Friday, December 30, 2022

Congressional Budget Guidance to CMS: Sepsis, WGS, Alzheimer's, TCET, More

At the end of December, Congress passed the $1.7T budget bill, which makes for a 1700 page PDF.  It's HR 2617, home page here, final PDF format here.  

Most of the Medicare details show up around page 1175, Title IV, Subtitles A-D with various Medicare extenders and provisions.  

E.g. 4121 provides coverage for marriage and family therapist services, 4136 relates to disposable negative pressure wound care devices.  Section 4114 delays PAMA lab test pricing by a year.  Section 4127 requires OIG to report on "Safe harbor for contingency management," e.g. where drug treatment patients receive a reward like a Starbucks card for showing up for drug counseling and whether that is a program kickback.  See also a March 2022 OIG Advisory Opinion #22-04 on this.

Genomeweb has an open access article highlighting top line budgets ($6.6B FDA [half user fees], $47B NIH, $9B CDC. 

But to understand more, you'll also want to see the 800-page Congressional Record document issued on December 20 (pp 58553-59323), the "Explanatory Statement" of additional instructions from Congress.  Here you'll find actions that various stakeholders are noting in press releases, but which may not always be explicit in HR 2617.

Below the break, I'm clipping a number of paragraphs related to AHQR and CMS.   

Topics include:

AHRQ, budget $373M.   Items mentioned here:

  • Antimicrobial resistance.
  • Primary care research.
  • Diagnostic error research ($20M).
  • Grief care.
  • Heart disease research.
  • Maternal health.
  • Long COVID ($10M).
  • Organ availability.
  • Disabilities.
  • Sepsis ($750K; pediatrics, maternal, nursing home, rehab, pandemic, total public costs).
Turning to CMS, special topics include:
  • Bundled payment for AD diagnostics (PET, Amyvid, radiopharmaceuticals.)
    • Not mentioned, proteomics for hospital-based CSF tests also bundled under CLFS rules.
  • Cardiac CT access.
  • CT colonography (encouraged to consider).
  • Diabetes technology (CMS & FDA uncoordinated).
  • E&M policies.
  • Rural hospital closures.
  • Sepsis - CMS and CDC to develop new (or use existing) measures, cf. measures adopted in NY State.
  • New public reports re sepsis care data.
  • TCET - Transitional Coverage for Emerging Technologies.  Report in FY2024 to Congress.
  • WGS - Whole genome sequence, guidance for state officials, Medicaid.  Includes WGS, WES, gene panels.
Clipped below.

Thursday, December 29, 2022

House Releases 47-page Report on Adulhelm Approval Process

Anticipated since 2021, the House released a 47-page report on the approval process for the Alzheimer drug Aduhelm (aducanumab), with rapid coverage at WSJ and NYT.  WSJ describes the report as, "an 18-month investigation by the Democrat-led House Oversight and Reform Committee and the Energy and Commerce Committee," with quotes from Rep. Maloney (D, NY) and Pallone (D, NJ).  WSJ adds, " Republicans didn’t contribute to the report, according to spokespeople from both parties."

Find the report here.

Find the initial NYT article here.

Find the initial WSJ article here.

Find the initial STAT article here.  

   STAT with focus on pricing here.

Biopharma Dive here.

In other Alzheimer news, 

  • ICER released a report on health economics-based pricing for lecanemab, news story here.  
  • An international group reported a better blood test for Alzheimer's based on a new monoclonal for "brain derived tau" - Gonzalez-Ortiz et al., here.  
  • Bloomberg reported that Fujirebio and others are hot on the trail of an FDA-approvable blood test for Alzheimer's, here.  
    • Fujirebio already has an FDA-approved, CSF-based Alzheimer test from May 2022.

Monday, December 26, 2022

Journal Club: Two CAP Today Articles on Digital Pathology, AI in Pathology

In the December issue, CAP TODAY has two articles on digital in pathology.  The first is focused on digital pathology implementation per se, the second on trends for AI in pathology.

Digital Pathology here:

This article also features a link to article(s) on the Mayo website about their AI plans and systems, here.

AI in Pathology here:

For supplemental reading on medical technology change, from our colleagues in the field of radiology, see Bluth op ed in J Amer Coll Radiol this month - here.

For an interesting article on the fast pace of AI (absorbing 4 gb, then later 750 gb of data) see Gil Press end of year review in Forbes, here.

Thursday, December 22, 2022

CMS Alzheimer News: PET Scan NCD Delayed; Alz Assoc Requests Drug Coverage Revisited

 A few pieces of year-end Alzheimer news on the CMS front.  An NCD about amyloid PET scans is delayed.  A new request for expansion is submitted, for the very narrow NCD on Alzheimer drug coverage.


Years ago, CMS reviewed the then-new amyloid PET scan biomarker AMYVID, and determined it would only be covered in endorsed clinical trials.  (One of these, IDEAS, was completed).   The NCD included a flat limit of one scan per patient. 

Now, there will potentially be Alzheimer drugs that require two or more serial amyloid PET scans.  In mid 2022, CMS announced it was revisiting its Amyloid/PET NCD, and posted an expected draft decision deadline of December 16, 2022.   Entry point here.

OK, the news:  That deadline has come and gone, and CMS posted a notice it was continuing to review recent data on the topic. Find update here, which states:

December 15, 2022 // CMS will not be issuing a proposed NCD on Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease today. A proposed decision is forthcoming after CMS has reviewed newly published evidence that is relevant to the proposed NCD.

That recent news, of course, is the lecanemab clinical trial, Van Dyck et al, November 29, 2022, NEJM here.


In 1H 2022, seems like a long time ago, CMS announced very limited clinical trial for the FDA-approved Alzheimer drug Aduhelm, with the result that the drug was essentially off the market. (Alz. Assoc comment here.)  

The NCD applies prospectively to future approvals of future amyloid drugs, something that riled some stakeholders and led Congr. Buchanan to introduce legislation - "MERIT" forbidding NCDs to have "class action" on all drugs in a class (here).  News item here, here.

What's new.  With a press release and an 11-page open letter to CMS, Alzheimer Associate asks CMS to substantially expand drug cover for this class of drugs.

NCD request letters are always worth reviewing to see how different stakeholders approach the problem.  It's an issue of providing thorough evidence, but not going on forever (10pp not 100pp).   It's an issue of convincingly stressing the positive, while not failing to mention or  deal with reader objections and counterarguments.   It's a tough balance and letters like this often go through a number of  re-writes.   


About the same time, ICER has released a pretty negative report on the health economics of  Alzheimer drugs.  Here.

For comparison, see a 14 page MolDx LCD request letter here.  For an extra type of comparison, see ACLA's short white papers and press releases on the validity and value of NIPS testing, here


For the CDC pages from HR 2617 and from Congr Record, here.

Tuesday, December 20, 2022

ACLA Press Release Fights Negative Media re Non-Invasive Prenatal Screening (NIPS)

The year 2022 saw some negative press about prenatal circulating DNA screening tests, from New York Times on January 1, from ProPublica on December 6.

In April ACLA issued a short rebuttal linked to a more detailed 3 page PDF on NIPS.

Now on December 12, ACLA specifically addressed ProPublica concerns and labeled it "misleading information" that "fails to provide an up-to-date picture."  Find the new ACLA press release here.

The December ACLA comment makes 6 points:

  1. NIPS is a screening test (it is not a diagnostic test, it is used to trigger other tests).
  2. NIPS is a significant advance over the prior status quo.
  3. Use of testing is voluntary.
  4. Only health care providers can order NIPS.
  5. Laboratories that offer NIPS have high standards.
  6. ACLA is actively engaged in regulatory reform discussions on Capitol Hill.

It's a jump, but for comparison, you might see new Alz. Assoc. letters re evidence & validity to CMS, here.

Very Brief Blog: Senate Finance Bill Released: PAMA Bumped a Year; no VALID

What is probably a final year-end financial bill was released on December 19, 2020, and two items of lab news.

One, a one-year delay of PAMA is included (Section 4114).  A bigger  PAMA reformed (abbreviated SALSA) didn't make it in.

Second, there is no "VALID" bill, meaning the end of FDA regulation of LDT's for this Congress.    (Recall that recently FDA leadership warned they may approach LDT regulation via FDA rulemaking (unless its general device authority) if VALID didn't pass).


The bill isn't final til its voted and signed, so stay tuned.  ACLA applauds the draft legislation, December 20.


PDF here per NYT.  Physician fee cuts tempered at 4112, telehealth extension 4113, coverage of marriage and family counselors in Part B at 4121.  Some singular items like lymphedema treatment 4133, negative pressure wound devices 4136, certain non-opioid treatments 4135.

The bill also gives FDA better authorities to withdraw accelerated approvals (per Endnotes).

Per NYT, the bill contains $858B in military spending and $772B in domestic programs.

Photo by George Dolgikh:

Sunday, December 18, 2022

CMS CCI Edits for 2023: Some New AMA DNA-RNA Codes "Mutually Exclusive"

Every fall, CMS releases new edits called "P2P" Procedure to Procedure Edits, which are pairs of codes are unpayable on the same claim.  (These are released as gigantic Excel spreadsheets).  And every fall CMS also releases its manual for correct coding in each area of AMA CPT.   

These documents have been released for 2023.  There are only tiny changes in the lab section of the manual, and regarding the new genomic sequencing tumor codes for RNA, CMS only quotes a phrase already in the code descriptor itself.  

Of more interest, I think they allow both a DNA code and an RNA code for solid tumors and for hematologic cancers (both, 5-50 gene range), but CMS pivots and doesn't plan to allow the 50+ tumor gene code to be used with its new RNA-only sibling codes.  

The New CMS Resources

NCCI home page here.

Find the new P2P edits in Excel here.

Find the new coding manual for 2023 here.

The AMA GSP CGP Changes

Basically, AMA has three familiar codes for cancer genomics, 81445 (solid cancer, 5-50 genes), 81450 (hematolymphoid cancer, 5-50 genes), and 81455 (any cancer, 51+ genes).  

These 3 codes are defined as representing either DNA only reports, or DNA/RNA reports when the DNA and RNA is done in an integrated procedure.   

New.  When RNA is done as a separate procedure, or later, AMA has new codes.  

These are 81449 (RNA analysis, 5-50 genes, solid cancer), 81451 (RNA analysis, 5-50 genes, hematolymphoid cancer), and 81456 (RNA analysis, 51+ genes, any cancer.

Let's list them as AMA does:

  • 81445 (5-50 genes, solid cancer, DNA or DNA/RNA analysis)
    • 81449, same but RNA only
  • 81450 (5-50 genes, hematolymphoid cancer, DNA or DNA/RNA analysis)
    • 81451, same but RNA only
  • 81455 (51+ genes, any cancer, DNA or DNA/RNA analysis)
    • 81456, same but RNA only
AMA adds some clarifying text to its discussion page for sequencing procedures.  Regarding these RNA codes, AMA writes,
  • Testing for somatic alternations in neoplasms may be reported differently  based on whether combined methods and analyses are used for both DNA and RNA analytes, or if separate methods and analyses are used for each analyte (DNA only, RNA only).  
    • For...a single combined method, use 81445, 81450, 81455.  
    • For targeted genomic sequence analysis of RNA when performed using a separate method, report 81449, 81451, 81456.  
  • For...DNA analysis AND RNA analysis performed SEPARATELY rather than via a combined method, report 81445, '50, '55 for DNA analysis AND REPORT 81449, '51, '56 for RNA analysis.

This fall, CMS priced the new RNA codes at the same price as their sibling DNA code, so if you are able to report both, the CMS payment would exactly double.

I would think that on the lab bench, RNA analysis is always at least partly separate from DNA analysis (reverse transcriptase etc), and there's no clear instruction for "partly separate" methods, so I am sure there are some dotted lines to be filled in at some point.  Alternately, the running of "partly separate methods" might lose out financially against a decision to shift lab chemistry towards "wholly separate" methods for the DNA and for the RNA.  

CMS P2P Codes and DNA/RNA Analysis

The P2P edits  are literally hundreds of thousands (100,000's) of lines long, and I'm not guaranteed to be reading them correctly.  

However, what I think I found, is that the 5-50 gene versions of RNA and DNA codes are NOT edited against each other (do NOT deny in tandem), but the 51+ versions ARE edited against each other (if you bill 81455, you can't bill any of the RNA codes).   See graphic: 

In other words, as I am reading this, 81445/81449 are "not" classed as mutually exclusive, but 81455/81456 "are" classified as mutually exclusive.  

Regarding the nuances of "separate method," CMS in its manual only quotes the same phrase the AMA uses:


An AMA workgroup is working in 2022, 2023, on further revisions to the tumor genomic sequencing codeset (e.g. here).

There are other examples of mutual exclusive procedures; for example, cytogenomics codes (81228, '229 (constitutional), 81277 (cancer), 81349 (germline by low pass NGS) appear to be generally blocked from use at the same time as tumor genomics codes (like 8145, '50, 55).   (Again, all the combinations and where they appear in the tables make it a bit confusing).  Shown below, if you bill 81228 microarray, they don't want to pay on the same day for tumor codes 81445 to 18456.

JAMA provides a brief review of the growing uses of RNASEQ in healthcare. 

Very Brief Blog: ARHQ Draft Report on Pre-Eclampsia (Hypertension in Pregnancy)

 I've occasionally run across projects to develop better biomarkers for pre-eclampsia in pregnancy and for the risk of progression to  eclampsia.

AHQR is running a 2022/2023 topic on the project.  In March, they posted a project plan and took comment; the plan is still online.

In November 2022, they posted a 76 page draft report with a 150 page appendix, and they are taking public comment til January 10, 2023.

Biomarkers are not a focus at all.   Topics include (1) whether to use home blood pressure monitoring, (2) value of diuretics, (3) value of magnesium sulfate.

There are a couple very short passing remarks regarding biomarkers (to predict response to treatment, or, to predict seizures related to magnesium therapy, but blink and you'll miss these).  See a recent LANCET article on, "Clinical tools and biomarkers to predict preeclampsia," McDonald et al, PMID 34954654, open access, here.   Review articles like that apparently live on a different planet than the AHRQ scope of review.

I've put the half-dozen or so relevant documents in a cloud Zip file here.

Friday, December 16, 2022

Very Brief Blog; CMMI Issues Annual Report to Congress (113pp)

The Center for Medicare & Medicare Innovation / CMMI, has published its annual report to Congress, the 2022 version weighing in at 113 pages.

Report here.   Coverage at RevCycle here.   See Laura Beerman's recent HealthLeaders article about CMMI here.

Thursday, December 15, 2022

Brief Blog: New Medicare Advantage Regs; Focus on New Coverage Rules & Misleading Advertising,

CMS has released proposed rules for Medicare Advantage (& Part D).  The rules cover numerous topics but the headline focus from CMS has been on "misleading advertising" in Medicare Advantage plans.

Note that there are also many pages, and new regulations, on how Med Adv plans must implement LCD coverage, other coverage, and clinical trial coverage (notes at bottom of blog).


The term "misleading" occurs 28 times in the proposed rule and 4 times in the Fact Sheet. (The term "fraud" occurs 34 times).

Note that, separately, CMS has proposed regulations that would affect prior authorization and require electronic submission and adjucation in Medicare Advantage, Medicaid, and Exchange Plans (here).   Congress had also proposed some statutory changes around Prior Auth, but only focused on Medicare Advantage. 

As usual, CMS issues three documents, a press release, a fact sheet, and the actual rule.   The typeset publication will be 12/27 in Federal Register.  Comment to February 13.  

The rule doesn't occur in isolation.  

  • CMS notes that a "request for information" last summer drew 4000 comments.
  • In October, 2022, CMS vowed to crack down on misleading M.A. marketing.  Here
  • The Senate recently looked at misleading M.A. marketing.  Here.
  • Initial press coverage Dec 14 from AP and from Fierce Healthcare.
    • The latter covers both the prior auth rule (12/7) and the misleading marketing rule (12/14).


CMS promises to clarify regulations for M.A. plans regarding clinical trials; see  rule preprint p 390ff and section G / Regulation 422.101, 422.109.  

See also discussion of Med Adv having "basic coverage" such as by reference to LCDs at page 130ff.   This is a basic idea in Medicare, but it is being beefed up by rulemaking and provides stakeholders a good change to comment.  (Also related are rules about utilization management and prior auth, p. 148ff).

Brief Blog: Palmetto Issues "Vitamin D" LCD; Hews Tightly to Guidelines

Medicare LCDs often stick closely to major guidelines, and we see that's the case again in a new LCD issued by Palmetto, for Vitamin D testing.

Code 82306 Vitamin D is one of the very highest codes in Medicare Part B, paying $191M in 2021 (6.5M uses).  

Palmetto has issued two clinical chemistry LCDs with breakneck speed.  One for magnesium was proposed September 1, received zero public comments, and was finalized December 8.   (Here). 

The LCD for  Vitamin D testing was issued the same day, September 1, but finalized on December 15, requiring an extra week to respond to the comment received.   Final LCD L39391 here.  Response to comment article A59276 here.

I've clipped the Q&A after the break.  Palmetto added conditions if they were endorsed by the Endocrine Society for Vitamin D testing.  Sarcoidosis, other granuloma disorders, are accepted.   Because they are not endorsed by Endocrine Society, claims for fibromyalgia and psoriasis are denied.  

Wednesday, December 14, 2022

Brief Blog; STAT Publishes Two "VALID" Articles; and the newest PDF version of VALID!

 As this  session of Congress comes down to the wire, STAT publishes two articles on whether VALID will be attached to a major bill and pass.

#1, Open access, see an op ed promoting VALID and ASAP by Scott Gottlieb and Mark McClellan, both former directors of the FDA.  Here.

#2.  The second article is behind a firewall, and two STAT journalists survey the legislative field and its dueling stakeholders.   While this is a news article, the headline is pretty biased ("Congress can close the Theranos loophole" rather than, say, "Congress can strangle innovation," or the more neutral, "VALID Debate Continues to the Wire.")  Behind the firewall here.  They say the future of VALID is uncertain, while noting that FDA has offered (or threatened) to reproduce VALID by regulation of LDTs via notice and comment rulemaking (Califf quoted here.)

Read the New PDF Version of VALID (December 2022)

According to the Stat article, House and Senate negotiators released a new draft of VALID around December 8, and they link to an open access 110 p PDF at SCRIBD.  I've included a cloud copy.


See a December 9 article in Genomeweb that the current VALID exemption for academic centers is too narrow to be useful.
See a December 16 op ed in WSJ that calls VALID, "The FDA's Power Grab."

Tuesday, December 13, 2022

Humor: Trying CHATGPT with Medical Policy Questions

You may have heard recently about CHATGPT, a service of OPENAI.COM that is free to try.   

You can ask the chatbot a question on any topic and it will respond with several sentences of text.

CNBC article here (worth reading).  See a similar favorable article at Harvard Business Review here. See GPT humor here.  McKinsey on ChatbotGPT here.

Landing page here; email signup required.

Before showing you CHATGPT, let me mention another open access AI service: Google BioMed Explorer.  This searches PubMed, uses Google AI to go beyond the direct literal keyword search you can enter at PubMed.  Worth trying.



When would I want genetic testing for cancer?

Genetic testing for cancer can be useful for a variety of reasons. It can help determine a person's risk of developing certain types of cancer, guide treatment decisions, and help identify clinical trials that may be appropriate for a person. Genetic testing is often recommended for people who have a family history of cancer, as it can help determine whether they may be at an increased risk for developing certain types of cancer. It can also be helpful for people who have been diagnosed with cancer, as it can provide information about the specific type of cancer they have and guide treatment decisions. In general, genetic testing for cancer is most often recommended for people who have a strong family history of cancer or who have been diagnosed with cancer and want to explore their treatment options.


How common are ALK gene fusions in lung cancer?

ALK gene fusions are relatively uncommon in lung cancer, occurring in about 5% of all cases. These gene fusions can cause the abnormal growth and proliferation of cancer cells in the lungs. Treatment options for lung cancer with ALK gene fusions can include targeted therapies that specifically target the ALK fusion protein.


Why do fraudulent providers often bill Medicare for genetic tests?

Fraudulent providers may bill Medicare for genetic tests in order to make a profit. Medicare, which is a government-run healthcare program, covers the cost of many types of medical tests and treatments for eligible individuals. This means that fraudulent providers can bill Medicare for services that were never actually provided, or for services that were not medically necessary, in order to receive payment from the government. This type of fraud is known as "Medicare fraud," and it can be a serious problem. The Centers for Medicare and Medicaid Services (CMS) works to identify and prevent fraudulent billing practices, but it can be difficult to detect and prosecute this type of fraud.


Sidebar: Can I make more money by becoming a criminal?

It is generally not advisable to engage in criminal activities in order to make more money. Not only is committing crimes illegal and can result in fines and imprisonment, but it can also damage your reputation and relationships with others. Furthermore, the money you make from criminal activities is likely to be unreliable and may not provide long-term financial stability. It is always better to earn money through legal and ethical means.


What are the differences between Medicare Part A and Medicare Part B?

Medicare is a federal health insurance program that is available to people who are 65 years of age or older, as well as some younger people with disabilities. Medicare is made up of several different parts, each of which provides coverage for different types of medical services.

Medicare Part A is hospital insurance. It covers inpatient hospital care, as well as skilled nursing facility, hospice, and home health care.

Medicare Part B is medical insurance. It covers doctor's visits, outpatient care, medical supplies, and preventive services. It also covers some home health care services.

One key difference between Medicare Part A and Part B is the way they are funded. Medicare Part A is funded through payroll taxes, while Medicare Part B is funded through monthly premiums that are paid by beneficiaries, along with a small amount of funding from general revenue.

Another difference is that Medicare Part A has no premium for most people, while Medicare Part B has a monthly premium that is determined by a person's income.

Overall, Medicare Part A and Part B are two important parts of the Medicare program that provide important coverage for a range of medical services.


Why do many people lack genomic testing for lung cancer?

There are a few reasons why many people may not have undergone genomic testing for lung cancer. One reason is that genomic testing can be expensive, and not everyone may be able to afford it. Additionally, not everyone may have access to a facility that offers genomic testing, particularly in more rural areas. Additionally, some people may not have been offered genomic testing by their doctor, either because it is not routinely recommended or because their specific type of lung cancer is not known to be influenced by genomic factors. Finally, some people may simply be unaware of the availability of genomic testing or the potential benefits it could offer.


What are AMA CPT Category III Codes?

 AMA Category III codes are codes used by the American Medical Association (AMA) to identify new and emerging technologies, procedures, and services that are not yet widely used, but are showing promise and may become more commonly used in the future. These codes are part of the AMA's Current Procedural Terminology (CPT) code set, which is used to report medical procedures and services to insurance companies and other healthcare payers. Category III codes are intended to provide a way for healthcare providers to be reimbursed for these new and emerging services, which may not have a corresponding code in the main CPT code set.


What is Chromothripsis?

Chromothripsis is a rare and poorly understood phenomenon in which a single cell undergoes a massive and catastrophic rearrangement of its chromosomes. This can result in the cell acquiring many new genetic mutations, which can lead to the development of cancer or other diseases. Chromothripsis is thought to occur when a cell experiences a severe physical trauma, such as exposure to high levels of radiation or a physical blow to the cell. The exact mechanisms underlying chromothripsis are not well understood, and further research is needed to better understand this phenomenon and its potential implications for human health.


Describe the importance of oncogenes in cancer in the style of the King James Bible.

Behold, the oncogenes are a powerful force in the realm of cancer. For when these genes, which are present in all living cells, are changed or corrupted, they can unleash a tide of uncontrolled cell growth and division. This can give rise to malignant tumors, which, if not checked, can spread throughout the body and bring misery and death. It is therefore of great import that we study the oncogenes, and use this knowledge to develop ways to combat this deadly scourge.

Describe the role of oncogenes in cancer, in the style of a kindergarten teacher.

Oncogenes are special genes that help cells grow and divide. Normally, these genes keep our cells healthy and make sure they grow at the right time and in the right way. But sometimes, oncogenes can get damaged or changed, and this can cause them to start making too many copies of themselves. When this happens, it can cause cells to grow out of control and form a mass of tissue called a tumor. Tumors can be either benign, which means they are not cancerous and won't spread, or malignant, which means they are cancerous and can spread to other parts of the body. Oncogenes play a role in cancer because they can help cause cells to become malignant and form tumors.

Finally, let's try asking the same question, but with opposite expectations:
Why is it a bad idea to have testing for pharmacogenetics?
While pharmacogenetic testing can provide valuable information about a person's genetic makeup and how it may affect their response to certain medications, it is not always a good idea to undergo this type of testing. This is because pharmacogenetic testing can sometimes produce false positive or false negative results, which can lead to incorrect or misleading information about a person's ability to tolerate a particular medication. Additionally, pharmacogenetic testing can be expensive, and it is not always covered by insurance. Furthermore, there are ethical concerns about the use of pharmacogenetic testing, including the potential for discrimination based on genetic information. For these reasons, it is important to carefully weigh the potential benefits and drawbacks of pharmacogenetic testing before deciding whether to undergo this type of testing.

Why is it a good idea to have testing for pharmacogenetics?
While there are potential drawbacks to pharmacogenetic testing, there are also several reasons why this type of testing can be beneficial. For example, pharmacogenetic testing can provide valuable information about how a person's genetics may affect their response to certain medications, which can help doctors prescribe the most appropriate and effective treatment for their patients. This can reduce the risk of adverse drug reactions and improve the overall effectiveness of treatment. Additionally, pharmacogenetic testing can help identify individuals who may need to be carefully monitored or who may require alternative medications to avoid potentially dangerous side effects. Furthermore, pharmacogenetic testing can be particularly useful for people who are taking multiple medications or who have complex medical conditions, as it can help doctors tailor treatment to the individual's unique genetic profile.


Will genetic testing make it possible for me to fly to the moon?

No, genetic testing will not make it possible for you to fly to the moon. Genetic testing is a medical procedure that involves analyzing a person's DNA to identify genetic variations or mutations that may be associated with certain traits or health conditions. This type of testing has no bearing on a person's ability to fly to the moon or engage in other physical activities. Flying to the moon requires advanced technology and extensive training, and is only possible for a select few individuals who are chosen to be astronauts by space agencies such as NASA.

How I heard about ChatGPT here.

MolDx Publishes Article Briefly Describing "Equitable Pricing Model" EPM

For pricing new tests, MolDx requires each lab to fill out a standard spreadsheet of financial information in multiple cost domains, and including information such as sales volume projections (to assist in capital investment amortization).  The spreadsheet is online on the same web page as other technology assessment guidelines, typically as Excel frameworks.

There is also an article on how the spreadsheet information will be used by MolDx, which depends on an internal (unpublished) framework called Equitable Pricing Model EPM.   In October 2022, MolDx provided a short article noting that it uses an internal reference rule-set called EPM.

The EPM is especially important in the national annual MAC gapfill pricing process, as MolDx MACs have more than half the states and therefore control the median price reported by all the MACs.  That is, the MolDx MAC price will be the de facto permanent median price for the new code.


Equitable Pricing Model

Published 10/26/2022

The Equitable Pricing Model (EPM) is a proprietary algorithm developed and used by Palmetto GBA® and other contractors affiliated with the MolDX® program to establish Gapfill pay rates.  Its purpose is to determine an accurate price for a molecular pathology service that is fair and equitable (as much as is possible) using available data in accordance with CMS instruction. 

Test price accuracy in the scope of this model is defined as:

  • a price that does not inhibit a provider from performing a reasonable and necessary service, while at the same time, 
  • preventing excessive or exorbitant reimbursement which is not consistent with our fiduciary responsibility to the Medicare trust fund or preclude accurate pricing of other, subsequent tests.  

This EPM model seeks to minimize arbitrary pricing and improve price reproducibility by establishing a framework around established pricing guidelines/consideration requirements defined in 42 CFR 414 subsection G: 

(A) Charges for the test and routine discounts to charges;

(B) Resources required to perform the test;

(C) Payment amounts determined by other payors;

(D) Charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant; and 

(E) Other criteria CMS determines appropriate.

Monday, December 12, 2022

Very Brief Blog: Agenda, Registration for AMA CPT Feb 2-4, 2023, Meeting (San Diego)

 Registration is open for the AMA CPT meeting February 2-4, 2023, in San Diego.  An agenda for the full meeting has been released.  (The agenda for lab tests was released a few weeks ago due to their earlier comment cycle).  There are 42 agenda items.

Tab 11 is a re-vamp of the genomic coding for tumor specimens.

Home page

PDF of Agenda (Check for updates)

 It's possible to review agenda items and comment on them as a member of the public but the status as a commenter must be justified (e.g. clinician in the specialty, manufacturer of the technology).

QUOTE:  Upon review of this agenda, [someone who] believes that they may want to provide written comments on an application, the reviewer must seek Interested Party status by submitting a request form. The form requires identification of the potential Interested Party, a brief summary of the basis for the request (e.g., associated vendor/ industry representative), and signature of the confidentiality agreement and disclosure of interest forms. 

Brief Blog: Savings/Losses in ACO Direct Contracting Ranged Plus-30%, Minus-30%

 According to an analysis presented by Healthcare Dive, the 2021 savings (or overruns) in the Direct Contracting Model ranges from -30% to plus 30%, averaging -2%.  For 2023 forward, the program has been renamed "ACO Reach."  Despite the wide outliers, nearly all programs clustered in the plus-minus 10% range.

See the article here:

In the dot plot below, the Y-axis ranges from minus to plus 30%.  The X-axis is plan size, with Clover being much larger than the other plans.

Thursday, December 8, 2022

Journal Club: DRGs and Strategies for Hospitals: A German View

There are a lot of articles on the pro's, con's, and strategies of hospital payment by DRG, and from as far away as Saudi Arabia (here).  

Here's a German viewpoint, from an English article.  See an article, "How to Save Germany's Hospitals," which describes the strategic need for long-postponed reforms.  By Ben Knight; December 2022; here.  

The long-postponed reforms are mostly framed as bad or perverse incentives arising from aspects of the DRG system.

See a 2017 article on the same theme by Knight, here.


Knight's 2022 article springs, in part, from a recent 50-minute German-language television documentary about their hospital system.

Very Brief Blog: The Fastest Ever Palmetto LCD?

OK, the title might be clickbait.  It's a Palmetto LCD, and a lab LCD, but it's not a MolDx LCD.  

On September 1, 2022, Palmetto posted an LCD for measurement of serum magnesium, comments ending October 15, 2022.   No comments were received.   The draft LCD was posted as a final LCD on December 8, 2022.  

That's just over 90 days from posted draft LCD to posted final.

Draft DL39400. Final L39400 here.

It's one of Palmetto's few LCDs that has a concise one-word title:

The code for magnesium is 83735.  About 5,000 ICD10 codes are covered under the billing article, which is 168 pages long.  Such as, T20.612A, corrosion of second degree of right ear, any part, except eardrum, and T47.95XD, adverse effect of unspecified agents affecting the GI system (when ordered in subsequent, not initial, encounter.)    

National payments in 2021 were about $22M (for 3M services, or about $7 a pop), which is about 50 cents per Medicare beneficiary.  

In 2020, almost 7000 different entities (labs, docs) billed Medicare for magnesium testing, but just 25 labs billing more than $150,000 garnered 37% of all payments.  Those large entities were almost all regional billing locations for Quest and Labcorp.  

Labcorp billed Medicare under about 90 different NPIs (locations) for 83735, ranging from $1M from Burlington NC, down to $80 from a Labcorp location on New Street in Greensboro NC.  CMS reports that Labcorp charges, per location, per test, ranged from $59 down to $22 (median $37).


The pre-PAMA price of 83735 Magnesium was $9.19; the PAMA weighted median was $6.12, down 33%.

Wednesday, December 7, 2022

OIG Reports on Pathogen Labs With Too Much Add-on Testing - But It Began Before COVID

OIG has issued a report that some labs have billed Medicare for dubious amounts of add-on testing for pathogens.  See the new 19-page OIG report here.  See coverage at Genomeweb here.  

The OIG provides an excellent public analysis of the abusive schemes and templates; having a background in this kind of thing, I really enjoyed it.

Previously, there have been some commercial insurer lawsuits against labs that billed for federally covered COVID testing during the pandemic, while adding on thousands of dollars of other pathogen testing.


Some Prior Data

In my recent analysis of 2021 Medicare Part B spending, I noted that COVID testing was about $1B, and other molecular testing about $2.8B (total, $3.8B).  

Much dubious spending occurs, around $1.5B over several years.  Highly dubious Tier 2 code spending ran about $500M in 2021 alone (that much in excess of base year 2017, and from little-known labs in a very limited geography, a number of which were indicted by DOJ.)   By "highly dubious" I mean patterns like billing 2 units of every Tier 2 code for every patient, or some some labs, as many as 4 units.  Statistically there may not be even 1 patient in the US that requires that billing pattern, let alone...every patient the lab sees.

Meanwhile, spending for "other pathogen 87798" was only around $20M in base years like 2016, 2017, but began rising sharply from 2018 forward.  

87798 was already skyrocketing in 2019, before the existence of COVID.   In COVID years 2020, 2021, 87798 spending was about $200M a year, up from the base of around $20M.   Interestingly, most 87798 spending in Part B was in "MolDx States" whereas other abusive codes were primarily in Novitas/FCSO MACs.   (The third MAC system, NGS MAC, had minimal spending for either tier 2 codes nor 87798, in any year.)  By 2022, MolDx MACs have far more restrictive policies on 87798 and pathogen panel codes than prior (here).

Brief Blog: HHS Proposes Widespread "Electronic Prior Authorization" by 2026

 In a new rulemaking proposal on December 6, 2022, CMS proposed to broadly require electronic versions of prior authorization by 2026.   The proposal will impact ACA Exchange Plans, Managed Medicaid, and Medicare Advantage.  

That makes the regulatory proposal much broader than 2022's Hill proposal, the "Improving Seniors' Access to Care Act," which pointed to Medicare Advantage plans (FN1).   Reducing the burdens of prior authorization has been an AMA priority, and also heavily impacts some diagnostic tests, including imaging and genomics.  

For a 2019 review of Lab Benefit Managers by Phillips and Deverka, here.  A 2020 6-page white paper on LBM by Kentmore consultancy, here.  A 2022 article comparing PBM and LBM, here.  Articles on radiology benefit management, RBM, go back 15 years or more (e.g. here). 

  • On the new HHS Prior Auth proposal, trade journal article in Fierce Healthcare here.  
    • And Healthcare Finance here.  
    • And Health Payor Intelligence here.
    • Healthcare Dive here. Update with more interviews, here.
  • Find a 403-page pre publication  document at Federal Register here.  
    • The typeset version will publish December 13.
  • CMS also issued a lengthy fact sheet summarizing the proposed rule - here.

The new proposal also withdraws aspects of a late Trump proposal in December 2020 (85 FR 82586).  (2020 press release here.)

December 6, 2022

Also of possible interests to labs and imaging centers, the rules propose to facilitate (within Medicare) exchange of information between ordering providers and rendering providers/suppliers.

The rule has a 90 day comment period (circa March 6, 2023).  

Sample text from 12/6 fact sheet:

The point of this article is new CMS rulemaking that affects health plans widely, from Medicare Advantage to ACA Exchange.   This contrasts to a Congressional bill cited above, that addressed only Medicare Advantage.

On the general topic of Medicare Advantage denials (and it's denials, not approvals, that rankle providers), there was a January 2022 Health Affairs article about MA denial rates (entry point here). What I highlighted in my blog then, and what was kind of lost in the article, most of the denials were for lab tests.    The OIG weighed in on MA denial rates in an April 2022 report (entry point here.)  Finally, on a somewhat nerdy policy point, MA plans aren't subject to lots of rules that apply to FFS Medicare.  For example, there's a big policy apparatus around AUC/Appropriate Use Criteria in Imaging, dating back to PAMA 2014 and slowly implemented.  All those rules apply to FFS Medicare, not MA plans.  (Entry point here).   Similarly, there's a big fuss every year about new tech add-ons to DRGs, but those formally apply to the half of patients in FFS Medicare, not the half in MA.

Tuesday, December 6, 2022

Brief Blog: Evicore's Lists of Experimental Tests Via Google

I may have mentioned this before, but ran across it again today . EVICORE is a laboratory benefit manager consultancy.  If you google     evicore investigational and experimental laboratory testing    you get several PDF documents.  

One is a 12 page, 2022 list of Evicore's experimental genomic tests, and one is a 17 page, 2021 list of Evicore's list of experimental general lab tests.

Genomics 2022 here:

Laboratory 2021 here:

Monday, December 5, 2022

MOLDX Updates FAQ for its Pathogen Policies

MOLDX in mid-2022 introduced a very elaborate set of policies for pathogen testing (with panels of different sizes; for different indications; for different classes of patients such as normal vs immunosuppressed).   See an OIG report on excessive pathogen billing (here).

On December 1, 2022, they have updated their FAQ for this policy, L38988.   (The  LCD is 9000 words long, excluding citations and before the 3000-word FAQ that explains the 9000 words.  Besides L38988, see its associated articles A58710, A59005, and any associated MolDx website technology assessment forms.)  

The FAQ has been updated in Question 3 (more about FDA tests), Question 6 (expanded) and added new sections 7-11, versus the June version.  MolDx does not highlight revisions, but I have done so in a cloud copy here.

In addition to updating the FAQ, they now provide a unique document called "Insufficient Literature for UTI Panels."   Apparently, different labs have resubmitted the same review or major publications on UTI molecular microbiology, that they have published a list of articles they are unimpressed by.  Also known as, please do not submit this publication to us again.  (This list [Index Prohibitorum] is currently 5 pages single-spaced and over 60 citations long.)

Find things here:

Headline: ADVI Health Joins Forces with Sheridan Capital Partners

See the December 1, 2022 press release, "ADVI Health Joins Forces with Sheridan Capital Partners," here.

ADVI, founded as a separate firm in 2013 by Marc Samuels, is one of the best known privately-held HHS/CMS consulting firms in DC.  (ADVI also has other lines of business.)   In a press release, Samuels notes, "We are excited to partner with the team at Sheridan. Their exclusive focus on healthcare and deep investment expertise will allow us to invest further in our team and more quickly expand our solutions, products, and reach so that we can collaborate in new ways...." 

See ADVI's website here.  

The Sheridan private equity firm describes itself as, "Sheridan partners with companies in the verticals of providers and provider services, healthcare IT and outsourced services, and consumer health and medical products."

The deal follows by 18 months the acquisition of Boston Healthcare Associates by Veranex in June 2021.

Friday, December 2, 2022

HHS Revisits Essential Health Benefits; Comment til January 31, 2023

On December 2, 2022, HHS published a notice that it is revisiting the definition(s) of Essential Health Benefits under the Affordable Care Act.   By law (ACA 1302), Exchange plans must have ten "categories" of service - defined as "emergency services, hospital services, pediatric services..." etc.   There's a benefit for "laboratory services," but what do those two words mean in this legal context?   The concept is further defined by "benchmark plans" but that can be vague, too.   

HHS doesn't have any answers, but is seeking public comment - til January 31, 2023.  See the full 6-page publication (87 FR 74097) here:

The fact the RFI is 6 pages long indicates that CMS has quite a few topics and questions, including some about access to new technologies.

The topic is also interesting in light of hit-and-miss efforts to add "biomarker mandates" to insurance laws in various - some fizzle, some pass, but even the ones that pass may be slow in implementation.  Some entry points at a blog here.

If a state does not name a benchmark plan, it is the largest plan serving small groups (e.g. small employers). See PDF.

Brief Blog: New & Evolving Presentations for Subscription-only Papers

 We typically divide the world into subscription-only publications and open-access ones.   Lately I've seen some innovations.   At both J Amer Coll Radiol and Ann Intern Med, I've started seeing editorially-produced 'Visual Abstracts' on selected papers in each issue.

Here's a paper in Critical Reviews in Oncology/Hematology which is of high interest in itself, but also shows some editorial innovations.  The title is, "The Evolving Landscape of Anatomic Pathology," by Pisapia et al., and basic makes the point that anatomic pathology matters, but that anatomic pathology in itself is rapidly becoming a dinosaur, and any modern anatomic pathologist is equally fluent in discussing and incorporating molecular plus anatomic findings.   It's subscription, but the "innovations" include an editor's Visual Abstract, and an online format that includes the full abstract (of course), plus, a long extract from the Introduction, and then,  select snippets from other parts of the publication.   This gives you a window into the publication - like browsing a hardcover book in a bookstore - that I haven't seen before.

Find it here:

Graphical Abstract:


I suspect that Visual Abstracts will vary widely in their actual impact and usability, that some will be very insightful and others just a confusing jumble of some illustrative material and an arrow or two.

Pisapia et al. Abstract

Anatomic pathology has changed dramatically in recent years. Although the microscopic assessment of tissues and cells is and will remain the mainstay of cancer diagnosis molecular profiling has become equally relevant. Thus, to stay abreast of the evolving landscape of today’s anatomic pathology, modern pathologists must be able to master the intricate world of predictive molecular pathology. To this aim, pathologists have had to acquire additional knowledge to bridge the gap between clinicians and molecular biologists. This new role is particularly important, as cases are now collegially discussed in molecular tumor boards (MTBs). Moreover, as opposed to traditional pathologists, modern pathologists have also adamantly embraced innovation while keeping a constant eye on tradition. In this article, we depict the highlights and shadows of the upcoming “Anatomic Pathology 2.0” by placing particular emphasis on the pathologist’s growing role in the management of cancer patients.

Thursday, December 1, 2022

Brief Blog: NEJM Article Reviews "Braidwood" Case, Would Overturn Role of USPSTF

The Affordable Care Act requires private health plans to cover preventive services endorsed by the USPSTF, and a separate section of Medicare law allows Medicare to create NCDs that give coverage one-by-one to USPSTF preventive services.   The Affordable Care Act use of USPSTF is challenged in a current court case, Braidwood v Becerra.

The topic is reviewed in a new New England Journal article by Mello & O'Connell - here.  In brief, the court case challenges whether USPSTF is an appropriately constituted federal body, when it comes to binding recommendations enacted through other laws by reference to USPSTF.

(Additionally, the judge also found that USPSTF preventive coverage of PrEP for HIV prevention violated employers' religious beliefs to not encourage homosexual behavior.   Religious objections would presumably only attack a few of the preventive requirements, such as contraceptive coverage or PrEP coverage). 

(I read somewhere that one remedy might be for the USPTF to make its independent findings and decisions, but then have them each copied, ratified, and signed by the Secretary of Health, and have the coverage proceed from that, the Secretary being a certified federal officer approved by the Senate.)


Mello & O'Connell is a subscription article; just google "Braidwood" for numerous open resources, e.g. here, here, here.

Brief Blog: Legislation Proposed Would Corral NCDs About Drugs

Legislation aiming to alter Medicare's ability to regulate Part B drugs through NCD's is launched, on the heels of better results in an Alzheimer drug study in New England Journal.

Last year, Medicare published an NCD requiring very limited coverage (within clinical trials) of Alzheimer drugs based on beta-amyloid mechanisms.   The NCD was proactive, applying to future FDA-approved drugs not yet developed.  See the NCD here.   The NCD is now coming back into focus, as a new Alzheimer drug enters the FDA approval process, heralded by a study in NEJM here (Van Dyck et al.).

According to a news item in Fierce Healthcare, here, the Access to Innovative Treatments Act (AITA) will require CMS to evaluate new drugs individually.

Another example of a class-wide NCD is the one for CAR-T therapies, unchanged since 2019.

For some April 2022 coverage of the Aduhelm NCD, here and here.

The CAR-T NCD results in meticulously burdensome claims-processing instructions, updated regularly - here.