Tuesday, January 28, 2020

Medicare's Revised NCD For Next Gen Sequencing in Cancer: Highlights and Quirks

On January 27, 2020, CMS released a revised NCD for next generation sequencing.
  • See the full CMS analysis here.
    • 41 pages as PDF; 33,000 words.
  • See my initial blog quoting the main decision points here.
  • In the cloud, see my lightly annotated extract of CMS's discussion of public comments, here.
In this blog, I'll recapitulate the highlights of the decision then describe some of the oddities.

DECISION IN BRIEF

Avoiding some details, let's summarize.  In February 2018, CMS issued an NCD guaranteeing coverage of FDA-approved NGS tests used on label in advanced cancer as companion diagnostics(e.g. the Foundation Medicine FDA-approved F1 test).   The NCD contains language implying that no NGS testing was covered (neither under LCD nor NCD) in non-advanced cancer.   CMS reiterated this stance in a transmittal in November 2018.  By early 2019, many stakeholders complained to CMS this would inadvertently block NGS testing of germline risk genes under guidelines (e.g. BRCA in high risk women post lumpectomy).   

In October 2019, CMS revised the NCD in a draft for public comment.  The revision included new sections on germline testing.   After public comments, CMS finalized the NCD on January 27, by inserting new language in and around the prior language, and by revising some of the prior language as well.     With the new language, germline hereditary risk testing is guaranteed national coverage in breast and ovarian cancer, if the NGS test is FDA approved or cleared (no genes are named).   For other cancers and for non-FDA tests, MACs can create coverage (or continue existing coverage).

In the new NCD, NGS tests for RNA (and oddly, "NGS tests for proteins" [sic]) are outside of scope.  Non-cancer tests, e.g. HIV genotyping tests by NGS methods, are also out of scope.

QUIRKS OF THE NEW NCD

It's helpful to read the NCD analysis as a whole, and in particular you get insights into CMS thinking by reviewing the Q&A to public comments (here).

1. The Title

The revisions were put forward in October under the old title, Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.   The new final version shows the same title at top of page.  However, Appendix B of the final revision this week shows us the new title is actually changed to:  Next Generation Sequencing (NGS) for Patients with Somatic (Acquired) and Germline (Inherited) Cancer.

We don't usually categorize patients as "Somatic Acquired Cancer" and "Germline Inherited Cancer."  See also my point below #6.  

2. "Scope" Language New in Section A

Scope language was added to the top of the NCD, Section A.  

"This National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer.  

Medicare Administrative Contractors (MACs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis.  

MACs also have discretion to determine coverage of diagnostic lab tests using NGS for any non-cancer (e.g., infectious disease and heart disease) use.  These uses are outside the scope of this NCD."

The first sentence is a little quirky.  Tests using NGS aren't "for somatic cancer" or "for inherited cancer" but rather "for somatic mutations" or "for germline mutations."   

Test for for RNA expression levels by NGS (a technology which is increasingly usable)are excluded from scope because it's NGS for RNA and NGS for RNA is "out of scope," period.  Good, and clearly written.   For example, if the Mammaprint or Oncotype Dx tests are converted to NGS RNA expression platforms, they are out of scope.   

But I think such tests are also excluded since the scope is only for NGS based somatic acquired ^mutation tests, though the word somatic acquired [^mutation] is missing.  Still, the wording is a little odd.


2B.  NGS for Protein Analysis [sic]

It's  unusual to refer to "NCS for protein analysis" although at least this is "out of scope" so one need to worry about it further.


3. Single Test Use Language

The prior NCD had this restriction on repeat testing.  A test could be covered only if: 

[Prior Statement: patient] "either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician."

The new language on repeat testing is found in both the germline and somatic mutation sections, and reads differently:

"[NEW: patient] not been previously tested [A] with the same test using NGS [and B] for the same cancer genetic content."

This is a little redundant.  If you are previously tested with literally the SAME test "A", then it was for the SAME genetic content "B," because the test was the SAME.   If the test is the SAME then the content of the test is the SAME.   Vice versa, if the genetic content of the test "B" is different, then the test "A" is not the SAME.    

I also wondered if this could be interpreted that you could use the SAME test but expecting DIFFERENT genetic content test results, for example, because the tumor has relapsed and therefore the tumor must have different genomic status now (different genomic content ^of the tumor), which we have to test for.  This fits the grammar and follows the legal rule that you should try to interpret a law so that no part is redundant and all parts matter (Scalia).   

4.  NCCN as a Guideline

The NCD analysis has two categories of guideline, "Evidence Based Guidelines" and "Professional Society Guidelines."  The draft in October placed the NCCN guideline under "Evidence Based Guideline" and then immediately criticized it for not being an evidence based guideline.  This was a little head-spinning.  They now acknowledge the NCCN guideline is "evidence based."

I think what happened is, there is indeed a kind of rigorous evidence based review that uses defined keywords, controlled literature searches, evidence admissibility criteria, meta-analyses, and so on.  NCCN would use that as an input, when available, but wouldn't produce it.  In addition, a comprehensive clinical guideline for physicians like an NCCN or ASCO guide has to consider all types of patients and situations, even those with less evidence.

5.  Lynch Syndrome "Not Enough Evidence"

CMS says it got submissions about Lynch Syndrome but there was not enough evidence.   Obviously, Lynch syndrome testing is included in all guidelines, covered by all MACs, by private insurers and so on.  So what gives?

I think the missing link here is that CMS was filtering only for Lynch syndrome evidence SPECIFICALLY conducted solely on NGS platforms.   That's not how the rest of the oncology and genetics community would sort the evidence for Lynch.

6. Weird Phrasing re Topics and Policy Categories

As noted earlier, the NCD refers to "acquired somatic cancer" and "germline hereditary cancer" rather than TESTS.

Weird things follow.   For example, look at new Section C, restrictions:

C. Nationally Non-Covered Indications
Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with acquired (somatic) cancer are non-covered if the cancer patient does not meet the criteria noted in section B.1. above.

This suggests like a patient getting the FMI test who has acquired non hereditary breast or colon cancer is targeted under "C" non-coverage, but a patient getting the FMI test who has BRCA- or Lynch-driven breast or colon cancer is outside the scope of restriction section "C."  I would have thought CMS referred to somatic acquired tumor mutation tests but they specificallyemploy the words "patients with" not the words "tests for."



Monday, January 27, 2020

CMS Posts Revised NCD for NGS Sequencing in Advanced Cancer

On January 20, 2020, CMS posted a revised NCD for uses of NGS testing in patients with cancer.

The original NCD, in February 2018, focused on companion diagnostic tumor tissue tests (e.g. the Foundation Medicine F1 test).   It gave special coverage benefits to tumor tests that were approved as FDA companion diagnostics. 

Stakeholders complained during 2018 and in early 2019 that the NCD inadvertently tended to block coverage of germline NGS tests, since the NCD focused coverage boundaries on "advanced cancer" patients.   CMS posted a draft revision of the NCD in October 2019, and the final revision now.

See the full NCD here:
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=296

CMS also issued a press release, here.

See coverage at Genomeweb here.  At MedCity News here.  HealthtechDive here.  Healthcare Finance News here.   Health Payer Intelligence here.  Becker's Hospital News, here.

In the press release, CMS Administrator Seema Verma is quoted: “We recognize that cancer patients shoulder a heavy burden, so we’re leaving no stone unturned in supporting women’s health and getting all patients the care they need. NGS testing provides clinically valuable information to guide patients and physicians in developing a personalized treatment plan....Innovative technologies are transforming medicine, and at every turn, President Trump has shown a dogged determination to give Americans access to them”




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Below, I primarily quote the text.  For a later blog that dissects some of the quirks and weirdness, here.

I've cut and pasted the pivotal text (the coverage text) below.  This is the NEW text, the text that is related to germline sequencing. 

A.  The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:
  1. The patient has:
    • ovarian or breast cancer; and
    • a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and
    • a risk factor for germline (inherited) breast or ovarian cancer; and
    • not been previously tested with the same germline test using NGS for the same germline genetic content.
  2. The diagnostic laboratory test using NGS must have all of the following:
    • Food and Drug Administration (FDA) approval or clearance; and
    • results provided to the treating physician for management of the patient using a report template to specify treatment options.
B.  Other
Medicare Administrative Contractors (MACs) may determine coverage of Next Generation Sequencing (NGS) as a diagnostic laboratory test when performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:
  • any cancer diagnosis; and
  • a clinical indication for germline (inherited) testing of hereditary cancers; and
  • a risk factor for germline (inherited) cancer; and
  • not been previously tested with the same germline test using NGS for the same germline genetic content.
We are making other technical, clarifying, and conforming changes in Section 90.2 of the National Coverage Determinations Manual.  We are clarifying the existing policy related to diagnostic tests for Somatic (Acquired) Cancer. 
See Appendix B for the draft manual language.
For ease of the reader, this National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer.  
Medicare Administrative Contractors (MACs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis.  
MACs also have discretion to determine coverage of diagnostic lab tests using NGS for any non-cancer (e.g., infectious disease and heart disease) use.  These uses are outside the scope of this NCD.

My head is spinning a bit from the fact they refer to "Patients with Somatic (Acquired) and Germline (Inherited) Cancer."   Normally you would refer to germline sequencing tests for inherited mutations and somatic sequencing tests for acquired mutations - not "germline and acquired cancers."

###

The full NCD coverage section, including both old and new text, 
is clipped below (as provided by CMS in its "Appendix B."

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90.2 Next Generation Sequencing (NGS) for Patients with Somatic (Acquired) and Germline (Inherited) Cancer [New title]
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.
This National Coverage Determination (NCD) is only applicable to diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer.  Medicare Administrative Contractors (MACs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis.  MACs also have discretion to determine coverage of diagnostic lab tests using NGS for any non-cancer (e.g., infectious disease and heart disease) use.  These uses are outside the scope of this NCD.
B. Nationally Covered Indications
  1. Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, when ordered by a treating physician, and when all of the following requirements are met:
  1. Patient has:
    1. either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and
    2. not been previously tested with the same test using NGS for the same cancer genetic content, and
    3. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).
  2. The diagnostic laboratory test using NGS must have:
    1. Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic; and,
    2. an FDA-approved or -cleared indication for use in that patient’s cancer; and,
    3. results provided to the treating physician for management of the patient using a report template to specify treatment options.
  1. (NEW) Germline (Inherited) Cancer
Effective for services performed on or after [DATE], CMS has determined that NGS as a diagnostic laboratory test is reasonable and necessary and covered nationally for patients with germline (inherited) cancer, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:
  1. Patient has:
    1. ovarian or breast cancer; and,
    2. a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer; and,
    3. a risk factor for germline (inherited) breast or ovarian cancer; and
    4. not been previously tested with the same germline test using NGS for the same germline genetic content.
  2. The diagnostic laboratory test using NGS must have all of the following:
    1. FDA-approval or clearance; and,
    2. results provided to the treating physician for management of the patient using a report template to specify treatment options.
C. Nationally Non-Covered Indications
  1. Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with acquired (somatic) cancer are non-covered if the cancer patient does not meet the criteria noted in section B.1. above.
D. Other
  1. Somatic (Acquired) Cancer
Effective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic laboratory test for patients with advanced cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, and when the patient has:
a. either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer; and,
b. not been previously tested with the same test using NGS for the same cancer genetic content, and
c. decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

  1. (NEW) Germline (Inherited) Cancer
Effective for services performed on or after [DATE], MACs may determine coverage of NGS as a diagnostic laboratory test for patients with germline (inherited) cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:
  1. any cancer diagnosis; and,
  2. a clinical indication for germline (inherited) testing of hereditary cancers; and,
  3. a risk factor for germline (inherited) cancer; and,
  4. not been previously tested with the same germline test using NGS for the same germline genetic content.

(This NCD last reviewed XX.)

Very Brief Blog: Chief Medical Officer, Chief Innovation Officer, Both Depart CMS

Two departures from CMS announced in January, and one from HHS.

CMS Chief Medical Officer, Dr. Kate Goodrich, will leave for an executive position at Humana.  Story at Modern Healthcare here, Healthcare Finance News here, Lousville Business Journal here.  Prior to CMS, Dr. Goodrich had been a senior hospitalist at George Washington University.  Goodrich joined CMS in 2012. 

CMS Chief Innovation Officer, Dr. Anand Shah, will leave for a full-time policy position at FDA.   Dr. Shah joined CMS in early 2019 (here, here).  He will be FDA Deputy Commissioner for Medical and Scientific Affairs (here).   Current FDA chief Dr. Stephen Hahn, sworn in to replace Scott Gottlieb on December 24, 2019, is trained in both medical oncoloogy and radiation oncology; Shah is a radiation oncologist.  Follow Shah on Twitter for FDA at https://twitter.com/AnandShahFDA .


And a departure from HHS.  

Dr. Mona Siddiqui, Chief Data Officer in the HHS Officer of the Chief Technology Officer, also is leaving HHS (here).  Siddiqui (Linked-In here) holds an MD from Johns Hopkins, an MPH from Harvard, and an MSE in Engineering from Stanford; she'd held a number of policy staff positions in government since 2010. 

Thursday, January 23, 2020

Medicare Trivia: As Noridian's Jurisdiction E Re-bids, Can It Go to a Non-MolDx MAC?

This blog is probably near a peak level of Medicare trivia, but it's interesting from the perspective of the MolDx policy system for lab tests, and the heavy concentration of Medicare's mopath spending in California.

It looks like none of the non-MolDx MACs could successfully take on Jurisdiction E, which is being re-bid right now, and take it out of the MolDx policy system.  Reasoning follows.

Jurisdiction E (California, Hawaii, Nevada) Is Up For Re-Bid

Jurisdiction E, one of the largest MACs, especially from the perspective of molecular testing, is up for re-bid.

The federal Request for Proposals (RFP) for Jurisdiction E posted on August 20, 2019, with responses due November 4, 2019.   See website here, solicitation number  75FCMC19R0023.  The anticipated award date for the new contract was posted as August 4, 2020.
(Click through the documents at the bottom of that webpage, 5 at a time, to see the most interesting document, the 150 page statement of work.  On my PC, I had to rename as a PDF-type file to open it.)  
See my cloud copy of the national MolDx statement of work here.  Each MAC in the MolDx policy system works with Palmetto under a "Joint Operating Agreement" or JOA; I don't have a copy of that.

Pp. 47-50 describe the medical director duties; there should be 3 FTE medical directors for this MAC.

CMS Caps Contractor at 26% of Workload; Contractor Group at 40%

In 2017/2018, the NGS MAC protested the limit on total share of MAC workload that can be held by any one MAC.   It lost.  Here.  According to the case, CMS caps workload of any one corporate entity to 26% of national MAC workload, and a group of companies shall not hold more than 40% of MAC workload.  My understanding is that Palmetto + CGS are a group of companies; and Novitas + FCSO are a group of companies.

Do The Math

Using a table included in the GAO case, I've rearranged the contractors by group.

There are three non-MolDx contractors, NGS MAC, FCSO, and Novitas.  Here's my math.  FCSO can win California, which has 9.1% of CMS workload, but then the FCSO+Novitas group will have 32%+9% = 41% of CMS workload, more than 40%.  So FCSO can't win California, I don't think.

Novitas can't win California, because it already has 25% of CMS workload, basically at its 26% limit.

NGS MAC has 20% of CMS workload, so it can't add 9.1% for California, which would give it 29%, over the 26% limit.  However, NGS MAC could spin off into two shell companies under one parent company, and then either NGS MAC company (with 7.8% and 12% respectively) could add the 9% JE MAC. 

Conclusion

So, taking this as a sort of puzzle, the only way I see that a non-MolDx MAC could win JE is by NGS MAC splitting into two companies (possibly under a parent company, something discussed in the GAO legal case cited) in which case it could win JE.  If that happen, JE might become a non-MolDx MAC.   Check back in August 2020 for the result.


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See the MolDx federal "Statement of Work" here.

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40% of Part B MoPath Claims Are in California
I looked at the national physician/lab/CPT open access database for CY2017 at CMS, which has 9M claim lines.  Codes starting with 812xx 813xx 814xx 815xx.   This is most of the MoPath codes.  In this 2017 data, there were $588M MoPath payments, $244M or 41% in California.   $408M or 69% were in MolDx states (29 states).  60% of MolDx payments are in California (244/408).

If you subtract the $118M of payments for Exact Sciences Cologuard, which are paid (1) under an NCD and (2) in a non-MolDx state of Wisconsin, then there are $470M national mopath payments controlled by LCDs, of which $408M or 87% are in MolDx states. 

However, if California left the MolDx system, there would be only $164M of payments left in MolDx states ($408M-$244M = $164M; and 164/588 means that MolDx minus California paid 28% of US mopath claims.)


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Unrelated to this blog, I noticed in this data for CY2017 that Exact Sciences Cologuard code 81528 is billed primarily by Exact Sciences (231,489 cases for $118,621,908) but also by Mayo in FL, MN, and AZ (FL: 89 cases, $45,606; MN: 18 cases, $8,874; AZ: 158 cases, $79,202.)

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If a MAC other than Noridian wins the JE contract, it could go into legal appeal cycles of many months.   We know the JE deadline for applications was November 2019; we know the award date is August 2020.  I believe that's the go-live date, since I recall the contract review only requires a matter of months.   I would expect an announcement of the winner in early spring 2020 and a "go live" date (not just an announcement of the winner) in August 2020.

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If a MAC other than Noridian wins the JE contract, it could trigger LCD "stasis" for 6-9 months due to a required harmonization process that suspends issuance of new LCDs.

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Many people here about the MolDx "Master Edit File" which is valid for all the MACs participating in MolDx.  I was able to get a copy via FOIA.  It is an Excel spreadsheet of 13,000 lines - essentially, 13,000 Z codes.   66% of all codes had non-covered status.   4,937 of the 13,000 Z codes were crossed to the unlisted code 81479 (38%).    From other data, the use of Unlisted Code 81479 in non-MolDx MACs is almost zero.





Wednesday, January 22, 2020

Very Brief Blog: Quest Acquires the Blueprint Genetics Laboratory

On January 22, 2020, multiple news outlets reporting that Quest has acquired Blueprint Genetics, a Helsinki-based genetics laboratory with a US center in Seattle.

Financial terms were not disclosed.

See stores at MedCityNews here, at MedTech Dive here.  Quest's press release here.

MedCityNews writes,
Secaucus, New Jersey-based Quest Diagnostics said Wednesday that it would acquire Helsinki-based Blueprint Genetics. Financial terms of the all-cash deal were not disclosed. Blueprint – not to be confused with Blueprint Medicines, a U.S.-based drugmaker (...) – makes tests for 200 genetic panels and 3,900 single genes, across 14 medical specialties. It has been expanding its U.S. presence as well, with a new hub in Seattle. It focuses on gene variant interpretation using next-generation sequencing and bioinformatics technology.
See Blueprint Genetics website here.  See Blueprint newsroom for information on their recent new tests and initiatives, here.

In October 2019, Genomeweb ran a subscription article on Blueprint's new lab in Seattle (here).  The firm had raised €23M from investors and had €15M in global CY2018 revenue, expecting that to double in CY2019.

Medicare Part B and Quest's 2017 Genomics Payments (Spreadsheet)

Medicare paid claims data for Quest and other providers for CY2017 is available at CMS (here). 

I've put an Excel spreadsheet in the cloud for 2017 Part B Quest paid claims for CPT codes 812xx 813xx 814xx (most of genomics) here.   

Part B 2017 payments to Quest tallied about $2.8M dollars allowed.  Total CMS genomic payments in 2017 were circa $500M, so Quest garnered about 0.5%.

Quest's billings are somewhat complicated; for example, they billed Medicare for 81206 (BCR ABL) from about 15 different locations. 

The two largest volume codes were 81206 (BCR ABL minor breakpoint), 2375 services for $522,000; and 81207 (BCR ABL major breakpoint), 1393 services for $220,000.   Quest also garnered around $500,000 for different codes under HLA genotyping.  BCR-ABL and HLA were about half of Part B payments to Quest in the genomics code series.

Quest also garnered about $440,00 for Level II codes (tiers 2,3,4), and almost nothing for unlisted code 81479.



(sample screenshot of spreadsheet)


Very Brief Blog: CMS To Cover Acupuncture as Non-Opioid Therapy for Back Pain

Last January, CMS unveiled a plan to review acupuncture again (it is a service that has been non-covered by NCD for decades).   See original blog here.

On January 21, 2020, CMS released a final decision covering acupuncture.  The final decision provides coverage to anyone with " chronic back pain" (not further defined, but not due to "systematic cause" like metastatic disease).   12 visits in 90 days are covered.   An additional 8 visits can be covered if the therapy is working.  A capped number of 20 visits per year are covered.

Two notable points - first, the decision was late; it was due in October.  Second, the draft decision in July had placed acupuncture under limited coverage with evidence development (coverage only in trials).

  • Read the NCD in full, here.
  • Read the CMS press release, here.
  • Story at Forbes, here.
CMS Press Release Quotes

Secr. Alex Azar:
“Expanding options for pain treatment is a key piece of the Trump Administrations’ strategy for defeating our country’s opioid crisis,” said HHS Secretary Alex Azar. “President Trump has promised to protect and improve Medicare for our seniors, and deciding to cover this new treatment option is another sign of that commitment. Medicare beneficiaries will now have a new option at their disposal to help them deal with chronic low back pain, which is a common and sometimes debilitating condition.”  
Deputy Administrator Kimberly Brandt:
“We are dedicated to increasing access to alternatives to prescription opioids and believe that covering acupuncture for chronic low back pain is in the best interest of Medicare patients.”

Administrator Seema Verma and Coverage Group leaders were not associated with quotes.


Opioid Policy

The NCD specifically cites Trump administration policy on the opioid crisis and the need for alternative therapies.  CMS also cites coverage of acupuncture to one degree or another by the VA and some private insurers.

CMS writes, "We believe that in light of the relative safety of the procedure and the grave consequences of the opioid crisis in the United States,  there is sufficient rationale to provide this nonpharmacologic treatment to appropriate beneficiaries with chronic low back pain."

Uses of acupuncture for other conditions than lower back pain remain non-covered.

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Coding and Payment

There are existing AMA CPT codes for acupuncture - 97810, 97811 for first and second 15 minutes.  They are priced at around $28 and $38 respectively (higher in cities).  Up til now, those two codes been categorized as nationally non-payable (non-processable) by CMS. 

Historically, it often takes over six months for CMS to issue claims processing instructions on new NCDs.  I would expect CMS will remove these codes from "rejection" status faster in this case.

CMS could elect to create and use other codes (G-codes) for the NCD.   I recall at 2019 recent AMA CPT meeting there were some extensive changes, additions, or Category III codes under debate in this area discussed.  I didn't track if they passed or not. 

Incident-To

Individuals with only a state healthcare acupuncture credential can't enroll for payment from Medicare.  Acupuncture has to be administered by (or under direct supervision of) someone who can enroll in Medicare, e.g. a doctor or nurse practitioner.

Normally CMS has pretty vague rules about who can perform services incident-to a physician (e.g. "appropriate" personnel.)   Here, the incident-to person must be a state licensed acupuncturist.  (See the NCD for full details and see the Q&A public comments section).

A chiropractor under Medicare law can only be paid for spine manipulation, but he/she could be paid for acupuncture if he/she was also (in parallel) a licensed acupuncturist and under the supervision of a physician.

Coverage with Evidence Development

The draft NCD last summer proposed coverage with evidence development; as far as I saw, there is no mention of the proposal in the final decision, it's just gone and replaced.




Tuesday, January 21, 2020

Very Brief Blog: CMS Somewhat Cleaned Up NCCI Genomic Edits for CY2020

Just over a year ago, in November 2018, CMS released a few  sometimes-bizarre new rules for coding of panel testing and especially genetic test panels (see original blog and links here and here).  This led to ongoing letters and meetings between ACLA and others for many months in CY2019.  See e.g. a subscription article on the topic in Dark Report in April 2019 here.

Without much fanfare, CMS released some revisions to its edits in November 2019 for Calendar 2020.   The revisions are in Section F (Molecular Pathology) of Chapter 10 of the National Correct Coding Edits Policy Manual.   (Download via link "NCCI Policy Manual Effective January 1, 2020" at this website here.)

ACLA has already publicly complained, in December 2019, about some of the NCCI language.  See online here.

You should read the ACLA letter for yourself.    I have a few comments below that may be a "glass half full" view of some of the edits, at least in Sections 7,8,9.   ACLA thanks CMS for some of the edits I'll be highlighting next, while complaining that elsewhere in the NCCI manuals there remains adverse language.  In particular, there are arguments that NCCI language would cause mass overuse of unlisted codes.

Mostly Favorable Small Revisions to Genetic Edits

Whereas Section 7 originally said that Tier 1 or Tier 2 MoPath codes "shall not" be reported with a genomic sequencing procedure (e.g. panel), it now says that those codes "should not, in general, be reported" with a GSP.  If procedures are reported together, they should both be medically reasonable and necessary.

Whereas Section 8 originally said that NGS procedures must be reported by a single CPT code (e.g. GSP) or 81479 (unlisted procedure), the text now says that if no single code accurately describes the NGS procedure, it MAY be reporting with 81479 or MAY be reported with multiple individual CPT codes "when medically reasonable and necessary."

Whereas Section 9 blocked some pairs of MoPath codes from being reported together, it now says that code-to-code edits are codes that "should not, IN GENERAL, be reported together."   Again, it is restated for the third time that if codes are reported together they must both be reasonable and necessary.

On the whole, improved.

NCCI labels changes in red, so it's easier to see additions than deletions. I didn't note any other changes that seemed significant, but you should check the manual yourself for your own area of interest. 

I've put a direct cloud link to a January 2020 version of the Pathology policy chapter in the cloud here.  However, the CMS webpage linked above should be checked for any possible updates.



Friday, January 10, 2020

Very Brief Blog: Coalition Files Citizen Petition, Urges FDA Stop Actions Against LDT PGx Labs

According to an article on January 10, 2019, in Genomeweb, a "Coalition to Preserve Access to Pharmacogenomics" has filed a federal Citizen Petition "asking the US Food and Drug Administration to stop its oversight attempts to limit these services.

  • See Genomeweb article here.
  • See Citizen Petition here.
    • The petition is signed by Hyman Phelps attorneys Gibbs and Javitt.
    • Dated January 9, 2020.

Nerd Note Deluxe!

The FDA published a draft 20pp guidance on how it handles Citizen's Petitions in October, 2018  here.  (Although primarily in regard to malicious submissions intended to delay competitors).  The corresponding Federal Register announcement was 83 FR 49935, October 3, 2019, here.  The agency received 21 comments (here, bottom).  For my money the most interesting was a 6 p comment from the Federal Trade Commission (here).

Thursday, January 9, 2020

Very Brief Blog: CareDx/Natera Court Case Cites MolDx Article

On January 8, 2020, Genomeweb ran an article about an ongoing legal dispute between CareDx and Natera regarding donor-DNA renal transplant tests - here.


I don't have any comment on the case, but the news article at Genomeweb includes a quotation that, "Medicare specifically rejected the very arguments CareDx advanced in its complaint when it finalized its Local Coverage Decision (LCD) for Natera's Prospera donor-derived cell-free DNA test."

How do you find that? 

  1. Go to Palmetto's "LCDs, NCDs, Coverage Articles" webpage - here.
  2. Click on "Future Effective LCDs."  Here.
  3. Look for L38041, MolDx: Prospera.   Here.
  4. Scroll to the bottom of the webpage of the online LCD text and see:
  5. A57821 - Response to Comments - Prospera.  Here.
  6. The CareDx comment is #4.
I've also put a cloud copy of the LCD here and a cloud copy of the article here.


You can also go to CMS Coverage Database and enter the document numbers in the small top-right box "Document ID" - here.

Tuesday, January 7, 2020

MolDx Posts Final LCDs for NGS Profiling of Solid Cancers and Myeloid Cancers

MolDx has finalized complex and important LCDs for comprehensive genomic profiling in cancer. Each of the two LCDs also has an accompanying coding & billing article, and a lengthy article which  is a response to public comments.

L38045 covers solid cancers, and L38047 covers myeloid cancers.  Expect other MACs in the MolDx policy system to roll out matching LCDs soon (WPS MAC, CGS MAC, Noridian MAC.)

One way to find these LCDs is to (first) go to the Palmetto MAC "LCDs, NCDs, Articles" page and (second) click on "future effective" LCDs.  Here.  Note, however, that after February 10, these become "effective" LCDs and will move to the "effective LCDs" link.

The Two LCDs - Each With Two Articles

When you open the two LCDs - L38045 and L38047 - near the bottom of each LCD is a link to its coding article and a link to its public comment Q&A article.   For L38045, see coding article A57831 and Q&A article A57830.  For L38047, these are found as A57387 and A57836.

You can find AMP's comments on the articles under the June 20 date at AMP's public policy webpage here.

MolDx doesn't use AMA CPT code 81455 (50 or more tumor genes) but wants large cancer tests coded as 81479 (molecular unlisted code).

You'll Also Want Article A57757

Note that you'll also want article A57757, which defines primary and recurrent tumors. Medicare's NGS National Coverage Decision 90.2 states that NGS tests can be provided only in advanced cancers and only one of the same test, per primary cancer.  MolDx defines a non-covered test as a second test on the same specimen on the same day, and a different primary cancer is a cancer that is "different enough to respond differently to therapy."  (To my eye, that suggests any tumor that stops responding to a prior effective therapy is different enough to escape the one-test-per-primary-cancer rule).   You may also want Article A54795 - which defines hotspot tests versus CGP or comprehensive genomic sequencing tests.  Find them using the document ID search box at CMS Coverage Database (here).



Grandfathered Tests Require TA's - and Fast

MolDx is also going to require that grandfathered NGS cancer tests, which might not have undergone detailed tech assessments in prior years, must have an approved TA on file as of February, 2020.  See article here.



Tech Assessment Documents

Some of the requirements for NGS tests are found not in LCDs, not in coding & billing articles, but rather in MolDx website technical assessment documents.  Entry point from the MolDx home page, here.  The TA assessments for NGS tests are exhaustive - MolDx doesn't let you by with just a CLIA certificate on file.

Cloud Copies of Documents Cited

I've put a Zip file with articles and LCDs cited in this blog, in the cloud - here.

Nerd Notes

L38045 states point blank that: "NGS is not a specific test but a sequencing methodology utilized to capture genomic information."   This is practically verbatim what stakeholders have been telling CMS regarding its NCD 90.2 - stakeholders like ACLA, CAP, AMP, 21st Century Coalition, NCCN, and others.  CMS seems to (??) view NGS as a "test" (sic), which is either "covered" or "not covered" in certain situations.  Thus, NGS is "not covered" in patients with cancer that is not advanced cancer, a nonsensical situation that means that even FDA approved HIV genotyping tests are "not covered" in these early cancer patients.   In this regard, the existing CMS NCD simply makes no sense at all.

The multi-level implementation of the LCD, with an LCD, an attached article, collateral articles for definitions, and then separate MolDx website documents like Tech Assessment spreadsheets with gene lists, means it would be very hard for a RAC or auditor to know if a given test was appropriate covered or not on any given day of service.  You'd need contemporary copies of all these documents, a real handful, for a particular date of service in the past.






Anthem Executive to Lead CMMI

Anthem executive Brad Smith has been appointed to head the Center for Innovation (CMMI) at CMS, announced January 6, 2020.

During the Trump administration, CMMI was headed by Adam Boehler until October 2019.   Boehler moved from CMS to head the U.S. International Development Finance Corporation (here).  Prior to CMS, Boehler had started Landmark Health, which aimed to assist Medicare Advantage and other plans in managing chronic disease better.

Long-time CMS executive Amy Bassano had been acting director of CMMI since last fall.

Interestingly,  Smith was CEO of Aspire Health (founded by former Senator Bill Frist), which provided home services to patients with complex and chronic illnesses, not too different from Boehler's background with Landmark.  Smith, a Harvard graduate, was a Rhodes scholar.  According to one news source, the head of CMMI oversees 600 employees.

Trade journal stories include:

  • Healthcare Dive here.
  • Modern Healthcare here.
  • The Tennessean here.
  • CMS press release here.

While CMMI is commonly described as having bipartisan support, in fact there were Senate (Republican) Hill hearings in 2016 that were highly confrontational and concerns that CMMI's authorities might exceed statutory limits.  For example, CMMI is allowed to set up "demonstration programs" by law (in the ACA), but there is no written restriction on the size, scope, duration, or content of the demo programs.   CMMI's statutory authorization is just a few sentences long and has been viewed as self-implementing.

Legislation to limit the powers of CMMI was introduced in February 2020 (news article here).  It's a House bill (H.R. 5741)  but has biparty support.


Friday, January 3, 2020

Books and Movies List - 2019

Off topic from my regular business blog, my fifth annual book list, 2019 version.

In the cloud as a PDF here.

Internet version here.

Best wishes in 2020 !!

Bruce Quinn
Bruce Quinn Associates LLC


Thursday, January 2, 2020

CMS Updates PAMA Page for New Law: Reporting Year Is Delayed, But Year 4 at 15% Cut Is Not

CMS has updated its PAMA REGULATIONS page to account for new law passed in late December, section 105(a)(2) of the Further Consolidated Appropriations Act of 2020 (FCAA).  See PL 116-94 (HR 1865) online here, here.  It's Division N, Title 1, Subtitle A, Section 105.  The statutory language is clipped here.  It's cryptic since it inserts and deletes bits and pieces of phrasing into existing law not directly shown in PL116-94 (see SSA 1834A, here.)

FCAA does the following:
  • Leave the payment data period for the next three-year PAMA cycle the same, 1H2019.
    • Claims paid during 1H2019 for active codes in 1H2019 will be part of the next PAMA data collection.
  • Delay the data collection from 1Q2020 to 1Q2021.
  • Delay the implementation of new prices to January 2022.
CMS notes that another time cycle is not changed, in its view.  This time cycle provided 10% pay cuts (at the max) in Year 1,2,3 under PAMA, and 15% pay cuts (at the max) in Year 4,5,6.   Since 2020 is Year 3, pay cuts are limited to 10%, but since 2021 is still year 4, pay cuts will be 15%.

Whether lab tests get a 15% cut in CY2021 depends on whether the 2020 price is still 15% higher than the price median found based on 2017 data.

CMS updated the top part of its PAMA page, here.  See table (click to enlarge) clipped below.

click to enlarge
By my informal tally, comparing 2020 current prices to the median of 2017 reported private payer prices, about 206 CLFS CPT codes will have a 15% cut in CY2021 if CMS's update is correct.   Another group of about 390 will have a 10-15% cut and finally about 130 will have a 0-9% cut.

I've put my personal best-effort spreadsheet in the cloud here.  This Excel has two tabs; one sorted by percent cut 2021 (my prediction), and one sorted by CPT.

Recall there were some huge anomalies in PAMA reporting pricing; for example, 81341 TRB gene rearrangement had a CPT price of $68 in 2017 but a PAMA median price target of one penny.   81435 Lynch Panel had a CMS 2017 price of $802, but a PAMA median price target of $37.99.