Passing the Test

By Jennifer Bolen, JD

For practicing pain management physicians, a federal government initiative to investigate clinical laboratory practices may mean changes in lab testing operations. The federal government is looking at point-of-care and traditional clinical laboratories (http://hcp.lv/fBTW7y) and examining test overutilization, inappropriate billing, and potential inducement and kickback issues designed to increase referrals for laboratory services (http://hcp.lv/gNd59P), Qualitative drug screens, such as those commonly used in pain management practices are included in the government’s focus (http://hcp.lv/dUzp8Y; http://hcp.lv/fyb1tQ; http://hcp.lv/en4SQV).

More broadly, the federal government recently passed legislation that includes use of “predictive modeling software” for shifting the government’s ability to track down and recover inappropriate reimbursements from the “pay and chase” method to the “weigh and pay” method.

The new strategies will examine claims and edit them at several levels prior to payment (http://hcp.lv/ie0NOz). Recent signals of more expansive government oversight in the clinical laboratory world demand attention by pain management practitioners engaged in any form of drug testing that results in a claim for reimbursement to federal and/or commercial health care benefit plans. Practices need to take control of their testing platforms—including their clinical laboratory partner—to reduce the risk of a fraud and abuse investigation and minimize the potential for an outcome related to any notice of overpayment/ recovery audit process. Failure to do so may be financially devastating, because test orders that rise to the level of abusive billing or false claims bring with them the potential for significant financial penalties and exclusion from participation in health plans.

A changing regulatory and coding landscape

The role of clinical drug testing in pain management, while frequently referenced in clinical guidelines and journal papers, is still a developing area and lacks clear clinical boundaries and consensus on proper selection of patients and drugs for testing, testing frequency, proper use of confirmation and quantitative testing, and interpretation and application of test outcomes to the treatment plan, along with proper documentation of test orders, outcomes, and changes to treatment. Sadly, inappropriate and uninformed marketing of laboratory services has resulted in the increased use of laboratory services without proper documentation from the ordering practitioner to support such claims (http://hcp.lv/fq73ba).1 Some practitioners simply turn over the decisions on drug testing to the laboratory sales representative (or the laboratory’s collector), not realizing that this is a bad idea for many reasons.

The increase in claims for reimbursement for laboratory services and reports of inappropriate marketing and reimbursement practices by some laboratories has resulted in increased government and payor scrutiny of both practitioners and traditional clinical laboratories. Examples of inappropriate laboratory practices include abusive coding and marketing the switching of testing platforms (cups to dips to analyzers) to physicians. Claim denials are also up on qualitative drug screens, and it’s hard to know where to turn for lawful and sound advice.

The US Department of Justice recently announced a settlement with Ameritox, Inc., one of the largest laboratories promoting the point-of-care testing model, for improprieties and questionable practices associated with its marketing strategies, including the provision of specimen collectors as an inducement for physician referrals to its laboratory (http://hcp.lv/glVpg1).2 The lawsuit papers show Ameritox made cash payments to its physician clients to induce the referral of drugtesting services. The lawsuit, filed by a former Ameritox employee under the “whistleblower” statute, resolves claims arising from Ameritox’s offer of free specimen collector personnel to its physician clientele in order to induce the referral of Medicare business.

The Centers for Medicare and Medicaid Services (CMS) and the American Medical Association (AMA) CPT Committee have been grappling with the development of new reimbursement codes and definitions to address confusion and the enormous increase in claim volume relating to qualitative drug screening. Since July 2009, CMS has issued a number of transmittals pertaining to qualitative drug screening codes (http://hcp.lv/fxDZdG).3 Likewise, several major carriers have issued revisions or new coverage determinations/medical policies governing qualitative drug screening (http://hcp.lv/dJ6NcR; http://hcp.lv/eJyoza).4 Medical staff should review these materials and consider them when developing compliance policies and drug-testing protocols for the medical practice.

For 2011, CMS and AMA have created new codes (CPT 80104, HCPCS G0434), deleted others (HCPCS G0430), and even supplied new definitions for old codes to more accurately reflect the tests performed in the laboratory setting (HCPCS G0431). CMS created the new test code HCPCS G0434 based on a programmatic need to accurately reflect both CLIA waived and moderate-complexity testing for drugs of abuse per patient encounter rather than per dipstick test. This change alone should prompt practitioners to evaluate their billing and coding practices relating to drug testing to ensure compliance and to seek expert help if they run into issues.

These changes, published in the Calendar Year (CY) 2011 Clinical Laboratory Fee Schedule (CLFS), directly impact drug testing performed by both physician-office laboratories and traditional clinical laboratories. Together with the announcement of the Justice Department’s settlement with Ameritox, these changes call for action and understanding.

Self-audit ideas

Practitioners, and coding and compliance staff, should review the compliance issues associated with laboratory services, take a serious look at their drug-testing platform, review the OIG Model Guidelines for Clinical Laboratories (http://hcp.lv/hNRwNq), and create appropriate compliance policies and operational/testing protocols.5 Practices who proactively address clinical-drug testing coverage and reimbursement matters will (1) improve their ability to identify and handle potential overpayments rather than waiting and wondering if the payor (or RAC) will investigate; (2) improve their control of clinical drug testing decisions and creation/documentation of “medically necessary and reasonable” drug-testing orders; and (3) establish and maintain an “arms’- length” relationship with outside clinical drug-testing laboratories, thereby further minimizing the potential for adverse clinical and financial outcomes associated with drug-testing in pain management. If you have concerns about your clinical drug testing platform and/or your clinical laboratory partner, take the time to read the materials cited in this article and then ask questions. On that note, be careful who you ask: laboratory sales personnel are generally not trained or qualified in coding and legal matters such as fraud investigations or regulatory compliance. Moreover, they may be paid a commission per specimen, which is questionable and unlikely to invite an informed discussion on your testing patterns. Go to true, credentialed third-party experts who have specialized (rather than generalized) experience in the science and compliance of clinical drug testing. A word of caution here as well: some individuals who teach in this area purport to be experts on the topic, but in fact may be misinformed and lack experience with CMS and OIG. They may be parroting what a transmittal says or what they heard someone do to try to “code around the denials” or “to avoid the MUE” by coding multiple lines. This is not only dangerous; it may be criminal! Do not be afraid to terminate your relationship with laboratories or persons that have provided you with erroneous information or omitted material facts during discussions about current events, testing, and compliance.

Protect your practice by knowing the rules

Recent government and payor actions relating to qualitative drug testing leave little room for doubt: it’s time to clean house and take a new approach to clinical drug testing and laboratory relationships. Survival in today’s tough economic times means making some hard choices; financial ruin awaits those who ask for or accept certain “freebies” that induce testing referrals. If your practice accepts free cups, free collector personnel, or free anything from an outside clinical laboratory, seek out professional legal help to ensure that you do not run afoul of federal or state laws prohibiting such arrangements.6 If laboratory sales representatives provide you with marketing information that suggests you can make more money by changing your point-of care testing method, or that you should use standing orders to ensure proper confirmatory testing with that laboratory, think twice and report the potential inducement/fraud to the OIG hotline. In many cases,

the standing orders and reminder systems used by some laboratories to “help you” with your drug testing may be setting you up for disaster if a payor wants to review your claims and underlying documentation.

Recent actions by the CMS are not intended to stop medically necessary and reasonable laboratory testing; the agency is required by law to take steps to protect the assets of the federal plans and in part intends for the new coding changes to provide clearer guidance to minimize the potential for abusive and fraudulent billing practices. The CY 2011 CLFS and new codes will make it much easier to differentiate between appropriate and inappropriate claims for reimbursement for laboratory services, a much-needed step to level the playing field so that point-of-care and traditional clinical laboratories that try to do it right can succeed and provide quality medical care. Finally, it is important to remember that it is the ordering practitioner who is responsible for claims associated with laboratory testing services. Practitioners who fail to take charge of their testing make easy targets for anti-fraud contractor audits and government investigations, the results of which cost much more than the short-term return promised by the wolf in sheep’s clothing.

Jennifer Bolen, JD, is the founder of The Legal Side of Pain® www.legalsideofpain.com). She is the owner of the law practice, The J. Bolen Group, LLC; is on the Board of Directors of the American Society of Pain Educators; and previously served as an Assistant US Attorney with the US Department of Justice.---endnotes

1. Some of this inappropriate and uninformed marketing is intentional,

and designed to create a back-scratching relationship

that induces overutilization of laboratory testing; other marketing

platforms are simply uninformed and lack properly educated

sales personnel, who give out dated or outright erroneous information

to get ahead of the competition. Practitioners should

insist on a laboratory partner that is accurate, complianceoriented,

and scientifi cally sound.

2. By itself, the point-of-care drug testing model is not inappropriate,

but Ameritox admitted to using marketing strategies that

were characterized as inducements (specimen collectors) and

kickbacks to induce physician referrals to its laboratory without

regard to CMS, OIG, and state law boundaries on the appropriate

role of a clinical laboratory. If you are involved with a laboratory

that proposes such arrangements, proceed with caution. Good

laboratories will take a strong stance on compliance and be

more interested in showing you how to properly utilize laboratory

testing so that only medically necessary and reasonable testing is

ordered rather than teaching you how to circumvent coding guidelines

just to get paid. Failure to address potentially inappropriate

relationships with laboratories and inappropriate billing puts the

practitioner, involved medical staff personnel, and the laboratory

at risk of federal and state administrative, civil, and criminal

investigations, as well as anti-fraud contractor review.

3. To view all of the relevant transmittals, use the CMS Clinical

Laboratory Center and follow the links to laboratory-specifi c

transmittals (http://hcp.lv/fxDZdG).For transmittals specifi cally

relating to qualitative drug screening, look for transmittals that

begin in July 2009, and continue to the present. You may also

want to search for “qualitative drug screen” on the CMS website

to get a broader perspective on where all of the changes have

been made and how this impacts the submissions of claims for

reimbursement and claims process.

4. For example, First Coast Services Organization (FCSO) published

a draft Local Coverage Determination (LCD) in the Fall of 2009,

and later revised it to stay current with CMS changes to the

temporary G0430 and G0431 codes in 2010. The FCSO LCD

(L-30574) makes clear that “Medicare will consider performance

of a qualitative drug screen (HCPCS codes G0430/G0431 and

CPT Code 80100) medically reasonable and necessary [in chronic

pain management] when . . . (a) there is a signifi cant pre-test

probability of non-adherence to the prescribed drug regimen as

documented in the patient’s medical record; or (b) the patients

are in a ‘designated’ pain management clinic where this select

population has a signifi cant pre-test probability of drug interactions

and side effects.” National Government Services (NGS) has

a more restrictive coverage determination. Both the FCSO and

NGS coverage determinations are available on-line.

1. Likewise, Palmetto GBA, a Medicare Part B Carrier in OH, SC, and

WV, published coding and billing guidance (later posted as a Medical

Policy) that stated “Effective 6/30/10, CMS will not recognize

CPT Code 80101 services for reimbursement. . .Test coded/billed

with HCPCS code G0430QW and G0431QW are non-instrumented

assays and must be billed with a quantity of one per episode of

care regardless of the number of collection/testing items used, the

number of procedures, and the drug classes screened. One test

per episode of care will be allowed because Palmetto GBA does not

consider multiple tests to be medically necessary when a single test

to screen for all drug classes is available. . . Note: POC physicians

and NPP who submit multiple G0431 and G0430 services per

episode are at risk of RAC and anti-fraud contractor review.

5. Many traditional drug testing laboratories lack familiarity with

the OIG guidelines; some say they follow them, but when you

look behind the scenes you see otherwise. While the OIG does

not require clinical laboratories to follow these guidelines, it

makes clear that doing so will facilitate proper test utilization

and an overall understanding of the proper relationship between

physicians and traditional clinical laboratories.

6. Some degree of materials provided to the ordering practitioner

at the laboratory’s expense may be appropriate and customary

in the industry. It is important to know the difference.