Posts Tagged payor

A New Anti-Kickback Law Targets Clinical Lab Marketing Arrangements

A New Anti-Kickback Law Targets Clinical Lab Marketing Arrangements

Some very important and potentially game-changing legislation was recently passed. On Oct. 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (or EKRA) – a statute that potentially eliminates legal protections (i.e., “safe harbors”) used by clinical laboratories to market their services. EKRA is part of the “Support for Patients and Communities Act,” comprehensive legislation designed to address the opioid crisis. The Act is clearly aimed at the use/abuse of opioids and the business practices of recovery centers.

EKRA has several potentially game-changing provisions. The first big development is EKRA’s definition of “clinical labs.” The definition of clinical labs used by EKRA is the extremely broad definition contained in 42 USC 263a. Rather than confining the definition of “clinical lab” to toxicology labs, which would satisfy the legislative purpose of the opioid crisis and business practices of recovery centers, the definition covers ALL clinical labs.  Consequently, the reach of the definition of “laboratory” is significantly broader than the purpose of the Support for Patients and Communities Act.

Another important provision of EKRA is the statute is an “all-payor” statute. This means it applies to services that are paid by commercial insurers in addition to services paid by Medicare and Medicaid. Unlike the Anti-Kickback Statute (“AKS”) that only applies to federal payors, EKRA applies to commercial payors as well. This is obviously more expansive than the AKS and may require many clinical labs to examine their business practices as they relate to commercial payors if the labs have carved out arrangements specifically to commercial payors.

Finally and most substantively, EKRA prohibits certain business practices that some clinical labs currently use. EKRA defines payment practices that violate the statute to include compensation to employees or contractors that is based on: the number of individuals referred to a particular recovery home, clinical treatment facility or laboratory; the number of tests or procedures performed; or the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility or laboratory.

This change is important because under the AKS, clinical laboratories and other providers are permitted to pay bona fide employees compensation based on revenues generated from their marketing activities. The OIG has even indicated in several Advisory Opinions that providers could pay independently-contracted sales agents percentage-based compensation so long as the arrangement contained adequate safeguards to address so-called “suspect factors.” The prohibition of paying an employee based on some type of formula that takes into account the amount of business generated by the employee should cause laboratories to review their compensation practices because these compensation arrangements used by any clinical laboratory may no longer be protected.

While there is a possibility the definition of clinical lab will be interpreted to apply only to toxicology labs, it is far from certain. Consequently, any/every clinical laboratory needs to be aware of the new legislation and examine its business practices immediately.

Jim Hoover is a partner at Burr & Forman LLP practicing in the Health Care Industry Group. Burr & Forman LLP is an official partner of the Medical Association.

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Liquid Gold or Reimbursement Trap? Payor Reimbursement Policies for Urine Drug Testing

Liquid Gold or Reimbursement Trap? Payor Reimbursement Policies for Urine Drug Testing

Last summer, we wrote about physician roles and responsibilities to implement best practices in pain management programs and other treatments involving the prescription of opioids.1 Here we discuss issues related to getting paid to implement one of these best practices — appropriate urine drug testing.

The urine drug testing field has been described as a huge profit center with a growing number of clinics that run their own testing operations instead of farming them out to independent labs;2 but the numbers don’t always add up. This article takes a closer look at urine drug testing guidance from the Alabama Board of Medical Examiners and the Centers for Disease Control and Prevention and examines the urine drug testing policies for Medicare and Blue Cross & Blue Shield of Alabama to highlight an area where best practice and payor policies don’t always agree.

The “Best Practices”

When the BME finalized a new rule last year regarding risk mitigation strategies (RMS) for physicians prescribing controlled substances, urine drug testing was one of several recommended aspects of the RMS.3 The BME’s rule does not specify the frequency with which physicians should use urine drug testing in their RMS, but the CDC’s guidance4 on opioid prescribing best practices is informative.

According to the CDC’s study, experts agreed clinicians should use urine drug testing before the initiation of treatment using opioids and periodically thereafter to assess for prescribed opioids, other controlled substances, and illicit substances that may increase the risk of overdose when
combined with opioids. However, experts disagreed on the frequency with which urine drug testing should be used to monitor treatment regimens
and patient compliance, as well as on the degree to which urine drug testing should apply to all patients uniformly, as compared to individual case-by-case determinations.

The study also addresses the appropriate use of qualitative “screening” panels and quantitative “confirmatory” or “definitive” testing. The CDC recommends relatively inexpensive screening panels for illicit drugs and commonly prescribed opioids prior to initiation of treatment. More expensive confirmatory testing should be reserved “for situations and substances for which results can reasonably be expected to affect patient management” (e.g. in the case of positive screenings or unexpected negative screenings).

These suggested best practices can have a positive impact on patient treatment involving opioids and other controlled substances, but they may put
physicians in the position of ordering tests for which reimbursement is not available. In fact, as the CDC report acknowledged, the direct costs of urine drug testing “often are not covered fully by insurance.”

Sometimes, it just doesn’t pay…

Payors impose different requirements regarding medical necessity and frequency of drug testing. If you read through the BCBSAL and Medicare urine drug testing policies, it may seem the differences between the two policies are minor. However, these two payors differ on the frequency of monitoring screenings (after the initiation of treatment) that are considered medically necessary, as well as on their coverage policies for confirmatory tests.5

The most notable coverage difference we have seen between the two programs is in their application of the confirmatory testing policies,
specifically each payor’s interpretation of the word “test.” To illustrate, consider the following G-codes for confirmatory/definitive drug testing: G0480 (definitive drug test for 1-7 drug class(es)), G0481 (definitive drug test for 8-14 drug class(es)), G0482 (definitive drug test for 15-21 drug class(es)), and G0483 (definitive drug test for 22 or more drug class(es)). Medicare treats each G-code as a “test” for purposes of counting tests toward a coverage or benefit limit.6

By contrast, it is our understanding from conversations with BCBSAL that they consider each drug or drug class to represent a “test” for coverage and benefit limits, despite the fact that each G-code comprises a range of drug classes in multiples of seven. Because BCBSAL limits coverage of confirmatory tests to three tests per qualitative drug screen, in theory, reimbursement to providers would only be covered by BCBSAL under G-code G0480 for up to three drug classes tested per qualitative screening. To the extent providers bill BCBSAL for additional confirmatory tests beyond the three-test limit, they would likely be non-covered or result in an overpayment. BCBSAL’s restrictive policies are certainly a limiting factor on physicians trying to implement the best practices described above, and physicians should be aware of the different coverage policies between Medicare and BCBSAL with regard to confirmatory tests.

We chose to highlight this particular coverage policy difference between Medicare and BCBSAL because it is not readily apparent from a reading of the two policies. However, there are other nuanced aspects of payor policies on urine drug testing. Physicians and billing/coding personnel should consult the relevant payor billing guidelines, with the assistance of counsel as necessary, in order to determine coverage for a particular test or service.

Sources

1 Christopher L. Richard, Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic, Alabama Medicine, Summer 2017, at 4.

2 See, e.g. David Segal, In Pursuit of Liquid Gold, New York Times (December 27, 2017), https://www.nytimes.com/interactive/2017/12/27/business/urine-test-cost.html.

3 Ala. Admin. Code r. 540-X-4-.09(2)(b) (March 9, 2017).

4 Deborah Dowell, MD et al., CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016, CDC: Morbidity and Mortality Weekly Report (March 18, 2016), available at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm#suggestedcitation.

5 See BlueCross BlueShield of Alabama Policy No. 566, Drug Testing (last reviewed December 2016), available at https://providers.bcbsal.org/portal/documents/10226/1791629/Drug+Testing/1c67985a-0c5d-4be9-aa3c-c49677cf6a93?version=1.1; Local Coverage Determination (LCD): Controlled Substance Monitoring and Drugs of Abuse Testing (L35724), CMS.gov, https://www.cms.gov/medicare-coverage-database/license/cpt-license.aspx?from=~/overview-and-quick-search.aspx&npage=/medicare-coverage-database/details/lcd-details.aspx&LCDId=35724&ver=41&CntrctrSelected=381*1&Cntrctr=381&name=&DocType=Active&s=34%7c48%7c53%7c58&bc=AggAAAQBAAAA&.

6 2017 Controlled Substance Monitoring and Drugs of Abuse Coding and Billing Guidelines (M00128 V5), Palmetto GBA, https://www.palmettogba.com/palmetto/providers.nsf/docscat/Providers~JM%20Part%20B~Browse%20by%20Topic~Lab~2017%20Controlled%20Substance%20Monitoring%20and%20Drugs%20of%20Abuse%20Coding%20and%20Billing%20Guidelines%20(M00128%20V5) (describing each G-code as a “service” and providing that providers may only perform and report one G-code per date of service).

Article contributed by Christopher L. Richard with Gilpin Givhan, P.C. Gilpin Givhan, P.C., is an official Bronze Partner with the Medical Association

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