News & Analysis
Reports: HIV Drugs Targeted for Black Market Bridget M. Kuehn, MSJ
E
xpensive HIV medications are likely being targeted for resale on the black market, according to a new report from a federal watchdog. The report explained that the patterns the agency detected could mean patients were diverting the drugs for sale on the black market or that pharmacies were fraudulently billing Medicare for drugs that were never dispensed. In August, federal investigators detailed $32 million in suspicious charges to Medicare’s Part D program for HIV drugs for beneficiaries with no evidence of an HIV infection in their Medicare records (http://1 .usa.gov/1oEfYgj). Earlier this year, the Community Access National Network (CANN), a group that supports access to HIV care, and the Partnership for Safe Medicines, a nonprofit organization targeting counterfeit medication, published a document (http: //bit.ly/1stOjhQ) alerting clinicians and patients to evidence that HIV medications were being resold illegally. “The pursuit of profit over patient safety puts both physicians and patients at tremendous risk,” the report from the 2 nonprofit groups stated. The CANN report noted that since 2006, 86 people have been charged with distributing HIV medications and HIV/ hepatitis testing kits on the black market for resale in the United States. In some of the cases, counterfeit medications or tests were sold to patients or pharmacies. In other cases, fraudulently acquired medications were repackaged and sold to pharmacies. The August report by the US Department of Health and Human Services Office of Inspector General (OIG) was the latest in a series of reports highlighting potential fraud involving prescription medications paid for by Medicare’s Part D program, which contracts with private insurers to provide prescription drugcoverageforMedicarebeneficiaries.PreviouslytheOIGidentifiedquestionablespending on opioid pain medications, potentially driven by their widespread abuse.
HIV Medications’ High Cost, Potential for Abuse
age age of 74 years, and most received a little more than a month’s supply of medication. By comparison, the OIG found that the average patient receiving HIV medication had 23 one-month supplies of HIV medication because most received more than 1 medication over the course of a year.
Doctor Shopping In other cases, the OIG found evidence of “doctor shopping,” in which 179 beneficiaries received prescriptions from at least 6 different prescribers, including 29 who had received prescriptions from 10 or more prescribers. In some cases, there was no evidence of the beneficiary ever seeing the prescriber. For example, one 48-year-old beneficiary had 16 different prescribers and visited 28 pharmacies for 15 different drugs in excessive doses. Medicare paid nearly $200 000 for these prescriptions. The OIG has recommended that CMS take steps such as locking in patients to certain pharmacies and enhancing monitoring for prescription fraud. CMS agreed with most of the recommendations. Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, said he was glad to see the government using big data as a tool to try to detect fraud. He noted that medication fraud and other types of health care fraud are common and likely account for 3% to 5% of US health care spending. Fraud involving HIV drugs may pose special risks to patients because it could contribute to the
Medicare Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs, 2012 Utilization Pattern No indication of HIV Excessive dose Excessive supply High No. of pharmacies High No. of prescribers Contraindicated HIV drugs Total
No. of Beneficiaries 888 226 206 213 179 10 1578a
a Sum does not equal 1578 because a number of beneficiaries had > 1 questionable utilization pattern. Source: Dept of Health and Human Services Office of Inspector General analysis of Part D data, 2013.
The high cost of HIV drugs, including a commonly used product costing $1700 for a 1-month supply, and the potential for the 1086
drugs to be abused may be making them a target for fraud, the OIG report stated. To assess this risk in the Part D program, the OIG analyzed Centers for Medicare & Medicaid Services (CMS) records for suspicious patterns involving HIV prescribing to beneficiaries between 2011 and 2012. In that year, the Part D program paid $2.8 billion for HIV medications. The OIG review of records for 135 554 patients who allegedly received those drugs found that about 1600 patients had no evidence of an HIV diagnosis or other HIV care, used an unusually high number of pharmacies or prescribers, received excessive amounts of the drugs, or received simultaneous prescriptions for drugs that should not be used together. The OIG acknowledged that some of the claims may be legitimate but noted that the questionable prescriptions it found “warrant further scrutiny.” For example, the OIG identified 888 patients who received HIV drugs despite no evidence of an HIV diagnosis in their Medicare records. These patients had never been diagnosed with HIV, had never received any HIV care from the prescriber, and hadn’t undergone any of the routine laboratory testing necessary to monitor levels of antiretroviral medications. Claims for more than one-third (321) of the individuals lacking a diagnosis came from a pair of Miami pharmacies. Medicare paid $359 456 to these 2 pharmacies, despite the unusual demographics and behaviors of the patients. Most of the patients were women, with an aver-
Suspicious patterns of HIV drug prescribing in the Medicare Part D program may indicate that HIV drugs are being targeted for diversion, according to recent reports.
JAMA September 17, 2014 Volume 312, Number 11
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Purdue University User on 05/20/2015
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News & Analysis
©iStock.com/bugphai
development of resistant strains of the virus. Even patients with HIV who take their drugs appropriately may develop resistance, so physicians carefully monitor for signs of resistance and make adjustments quickly. Without proper medical supervision, if patients don’t take medications as prescribed it could contribute to the emergence of resistance. If patients with HIV are turning to the black market for drugs, it could also indicate ongoing concerns about stigma or affordability of antiretroviral medications that public health authorities need to address. “I hope people aren’t afraid of getting diagnosed,” Kesselheim said. Patients have historically had legitimate reasons to be concerned that having an HIV diagnosis could harm their job prospects or cause them to be discriminated against, he explained. The high costs of HIV drugs or a lack of insurance might also drive some patients to the black market. The OIG report suggested that drug abuse might also contribute to diversion. It cited evidence that when taken with opioid medications, certain anti-HIV medications,
Pharmacists on Alert
Pharmacists need to be alert to such discrepancies and talk to the patient or physician when they have a concern to make sure patients are getting the care they need and to rule out fraud. “The pharmacist has to be the detective to find out what is going on,” explained Free. This is particularly important with HIV drugs and other specialty medications, Free said. She explained she has encountered patients filling only some of their prescriptions because they can’t afford to fill them all or because they are worried that having too many medications may tip off others to their HIV status. She said it is important for the pharmacist to build strong relationships with patients and physicians to foster good communication. The report urges clinicians to purchase medications from distributors licensed by the US Food and Drug Administration (http://safedr.ug/fdalicense), monitor for signs a medication isn’t working, and educate patients about getting medications only from reputable pharmacies in person or online. (A list of online pharmacies certified by “Physicians should be aware of the the National Assopotential for identity theft because ciation of Boards of substantial profits can be made from Pharmacy can be found at http://bit.ly diversion of prescription drugs.” /1sK4YB5.) Physi—Aaron S. Kesselheim, MD, JD, MPH cians can also alert patients to examine their drugs for ritonavir or lopinavir/ritonavir combina- signs of repacking. For example, drug tions, may enhance feelings of intoxication labeling in a foreign language or packaging (Nieminen TH et al. Eur J Clin Pharmacol. that appears to have been tampered with could be signs that a drug is counterfeit or 2010;66[10]:977-985). Heather Free, PharmD, a practicing has been resold. It is also important for physicians to pharmacist in Washing ton, DC, and spokesperson for the American Pharma- carefully guard against identity theft by cists Association, said the report’s results protecting their prescription pads, Drug were not surprising and that diversion is a Enforcement Administration numbers, concern with all prescription medications. and other professional information, KesShe noted that some of the discrepancies selheim said. Additionally, physicians identified by the OIG may result from poor should check state prescription monitorcommunication rather than fraud. For ing programs to look for signs their preexample, if a physician changes a patient’s scribing information has been stolen. “Physicians should be aware of the regimen mid-month because of emerging resistance and doesn’t alert the pharmacy potential for identity theft because subto discontinue the old regimen, a patient stantial profits can be made from divermay receive both drugs or appear to have sion of prescription drugs,” Kesselheim said. refilled too early. jama.com
news@JAMA FROM JAMA’S DAILY NEWS SITE
Youth Suicide Linked With Economic Downturns Mass job layoffs increase the risk of suicide among adolescent girls and black youths, according to a new study. Suicide is the third leading cause of death among youths and young adults aged 10 to 24 years, claiming 4600 lives annually, the authors noted. Researchers analyzed data on adolescent suicide from 403 457 youths who participated in the Youth Risk Behavior Survey from 1997 to 2009. They explored responses to questions asking the youths whether, in the previous 12 months, they had seriously considered attempting suicide, made a plan for doing so, or actually attempted suicide. The researchers also examined Bureau of Labor Statistics reports on mass layoffs for each state and the District of Columbia. Overall, 16.3% of youths included in the analysis considered suicide, 12.6% made suicide plans, and 8.5% attempted suicide. The analysis showed that statewide job losses increased suicide-related behaviors among all girls and black adolescents in the study. Boys and white or Hispanic youths weren’t affected. Controlling for variables such as poverty rate and overall unemployment indicated that job loss wasn’t a proxy for states’ other economic problems. http://jama.md/1q6gR1W Tool May Predict Kidney Stone Recurrence A new tool may help predict which patients with a first-time kidney stone are at risk of a recurrence. The tool was developed based on an analysis of medical records from 2239 patients treated for their first stone, 707 of whom had a recurrence. The Recurrence of Kidney Stone nomogram evaluates 11 patient characteristics to calculate the risk of recurrence. In addition to age, sex, and race, they include whether imaging had been performed and the stone’s composition and location.. Characteristics that predicted a higher risk of recurrence included younger age, male sex, white race, family history of kidney stones, visible blood in the urine, stones made of uric acid rather than calcium, an obstructing stone in the renal pelvis, and any additional nonobstructing stones. Identifying patients at high risk for a recurrence would allow clinicians to advise them about preventive measures. http://jama.md/1oq6ot3
For more on these stories and other medical news, visit http://newsatjama.jama.com. JAMA September 17, 2014 Volume 312, Number 11
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Purdue University User on 05/20/2015
1087
Reports: HIV Drugs Targeted for Black Market Bridget M. Kuehn, MSJ
E
xpensive HIV medications are likely being targeted for resale on the black market, according to a new report from a federal watchdog. The report explained that the patterns the agency detected could mean patients were diverting the drugs for sale on the black market or that pharmacies were fraudulently billing Medicare for drugs that were never dispensed. In August, federal investigators detailed $32 million in suspicious charges to Medicare’s Part D program for HIV drugs for beneficiaries with no evidence of an HIV infection in their Medicare records (http://1 .usa.gov/1oEfYgj). Earlier this year, the Community Access National Network (CANN), a group that supports access to HIV care, and the Partnership for Safe Medicines, a nonprofit organization targeting counterfeit medication, published a document (http: //bit.ly/1stOjhQ) alerting clinicians and patients to evidence that HIV medications were being resold illegally. “The pursuit of profit over patient safety puts both physicians and patients at tremendous risk,” the report from the 2 nonprofit groups stated. The CANN report noted that since 2006, 86 people have been charged with distributing HIV medications and HIV/ hepatitis testing kits on the black market for resale in the United States. In some of the cases, counterfeit medications or tests were sold to patients or pharmacies. In other cases, fraudulently acquired medications were repackaged and sold to pharmacies. The August report by the US Department of Health and Human Services Office of Inspector General (OIG) was the latest in a series of reports highlighting potential fraud involving prescription medications paid for by Medicare’s Part D program, which contracts with private insurers to provide prescription drugcoverageforMedicarebeneficiaries.PreviouslytheOIGidentifiedquestionablespending on opioid pain medications, potentially driven by their widespread abuse.
HIV Medications’ High Cost, Potential for Abuse
age age of 74 years, and most received a little more than a month’s supply of medication. By comparison, the OIG found that the average patient receiving HIV medication had 23 one-month supplies of HIV medication because most received more than 1 medication over the course of a year.
Doctor Shopping In other cases, the OIG found evidence of “doctor shopping,” in which 179 beneficiaries received prescriptions from at least 6 different prescribers, including 29 who had received prescriptions from 10 or more prescribers. In some cases, there was no evidence of the beneficiary ever seeing the prescriber. For example, one 48-year-old beneficiary had 16 different prescribers and visited 28 pharmacies for 15 different drugs in excessive doses. Medicare paid nearly $200 000 for these prescriptions. The OIG has recommended that CMS take steps such as locking in patients to certain pharmacies and enhancing monitoring for prescription fraud. CMS agreed with most of the recommendations. Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, said he was glad to see the government using big data as a tool to try to detect fraud. He noted that medication fraud and other types of health care fraud are common and likely account for 3% to 5% of US health care spending. Fraud involving HIV drugs may pose special risks to patients because it could contribute to the
Medicare Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs, 2012 Utilization Pattern No indication of HIV Excessive dose Excessive supply High No. of pharmacies High No. of prescribers Contraindicated HIV drugs Total
No. of Beneficiaries 888 226 206 213 179 10 1578a
a Sum does not equal 1578 because a number of beneficiaries had > 1 questionable utilization pattern. Source: Dept of Health and Human Services Office of Inspector General analysis of Part D data, 2013.
The high cost of HIV drugs, including a commonly used product costing $1700 for a 1-month supply, and the potential for the 1086
drugs to be abused may be making them a target for fraud, the OIG report stated. To assess this risk in the Part D program, the OIG analyzed Centers for Medicare & Medicaid Services (CMS) records for suspicious patterns involving HIV prescribing to beneficiaries between 2011 and 2012. In that year, the Part D program paid $2.8 billion for HIV medications. The OIG review of records for 135 554 patients who allegedly received those drugs found that about 1600 patients had no evidence of an HIV diagnosis or other HIV care, used an unusually high number of pharmacies or prescribers, received excessive amounts of the drugs, or received simultaneous prescriptions for drugs that should not be used together. The OIG acknowledged that some of the claims may be legitimate but noted that the questionable prescriptions it found “warrant further scrutiny.” For example, the OIG identified 888 patients who received HIV drugs despite no evidence of an HIV diagnosis in their Medicare records. These patients had never been diagnosed with HIV, had never received any HIV care from the prescriber, and hadn’t undergone any of the routine laboratory testing necessary to monitor levels of antiretroviral medications. Claims for more than one-third (321) of the individuals lacking a diagnosis came from a pair of Miami pharmacies. Medicare paid $359 456 to these 2 pharmacies, despite the unusual demographics and behaviors of the patients. Most of the patients were women, with an aver-
Suspicious patterns of HIV drug prescribing in the Medicare Part D program may indicate that HIV drugs are being targeted for diversion, according to recent reports.
JAMA September 17, 2014 Volume 312, Number 11
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Purdue University User on 05/20/2015
jama.com
News & Analysis
©iStock.com/bugphai
development of resistant strains of the virus. Even patients with HIV who take their drugs appropriately may develop resistance, so physicians carefully monitor for signs of resistance and make adjustments quickly. Without proper medical supervision, if patients don’t take medications as prescribed it could contribute to the emergence of resistance. If patients with HIV are turning to the black market for drugs, it could also indicate ongoing concerns about stigma or affordability of antiretroviral medications that public health authorities need to address. “I hope people aren’t afraid of getting diagnosed,” Kesselheim said. Patients have historically had legitimate reasons to be concerned that having an HIV diagnosis could harm their job prospects or cause them to be discriminated against, he explained. The high costs of HIV drugs or a lack of insurance might also drive some patients to the black market. The OIG report suggested that drug abuse might also contribute to diversion. It cited evidence that when taken with opioid medications, certain anti-HIV medications,
Pharmacists on Alert
Pharmacists need to be alert to such discrepancies and talk to the patient or physician when they have a concern to make sure patients are getting the care they need and to rule out fraud. “The pharmacist has to be the detective to find out what is going on,” explained Free. This is particularly important with HIV drugs and other specialty medications, Free said. She explained she has encountered patients filling only some of their prescriptions because they can’t afford to fill them all or because they are worried that having too many medications may tip off others to their HIV status. She said it is important for the pharmacist to build strong relationships with patients and physicians to foster good communication. The report urges clinicians to purchase medications from distributors licensed by the US Food and Drug Administration (http://safedr.ug/fdalicense), monitor for signs a medication isn’t working, and educate patients about getting medications only from reputable pharmacies in person or online. (A list of online pharmacies certified by “Physicians should be aware of the the National Assopotential for identity theft because ciation of Boards of substantial profits can be made from Pharmacy can be found at http://bit.ly diversion of prescription drugs.” /1sK4YB5.) Physi—Aaron S. Kesselheim, MD, JD, MPH cians can also alert patients to examine their drugs for ritonavir or lopinavir/ritonavir combina- signs of repacking. For example, drug tions, may enhance feelings of intoxication labeling in a foreign language or packaging (Nieminen TH et al. Eur J Clin Pharmacol. that appears to have been tampered with could be signs that a drug is counterfeit or 2010;66[10]:977-985). Heather Free, PharmD, a practicing has been resold. It is also important for physicians to pharmacist in Washing ton, DC, and spokesperson for the American Pharma- carefully guard against identity theft by cists Association, said the report’s results protecting their prescription pads, Drug were not surprising and that diversion is a Enforcement Administration numbers, concern with all prescription medications. and other professional information, KesShe noted that some of the discrepancies selheim said. Additionally, physicians identified by the OIG may result from poor should check state prescription monitorcommunication rather than fraud. For ing programs to look for signs their preexample, if a physician changes a patient’s scribing information has been stolen. “Physicians should be aware of the regimen mid-month because of emerging resistance and doesn’t alert the pharmacy potential for identity theft because subto discontinue the old regimen, a patient stantial profits can be made from divermay receive both drugs or appear to have sion of prescription drugs,” Kesselheim said. refilled too early. jama.com
news@JAMA FROM JAMA’S DAILY NEWS SITE
Youth Suicide Linked With Economic Downturns Mass job layoffs increase the risk of suicide among adolescent girls and black youths, according to a new study. Suicide is the third leading cause of death among youths and young adults aged 10 to 24 years, claiming 4600 lives annually, the authors noted. Researchers analyzed data on adolescent suicide from 403 457 youths who participated in the Youth Risk Behavior Survey from 1997 to 2009. They explored responses to questions asking the youths whether, in the previous 12 months, they had seriously considered attempting suicide, made a plan for doing so, or actually attempted suicide. The researchers also examined Bureau of Labor Statistics reports on mass layoffs for each state and the District of Columbia. Overall, 16.3% of youths included in the analysis considered suicide, 12.6% made suicide plans, and 8.5% attempted suicide. The analysis showed that statewide job losses increased suicide-related behaviors among all girls and black adolescents in the study. Boys and white or Hispanic youths weren’t affected. Controlling for variables such as poverty rate and overall unemployment indicated that job loss wasn’t a proxy for states’ other economic problems. http://jama.md/1q6gR1W Tool May Predict Kidney Stone Recurrence A new tool may help predict which patients with a first-time kidney stone are at risk of a recurrence. The tool was developed based on an analysis of medical records from 2239 patients treated for their first stone, 707 of whom had a recurrence. The Recurrence of Kidney Stone nomogram evaluates 11 patient characteristics to calculate the risk of recurrence. In addition to age, sex, and race, they include whether imaging had been performed and the stone’s composition and location.. Characteristics that predicted a higher risk of recurrence included younger age, male sex, white race, family history of kidney stones, visible blood in the urine, stones made of uric acid rather than calcium, an obstructing stone in the renal pelvis, and any additional nonobstructing stones. Identifying patients at high risk for a recurrence would allow clinicians to advise them about preventive measures. http://jama.md/1oq6ot3
For more on these stories and other medical news, visit http://newsatjama.jama.com. JAMA September 17, 2014 Volume 312, Number 11
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Purdue University User on 05/20/2015
1087
