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.
______
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.
Qui Tam Law Firm Profiles "Operation Double Helix" - December 2019
https://www.fraudwhistleblowersblog.com/category/healthcare/
https://www.fraudwhistleblowersblog.com/federal-false-claims-act/genetic-testing-gold-rush-gives-rise-to-fraud-allegations/
Genetic Testing Gold Rush Gives Rise To Fraud Allegations
December 10th, 2019 by Alexander Owens
On Sept. 27, the U.S. Department of Justice announced criminal charges against 35 individuals across various jurisdictions, allegedly involved in genetic testing fraud schemes that cost taxpayers over $2.1 billion.
The government asserted that the individuals had engaged in audacious schemes to target seniors and the disabled through the ordering of cancer genetic screening, or CGx, laboratory tests. CGx tests are performed to screen patients for genes that may show that a patient is predisposed to developing certain cancers.
The DOJ alleged that physicians were bribed to order these very expensive DNA tests. The government claimed that in many cases the physicians did not even treat the patients or only saw them via a cursory telemedicine consultation.
U.S. Attorney Bobby L. Christine of the Southern District of Georgia warned that “[w]hile these charges might be some of the first, they won’t be the last.” Christine’s warning may prove prescient.
Just last month, Reuters labeled genetic testing in the elderly as the “[n]ew frontier in health fraud.” Genetic testing fraud indeed appears to be very much on the rise and these recent indictments are not the DOJ’s first foray into the area. The federal government has launched over 300 investigations into alleged fraud in the genetic testing industry, many of which are almost certainly ongoing.
Just as several years ago the toxicology industry became inundated with fraudulent schemes, genetic testing, which is similarly lucrative and prone to abuse, is particularly fertile ground for fraudulent diagnostic testing schemes.
Genetic Testing: The Basics
Genetic tests are not limited to CGx cancer screenings. Genetic testing can be used in various other respects, both legitimate and illegitimate. For example, pharmacogenetic/pharmacogenomic, or PGx, tests are another major growth area in the genetic testing arena where concerns over fraudulent conduct have grown substantially in recent years.
PGx tests, when used legitimately, are aimed at identifying genetic variations suggesting that a patient may have an unusual reaction to a specific medication (e.g., a certain genetic variation may show that a patient may metabolize a medication at an unusually low or high rate). PGx tests may, therefore, be useful if a patient has shown an otherwise unexplained reaction to a certain medication.
Yet, the scientific evidence supporting PGx tests (and genetic testing generally) in the vast majority of cases remains quite slim. To date, Medicare has generally recognized that PGx and other genetic tests are medically necessary in only a very narrow set of cases. Medicare administrative contractors have issued numerous local coverage determinations making that clear.
Even where no local coverage determination is at issue, to be reimbursable, a test must still be medically necessary and thus the absence of an local coverage determination addressing a particular test does not mean that the test meets the medical necessity standard.
Further, the Medicare claims processing manual explains that screening tests (genetic or otherwise) are generally not covered by Medicare.[1] A practitioner who routinely performs genetic tests on patients, regardless of each patient’s clinical history and presentation, would almost certainly run afoul of Medicare’s requirements.
Despite the currently limited utility of genetic tests, Medicare has paid billions for these services. Between 2015 and 2018, Medicare payments for genetic tests more than doubled, to well over $1 billion in 2018. As the recent indictments show, the widespread use of these tests may have less to do with clinical utility and more to do with financial incentives.
Other genetic testing cases show that the DOJ’s recent crackdown is not a flash in the plan.
Given the sums of money at issue, the genetic testing industry has become a magnet for enterprising individuals. As has occurred in health care bonanzas of past, with the potential for great riches have come bad actors. Fraudulent schemes vary from the more nuanced to the facially egregious.
Regulators and whistleblowers have taken notice. In the indictments discussed above, the scheme fell on the latter end of the spectrum, involving payments to doctors to issue referrals for patients that, in some cases, they never even saw. More nuanced but not doubt troubling schemes have drawn the DOJ’s ire. Recent False Claims Act settlements are instructive.
Just weeks after the September indictments, the DOJ announced a False Claims Act settlement on Oct. 9, with pharmacogenetic lab UTC Laboratories Inc. and three of its principals. The lab agreed to pay $41.6 million with the three individuals responsible for another $1 million. The case resolved allegations, brought to light via numerous whistleblower complaints, that the lab paid kickbacks to doctors as well as marketers and relatedly billed for medically unnecessary tests.
The physician kickbacks were, as the government described them, thinly disguised as seemingly legitimate payments for physician work on a UTC-led clinical study. In fact, the government alleged, the payments were used to leverage referrals from the physicians. The clinical study work was purportedly no more than smoke and mirrors.
The UTC case, more so than that set out in the recent indictments, is likely more indicative of the sort of kickback schemes most common in the genetic testing industry, where the kickback is, at least to some degree, concealed as a seemingly legitimate form of remuneration.
In fact, the physician kickback in the UTC case is remarkably similar to that alleged by the DOJ in another multimillion dollar genetic testing fraud settlement involving Primex Clinical Laboratories LLC and its owner, where Primex purportedly concealed its kickbacks as payments to doctors for providing clinical data to the lab. Whenever there is a remuneration arrangement between a laboratory and a referral source (be it in cash or otherwise), the DOJ and relators are likely to take note.
The fact that the DOJ, in both the UTC and Primex civil cases, held individuals to account is notable. Despite robust revenue, oftentimes labs may be thinly capitalized and may move funds to individuals, trusts or shell companies to hide assets from regulators. Individual accountability helps to mitigate those concerns.
That is to say, if the DOJ, consistent with the Yates Memo, continues to hold individuals accountable, the government may be able to avoid what so often occurred during the (still ongoing) toxicology lab crackdown that started earlier this decade: Labs billed the government for billions, moved assets out of their corporate coffers, sought bankruptcy protection once regulators placed them in the crosshairs and avoided the full brunt of FCA liability.
In an earlier January FCA settlement, GenomeDx Biosciences Corp. agreed to pay $1.99 million to resolve allegations that it billed Medicare for medically unnecessary genetic tests. Unlike in Primex, there was no claim that the lab had paid kickbacks to obtain its referrals. While the DOJ has shown a preeminent focus on holding companies and individuals accountable for kickback schemes, GenomeDx serves as a warning to labs that are engaged in billing government payors for tests that are simply unnecessary, a substantial concern given the narrow set of circumstances where genetic testing has been deemed necessary by the Centers for Medicare and Medicaid Services and its contractors.
Ultimately, genetic testing schemes are likely to fall into a discrete number of fact patterns (which may overlap in the event multiple arrangements are at play).
Remuneration to Physicians
As the UTC and Primex cases show, remuneration to physicians for referrals may be disguised as superficially legitimate payments (e.g., consultation fees), services or other forms of remuneration. In some cases, a physician (or his or her practice) may have an equity (or other financial interest) in the genetic testing lab which may give rise to violations of the Anti-Kickback Statute and/or Stark Law.
Payments to Marketers
DOJ has made clear that paying commissions to independent contractors for referrals runs afoul of the Anti-Kickback Statute. In the UTC case, the lab allegedly paid independent marketers for referrals on a commission basis. The facts of UTC are not unusual. It is common practice in the genetic testing industry for labs to pay independent marketers for referrals. In such cases, both the marketers and the lab may be held liable.
Waiving Copays and Other Forms of Remunerations to Patients
Given that genetic testing services can cost upwards of $5,000 per test, patient copays tend to be substantial. In order to avoid scaring off patients via sticker shock, laboratories may waive or substantially reduce copays or similar patient payment obligations. If copay waivers (or other forms of financial assistance) are provided systemically or otherwise without legitimate consideration of a patient’s financial condition, then regulators may find that the arrangement violates the Anti-Kickback Statute.
Policies That Lead to Medically Unnecessary Tests
Practices, particularly those with a financial interest in a genetic testing lab, may institute policies that coerce their practitioners to order genetic tests when they are otherwise unnecessary. These policies may be issued under the guise of the standard of care, claiming that the practice is providing cutting-edge personalized or precision medicine services to its patients. Even in the rare case when a genetic test is necessary to identify a specific genetic variation, an entity may have a policy that pushes physicians to order additional, unnecessary tests to identify other genes.
Upcoding
In some cases, labs may be upcoding, which means billing payors for a more expensive test (or panel of tests) than that which was actually performed. In that genetic testing is relatively new, Medicare and other insurance auditors may find it difficult to adequately crack down on such practices as the auditors may not be fully familiar with the relevant coding standards.
Conclusion
If fraud hotbeds of the past are any indication (e.g., toxicology labs and compounding pharmacies), once the federal government and relators take notice of rapid growth and noncompliance in a specific corner of the health care industry, they are not likely to sit idly by as untoward amounts of government funds are siphoned off to bad actors. The recent indictments as well as the UTC, Primex and GenomeDx cases are likely just the tip of the genetic testing iceberg as whistleblowers and regulators continue to scrutinize this still growing industry.
[1] Medicare Claims Processing Manual, Ch. 16, § 120.1 (“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.”).
Alexander M. Owens, Genetic Testing Gold Rush Gives Rise To Fraud Allegations, Law360 (November 12, 2019), https://www.law360.com/articles/1218668/genetic-testing-gold-rush-gives-rise-to-fraud-allegations
GAO Reviewed Pathology Self Referral in 2013
https://www.gao.gov/assets/660/655442.pdf
GAO reviewed pathology self-referral in 2013. At first, I thought, this was about pathologists ordering tests to complete a service, an odd exemption in Medicare law that has never been very explicitly defined. (If you think you see TB bacilli, you can order a TB stain. I don't think, if you see breast cancer, you can order an Oncotype Dx test. However, the point is, the gray zone isn't well-defined in regulations).
However, the report on "self referral" was directly more at e.g. urologists employing (sic) pathologists. Anyway, it's at the link above.
Friday, December 25, 2020
Ten Labs Paid for 81408 in 2017; How their billings for Tier 2 codes looked in 2018
Payments for code 81408 have grown 580% from 2016 to 2019; see my main blog.
Only about ten labs were paid for >10 81408 services in CY2017.
Coincidentally, about 80% of these labs were mentioned in DOJ documents called "operation double helix" (I'm inferring no meaning from that.)
Here's today's exercise.
If you take the ten labs which were paid for 81408 in CY2017, and look at their CY2018 payments for all lab services, you can can (A) highlight their payments by level for all Tier 2 codes (81400-408) and (B) find out how much of all their lab payments were attributed to Tier 2 codes.
OK.
These ten labs collectively were paid $135M for Tier 2 codes, which is about 70% of all Part B payments for Tier 2 codes in 2018 ($135M/$190M). (Here).
Having collected this data, you can see how the Tier 2 payments for each lab distributed amongst the codes. You'll see that one lab got paid 18% for 81407 and 69% for 81408, but most labs got 0% for 81407. One lab got 93% of its 81400-81408 payments from 81408.
If you look at the portion of all their lab payments these labs got from their Tier 2 genetic codes, it's 38% to a 88%, and usually >50%.
Click to enlarge.
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Payments for Tier 2 codes in 2017 were:
No Medicare Payments for NIPT, Carrier Screening
There are several CPT codes associated with family planning or childhood disorders, such as 81443 (extended carrier screening), 81412 (Ashkenazi carrier screening), 81470 (X linked developmental deficiency), 81422 (NIPT).
In date for CY2019, there are essentially no Part B payments for these codes.
Wednesday, December 23, 2020
MolDx in Jurisdiction J Began June 1, 2018 (TN GA AL)
MolDx website states that transition to MolDx rules in Jurisdiction J (former Cahaba = TN GA AL) was in June 2018.
https://www.palmettogba.com/palmetto/MolDX.nsf/vMasterDID/8N3ELL4072?open
5. Is the MolDX Program national in scope?
The MolDX Program currently covers JE (American Samoa, Calif., Guam, Hawaii, Nev., North Mariana Islands), JF (Ark., Ariz., Idaho, Mont., N.D., Ore., S.D., Utah, Wash., Wyo.), JM (N.C., S.C., Va., W.Va.), J15 (Ky., Ohio), JJ (Tenn., Ga., Ala.) J5 (Iowa, Mo., Kan., Nev.), and J8 (Mich., Ind.). The role-out of JJ [Jurisdiction J] by Palmetto GBA began in early 2018. Labs that perform services for patients in those states have been notified to begin DEX Z-Code registration. Claims submitted after June 1, 2018, must have a Z-Code.
I also saw this date mentioned in a coding compliance article from that period.
http://mmplusinc.com/news-articles/item/the-molecular-diagnostic-services-moldx-program
Monday, December 21, 2020
December 21, 2020: No Surprises (Surprise Billing) Act
https://www.healthaffairs.org/do/10.1377/hblog20201217.247010/full/
https://www.cnn.com/2020/12/21/politics/surprise-medical-billing-congress/index.html
One draft as follows. [Plain English Summary]
##
Title I – No Surprises Act
Section 101. Short title.
Section 101 states that this title may be cited as the “No Surprises Act”.
Section 102. Health insurance requirements regarding surprise medical billing.
Section 102 requires health plans to hold patients harmless from surprise medical bills. Patients are only required to pay the in-network cost-sharing (i.e., co-payment, coinsurance and deductibles) amount for out-of-network emergency care, for certain ancillary services provided by out-of-network providers at in-network facilities, and for out-of-network care provided at in-network facilities without the patient’s informed consent. It also requires that patients’ in-network cost-sharing payments for out-of-network surprise bills are attributed to a patient’s in-network deductible.
Section 103. Determination of out-of-network rates to be paid by health plans; Independent dispute resolution process.
Section 103 provides for a 30-day open negotiation period for providers and payers to settle out-of-network claims. It also states that if the parties are unable to reach a negotiated agreement, they may access a binding arbitration process – referred to as Independent Dispute Resolution (IDR) – in which one offer prevails. Providers may batch similar services in one proceeding when claims are from the same payer. The IDR process will be administered by independent, unbiased entities with no affiliation to providers or payers. The IDR entity is required to consider the market-based median in-network rate, alongside relevant information brought by either party, information requested by the reviewer, as well as factors such as the provider’s training and experience, patient acuity and the complexity of furnishing the item or service, in the case of a provider that is a facility, the teaching status, case mix and scope of services of such facility, demonstrations of good faith efforts (or lack of good faith efforts) to enter into a network agreement, prior contracted rates during the previous four plan years, and other items.
Billed charges and public payer rates are excluded from consideration. Following IDR, the party that initiated the IDR may not take the same party to IDR for the same item or service for 90 days following a determination by the IDR entity, in order to encourage settlement of similar claims, but all claims that occur during that 90-day period may still be eligible for IDR upon completion of the 90-day period.
Section 104. Health care provider requirements regarding surprise medical billing.
Section 104 prohibits out-of-network facilities and providers from sending patients surprise bills for more than the in-network cost-sharing amount, in the surprise billing circumstances defined in Sec. 102. It also prohibits certain out-of-network providers from surprise billing patients unless the provider gives the patient notice of their network status and an estimate of charges 72 hours prior to receiving out-of-network services and the patient provides consent to receive out-of-network care. In the case of appointments made within 72 hours of receiving services, the patient must receive the notice the day the appointment is made and consent to receive out-of-network care.
Section 105. Ending surprise air ambulance bills.
Section 105 states that patients are held harmless from surprise air ambulance medical bills. Patients are only required to pay the in-network cost-sharing amount for out-of-network air ambulances, and that cost-sharing amount is applied to their in-network deductible. Air ambulances are barred from sending patients surprise bills for more than the in-network cost-sharing amount. It also provides for a 30-day open negotiation period for air ambulance providers and payers to settle out-of-network claims. If the parties are unable to reach a negotiated agreement, they may access the binding arbitration, which is the same as outlined in Section 103, with additional factors to account for the cost of providing air ambulance service in rural and frontier areas.
Section 106. Reporting requirements regarding air ambulance services.
Section 106 requires air ambulance providers to submit two years of cost data to the Secretaries of Health and Human Services (HHS) and Transportation and insurers to submit two years of claims data related to air ambulance services to the Secretary of HHS. The section requires the Secretaries to publish a comprehensive report on the cost and claims data submitted, and it also establishes an advisory committee on air ambulance quality and patient safety.
Section 107. Transparency regarding in-network and out-of-network deductibles and out-of-pocket limitations.
Section 107 states that a group or individual health plan shall include on their plan or insurance identification card issued to the enrollee the amount of the in-network and out-of-network deductibles and the in-network and out-of-network out-of-pocket maximum limitations.
Section 108. Implementing protections against provider discrimination.
Section 108 requires the Secretaries of HHS, Labor, and Treasury to promulgate a rule no later than January 1, 2022implementing protections against provider discrimination.
Section 109. Reports.
Section 109 requires the Secretary of HHS, in consultation with the Federal Trade Commission and Attorney General, to conduct a study no later than January 1, 2023and annually thereafter for the following four years on the effects of the provisions in the Act. It also requires the Government Accountability Office (GAO) to submit to Congress a report on the impact of surprise billing provisions and a report on adequacy of provider networks.
Section 110. Consumer protections through application of health plan external review in cases of certain surprise medical bills.
Section 110 allows for an external review to determine whether surprise billing protections are applicable when there is an adverse determination by a health plan beginning no later than January 1, 2022.
[BQ: What if the out of network service "isn't covered," e.g. medically unnecessary per health plan.]
Section 111. Consumer protections through health plan requirement for fair and honest advance cost estimate.
Section 111 requires health plans to provide an Advance Explanation of Benefits for scheduled services at least three days in advance to give patients transparency into which providers are expected to provide treatment, the expected cost, and the network status of the providers.
Section 112. Patient protections through transparency and patient-provider dispute resolution.
Section 112 states that health care providers and facilities must verify, three days in advance of service and not later than one day after scheduling of service, what type of coverage the patient is enrolled in and provide notification of a good faith estimate to the payer or patient whether or not the patient has coverage. It also requires the Secretary of HHS to establish a patient-provider dispute resolution process for uninsured individuals no later than January 1, 2022.
Section 113. Ensuring continuity of care.
Section 113 states that if a provider changes network status, patients with complex care needs have up to a 90-day period of continued coverage at in-network cost-sharing to allow for a transition of care to an in-network provider.
Section 114. Maintenance of price comparison tool.
Section 114 requires health plans to offer a price comparison tool for consumers.
Section 115. State All Payer Claims Databases.
Section 115 establishes a grant program to create and improve State All Payer Claims Databases. It also requires recipients of the grants from this program to make data available to authorized users, including researchers, employers, health insurance issuers, third-party administrators, and health care providers for quality improvement and cost-containment purposes. The Secretary of HHS may waive these requirements if a State All Payer Claims Database is substantially in compliance. It also requires the Secretary of Labor to convene an advisory committee and develop a standardized format for voluntary reporting by group health plans to State All Payer Claims Databases.
Section 116. Protecting patients and improving the accuracy of provider directory information.
Section 116 requires health plans to have up-to-date directories of their in-network providers, which shall be available to patients online, or within one business day of an inquiry. If a patient provides documentation that they received incorrect information from a plan about a provider’s network status prior to a visit, the patient will only be responsible for the in-network cost-sharing amount.
Section 117. Advisory committee on ground ambulance and patient billing.
Section 117 requires the Secretaries HHS, Labor, and Treasury to establish an advisory committee for reviewing options to improve disclosure of charges and fees for ground ambulance services, inform consumers of insurance options for such services, and protect consumers from surprise billing. It also requires a report on recommendations from the committee not later than 180 days after first meeting.
Section 118. Implementation funding.
Section 118 provides funding to the Secretaries of HHS, Labor, and Treasury for purposes of carrying out the amendments made by the No Surprises Act, including preparing, drafting, and issuing proposed and final regulations or interim regulations; preparing, drafting, and issuing guidance and public information; preparing and holding public meetings; preparing, drafting, and publishing reports; enforcement of such provisions; reporting, collection and analysis of data; establishment and implementation of processes for independent dispute resolution and implementation of patient-provider dispute resolution; conducting audits, and other administrative duties necessary for implementation. Each of the Secretaries shall report annually to Congress on the funds expended under this section.
Title II – Transparency
Section 201. Increasing transparency by removing gag clauses on price and quality information.
Section 201 bans gag clauses in contracts between providers and health plans that prevent enrollees, plan sponsors, or referring providers from seeing cost and quality data on providers. It also bans gag clauses in contracts between providers and health insurance plans that prevent plan sponsors from accessing de-identified claims data that could be shared, under Health Insurance Portability and Accountability Act (HIPAA) business associate agreements, with third parties for plan administration and quality improvement purposes.
Section 202. Disclosure of direct and indirect compensation for brokers and consultants to employer-sponsored health plans and enrollees in plans on the individual market.
Section 202 requires health benefit brokers and consultants to disclose to plan sponsors any direct or indirect compensation the brokers and consultants may receive for referral of services. The section requires health benefit brokers to disclose to enrollees in the individual market or enrollees purchasing short-term limited duration insurance any direct or indirect compensation the brokers may receive for referral of coverage. It also establishes a disclosure requirement for compensation that is not known at the time a contract is signed.
Section 203. Strengthening parity in mental health and substance use disorder benefits.
Section 203 requires group health plans and health insurance issuers offering coverage in the individual or group markets to conduct comparative analyses of the nonquantitative treatment limitations used for medical and surgical benefits as compared to mental health and substance use disorder benefits. It requires the Secretaries of HHS, Labor, and the Treasury to request comparative analyses of at least 20 plans per year that involve potential violations of mental health parity, complaints regarding noncompliance with mental health parity, and any other instances in which the Secretaries determine appropriate. If, upon review of the analysis, the Secretaries of HHS, Labor, and the Treasury find that a plan or coverage offered by an issuer is out of compliance with mental health parity law, the Secretary must specify corrective actions for the plan or coverage to come into compliance, which the plan will have 45 days to implement.If the plan is still not in compliance after those 45 days, the plan shall notify all individuals enrolled in noncompliance plans within seven days. Finally, Section 203 requires the Secretaries of HHS, Labor, and the Treasury to publish an annual report with a summary of the comparative analyses.
Section 204. Reporting on pharmacy benefits and drug costs.
Section 204 requires health plans to report information on plan medical costs and prescription drug spending to the Secretariesof HHS, Labor, and the Treasury. It also states that the Assistant Secretary of Planning and Evaluation, in coordination with the Office of the Inspector General, shall publish a report on the HHS website on prescription drug pricing trends and the contribution to health insurance premiums 18 months after the date of enactment, and every two years thereafter.
Title III – Public Health Provisions
Subtitle A – Extenders Provisions
Section 301. Extension for community health centers, the National Health Service Corps, and teaching health centers that operate GME programs.
Extends mandatory funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education Program at current levels for each of fiscal years 2021 through 2023.
Section 302. Diabetes programs.
Extends mandatory funding for the Special Diabetes Program for Type I Diabetes and the Special Diabetes Program for Indians at current levels for each of fiscal years 2021 through 2023.
Subtitle B – Strengthening Public Health
Section 311. Improving awareness of disease prevention.
Section 311 authorizes a national campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for the prevention and control of diseases, to combat misinformation, and to disseminate scientific and evidence-based vaccine-related information. It also directs the Department of HHS to expand and enhance, and, as appropriate, establish and improve, programs and activities to collect, monitor, and analyze vaccination coverage data (the percentage of people who have had certain vaccines). The section also requires the National Vaccine Advisory Committee to update, as appropriate, the report entitled, “Assessing the State of Vaccine Confidence in the United States: Recommendations from the National Vaccine Advisory Committee.” Finally, it authorizes grants for the purpose of planning, implementation, and evaluation of activities to address vaccine-preventable diseases, and for research on improving awareness of scientific and evidence-based vaccine-related information.
Section 312. Guide on evidence-based strategies for public health department obesity prevention programs.
Section 312 authorizes HHS to develop and disseminate guides on evidence-based obesity prevention and control strategies for State, territorial, and local health departments and Indian tribes and tribal organizations.
Section 313. Expanding capacity for health outcomes.
Section 313 authorizes the provision of technical assistance and grants to evaluate, develop, and expand the use of technology-enabled collaborative learning and capacity building models to increase access to specialized health care services in medically underserved areas and for medically underserved populations.
Section 314. Public health data system modernization.
Section 314 requires HHS to expand, enhance, and improve public health data systems used by the Centers for Disease Control and Prevention (CDC). It also requires HHS to award grants to State, local, Tribal, or territorial public health departments for the modernization of public health data systems in order to assist public health departments in assessing current data infrastructure capabilities and gaps; to improve secure public health data collection, transmission, exchange, maintenance, and analysis; to enhance the interoperability of public health data systems; to support and train related personnel; to support earlier disease and health condition detection; and to develop and disseminate related informationand improved electronic case reporting. Section 314 also requires the Secretary of HHS to develop and submit to Congress a coordinated strategy and accompanying implementation plan that identifies and demonstrates measures utilized to carry out such activities, and requires HHS to consult with State, local, Tribal, and territorial health departments and other appropriate public or private entities regarding the plan and grant program to modernize public health data systems pursuant to this section.
Section 315. Native American suicide prevention.
Section 315 ensures states consult with Indian tribes, tribal organizations, urban Indian organizations, and Native Hawaiian Health Care Systems in developing youth
suicide early intervention and prevention strategies.
Section 316. Reauthorization of the Young Women’s Breast Health Education and Awareness Requires Learning Young Act of 2009.
Section 316 reauthorizes the young women’s breast health awareness and education program at $9 million for each of fiscal years 2022 through 2026.
Section 317. Reauthorization of school-based health centers.
Section 317 reauthorizes the School-Based Health Center program for fiscal years 2022 through 2026.
Subtitle C – FDA Amendments
Section 321. Rare pediatric disease priority review voucher extension.
Section 321 allows the Food and Drug Administration (FDA) to continue to award priority review vouchers for drugs that treat rare pediatric diseases and are designated no later than September 30, 2024, and approved no later than September 30, 2026.
Section 322. Conditions of use for biosimilar biological products.
Section 322 clarifies that biosimilar applicants can include information in biosimilar submissions to show that the proposed conditions of use for the biosimilar product have been previously approved for the reference product.
Section 323. Orphan drug clarification.
Section 323 clarifies that the clinical superiority standard applies to all drugs with an orphan drug designation for which an application is approved after the enactment of the FDA Reauthorization Act of 2017, regardless of the date of the orphan drug designation.
Section 324. Modernizing the labeling of certain generic drugs.
Section 324 allows FDA to identify and select certain covered generic drugs for which labeling updates would provide a public health benefit and require sponsors of such drug applications to update labeling. It also requires FDA to report on the number of covered drugs and a description of the types of drugs selected for labeling changes, and the rationale for such recommended changes, and to provide recommendations for modifying the program under this section.
Section 325. Biological product patent transparency.
Section 325 increases transparency of patent information for biological products by requiring patent information to be submitted to FDA and published in the “Purple Book.” It also codifies the publication of the “Purple Book” as a single, searchable list of information about each licensed biological product, including marketing and licensure status, patent information, and relevant exclusivity periods.
Subtitle D – Technical Corrections
Section 331. Technical corrections.
Section 331 makes technical amendments to the Coronavirus Aid, Relief, and Economic Security Act.
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