Thursday, August 30, 2018

MolDx Retires Special Coding, Pricing for Biofire FilmArray GI Panel

As of August 2018, MolDx was still running a "provider alert" that in March 2018, it was retiring its article on the Biofire FilmArray GI panel.

I'm guessing the article was similar to a MolDx article on Biofire GI coding and billing that was still available in August on the CGS MAC website.  Note the publication date is the beginning of 20016 (January 9, 2006). 

I've clipped a cut/paste of the article below and put a web version of the article in the cloud here.

According to the Biofire website, at least as of 2017 coding, the GI test panel would be coding as 87507 and CMS priced at $571.72.   The PAMA target price for this panel is $300, so it is falling 10% a year toward $300 (2018 price at $463).

Biofire GI Coding for 2017 (released 082016)

It looks to me like Medicare paid $12.7M for 87507 in CY2016, per public CMS data at the lab (or doctor) level, for about 28,000 tests.   Test volume was highly unevenly distributed, with "RK" in Memphis being credited with 5,845 tests and  Diatherix in Alabama with 8,954.  These two providers were near half of total volume (of 109 billing entities.)   See the full 2016 data in the CMS cloud here.

Virtually all providers providers billed CMS greater than the CMS fee schedule of about $567.   However, Diatherix, just mentioned, billed $299.  Puzzlingly, Labcorp billed $781 but was paid $267.   Diagnostic Reference Group and Piedmont Pathology also charged well above Medicare's rate but were paid $230-260 per test.   (These billing records have stumped the expert).  Labcorp and Piedmont are in NC, a MolDx state.    Only these two labs and one other (in GA) were substantially underpaid, both below the fee schedule AND below charge.

It's hard to know what MolDx paid for the Biofire test because it had the test recoded as 87999, as shown below.  HOWEVER, it appears that MolDx was paying for 87507 in some MolDx states (e.g. see for Genesis Molecular in Torrance, CA, 2,347 cases) without voiding 87507 or requiring recoding as 87999.   (Note, though, that the article is specific for Biofire trademark product but the AMA CPT code 87507 is not, and the code service could be replicated with LDT probes without triggering the instructions of the Biofire article). 

Cut Paste of CGS Biofire Article (2016 article, captured 20180830).

January 9, 2016

MolDX: BioFire Gastrointestinal (GI) Panel Coding and Billing Guidelines (CM00099)

The BioFire FilmArray GI Panel is a 510(k)-cleared in vitro diagnostic (IVD) test capable of simultaneous detection and identification of nucleic acids from multiple bacteria (n=13), viruses (n=5), parasites (n=4), directly from stool samples collected in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal (GI) infection. The FilmArray GI Panel is indicated as an aid in the diagnosis of specific agents of GI illness, and is used in conjunction with other clinical and laboratory data.

The FilmArray reagent pouch stores all the necessary reagents for sample preparation, reverse transcription, PCR and detection for 22 targets in a freeze-dried format. Hydration solution is added and combined with sample buffer in the FilmArray Pouch requiring 2 minutes of hands-on time, and approximately 1 hour for specimen analysis on a desk-top FilmArray instrument.

Laboratory testing for infectious causes of diarrhea are generally not indicated when the diarrhea is community acquired and of less than 7 days duration, and without signs or risk factors for severe disease such as fever, bloody diarrhea, dysentery, dehydration, severe abdominal pain, hospitalization and/or immunocompromised state. Laboratory testing for an infectious etiology of diarrhea may be indicated in community-acquired diarrhea of ≥ 7 days duration or travel-related diarrhea or diarrhea with signs or risk factors for severe disease.1

Although MolDx recently published an article addressing panel testing with a large number of targets as "screening and not a Medicare benefit", the FilmArray GI panel is a closed system that does not allow random access for selection of specific targets that are appropriate for an individual based on signs and symptoms. As such, the BioFire FilmArray GI Panel is a covered Medicare benefit. As with any test, providers must document that utilization is reasonable and medically necessary.

Each laboratory billing Medicare must register the FilmArray GI Panel with the McKesson Diagnostics ExchangeExternal Website to obtain a DEX Z-Code™ identifier. Until February 1, 2017, claims may enter 'BioFire GI' in the claim line comment/narrative field. Effective February 1, 2017 claims submitted without the DEX Z-Code™ identifier will reject.

To bill Part B for the FilmArray GI Panel services, please provide the following claim information:
  • Effective immediately: CPT code 87999 – Unlisted microbiology procedure
  • Enter the assigned DEX Z-Code™ identifier or 'BioFire GI' in the comment/narrative field for the following claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P electronic claim
    • Submit assigned DEX Z-Code™ identifier on an attachment to the claim form for paper claim
  • Select the appropriate ICD-10-CM diagnosis
To bill Part A for the FilmArray GI Panel services, please provide the following claim information:
  • Effective immediately: CPT code 87999 – Unlisted microbiology procedure
  • Enter either the assigned DEX Z-Code™ identifier or enter 'BioFire GI' in the narrative field for the following claim field/types:
    • Block 80 for the UB04 claim form
    • Line SV202-7 for the 837I electronic claim
  • Select the appropriate ICD-10-CM diagnosis
1. Riddle MS, DuPont, HL, Connor BA. ACG Clinical Guideline: Diagnosis, treatment, and Prevention of acute diarrheal infections in adults. Am J Gastroenterol 2016;111:602-22.

Sunday, August 26, 2018

Senate Finance Bill Zeroes in on Entities CMS Pays That Also Do Exomes & Genomes in China, Russia

In mid August, the Senate passed a 340 page bill related to Department of Defense, NIH, and CMS funding.   If you read to page 277, there is a section regarding CMS payments to entities that do exome and genome funding in China.

Full Bill

Page 277-278

 SEC. 251. Not later than 90 days after the enactment
24 of this Act, the Secretary of Health and Human Services
25 shall submit a report to the Committee on Appropriations
and the Committee on Finance of the Senate and the Com-

2 mittee on Appropriations and the Committee on Ways and
3 Means of the House of Representatives, detailing the cir-
4 cumstances in which the Centers for Medicare & Medicaid 
5 Services may be providing Medicare or Medicaid payments 
6 to, or otherwise funding, entities that process genome or 
7 exome data in the People’s Republic of China or the Rus-
8 sian Federation. The report shall outline the extent to which
9 payments or other funding have been provided to such enti-
10 ties over the past 5 years, including amounts paid to each
11 entity, the implications of such payments, including
12 vulnerabilities, and specific recommendations on steps to
13 ensure that payments are lawful and appropriate in the
14 future. In developing the report, the Secretary shall also co-
15 ordinate with other relevant agencies, as determined by the
16 Secretary, to examine the potential effect of allowing bene-
17 ficiaries’ genome or exome data to be processed in the Peo-
18 ple’s Republic of China or the Russian Federation on
19 United States national security, United States intellectual
20 property protections, HIPAA privacy protections, future
21 biomedical development capabilities and competitiveness,
22 and global competitiveness for United States laboratories.

Sunday, August 19, 2018

Precision Medicine for Hospital CEO's (9/2018)

Note interesting links both for Ebriefings and Agenda.

Agenda includes the CEO and Dean of Vanderbilt University Medical Center on "What we've achieved, what's next."  SVP and CCO of Illumina on "Future of Genomics in Clinical Care."  Vanderbilt professor on Big Data to support hospital precision medicine.  Univ. Florida faculty on pharmacogenomics.  Zucker School of Medicine faculty on precision medicine in primary care settings.  Univ. Washington/Seattle on labs, patients, physicians, payers.   Sonic Healthcare lab, Austin, on diabetes and healthcare improvement data.  Chief Medical Officer of Genome Medical on what's changing in physician use.  Genomics in pediatrics by Rady Children's Hospital (big program in newborn critically ill WGS).  President of CQuentia on data, pharmacogenomics, Rx management.  Geisinger on that institution's approach to genomics and population health.  Moffitt on genomics in a cancer center.  Vanderbilt on data and clinician tools for access.  TriCore Lab, Albuquerque, on the lab's role.

Ebriefings cut/pasted below.


NIH Enlists Mayo Clinic, Dozens of Health Networks and Hospitals to Gather Genetic Data in a Billion-Dollar Program

August 16, 2018
Prominent health networks/hospitals participate in NIH genetic research supported by more than one billion dollars in funding from the federal government…

Ongoing Growth in Consumer Genetic Testing Pressures Hospitals, Healthcare Networks to Educate and Prepare Physicians

August 14, 2018
Ongoing growth in consumer genetic testing pressures hospitals and healthcare networks to educate and prepare their primary care physicians for informed patients…

Syapse Creates Precision Medicine Council That Quickly Attracted 200 of the Biggest Hospitals and Health Networks as Members

August 8, 2018
Syapse of San Francisco has created a precision medicine council that quickly attracted 200 of the biggest hospitals and health networks as members…

When Ramping Up Genomic Programs, Health Network/Hospital CEOs and Executives Must Consider Emerging Technologies, Swiftly Rising Consumer Demand

August 6, 2018
Hospitals and healthcare systems increasingly using genomic profiling must integrate it into all facets of care delivery, not just add it to patients’ EHRs…

Hospitals and Health Networks Gearing Up for Precision Medicine Must Make Tough Choices on Hiring Knowledgeable Physicians and Suppliers

August 1, 2018
When a health network CEO considers how to introduce a precision medicine service into clinical care, the up-front costs can be substantial, but the potential rewards are significant …

English Hospitals Will Be First In UK to Offer Routine Precision Medicine, Genomic Sequencing

July 16, 2018
When it comes to precision medicine, health networks and hospitals in the United States are rolling out routine genetic sequencing in a piecemeal fashion. Most prominently, Geisinger Health system in Pennsylvania announced it would begin routinely performing the service on all of its patients starting this month…

Example E Briefing

When Ramping Up Genomic Programs, Health Network/Hospital CEOs and Executives Must Consider Emerging Technologies, Swiftly Rising Consumer Demand

Patients will soon know much more about their genome—and they expect their hospitals and physicians will have precision medicine programs that know what to do with it
There’s an interesting challenge coming to the CEOs and senior administrators at the nation’s health networks and hospitals. Consumers increasingly are more knowledgeable about how their personal geneticsshape their health than their physicians and caregivers. It is a trend that requires every institution to have a strategy in place to serve the needs of these informed patients.
The stakes are high because precision medicine promises to deliver personalized treatments tailored to each patient. As hospitals and healthcare systems move toward the use of genomic profiling in everyday delivery of care, embedding such data into patient electronic health records(EHRs) should only be a preliminary goal; it must be integrated into all facets of care delivery. Executives should also be keenly attuned to how patients will understand what their genetic information contains, and what services they may demand.
Some large providers have already recognized the need for routine genomic profiling. Geisinger Health System announced in May that it would fold genomic profiling into its routine care. It will treat a patient’s genomic profile as something akin to a mammogram or cholesterol screening.
“Understanding the genome warning signals of every patient will be an essential part of wellness planning and health management,” said Geisinger Chief Executive Officer David Feinberg, MD, when he announced the new initiative at the 2018 HLTH Conference in Las Vegas. “Geisinger patients will be able to work with their family physician to modify their lifestyle and minimize risks that may be revealed. This forecasting will allow us to provide truly anticipatory healthcare instead of the responsive sick care that has long been the industry default across the nation.”
Geisinger had previously launched the MyCode Community Health Initiative, which has enrolled some 190,000 participants. Patients have their DNA partially or fully sequenced, and are notified of any genetic issues that may put them at greater risk for health issues. About 500 patients so far have been told they have an increased risk for certain cancers or heart disease.
David Feinberg
Geisinger Health CEO David Feinberg, MD (above) was one of the first hospital leaders in the nation to announce that genomic profiling would become a routine part of care delivery within his system. In a recent article he co-authored in the Harvard Business Review, Feinberg observed that “millions of Geisinger family members … no longer have to rely on the law of averages to forecast their health and make plans about their life and how they live it.” However, nimble integration of genomic data into all facets of patient care is likely years away. (Photo copyright: Geisinger Health)
But simply analyzing a patient’s genomic profile and warning them of potential health risks down the line won’t be an effective long-term strategy for most providers. Pharmacogenomic testing is already on the rise. Meanwhile, hospitals will quickly have to adapt next generation technologies—such as software with artificial intelligence (AI) capabilities—to absorb and appropriately analyze the coming flood of genomic data and provide effective treatment plans for patients.
Joel Diamond, MD, Chief Medical Officer for 2bPrecise Health, which creates clinical models for genomic information, noted that there will soon be patient data from proteomicsmetabolomicsmicrobiomes such as the gut, and other genomic sources. Diamond told Healthcare IT News that “there will be an increasing need for the merging of this data with clinical information.”
Genomic data also will need to be worked into a patient’s EHR in a way that it can be easily reconciled with treatment decisions. Interfaces also may have to be created to easily integrate the data into ancillary applications such picture archive and communication systems (PACS) or medication systems, according to Don Rule, CEO of Translational Software, a Seattle area firm that provides analytical options for providers with genomic data.
Moreover, according to Diamond, the rise of consumerism in healthcare—where patients can shop around for services and are motivated by ever-rising out-of-pocket costs—means they will insist more be done with their genomic profiles. He observed that “consumer demand will be like nothing we have seen previously” and providers are “ill-prepared for that now.”
Among the treatments expected to become commonplace due to genomic profiling is gene therapy using technology such as CRISPR/Cas, which could be used for patients to better fight diseases.
While Geisinger Health is currently on the cutting edge of using genomics in patient care, what constitutes it will change swiftly. Hospitals and health networks systems will have to plan strategically and invest heavily in precision medicine services to keep up.
Already, first-mover health systems have such services in place for oncology, pharmacogenetics, sepsis and anti-microbial stewardship, and non-invasive pre-natal genetic screening.
—Ron Shinkman
Related Information:

Google: The term Precision Medicine Institute

In September 2018, a conference on genomics for health systems will be held in Nashville and sponsored by the Precision Medicine Institute (here).

I googled the term Precision Medicine Institute in August 2018.

Among others, this pulled up an Institute for Precision Medicine at Univ Pittsburgh/UPMC (here), a Precision Medicine Institute at Baylor (here), a Bay Institute for Precision Medicine in Seattle (here) (here), a California Initiative to Advance Precision Medicine (here).  There is a Stanford Precision Health Center (here).  There was also a Chan Soon-Shiong Children's Precision Medicine Institute in Phoenix (here), which was currently a dead link (8/19/2018).*  There is an Institute for Molecular Medicine active webpage at Phoenix Children's (here). 

* Google Cache

This is Google's cache of 

Chan Soon-Shiong Children’s Precision Medicine Institute at Phoenix Children’s Hospital
About Us
Clinical Research
Translational Research
Chan Soon-Shiong Children’s Precision Medicine Institute
Institute for Molecular Medicine
Support Services
Core Services
Contact Us

Thursday, August 16, 2018

Azar Meets With Stakeholders re Step Therapy

ASCO press release, August 8 here.

Trade press - 

CMS To Create Separate Appeals Process For MA Step Therapy
August 16, 2018

CMS officials plan to create a separate process for patients to appeal Medicare Advantage plans’ use of step therapy for Part B drugs, HHS Secretary Alex Azar told doctor and patient representatives at a meeting Wednesday (Aug. 15).

The meeting was called in response to criticism from provider and patient groups over CMS’ announcement that it will let Medicare Advantage plans make beneficiaries use less expensive doctor-administered drugs before getting more expensive therapies. MA plans will be able to use step therapy across doctor-administered drugs and retail drugs, but plans also must share half of savings from step therapy with beneficiaries.

The meeting was attended by American Academy of Ophthalmology, the American Cancer Society’s Cancer Action Network, the American College of Rheumatology, the American Society of Clinical Oncologists, and Patients for Affordable Drugs, according to an HHS release. The release states that most attendees said they are worried about the step therapy policy, and that Azar is open to “solutions that may alleviate the burden that could be imposed on physicians by the new negotiation tools.”

David Glasser, associate secretary for health policy for the American Academy of Ophthalmology, said Medicare has a poor track record of policing MA plans, and he worries that MA plans will abuse step therapy, just as some already abuse prior authorization. Glasser said he has heard complaints about MA plans using prior authorization to routinely deny access to treatments, only to reverse those denials nearly every time they’re challenged. He said the tactic slows treatment, which can lead to avoidable, permanent damage in patients.

To help avoid unnecessary treatment delays, Azar said CMS plans to create a separate appeals process for MA step therapy decisions. Glasser said it is encouraging that CMS is trying to reduce the potential burden of the step therapy policy, but he said the separate appeals process would have to be well staffed to avoid the same backlogs that exist with other appeals processes. He added that although a new process wouldn’t have a backlog, there often are kinks to work out in new systems that could cause delays all the same.

Azar also urged doctors to work with MA plans on incorporating their medical societies’ clinical pathways and prefered practice patterns into step therapy processes, Glasser said. That’s a laudable goal, Glasser said, but the problem is there are many MA plans, each with their own process for prior authorization. Doctors want a uniform process, but Azar wants plans to develop their own protocols because that is part of the way they compete for enrollees.

Doctors are in favor of using clinical pathways and prefered practice pattern. However, Glasser said, doctors are wary of letting plans, which are not as familiar with the nuances of therapies as ophthalmologists, make those decisions.

The American Cancer Society Cancer Action Network said step therapy policy should be accompanied by a set of patient protections including:

·         Evidence-based treatment guidelines that avoid making patients use medically inappropriate therapies.
·         A simple, fast waiver processes that avoids treatment delays. Also, CMS should monitor exception requests to determine whether categories of drugs should be exempted from step therapy.
·         Full transparency so Medicare beneficiaries who are shopping for plans can tell whether Part D plans use restrictive step therapy. While CMS intends to require plans to notify beneficiaries through the Annual Notice of Coverage, new MA beneficiaries may not be given advance notice of this policy.The cancer group says it also isn’t clear to what extent the plan finder will convey this information.

Error in August 7, 2018 CMS memo on Medicare Advantage Plans Step Therapy

Memo version as reviewed August 15, 2018.

I have the impression there is an error on page 3 of the August 7 memo on Step Therapy.  (PDF)

As clipped below, in the four page memo, CMS states that consistent with 422.134, rewards like gift cards must comply to be "reasonable."  CMS will presume the award is "reasonable" if it is MORE THAN HALF the amount saved on average per participant (p. 3).

However, 422.134 states that,
 [must]  Have a monetary cap as determined by CMS of a value that may be expected to impact enrollee behavior BUT NOT EXCEED the value of the health related service or activity itself;

It appears that CMS on page 3 should state, the value should be LESS THAN HALF.
 A value LESS THAN HALF will not exceed the amount of the service.  A value that is any number MORE THAN HALF the service can be any amount much higher than the value of the service.   For example, if the average value saved is $200, a gift card of $90 would fail under the memo (not more than half), but a value of $1000 would pass (more than half).

August 8 MEMO
"...Consistent with 42 CFR §422.134, plan rewards cannot be
offered in the form of cash or monetary rebate, but may be offered as gift cards or other items of
value to all eligible enrollees.  MA plans should make sure any rewards or incentives comply
with all rules at 42 CFR § 422.134 and Chapter 4 of the Medicare Managed Care Manual.  Under
these rules, the value of the rewards or incentives must be reasonable and appropriate. In this
particular context, CMS will presume that the reward or incentive is reasonable and appropriate 
if it is equivalent to more than half the amount saved on average per participant by a more
efficient use of health care resources, promotion of improved health, or prevention of injuries
and illness."

REG 42 CFR 422.134
A rewards and incentives program must -

(i) Be offered in connection with the entire service or activity;

(ii) Be offered to all eligible members without discrimination;

(iii) Have a monetary cap as determined by CMS of a value that may be expected to impact enrollee behavior but not exceed the value of the health related service or activity itself;

Managed Care Manual, Ch 4, Section 100, quotes the above regulation ("must not exceed the value").

The term "half" (whether more or less than half) appears in the August 8 memo, but doesn't seem to be in either the Reg or Chapter.

Wednesday, August 15, 2018

Archive: Molecular Diagnostic Tests and Medicare (M00104, V2) August 2018

Captured 8/15/2018.

Molecular Diagnostic Tests and Medicare (M00104, V2)

Medicare is a defined benefit program. In order to be considered for Medicare coverage, an item or service must fall within a statutory benefit category. Although IOM 100-2, Ch. 15, Sec 10 identifies 'Diagnostic X-Ray tests, laboratory tests, and other diagnostic tests;' as a benefit category; Sec. 1862 (1)(A) Statutory Exclusion “except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” must also be applied. In order to be paid under this benefit category, a diagnostic test must be ordered by a physician who is treating the beneficiary and the results used in the management of a beneficiary’s specific medical problem.
Step 1 for test assessment: Does the test fall within a Medicare benefit category?
Although many molecular diagnostic tests may provide valid and useful information, they do not meet this definition. Based on the Medicare Benefit requirements, the following test types are examples of services that may not be considered a benefit (statutory excluded) and therefore would be denied as Medicare Excluded tests:
  • Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law
  • Tests that confirm a diagnosis or known information
  • Tests to determine risk for developing a disease or condition
  • Tests performed to measure the quality of a process
  • Tests without diagnosis specific indications
  • Tests identified as investigational by available literature and/or the literature supplied by the developer and are not a part of a clinical trial
Step 2 for test assessment: Is the test reasonable and necessary?
If the test can be described and categorized in the Medicare Benefit, then a “Reasonable and Necessary” determination of the test is made according to Section 1862(a)(1)(A) – “…no Medicare payment shall be made for items or services that "are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of malformed body member.” MolDX starts this process by determining the clinical value/utility of the test – i.e. does the test provide the clinician with actionable data that will improve patient outcomes and/or change physician care and treatment of the patient that results in improved patient outcomes. During the determination the following questions about the test are examined:
  • Who should be tested and under what conditions?
  • What does the test tell us that we do not know?
  • Can we act on the information provided by the test?
  • Will we act on the information provided by the test?
  • Do/Will the results change the outcome?
Step 3 for test assessment: Test Assessment Outcome
Based on the answers to these questions, the MolDX program will address test coverage through one of the following methods:
  • Covered without limitations beyond those inherent in its design and purpose
  • Limited coverage (i.e. for specific DX, clinical indications) (LCD)
  • Coverage with data development (CDD) (very specific coverage criteria) (LCD)
  • Non-covered determination because the test was not found to be medically reasonable and necessary for the diagnosis and/or treatment of the patient (LCD)

Allosure LCD CDD or COA

Source (8/2018) 


click to enlarge

click to enlarge

Sunday, August 12, 2018

Informal Blog: CMS Hopes NCD on Treatment Resistant Depression

CMS has gone through multiple cycles of review, for many years, on whether it would pay for vagus nerve stimulation for treatment resistant depression (TRD).  It doesn't pay.   

On May 30, CMS opened the NCD for review yet another time:

The review is based on a request from Liva Nova (formerly Cyberonics):   [14 pages]

Liva Nova issued a press release acknowledging the event, which was based on the November 2017 request letter linked above.
In June 2018, there have been a few trade journal articles on the topic:

Of note, the case went to a Departmental Appeals Board decision in 2014, which uphold the NCD as it stood,  The judges' decision is a remarkable 96 pages long:

Although Medicare doesn't cover VNS for TRD, it does cover the Myriad/AssureX pharmacogenetic test GeneSight for TRD: