go a long way toward removing some of these barriers. An example: On July 15 the FDA approved a waiver that allows Theranos to run its herpes simplex virus 1 test at its retail Wellness Centers, where samples can be analyzed on the spot instead of being shipped to a centralized facility, and results reported quickly.

Convenience also matters. the more accessible care locations become, and the longer hours they are open, the better people can take control of their own health.

Finally, public policy has an important role to play in furthering the goal of patient-centered health care. I recently worked with leaders in Arizona to pass a state law that allows individuals to order and pay for any laboratory test without having to justify a health concern or rely on insurance eligibility. The law also provides protections for physicians so they can work with patients in a preventive manner around direct-access tests. Individuals across the country should have the same freedom.

You have a fundamental right to access information about your own health. And you should be able to access that information when it matters most—when there is still time to change your life, and the lives of those you love, for the better.

The answers to our challenges in health care lie in the individual. By empowering individuals to engage in their own health, we can build a preventive care system in America—and a world in which fewer people have to say goodbye too soon.

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Ms. Holmes is the founder and CEO of Theranos, a consumer health-technology and medical-laboratory-services company.



Carreyou Screen Shots: Tampa Visit to Mattis

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Saturday, May 26, 2018

Carreyou Book Screen Shots: FDA Internal Documents

Supporting:
http://www.discoveriesinhealthpolicy.com/2018/05/did-fda-inappropriately-leak-pre-public.html

Bad Blood, John Carreyou, May 2018, Kindle edition.  Click to enlarge.


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