Overview
During our audit period, MassHealth may have unnecessarily paid as many as 194,232 claims, totaling as much as $6.2 million, for drug tests that were not ordered for diagnosis, treatment, or other medically necessary purposes. In many instances, MassHealth paid for drug tests for members who were tested at high frequencies (one, two, or three days apart) but did not receive any related medical treatments or services within a timeframe in which it was reasonable to expect them to receive such treatments according to professional guidelines. These funds could have been used to pay for other medical services to MassHealth members.
The Office of the State Auditor (OSA) initially performed site visits at three laboratories: a hospital laboratory, a freestanding independent clinical laboratory, and a substance use disorder (SUD) treatment facility laboratory. At these laboratories, we reviewed all claims for a judgmental sample of 15 MassHealth members who received the most drug tests from each laboratory. For each member, we reviewed all order forms and results for every drug test performed. When reviewing the information from the hospital laboratory and the SUD treatment facility laboratory, we found that all drug tests were properly documented as being for diagnosis, treatment, or other medically necessary purposes.
However, when reviewing the information from the freestanding independent clinical laboratory, we found that all drug test order forms for 12 of the 15 members in our sample appeared to have been authorized by the laboratory and not by the healthcare professional listed on the order form. Therefore, it was questionable whether they were used as a tool to diagnose or treat the members as required by MassHealth regulations. In addition, through data analysis, we learned that none of these 12 members had received any other medical services at the time of the drug testing that would have necessitated the testing (e.g., SUD counseling, emergency-room visits, therapy, or evaluation and management [E/M] services), which raised concerns about whether the tests were used to treat the members.
The table below summarizes the results of our analysis in this area.
|
Laboratory |
Total Drug Tests in Sample |
Total Paid When Other Medical Services Were Received |
Total Paid When No |
|---|---|---|---|
|
Hospital Laboratory |
1,501 |
$36,216 |
$0 |
|
SUD Treatment Facility Laboratory |
1,794 |
$30,415 |
$0 |
|
Freestanding Independent Clinical Laboratory |
2,722 |
$0 |
$21,073 |
Based on the results of our site visits, our follow-up with a SUD treatment professional, and our own analysis of member drug tests, we performed data analytics to determine whether all drug test claims paid by MassHealth during our audit period correlated with medical services provided by healthcare professionals, who typically use drug tests as a tool when diagnosing and treating members and when developing treatment plans for members with SUDs or providing chronic opioid therapy (a type of pain management). As part of this analysis, we considered the effect of detection times to determine how long a drug test result is useful to a provider as a tool to measure any illicit drug use. For example, if a member receives a drug test and the results are not evaluated or used by the provider, discussed with the member, or used to update the member’s treatment plan in a timely manner, the drug test may not have been necessary.
Using this information, our data analysis focused on comparing drug test dates of service with other medical services3 the member received within the 7 days before and after the drug test. We also performed this analysis using services received within the 15 days before and after the drug test. We selected 7 days and 15 days for our analyses because healthcare professionals who treat patients for SUDs and chronic pain require frequent drug testing, during patient office visits and when new prescriptions are written.
Our results indicated that approximately $3.3 million and as much as $6.2 million, respectively, was paid when the members had not had any related medical treatment requiring the use of drug test results:
|
Days Analyzed |
Questioned Claims |
Questioned Costs |
|---|---|---|
|
No other medical services within 7 days |
194,232 |
$6,165,525 |
|
No other medical services within 15 days |
87,022 |
$3,281,628 |
In addition to identifying drug tests paid for by MassHealth for which there were no corresponding medical services provided within a 15- or 30-day timeframe, we found that some MassHealth members were frequently drug tested without having any other related medical services well beyond our established timeframes. Some examples are below.
- One member was drug tested on Tuesdays, Thursdays, and Saturdays, at an average of 12 times per month, for 8 months, receiving a total of 95 drug tests costing $4,069. The only medical service this member received during this time was one E/M service.
- One member was drug tested on Tuesdays and Saturdays, at an average of 7 times per month, for 9 months, receiving a total of 65 drug tests costing $3,171. The only medical service this member received during this time was one hospital outpatient visit.
- One member was drug tested on Tuesdays and Saturdays, at an average of 5 times per month, for 14 months, receiving a total of 75 drug tests costing $3,659. The only medical services this member received during this time were one hospital outpatient visit and two E/M services.
- One member was drug tested on Mondays, Wednesdays, and Fridays, at an average of 9 times per month, for 5 months, receiving a total of 46 drug tests costing $2,306. This member did not receive any other medical services during this time.
Authoritative Guidance
“Authorized prescriber” is defined by Section 401.402 of Title 130 of the Code of Massachusetts Regulations (CMR) as follows:
Any individual who is authorized under state law to prescribe drugs pursuant to M.G.L. c. 94C and also authorized to order the test under M.G.L. c. 111D and for the sole purpose of ordering medically necessary drug screen services, Massachusetts Department of Public Health licensed substance abuse treatment programs only when such requests are initiated in writing by a physician who is employed or contracted by the substance abuse treatment program to make such requests and whose written request fully complies with all requirements set forth in 130 CMR 401.416(A) through (C).
According to 130 CMR 401.416(A), MassHealth only pays for drug tests when a medical professional uses their results when treating its members:
The independent clinical laboratory may not bill for a [drug testing] service unless it has received a written request to perform that specific service from an authorized prescriber who is treating the member and will use the test [emphasis added] for the purpose of diagnosis, treatment, or an otherwise medically necessary reason.
Most drug testing occurs in SUD treatment settings. According to Appendix B of the federal Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) Treatment Improvement Protocol 47, which sets forth industry guidelines on addiction treatment services and drug testing, “Routine specimen collection after admission should take place in conjunction with regular clinic visits.” Additionally, according to Boston Medical Center’s4 Office Based Addiction Treatment Manual, office visits for patients undergoing SUD treatment occur every 7, 15, or 30 days and drug tests are performed at each of these visits:
Patient sees Nurse Care Manager weekly for 4–6 weeks until stable [no longer using illicit drugs]. If urine screens are negative, patient is attending counseling and weekly clinic visits as scheduled, they then may progress to the maintenance phase. . . .
Once stable, clinic visits every 2 to 4 weeks, with refills that coincide with visits. . . .
Urine samples will be required at each visit.
Based on these standards, it is reasonable to expect that medical services, such as office visits, should occur in most situations within 15 days before or after a drug test.
Reasons for Improper Payments
MassHealth does not have adequate internal controls in place to ensure that drug tests are ordered for medically necessary purposes. Instead, order forms and urine samples are sent directly to laboratories for processing, and the laboratory personnel do not always know whether authorized prescribers of drug tests have ordered them for diagnosis, treatment, or otherwise medically necessary reasons. Further, MassHealth does not conduct any reviews of laboratory order forms and result reports to determine whether drug tests are ordered only for diagnosis, treatment, or otherwise medically necessary purposes.
In addition, because MassHealth does not require referring-provider information to be included in each claim submission, it cannot effectively track whether providers prescribing drug tests are affiliated with SUD treatment services or programs and are ordering the drug tests for diagnosis, treatment, or otherwise medically necessary purposes.
Recommendations
- MassHealth should establish controls to ensure that it only pays for drug tests that are used for diagnosis, treatment, and otherwise medically necessary purposes.
- MassHealth should ensure that all claim submissions include the referring provider’s identification number. MassHealth should use this information to create a system edit and/or monitor claims to limit payments for drug tests to those ordered by authorized prescribers who are currently treating the members.
- MassHealth should require laboratories to send all drug test results directly to the prescribing providers who ordered them.
Auditee's Response
MassHealth disagrees with the finding that it may have paid as much as [$6.2] million for unnecessary drug tests. . . .
OSA based its [$6.2] million finding on its determination that at one of the three labs reviewed, . . . ”drug test order forms for 12 of the 15 members in our sample appeared to have been authorized by the laboratory and not by the healthcare professionals on the order form. Therefore, it is questionable whether they were used as a tool to diagnose or treat the members as required by MassHealth regulations.”
MassHealth reviewed the sample provided by OSA and found that the documentation provided by the clinical laboratory did not include sufficient documentation required under 130 CMR 401.416 (Request for Laboratory Services). Based on OSA’s findings, MassHealth will further review this independent clinical laboratory provider to ensure that the services it provides meet all applicable regulations including 130 CMR 401.416.
OSA also observes, “In addition, through data analysis we learned that none of these 12 members had received any other medical services at the time of the drug testing that would have necessitated the testing (e.g., SUD counseling, emergency room visits, therapy, or evaluation and management [E/M]), which raises concerns about whether the tests were used to treat members.” OSA then goes on to extrapolate that all claims for drug tests in which the member did not have a claim for an “associated” medical services within seven or 15 days before or after the test may have been improperly paid. As described in detail below, MassHealth strongly disagrees with OSA’s extrapolation methodology and associated finding.
While drug tests must be ordered by authorized prescribers as part of medically necessary treatment, OSA references no authority for its conclusion that drug testing must be “necessitated” through the provision of particular medical services within a particular timeframe. That standard is without basis in MassHealth regulations or clinical guidance, and apparently reflects the OSA’s own opinion. Because OSA’s requirement of a particular “necessitating service” is its own opinion, no authority is referenced for OSA’s clinical determinations of which medical services are considered “necessitating services” and which are not. Instead the audit report offers a non-exclusive list of “necessitating services” comprising three items: counseling, therapy, and evaluation and management. Emphasizing the vague and fluid nature of OSA’s medical necessity construct, OSA later states that it “focused on comparing drug test dates of service with other medical services the member received (around the same date of service)” and provides a different non-exclusive list of services, which it no longer characterizes as “necessitating” drug testing: “Medical services associated with ordering drug tests could include SUD counseling, emergency room visits, evaluation and management services, or therapy.”
OSA compounds these methodological problems by establishing two arbitrary time parameters during which a service from OSA’s list of “necessitating” or “associated” services must occur: either within seven or 15 days before or after the date of the drug test. OSA states that it chose those parameters because “(Substance Use Disorder or SUD) treatment professionals indicated that they require follow-up visits with their patients either weekly or monthly, and a 31-day period (15 days before and after a given date) should encompass monthly visits,” noting that “most members requiring frequent drug testing are receiving SUD treatment.” Because the notion of “necessitating” or “associated” medical services has no basis in MassHealth regulations or clinical guidelines, neither does the creation of a period during which those designated services must occur. There are no regulations in place nor clinical requirements establishing an appropriate or required proximity between medical services and drug tests for substance abuse monitoring. For example, members in a maintenance or continuation of care phase of treatment may be receiving randomized drug testing without having a regular visit to their treatment providers. Even if there were a basis for creating such a timeframe, consulting with several providers representing only one provider type authorized to order drug tests would be an inadequate approach to creating the timeframe.
OSA’s process for selecting these timeframes reflects another broad issue with OSA’s methodology: it appears to only consider drug testing in the context of substance use disorder services. From the preliminary sections of its report to the providers and entities discussed in the report, the report reflects an assumption that the tests represented in its finding must have been performed to treat substance use disorders. The assumption ignores that there are other medically necessary reasons why a member might receive drug testing. For example, it is standard practice for patients prescribed long term opioid use for pain management to be routinely drug tested. OSA did not consult with any pain management providers, nor did it identify any clinical documentation supporting the appropriate use of drug testing for pain management. The Massachusetts Department of Industrial Accidents published an Opioid/Controlled Substance Protocol in May 2016. . . . For ongoing long term opioid management, the protocol recommends visits every 2–4 weeks for the first 2–4 months of treatment and then every 6–8 weeks later in treatment. This highlights the arbitrary nature of OSA’s designated timeframes, as there would no basis for denying drug test claims in such a case simply because no other services were provided within a 15- or 31-day window around the test.
MassHealth also determined that OSA took no steps to determine whether members were enrolled for the duration of the 15- and 31-day windows it established. Even by OSA’s terms, tests for members that added or lost coverage within those windows could have been “necessitated” by services that were received before or after MassHealth coverage was effective, but still classified as “unnecessary.” Similarly, OSA’s method does not account for members that change coverage, for instance, from a MassHealth fee for service plan to a managed care plan. For those members enrolled in a managed care plan, it is the managed care plan and not MassHealth who pays for the members’ claims. The methodology MassHealth reviewed did not describe steps OSA took to ensure that members were in a MassHealth fee for service or Primary Care Clinician plan for the duration of the 15- and 31-day windows. . . .
Although MassHealth does not agree with OSA’s methodology for identifying unnecessary claims, MassHealth supports the effort to identify medically unnecessary testing. As noted in the executive summary, MassHealth continually establishes, updates, and refines controls as part of its broader efforts to strengthen program integrity, including identifying providers with increased billing activity or aberrant billing practices. For certain drug screening and testing providers, MassHealth has been suspending these providers’ claims prior to payment and requiring submission of additional documentation. Further, MassHealth has been reviewing providers who consistently bill high level definitive testing. For these providers, MassHealth plans to suspend the relevant claims and require submission of additional documentation to ensure the claims meet applicable regulations and are medically necessary. MassHealth also has been reviewing utilization to identify those members that receive a high volume of drug testing, and is the process of developing strategies to ensure that those members’ claims are medically necessary. . . .
MassHealth implemented regulation and billing instruction changes in October 2017 requiring providers to include the ordering or referring provider’s national provider identification (NPI) number on claims requiring an order or referral and to verify such providers’ eligibility. The change applies to services provided by independent clinical laboratory providers. The change, which is detailed in All Provider Transmittal Letter [223] and the mass.gov website, . . . required MassHealth to establish new enrollment processes for ordering and referring providers. Additionally, this project required MassHealth to work closely with state licensure boards to establish MassHealth enrollment as a licensure requirement. At this time, MassHealth is editing claims against this requirement, though claims are not yet being denied. MassHealth is identifying providers who are routinely omitting the ordering NPI on claim transactions.
MassHealth’s customer service department is planning targeted outreach to ensure greater compliance prior to denial of claims missing the NPI.
MassHealth disagrees however, that OSA’s proposed system edit is either appropriate or practical. As discussed in MassHealth’s response to finding 1, MassHealth regulations do not establish a definition for which providers are “currently treating” a member, nor would it be practical to do so, given the range of treatment protocols and approaches for individual members’ circumstances. Also, determining which authorized prescriber or prescribers are “currently treating” a member poses practical challenges—as illustrated [above], it would not be appropriate to rely on claims transaction data alone to make such a determination. . . .
The Department of Public Health’s Clinical laboratory regulations 105 CMR 180.290 . . . establishes the reporting and recordkeeping standards for all licensed Massachusetts clinical laboratory providers. The regulation states: “The laboratory report shall be sent promptly to the licensed physician or other authorized person who requested the test. . . .”
Auditor's Reply
Our report explains that our $6.2 million calculation was not based on the results of our audit testing at one laboratory; rather, our audit work at laboratories was only the initial testing we conducted that helped us identify what appeared to be a high risk of improper payments for drug testing. As noted in this report, after analyzing the information from the testing at the laboratories, OSA performed data analytics on the whole population of payments made by MassHealth during the audit period and based our results on our analysis. We did not extrapolate results of our site visit audit testing to the entire population of drug tests, since our test samples at the three laboratories were judgmental. Extrapolation of errors to a population can only be performed when a statistical sampling method is used. Our questioned amount of $6.2 million was determined by performing a separate, independent calculation using the population of all MassHealth member claim data.
We acknowledge that there are no standards in MassHealth regulations that require members who are drug tested to receive related medical services within a specific time. However, as previously noted, SAMHSA guidelines state that drug tests are prescribed as part of a treatment program that involves other medical services. Appendix B of SAMHSA Treatment Improvement Protocol 47 states that drug tests should occur as a “routine part of therapy . . . in conjunction with regular visits,” and SAMHSA Technical Assistance Publication 32 states that drug tests should “never be the sole basis for diagnosis and treatment decisionmaking,” “should not be the only tool” used in treating patients, and “can be done randomly, during every visit, before providing prescription refills, or if the patient exhibits aberrant behavior.” In addition, MassHealth’s own regulations recognize the relationship that should exist between drug testing and other medical services: they require healthcare professionals to use the drug tests ordered when they are treating their patients. OSA constructed a timeframe that was not arbitrary but was based on SAMHSA Treatment Improvement Protocols and Technical Assistance Publications, and OSA believe it to be a reasonable period of time during which a member who is drug tested should have received some other related medical services. The information we used to construct this timeframe includes (1) the fact that it specifically matches the weekly, biweekly, and monthly office visits that our research indicated SUD treatment professionals require while members are going through the three phases of their recovery treatment; (2) the usefulness of drug test results based on drug detection times, described in the Overview of Audited Entity section of this report; and (3) the fact that prescriptions for medications used to treat SUDs and chronic pain typically do not exceed 30 days, which means a medication visit is required in that timeframe.
Although it is not detailed in this report, even looking beyond our established timeframes, we found that a significant number (31%) of our questioned costs included drug tests when the members did not receive any medical services at all within 60 days of the test date (for 30 days before and 30 days after). We also found many instances of members receiving frequent drug testing for even more extended periods (e.g., for many months) with minimal or no other related medical services. In OSA’s opinion, these analytical results call into question whether much of the questioned testing was actually used in the treatment of members and whether it represents situations that at least should be reviewed by MassHealth.
OSA did consider members receiving chronic opioid therapy in our analysis. In doing so, OSA found that, according to SAMHSA’s Technical Assistance Publication 32, chronic opioid therapy patients must be closely monitored for medication adjustments and to prevent opioid abuse. Therefore, it was reasonable for OSA to look for office visits in relation to the drug testing provided to these members in our sample. Further, our analysis included drug testing paid for by managed-care organizations as well as drug testing that was paid for directly by MassHealth on a fee-for-service basis and therefore accurately accounts for any members who may have switched their form of coverage during the period reviewed.
Although our report only cites a few medical services that we believe should have been provided in relation to members’ drug testing, our analysis in this area used a comprehensive list of 168 procedure codes derived from MassHealth’s own provider manuals (the Substance Abuse Disorder Treatment Manual, Mental Health Center Manual, and Physician Manual) that relate to drug testing. OSA shared this list of 168 procedure codes that we were going to use in our analysis with MassHealth during the audit, and MassHealth officials did not express any concerns about its being exclusive or not comprehensive enough to use in our analysis.
MassHealth cites the Department of Industrial Accidents’ May 2016 Opioid/Controlled Substance Protocol as recommending infrequent provider visits for long-term opioid pain management. In fact, this document states that patients receiving such treatment should have random drug screenings “at least twice and up to 4 times per year, or more if clinically indicated, for the purpose of improving patient care.”
Regarding our recommendation that MassHealth create a system edit to detect questionable drug testing, OSA does not dispute MassHealth’s assertion that its regulations do not establish a definition for when providers are “currently treating” a member. However, OSA believes that it would be practical for MassHealth simply to create a system edit that would deny any claim if the provider’s National Provider Identifier (NPI) field were left blank. During our audit period, MassHealth did not require laboratories to include ordering physicians’ NPI numbers when submitting claims for drug tests. Therefore, MassHealth did not have the necessary information to determine whether healthcare professionals used the tests to diagnose and treat its members in accordance with its regulations. MassHealth states that, effective October 2017, it required all laboratory claim submissions, including drug tests, to list the ordering and referring providers’ NPI numbers. However, OSA reviewed claim data from drug test claim submissions between November 2017 and April 2018 and found that only 2 out of the 804 claims submitted listed the prescribing provider’s NPI number. If MassHealth plans to use prescribing providers’ NPI numbers to monitor drug test claims more closely and help it identify high-risk ordering providers, it needs to ensure that all drug test claim submissions include NPI numbers.
Regarding OSA’s recommendation that MassHealth require laboratories to send drug test reports to the ordering prescribers, MassHealth states that there already is a regulation that requires this; it refers to the Department of Public Health (DPH) regulation 105 CMR 180.290. Although this may be true, our audit found that many drug test reports were sent directly to sober-home addresses and not to the ordering prescribers, and therefore MassHealth needs to take additional measures to ensure compliance with this requirement.
| Date published: | July 27, 2018 |
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