October 14, 2020: My Open FOIA Request to CMS for CY2018 Utilization Data for MoPath

 As I have discussed on my main blog in multiple articles, there has been an explosion in genomic test Medicare fraud from 2017 to 2018 to 2019.  Much of this uses code 81408, a grabbag code applicable mostly for full sequencing of ultra rare genes such as fatal diseases in infants.  At $300M in 2019, this was the highest paid of all molecular CPT codes, but only paid in a handful of states (not paid at all in 5 of 7 MACs as "never medically necessary" in Medicare).

CMS has delayed release of CY2018 provider data by CPT code, data that would normally be released in May.  See my September correspondence with CMS here.

On October 14, 2020, I made two submission requests to CMS FOIA.   One was for code 81408 spending by NPI in 2018 (probably 10-20 data lines), and the other was all MoPath codes by NPI in 2018 (81162-81599).

Model letter as below.

__________________________________________________________

October 14, 2020

FOIA_Request@cms.hhs.gov 

 

CMS FOIA Officer

Centers for Medicare & Medicaid Services

Mailstop N2-20-16

7500 Security Blvd

Baltimore MD 21244

 

Dear FOIA Officer:

 

Under the Freedom of Information Act, Subsection 552, I am requesting access to the following records:

 

·        Since 2014, CMS has annually released data on prior-year utilization of CPT codes, with payment information, for all participating physicians and laboratories.  

·        The release is usually in May for the calendar year 18 months prior.  This represents official agency policy (January 17, 2014, 79 FR 3205) and has a standard website:

o   https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier

·        Per correspondence with CMS Medicare Provider Data Team, September 29, 2020, the full public release of CY2018 data has been delayed from May 2020 to time indefinite.

·         

·        I request the following limited information via FOIA:

o   2018 payments to physicians and laboratories for CPT CODE RANGES:

§  EITHER 81162-81599

§         OR ELSE (EQUIVALENTLY)

o   811xx

o   812xx

o   813xx

o   814xx

o   815xx

§  I believe this will be an excel spreadsheet of about 2000-2500 liones.

§  Key fields include:  NPI, Provider last name, city, state, CPT code range 81162-81599, Number of services, Average Medicare Allowed Amount. 

§  Providing all the data fields per each NPI would also be acceptable.

 

I believe the time to obtain this is reasonable.  For 2016 and 2017 data, which is already online at CMS in a cloud database, I can extract this data in a minute or so.

To determine my status for the purpose of fees, I am an individual seeking information for personal use and not commercial use.  

In addition, when I identify suspicious payment information I periodically report this to MACs, or CMS, or OIG.  Disclosure of the requested information to me is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not primarily in my commercial interest.

I am willing to pay fees to a maximum of $300.

I request information in an electronic format and either email or CD is OK.

I request this information be expedited because of recent reports by OIG, by DOJ, in news media, and on my public blog that there has been a rise in anomalous payments for genetic CPT codes in 2017, 2018, 2019.  My work has been covered in two recent trade journal news stories and this reflects current urgency to inform the public concerning actual or alleged Federal Government activity

CONTACT

If you have any questions you may please telephone me at XYZ.   My email is XYZ.

 

Bruce Quinn MD
649 South Mansfield Ave

Los Angeles CA 90036

 

 

Lab Solutions LLC CYP Tests Covered by MolDx (per DEX)

 

Tuesday, October 13, 2020

 https://app.dexzcodes.com/app#!catalogDetailPage

COMT - not covered

CYP1A2 - not covered

CYP2B6 - not covered

CYP2C19 - covered

CYP2C8 - not covered

CYP2C9 - not covered

CYP2D6 - covered

CYP3A4 - not covered

CYP3A5 - not covered

MSH6 - covered

Medicare Advantage Must Pay for Services Covered Under FFS Medicare A/B

Medicare Advantage plans must pay for services covered by local or national decisions and articles of Medicare A/B.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf

As discussed in section 10.2 of this chapter, an item or service classified as an original

Medicare benefit must be covered by every MA plan if:

• Its coverage is consistent with general coverage guidelines included in original

Medicare regulations, manuals and instructions (unless superseded by written CMS

instructions or regulations regarding Part C of the Medicare program);

• It is covered by CMS’ national coverage determinations (see sections 90.3 and 90.4,

below); or

• It is covered by written coverage decisions of local Medicare Administrative

Contractors (MACs) with jurisdiction for claims in the geographic area in which

services are covered under the MA plan, as described in section 90.2 below.

90.4.1 – MAC with Exclusive Jurisdiction over a Medicare Item or Service 

(Rev. 120, Issued: 01-16-15, Effective: 01-01-15, Implementation: 01-01-15) In some instances, one Medicare A/B MAC processes all of the claims for a particular Medicare-covered item or service for all Medicare beneficiaries around the country. This generally occurs when there is only one provider of a particular item or service (for example, certain pathology and lab tests furnished by independent laboratories). In this situation, MA plans must follow the coverage policy reflected in an LCD issued by the A/B MAC that enrolled the provider and processes all of the Medicare claims for that item or service.

HDL Successor Lab True Health Diagnostics Files for Bankrupty

 https://richmond.com/business/blood-testing-lab-in-richmond-in-former-hdl-headquarters-files/article_a1fce89b-b015-59cd-85b1-ba2be3348ac0.html

Blood-testing lab in Richmond, in former HDL headquarters, 

files for bankruptcy and lays off employees

July 30 2019

John Reid Blackwell

blood-testing company that has been operating a laboratory formerly run by the now defunct Health Diagnostic Laboratory has filed for bankruptcy protection and has laid off some of its employees in downtown Richmond.

Texas-based True Health Diagnostics LLC notified state and local officials of the job cuts on Monday and warned that the company may be forced to close its operations entirely.

On Tuesday, the company filed for Chapter 11 bankruptcy protection in U.S. Bankruptcy Court in Delaware.

The company operates the laboratory at 737 N. Fifth St. in the Virginia Bio+Tech Park.

True Health Diagnostics said the job reductions were necessary because the Centers for Medicare and Medicaid Services has suspended all Medicare payments to the company, according to a letter sent to the Virginia Employment Commission’s rapid response unit and the Richmond mayor’s office.

“Medicare payments are a significant source of revenue for the company, and without these payments the company must commence employee layoffs and may need to commence additional employee layoffs and/or a business shutdown,” said the letter, signed by True Health’s chief financial officer, Christian Richards.

The company’s notice to government officials lists 392 jobs that it says are “currently affected.”

However, True Health’s newly hired chief restructuring officer, Clifford Zucker, said Tuesday that the 392 jobs listed in the notice include employees working outside of the Richmond area. He said 80 employees were laid off on Monday and that one-third of those worked in Richmond.

In its Chapter 11 bankruptcy filing, True Health estimates it has between $10 million and $50 million in assets and between $100 million and $500 million in liabilities.

The city of Richmond is listed among the company’s 30 largest unsecured creditors with a claim of $690,290.

“Should the company fail to obtain additional funding, then the company will likely lay off additional employees at the company’s laboratory operations, and the company may also need to completely shut down operations at the company’s laboratory operations,” the company’s notice to state and local officials says.

***

True Health, based in Frisco, Texas, got into its financial problems because it has been in a dispute with the federal government over Medicare reimbursements.

The company filed a lawsuit on July 2 in U.S. District Court for the Eastern District of Texas claiming that the Centers for Medicare and Medicaid Services had withheld $20 million in payments to the company since 2017 without due process.

“The result of all of this has been financial ruin for True Health,” the lawsuit claims.

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True Health said in its lawsuit that it serves about 335,000 individuals per year, more than 65,000 of whom are Medicare beneficiaries. The company said in its lawsuit that it employs about 400 people nationwide.

The government agency initially imposed a 100% suspension of payments to the company in May 2017 based on “credible allegations of fraud,” but then reduced the suspension to 35% of payments, withholding about $800,000 a month from the company, according to the lawsuit.

“Although this allowed True Health to survive, it still left the company without the financial means to clear existing obligations and required it to seek loans to stay in business,” the lawsuit said.

This June, the agency again suspended 100% of its payments to the company, again based on “credible allegations of fraud,” according to the lawsuit.

True Health said in court documents that it had never received an adequate opportunity to challenge the merits of the suspension, and it warned that unless the suspension was lifted, the company would file for bankruptcy or liquidate outside of bankruptcy.

The federal court dismissed True Health’s lawsuit on July 22, enabling the Centers for Medicare and Medicaid Services to continue withholding payments.

True Health said in its notice to state and local officials that the company is “exploring all options to obtain additional funding to keep the company fully operational and prevent further mass layoffs or a business shutdown.”

A representative from the Centers for Medicare and Medicaid Services did not respond for a request for comment.

***

True Health bought most of the assets of Richmond-based Health Diagnostic Laboratory in 2015 in a bankruptcy court auction.

Health Diagnostic Laboratory, a fast-growing blood-testing company that once employed hundreds of people in Richmond, went into Chapter 11 bankruptcy in June 2015 after settling a federal investigation into its physician reimbursement practices.

Like HDL, True Health offers blood tests to identify early biomarkers for chronic disease, but True Health has a broader platform than just cardiovascular disease and diabetes, Chris Grottenthaler, True Health’s founder and chief executive officer, said in an interview in 2015.

At the time, Grottenthaler said his company offered jobs to about 350 former HDL employees, and the company was continuing to operate in about 100,000 square feet of the more than 250,000-square-foot office and laboratory space that HDL had been using.

In 2015, True Health had a 15,000-square-foot office and lab in Frisco, with about 85 employees. Grottenthaler said then that the company was adding jobs in Texas, and that it planned to maintain operations there and in Richmond.

“The Richmond lab has some unique capabilities, and some fairly advanced technology, so we will continue to operate that, but the core operations in Texas will remain intact as well,” Grottenthaler said at the time.

Grottenthaler started True Health in March 2014, at first financing the startup business with investments from friends and family. True Health got additional rounds of financing to help support the development of its lab and office in Texas and received institutional funding for its acquisition of HDL.

Grottenthaler grew up in Loudoun County and went to high school in Ashburn. He studied international affairs at James Madison University and received an MBA from American University.

###

https://www.hipaaspace.com/medical_billing/coding/national_provider_identifier/codes/npi_1619376316.aspx 

Pricing Myriad's Genesight vs Other Psychiatric Panel Tests

In a September 16, 2020 blog, I noted that Nephron Research had, through a FOIA request, determined that the Myriad Genesight test had been repriced by MolDx at a new lower price of $1569 - here.

This documents blog lists some comparable tests and where they stand.

0078U - $450

Last year, on the CLFS fee schedule, CMS priced the pain pharmacogenetic panel 0078U.  It was priced by CMS by the "crosswalk" method, at $450.91.

The AMA CPT code book gives the origin of this test.  It's attributed to the INFINITI Neural Response Panel, PeersonzeDx Labs, AutoGenomics Inc.  The text is "pain management (opioid-use disorder), genotyping panel, 16 common variants (ie ABCB1...OPRM1), buccal swab or other germline tissue sample, algorithm reported as positive or negative risk of opioid use disorder.

0173U and 0175U - In the Current Crosswalk-Setting Process

Two similar psychiatric gene panel codes are in the current (summer/fall 2020) price-setting process at CMS.  Proposed prices were released by CMS in September, and final prices for CY2021 will be released by CMS in November.

Test 0173U is the Psych HealthPGx Panel, RPRD Diagnostics, described as "psychiatry (ie depression, anxiety), genomic analysis panel, includes variant analysis of 14 genes."

Test 0175U is the Genomind Professional PGx Express CORE, Genomind, Inc, described as "psychiatry (e.g. depression, anxiety), genomic analysis panel, variant analysis of 15 genes."

Although these two tests have similar descriptors, the CMS lab test advisory panel in July recommended different pricing for them.  For 0173U, 11 recommended gapfill.  For 0175U, 8 recommended crosswalk to 0078U, and 4 recommended gapfill.  (While 0078U is not so similar to Genesight, 0175U is, and 8 national expert panelists recommended crosswalking 0175U to 0078U).

CMS proposed in September that both 0173U and 0175U be priced by the CMS gapfill process during CY2021.  Because they are too new, they don't have any current CLFS price now in 2020.

Other Possible Comparators

Other comparators would be further afield, but may be relevant.  

81432, for example, is sequencing of a panel of 10 or more genes, including BRCA1-2, related to breast cancer.  That's a lot of sequencing of a lot of genes.  CMS prices 81432 at $679, much less than $1569.  BRCA and related genes sometimes use copy number (dup del) analysis, which pays an extra $439 as code 81433 (totalling $1118 this year, still quite a bit less than $1569).

One could argue that the Genesight test involves algorithmic analysis not used by 81432/81433.  However, Palmetto said in its final pharmacogenetics LCD  in summer 2020 that it was not giving credit for (finding value in) the "algorithmic"  component of psychiatric gene panel tests.  See CMS LCD L38335.  Writing: "Based on our review of the evidence and on expert feedback submitted both during the CAC meeting and during the comment period for this policy, it’s been determined that there are insufficient data to support coverage for any combinatorial test."

House and HHS Documents re LDT law

On October 7, FDA announced it wouldn't review LDTs for EUA status, and the House E&C committee sent a six page letter to Alex Azar at HHS about his recent decisions regarding FDA and LDTs.

Stories cited back to an October 2 Politico article that unveiled a June 2020 17-page legal memo, by HHS, arguing that FDA didn't have authority to review LDTs.

See my blog here:

http://www.discoveriesinhealthpolicy.com/2020/10/legislators-say-hhs-decision-to-remove.html

I've put six documents together in one cloud zip file, here:

https://drive.google.com/file/d/1m7oZjcgBu6YuLzYOFWQXztBKTVEuBTpO/view?usp=sharing

2020 MHC 1007 New News re Hill Letters to Azar re LDT.pdf

     2020 HILL 1007 Energy and Commerce to Azar re LDT FDA 6p.pdf

     2020 HILL 1007 Press Release re Letter to Azar on LDT.pdf

2020 Politico 1002 Re June Legal Memo HHS to FDA Nix LDT Review.pdf

     2020 HHS 0622 Legal Memo to End FDA Review of LDTs 17pp.pdf

     2020 HHS 1001 Two Pager FAQ on FDA LDT status.pdf

Example from DEX(TM) of MOLDX Non-Covered 81408 Gene

 https://app.dexzcodes.com/app#!catalogDetailPage

MolDx Genomic Payments 87% of CY2017 Payments (Excepting Cologuard)

 This is summary data on CY2017 Part B payments for genomics.  To run this data, I searched the 2017 physician/lab payment database for all 28 MolDx states, and all states in total.  I used CPT codes 812xx, 813xx, 814xx, 815xx.   (Other codes, such as PLA codes, were negligible in CY2017).   

Since a large part of MolDx payments was one test, Exact Sciences Cologuard, I ran data without that test as an alternate analysis.  Cologuard payments are covered nationally by an NCD and paid at a national rate, so the MAC has no hand in the payment volume for this test.

In brief:

In CY2017, about 41%, or $244M/$588M, of the payments were in California.  About $408M/$588M, or 69%, were in MolDx states.  Only $180M/$588M were in non-MolDx states.

The main driver of the non-MolDx payments is one single provider, Exact Sciences, which billed $118M in CY2017 in Wisconsin, a non-MolDx state.  Of the $180M of non-MolDx payments, $118M/180M (65%) were due to one test, Cologuard.  Said differently, only $62M of $588M (10%) were regular non-MolDx MAC payments, that is, neither Cologuard nor a MolDx payment.  

Alternate Analysis.  If we ignore the $118M in payments for the single test Cologuard, MolDx handled 87% of the remaining Medicare molecular pathology payments.

Source:

https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier

__

Cologuard (81528) dollars paid in Part B were $116M in 2017, $168M in 2018, and $241M in 2019.   The above data may use dollars allowed which are slightly higher than dollars paid by CMS.