The Necessity of New Drug Testing Guidelines

September 3rd, 2010

Since the inspection of “medication assisted treatment for opiate addiction (methadone and drug free clinics) drugs of abuse and methadone compliance testing served the following purposes: “…..drug testing has provided both an OBJECTIVE measure of TREATMENT EFFICIENCY and a tool to MONITOR PATIENT PROGRESS.” In the publication of TIP 1 the State Methadone Treatment Guidelines (CSAT 1993b):

“Testing now is performed extensively to detect substance use and monitor treatment compliance. Analysis of test results provides guidance for clinics ACCREDITATION AGENCIES as well as information for program planning and performance improvement.

Compliance testing determines whether or not methadone diversion (selling on the streets) is a concern. In-house testing prevents objectivity of drug testing. When the clinics order, run and interpret their own test results in-house it loses the impartiality verses a federal and state licensed independent clinical laboratory. The clinic in-house testing was adopted exclusively for financial gains not for medical necessity. The illegal billing procedures resulted in phony medicaid billings recently exposed for medicaid losses of millions of dollars (see press release).

To prevent these practices the guidelines of drug treatment clinics in New Jersey must be ammended / updated. The new guidelines must state that required drugs of abuse testing must be sent to independent federally and state licenses clinical laboratories.

This ammendment will restore the original purpose of drug testing in methadone and drug treatment clinics, as stated in the first paragraph. There will be impartial, independent test results to evaluate by the accrediting organizations about patient compliance and treatment performance.

Also, this ammendement to the guidelines will prevent over charging medicaid by ordering more frequently and / or more analytes than needed. This practice was recently exposed by the New Jersey medicaid Inspector General. Eight New Jersey clinics improperly billed $3.5 million from 2007 to 2009. With a penalty of $1,000 per claim, the inspector general is trying to recover a total of $51.5 million from the clinics using in-house drug testing.

In conclusion the updated guidelines will restore the original purpose of drug testing in drug treatment clinics and prevent medicaid fraud. It will save millions of dollars for the State of New Jersey.

“New Drug Use vs. Residual Excretion”

September 2nd, 2010

“New Drug Use vs. Residual Excretion”:

Normalization of Cannabinoid Levels to Creatinine Concentrations

Interpretation of cannabinoid test results is complicated by the lengthy detection time after a person ingests marijuana. Chronic marijuana users can continue to test positive for cannabinoids up to 30 days after cessation from smoking.

If a patient is tested on a periodic basis the levels of cannabinoids detected in the patient’s urine can appear to fluctuate depending on time of day, state of hydration, and other factors. If the cannabinoids level is normalized to creatinine, the apparent levels are able to be interpreted in a more reliable manner.1 Based on research reported by Huestis and Cone the predictability of whether a patient has experienced new drug use is possible.2 The cannabinoids to creatinine ratio is compared in timed serial samples. If the ratio increases by 50 %, a new drug use is indicated. Depending on the consequences to the patient, the following guidelines should be followed:

1) If the patient is in a clinical situation, the ratios of the cannabinoids screening results to creatinine are useful indicators of recent drug use.
2) If the donor is in a forensic situation and the results could effect their liberty or livelihood, the ratios of the GC/MS analyses for delta-9-carboxy-THC to creatinine provide a more reliable indicator of recent drug use.

If you have any questions about these matters, please contact one of the Ammon Analytical Laboratory’s Forensic Toxicology Staff at your earliest convenience.

1. Manno JE: Interpretation of urinalysis results; In Hawks RL, Chiang CN (Eds): Urine Testing for Drugs of Abuse, Research Monograph 73; National Institute on Drug Abuse: Rockville, MD; p 54; 1986.
2. Huestis MA, Cone EJ: Differntiating new marijuana use from residual drug excretion in occasional marijuana users; J Anal Toxicol 22:445; 1998.

Calloway Lab Medicaid Fraud

August 6th, 2010

ATTORNEY GENERAL
July 02, 2010 - For immediate release:
Woburn Drug Screening Lab Indicted for Medicaid Fraud and Kickback Scheme
WOBURN — A Woburn-based clinical testing laboratory has been indicted for allegedly orchestrating an extensive Medicaid Fraud and kickback scheme using “straw companies” and overcharging the state’s Medicaid program, Attorney General Martha Coakley announced today.
A Middlesex Grand Jury returned 42 indictments yesterday against Callow Laboratories, Inc. (“Calloway”), two of its principals, and two employees of a sober house in connection with a wide-ranging investigation by Attorney General Coakley’s Medicaid Fraud Division.

The indictments allege that Calloway, Chief Executive Officer Arthur Levitan, and Chief Operating Officer Patrick Cavanaugh, engaged in a pervasive kickback scheme involving two straw companies which funneled kickbacks to sober houses, as well as paid middlemen and a medical office to illegally obtain urine drug screening business paid by MassHealth, the Commonwealth’s Medicaid program. The Commonwealth alleges that MassHealth paid in excess of $10.6 million for urine drug screen business obtained by Calloway as a result of these illegal kickbacks.

Other indictments returned today allege submission of false claims to MassHealth, Larceny Over $250, and Corruption of a Witness.

The defendants are charged as follows:

Calloway Laboratories, Inc.
Medicaid False Claims (3 counts)
Medicaid Kickbacks (16 counts)
Larceny over $250 (2 counts)

Arthur Levitan, 38, of Weston
Medicaid Kickbacks (12 counts)

Patrick Cavanaugh, 46, of Gloucester
Medicaid Kickbacks (5 counts)
Corruption of a Witness (1 count)

William Maragioglio, 41, of Malden
Medicaid Kickbacks (2 counts)

Kelli Ann Cavanaugh, 41, of Lynn
Medicaid Kickbacks (1 count)

The indictments allege that between 2005 and 2007, Calloway set up two corporations, JAC Resources, Inc. (“JAC”) and MJK & Associates, LLC (“MJK”), and a bank account for the purpose of carrying out a Medicaid Fraud kickback scheme. Calloway, Levitan and Cavanaugh allegedly made a series of inappropriate kickbacks through JAC, MJK and the bank account in order to induce sober houses to order urine drug screens from Calloway. Payments for those tests were then made to Calloway by MassHealth, a state program that provides health insurance for the economically disadvantaged.

These indictments allege that Calloway made inappropriate payments to Maragioglio, owner and manager of New England Transitions, and to Cavanaugh, the sister of Patrick Cavanaugh and a former manager of New England Transitions, a group of sober houses, in return for ordering, arranging for or recommending that urine drug screens for the residents of the sober houses be performed by Calloway.

It is alleged that payments to third parties to induce the ordering of drug screens from Calloway continued into 2010. Upon learning that a woman had been subpoenaed by the Attorney General’s Office to testify before a grand jury, it is alleged that Cavanaugh offered her a highly compensated sales position with Calloway.

The indictments further allege that Calloway paid an office manager and the salaries of office staff of a Brighton medical office to induce the ordering of drug screens from Calloway.

In addition to the schemes outlined above, it is alleged that Calloway was falsifying laboratory records and submitting claims to MassHealth for urine drug screens that were not ordered by an authorized prescriber for a medically necessary purpose, a requirement of the MassHealth program.

After a thorough investigation, the case was presented to a Middlesex Grand Jury which returned indictments yesterday against the defendants. The defendants will be summonsed for arraignment in Middlesex Superior Court at a later date.

Assistant Attorney General Toby Unger, of Attorney General Coakley’s Medicaid Fraud Division, is the prosecutor assigned to this case. The case was investigated by investigators Joseph Shea; Denise Long; Lisa Bailey; Donna Mitchell and Assistant Investigators Erica Schlain and Bridget Horan. Both the Massachusetts Medicaid Program and the Department of Public Health assisted in this investigation.

New Jersey Drug Testing

April 21st, 2009

Student Drug Testing in New Jersey

The Vernon Township School Board is considering the implementation of a random drug testing program for high school students next year. The program, which will be discussed at a public hearing Thursday, would be similar to others in place in about 25 other New Jersey school districts, school officials said. Last year, Sparta adopted a random drug testing policy but never implemented it. No other county school has such a program.

The program would include students with parking privileges, students participating in co-curricular programs and athletics and students recommended for testing by their parents.

Vernon Township School Sup-
erintendent Anthony Macerino said approximately 600-700 students participate in athletics and co-curricular activities per year and all of the 350-400 seniors are eligible for parking. The high school has about 1,650 students.

Macerino said if the board does approve implementing the testing next September, it then must determine how many and how often the tests would be administered.

Usually districts decide on a percentage of the whole student population, Macerino said, which would determine the number of test kits purchased.

The estimated cost of the program would be about $10,000 to $15,000 per year, assuming the program is administered by existing staff. Two high school nurses would be trained for about $500 and the remaining cost would be the cost of $15 per test kit. The estimated amount of tests and testing would be budgeted in the 2009-10 budget, Macerino said.

While students found with a confirmed positive test will face consequences, they will not be disciplined with suspension and/or expulsion, Macerino said. A draft of the policy says anyone testing positive will be removed from any athletics, co-curricular activities or school clubs, as well as have their parking permit revoked for a minimum period of 30 consecutive school days.

Within a week of a positive result, a participant must begin a minimum of six visits with the student assistance counselor and attend an early intervention program. Parents or guardians will be responsible for the cost of the treatment program.

Random drug testing is separate and apart from the state mandated referral process. All staff members are required by law to refer a student who they observe to be under the influence of drugs or alcohol to an administrator.

Macerino said nearly 50 people attended the first public hearing on the policy earlier this month. He said the crowd was divided on whether or not implementing the program in Vernon is a good idea.

At Thursday’s hearing, specific statistical information about the extent of substance abuse at the high school and the middle school for the past two years will be presented. Chris Steffner, principal of Hunterdon Regional High School, also will be in attendance to share information related to the success of existing programs in the state, including at her school.

The board is not expected to vote on whether to implement the program until around the first of the year.

If the decision is made to implement the program, the board will have to adopt the policy and guidelines. The process would include establishing an implementation date, likely to be July 1, 2009, school officials said.