https://www.statnews.com/2018/01/07/jpm-gender-diversity/
Sunday, January 14, 2018
Very Brief Blog: JPM and Biotech Leadership: The "Men Named MIchael" Quote
Seen at Boston Globe STAT: "There are more men named Michael presenting at JP Morgan, that there are female CEOs."
https://www.statnews.com/2018/01/07/jpm-gender-diversity/
https://www.statnews.com/2018/01/07/jpm-gender-diversity/
Friday, January 12, 2018
Very Brief Blog: The Halteres Consultancy Deck on "Why Dx Companies Fail"
Email this morning brought a citation to a 2015, 20 page deck by Halteres Associates on "Why Diagnostic Companies Fail?" It's online at their website, here.
One of the take home lessons for me is page 7, where they rate a couple dozen companies against about a dozen performance metrics or key competencies. The point is, if you miss almost any of the dozen metrics, you won't succeed. It's like an electric circuit in series where every step has to be active.
One of the take home lessons for me is page 7, where they rate a couple dozen companies against about a dozen performance metrics or key competencies. The point is, if you miss almost any of the dozen metrics, you won't succeed. It's like an electric circuit in series where every step has to be active.
 |
| click to enlarge |
Thursday, January 11, 2018
Is the FDA FMI CDx Approval "Really" A Very Elaborate Analytical Validity Assessment?
In mid-December, the FDA released its main safety & effectiveness review document on the Foundation Medicine CDX 384-gene test (here). As commentators have noted, CMS gives very high priority to FMI's PMA approval - "This tells us that it really has clinical utility." Far lower status is given to tests with published data, NYSDOH approval, or the new 510(k) somatic gene panel approval. As proposed, those tests get coverage only if $10,000 or more, such as RECIST studies, are deployed for each test paid by CMS.
The 58-page FDA review is worth reading in detail, which probably few people have invested several hours in doing. The review is mostly an exhaustive analytical validity assessment. FMI CDx is verified to have 700-800X coverage for targeted regions; which was information already used in publications, its website, I assume its CAP validations, NYS approval, and MolDX approval. FMI CDx has a net sequencing error rate of .003 percent (below the FDA's stated threshold of .01 percent or 1 base in 10,000). But again, this is sequencing accuracy level that is known to be met for clinical genetic tests. And it's analytical data.
The heart of the review assesses the performance of six very specific outputs of the FMI CDx test against six prior art PMA comparators, as diverse as the Ventana ERBB2/Her2 FISH test and the Roche EGFR T790M point mutation test.
Two of the comparisons involved clinical blocks, but these were much noisier (with missing blocks, differing results, etc) than the four comparisons that involved running the predicate test on merely available tumor blocks.
The two comparisons that are cross-modality (between ALK FISH and ERBB2 FISH and sequencing) are much noisier than accuracy between an FMI point mutation and a PMA kit point mutation. I summarize the results in the first figure below by gene reviewed, and give representative examples of "very tight" and "noisier" concordance in the second figure below.
I provide a more detailed, but still informal, summary of the S&E key findings in a sidebar blog, here. In general, whether clinical trial or "available" blocks were used, about 100-150 positive blocks and a similar number of negative blocks were required. However, even when clinical trial archives were used, the assessing for a passing grade is based on the analytical validity concordance of FMI and prior art results.
The FDA approval is, no question, an exhaustive view that gives a great deal of confidence in the test. But few commenters actually read it. The key pivotal tables are mostly based on "available" blocks. All the data on concordance to prior art is "analytical" and "statistical." The bar is within 10% noninferior to a comparator.
It's a big, big achievement. But I'm unconvinced it's light-years and night and day different than an academic NGS test which has, say, 99% concordance to Sanger in hundreds of specimens and 95-99% concordance to an IVD in dozens of specimens. Or for that matter, the 99.9% accurate MSK IMPACT test with its new 510(k) approval.
As I noted earlier (here), the FDA review defines away any issues about accuracy outside the claims. The FDA tested accuracy in some cases to match a single point mutation; in writing up its pivotal risk-benefit decision, FDA states that: the test matches those several cases of prior PMA art and therefore the whole test (which also reports sequencing on some 377 other genes and things like Total Mutational Burden) introduces no new medical issues or risks beyond the prior art such as a point mutation T790M test or a point mutation L858R test.
The 58-page FDA review is worth reading in detail, which probably few people have invested several hours in doing. The review is mostly an exhaustive analytical validity assessment. FMI CDx is verified to have 700-800X coverage for targeted regions; which was information already used in publications, its website, I assume its CAP validations, NYS approval, and MolDX approval. FMI CDx has a net sequencing error rate of .003 percent (below the FDA's stated threshold of .01 percent or 1 base in 10,000). But again, this is sequencing accuracy level that is known to be met for clinical genetic tests. And it's analytical data.
The heart of the review assesses the performance of six very specific outputs of the FMI CDx test against six prior art PMA comparators, as diverse as the Ventana ERBB2/Her2 FISH test and the Roche EGFR T790M point mutation test.
Two of the comparisons involved clinical blocks, but these were much noisier (with missing blocks, differing results, etc) than the four comparisons that involved running the predicate test on merely available tumor blocks.
The two comparisons that are cross-modality (between ALK FISH and ERBB2 FISH and sequencing) are much noisier than accuracy between an FMI point mutation and a PMA kit point mutation. I summarize the results in the first figure below by gene reviewed, and give representative examples of "very tight" and "noisier" concordance in the second figure below.
 |
| My Brief Informal Summary of Results from FDA S&E Document |
 |
| Examples of Tight (Left) and Noisier (Right) Concordance |
I provide a more detailed, but still informal, summary of the S&E key findings in a sidebar blog, here. In general, whether clinical trial or "available" blocks were used, about 100-150 positive blocks and a similar number of negative blocks were required. However, even when clinical trial archives were used, the assessing for a passing grade is based on the analytical validity concordance of FMI and prior art results.
The FDA approval is, no question, an exhaustive view that gives a great deal of confidence in the test. But few commenters actually read it. The key pivotal tables are mostly based on "available" blocks. All the data on concordance to prior art is "analytical" and "statistical." The bar is within 10% noninferior to a comparator.
It's a big, big achievement. But I'm unconvinced it's light-years and night and day different than an academic NGS test which has, say, 99% concordance to Sanger in hundreds of specimens and 95-99% concordance to an IVD in dozens of specimens. Or for that matter, the 99.9% accurate MSK IMPACT test with its new 510(k) approval.
As I noted earlier (here), the FDA review defines away any issues about accuracy outside the claims. The FDA tested accuracy in some cases to match a single point mutation; in writing up its pivotal risk-benefit decision, FDA states that: the test matches those several cases of prior PMA art and therefore the whole test (which also reports sequencing on some 377 other genes and things like Total Mutational Burden) introduces no new medical issues or risks beyond the prior art such as a point mutation T790M test or a point mutation L858R test.
Tuesday, January 9, 2018
CMS Transmittal Resolves Madcap Federal Register Errors on Date of Service 2018: Ignore CMS Errors
In final rulemaking for CY2018, CMS revised its date of service rules for hospital outpatient biopsies, in a manner that requires the performing laboratory to bill for molecular tests. This may be the hospital's own molecular lab but often may be an outside independent lab.
However, CMS did some really weird twists, turns, and misstatements in finalizing the rule. For example, they stated point blank it referred to "molecular pathology tests" and equally point blank it did not apply to "genomic sequencing procedures or PLA tests." This is like saying a rule applies to household pets, including cats and dogs, except not dogs.
In producing its operating instructions to providers and MACs, on December 22, 2017, CMS simply ignored the weirder misstatements in its own rule and provides simple instructions. If it's a molecular pathology test, then it has "OPPS Status Indicator A" in a policy spreadsheet called Appendix B which is mainly issued annually but gets small updates quarterly. See the CMS webpage, "Addendum B Updates," here.
If the CPT code is paired with Status Indicator A, then that CPT code is billed by the providing lab (be it hospital or independent.)
See Medline Matters MM10417, here. See also Instructions to Contractors, CR10417 (Transmittal CP3941), here.
They left one quirk, which is that the new DOS for Status "A" tests is "the date they are performed." Is that the date they are signed out? Probably? We think? CMS declined to specify for us, and even declined to say it was in fact the date of sign out or the date of final report, it's "the date they are performed" whatever that is (rule, pp 52538-9).
See new 2018 regulation at 42 CFR 414.510 here. For final rulemaking, see 82 FR 52533ff, here.
However, CMS did some really weird twists, turns, and misstatements in finalizing the rule. For example, they stated point blank it referred to "molecular pathology tests" and equally point blank it did not apply to "genomic sequencing procedures or PLA tests." This is like saying a rule applies to household pets, including cats and dogs, except not dogs.
In producing its operating instructions to providers and MACs, on December 22, 2017, CMS simply ignored the weirder misstatements in its own rule and provides simple instructions. If it's a molecular pathology test, then it has "OPPS Status Indicator A" in a policy spreadsheet called Appendix B which is mainly issued annually but gets small updates quarterly. See the CMS webpage, "Addendum B Updates," here.
If the CPT code is paired with Status Indicator A, then that CPT code is billed by the providing lab (be it hospital or independent.)
See Medline Matters MM10417, here. See also Instructions to Contractors, CR10417 (Transmittal CP3941), here.
They left one quirk, which is that the new DOS for Status "A" tests is "the date they are performed." Is that the date they are signed out? Probably? We think? CMS declined to specify for us, and even declined to say it was in fact the date of sign out or the date of final report, it's "the date they are performed" whatever that is (rule, pp 52538-9).
See new 2018 regulation at 42 CFR 414.510 here. For final rulemaking, see 82 FR 52533ff, here.
AMA Reaches 34 PLA Codes; Next Deadline Friday January 12
The AMA released an update of its active Proprietary Laboratory Analyses (PLA) codes on December 20, 2017, bringing the total published codes to 34, with two already-deleted codes (0004U, 0015U). The PLA homepages are here; see the full table online here. 11 of the 34 codes were applied for by Mayo (0004U, 0010U, 0012U-14U, 0027U-32U).
PLA deadlines for CY2018 are on January 12, April 11, July 12, and October 9. The PLA application portal is here (I believe you must be signed in to the AMA website itself to access that.)
Key parts of the application are currently:
(Note that I have summarized the questions; see the full AMA website for the full questions). Authors can prepare their application via online forms and store and revise until it's ready to submit.
PLA deadlines for CY2018 are on January 12, April 11, July 12, and October 9. The PLA application portal is here (I believe you must be signed in to the AMA website itself to access that.)
Key parts of the application are currently:
- PMA, 510K, or Non FDA?
- Link for how providers can order the test.
- Terminology for the code.
- Disease; chemistry (RNA, DNA), number of markers, methods (e.g. qPCR), number of functional domains if indicated; specimen type; algorithmic result (e.g. if prognostic0, report type (e.g. risk score).
- Are any CPT codes currently used to report the test?
- Are existing codes "integral to" the test (e.g. do not report duplicatively).
- For what diagnoses does the test have clinical utility?
- Provide a clinical vignette (short template provided; a sentence or two).
- Provide a brief description of the service (short template provided; a couple sentences).
- Attach documentation via file upload.
- CLSI lab protocol.
- FDA insert if relevant.
- Copies of positive and negative reports
(Note that I have summarized the questions; see the full AMA website for the full questions). Authors can prepare their application via online forms and store and revise until it's ready to submit.
The Strangest Ever: FMI CDx at MAC, FDA, and CMS Without Review of Panel Utility
On November 30, 2017, CMS released a draft blanket coverage determination for the Foundation Medicine F1CDx test for all cancer patients with tumors for which it is on-label, expanding on a rolling basis with label expansion.
There are some unusual follow-on aspects of the decision. For example, if the F1CDx covers one PMA gene in a certain cancer, and even if that gene is already known positive or negative based on the prior IVD that F1CDx is itself based on, F1CDx is still covered. (Let's say for a million patients at $3000, or $3B). This seems to imply F1CDx has some value beyond its on-label genes. However, neither FDA nor CMS ever broached that conclusion. Also puzzlingly, there will be some cancers where the F1CDx points only to off-label drugs for 95% of patients (especially if common mutations like EGFR have already been filtered out by prior testing). Despite requiring CED for all other testing approaches, the NCD doesn't require (or misses the opportunity to require) any form of records, tracking or CED for this huge cancer population, as long as their pathway to off-label drugs was via "failing to have an on-label drug on the F1CDx test."
Everybody "Defined-Away" the Clinical Utility of Large Panels
There has been huge debate in the US and world oncology literature on the value of large gene panel tests, and Vinay Prasad of OHSU has publicly protested that the F1CDx coverage decision is premature (here).
In succession, MolDX, FDA, and CMS defined away this question in their reviews.
MolDx Decision
The MOLDX LCD for FMI F1 (L36198) doesn't state that 300- or 400 gene panel tests are medically necessary. Rather, the LCD discusses that for one or two identified genes, like EGFR, if you do an FDA IVD point mutation test, it will pick up certain common mutations, and if you sequence that known PMA biomarker gene, you will pick up several extra actionable mutations (e.g. 17% more). What is done with, or why, regarding the other 300 or 400 genes that the test reports simply isn't brought into the question.
FDA Decision
Go to the FDA F1CDx webpage (P170019, here) and look up the safety and effectiveness review document. In the pivotal risk-benefit determination, page 55, section C, FDA states that "F1CDx assay has demonstrated non inferiority to companion diagnostics [reviewed in Section X] and therefore, does not introduce additional risks above [the] other approved devices." FDA has been able to define away any actions with any of the additional several hundred genes since they are not on-label claims, so, as judges say, FDA need not reach or speculate towards any conclusion on the large panel, in order to approve F1CDx.
FDA also comments that the F1CDx was not referred to an advisory panel because all questions or issues in the F1 PMA duplicate information already reviewed (e.g. the prior review of the single EGFR gene for erlotinib.)
CMS Decision
Finally, while CMS's NCD is 40 to 60 pages long, depending how you print it, the pivotal decision for coverage of F1CDx at the end is extremely brief, and merely states because F1CDx includes PMA on label genes, F1CDx is "reasonable and necessary." Any emergent or associated collateral risks or benefits, or whether the test "meets but does not exceed the patient's need" (a traditional CMS metric), simply don't enter into the final decisional sentences.
Is This Good Or Bad?
I mostly see the NCD as having a lot of weird consequences that people will look back in in 3, 6 or 12 months and say, "Wow." For example, leukemia seems to be under the NCD (it's oncology), but there are no PMA gene panel tests, and no 510(k) tests, so coverage of genetic testing is available only in NCI trials, and for the most common genes and drugs, those trials won't even exist any more. (Alternately, leukemia patients must be in C.E.D., for which CMS mandates RECIST imaging testing for participation, which leukemia patients can't do, so they can't get the C.E.D. arm.) Another "wow" is that very soon, massive numbers of Medicare patients without any on-label genetic results will get lots and lots and lots of off-label genetic results, for which no plan is made.
My main point is that one would think that along the pathway to this decision, CMS or FDA would have "had to have" looked at clinical utility (or net risk benefit) of large gene panel tests, and they didn't, at least not in the pivotal decisional parts of their documents.
____
I posted a very informal, freehand summary of the FDA concordance studies for F1 CDx, here.
There are some unusual follow-on aspects of the decision. For example, if the F1CDx covers one PMA gene in a certain cancer, and even if that gene is already known positive or negative based on the prior IVD that F1CDx is itself based on, F1CDx is still covered. (Let's say for a million patients at $3000, or $3B). This seems to imply F1CDx has some value beyond its on-label genes. However, neither FDA nor CMS ever broached that conclusion. Also puzzlingly, there will be some cancers where the F1CDx points only to off-label drugs for 95% of patients (especially if common mutations like EGFR have already been filtered out by prior testing). Despite requiring CED for all other testing approaches, the NCD doesn't require (or misses the opportunity to require) any form of records, tracking or CED for this huge cancer population, as long as their pathway to off-label drugs was via "failing to have an on-label drug on the F1CDx test."
Everybody "Defined-Away" the Clinical Utility of Large Panels
There has been huge debate in the US and world oncology literature on the value of large gene panel tests, and Vinay Prasad of OHSU has publicly protested that the F1CDx coverage decision is premature (here).
In succession, MolDX, FDA, and CMS defined away this question in their reviews.
MolDx Decision
The MOLDX LCD for FMI F1 (L36198) doesn't state that 300- or 400 gene panel tests are medically necessary. Rather, the LCD discusses that for one or two identified genes, like EGFR, if you do an FDA IVD point mutation test, it will pick up certain common mutations, and if you sequence that known PMA biomarker gene, you will pick up several extra actionable mutations (e.g. 17% more). What is done with, or why, regarding the other 300 or 400 genes that the test reports simply isn't brought into the question.
FDA Decision
Go to the FDA F1CDx webpage (P170019, here) and look up the safety and effectiveness review document. In the pivotal risk-benefit determination, page 55, section C, FDA states that "F1CDx assay has demonstrated non inferiority to companion diagnostics [reviewed in Section X] and therefore, does not introduce additional risks above [the] other approved devices." FDA has been able to define away any actions with any of the additional several hundred genes since they are not on-label claims, so, as judges say, FDA need not reach or speculate towards any conclusion on the large panel, in order to approve F1CDx.
FDA also comments that the F1CDx was not referred to an advisory panel because all questions or issues in the F1 PMA duplicate information already reviewed (e.g. the prior review of the single EGFR gene for erlotinib.)
CMS Decision
Finally, while CMS's NCD is 40 to 60 pages long, depending how you print it, the pivotal decision for coverage of F1CDx at the end is extremely brief, and merely states because F1CDx includes PMA on label genes, F1CDx is "reasonable and necessary." Any emergent or associated collateral risks or benefits, or whether the test "meets but does not exceed the patient's need" (a traditional CMS metric), simply don't enter into the final decisional sentences.
Is This Good Or Bad?
I mostly see the NCD as having a lot of weird consequences that people will look back in in 3, 6 or 12 months and say, "Wow." For example, leukemia seems to be under the NCD (it's oncology), but there are no PMA gene panel tests, and no 510(k) tests, so coverage of genetic testing is available only in NCI trials, and for the most common genes and drugs, those trials won't even exist any more. (Alternately, leukemia patients must be in C.E.D., for which CMS mandates RECIST imaging testing for participation, which leukemia patients can't do, so they can't get the C.E.D. arm.) Another "wow" is that very soon, massive numbers of Medicare patients without any on-label genetic results will get lots and lots and lots of off-label genetic results, for which no plan is made.
My main point is that one would think that along the pathway to this decision, CMS or FDA would have "had to have" looked at clinical utility (or net risk benefit) of large gene panel tests, and they didn't, at least not in the pivotal decisional parts of their documents.
____
I posted a very informal, freehand summary of the FDA concordance studies for F1 CDx, here.
Sunday, January 7, 2018
Very Brief Blog: Tracking JP MORGAN HEALTHCARE CONFERENCE
The JP Morgan Healthcare conference 2018 (36th Annual) is meeting this week in San Francisco, with satellite events Sunday, January 7, and the main invitation-only conference running all week at the St Francis Hotel Convention Center at Union Square.
Even the agenda of the conference is not readily available. JP Morgan publishes a very short website for JPMHC18 here, and JP Morgan Global publishes a somewhat longer website here. (IT has a rather curt FAQ section, such as: Q: Where can I get an agenda? A: Agendas are available only to attendees.")
JPMorgan seems to endorse #JPMHC18 as the official Twitter hashtag, although there is also a lot of usage of #JPM18 too.
See a webfeed on Twitter for #JPMHC18 by clicking here. (Hardcore Twitter fans that also want to see #JPM18 can find it here.)
There is a long list of activities (including listing for many marked as "private"like the Harvard Business School JPM recewiption) at: JPM.HEALTH, here.
Update.
From the public INVIDIOR.COM investor web site, here, there is a public link to the JP Morgan webpage for agenda and links to most all presentations on the conference as archived streaming audio or video, here. Email registration required for entry.
Even the agenda of the conference is not readily available. JP Morgan publishes a very short website for JPMHC18 here, and JP Morgan Global publishes a somewhat longer website here. (IT has a rather curt FAQ section, such as: Q: Where can I get an agenda? A: Agendas are available only to attendees.")
JPMorgan seems to endorse #JPMHC18 as the official Twitter hashtag, although there is also a lot of usage of #JPM18 too.
See a webfeed on Twitter for #JPMHC18 by clicking here. (Hardcore Twitter fans that also want to see #JPM18 can find it here.)
There is a long list of activities (including listing for many marked as "private"like the Harvard Business School JPM recewiption) at: JPM.HEALTH, here.
Update.
From the public INVIDIOR.COM investor web site, here, there is a public link to the JP Morgan webpage for agenda and links to most all presentations on the conference as archived streaming audio or video, here. Email registration required for entry.
Tuesday, January 2, 2018
Very brief blog: MobiHealthNews Summarizes 224 DHealth Investments ($5B)
In a year-end article for 2017, MobiHealthNews summarizes 224 investments in digital health, ranked in tiers ($100M or more; $50M-100M, etc). Each investment is briefly summarized and carries a link to more information. Online here.
Investments tallied $1.3B in Q1, $2.6B in Q2, and about $550M in Q3 and Q4 each.
Investments tallied $1.3B in Q1, $2.6B in Q2, and about $550M in Q3 and Q4 each.
 |
| click to enlarge |
Tuesday, December 26, 2017
NEW 20 PAGE WHITE PAPER ON CMS NEXT GEN SEQUENCING NCD
On November 30, 2017, CMS released a 65-page, 45,000 word NCD proposing an entirely new policy approach to all uses of next generation sequencing in oncology.
I've had the chance to talk to a number of stakeholder groups and read the NCD several times, as well as underlying documents such as the FDA approval review for FMI F1 CDx.
Here, I post a 20 page (7000 word) white paper on the NCD and its potential implications.
Version: 03, January 2, 2018. * HERE * - click arrow upper right to download.
This white paper was downloaded 450 times (December 25-January 5). More after the break.
I've had the chance to talk to a number of stakeholder groups and read the NCD several times, as well as underlying documents such as the FDA approval review for FMI F1 CDx.
Here, I post a 20 page (7000 word) white paper on the NCD and its potential implications.
Version: 03, January 2, 2018. * HERE * - click arrow upper right to download.
This white paper was downloaded 450 times (December 25-January 5). More after the break.
Sunday, December 24, 2017
Friday, December 22, 2017
Very Brief Blog: J Mol Dx Article on History of Genomic Reimbursement & Coding
New online at Journal of Molecular Diagnostics (included with Association for Molecular Pathology membership). Hsiao, Mansukhani, Carter, and Sireci of Columbia University have written an in depth study of actual changes in reimbursement (and coverage) in their molecular laboratory as policy, coding, and fee schedules have rapidly evolved in recent years.
The in press manuscript is online here. Don't miss the interesting graphics from page 20 forward.
ABSTRACT
Changes in coding and coverage create uncertain reimbursement environment for molecular pathology laboratories.
We analyzed our experience with two representative molecular oncology tests: a T-cell receptor (TCR) beta rearrangement test and a large (467 gene) cancer next-generation sequencing panel the Columbia Combined Cancer Panel, CCCP.
Prior to 2013, the TCR beta test was coded using “stacked” current procedural terminology codes and subsequently transitioned to a tier 1 code. CCCP was coded using a combination of tier 1 and 2 codes until 2015, when a new Genomic Sequencing Procedure code was adopted. A decrease in reimbursement of 61% was observed for the TCR beta test upon moving from stacking to tier 1 codes. No initial increase in total rejection rate was observed but a subsequent increase in rejection rates in 2015 and 2016 was noted.
The CCCP test showed a similar decrease (48%) in reimbursement following the adoption of the new genomic sequencing procedure code and was accompanied by a sharp increase in rejection rates both on implementation of the new code and over time.
Changes in coding can result in substantial decreases in reimbursement. This may be a barrier to patient access due to the high cost of molecular diagnostics. Revisions to the molecular code set will continue. These findings help laboratories and manufacturers prepare for the financial impact and advocate appropriately.
Sample graphic:
The in press manuscript is online here. Don't miss the interesting graphics from page 20 forward.
Changes in coding and coverage create uncertain reimbursement environment for molecular pathology laboratories.
We analyzed our experience with two representative molecular oncology tests: a T-cell receptor (TCR) beta rearrangement test and a large (467 gene) cancer next-generation sequencing panel the Columbia Combined Cancer Panel, CCCP.
Prior to 2013, the TCR beta test was coded using “stacked” current procedural terminology codes and subsequently transitioned to a tier 1 code. CCCP was coded using a combination of tier 1 and 2 codes until 2015, when a new Genomic Sequencing Procedure code was adopted. A decrease in reimbursement of 61% was observed for the TCR beta test upon moving from stacking to tier 1 codes. No initial increase in total rejection rate was observed but a subsequent increase in rejection rates in 2015 and 2016 was noted.
The CCCP test showed a similar decrease (48%) in reimbursement following the adoption of the new genomic sequencing procedure code and was accompanied by a sharp increase in rejection rates both on implementation of the new code and over time.
Changes in coding can result in substantial decreases in reimbursement. This may be a barrier to patient access due to the high cost of molecular diagnostics. Revisions to the molecular code set will continue. These findings help laboratories and manufacturers prepare for the financial impact and advocate appropriately.
Sample graphic:
 |
| click to enlarge |
Thursday, December 21, 2017
Health Executive Adam Boehler Might Head CMMI Next
According to a tweet from PoliticoPro, health executive Adam Boehler might become the new head of the billion dollar Center for Innovation at Medicare (the CMMI). Tweet here.
Boehler's Linked In is here. He's also listed at Bloomberg biographies here, and his profile as CEO of Landmark Health is here.
Boehler comes out of the Wharton School and has had both venture capital and operational roles. He was previously involved with a 25-lab network with 3000 employees, aLabs. According to Bloomberg, he's Chair and President at Landmark; Executive Chairman at Avalon Health.
Landmark Health, where he's currently CEO, is designed to provide superior, next-generation home health care and home based medical care to patients "24/7/365." Earlier this month, Landmark recently hired Christopher Goldsmith (of Optum and with an INSEAD MBA) as President.
Previous CMMI director Dr Patrick Conway stepped down in mid-year to join North Carolina BCBS. CMMI is rebooting itself for new directions under the new administration.
Boehler's Linked In is here. He's also listed at Bloomberg biographies here, and his profile as CEO of Landmark Health is here.
Boehler comes out of the Wharton School and has had both venture capital and operational roles. He was previously involved with a 25-lab network with 3000 employees, aLabs. According to Bloomberg, he's Chair and President at Landmark; Executive Chairman at Avalon Health.
Landmark Health, where he's currently CEO, is designed to provide superior, next-generation home health care and home based medical care to patients "24/7/365." Earlier this month, Landmark recently hired Christopher Goldsmith (of Optum and with an INSEAD MBA) as President.
 |
| click to enlarge |
Previous CMMI director Dr Patrick Conway stepped down in mid-year to join North Carolina BCBS. CMMI is rebooting itself for new directions under the new administration.
Feds Release Surprisingly Affordable Report on Excessive Drug Prices
On November 30, 2017, the National Academy of Medicine released a free 200 page report on the problem of excessive drug prices.
Drug costs have been a concern for generations; Senator Kefauver of Tennessee began hearings on drug price-fixing when he was told (in 1955!) that two different antibiotics at his corner pharmacy both cost exactly $3. (This vendetta eventually transformed and morphed into the Kefauver FDA amendments of 1963).
The NAM press release is here and the PDF report is available here. It comes with a one hour panel media presentation as archived video, here.
Coverage at:
This National Academies project is different than a mid November GAO report on drug profits compared to R&D spending; see the 70 page GAO report here and the Endpoints blog on it here.
Bonus reading.
For Bloomberg December as "Diabetes as the Messiest Drug Market," here. Also from Bloomberg in December, "FDA Targets Insulin" for excessive prices, here. Fpr a summer article at Bloomberg on "Crazy Math Behind Drug Prices," here.
Drug costs have been a concern for generations; Senator Kefauver of Tennessee began hearings on drug price-fixing when he was told (in 1955!) that two different antibiotics at his corner pharmacy both cost exactly $3. (This vendetta eventually transformed and morphed into the Kefauver FDA amendments of 1963).
The NAM press release is here and the PDF report is available here. It comes with a one hour panel media presentation as archived video, here.
Coverage at:
This National Academies project is different than a mid November GAO report on drug profits compared to R&D spending; see the 70 page GAO report here and the Endpoints blog on it here.
For Bloomberg December as "Diabetes as the Messiest Drug Market," here. Also from Bloomberg in December, "FDA Targets Insulin" for excessive prices, here. Fpr a summer article at Bloomberg on "Crazy Math Behind Drug Prices," here.
CMS Extends Comment Period on NGS/Cancer Proposed NCD
CMS has extended the comment period to January 17, 2017, on the currently debated National Coverage Determination for all uses of next generation sequencing in cancer. The NCD provides coverage only for PMA-approved tests used on-label in the relevant cancers. The NCD would cover patients who are part of clinical studies (coverage with evidence developments) for other uses of PMA- or 510(k)-approved NGS tests.
The tracking and dates page is here. The NCD is here.
The tracking and dates page is here. The NCD is here.
 |
| Comment deadline has been revised (old, Dec 29, new Jan 17) |
Tuesday, December 19, 2017
Regulatory Nerd Corner: Medicare Review Board Decision Narrows Scope of ALJ Review of LCDs
A section of law called BIPA 522, more than a decade old, gives a channel whereby a beneficiary can appeal an entire LCD rather than just his personal claim. The decision is fast-tracked to an Administrative Law Judge (ALJ).
In past cases, ALJs have ruled that there can be "constructive LCDs" - for example, if a contractor says in an Article that Service XYZ is not reasonable and necessary and is non-covered, that may not be formally called an LCD by its MAC author, but it is a de facto LCD, and can be appealed through the BIPA 522 channel.
A 2017 Medicare review board case reversed an ALJ who had broadly construed his ability to call something a constructive LCD based on a reasonable and necessary decision. In the case, a DME MAC had ruled that continuous glucose monitors were "not a benefit category" because they were "precautionary" to check for low glucose levels. The ALJ ruled this was equivalent to saying they were not reasonable and necessary and found the CGM should be covered. CMS escalated the case to a panel of review judges, who ruled that the decision of the MAC was a "benefit category decision" and therefore not accessible by the LCD review process, which is only for "reasonable and necessary" decisions.
The potential adverse affect is for devious MACs to couch decisions in articles rather than in LCDs and switch to terms like "experimental and investigational" or as "precautionary" or as "benefit category decisions" with an eye to avoiding the textual keywords that would allow review by ALJs under the LCD review channel. I never understood the reasoning around "precautionary" - all glucose tests are precautionary for an abnormal glucose finding, INR tests in warfarin patients are "precautionary" for an abnormal INR finding. An MRI in a unilateral headache patient could be styled as "precautionary" for discovering if he has a brain tumor, and so on.
The particular decision about CGMs is of historic interest now as later CMS decisions allow coverage of some CGMs.
In past cases, ALJs have ruled that there can be "constructive LCDs" - for example, if a contractor says in an Article that Service XYZ is not reasonable and necessary and is non-covered, that may not be formally called an LCD by its MAC author, but it is a de facto LCD, and can be appealed through the BIPA 522 channel.
A 2017 Medicare review board case reversed an ALJ who had broadly construed his ability to call something a constructive LCD based on a reasonable and necessary decision. In the case, a DME MAC had ruled that continuous glucose monitors were "not a benefit category" because they were "precautionary" to check for low glucose levels. The ALJ ruled this was equivalent to saying they were not reasonable and necessary and found the CGM should be covered. CMS escalated the case to a panel of review judges, who ruled that the decision of the MAC was a "benefit category decision" and therefore not accessible by the LCD review process, which is only for "reasonable and necessary" decisions.
- I describe in more detail here and provide links.
- DME benefit category decisions can have close overlap with reasonable and necessary decisions because categorizing something as DME invokes some steps that involve its medical use and purpose.
The potential adverse affect is for devious MACs to couch decisions in articles rather than in LCDs and switch to terms like "experimental and investigational" or as "precautionary" or as "benefit category decisions" with an eye to avoiding the textual keywords that would allow review by ALJs under the LCD review channel. I never understood the reasoning around "precautionary" - all glucose tests are precautionary for an abnormal glucose finding, INR tests in warfarin patients are "precautionary" for an abnormal INR finding. An MRI in a unilateral headache patient could be styled as "precautionary" for discovering if he has a brain tumor, and so on.
The particular decision about CGMs is of historic interest now as later CMS decisions allow coverage of some CGMs.
Subscribe to:
Posts (Atom)