CMS MFN PAGE
https://innovation.cms.gov/innovation-models/most-favored-nation-model
LINK TO DEC 28 RULING:
https://innovation.cms.gov/media/document/mfn-ca-50-order-prelim-injunct
4pp
Thursday, December 31, 2020
Tuesday, December 29, 2020
Remarkably, CMS Will Let You Download Full CPT Code Names
Generally, the full names of CPT codes are copyright AMA and used in limited ways by payers, including CMS and its MACs. However, abbreviated names are used more freely. For example, you may get CPT edit lists or fee schedules that show the CPT code along with a very brief abbreviated code descriptor.
However, if you're willing to go 2 years into the past, you can apparently see nearly full code name descriptors via the CMS physician/code utilization website. Find the 2018 data here:
Go to the HCPCS Aggregate Data, and you'll see a cloud database of 13000 lines. The first column is CPT/HCPCS code and the second column seems to be the full descriptor name. You can click on "export" to produce an Excel CSV table, which can be re-saved inside Excel as an Excel XLS table.
The code name descriptors aren't the FULL ones, but they're pretty long.
There are Excel functions that will let you take index codes (such as CPT code) in a CMS table like the CLFS Fee Schedule, and search for a corresponding rows/columns in another spreadsheet and import cells. So you could import these field names into a copy of the CLFS even if the CLFS had only digital CPT codes to mark the rows.
The names are a little funny, for example, 81246 is FLT3 gene, Tyrosine Kinase varians, in the full CPT manual, and here it's shortened to "testing for genes associated with blood cancer) and a daughter code for 81245 FLT3, which is here called "gene analysis (fms-related tyrosine kinase 3) internal tandem duplication variants." The corresponding Short Names in the CMS CLFS table are 81426, FLT3 gene analysis, and 81425, FLT3 gene.
In the table above, I've created the "sum of dollars" column at the far right, which CMS doesn't provide in this view.
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Additionally, you can get usage data by CPT code in Excel files from CMS called National Summary Data File, for 2019 (here) which has ONLY CPT code digits as row markers, and use the above data to import full code names - at least for all the codes that were in use in both 2018 and 2019.
There are different ways of doing this lookup function, one is called VLOOKUP, e.g.
Monday, December 28, 2020
Lee Fleisher, New Chief Medical Officer for CMS, 7/2020
Dr. Lee Fleisher, an anesthesiologist at U Penn, became Chief Medical Officer of CMS in July 2020. The prior Chief Medical Officer, Kate Goodrich MD, joined Humana in March 2020.
New stories include:
Home Health News, New CMO, here. UPenn news, here. Anesthesia society IARS, here.
CMS org chart here.
From Qui Tam to Quistone Kops: Millenium Qui Tam Still Battling Over Who's First
According to the Department of Justice, October 19, 2015, Millenium Health, a San Diego lab for toxicology and pharmacogenetics, agreed to pay $256M to "resolve allegations" of illegal renumeration, with no admission of wrongdoing - here. See follow-up at Fierce Healthcare in February 2016 on Millenium's bankruptcy and other fall-out.
It turns out that the Qui Tam ligitants, Cunningham (estate) and McGuire, are still at it in 2020. It reached a petition to the Supreme Court in 2019 - here. (Cert denied 1-2020 here).
Complex legal actions have gone back and forth over which party (Cunningham or McGuire) provided the first qui tam evidence to authorities back around 2010.
The legal machinations are complex and include a Circuit Case decision in May 2019.
Circuit court cert petition 5-2019 here.
"$34M Reversal, First Circuit Redirectors Award to Another," 5-2019 here.
"First to File is Not Jurisdictional," 5-2019 here.
"Second whistleblower is deemed first to file" 8-2019 here.
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An earlier motion to dismiss the whole case in 2013 here.
Sunday, December 27, 2020
Medicare *Does* Have a Definition of "Screening Tests"
Medicare's Internet Only Manual, Series 4 (Claims), Chapter 16 (Labs), does have a definition of "screening tests" in Section 120, which I don't recall noticing before, or had forgotten.
https://www.cms.gov/Regulations-and-guidance/Guidance/Manuals/Downloads/clm104c16.pdf
Section 120 is "Negotiated Rulemaking Implementation." Negotiated Rulemaking was a law circa 1999 that required CMS to standardize, as much as possible, procedures for common lab tests across MACs.
Here we read:
Clarification of the Use of the Term “Screening” or “Screen"
The final rule clarifies that effective February 21, 2002, the use of the term “screening” or “screen” in CPT code descriptor does not necessarily describe a test performed in the absence of signs and symptoms of illness, disease or condition.
Contractors do not deny a service based solely on the presence of the term “screening” or “screen” in the descriptor.
Tests that are performed in the absence of signs, symptoms, complaints, personal history of disease, or injury are not covered except when there is a statutory provision that explicitly covers tests for screening as described.
If a person is tested to rule out or to confirm a suspected diagnosis because the patient has a sign and/or symptoms, this is considered a diagnostic test, not a screening test.
Contractors have discretionary authority to make reasonable and necessary scope of benefit determinations.
PerkinElmer and ARUP as Reference Labs vis-a-vis MOLDX
It's well known that ARUP, in Utah, is a reference laboratory that does not directly bill Medicare. (I'm not sure how that will be affected by new rules in the last year requiring labs that perform tests on Medicare hospital outpatients to bill Medicare directly - a change that sole source labs like Genomic Health generally like, but a change that would be a new practice for ARUP).
Recently, PerkinElmer Genetics was in the news as a reference lab for labs allegedly being investigated by the DOJ. PerkinElmer on May 18, 2020, "denies Reuters report that it is being investigated." Here. This was in response to a Reuters report that is still online here. Also with a date of May 18.
NPI
Even if you never bill Medicare, if other labs bill your tests, the other lab will list -90 (modifier 90, reference test) and the NPI of the performing laboratory. So the lab, not billing Medicare, will still have to have an NPI. ARUP has an NPI of 1982694931 and Perkin Elmer has two, 1781585067 in Pittsburgh and 1033520028 in New York.
I checked all three NPI's against the CMS 2018 provider billing database, and there were no claims for any codes under any of the NPIs. Here.
MolDx Public Database
MolDx and Palmetto have a public website database that amounts to tests with registered Z-codes, although the Z codes are not shown. Here. If a lab in a MolDx (e.g. Palmetto) MAC bills Medicare, it is supposed to list the Z code of the lab that performed the test (e.g. ARUP). Accordingly, ARUP, though it never bills Medicare and certainly not Palmetto, has 392 registered tests. PerkinElmer (Pittsburgh) ahs 53 registered tests. A person could click on all 392 and 53 tests, and see if they are listed as covered or not covered by Palmetto MolDx. The several PerkinElmer tests I clicked on werre listed as "not covered" but I did not take the time to click on all 53. A person who was interested in which tests PerkinElmer had listed with Palmetto, could see them enumerated in a list of 53.
PerkinElmer Website
You can also look up offered tests directly on the PerkinElmer Genomics website. For one example, if you look up gene TUBGCP4, you get several Autism and Intellectual Disability Panels (which seem to be listed as having 2436 to 3439 genes). This panel doesn't seem to be listed with MolDx, but Perkin Elmer's Exome test is listed (WES, Proband, Not Covered).
Summary
If a lab in the MolDx jurisdictions were to use PerkinElmer as a reference lab, it would be able to use the corresponding Z codes in its submissions to the MACs (along with the nationally required -90 modifier).
Footnote.
The 70/30 law at SSA 1834(h)(5)(C) stems from OBRA 1989 6111b as slightly modified by OBRA 1990 4154.
Saturday, December 26, 2020
August 2020: ASCP Article Profiles Lab Compliance "New News" - A few other links
https://www.ascp.org/content/news-archive/news-detail/2020/08/12/beyond-covid-19-the-6-biggest-lab-compliance-stories-that-almost-nobody-is-paying-attention-to
Beyond COVID-19: The 6 Biggest Lab Compliance Stories That Almost Nobody Is Paying Attention To
If not burnout, you may be suffering from a case of COVID-19 fatigue right now. And you’re not alone. The monster virus has seemingly consumed everything in its path over the past six months, including the world’s attention. While completely understandable, the current fixation on COVID-19 belies the fact that there are other important developments taking place that may directly affect your lab. So, as we move into the second half of 2020, let’s step back and recognize the year’s biggest non-COVID-19 stories in lab compliance that have flown under the radar due to the pandemic.
1. The Continuing Crackdown on Urine Drug Testing
Before the pandemic, the opioid crisis was the primary driver of health care fraud and abuse enforcement activity. COVID-19 has done little to alleviate either the opioid problem or level of pressure enforcers are exerting against labs and other providers involved in opioid-related testing scams, most of them for billing Medicare and Medicaid for medically unnecessary drug tests. Since April 24, there have been at least five high profile settlements or convictions announced, as summarized by the Scorecard below:
Scorecard: Recent Medically Unnecessary Drug Testing Enforcement Actions
Status of Case | Accusations |
Operators of American Toxicology Labs (Virginia) plead guilty to fraud + await sentencing | Excluded provider opens and runs a lab that generates $8.5 million in billings for urine screens for entities representing themselves to be opioid treatment facilities |
Co-founder of Liberation Way drug and alcohol rehab clinic in Pennsylvania sentenced to 37 months’ prison + $3.1 million in restitution for health fraud conspiracy* | Defendant ran an overbilling and elaborate kickback scheme involving thousands of medically unnecessary urine tests sent to Florida-based labs for analysis |
Physician owner of Seattle Pain Center + Northwest Analytics testing lab pays $2.85 million to settle false claims charges | Clinics required all patients to undergo urine drug screening, generating thousands of medically unnecessary tests performed by the lab and then billed to Medicare + Medicaid |
Connecticut Counseling Centers pays $295K to settle claims of overbilling Medicaid for outpatient substance abuse services | Methadone clinic billed Medicaid for urine drug tests even though reimbursement for those services were included as part of its bundled weekly payment rate |
Logan Laboratories and Tampa Pain Relief Centers, Inc. + two executives pay $535,449 to settle claims of falsely billing Medicaid for medically unnecessary urine drug tests | Defendants automatically ordered both presumptive and definitive urine drug testing for all patients at every visit, without having a physician determine that the testing was medically necessary for those particular patients |
Lab owner sentenced |
|
*Owner of Florida lab separately sentenced to 15 months’ prison and $3.4 million in restitution for his part in scheme
2. The Continuing Crackdown on Genetic Testing Consumer Scams
Consumer scams involving genetic testing labs (CGx) continue to represent perhaps the fastest-growing segment of the federal enforcement industry, probably because they target the most vulnerable. Far from slowing the momentum, the pandemic is actually fueling the scammers by creating new opportunities for SARS-CoV-2 testing schemes.
Under the typical modus operandi, “recruiters” contact Medicare beneficiaries online, on the phone or face-to-face at health fairs, senior centers, low-income housing areas or religious institutions like churches and synagogues promising free genetic testing to determine the individual’s cancer risks and how they’d respond to certain drugs in exchange for a cheek swab, personal Medicare information and a copy of their driver’s license. Next, the scammers contact the beneficiaries’ doctors and ask them to order the tests in return for a cut of the Medicare payment. Even if the doctor refuses, the scammers can count on the cadre of doctors they’ve lined up who are willing to prescribe the tests without seeing or making a determination of whether those tests are medically necessary.
The enforcement momentum that began in 2019 with the nationwide “Operation Double Helix” takedown has continued into 2020. Consider the following cases, all of which came down since June:
- July 9: Pennsylvania U.S. Attorney indicts seven people for role in massive CGx scam in which physicians were paid kickbacks of $5,000 to order more than $2 million worth of medically unnecessary CGx tests;
- July 1: California-based molecular testing firm Agendia, Inc. pays $8.25 million to settle charges of running a nationwide scheme to falsely bill Medicare for its flagship MammaPrint genetic test for predicting breast cancer recurrence risk;
- June 5: The operator of recruiting firm Privy Health Inc. pled guilty to conspiring with a Florida lab network and ordering physician to bill Medicare for nearly $5 million in CGx tests without regard to medical necessity and will be sentenced in October; and
- June 3: Owners of labs in Texas and Mississippi admitted their roles in a scheme to pay kickbacks in exchange for referrals of patient DNA samples for genetic testing and are awaiting sentencing.
RE: TX MS
https://www.justice.gov/usao-nj/pr/owners-texas-and-mississippi-laboratories-admit-roles-kickback-scheme-related-genetic
Owners of Texas and Mississippi Laboratories Admit Roles in Kickback Scheme Related to Genetic Testing
NEWARK, N.J. – The owners of two clinical laboratories in Texas and Mississippi today admitted their roles in a scheme to pay kickbacks in exchange for referrals of patient DNA samples and genetic tests to the laboratories, U.S. Attorney Craig Carpenito announced.
Sherman Kennerson, 55, of Plano, Texas, and Jeffrey Madison, 54, of DeSoto, Texas, each pleaded guilty by videoconference before U.S. District Judge Brian R. Martinotti to one count of conspiracy to defraud the United States in connection with a scheme to violate the Anti-Kickback Statute.
According to documents filed in this case and a related matter and statements made in court:
Kennerson and Madison co-owned and operated with other individuals Spectrum Diagnostic Labs LLC (Spectrum Lab) and Metric Lab Services LLC (Metric Lab), two clinical laboratories, located in Texas and Mississippi, respectively, that performed genetic tests and submitted claims to Medicare. Kennerson and Madison oversaw the laboratories’ marketing and sales operations through which outside marketing groups recruited physicians to refer patients’ DNA samples to the laboratories for genetic tests and related services.
Kennerson and Madison paid bribes to Ark Laboratory Network LLC (Ark), one the marketing groups for Spectrum Lab and Metric Lab, and Jeffrey Tamulski, to induce Ark to refer patients’ DNA samples to the laboratories. Tamulski and the owners of Ark, Edward B. Kostishion, Jeremy M. Richey, and Kacey C. Plaisance, were previously charged by indictment in September 2019 in connection with a related kickback conspiracy involving referrals to laboratories for genetic testing. Plaisance pleaded guilty to his role in the conspiracy on May 6, 2020.
As part of the scheme, the laboratories entered into sham agreements with Ark and Tamulski under which Ark purported to provide various consulting, marketing, and other services at an hourly rate. Kennerson and Madison, however, paid Ark and Tamulski in exchange for referrals and DNA samples based on a percentage of the revenue the laboratories received from federal health care programs, including Medicare. Once the amount of the bribe was calculated, Ark and Tamulski drafted and submitted sham invoices to the laboratories that backed into the agreed upon bribe amount and attempted to conceal the scheme through describing various services provided at hourly rates. Metric Lab paid Ark over $136,000 in bribes and the laboratories received over $517,000 in payments from Medicare for claims connected to the kickback scheme with Ark and Tamulski.
The conspiracy charge to which Kennerson and Madison each pleaded guilty carries a maximum penalty of five years in prison and a fine of $250,000, or twice the gross gain or loss from the offense, whichever is greatest. Sentencing for both defendants is scheduled for Oct. 5, 2020.
U.S. Attorney Carpenito credited the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert; and special agents of the U.S. Attorney’s Office for the District of New Jersey, with the investigation leading to today’s guilty pleas.
The government is represented by Senior Trial Counsel Bernard J. Cooney of the Health Care Fraud Unit of the U.S. Attorney’s Office in Newark.
The charge and allegations against the remaining defendants are merely accusations, and they are presumed innocent unless and until proven guilty.
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