Very Brief Blog: CPT Posts Website for September Seattle Meeting

Every four months, AMA CPT creates a new webpage for its next upcoming CPT editorial meeting.   This is where you find meeting agendas, registration links, etc.

The webpage for the AMA CPT September 2022 meeting in Seattle has been created.   Registration will open in early July.    

The opportunity for comment on lab applications for this cycle opens first, around July 1.  The opportunity to comment on other applications for this cycle should open around July 15.

https://www.ama-assn.org/about/cpt-editorial-panel/cpt-september-2022-editorial-panel-meeting

Cat III

On a separately note, I think that the Category III codes which will be effective in January 2023 will be posted around July 1, here.  It looks like new Cat III codes from the Feb 2022 and May 2022 meetings will release on July 2022, effective January 2023, but not published in the CPT book til 2024.  Multi-year Cat III calendar here.

PLA

On another calendar, the quarterly new PLA codes appear July 1, October 1, etc, at the bottom of this page here.

Very Brief Blog; SALSA Act, PAMA Reform: 13 Page Copy Here

Over the past week, there have been press releases and announcements about the proposed SALSA ACT, which would introduce several modifications to PAMA law for pricing lab tests at Medicare.  See the ACLA two-pager about PAMA SALSA, here.

See SALSA as Senate Bill 4449, online at Congress.gov here:

https://www.congress.gov/bill/117th-congress/senate-bill/4449/text

See my June 27 blog for additional links:

http://www.discoveriesinhealthpolicy.com/2022/06/very-brief-blog-congress-considers.html

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For a non random glimpse into the world of payer charges, discounts, private plan rates, and CMS rates, I've posted charges on some recent lab work for myself here.

Very Brief Blog; AMA Posts Webpage for "Tumor Genomics Testing Workgroup" for coding reform

The AMA is hosting a multi-stakeholder multi-session workgroup on potential coding reforms in genomics for tumor testing.   Note that the AMA recently made some published changes, such as codes for RNA-only studies in tumor tissue.

Find the web page as below.  Meetings will be held on July 11 (630 ET) and August 18 (6 ET).

https://www.ama-assn.org/about/cpt-editorial-panel/cpt-workgroups

Email registration is required, which is paired with a docusign confidentiality document.

Very Brief Blog: Congress Considers Legislation to Fix PAMA Lab Pricing

 A brief heads-up blog.  ACLA and other lab stakeholders support, and Congress has introduced, a legislative fix for PAMA called "SALSA" - Saving Access to Laboratory Services Act.

• Open coverage at 360Dx here.
• News at XIFIN, here.
• Press release from NILA, here.
• Press release ("two pager") from ACLA, here.  Advocacy page from ACLA, June 30, here.
• News from Congr. Pascrell (NJ) here. (Wednesday, June 22, 2022).

The most complete analysis is at the ACLA two-pager, linked above.  It's now also posted at CONGRESS.GOV, as S. 4449, here.

From ACLA's two pager, key bullets are:

• Use statistical sampling instead of reporting billions of transactions.
• Guardrails against too-rapid payment reduction.
• Exclude Medicaid managed-care rates.
• By law, Medicaid rates can't exceed Medicare rates, so these could only pull downward.  Manually-processed claims would also be excluded from PAMA.
• Report every 4 years (not every 3).

PAMA Sometimes Yielded Crazy Rates on New Codes

PAMA sometimes yielded crazy rates especially on more recent codes.  For example, in 2017, CMS paid about $2500 for BRCA testing (81162) and $931 for 81432 (BRCA and related genes panel.)  But 81432 priced at $136 via PAMA, a crazy price unrelated to costs.   81435, Lynch colon cancer panel, was being paid at $802 on the CLFS, but got a $37 price under PAMA - even crazier.  The impact of these lunatic PAMA results was tempered by the guardrails on the speed of annual price reductions.  Oops:  SALSA limits rate decreases to 5% or less, but also, caps rate increases to 5%.   This means the Lynch gene code priced at $37 would never normalize to the $500 range (rising at 5% a year from $37; 54 years to reach $500).  

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History tidbit.  PAMA comes from March 2014; in 2008, an effort to replace lab pricing by competitive bidding was stopped in court - here.

SALSA Support:

Representatives Bill Pascrell (NJ-09), Richard Hudson (NC-08), Scott Peters (CA-52), Kurt Schrader (OR-05), and Gus Bilirakis (FL-12) introduced companion legislation in the U.S. House of Representatives on June 22, 2022.

Senator Richard Burr (R-NC), Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP), and Senator Sherrod Brown (D-OH) introduced the Saving Access to Laboratory Services Act, bipartisan legislation to update Medicare’s payment system for clinical diagnostic laboratory services, ensuring seniors have access to the most innovative tests and treatments on the market.

Very Brief Blog: Heads Up: Optum Press Release on Lab Waste; Press.

 A "heads-up" brief blog.

On June 22, 2022, Optum issued a press release on new programs to reduce unnecessary lab testing through lab benefit management (LBM).   Find it here:

https://www.unitedhealthgroup.com/newsroom/2022/2022-06-22-optum-launches-lab-benefit-mgmt-solution.html

Note there is a link to Optum's home page for its suite of LBM services:

https://www.optum.com/business/solutions/health-plans/cost-of-care/laboratory-benefit-management.html

See some coverage at the trade journal Health Care Dive, here:

https://www.healthcaredive.com/news/unitedhealth-optum-cut-down-unnecessary-lab-testing/626080/

See one of many articles on LBMs at Dark Report / Dark Daily - here; see a 2019 article by Phillips and Deverka at Heath Affairs, here.

There's some math in the press release, suggesting the program will save "$3B" which is correct if applied to 85M people at $36 per year (PMPY).  Predicted savings are $12-36 PMPY or around $2 PMPM.   

Very Brief Blog: CMS Updates Roster of Lab Pricing Panel Members

 On June 23 last week, CMS held the public comment meeting for pricing new lab tests (there were 35 speakers and a spectrum of about 100 codes in play).   The next step in this process is the publicly streamed meeting of a CMS advisory panel of experts, which will be July 18-19.

The panelists will form four or five subgroups, each of which will take a deep dive on about 20 codes.  During the meeting, the subgroup for each code will describe its findings (for a minute or two), and the panel will discuss.   The public does not have a voluntary opportunity to comment, but panelists MAY elect to ask if their is a representative for that code observing online, and if he/she can answer a question.

Panelists then vote on one or more pricing choices.

In June 2022, CMS updated the public list of the 14 panel members.  

Here's the web page for the panel:

https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests

Here's the link to the PDF Roster:

https://www.cms.gov/files/document/panel-roster.pdf

Nerd Note: Medicare Advantage Plans Don't Have to Follow Many Part B Rules; Example

There's a general principal that Medicare Advantage plans aren't required to follow the (tens of thousands of pages of) CMS Part B claims processing rules.   But sometimes it's nice to have a citation to that at hand.

Here's one.

In November 2021 rulemaking for CY2022, in the Physician rule, CMS discussed the uber-complex area of Appropriate Use Criteria (AUC) for advanced imaging.  This is software that clinicians are supposed to use when ordering e.g. MRI for back pain.  Much ink has been spilled over this since 2014 (start here), when it was introduced in the same legislation that created PAMA rules for lab pricing.

After another year of numbingly detailed rules and exceptions for AUC claims processing, CMS fields a question "Do Medicare Advantage claims require AUC information?"   86 Fed Reg 65235.

The answer is NO, but they MIGHT, and you have to check with each Medicare Advantage plan to find out.  (There are LOTS of Medicare Advantage plans, making this tedious.   But the general principal, you can cite to 86 Fed Reg 65235, 2021.  Fun fact: Kaiser says there are 3,834 Med Adv plans.

(For a really useful table of when commercial insurance follows, or don't follow, bundling rules similar to CMS for lab tests, see my June 2022 blog here.)

86 FR 65235

SCOTUS Lets CMS Rule for Hospital Payments Stand; But Dissent is Interesting

We often think of SCOTUS decisions has having major moral or political debates at risk (gun rights, inter-racial marriage).   But many cases hinge on what a term means, or whether two terms are synonyms, or whether an adjective modifies one word or another.

Such a syntactical decision was handed down June 24, 2022, as  Becerra v Empire Health.  It has to do with the way Medicare "disproportionate share" extra dollars are divided up, and in particular, how the Medicare patients and days are accounted for.   Empire Health thought the statute requires hospitals to get a better deal, but SCOTUS decides the current CMS regulations are correct and no change is warranted.

It's interesting for two reasons:

First, the 5-4 decision split the conservative bench.  The dissent, beginning on page 24 of 27, is written by Kavanaugh with Roberts, Alito, and Gorsuch joining him.   (In short, a lot of conservatives dissented, and would have taken a position helpful to hospitals.)   

The majority opinion comes from Kagan and Breyer and Sotomayor, but was joined by both Thomas and Barrett as well.

Second, the dissent is pretty fun to read, once you know the basic issue in the case.

Sources include:

• CNN here.
• Law and Crime blog here.  
• Bloomberg here.
• An older article on the live hearing.
• Decision here, 27-page PDF, dissent at p. 24.

Opening of the Kavanaugh Dissent clipped below:

Under the Medicare statute, HHS pays higher reimbursements to hospitals that serve a significant number of low-income patients. The statutory formula for determining exactly how much HHS will pay to those hospitals is mind-numbingly complex. But embedded within the complicated overall formula are various subsidiary calculations, some of which are relatively straightforward. 

This case concerns one of those straightforward subsidiary calculations. 

Consistent with traditional insurance and coordination-of-benefits principles, Medicare by statute cannot pay for a patient’s hospital care if, for example, the patient is covered by private insurance, the patient has exhausted her Medicare benefits, or a third-party tortfeasor is liable for the patient’s care. 

The retrospective reimbursement question raised by the statutory provision in this case is this: Was a patient “entitled to” have payment made by Medicare for a particular day in the hospital if the patient by statute could not (and did not) have payment made by Medicare for that day? In my view, the answer to that narrow question is straightforward and commonsensical: No.

Importantly, from the time the statute was enacted in 1986 until 2003, HHS interpreted this statutory provision in the exact same way that I do. See 51 Fed. Reg. 31460−31461 (1986); Brief for Petitioner 32−33. Then in 2004, HHS abruptly changed course. Why? Presumably to save money. HHS was trying hard to find ways to contain Medicare costs in light of increasing Medicare expenditures and the country’s fiscal situation. ....

To begin, both parties offer a dog’s breakfast of arguments about broad statutory purposes, real-world effects, surplusage, structure, consistent usage, inconsistent usage, agency deference, and the like. But this case is resolved by the most fundamental principle of statutory interpretation: Read the statute.....

 Zero in on the phrases “entitlement to have payment made” and “for such days.” In my view (and in HHS’s view from 1986 to 2003), a patient was entitled to have payment made by Medicare for particular days in the hospital if Medicare was obligated to pay for the patient’s care for those days. Stated the other way, a patient was not entitled to have payment made by Medicare for particular days in the hospital if the patient by statute could not (and did not) have payment made by Medicare for those days—for example, because the patient had other insurance, the patient had exhausted his Medicare benefits, or a third-party tortfeasor was paying. Simple enough. To be sure, patients who satisfy certain criteria (for example, those who are age 65 or older) are generally “entitled” to Medicare hospitalization benefits. No one disputes that point. But this reimbursement provision looks to whether the patient was entitled to have payment made by Medicare for a particular day in the hospital. And the answer to that question is no if Medicare by statute could not (and did not) pay for that day in the hospital.

[Schroedinger's Cat here:]

...A patient cannot be simultaneously entitled and disentitled to have payment made by Medicare for a particular day in the hospital.

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Referring to the majority ruling, "The Court concludes otherwise...[by #3...]...invoking a parade of horribles about what could happen to other provisions of the Medicare statute if the Court were to read this as I would.   With respect, none of that stands up."   ....

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I like the term "Parade of horribles;" I used it in a webinar earlier this week.   Opponents of the 2016 MCIT policy at Medicare "invoked a parade of horribles" which I felt were over hyped.  

 

MolDx Releases Draft LCD: Diagnosis of the Difficult Melanoma

See an October 2022 update with some additional facts and comments.

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One of the first gene expression tests to help decide ambiguous pathology was the Veracyte AFIRMA test, for thyroid FNA cases that were not clearly benign or malignant.

Here's a MolDx LCD for similar tests designed for the difficult melanoma biopsy.  It's DL39345, released on June 23 for comment.  Find it here.  Comment open til August 6.

The LCD has a direct cross-reference to L37859, "MyPath Melanoma Assay."  It has a new proposed billing article, DA59109.  The billing article lists the DL39345 as pertaining to 0090U (melanoma, mRNA, 23 genes) and 0314U (melanoma, mRNA, 35 genes).   0090U is Myriad MyPath, now, Castle MyPath, and 0314U is DecisionDx DiffDx Melanoma, also Castle.  0314U is in the CMS crosswalk/gapfill new code process this summer.   0090U is an ADLT test priced at $1950 in 2019 and still $1950 on the 2022 CLFS fee schedule.

 L37859:

The older myPath LCD has a short rule list:

• The test is ordered by a board-certified dermatopathologist,
• The specimen is an equivocal primary cutaneous melanocytic neoplasm,
• The patient may be subject to additional intervention, such as re-excision or sentinal node biopsy.

DL39345:

• The test is ordered by a board-certified or board-eligible dermatopathologist
• The specimen is a primary (non-metastatic, non-re-excision specimen) cutaneous melanocytic neoplasm for which the diagnosis is equivocal/uncertain (i.e., clear distinction between benign or malignant cannot be achieved using clinical and/or histopathological features alone) despite the performance of standard-of-care test procedures and relevant ancillary tests (i.e., immunohistochemical stains)
• The specimen includes an area representative of the lesion or portion of the lesion that is suspicious for malignancy
• The patient may be subjected to additional intervention, such as re-excision and/or sentinel lymph node biopsy, as a result of the diagnostic uncertainty
• The patient has not been tested with the same or similar assay for the same clinical indication
• The test is validated for use in the intended-use population and is performed according to its stated intended-use
• The test demonstrates Analytical and Clinical Validity (AV and CV) and Clinical Utility (CU) and undergoes a technical assessment (TA) by MolDx®to demonstrate compliance of the service with this policy

Pricing at Annual Lab Meeting, June 23, 2022

Castle presented at the CMS CLFS Annual Lab Meeting (aka the crosswalk gapfill meeting) today, June 23.   They requested that 0314U, their 35 gene melanoma test, be crosswalked to 0090U $1950, a test they now own, acquired from Myriad.    

Separately, they are looking for a price on 0315U, their squamous cell carcinoma test, and are asking for that to be priced at $7193, the same as code 81529.  their recurrence-risk test for cases of known cutaneous melanoma.  81529 is an ADLT test, as is 81552, their earlier uveal melanoma test, $7776.   

Today, Castle rose steadily 20%, from about $18 to $22.  (NASDAQ was up 1%).   However, Castle is down from an August 2021 high of $76. 

Regarding MyPath and Clinical Utility

Medicare likes to know what happens when tests are actually put into the clinic.  Here's a quote from DL39345 regarding MyPath and clinical behavior:

• The treatment differed from the pre-test recommendation in 55 of 77 (71.4%) cases, 44 of which produced a benign myPath® test result. 
• 
  
• Re-excision was the pre-test treatment recommendation for 41 of these 44 cases, yet re-excision was ultimately performed in just 7, indicating that a benign myPath® test result enabled dermatologists to forego further intervention in 33 of the 41 cases, yielding an 80.5% reduction in re-excisions.

From Branded to Foundational LCD

MolDx is shifting from branded LCDs and to "foundational" (categorical) LCDs.  

L37859 was titled, "MolDX: myPath(R) Melanoma Assay."  The replacement LCD has a broader and non-branded title:  "MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma."

Congress: Make ARPA-Health More Independent of NIH

The usually reliable "Government Executive" trade journal has an article today that "Defying Biden, Congress Moves to Give New Health Research Agency More Independence."  The trigger is, they say that H.R. 5585, the Advanced Research Project Agency-Health (ARPA-H) is close to moving forward on the hill.  And it sets up ARPA-H as a largely independent agency, not just a new division inside NIH.

• See the article here.
• See the text of HR 5585 here.
• See June 23 article on ARPA location  here.
• (See also a June 27 op ed at WSJ here.)

The article emphasizes this was not the direction desired by either the White House or HHS itself.  (By the way, see Federal Register organizational postings from NIH and HHS on ARPA-H on May 27 here (87FR32174) and April 20 here (87FR23526).  See also a March 2022 article in Science about "the way it was" a few months ago - here.  See a May article, search down for ARPA (here).

The overall goal is that ARPA will resemble the impact and flexibility of DARPA and BARDA (Defense and Biodefense research institutions), and recreate the impact and flexibility of "Operation Warp Speed" for COVID in 2020.   

See my blog collating some OWS resources in January 2022 (here).  There's definitely been a bit of an uptick lately in the ARPA-H echo chamber.   See a May 2022 anti-ARPA-H article here.  See a STAT-PLUS article on ARPA-H's future "independentness," June 3, 2022, here.

Related Theme: Payers and Health Innovation

ARPA-H is meant to greatly increase the resources and effectiveness of translational research and implementation of innovations.  There have been a handful of articles on this general topic lately.  See an article this week (June 21) by Blanco et al. (NIH and CMS authors) in JAMA:

• From Scientific Discovery to Covered Treatments: Understanding the Payer Perspective as a Keystone to Achieving High-Value Care.  JAMA 327:2285, Blanco et al., 6/2022.  (This quite short article has a title word to text word ratio of 1:88, not sure if that is a good thing or a bad thing.)

There was also an article on the same theme in Cancer a few months ago regarding industry, payors, and MCED:

• Industry engagement: Accelerating discovery, application, and adoption through industry partnerships.  Cancer 128:S4:918, Peralta et al. (authors include Exact and Grail), 2/2022.

I'm not sure it's a natural partnership, or even a possible one, as Blanco and Peralta might content.  See a Supreme Court decision today allowing health plans to turf ESRD patients efficiently to Medicare ESRD programs, by making dialysis almost impossible to receive within the commercial health plan.  This does not discriminate against ESRD patients, which would be illegal, because the plan has negligible dialysis benefits equally both for ESRD patients and patients without ESRD.   The case is called Marietta.  (That stretch for a non discrimination stance reminds me of an argument with the Loving v West Virginia case in the 1960s, where it was argued that laws banning inter-racial marriage were not racially discriminatory because they prevented black period from marrying whites but equally, prevented white people from marrying blacks.  Pari passu, Marietta makes it equally difficult for the ESRD people and the non-ESRD people to get dialysis.)  

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For more on Operation Warp Speed, I have three book titles at hand:

• Longshot: Inside Story of the Race for a COVID 19 Vaccine, David Heath, 2/2022
• https://www.amazon.com/dp/B0942ZCK3X/ref=dp-kindle-redirect?_encoding=UTF8&btkr=1
• 
  
• The First Shots: Epic Rivalries and Heroic Science Behind the Race to the Corona Vaccine, by Brendan Borrell, 10/2021 
• https://www.amazon.com/dp/B095H82877/ref=dp-kindle-redirect?_encoding=UTF8&btkr=1
• 
  
• A Shot to Save the World: Inside Story of the Life or Death Race for a COVID 19 Vaccine, by Gregory Zuckerman, 10/2021  
• https://www.amazon.com/dp/B098RQP754/ref=dp-kindle-redirect?_encoding=UTF8&btkr=1

Very Brief Blog: CMS Starts NCD Process on Beta-Amyloid PET Scans

CMS reopens discussion on a ten-year-old NCD that allows beta-amyloid PET scans to be covered only in clinical trials.

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Famously, over the past year CMS announced then finalized a decision not to cover the Alzheimer drug Aduhelm (except in new RCTs).  Here.   In the background was the last time they considered a NCD on an Alzheimer product - when they reviewed the Lilly amyloid tracer Amyvid in 2013 (negative outcome here.)   Since then, for nearly a decade, CMS has covered PET scans with Amyvid (or similar tracers) in a few studies, notably one called IDEAS.   From time to time there have been complaints (e.g. a 2021 letter to CMS on the poor Amyvid coverage, here. Authors included the American Academy of Neurology.) 

With the uptick in interest in Alzheimer's disease drugs, and more coming through the FDA pipeline, it's been asserted that this should be a golden age for Alzheimer diagnostics - for example, a 2021 article in Forbes, here.  The FDA approved the first-ever CSF test for Alzheimer's disease, a Fujirebio amyloid protein test, in May 2022, here.  And with the current boom in the horizons of sensitive proteomics, blood-based Alzheimer tests for tau and amyloid may not be far off.  See a 2022 open access review on PubMed, here.

On June 16, 2022, CMS opened a new NCD process, seeking public comment on whether (and how) to reconsider its non-coverage of Amyloid PET scans.  See the CMS webpage for this topic here.   

CMS writes, 

CMS internally generated the opening of this NCD analysis based on stakeholder feedback, including public comments received during the finalization of the NCD for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease because clinical study protocols may involve more than one PET Aß scan per patient.

The timeline proposed is the typically slow one for NCDs.  CMS opens public comment on the "idea," now, til July 15, and then will issue a proposed decision by December 16.   While CMS could issue a proposed decision faster, it almost always issues a proposed decision after the full six month delay the law allows.

Neogenomics Provides Insights Into Commercial Payers & Hospital Test Bundling

Note, on August 2, the main link of the original blog doesn't appear to be a live link at Neogenomics anymore.   

Neogenomics does have a webpage for "billing" and one for "third party billing" which have other useful resources.

https://neogenomics.com/billing

https://neogenomics.com/billing/third-party-billing

Original blog follows.

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Recently, on June 3, 2022, I published a blog about how the Medicare outpatient test bundling system works.   For example, CMS defines DNA-RNA MAAA tests as "molecular pathology" and unbundles them from a hospital outpatient visit.  But conventional tests (such as thyroid hormone or PSA) and non-DNA-RNA tests (like proteomic MAAA tests) are generally assigned a "Q4" modifier and bundled to the visit or procedure.  See June 3 blog here.  The rules were complexified during the Trump Administration, although basically in a way that made more tests separately billable.

One question clients always ask is, OK, Medicare bundles inpatient and outpatient tests under various (sometimes complexified) rules, what do commercial payers do?    

Neogenomics provides us some answers online.   Neogenomics is a large genomics laboratory, with a market cap approaching $1B and some $500M in 2021 revenue (here).

Neogenomics has a helpful claims processing overview on its website -

• https://neogenomics.com/sites/default/files/2021-07/Billing_Flow_Chart_for_Testing_CORP-MRKT-0061_042021_FINAL.pdf

Neogenomics notes (fine print) it is an educational tool and each lab or party has to ascertain the correct rules that apply to it.

Basically, payors that follow the Medicare rules tend to be Med Adv plans, Humana, United Healthcare, and several BCBS plans for inpatient bundling.  (Other payers may except a test claim for the inpatient).   For hospital registered outpatients, molecular tests are billed straight to medicare (outside the bundle), while for many private payers, for their hospital outpatients, the molecular lab bills to the hospital, who presumably bills it onward to the payor.   For other private payers, they want to be billed directly for outpatient molecular testing, and NOT use the hospital as a middleman.   It's all on the slide at the PDF link above.

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They also provide a PDF listing of payers that typically require prior auth for genomics:

https://neogenomics.com/sites/default/files/2021-07/Prior-Authorization-Insurance-Plans-and-CPT-Codes_CORP-MRKT-0038_120820.pdf

CMS Cancels ICD-10 Changes That Erroneously Made Your Cancer Claims Unpayable

Summary

In May 2021, CMS announced it was deleting a significant number of  ICD-10 cancer codes that had historically been payable (5/5/2021 blog here).   The deletions affected the operation of NCD 90.2, which governs next-gen sequencing in cancer payments.  

I also made a video explaining how nutty this was - May 5, 2021 here.  In June 2022, CMS has given up the crazy idea.  

See June 30 coverage at Genomeweb, here.  See press from Diaceutics here.

_________

In brief, in May 2021, CMS was about to delete from coverage, codes of moderate specificity (breast cancer, left breast), and would have required the highest specificity (breast cancer, left breast, upper outer quadrant.)  Often, the former but not the latter level of detail is available to labs.   By May 18, 2021, CMS put the plan on a one-year delay (blog here.)  (This May 18 blog contains a lot of detail and background about the crazy period.)  See an excellent May 2021 article at Genomeweb by Kelsy Ketchum here.   See an April 2022 letter to CMS from numerous organizations decrying the idea (here).

_________

In  new transmittal, June 10, 2022 (CR12124) CMS permanently cancels the plan to make the intermediate specificity codes non-payable.  (However, CMS also asserts it will continue to review issue.)  

In the interim, in spring and summer inpatient rulemaking, CMS discussed nonspecific and less-specific codes in the setting of hospital DRGs.  CMS determined in last August's inpatient rules that the intermediate codes (such as breast cancer, left breast) were fully adequate for ICD-10 coding for Medicare decisions and claims processing.

June 2022 - A Sane and Wise Final Decision

May 2021 - A Lot of Crazy

May 2021 at Genomeweb

Partly, the terminology made the arguments difficult.  CMS referred to the potentially deleted codes as "NOC" or not otherwise classified codes, which sounds reasonable to delete.   However, the codes in question were actually subsets of the smallest anatomical units - like left breast, outer half, upper quadrant, a level of anatomical detail that is meaningless for decisions like ordering a genomic test or providing a hospital admission or validating a chemotherapy order.   

Very Brief Blog: CMS Publishes Speaker Agenda for Annual Lab Meeting June 23, 2022

The "Annual Lab Meeting" for pricing new lab codes at CMS is coming, on June 23, 2022.  See prior blog.    Speaker registration was back on June 3, while audience members can just log on to an open webinar code that CMS will provide.

CMS has updated the day's agenda to list the speakers.  Find it here:

http://www.discoveriesinhealthpolicy.com/2022/05/cms-expands-annual-lab-meeting-new.html

The agenda PDF includes a live ZOOM link.  Find the whole web page for the lab meeting here.

NEW TO ME:

See a two-page colorful infographic, resembling the games Chutes and Ladders, at CMS here:

https://www.cms.gov/files/document/clinical-laboratory-fee-schedule-annual-payment-determination-process.pdf

BACK TO THE AGENDA:

There are 35 registered presentations (suggesting up to 350 minutes, or six hours, at 10 minutes each).  The speakers include large associations such as College of American Pathologists and individual companies, typically, to comment on a PLA code.   I count 28 stakeholders who are coming to comment on 1, or just a couple, PLA codes.  

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The infographic shown and linked above, is dated 6/2020.

Master Class: Does the Lab Outpatient Bundling System Have Mistakes?

See a follow up in September 2022 here.

_____

I'm going to jump to the "master class" level with this one, with just a brief preface.   Medicare bundles ("packages") most lab tests performed in the hospital outpatient setting (include hospital outpatient surgery and hospital outpatient visits and hospital based ER's), unless they meet an exception, primarily, human DNA-RNA tests.   

CMS publishes an outpatient claims-processing table called "Appendix B" where payable tests are "A" and packaged tests are "Q4."

See a screen shot below.  

click to enlarge

Most of the Status Indicators (SI) make sense to me, but not all.

0199U-0201U are "A", payable, as human DNA RNA tests.  0202U is also payable, because it contains a COVID report (special rule).   0204U, 0205U are "A" as human DNA RNA tests.

But as an expert, I can't always figure out what CMS is thinking.   

0203U is an RNA expression test for inflammatory bowel disease (PredictSURE) from whole blood, and I'm pretty sure it's WBC RNA expression, so it should be "A" rather than the published Q4 nonpayable.

And 0211U is the Caris comprehensive tumor genomics test, and it's the rare status E1 which means not covered by any outpatient benefit category.   I don't know why this isn't "A," the similar Foundation Medicine test 0037U is "A" and so are many other complex tumor tests with PLA codes.

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See status indicators table here.  Find updates to Appendix B OPPS, here.  CMS publishes a quarterly update classifying new lab codes with letter designators, find one recent example here.

COVID: Labcorp/FDA/ EUA for NGS Test for COVID Strains

FDA announced Friday evening June 10, 2022, that it had awarded LabCorp an EUA for an NGS-based COVID sequencing test.  The test runs on a Pac Bio Sequel II platform.   

Links below:

• Brief notice at Genomeweb here.
• Provider fact sheet here.  Patient sheet here.
• EUA letter here.
• 16-page performance and intended use sheet here.

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I'm not sure how many NGS-based EUA tests there are, but to the day, exactly two years prior FDA had issued an EUA for an Illumina COVID sequencing test - here.  The Illumina 2020 test was a packaged test (sold like an IVD) but partial targeted sequencing of COVID.   The LabCorp test provides for EUA-endorsed full sequencing of COVID, but at LabCorp facilities (not in a kit).

For the new LabCorp EUA NGS test, samples will first be identified as positive (such as LabCorp COVID PCR Test or COVID/INF-A-B test. (Ct < 31).   The probe set includes 1000 tiled molecular loop inversion probes (MIPS) reaching "99.6% of the SARS CoV-2 genome with most bases covered by 22 MIPs."  The instructions note that up to 752 specimens (8 plates) can be processed in one batch. 

See earlier 2021 press release about LabCorp using a Molecular Loop Bioscience research panel for viral surveillance, here.  See a current LabCorp page on variant testing, here.

 

Recall that in February 2022, AMA created a new COVID test code 87913 to report "mutation identification in targeted regions," 87913.  (This is less extensive that a full sequencing code).   This will be item #68 in the CMS Annual Lab Meeting for new code pricing on June 23.   Possible crosswalks might include the nearly-adjacent older code 87910 for viral genotyping ($257).   On the other hand, there could be a premium for COVID testing, and CMS has placed a number of the COVID lab codes into the gapfill process during the last couple years.  

click to enlarge

Nerd Note: AMA Publishes Panel Actions from May 2022 CPT Meeting

AMA publishes "Panel Actions" to report in brief the results of each CPT agenda item from the most recent CPT meeting.   It takes about 30 days, and now the "Panel Actions" from the early May 2022 CPT meeting are online.  Find the 10 page document here:

https://www.ama-assn.org/system/files/may-2022-cpt-summary-panel-actions.pdf

From a simple "Find" word count, I count about 23 withdrawals and 8 rejections.  This follows the rule of thumb that most candidates withdraw if they're told the public hearing of their code would only result in a rejection.   

On the lab side, codes for HPV extended genotyping and for Gadolinium (measures as concentration of the blood analyte) were rejected.  A tumor methylation classifier was also "rejected" rather than withdrawn, as was a code for tumor-tissue-modified HPV.  A proposal to edit the respiratory pathogen panels 87631-33 was withdrawn.   

An interesting-sounding code for "AI generated oncologic therapies" was "rejected."  Then, so was a code for "human milk donation services."

A range of of 13 codes for "Digital Pathology" add on services will appear in Category III codes, along with a heading and guidelines.   This will be in the January 2023 book, and may be published on the Cat III pages of the AMA CPT website for July 1 (not 100% sure but I think so).

Several Cat III codes for virtual reality procedures and therapies were added.  

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Medicare Test Coverage Without Any Coverage Articles: An Overview

Recently, clients asked me about coverage rules for two different tests, and while the tests are apparently covered, the rules were hard to find.    The tests are (1) Alzheimer skin cell culture tests from Neurodiagnostics LLC, Maryland, (doing business as SynapsDx, PLA Codes 0206U, 0207U), and (2) the Cernostics test TissueCypher (0108U). Cernostics is based in Pittsburgh and was acquired some months about by Castle Biosciences.  Given the geography, one's first guess is that coverage would be handled by Novitas MAC.   

Let me add, this article is based on simple public websites like Google and CMS.gov.  I haven't gotten any deeper information, such as one might get from FOIA requests.

Medicare Coverage Database

On June 12, I searched the Medicare Coverage Database successively for 0108U, for 0206U, and for 0207U.  Each time the database said "Your search returned zero results."  I also had no hit on the "MCD" for the brand name "TissueCypher."

However, when I entered the same coverage database via Google, there was a hit for 0206U under Novitas molecular billing article A58918, version 11/8/2021, here.  

However, that Novitas article seemed to list all the PLA codes, in a very long listing of the PLA code names one after another in sequence, without specific coverage rules related to 0206U, 0207U.  0108U is also listed here with all the other PLA code names, in this version of A58918. 

But wait, there's more.  In a more recent version of the same A58918 Novitas lab billing article, 0108U, 0206U, 0207U have been deleted (here).  

I'm not sure why, although one possible reason is that the 0108U code is a glass slide code, 0206U, 0207U are cell culture codes, so they are not "molecular" or DNA-RNA tests which is the focus of A58918.  The CMS coverage database presumably searches current articles which would explain why a search of our codes of interest today doesn't return Novitas 2022 A58918, but a Google search with a historical archive does (via the replaced, 2021 version of A58918).  

How About Novitas MAC Website?

Also on June 12, I turned to the Novitas MAC website.  This is because the Cernostics lab is in Pittsburgh, and the SynapsDx/Neurodiagnostics LLC lab is in Maryland, both Novitas states and in Jurisdiction L.  None of the PLA code searches had any hits at Novitas Jurisdiction L (PA/MD), (0108U, 0206U, 0207U).

(Extra; MolDx DEX Website)

I also double-checked the MolDx DEX website.  

Regarding 0108U, DEX didn't have a listing for Cernostics, and the Castle lab showed 4 tests, all related to skin lesions (melanoma, etc).  Regarding 206/207U, I didn't see a lab name hit at DEX for either Neurodiagnostics (MD) or Synaps Dx.     

How Do We Know the Tests are Covered?

Yes.  

First, the 0108U test, from Cernostics/Castle, is now an ADLT category test.  You have to be covered by Medicare to get classified as an ADLT, so there must be Medicare coverage.  (In fact, if I recall correctly, I saw about 50 paid claims for 0108U in 2020 CMS data).  So the 0108U test is covered.

Turning to the Alzheimer test.  "DiscernTest" is the brand name for the Alzheimer skin cell culture tests 0206U, 0207U.  I had their website up this past week and they stated the tests were covered by Medicare.  Here's a Google clip and a company website screen shot:

Under What Terms are the Tests Covered?

Which patients and for just what circumstances are the Alzheimer test and the Cernostics GI test covered?   Well, someone please point this out to me if this is published, but I didn't find such coverage rules on the various websites using keywords of the codes, which is the most natural way to search Medicare for coded tests.

Rules for Auditors to Apply?

It might be difficult for outside auditors (such as the CERT program, RACs, or ZPICs or OIG) to verify if the tests are paid correctly by Novitas, since it seems difficult to find published rules from Novitas to apply during the audit.

Is Novitas More Friendly to PLA Codes than MolDx Is?

MolDx: Start from "Red Light"

For all the codes in its domain - human DNA/RNA codes - and especially for molecular LDT tests, MolDx states generally apply noncoverage to new PLA codes, and grant coverage based on a substantial amount of technical assessment and review.   So the starting position is "red light."

Novitas Could Start from "Green Light" 

Possibly, and I haven't heard this directly from Novitas, they might take the viewpoint that most PLA codes getting very little if any utilization, and leave them on autopay ("green light") unless they have a reason to review them and write an LCD for them.   

For example, Novitas might wait and watch utilization; if it stays at zero, no work effort is warranted, and if it exceeds some amount (I'm guessing, 100 or 1000?) they might look further.   (I've definitely known of situations where MACs leave codes on autopay and wait to see "if a fish bites." A MAC can wait to see if there is much activity on the code, before expending work effort to write either positive or negative rules.  So I know that can happen, but I have no knowledge if that's the current Novitas rule for PLA codes).  

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A short deck on the 0206U test, presented at CMS in June 2020 during the new code pricing process, is online at CMS here.  

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A third example  arose from a client email the next day. Pacific Edge has a July 2020 press release that its tests CXBladder (0012M, 0013M) are covered by Medicare.  Being in Pennsylvania, they would bill to Novitas, and in fact, the codes were together paid $1.5M by Medicare Part B in CY2020.   However, specific coverage rules were again difficult to find.   The relevant LCD, L35936 , contains historical remarks the tests were not covered (see remarks for R17 and R24, in 2017 and 2018), while a November 2019 meeting transcripts has Novitas stating the tests were not covered (here).   The two codes DO appear in Novitas article A58917, Billing and Coding, Molecular Pathology, but only by listing the two codes in a long list of hundreds of genetic/genomic codes that follow under generic coverage and non-coverage principles (basically, in short, the article states that the following codes are covered when medically necessary and not covered when not medically necessary.)   Turning to the MolDx system, which does not have primary payment authority anyway, the Palmetto MolDx DEX database lists one CXBladder test with a remark it is "not covered by Medicare."   

So, given the fact pattern as far as I could find it, CXBladder would also be an example of codes that are covered by Medicare, but without specific or granular, A,B,C, rules for when it is covered and it what circumstances.   Again, one could submit a FOIA request to Novitas for email chains to the company, which might shed more light.

Novitas and FCSO MACs Propose New LCD for Oncology Genomics

For a number of years, the Novitas MAC has used an old LCD "Biomarkers for Oncology," which has undergone repeated revisions.   Find L35396 here. (The current update is labeled, "R31," the 31st revision.)

On June 9, 2022, Novitas posted what I assume is a new version of the LCD, for 45 days public comment.  Find it here: DL39365.  Comment info is posted near the bottom of the LCD, comment open until July 23.  There's also a new draft billing article, DL59125 here.  The LCD also links to a second, existing billing article, MoPath and Genetic Testing, A58917, here.

"Compliance Through Audits"

Novitas says in the opening sentence that compliance will be monitored through post payment ("pay & chase") data analysis or through medical review audits.   The policy also states, at the bottom, under "Rationale," that it will allow automated edits.

The LCD views tests as falling in 3 buckets, Diagnostic, Prognostic, Predictive, Therapeutic.   (It's unclear to me how the last two differ, even reading their definitions, which seem to overlap)

In the coverage rules, #1 always applies:  the patient must have cancer, or a significant suspicion of cancer, AND, genetic testing would be the next step in the clinical management which would directly impact the management.

Then, the test must meet one of several pathways to coverage.  #2 has five different criteria which must be met, or  (#3) the test is endorsed by NCCN. or (#4) the test is actionable via the OncoKB database, and meets another chain of criteria such as FDA approval or NCCN status.   

Pretty Complex

The multiple layers of intersecting rules and chains of OR statements is kind of baffling.   

You tend to  want to hang on to a few concrete statements (such as endorsement by NCCN).  I count at least 16 or more individual statements to verify working through the chain of sections and bullets and sub bullets.

The discussion section describes the three external databases, CLINGEN, NCCN, and ONCOKB, in some detail.   (Another one that I'd consider important, but not mentioned, are ASCO guidelines for biomarkers, such as a Summer 2022 ASCO guideline for therapy selection in advanced breast cancer here.)

FCSO

Novitas has two MAC regions, one around Pennsylvania, and one surrounding Texas.   It makes decisions in tandem through joint LCDs with FCSO, which is the MAC for Florida and Puerto Rico.   Novitas and FCSO are both parts of a complex chain of management entities that are ultimately related to Florida BCBS.

 

FDA: Taking Comments on ctDNA Diagnostics in Cancer

I don't think I've flagged this - 

On May 2, 2022, FDA released a draft guidance on use of ctDNA in early tumors.  Comment is open til the end of the month.

Home page at FDA here:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-circulating-tumor-deoxyribonucleic-acid-early-stage-solid-tumor-drug-development-draft-guidance

Comment page at regulations.gov

https://www.regulations.gov/document/FDA-2022-D-0084-0001

Note that  FDA previously produced draft and final documents on minimal residual disease in hematopoietic cancers:  here.

Nerd Note: Online Site for Comparing Medicare PDFs

While there is a built-in function in Word for comparing two documents as a "redline," this can be trickier for PDF documents.

There are times when you want to compare edits between two documents.  For example, Medicare always posts both a draft LCD (or NCD) and a final one.   Similarly for billing & coding articles on the CMS coverage database website.   So you can always get the two documents you want to compare. 

Trickier - there are other documents (such as MolDx website guidance articles and FAQs) that are frequently updated but with no archive and no version control.   If you do have a stored copy of a prior MolDx document, and you notice there is a newer one online, you can make a redline to understand the updates.   

One free website for online PDF comparisons is draftable.com  .   There's a free online entry point here.  You just drag the older PDF into the left box (drag and drop) and drag the newer PDF to the right box.  Click "Compare" and you get a left panel, right panel display.  The left panel is highlighted in red, to show where text disappeared.   The right panel is highlighted in green, to show where new text appears.   There's an option to download as a new comparative PDF.   

Here we compare MolDx draft LCD for infectious disease (DL38988) and the final version, released in April 2022 (L38988).

That was online.  Here's a downloaded permanent PDF version of the comparison:

Draftable has additional options for paid subscribers.

There are some interesting changes in the draft and final LCD that affected stakeholders.  For example, near the top, the draft LCD clearly stated "This is NOT a coverage policy...for testing using techniques other than multiplex polymerase chain reactions."  (Capitals in the original).   However, this limitation was deleted for the final effective policy, make the scope of the LCD wider than readers expected based on the proposed text.

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I found Draftable after running across a citation to "Diffchecker," but I found that Draftable had easier download features.   

Draftable will also compare different types of files (.doc, .pdf). 

Medicare Lab Tests and the Complications of Outpatient Bundling: The OPPS "A" Modifier Wears Many Hats

We're coming around to another July 1, which means CMS will release hundreds of pages of rulemaking for both Physician (Part B) and Hospital Outpatient (OPPS) policies.   From time to time, some new policy has a big impact on lab test claims processing.   I'll very briefly review these, and then show how the "A" status indicator is called on to play several different roles.

Before 2007

Before 2007, hospital outpatient lab tests (whether clin lab or pathology) were paid by the lab that performed them.

2007 14 Day Rule

Around 2007, CMS brought in the 14 day rule. All lab tests performed on specimens (blood or tissue) from hospital outpatient clinic days or procedures had to be billed BY THE HOSPITAL.   They could be billed, but only by the hospital.  This led to a derangement of care for example for breast cancer lumpectomy patients.  The hospital in Vermont didn't want to be responsible for billing a $3500 Oncotype Dx Breast test performed in California.  

We settled into an unpleasant period where the molecular test was delayed for 14 days and ordered on the 14th day post biopsy, so you'd hope to have results by day 20 or so with shipping and lab time.   

OIG sometimes enforced this rule with hefty settlements (here).  Find the date of service rule at 42 CFR 414.510 and its web page here.

2014 Bundling Rule

Around 2014, CMS passed a new rule, in a separate regulation. that most lab tests were bundled (42 CFR 419.2(b)(17)),  meaning they are ancillary part of another service (an office visit or a biopsy) which is not paid separately.  

It took several years to fully implement this rule, see the delays memorialized under the caption "enforcement discription" at CMS.   The bundling or packaging rule now applies to both clin lab and pathology tests, unless an exception intervenes.    The "packaging" regulation did not affect the 14 day rule exceptions which continued to operate the same way.

2018 Rule

As explained on the Date of Service homepage, CMS altered the Date of Service regulation 414.510 on January 1, 2018, with the net effect that "molecular pathology" tests were unpackaged and were payable immediately and to the lab that performed the molecular test (be it the hospital lab or the outside reference lab).  Not on the home page or regulation, but elsewhere in CMS policymaking, CMS ruled in early 2020 that COVID tests were separately payable, which is a variance from the general rule that microbiology tests are packaged.

The Status Indicator System (SI)

Every quarter, CMS updates its hospital patient policies for new codes and other changes via quarterly transmittals, and each quarter, CMS updates a master OPPS file called "Appendix B" which gives the claims processing status indicator (SI) of every CPT code.   See the OPPS quarterly files here.   Noridian provides a handy table of the numerous OPPS status indicator abbreviations (here).

Generally, lab tests are status indicator Q4, meaning they are bundled or packaged as long as there is an event to package them to (an outpatient clinic visit at the hospital, or, a procedure).    Tests that are payable separately (possibly depending on other rules, though) are Status A.

The Hard-Working Status A Indicator

There are at least four conditions under which Status A is deployed.   CMS provides a Zip file of all current Status A lab tests at the bottom of the Date of Service home page.  (See Zip file, Laboratory tests subject to exceptions...zip).

• A (A1) - The test is a molecular pathology, which in practice, CMS defines as a test of human DNA or RNA.
• A (A2) - The test is a Type A (MAAA-like) ADLT.
• A (A3) - The test is related to COVID.
• A (A4) - The test is a chemosensitivity test of living cancer cells.
• A (A5) - Proteomic MAAA tests for cancer with Category I CPT codes

CMS  doesn't use the A1-A4 nomenclature, I've used use it to show the different ways "A" is arrived at.  CMS reserves the right to add one-off additions to the above lists, so there is literally one test called out by CPT code in the regulation as unbundled although it doesn't fit any of the regular rules (81490). 

Note that A1 is operative only if the test is performed after the patient's discharged and this "effectively unbundles" the date of the test performance away from the date of specimen collection (here). 

However, for what I am calling "A3," for COVID, the unbundling presumably applies even if the date of testing is the same as the date of collection.

Note that most, but not all, tests that are MAAA-like ADLTs (rule A2) are already unbundled because they usually DNA/RNA tests (A1) or cancer-related proteomic tests (A5).

Category A4, chemosensitivity tests, are a group with a lot of policy.  CMS classifies them as Status A, payable, on Appendix B.   But if you read the regulations at 414.510, the unbundling requires more than the letter "A" on the spreadsheet, it requires the specific drugs tested on the cancer cells must be ordered no earlier than Day 14 after biopsy (414.510).    

It remains to be seen how that rule (regarding day 14 drug order) will fit with newer tests like 0324U/0325U, which have the four drugs tested already named right in the test descriptor, so there isn't any mystery to solve when you "order" the specific drugs on Day 14 as the regulation demands.    You already ordered carboplatin and 3 named other drugs by ordering the 0324U test on day 1.  

CR12761 classifies 0324U/5U as A tests, presumably in respect to the chemosensitivity test clause (with its 14 day rule analog) found at 414.510.  (One more thing: there is a 30-year-old NCD, 190.7, that makes cryptically described types of chemosensitivity tests unpayable, here.)

I'm not suggesting CMS should divide up "A" into A1...A5 (they have divided Q into Q1...Q4) but for learning purposes, to understand the diversity of different ideas packed into the A modifier, it may help students to see the different actions of the "A" modifier listed as A1...A5.

Nerd Note Summary

CMS causes the packaging of lab tests via the global regulation at 419.2, but generally unbundles things from the bundling by revisiting and tweaking little complexifying edits at the separate date of service rule at 414.510.

For a chart from Neogenomics that compares commercial payer rules, here.

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Photo Wesley Tingey, Unsplash

https://unsplash.com/photos/MldQeWmF2_g

The CMMI Kidney Care Demo: Physician Transplant Bonus

One of the high-priority initiatives of the Trump administration was to improve incentives and processes for end stage renal disease and to improve solid organ transplant incentives and outcomes for both kidney patients and other transplant patients.   Solid organ info here, solid organ fact sheet here, my blog on the programs in 2019, here, and HHS 38 page white paper on the programs here.  For renal patients, incentives programs were strengthened to move patients from clinic dialysis (where most sit) to either home dialysis or better, to transplant.

While doing some client research on CMMI, I ran across the March 2022 RFP for applications to the Kidney Care Choice (KCC) program - notice here.  The 90 page application for the 2023 program year is here at CMS (RFP response due March 25), and I placed an RFP cloud copy here.  The CMMI KCC home page is here, a press fact sheet from December 2019 here.

Much has been written on the theme that most physician incentives in quality programs are too small to move the needle and make a difference (e.g. Delbanco et al., 2018, here.)   

Without looking for it, I stumbled across the bonuses for kidney transplant buried down on page 24 of the 90 page application.  They run up to $15,000 per patient.  That's an incentive indeed.  I don't think this has been widely remarked on.  (Find an excellent 2020 article by Lentine in Kidney360, discussing pro's and con's of recent chagnes, here.)  

I include some clippings from the 90 page application below. Click to enlarge.

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For a 2016 article on how CMS paid for dialysis forever but only limited payment for kidney transplant rejection drugs, here.  This transplant drug benefit was extended in December 2020 (here, here).  ("The US Senate passed the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act as part of a broad year-end legislative package, extending Medicare coverage of life saving immunosuppressive medications for the life of the kidney transplant. An estimated 375 adult kidney transplant recipients lose their transplant every year due to a lack of coverage of immunosuppressive medications after the prior 36-month Medicare coverage period.") (See S 3353.)  (See also Gill, 2021 here).

I wondered if KCC is an incentive to delay transplants for patients in, say, December 2022, if the program starts at a center on January 1, 2023.  E.g. would one want to shift four transplants from December 2022 to January 2023 and trigger a $60,000 bonus thereby.

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For the Fact Sheet on the CY2023 ESRD proposed rule, here, June 21, 2022.

For the proposed rule CY2023 ESRD, here.

For the December 2021 public comment solicitation on ESRD and transplant equity, here.