Wednesday, July 29, 2015

The Popularity of Palmetto’s Approach to Urine Drug Tox Coding and Payment

  • Medicare and stakeholders has sparred for years over correct coding and pricing for urine drug tests (UDTs.
  • AMA and CMS are using quite different systems in the current year, 2015 – private payers could probably pick either.
  • Palmetto GBA has come up with a “tiered” coding and pricing system that was praised by many stakeholders at the July 16, 2015 CMS CLFS meeting.

Details after the break.

The Rapid Growth of Urine Drug Testing
The rapid growth of urine drug testing, typically used in pain management and addiction treatment programs, has raised payer concerns in recent years.  Medicare’s laboratory pricing schedule is relatively inflexible to change, and according to the Wall Street Journal, some provdiers were “cashing in…[on] costly tests for illegal drugs such as cocaine and angel dust, which few seniors ever use.”  (WSJ, November 10, 2014, here. For an open access article – “Is high tech drug testing Medicare’s new fatted calf?” – see here.)   The government has brought expensive recoupment cases against some laboratories – see “Millenium loan plunges as lab tester negotiates settlement,” June 15, 2015 – here.

Sparring Over Coding: the CMS July 2015 Position
Medicare officials, AMA CPT, and other stakeholders have sparred over correct coding and prices for a number of years.  AMA CPT introduced a new coding program in January, 2015 – which Medicare declined to use, and instead replicated all the old AMA CPT 2014 codes (and their semantic ambiguities) as “G codes.”  While Medicare continues to use the “old” codes as “G codes” so far in 2015, this summer Medicare also proposed to replace the elaborate coding system (whether the 2014 one or the 2015 one) with just two codes.  Medicare’s summer proposal tells the tale (here):

·         Continue to not recognize AMA CPT codes 80300-80377 (64 codes)
·         Delete (2015) G-Codes G0431, G0434, G6030-6058 (28 codes)
·         Create two new codes
o   GXXX1
o   GXXX2

The new codes CMS hopes to implement would be:

GXXX1, Drug screen, any number of drugs or drug classes, any procedures, methodologies, any sources, per day
GXXX2, Drug test(s), (Confirmatory or definitive, qualitative and quantitative), , any number of drugs or drug classes, any procedures, methodologies, any sources, includes sample validation, per day

Public Response to CMS Coding Proposal
Virtually all speakers at the July 16, 2015, public meeting on the 2016 lab pricing issues opposed the two-code CMS proposal (for my blog, here.)

AMA:  While opposing the two-code CMS system, the AMA supporting using the publicly vetted codes they have already put in place for 2015 and future years.

Various Stakeholders Support Palmetto:  Many other groups supported a distinctive approach – neither the AMA’s nor CMS’s.  These groups endorsed the approach proposed by Palmetto GBA, which operates the national demonstration program MolDx (here).   This proposal was supported by the ACLA, by Two Dreams Treatment Centers, and by the Center for Lawful Access and Abuse Deterrence, as well as the Drug Testing Coalition (DTC), these latter three entities more less supporting both Palmetto’s coding and its LCD.   Advamed said it most preferred AMA CPT codes, but was considering as an alternative stance that might support the DTC.  Dominion Diagnostics supported the Palmetto method and participates in the DTC.  The American Academy of Pain Management supported the Palmetto method;  Lab Source supporting tiering, but somewhat different tiers. 

What IS the Palmetto System?

Palmetto has an LCD for “Controlled Substance Monitoring and Drugs of Abuse Testing,” LCD L35105, most recently revised as effective on 5/7/2015 (here).  The policy describes “appropriate indications and expected frequency of testing,” designates medically necessary documentation on record at the ordering physician, and clarifies the meaning of “presumptive” versus “definitive” urine drug testing (UDT).

Note that I have summarized the policy and paraphrased it; see the original document for full and accurate details.

Financially, the main result (besides coverage rules and definitions), is to categorize the CMS G codes for drug tests into groups with the net effort of "tiered" pricing.

Palmetto LCD Definitions:
Presumptive/Qualitative testing is medically necessary testing to determine the presence or absence of drugs or drug classes as a UDT; results may be negative, positive, or numeric, and methods may be TLC or immunoassay.

Definitive/Quantitative testing identifies specific medications, illicit drugs, or metabolites [note these are specific chemical entities, not classes], which are absent or present in ng/ml; and tested by GC-MS or LC-MS methods.

Specimen validity testing does not test drugs (or classes) but pH, specific gravity, etc. 

Point of care testing provides immediate results, e.g. dip stick usually for drug classes not specific drugs, and is read “by human eye.”  “Immunoassays” are biochemical tests read by photometric technology. 

Standing orders signal a request for repetitive testing and are designed per-patient.  In contrast, blanket orders are not individualized but apply a priori to classes of patients.  Reflex testing is performed when a result “X” is obtained and another test “Y” will follow.

Regarding medical necessity:

·         CLIA-waived presumptive tests should be used only when results are needed immediately.
·         Immunoassay photometric tests are presumptive testing and are never considered confirmatory/definitive testing.
·         LDTs may include tests for analytes without FDA approved tests.

·         Presumptive drug testing: It may be ordered when “it is necessary to rapidly obtain and integrate results into clinical assessment and treatment decisions.”Is limited in value due to class detection features and due to interference problems.  It “may be medically necessary” to proceed with definitive testing after a positive presumptive test. 
o   Medicare uses special codes for presumptive panels: G0431 and G0434.
§  G0431 is screening any number by complex method, G0434 is screening any number by CLIA waived or moderate complexity method.   
§  A urine cup with colored strips for amphetamines and for opioids would be G0434.
·         Definitive drug testing:  Is for GC MS with volatile analytes, while LC-MS is 100x more sensitive and selective.  It may be reasonable under 8 circumstances, such as “to identify a specific substance inadequately detected by presumptive UDT” or “to identify a non-prescribed medication” or “to identify a negative or positive test inconsistent with a patient’s presentation, medical history, or current [prescription].”

Patient Care Scenarios
Palmetto then goes on to describe several detailed patient categories or scenarios (Group A, Group B, etc.)   For example, patients with “symptoms, multiple drug ingestion, or unreliable history” are Group A and those with known substance abuse or dependence are Group B.  Medical records should be sufficient to class patients in one or another group, e.g. unexpected seizures may be Group A.  Patients in Group B may be tested by UDT at random intervals.  Another group, Group C, is chronic pain patients on opioid therapy.

Frequency Guidelines
Palmetto also provides frequency of testing guidelines, e.g. for patients with 0 to 30 days abstinence, presumptive testing up to 3 panels per week.  For patients with > 90 days abstinence, no more than 3 UDT per month. 

For full details, see the entire LCD.  The policy also details certain circumstances that allow for reflex testing, or for using definitive testing direct without a preceding screening UDT.

Never Do These:  Blanket orders are never covered, and another 9 or 10 circumstances are listed as never covered (including, for example, “UDT for employment purposes.”)

Billing Guideline
Palmetto has a number of billing guidelines (here): for example, a number of tests can be billed with only 1 unit of service (UOS) per class of drugs, such as amphetamines.  Opioids are divided into three subsets, natural, semisynthetic, and synthetic, for this unit of service purpose.   

Thus, these definitions of classes and units of service serve as a special “tiered” pricing mechanism.  A patient tested for amphetamines, and the three opioid classes, would get “four” units of service, the highest tier.

Palmetto Published Comments on its Original Draft LCD
The LCD has changed very little since it was finalized in the fall of 2014.  Palmetto published a discussion of comments received on the draft LCD - the comments are here.

To discuss how the changing healthcare system and Medicare policy affects your company, association, or investments, contact Dr Quinn through FaegreBD Consulting