Internet System For Tracking Over-Prescribing (I-Stop) : New York State O Ce of The Attorney General
Internet System For Tracking Over-Prescribing (I-Stop) : New York State O Ce of The Attorney General
Internet System For Tracking Over-Prescribing (I-Stop) : New York State O Ce of The Attorney General
A Proposal Addressing New Yorks Prescription Drug Abuse and Drug Diversion Epidemic
The following report describes the background and rationale for New York Attorney General Eric T. Schneidermans proposal to address the prescription drug crisis through a modernization of the states Prescription Monitoring Program.
I-STOP will vastly enhance the effectiveness of the present system. Its goal is to enable doctors and pharmacists to provide prescription pain medications, and other controlled substances, to patients who truly need them. At the same time, it will arm them with the necessary data to detect potentially dangerous drug interactions, identify patterns of abuse by patients, doctors and pharmacists, help those who suffer from crippling addictions and prevent potential addiction before it starts.
TABLE OF CONTENTS
PART 1: THE PRESCRIPTION DRUG ABUSE & DIVERSION EPIDEMIC A. B. C. The Drug Use and Diversion Crisis Underlying the Prescription Drug Abuse Epidemic The Prescription Drug Epidemic and New Yorks Medicaid Problem pp. 3-11 pp. 12-14 pp. 15-17
PART 2: I-STOP A SOLUTION FOR NEW YORK A. B. C. D. E. National Consensus on Prescription Monitoring Programs New Yorks Current Prescription Monitoring Program Proposal The Internet System for Tracking Over-Prescribing (I-STOP) Cost Estimate of the I-STOP Proposal Consideration of NYS Practitioners without Internet p. 18 pp. 18-21 pp. 22-25 pp. 25-34 p. 34
APPENDICES A. B. C. D. Licensed Practitioners in New York State Summary of State Spending on Substance Abuse and Addiction (2005) Op-eds and Editorials Definition of Controlled Substance Schedules pp. 35-36 p. 37 pp. 38-40 pp. 41-42
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From 2002 to 2009, there was an increase among young adults aged 18 to 25 in the rate of current nonmedical use of prescription-type drugs (from 5.5 to 6.3 percent), driven primarily by an increase in painkiller misuse (from 4.1 to 4.8 percent). Interestingly, the survey showed decreases in the use of cocaine (from 2.0 to 1.4 percent) and methamphetamine (from 0.6 to 0.2 percent), indicating that prescription drug abuse in the early part of the 21st century may be displacing more traditional recreational drugs. The Survey also found that most illicit drug users were employed - of the 19.3 million current illicit drug users aged 18 or older in 2009, 12.9 million (66.6 percent) were employed either full or part time. The number of unemployed illicit drug users increased from 1.3 million in 2007 to 1.8 million in 2008 and 2.5 million in 2009, primarily because of an overall increase in the number of unemployed persons.5
'Opiates' are drugs that are derived from the Opium poppy plant. 'Opioids' are compounds that bind opioid receptors in the brain, producing effects characteristic of naturally occurring opiates. 2 Manchikanti, L. National Drug Control Policy and Prescription Drug Abuse. Pain Physician Journal. 2007; 10:399424. Available at http://www.painphysicianjournal.com/2007/may/2007;10;399-424.pdf. 3 Cohen, J.R. The health crises of chronic pain and prescription drug misuse. Medical Laboratory Observer. 9/1/2011. Available at http://web.ebscohost.com.dbgateway.nysed.gov/ehost/pdfviewer/pdfviewer? vid=3&hid=122&sid=6e43f0ff-58aa-4b6e-af63-161107cf2ef6percent40sessionmgr112 4 Supra. Note 2 5 U.S. Department of Health and Human Services. Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of National Findings. September, 2010. Available at http://www.oas.samhsa.gov/NSDUH/2k9NSDUH/2k9ResultsP.pdf.
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The Societal Manifestations of Prescription Drug Addiction The prescription drug addiction epidemic exhibits all the societal manifestations of any drug addiction, including accidental overdose, violence, and its transmission from mothers to newborn babies. While it is difficult to isolate its specific fiscal impact from that of all substance abuse, because the prescription drug abuse epidemic is such a rapidly growing problem, its implications can be intuitively extrapolated from aggregate data. 1) Accidental Overdose In its most recent study of prescription drug abuse and diversion, the CDC found prescription painkiller overdoses killed nearly 15,000 people in the U.S. in 2008, and that enough were prescribed in the United States in 2010 to medicate every American adult around-the-clock for a month.6 In New York, the number of prescriptions for all narcotic painkillers has increased from 16.6 million in 2007 to nearly 22.5 million prescriptions in 2010 (Figure 1).7
Figure 1
Nationally, the treatment admission rate for opiates other than heroin increased from 10 admissions per thousand to 53 per thousand - an increase of 430 percent - from 1999 to 2009. New York is higher than the national average for the time period - 450 percent -8 ranking the state 11th in the nation for admissions to chemical dependence programs for abuse of opioids other than heroin.9 Since 2007, when the state Bureau of Narcotic Enforcement (BNE) started collecting data on all narcotic prescriptions dispensed in the state (see below), prescriptions for hydrocodone have increased 16.7 percent, while those for oxycodone have increased an astonishing 82 percent (Figure 2).
Centers for Disease Control and Prevention (CDC). Prescription Painkiller Overdoses in the US. "Prescription painkillers" refers to opioid or narcotic pain relievers, including drugs such as Vicodin (hydrocodone), OxyContin (oxycodone), Opana (oxymorphone), and methadone. Available at http://www.cdc.gov/VitalSigns/PainkillerOverdoses/index.html 7 NYS Department of Health, Bureau of Narcotics Enforcement. 8 Department of Health and Human Services, Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration (SAMHSA). Treatment Episode Data Set (TEDS) 1999-2009, p. 77. Available at http://wwwdasis.samhsa.gov/teds09/teds2k9nweb.pdf. 9 National Survey on Drug Use and Health (NSDUH). Available at http://oas.samhsa.gov/nsduhLatest.htm.
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Figure 2
In the spring of 2011, the Buffalo News published a series of stories about the impact of prescription drug abuse and misuse throughout New York, and particularly in the western part of the state. Heart-wrenching stories of individual and family tragedy,10 unintentional overprescription of controlled substances, and shocking cases of intentional abuse of medical authority depict an environment of unchartered seas.11 The series found that doctor shopping, the use of multiple painkiller prescriptions and easy access to opioids have created a perfect storm, not only in the western part of the state, but throughout New York.12 In the North Country, prescription narcotics have displayed an alarming increase in the percentage of non-crisis admissions for substance abuse, eclipsing cocaine and heroin in Clinton and Franklin Counties, and surpassing even marijuana in St. Lawrence County. Prescriptions for hydrocodone and oxycodone have increased significantly in the region as well. From 2008 to 2010, Clinton County saw an increase of 18 percent and 28 percent for each substance, respectively. During the same period, St. Lawrence County saw increases of 32 percent for each substance, and Franklin County saw increases of 48 percent for hydrocodone and 49 percent for oxycodone.13 The implications of this increased use are compelling. The Village of Massena, St. Lawrence County, provides a case in point. In the first three weeks of November 2011, the community of about 10,000 saw three prescription drug suicides. From 1993 to 2010, the village police department investigated 18 suicides - eight of which have taken place since 2007.14
Michel, L., and Schulman, S. A journey to disaster. Buffalo News 4/27/2011. Available at www.buffalonews.com/city/special-reports/article372060.ece. 11 Fairbanks, P. Defense points to unchartered seas in Falls doctors painkiller case. Buffalo News 9/21/2011. Available at www.buffalonews.com/city/police-courts/courts/article565059.ece. 12 Supra. Notes 10, 11. See also Davis, H.L. Study finds multiple painkiller prescriptions. Buffalo News 4/5/2011. Available at www.buffalonews.com/city/special-reports/rx-for-danger/article385481.ece. 13 Selected Data on Prescription Drug Abuse in the NY/NJ HIDTA Region. Office of National Drug Control Policy, the White House, using data from the New York State Office of Alcohol and Substance Abuse Services (OASAS) and the NYS Department of Healths Bureau of Narcotics Enforcement (BNE). 14 Martin, R. "Prescription drug crime on the rise." (Potsdam-Massena) Daily Courier-Observer. 11/23/2011. Available at wwwwatertowndailytimes.com/article/20111123/DCO01/311239981.
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On Long Island, both crisis and non-crisis admissions to drug treatment that involve cocaine and opiates other than heroin have increased at alarming rates. In Nassau and Suffolk Counties, admissions increased 57 percent and 40 percent, respectively, for crisis admissions from 2007 to 2010. Non-crisis admissions are even more shocking such admissions increased almost 70 percent in Nassau County, and nearly 80 percent in Suffolk County over the same time period. Since 2006, oxycodone has contributed to more deaths than any other prescription opioid in Nassau County, and the prescriptions for the drug increased 42 percent from 2008 to 2010. Suffolk County saw prescriptions for oxycodone increase 23 percent during the period.15 Maps 1 and 2 depict the geographic distribution of the two drugs. Hydrocodone use appears concentrated in the western and central parts of the state, while oxycodone use is prevalent in the south eastern part of the state and Long Island. Map 1 Oxycodone Scripts in New York State
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The situation is similar in New York City. In a report released in May of 2011, the New York City Department of Health and Mental Hygiene found that the rate of prescription pain medication misuse by New York City residents who are 12 or older has increased by 40 percent from 2002 to 2009. Oxycodone and hydrocodone were the most commonly prescribed opioid analgesics in 2008-2009, with nearly 900,000 oxycodone prescriptions and more than 825,000 hydrocodone prescriptions filled in 2009. The highest rates of prescriptions filled per 100,000 residents were in high- and medium-income neighborhoods of the five neighborhoods with the highest fill rate, four were in Staten Island. Maps 3 and 4 illustrate this overlap.17
Maps 1 and 2 are reproduced from original graphics created by the Buffalo News Map was originally published by BuffaloNews.com on March 28, 2011 as part of a Special Report entitled, RX for Danger. Available at: http://www.buffalonews.com/incoming/article368405.ece/BINARY/Oxycodone+Map, and http://www.buffalonews.com/incoming/article368343.ece/BINARY/Hydrocodone+Map+, respectively. 17 New York City Department of Health and Mental Hygiene. Opioid Analgesics in New York City: Misuse, Morbidity and Mortality Update. Available at http://home2.nyc.gov/html/doh/downloads/pdf/epi/epi-data-brief.pdf.
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Map 3
Map 4
In 2008-2009, 4 percent of City residents (263,000 people) said they had misused prescription painkillers.18 Such misuse is tragically reflected in the unintentional opioid analgesic poisoning death rate, which increased by 20 percent between 2005 and 2009 from 2.0 to 2.4 per 100,000 residents, while the heroin poisoning death rate decreased by 24 percent. Nowhere is this trend more alarming than on Staten Island, where the rate increased by 147 percent from 3 per 100,000 in 2005 to 7.4 per 100,000 in 2009 more than double that of any other borough (Figure 3).
Figure 3 - Opioid Analgesic Poisoning Deaths by Borough (2009)19
StatenIsland
BoroughofResidence
Bronx Brooklyn Queens Manhattan 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0
AgeAdjustedRateper100,000Population
Ibid. Mortality data result from an in-depth review by the Health Departments Bureau of Alcohol and Drug Use Prevention, Care and Treatment (BADUPCT), Bureau of Vital Statistics and the Office of the Chief Medical Examiner records for 2005-2009. Data is available at http://www.nyc.gov/html/doh/downloads/pdf/epi/datatable3.pdf.
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As with many drugs, the manifestations of addiction can turn tragically violent. On Father's Day of 2011, David Laffer walked into a small Suffolk County pharmacy, intending to rob the store to feed his addiction to prescription painkillers. Laffer killed two employees and two customers before stuffing his backpack full of prescription narcotics and running to a getaway car driven by his wife, Melinda Brady. It was later revealed that in the days before the shooting, Laffer had filled six prescriptions for more than 400 pills from five different doctors. As often as 11 times a month, the couple had visited medical professionals, who prescribed 11,881 pills beginning in June 2007. More than a third of that total - 4,251 pills - was obtained in the first six months of this year.Laffer was sentenced in early November to consecutive life prison terms after pleading guilty to four counts of murder; Brady received 25 years after pleading guilty to robbery charges.20 On New Year's Eve, John Capano, an agent with the federal Bureau of Alcohol, Tobacco and Firearms, was mistakenly killed by a retired police lieutenant outside a pharmacy in Seaford in Nassau County. Capano, who was picking up cancer medication for his father, tried to thwart a cash-and-drug robbery attempt by James McGoey, who had recently been released from prison, where he served time for prior robbery convictions - some of them involving pharmacies.21 In New York City, the increase in numbers of prescriptions strongly correlates with the increase in prescription drug crime. In 2007, 6 percent of the Special Narcotics Prosecutor's (SNP) caseload was comprised of prescription drug-related arrests. By 2010, that percentage had more than doubled to nearly 15 percent. The SNP has also noted that violence is becoming more commonly associated with the black market prescription drug trade, as prescription drug investigations have involved robberies, gun seizures and, in some cases, even seizures of small arsenals.22 The North Country Village of Massena has seen a 160 percent increase in violent crimes over the past 15 years - from 273 offenses in 1995-96 to 582 in 2003-04 to 711 in 2009-10. Authorities attribute the rise in armed robberies, aggravated assaults and burglaries to prescription drug abuse and addiction. Users are smoking, snorting and injecting the pills in an effort to sustain the high, and are more prone to violence than cocaine addicts because the withdrawal is so painful. Village police are even aware of addicts assaulting drug dealers to get pills.23 "We've seen an escalation of violent assaults people sticking guns in the faces of working people and threatening their lives. Defendants are admitting to us that they are addicted to painkillers and are stealing to sustain their habits."
Joseph W. Brown, Massena Village Police Investigator
Associated Press. " NY killer legally got 12,000 pain pills from docs." 11/18/2011. Available at http://online.wsj.com/article/AP291d30e080fa47b2ac686964f720410a.html 21 Kleinfield, N.R. "Behind the Counter, an Acute Anxiety." New York Times. Available at http://www.nytimes.com/2012/01/09/nyregion/anxious-days-for-long-island-pharmacies.html 22 Office of the Special Narcotics Prosecutor for the City of New York, 2010 Annual Report. Available at http://www.nysenate.gov/files/Roundtable-Materials-3.pdf 23 Martin, R.R. "Prescription Drug Crime on the Rise." (Potsdam and Massena) Daily Courier and Observer. 11/23/2011. Available at www.watertowndailytimes.com/article/20111123/DCO01/311239981.
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3) Transmission of Addiction to Newborns Like drug addiction epidemics of the past - cocaine in the 1980s and crack in the 1990s health care professionals across the nation are witnessing explosive growth in the number of prescription drug-addicted mothers giving birth to babies hooked on powerful prescription narcotics. Though precise national statistics are not available, the number of babies diagnosed with newborn withdrawal syndrome - known as Neonatal Abstinence Syndrome (NAS) - more than doubled to almost 12,000 between 2003 and 2008.24 States with the worst problems have only begun to collect data, but scattered reports indicate that the number of addicted newborns has perhaps more than tripled over the past decade. In Florida, which has been ravaged by the illicit prescription drug trade, the number of babies suffering from NAS soared from 354 in 2006 to 1,374 in 2010, according to the Florida Agency for Health Care Administration.25 Actual numbers may be much higher than reported, because many pregnant women are neither tested for drug use, nor admit to using drugs during pregnancy.26 In Maine, which has also been plagued by prescription drug abuse, the number of newborns treated or watched for NAS at the states two largest hospitals climbed to 276 in 2010 from about 70 in 2005.27 In Ohio, some hospitals have seen more than a four-fold increase in the NAS cases, resulting in longer hospital stays for the affected babies and higher public health care costs.28 New York State has not been spared the increases in neonatal abstinence syndrome. At the Catholic Health System in Buffalo, which operates New York State's largest methadone clinic outside of New York City, physicians used to see one to three babies a month with symptoms of withdrawal from narcotic pain pills. Now, the number approaches 10 a month, and the number of cases has grown enough that the hospital network is reorganizing services to standardize the care of addicted mothers-to-be and their newborns.29 4) The Fiscal Consequences of Substance Abuse In terms of fiscal costs, the numbers are staggering. In May of 2009, the National Center on Addiction and Substance Abuse (CASA) released a report that analyzed the fiscal impact of substance abuse including the growing problem of prescription drug abuse and addiction on federal, state and local budgets. CASA measured the impact of the problem on all public programs, from education to health to the criminal justice system, and found that in 2005, federal, state and local government spending as a result of substance abuse and addiction was at least $467.7 billion - $238.2 billion at the federal level; $135.8 billion at the state level; and $93.8 billion at the local level. The total of $467.7 billion constituted 10.7 percent of the entire $4.4 trillion contained in federal, state and local budgets.
24 Colon, D. "Number of Newborns Addicted to Painkillers Rising." National Public Radio. Available at http://www.npr.org/2011/02/16/133805289/number-of-newborns-addicted-to-painkillers-rising 25 Leger, D.L. Doctors see surge in newborns hooked on mothers' pain pills. USA Today. 11/13/2011. Available at http://yourlife.usatoday.com/parenting-family/babies/story/2011-11-13/Doctors-see-surge-in-newborns-hooked-onmothers-pain-pills/51186076/1. 26 Training Presentation by the Office of the Attorney General, State of Florida. Prescription Drug Abuse: Floridas Health Crisis. Available at http://leonrdmc.org/docs/pdf/Aronberg%20Rx%20Drug%20Abuse%20Training.pdf 27 Goodnough, A., and Zezima, K. Newly Born, and Withdrawing From Painkillers. New York Times. 4/9/2011. Available at http://www.nytimes.com/2011/04/10/us/10babies.html?pagewanted=all 28 Larsen, D. Prescription drug abuse nations fastest-growing drug problem. Dayton Daily News. 12/7/2011. Available at http://www.daytondailynews.com/news/dayton-news/more-babies-born-addicted-to-opiates-1295255.html. 29 Davis, H.L. "Treating the tiniest addicts: Mothers' pill abuse leads to newborns' exposure." Buffalo News. 6/1/2011. Available at http://www.buffalonews.com/city/article439798.ece
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CASA also found that these massive expenditures were grossly skewed toward dealing with the consequences of substance addiction rather than prevention and treatment. For every dollar federal and state governments spent on the latter, they spent $59.83 on public programs shoveling up the wreckage left by substance addiction, despite a substantial and growing body of scientific evidence confirming the efficacy of science-based interventions and treatment and their cost-saving potential.30 In New York, spending on prevention, treatment and research constituted only 2.14 cents of every dollar that was spent on the burden that substance abuse and addiction placed on all impacted public programs.31 The state ranked third among all states in 2005, with regard to this burden 21.1 percent of the General Fund ($13.132 billion), which translates into $680.19 per capita - ranking New York eighth in the nation (Appendix B).32 It is not possible to filter prescription drug abuse from the broader category of substance abuse in CASAs data. It is logical to assume, however, that because diversion and abuse of prescription drugs has been increasing at an accelerated rate over the last five years, the problem is consuming an ever-larger piece of the budgetary pie. Figure 4 illustrates the composition of that pie in 2005. Figure 5
National Center on Addiction and Substance Abuse (CASA). Shoveling Up II: The Impact of Substance Abuse on Federal, State and Local Budgets. CASA has not updated the 2009 report, nor does it have specific data broken out. 31 Ibid. p. 4. 32 Ibid., Table 1 is reproduced from p.119.
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Centers for Disease Control (CDC). Prescription Painkiller Overdoses in the US. Available at http://www.cdc.gov/VitalSigns/PainkillerOverdoses/index.html 34 Michel, L. and Shulman, S. A journey to disaster. Buffalo News. March 20, 2011. Available at www.buffalonews.co/city/special-reports/article372060.ece. A similar National Prescription Drug Take-Back event, the third sponsored by the DEA, collected 188.5 tons of unused prescription drugs from 5,327 take back sites across all 50 states on a single day. Press Release available at justice.gov/dea/pubs/pressrel/pr110311.html.
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diction on an out-patient basis, with little success. By June, Michael tried to be readmitted to the center, and was told there were no beds. Seeing no alternative to the pain and addiction, Michael, age 20, went to the bedroom of his parents home, pulled out his shot gun and took his own life.35
Similarly, Dr. Andrew Kolodny, Chair of the Department of Psychiatry at Maimonides Dr. Frank Dowling, before the Medical Center, noted that when his staff NYS Senate Drug Diversion Roundtable investigated the deaths of several patients, they were found to have been prescribed benzodiazepines for anxiety by staff psychiatrists. Unbeknownst to these psychiatrists, the patients were also taking opioids prescribed by other physicians outside the clinic. 36 In either of these cases, and many like them, it is possible that tragedy could have been averted if all practitioners had access to a central data repository from which patients entire prescription history could be consulted. 2) Easy Access to Prescription Narcotics for Abusers Another major cause is access to the ever-increasing supply of controlled narcotics by nonlegitimate means. In addition to the unintentional over-prescription described above, other avenues of access range from the crooked doctor, to the street-level drug dealer, to fraudulent prescriptions. Indeed, as shown below, a single crooked doctor can result in hundreds of thousands of doses of controlled substances on the street, and reports of prescription pad thefts indicate millions of such doses. Crooked Doctor: In April of 2006, Dr. Apryl Mamzette McNeil, MD of New York City pled guilty in federal court to one count of conspiracy to distribute Schedule III and IV controlled substances and one count of conspiracy to launder money.37 Between November 2003 and May 2004, McNeil authorized at least 220,090 dosage units of Schedule III controlled substances and 15,510 dosage units of Schedule IV controlled substances over the internet. The prescriptions were not issued for a legitimate medical purpose and not in the usual course of a practitioners professional practice.38 The Street-Level Dealer: After pleading guilty to felony drug-possession and conspiracy charges, a Staten Island man was
35 36
What should be [available] is that a physician can look up any patient, any time and get any information on controlled substances that have been prescribed as recent and far back as the database goes, even if its one prescription.
Easy Access A NYC doctor pled guilty in 2006 to authorizing at least 235,600 dosage units of Schedule III and Schedule IV narcotics for nonmedical purposes. In 2011, a Staten Island man pled guilty to distributing 42,775 oxycodone pills from his ice-cream truck. In western NY, a voluntary collection of unused and unwanted prescription narcotics yielded 652 pounds of pills over two years.
Recounted by the parents of Michael David Israel. Testimony before Senator Hannons Roundtable, August 31, 2011. 37 Controlled substance schedules are defined under Title 21 of the U.S. Code - The Controlled Substances Act. Schedule definitions can be found in Appendix D. 38 US Drug Enforcement Administration. Cases Against Doctors. Available at http://www.deadiversion.usdoj.gov/crim_ admin_actions/doctors_criminal_cases.pdf
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sentenced in October of 2011 to 3 1/2 years in prison. Louis Scala operated a Lickety Split ice-cream truck that served the South Shore, and was part of a group that distributed some 42,755 oxycodone pills across the borough in 2009 and 2010. Customers knew where and when to wait for the truck to arrive. Supply was maintained by recruiting 28 "runners," many of whom were addicts desperate for cash, to fill forged prescriptions on forms that a coconspirator stole from the doctors office she managed.39 Fraudulent Prescriptions: Stolen prescription pads are big business for prescription drug dealers. Recently, a Monroe County drug ring was caught with purloined pads, but not before 40,000 prescriptions had been written under one doctors name without the doctors knowledge.40 In the spring of 2011, Newsday reported that as many as 1.4 million scripts had been stolen since 2008 from several different hospitals within the New York City Health and Hospital Corporation, the citys public hospital system. Most of the fake scripts were written for oxycodone.41 In the fall of the same year, DOH confirmed that another 14,000 blank prescriptions were missing from Westchester Countys Mount Vernon Hospital.42
F. Staten Island man admits selling prescription drugs from ice cream truck. Available at http://www.silive.com/southshore/index.ssf/2011/08/staten_island_man_admits_selli.html 40 Crowley, CF. Taking pulse of Medicaid costs. Times Union (Albany). October 26, 2011. 41 Lewis, R. and Van Sant, W. Up to 1.4 million stolen Rx forms. Newsday. October 22, 2011. Available at http://www.newsday.com/news/region-state/ny-up-to-1-4m-prescription-forms-stolen-1.3265916. 42 Lewis, R. and Van Sant, W. State: More hospital prescription forms missing. Newsday. 11/10/2011.
39Donelly,
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C. The Prescription Drug Abuse Crisis and New Yorks Medicaid Problem
The New York State Medicaid program spent over $1 billion on controlled substance prescriptions over the past four years. This cumulative figure does not, however, reflect a stable annual rate of $250 million per year, but rather an alarming trend, manifested by a 38.4 percent increase from 2007 to 2010 (Figure 5).43
Figure 5
NewYorkMedicaidPaymentsfor ControlledSubstances20072010
600,000,000 500,000,000 400,000,000 300,000,000 200,000,000 100,000,000 0 TotalPaid 2007 TotalPaid 2008 TotalPaid 2009 TotalPaid 2010 TotalPaid From2007 2010
The increase in Medicaid payments is due to the increase in prescriptions written for controlled substances during this time frame. From 2007 to 2010, the number of scripts for Schedules II through IV drugs paid by Medicaid increased from 3,126,268 to 4,611,002, or 47.5 percent (Figure 6).
Figure 6
NewYorkMedicaidPrescriptionsfor ControlledSubstances20072010
8,000,000 7,000,000 6,000,000 5,000,000 4,000,000 3,000,000 2,000,000 1,000,000 0 TotalScripts TotalScripts TotalScripts TotalScripts Scriptsfrom 2007 2008 2009 2010 20072010
43
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The underlying elements of the epidemic cited above are reflected in the Medicaid program as well. While there are no actual numbers that demonstrate how much prescription drug fraud/diversion costs Medicaid (and New York taxpayers) annually, a very small increase in prevention recoveries could amount to tens of millions of dollars in savings every year. Indeed, New York States Medicaid Fraud Control Unit estimates that the cases the unit prosecutes for fraudulent prescriptions average a $1 million loss per case. Several prominent cases involving doctors who are no better than drug dealers, and others who entered a downward, out-of-control spiral, support the MFCUs estimates: Case 1 - Drug Dealing Doctor: In a sting NYS Medicaid spent over $1 billion operation conducted by government on controlled substance prescriptagents posing as Medicaid patients, Dr. ions over the past four years. Abdolhosein Baghai-Kermani, a licensed psychiatrist in New York, knowingly sold Medicaid fraud cases prosecuted by prescriptions for controlled substances. New Yorks Medicaid Fraud Control Upon arrival at the Baghai-Kermanis Unit (MFCU) average a $1 million office, the patients would register with loss to the states taxpayers per a receptionist, provide a photo ID, a case. Medicaid card and $80 to $90 in cash. The doctor would conduct a brief five- to ten-minute session, then give the patient a prescription for the agreed upon controlled substance. Baghai-Kermani sold prescriptions for Valium on six occasions, Ativan on three occasions, and a prescription for Xanax once to agents, where no medical necessity for these prescriptions existed. MFCU estimated that over the course of 18 months, Baghai-Kermani pocketed $1,200,000 in cash by selling over 13,000 prescriptions. Case 2 - Out-of-Control Doctor: In 2002, Dr. David Roemer engaged in a conspiracy to possess and sell narcotic/controlled substance/non-controlled substance prescription medications. Roemer wrote prescriptions that were not medically necessary to Medicaid patients, charging $100 cash for each. A group of patients recruited, and even drove, other patients to Roemers High Falls office to receive the prescriptions. Roemer and 39 other defendants were indicted for Criminal Controlled Substance in the First Degree and other criminal charges. Roemer pled guilty and received a jail sentence as well as other defendants, patients-drivers-recruiters. Roemer is a classic example of a physician who went out of control. In 2000, he wrote a weekly average of one controlled substance prescription, and a weekly average of 19 controlled substance prescriptions the following year. By 2002, that weekly average had increased to 71 controlled substance prescriptions for Medicaid recipients, and by the third quarter of that year, he prescribed Xanax, oxycodone, and Klonopin more than 79 percent of the time for Medicaid recipients. Of those prescriptions, 159 were made out to Medicaid recipients who resided at a drug rehabilitation treatment house in the Bronx. While Roemer was not enrolled as a provider in the Medicaid program, and his act
Over one 18-month period, a licensed psychiatrist in New York sold over 13,000 prescriptions for controlled substances, pocketing $1.2 million in cash. A Long Island physician went from writing only 18 prescriptions for controlled substances over a ten-year period to issuing 380 scripts over three months, and billing Medicaid $940,000. Over two years, a High Falls physician went from writing one controlled substance prescription per week to writing an average of 71.
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ivities flew under the radar, Medicaid (and ultimately New York taxpayers) reimbursed for the drugs that he prescribed. Case 3 - Out-of-Control Doctor: In 2007, Dr. Michael Chait of Amagansett, Long Island, was charged for writing hundreds of illegal prescriptions for patients from New York City. Chaits patients would drive from the Bronx and Manhattan to his practice far out on the Long Island shore, where they paid him for controlled substance prescriptions. While they were frequently filled at pharmacies that could be mapped out along exits on the Long Island Expressway, one pharmacy accounted for 86 percent of the filled prescriptions, even though it, and the patients residences, were literally hours away from Chaits practice. Another example of an out of control doctor, Chait went from prescribing controlled substances only 18 times in ten years to issuing over 380 scripts in three months, for drugs that cost Medicaid and other insurers over $940,000. Chait was convicted in 2009 and sentenced to three years in prison followed, by five years of post-release supervision. Case 4 - Counterfeit Prescriptions: Between 2009 and 2011, Suzanne Benizio of the Bronx created more than 250 forged prescriptions for OxyContin and Roxicodone, written on prescription paper stolen from doctors and hospitals in the New York City area. Benizio arranged for the counterfeit scripts to be filled at pharmacies in 20 counties across the state through a group of co-conspirators that presented misappropriated Medicaid cards to the pharmacies. MFCU estimates Benizio's operation resulted in the diversion of $200,000 in controlled substances. At the time of her arrest in March of 2011, she possessed enough prescription paper to create an additional 1,500 prescriptions, and a special printer needed to process the thermal prescription paper the state uses for the official prescription pads it distributes to practitioners.44
44
Associated Press. "Bronx Woman Pleads Guilty To Forging Painkiller Prescriptions." Available at http://newyork.cbslocal.com/tag/prison/feed/.
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45 White House Office of National Drug Control Policy. Available at http://www.whitehouse.gov/ondcp/prescription-drugabuse 46 Centers for Disease Control (CDC). Prescription Painkiller Overdoses in the US.
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The BNE began the program in 1973, limiting data collection to Schedule II controlled substances, expanded it to include benzodiazepines in 1989, and all controlled substance prescriptions in 2007. Under the current program, a practitioner must maintain a record of every controlled substance prescription written for a patient and such patient's record must contain sufficient information to justify a diagnosis that warrants a controlled substance prescription. Data collected from the dispensing pharmacy include: Pharmacy identification; Patient information, including name, address, date of birth and gender; Prescription information, including number, date written and dispensed, drug type and quantity, and refill information; Practitioner information, including DEA number and NPIU number (if available); and The unique Official NYS Prescription serial number (see below).
Unfortunately, few health care practitioners have used the current PMP system to access to their patients' controlled substance prescription history. Although a recent change allows doctors to check the data, they are not required to do so. The system will therefore fail to prevent dealers, crooked doctors, and addicts from obtaining or diverting prescription drugs. Furthermore, a practitioner may only be informed of a patient's documented controlled substance prescription history if such practitioner has signed up to receive information from BNE, the patient has been prescribed a controlled substance by two or more practitioners, and the patient has had those prescriptions filled by two or more pharmacies within a month.
if the patient is getting all their medications from one pharmacy, you get no information back; or if theyre going to different pharmacies but getting all their prescriptions from the same doctor, you get no information back. So, in effect, the system that we have was useless for our purposes.
Dr. Andrew Kolodny
Pharmacists also have a responsibility to see that controlled substances are dispensed for legitimate medical use, and are required by law to report any suspected diversion to the BNE. They are, however, currently prohibited from accessing a customer's controlled substance prescription history on the PMP. Such limitations have not gone unnoticed by pharmacists and other interested parties, and the BNE is currently working to improve information access and program effectiveness. At a New York State Senate Roundtable discussion in August of 2011, Dr. Andrew Kolodny of Maimonides Medical Center notes that: weve got terrific data in New York State probably better than any place else in the country, but were not using it we need to allow the providers to utilize the prescription data thats available. Right now the system weve got does not work for clinical practice. New York State allows a physician to go on the database to find individuals who meet the definition of a doctor shopper, but if you want to see if a
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patient is already on an opioid you get no data back unless the patient fits the definition of a doctor shopper.47 Other observations and recommendations for the existing PMP that emerged from the Senate Roundtable and subsequent interviews by OAG staff with practitioners include: Lack of User-Friendliness: the website is difficult to find; only the practitioner is permitted access; there is no singular patient identifier, making it very easy to fake out the system. Time Consuming: the lack of user-friendliness makes the current system too timeconsuming for a physician to use. A misspelling or typo on a birth date can slow down the process, which averages three to four minutes. In a busy office, this poses significant doctor-patient time constraints. Limited Data Access: under the current access protocol, a patients data is only available to an inquiring physician if the patient meets the following criteria, which flags them as a possible abuser/diverter: the filling of two or more prescriptions for controlled substances from two or more physicians at two or more pharmacies. If a patient does not fit this profile, the physician will get no information back, even though the patient might have a substantial controlled substance use history. Limited Information: the information provided when all these criteria are met only goes back a few months, and is likely to be as much as a month behind, due to the 45day reporting requirement for pharmacies. In addition, known abusers are not always in the database. Monthly Statement: To detect stolen prescriptions, physicians should be able to get a monthly statement of their prescription activity to make sure the record matches their actual history. If a prescription appears that the physician didnt write, it would be a forged prescription. Such procedure would also detect changed prescriptions.48
But the true Achilles heel of the current PMP is that doctors are not required to provide any data to the system whatsoever. There simply is no tracking of prescriptions issued. Accordingly, when a doctor writes a prescription for a controlled substance (e.g. Oxycontin), he or she has no knowledge that the patient may have received one, two, three, or even a dozen scripts for the same or similar medication from multiple doctors over a short period. In addition, the system does nothing to prevent drug abusers or criminal drug gangs from getting narcotics with stolen or forged prescription pads. Section 3338 of the NYS Public Health Law requires the DOH to prepare and issue prescription blanks, with unique serial numbers, to all practitioners authorized to write such prescriptions, as well as to institutional dispensers. With the exception of emergency and oral prescriptions, which can be prescribed for only up to five days, all controlled substance prescription and dispensation may be done only via an Official NYS Prescription, an electronic prescription or out-of-state prescription.
47 Andrew Kolodny, M.D., Chairman of the Department of Psychiatry, Maimonides Medical Center, member of Physicians for Responsible Opioid Prescribing , NY Society of Addiction Medicine. 48 Ibid.
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It is this written "script" that gives legitimacy to the entire prescription transaction, whether the patient is doctor shopping or the prescribing practitioner is no better than a drug dealer with a medical license. A stolen script pad empowers the thief with a pass to obtain any kind of prescription drug, as we have seen in just two recent cases of prescription While New Yorks PMP collects fraud cited above. The BNE estimates that substantial data from pharmthe street value of blank Electronic Medical acists, it is lacking a verification Record (EMR) forms ranges from $100 to mechanism to ensure that the $300 per form. The street value of a single script the pharmacist fills is auth30 mg tablet of Oxycontin is between $25 entic. The true Achilles heel of our and $35;49 and a single 80 mg Oxycontin current system is the possibility of can bring as much as $70 per pill on the stolen prescription pads. street. A prescription for 30 can bring over Assemblyman Michael Cusick $2,000 to the dealer.50 Cost of the Current System The Department of Health does not use an outside vendor in any aspect of the current data gathering process, and has done all data collection and technical work in-house. The total cost of the PMP for the current fiscal year is $16.4 million, which is significantly more than the cost of other state programs examined by staff (see below). A direct total cost comparison would be, however, misleading. While New York does not contract for data collection, standardization and maintenance, it does contract for other services, including the printing and distribution of all Official NYS Prescription pads. In SFY 2011-12, this cost was $11.66 million, or more than 71 percent of the entire program cost.51 This is a cost that no other state incurs, without which New Yorks program cost would currently be $4.74 million the cost of personnel ($2,186,000) and other contractual services. Other contractual services include a Program Help Desk, manned by three contract staff for a total cost of $225,000; a program hotline ($5,000); postage ($10,000); cell phones ($6,000); vehicle maintenance ($20,000); and miscellaneous contractual services ($74,000). Supplies ($220,000), travel ($100,000), equipment ($200,000), fringe benefits ($1,059,000) and indirect cost ($635,000) round out non-personal program expenses for a total of $14,214,000. The Department of Health is also reported to have contracted with a software company to track Medicaid expenses in real time. The Albany Times Union reports that DOH has recently contracted with Salient Management Services to track Medicaids $52 billion annual budget, 4.7 million recipients and 60,000 health care providers, at a cost of $1.4 million over three years.52
49 50
DOH internal memorandum Diversion and Counterfeit New York State Official Prescription Forms. Herbeck, D. New breed of drug dealer. Buffalo News. March 21, 2011. 51 All current program cost figures provided by the NYS DOH. 52 Crowly, CF. Taking pulse of Medicaid costs. Albany Times Union. 10/26/2011. Available at http://www.timesunion.com/local/article/Taking-pulse-of-Medicaid-costs-2236429.php. The cost of this contract could not be readily verified at the time of this writing.
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To ensure privacy, I-STOP prohibits the disclosure of viewing of all statutorily-required data collected on the system by a practitioner, pharmacist or the Commissioner of Health, unless authorized by law, and imposes new civil penalties for violations. It also provides for immunity for public officers acting in good faith and civil penalties for those persons who knowingly violate privacy provisions in the Public Health Law. It also creates a specific new crime penalizing anyone who accesses the data in violation of the law. To keep users current with system capabilities and proper usage, the bill requires continuing education programs to practitioners, pharmacists and law enforcement. I-STOP will be fundamentally more effective in reducing the abuse of prescription drugs than the present system. It will arm physicians and pharmacists with the necessary data to protect those who suffer from crippling addictions, while ensuring they can provide prescription pain medications, and other controlled substances, to patients who truly need them. In addition, I-STOP will render useless to the drug addict or drug gang stolen or forged prescription pads. If there's no record in the database to match the paper script, a pharmacist cannot fill the prescription. This is another improvement over the present practices, which doesn't include data from the physician to verify paper prescriptions. I-STOP also recognizes that not every physician in the state has Internet access, and directs the Commissioner of Health to promulgate rules and regulations to create alternate methods of reporting for those practitioners who do not have access to broadband Internet (described more fully below). Finally, the I-STOP legislation prohibits the Commissioner from imposing a fee or tax on a practitioner or pharmacist to pay for the system. INTERNETSYSTEMFORTRACKINGOVERPRESCRIBING(ISTOP) Page22
Current PMP
Optional; access to information restricted Mandated review of patient history prior to prescribing
None
None
Mandatory reporting of controlled substances at least once every 45 days Mandatory reporting of controlled substances as they are dispensed
I-STOP
Benefits of Critical I-STOP Requirements Enhanced prevention of doctor shopping. Doctor shopping refers to the practice of a drug-seeking patient requesting prescriptions from multiple physicians, often simultaneously, without informing the physician they have done so. This practice is usually for the purpose of obtaining medically-unnecessary prescription drugs for use and/or re-sale. By mandating that doctors report their prescriptions in real time, I-STOP enables subsequent doctors to detect that they are issuing a script to a person who has recently obtained one from another source. And while perhaps a second doctor can be duped into giving an abuser a wholly duplicative prescription (a patient can always claim the script was lost), the information is likely to stop the cycle, as a subsequent doctor and a pharmacist will both see the pending prescription and can make responsible inquiries to the original prescriber. Enhanced prosecutions and increased deterrence of crooked drug-dealing doctors. Currently it is nearly impossible to prosecute drug dealing doctors or crooked doctor cases without extraordinary deployment of traditional law enforcement methods (Crooked Doctor is a phrase to describe doctors who do little more than sell prescriptions, rather than treat patients' health needs). In essence, the practice of crooked doctors intentionally dealing in prescription drugs approaches the perfect crime, because everyone involved is covered by the paperwork. The patient has the script, issued by a licensed physician, and presents to the pharmacist for dispensing. Furthermore, only the worst cases of a crooked doctor are generally susceptible to prosecutions. This is because the defense of the accused practitioners in such cases is that the patients lied about their symptoms and that the defendant doctor was merely duped - the process allows the practitioner to hide behind a faade of plausible deniability. It is a very effective defense, as juries tend not to believe addicts over practitioners. I-STOP grants the ability to break this criminal chain. By mandating that doctors review a patient's prescription history and enabling and requiring both doctors and pharmacists to create a real time history of that patient I-STOP eliminates the crooked doctors defense.
Neither I-STOP nor the current pharmacist reporting system covers the in-house dispensing of drugs in emergency rooms or by practitioners.
53
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A doctor cannot escape conviction by claiming to have been lied to by an addict when the patients accurate and real time history is accessible, and the doctor is required to check it. Prevention of dealers and addicts from using stolen or forged prescriptions to obtain drugs. The pass-key to a prescription drug in our society is the prescription itself, which is presumptively valid when presented to a pharmacist. This is particularly true in New York State, under the current Official NYS Prescription process, by which it constitutes what is essentially the legal currency, upon which the prescription transaction system is based. As seen above, one of the most destructive ways around any controls over the obtaining of prescription drugs is when addicts and dealers steal prescription pads or forge prescriptions or more likely re-write the numbers on the prescriptions to increase the amount of drugs dispensed.
Last spring, Newsday reported on a BNE internal memo revealing as many as 1.4 million scripts had been stolen since 2008 from several New York City hospitals. That much paper getting out into the community its akin to letting the most virulent virus you can find loose in New York State and not telling anyone.
Jeff Reynolds, LI Council on Alcoholism and Drug Dependence
By mandating that practitioners create an electronic record of the issuance of a prescription and that pharmacists check to see if the prescription handed to them matches that record, ISTOP will make it nearly impossible for forgers or those with stolen pads to use those scripts to obtain drugs. Enhanced communication, early prescription drug abuse detection and prevention. We should not think of I-STOP only as a law enforcement tool. I-STOP will also be a diagnostic tool. The very same enhanced communication aspect that will increase the ability to detect fraud and doctor shopping will also provide practitioners with the means to confirm a patients controlled substance history electronically. This will not only enable them to better identify addicts, but will also help them evaluate a patients prescription drug history as part of determining the proper treatment for that patient. The same components that make ISTOP an effective law enforcement tool also make it an effective prevention tool. I-STOP will help shift the public policy focus of prescription drug abuse from reaction to its consequences to pro-active prevention.
In addition, I-STOP will be an important back-stop to alerting a practitioner about dangerous mixing of prescription drugs should a patient fail (or be unable) to accurately describe his or her own prescription drug history. In short, I-STOPs provisions significantly enhance the possibility for early prescription drug abuse detection, and therefore early and less costly intervention. In this regard, I-STOP is a win-win proposition that will save lives and money by shifting the public policy focus of prescription drug abuse and addiction from reaction to its consequences to the proactive prevention of such abuse in the first place.
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Table 2 - Benefits of Critical 'I-STOP' Provisions I-STOP Provision Necessary to Address Diversion Problem
Practitioner Reviewing Practitioner Reporting "Real Time" aspect of practitioner reviewing & reporting Pharmacist Reviewing Pharmacist Reporting "Real Time" aspect of pharmacist reviewing & reporting
Enhanced prevention of doctor Shopping Enhanced prosecutions & and increased deterrence of drug dealer doctors Necessary to prevent dealers and addicts from using stolen prescriptions to obtain drugs Necessary to prevent dealers and addicts from using forged prescriptions to obtain drugs Helping doctors better judge whether prescriptions are medically necessary
reporting only
reviewing only
reviewing only
reviewing only
Overall, as described in detail below, OAG has concluded after a detailed review of these sources that I-STOP will require an initial investment of no more than $10 million.
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3) OAG Private Vendor Outreach: OAG staff made inquiries of several private vendors that have experience in establishing similar systems in other states. Two vendors responded to this inquiry in time to be incorporated into this report. (Cost Estimate: $7.5 million) 4) Other State Comparisons: OAG also looked at other states that have implemented real-time reporting for pharmacists (none require such reporting of doctors). California and Oklahoma were the states chosen for these inquiries, because they have both recently initiated real-time, or near real-time pharmacist reporting systems. PMP costs in those states are derived from conversation with respective state officials. (Cost Estimate: $350,000) Overall, as described in detail below, OAG has concluded after a detailed review of these sources that ISTOP should require an initial investment of no more than $10 million, and that the costs associated of running the I-STOP program do not require any significant amount funds above that the New York currently allocates to run the current PMP program.
1) I-STOP Cost Analysis from OAG Tech Staff Given the myriad of hardware, software, programming languages, and network infrastructure solutions available there are a large number of possible designs for such a system. The following outlines possible design approaches, each varying in complexity, cost, and usability. Three possible system designs were identified (1) Basic Web Application, (2) Systems Integrated Web Application, and (3) Provider-Integrated and Provider-Built Application (below). Each application incurs costs in hardware, software and development.
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This system might require duplicate data entry on the part of physicians and pharmacists since they require access to their regular electronic medical record (EMR) systems and there might be no inherent integration with the ISTOP system. Since real-time transactions are a requirement, some form of redundancy and high availability will be required to ensure system availability, increasing the cost of this option significantly. Design Approach #2 - Systems-Integrated Web Application The basic functionality from the perspective of physicians and pharmacists will be the same, but user authentication and potentially data input could come from their own internal or 3rd- party providers. This design assumes physicians and pharmacists already have some internal and/or 3rd-party provider systems. Highlights: User authentication is off-loaded to their internal or provider systems, significantly decreasing account maintenance. This is referred to as a "federated security model". While decreasing individual account maintenance, having to interface with so many external systems increases the application complexity and potentially cost, though some of the burden may be assumed/ transferred to those responsible for those external systems. By interfacing with their systems, it has the potential to reduce or eliminate redundant data entry.
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ers to also process controlled substance prescriptions could negate the need for this system altogether. ProviderIntegrated ProviderBuilt
Basis for Cost Estimations of Each Approach: Cost estimates were developed using available hardware pricing and development costs of initiatives of similar size, though in the case of the Systems-Integrated Design the complexity of integrating with so many disparate systems is a reasonable estimate. In the case of the Provider-Built Design, the costs could conceivably be zero. Research has shown that the company SureScripts already seems to provide the necessary integration and services between physicians and pharmacists and has recently been approved to handle controlled substances.54 Any cost estimate must include the following considerations: Hardware: Estimates will vary depending on the DOH environment and whether high availability (HA) is required, which would seem to be the case here. Hardware HA usually means duplicative servers and storage configured for business continuity (BC) to allow fail-over in the event of a disruption of services. Network load-balancers may be required to distribute network traffic/load across multiple servers as will SSL accelerators used to offload from servers the process of encrypting/decrypting web traffic to/from physicians and pharmacists. Software: Costs will also vary depending on the database used, the type of application server facilitating the application, sever operating systems, annual maintenance, and so on. There may be
54 Surescripts Announces Network Upgrade for E-Prescribing of Controlled Substances. Press release available at http://www.surescripts.com/news-and-events/press-releases/2011/september/sept12-epcs.aspx. Staff has consulted with Surescripts representatives, and requested a cost estimate for I-STOP. While Surescripts agreed to provide such as estimate, it was not completed at the time of this writing. The Attorney General will make that estimate available as soon as it is received. At this time, it is unknown whether either of these designs can be implemented without more research.
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software components of HA that may be required and if servers are virtualized, then there would be added costs for that software and maintenance. Application Development: Developing the actual applications are where estimates will vary the greatest and is dependent on the rates of the project managers, business analysts, programmers and the scope/complexity of the project. In addition, it must be determined whether to import historical data, which could add considerable cost to the project. Administrative: Additionally, there may be costs that are not strictly technical in nature, such as an administrative process to set up, verify, and maintain accounts for physicians and pharmacists (This is not reflected in the costs below, but was reflected in the $10 million cost estimate of the entire system).
Figure 7 breaks down estimated costs for each of the three applications. In addition, it provides three possible variants of Application I (Basic Web Design): Low, High and High Availability, with cost estimates or each, in reference to system data storage and availability. Figure 7
Low would be adequate for limited data entry, storage and access essentially rudimentary patient data entered by both the practitioner and the pharmacist. High includes more servers and greater storage capacity. High Availability includes redundancies that ensure access for review and reporting at any time. Development costs are reasonable estimates for staff augmentation through an outside vendor. However, they could increase significantly even double - if an outside firm were to contract for the complete development solution. Annual system maintenance can be estimated at 20 percent of initial hardware/software costs. This results in an annual cost range of $163,000 to $460,000, depending of the application chosen. Of course, these costs will be offset by the costs currently borne by the State to maintain the current PMP system. 2) I-STOP Cost Analysis from the OAG Medicaid Fraud Control Unit As with the Attorney Generals IT staff, initial estimates arrived at by MFCU IT staff are based on imperfect information, such as current Health Department capabilities. Based upon conversations with DOH, nationally recognized vendors, vendors partners, white papers, and consultants, MFCU IT staff estimate that the initial startup costs for a project of this type for items including hardware, software, licensing, design, development, disaster recovery, should not exceed $5 million dollar range.
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Recurring expenses could range from 10 to 25 percent of the original cost depending on various factors and requirements that have yet to be defined. Staff bases this estimate on a number of factors, some that are readily definable, such as hardware and licensing costs for the required servers, disk storage, and infrastructure improvements, to lesser known (and probably more costly) factors that impact the existing system applications utilized by both prescribers and drug dispensers. Other considerations could be the costs of owning versus not owning the equipment, or leaving the hosting of the data facility to an experienced private sector identity.55 Generally, hardware and equipment would range from 500,000 to 1,500,000 depending on various configurations and requirements. The remaining costs would be associated with the development of software applications or systems to receive, retrieve, manage and integrate existing systems into a new highly performing automated system to facilitate the access, security, input, delivery, reporting, and exchange of data. These costs are probably one and one half to two times the hardware acquisition costs, again subject to any number of factors that could affect development, performance, access, and participation by both prescribers and dispensers. 3) Vendor Estimates Staff requested I-STOP cost estimates from three different vendors. The first was made of Health Information Designs (HID), which has won PMP competitive bids in 15 states. Estimated pricing from HID included enhancements to the current system to include real-time access for practitioners and pharmacists, design, configuration and implementation of the enhancements over a 6-month time period, and ongoing maintenance and technical help desk operational support (Vendor Estimate Figure 1). Start-up costs, including the annual operational costs in the first year, would be $619,300. Annual operational costs thereafter would be $275,000 similar to operational costs for both the Oklahoma PMP and Californias CURES (see below).56 Of course, these costs will be offset by any such costs currently borne by the State to maintain the current PMP system. Vendor Estimate Figure 1
300,000 250,000 200,000 150,000 100,000 50,000 0 RealTimeEnhancement toCurrentSystem Hardware Design,Implementation OngoingOperation, andConfiguration MaintenanceandHelp DeskSupport
55 The variations and complexities that must be considered in all phases of the development of the system cannot be thoroughly reviewed and enumerated without weeks of discussions to fully define the business requirements of the users or the complexities involved in assuring seamless data integration from various existing prescriber and dispensing applications for such a system. 56 This estimate was provided in response to a telephone interview with Susan Cotton, HIDs Director of Business Development, with subsequently submitted in writing to OAG staff.
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A second request, referred to above, was to Surescripts, which operates the nation's largest health information network, and was not received by the time of this writing. Finally, MFCU IT staff consulted with Coraid, a technology manufacturing company that designs and manufactures a full line of computer data storage products branded under EtherDrive storage. Coraid counts General Electric, Harvard University, Lockheed Martin and the United States Marine Corps among its clients. The company also currently works with the Medicaid Fraud Control Unit. Coraid responded to MFCUs non-formal Request for Information (RFI) with a detailed analysis of cost (Appendix C), given what information staff could make available, and subject to limitations cited above, with a basic conceptual system design (below). Coraid Conceptual System Design
Initial start-up costs for hardware and software are estimated at $3,744,773. This cost does not include system integration, by which all components of the system will communicate with each other. This cost is difficult to estimate with current information on the low end, it could be a relatively small additional cost on top of the start-up cost; on the high end, it could be as much as 100 percent of the startup cost, or an additional $3.7 million, though it would be non-recurring. Assuming the lowest-cost for integration is 20 percent of hardware and software costs, and the highest-cost would double hardware and software costs, the start-up scenario runs $4.5 million to $7.5 million (Vendor Estimate Figure 2).57
57
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Over ten years, Coraid estimates total costs of $23,326,440, not including the cost of integration. Using the same estimate range for integration costs, the total over the next decade ranges from $24 million to $27 million (Vendor Estimate Figure 3) with an annualized cost range of $2.4 million to $2.7 million. This includes estimates for adjustments made over time, such as data growth, maintenance, and a technology refresh after the fourth year. Vendor Estimate Figure 3
20,000,000 18,000,000 16,000,000 14,000,000 12,000,000 10,000,000 8,000,000 6,000,000 4,000,000 2,000,000 0 Servers/Software+ maintenance Switching HighPerformance Integration range Computing,NoSingle between20%and100% PointofFailureStorage ofhardware/software andmaintenance
4) Other States The cost of implementing and operating a PMP varies from state to state. Average cost for implementation is approximately $350,000, while annual operating costs have been estimated to range from $100,000 to $1 million. Many factors contribute to this variation, including: the population of the state, program differences, the number of drugs being monitored, the number of practitioners and pharmacies, the number of staff, and whether the state has enlisted the services of an outside vendor.58
58 Institute for Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Kentucky. Review of Prescription Drug Monitoring Programs in the United States. Kentucky All Schedule Prescription Electronic Reporting Program
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OAG Staff made inquiries to two states that have implemented real-time or near-real-time pharmacist reporting, California and Oklahoma. California: Californias PMP was originally established in 1939. The Controlled Substance Utilization Review and Evaluation System (CURES) was automated in 1997 and enhanced again in 2009. According to the System Manager, the initial upgrade in 1997 was done at a cost of $1 million, which included the purchase of additional servers and consultative services. The 2009 enhancement, which gave physicians access to the data and required real-time reporting of dispensed controlled substances by pharmacists (and physicians and dentists who dispense such substances directly to the patient) currently costs about $296,000 a year to operate and maintain.59
The initial 1997 upgrade for CURES costs approximately $1 million for additional servers and consultative services. CURES currently costs approximately $296,000 each year to operate and maintain. The annual cost for Oklahomas real-time PMP is about $300,000.
Physician enrollment is voluntary, with about 8,000 of the states 165,000 licensed physicians, and all of the states 3,600 pharmacists are now participating. The program is gaining in popularity; prior to the 2009 enhancement, it averaged about 65,000 inquiries each year. Since October of 2009, the system has responded to over 1 million inquiries. Oklahoma: The Oklahoma PMP is housed with the states Office of the Bureau of Narcotics (OBN), an independent agency with a very small staff. It was created through the Oklahoma Anti-Drug Diversion Act, which requires all dispensers of Schedule II, III, IV, and V controlled substances to submit prescription dispensing information to the OBN within 24 hours of dispensing a scheduled narcotic.60 The program requires dispensers (mainly pharmacies) to report electronically every 5 minutes.61 Although there are no waivers, mail order pharmacies are given up to seven days to report all controlled substance prescriptions after such prescriptions are filled.62 Oklahoma officials do not view compliance as a problem: by this past September, one-third of all pharmacies were already reporting in real time. And while pharmacists are required to report dispensed narcotics to the system, they are not required to review the PMP database prior to dispensing.63 Physicians are not required to report to the system, and consultation of the PMP database, which holds reliable data back to 2006, is on a voluntary basis. Physicians can acquire an account for themselves and a sub-account for staff. The system provides secure system access to other interested parties, including regulatory and law enforcement agencies, district attorneys and the Attorney Generals Office. Other agencies must make an official request for access based on appropriate use (e.g. the Highway Patrol was denied access because it did not make an effective appropriate use argument).
(KASPER) Evaluation Team. Report cites GAO 02-634: Prescription Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion. GAO, May 2002, available at http://www.gao.gov/new.items/d02634.pdf. 59 Conversations with John Masoney, Director of CURES, and Kathy Ellis, CURES System Manager. September 8, 2011. 60 63 O.S. Section: 2-309 61 Beginning on January 1, 2012, all dispensers must report the dispensing of scheduled narcotics within 5 minutes of being delivered to the customer. See the Oklahoma PMP website at http://www.ok.gov/obndd/Prescription_Monitoring_Program/ 62 This exception was a last-minute amendment to the legislation as it worked its way through the State Legislature. 63 OAG staff contacted Don Vogt, Director of the Oklahoma PMP, on September 8, 2011. Information otherwise unattributed regarding the Oklahoma program derives from that conversation.
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Oklahoma has 15,000 practitioners, of which OBN estimates only 50 percent write more than 10 scripts per month for controlled substances. 60 percent of those who do write 10 or more scripts per month have already applied for access. They are generally excited about the program, as indicated by the number of physician queries, which had increased this year from 30,000 to 45,000 per month. Oklahoma's approximate $300,000 cost is financed through a biannual licensing fee on practitioners.
64 Two reasonable estimates can be made as to the number of practitioners who cannot obtain broadband Internet access by virtue of their location in the state. These estimates can be obtained by using NYS Department of Education (SED) data of licensed practitioners in the state or by using data from the Broadband Mapping Project. By the former approach, 94.5 percent of all NY licensed physicians are in counties that are close to 100 percent covered by broadband access. This estimate in all probability is low, because it eliminates the entire practitioner population of the states most rural 35 counties (Appendix A Licensed Physicians in New York State). Under the Broadband Mapping Project, the New York State Office of Cyber Security (OCS) estimates that broadband access reaches 99 percent of the states population, in one form or another. In a population of nearly 20 million, this means that almost 200,000 New Yorkers do not have such access, and that population is geographically dispersed in pockets throughout the state. Data available at http://www.broadbandmap.ny.gov/content/compare-areas.html.
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65
http://www.op.nysed.gov/prof/med/medcounts.htm
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% of State Budget
21.1
5.0
Per Capita
680.2
160.7
Regulation/Compliance
Licensing and Control Collection of Taxes
21,720.0
14,720.0 7,000.0
21,720.0
14,720.0 7,000.0
1 00.0
1.1
287,641.0
49,577.0 283,063.9 N/A
287,641.0
49,577.0 283,063.9 N/A
100.0
0.5
14.9
Total
13,441,139.0
21.6
692.6
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access substances like oxycodone, Vicodin and Xanax. I-STOP provides our medical professionals with the information they need to prescribe medications to patients who truly need them, and prevent those same substances from falling into the wrong hands. Doctors and pharmacists who act in good faith will have better tools to treat their patients. If a patient complains of severe pain and asks for a prescription, the provider will immediately be able to see if that same patient already has multiple outstanding prescriptions for painkillers. In that case, the doctor could not only decline to write a new prescription, but also have a conversation with their patient about whether they are at risk for drug abuse, and recommend treatment options. If a doctor or pharmacist sees a disturbing pattern in prescriptions that have been written or filled by other providers they could also report their concerns to state health authorities. For the small number of bad actors who fuel prescription drug abuse by selling drugs to anyone who asks for them, or simply turning a blind eye to obvious signs of abuse, this law will give them fewer places to hide. In the past, unscrupulous providers could hide behind their patients by claiming that a patient didn't report their history. Under I-STOP, providers will be required to check the patient's prescription history, so they won't be able to plead ignorance if they willfully overlook evidence of abuse. I-STOP would be a vast improvement over the present system. Current practice requires pharmacies to report sales of controlled substances, but only several weeks after the event and not in coordination with the doctors who make the prescriptions. A recent change allows doctors to check the data, but they are not required to, allowing addicts and dealers to slip through the cracks. I-STOP will also invalidate the use of stolen prescription pads because if there's no record in the database to match the paper script, a pharmacist will not be able to fill the prescription. This is another improvement over the present practices, which doesn't include data from the physician to verify paper prescriptions. We want doctors and pharmacists to be able to provide prescription pain medications and other controlled substances, to patients who truly need them. To do so, they must be armed with the necessary data so that we can protect those who suffer from crippling addictions. The time to act is now; we can't afford to lose another life. The writer is the Attorney General of New York. Track the abusers; State database would help in struggle against illicit use of prescription drugs Buffalo News July 2, 2011 Attorney General Eric T. Schneiderman has stepped up to bring the authority of the state into the burgeoning social-medical-criminal crisis of prescription drug abuse. The new attorney general, responding in part to a Buffalo News series on the problem, "Rx for Danger," is proposing a tracking system that he believes could be a model for the rest of the nation. The nation needs it, as does Western New York. The problem is urgent and hasn't received the attention it demands. As reported in The News series in March, more people die in Erie County from using prescription opiates than cocaine and heroin combined. Nationally, accidental drug deaths involving prescription opioids more than tripled from 4,000 in 1999 to 13,800 in 2006. The causes range from inadvertent addictions to doctors providing drugs to dealers for money. The series found that addicts and dealers often get the drugs from friends and family members, but also steal them from pharmacies or persuade doctors to write prescriptions for which the patients have no medical need. The Schneiderman bill would provide doctors and pharmacists with real-time information to avert
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overprescribing and doctor-shopping by patients. The measure would require health care professionals and pharmacists to report to the state when certain controlled substances are prescribed and dispensed. It's a common-sense measure that treats the problem on the front end, by helping to prevent crimes from being committed and addictions from being created or nourished. More may be needed on the back end to punish and, thus, to deter doctors and patients from gaming the system, but Schneiderman's bill fills a critical need. This is, by and large, an issue for the states, and Schneiderman's bill would put New York in the forefront in seeking strategies to cope with a new and difficult problem. Albany should take it up as promptly as it can. That's not to say Washington plays no role in combating this problem. Sen. Charles E. Schumer, DN.Y., has announced that he is co-sponsoring legislation that would require doctors to receive specialized training before prescribing opioid narcotics. The goal of that legislation is to help doctors better identify patients vulnerable to addiction. In addition, Washington can function as a funding source and clearing house for states seeking to deal with this problem. Addiction is fierce. It resists taming as it ruins lives, families, friendships and careers. It takes a toll on the economy. This expanding problem must be confronted quickly and firmly, punishing those who abuse the system and helping those who are in the deadly grip of addiction. HEADS UP: Control drugs, prevent suicides Newsday June 17, 2011 A disturbing study released on Thursday by the federal Substance Abuse and Mental Health Services Administration finds drug-related suicide attempts by men ages 21 to 34 increased 55 percent from 2005 to 2009. This rapid rate of growth calls for an urgent response. New York Attorney General Eric Schneiderman has introduced a bill to allow doctors and pharmacists to monitor drug prescriptions in real time. Should this become law, doctors will be able to avoid prescribing drugs to patients who have already been given the medication. The federal study cited prescription drugs as part of the problem, and in the fight against drug-related suicide, restricting access is the most important step. Though a new prescription-drug law would be a key step in preventing suicides, it is the first of many that are needed. This is a crisis that needs a response.
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Appendix D
Definition of Controlled Substance Schedules66
The drugs and other substances that are considered controlled substances under the CSA are divided into five schedules. A listing of the substances and their schedules is found in the DEA regulations, 21 C.F.R. Sections 1308.11 through 1308.15. A controlled substance is placed in its respective schedule based on whether it has a currently accepted medical use in treatment in the United States and its relative abuse potential and likelihood of causing dependence. Some examples of controlled substances in each schedule are outlined below. NOTE: Drugs listed in schedule I have no currently accepted medical use in treatment in the United States and, therefore, may not be prescribed, administered, or dispensed for medical use. In contrast, drugs listed in schedules II-V have some accepted medical use and may be prescribed, administered, or dispensed for medical use.
66 Reproduced from U.S. Department of Justice, Drug Enforcement Administration. Available at http://www.deadiversion.usdoj.gov/schedules/index.html#define
Examples of schedule III narcotics include combination products containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin) and products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with codeine). Also included are buprenorphine products (Suboxone and Subutex) used to treat opioid addiction. Examples of schedule III non-narcotics include benzphetamine (Didrex), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin).
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