Recently released federal Medicare data show that Heather Alfonso, formerly a nurse with the Comprehensive Pain & Headache Treatment Centers, LLC, in Derby, and four other advanced practice registered nurses (APRNs) at the clinic in 2014 dispensed more than $8.4 million in opioids in the Medicare program – accounting for a full 15 percent of all such prescriptions in the state. They were among the top 10 opioid prescribers in 2014, who accounted for $13 million of the $56 million spent on the drugs, the data show.

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Ten prescribers were responsible for more than 23 percent of the state’s Medicare spending on opioids.

More than 4,800 Connecticut clinicians, mostly physicians, wrote Medicare prescriptions for oxycodone, fentanyl and other opioids. But the prescribing was not evenly spread out – only two-dozen prescribers wrote out more than $250,000 worth of prescriptions. On average, the 4,830 providers billed Medicare for about $11,000 in opioids.

Alfonso has pleaded guilty to accepting kickbacks from Arizona-based Insys Therapeutics in exchange for prescribing Subsys, a powerful fentanyl pain medication intended for patients with cancer. A previous C-HIT story reported that she and three other nurses at the Derby clinic were responsible for nearly all of the state’s 2014 Medicare spending on Subsys – 279 claims, at a cost of $2.3 million.

None of the other three nurses has been implicated in a federal probe of Insys’ marketing of Subsys that resulted in criminal charges against Alfonso. The Derby clinic, located in Griffin Hospital, and a Meriden affiliate remain in operation.

Dr. Mark Thimineur, who runs the treatment clinic, also has not been implicated. He did not return messages seeking comment on the clinic’s opioid prescribing.

Alfonso topped the list of opioid prescribers, with $3.5 million in prescriptions (6,240 claims). Second on the list was Monika Chaves, a former APRN at the clinic, with $1.85 million (3,664 claims).

Dr. Michael Brennan, a Fairfield pain specialist, was the third highest prescriber, with $1.84 million (4,596 claims). Brennan declined comment, but previously told C-HIT that he specialized in patients with chronic pain and was selective in accepting patients and diligent in monitoring prescriptions.

The three other APRNs who worked at the clinic were: Jean Vulte, with $1.7 million in opioid charges; Ashley Dizney, with $773,000; and Karlene Jean-Pierre, with $594,700.

The other prescribers in the top 10 were: Dr. Vincent Carlesi, medical director of Pain Management Associates of Connecticut, in Stamford, with $817,000; Dr. Mohan Vodapally, of Connecticut Regional Pain Specialists, LLC, in New Haven, with $692,360; Jon Lum, a physician assistant in New Haven, with $639,000; and Dr. Christopher Mastino of Fairfield, with $524,400.

None of them returned messages, but managers at several of their offices noted that the practices specialize in pain management and said prescribing is carefully monitored.

Drug overdose deaths in Connecticut have climbed in recent years, with fentanyl partly to blame. In 2015, 729 people died of accidental overdoses, 188 of them involving fentanyl. Dr. James Gill, the chief state medical examiner, said in a September report that he expects the total for 2016 could reach nearly 900.

The rise in overdose deaths has strained Gill’s office, which was told in October that it will lose its national accreditation and be placed on probation by the National Association of Medical Examiners.

The state has adopted a number of legislative changes to regulate prescribing of opioids and improve reporting. In July, the state shifted from weekly to “real-time” reporting of prescriptions for opioids and other controlled substances. Pharmacies are now required to report controlled substance (Schedule II to V) prescriptions “immediately,” or at least within 24 hours after they are dispensed, into a central database, known as the Connecticut Prescription Monitoring and Reporting System (CPMRS).

The CPMRS, maintained by the Department of Consumer Protection, can be accessed by doctors and pharmacists to give them a complete picture of a patient’s medication use, and also can be used by law enforcement officials to investigate physician prescribing. However, Connecticut’s program is one of only two in the country housed in the consumer protection department, according to the National Alliance for Model State Drug Laws; most are overseen by state health departments, which license and discipline doctors. And unlike other states, Connecticut does not have specific laws regulating pain clinics or pain management.

In addition to the change in the reporting requirement, reforms effective in July included a provision that limits initial prescriptions for opioids to a seven-day supply in most cases.

Alfonso also was the highest prescriber of Schedule II controlled substances in 2013, Medicare data show, accounting for $2.7 million in prescriptions. She is now cooperating with federal investigators in the ongoing probe of Subsys.

C-HIT data analyst Matt Wynn contributed to this story.

New Medicare data for 2014 show the four nurses, all who worked at the Comprehensive Pain and Headache Treatment Center of Derby, were responsible for 279 claims for Subsys, at a cost of $2.3 million. The highest prescriber was Heather Alfonso, an advanced practice registered nurse (APRN) formerly employed by the clinic who is awaiting sentencing on charges she took kickbacks from Arizona-based Insys Therapeutics for dispensing Subsys to patients.

The new data is the first indication that the propensity to prescribe Subsys extended beyond Alfonso, to other clinic staff. None of the other three nurses has been implicated in an ongoing federal probe of Insys’ marketing of Subsys that resulted in the criminal charges against Alfonso. The Derby clinic, located in Griffin Hospital, and a Meriden affiliate remain in operation.

Dr. Mark Thimineur, who runs the treatment centers, also has not been implicated. He did not respond to questions about the Subsys prescribing, and a clinic manager said she had no comment.

The data show that Alfonso wrote out 170 prescriptions for Subsys in the Medicare Part D program in 2014, at a cost of $1.2 million. The other three Connecticut prescribers of Subsys were all listed as APRNs at the pain center in 2014. They are: Monika Chaves, responsible for 57 prescriptions, at a cost of $521,242; Ashley Dizney, with 29 prescriptions, at a cost of $341,132; and Jean Vulte, with 23 prescriptions, at a cost of $209,970.

The Medicare records show that only 10 other nurse practitioners in the country prescribed Subsys in 2014, most of them at lower amounts than the clinic nurses. The four Connecticut nurses were responsible for more than half of all Subsys claims (519) submitted nationally by nurses, according to the data.

The bulk of Subsys prescriptions were written by physicians. Nationally, 846 providers in the Medicare program prescribed Subsys to some 2,700 patients, at a cost of $97.2 million.

The 2014 dataset –released by the Centers for Medicare & Medicare Services (CMS) — describes only those medications prescribed for the 38 million elderly and disabled enrollees in Medicare Part D – a portion of the total patient population.

Chaves and Dizney, who is still employed at the pain center, did not return messages seeking comment. Vulte could not be reached. Alfonso’s lawyer, Ryan McGuigan of Hartford, declined comment.

The 2014 Medicare data show Alfonso was the state’s highest prescriber of opioid medications, which include Subsys. She was responsible for 6,240 opioid prescriptions, at a cost of $3.5 million. Chaves had the second-highest dollar volume of opioid prescriptions in the state, at $1.84 million, while Vulte was fourth highest and Dizney was sixth highest.

Subsys, which was launched by Insys in 2012, is a spray that contains fentanyl, a highly addictive opioid. It is approved by the Food and Drug Administration only for managing breakthrough cancer pain that is not controlled by other medications. Insys reported $329 million in net revenue from Subsys in 2015.

Alfonso, of Middlebury, pleaded guilty in June 2015 to receiving $83,000 in kickbacks from Insys from January 2013 to March 2015, while she was employed at the pain clinic. She admitted in court that Insys paid her through a sham “speakers program,” supposedly to give presentations to other prescribers about Subsys. Instead, court documents say, Insys paid her about $1,000 per event for going out to dinner with friends and co-workers, or with just an Insys sales rep. At the same time, she wrote out Subsys prescriptions at what prosecutors called “an alarming rate.”

Court documents in Alfonso’s case say that some of the patients who were given Subsys did not have cancer, which would have led Medicare and private insurers to refuse to pay claims. But “prior authorizations” submitted on behalf of some patients falsely represented that they had cancer, misleading insurers into paying for the drug, federal prosecutors have said.

Heather Alfonso

A year ago, after Alfonso was charged with accepting kickbacks, state officials dropped the Comprehensive Pain and Headache Treatment Center from the Medicaid program, citing improprieties involving treatment and oversight. Both Thimineur and Alfonso are still enrolled in the federal Medicare program as providers, a CMS spokesperson said.

Last month, Alfonso’s Sept. 13 sentencing date was pushed back indefinitely, on a request from McGuigan – supported by prosecutors — that said Alfonso was cooperating with a federal prosecution by the U.S. attorney’s office in Boston.

Alfonso also filed a request last week for her legal costs to be paid through a program for indigent defendants, saying she had “exhausted funds and resources and has no equity in any other assets available to her” and was unable to pay the fees for her private attorney. The court approved the request Monday.

Insys’ marketing of Subsys is the subject of various state and federal probes. Last week, two former Insys employees pleaded not guilty in Manhattan federal court to charges they violated anti-kickback laws by engaging in a scheme to pay doctors to participate in phony educational programs in exchange for high prescribing of Subsys.

The licenses of Chaves, Vulte and Dizney remain active, with no past or pending disciplinary charges. Records show the state Board of Examiners for Nursing held a pre-hearing review of a case involving Dizney in June 2015, but determined that the situation did not warrant discipline.

Both Thimineur and Alfonso faced disciplinary action by state boards in the past several years related to prescribing, but continued practicing without restrictions.

In June 2015, Thimineur was reprimanded and fined by the state Medical Examining Board for writing prescriptions for patients based on assessments of their appearance or behavior that were conducted by unlicensed medical assistants.

Alfonso received a reprimand and fine in 2014 by the Board of Examiners for Nursing for failing to personally examine a patient before renewing a narcotic pain medication. Last year, she surrendered her state and federal licenses to prescribe controlled substances.

Heather Alfonso, an advanced practice registered nurse (APRN) at the Comprehensive Pain & Headache Treatment Centers, LLC, wrote out 8,705 prescriptions for opioids and other Schedule II drugs in 2012 – the most prolific prescriber among all Connecticut practitioners, including pain specialists and other physicians, according to Medicare data compiled by ProPublica.

She wrote out more prescriptions for the opioid Exalgo than any other Medicare provider in the country, and was the seventh highest prescriber nationally of Oxycontin, writing out more than twice as many prescriptions for that narcotic as the next highest prescriber in Connecticut. She also was the 10^th highest prescriber nationally of Avinza, a morphine product.

There is no indication that Alfonso’s unusual prescribing frequency drew scrutiny from state or federal officials. Last July, she received a reprimand and fine from the state for improper prescribing practices related to one patient, but was allowed to continue practicing without restrictions.

Alfonso and Dr. Mark Thimineur, an anesthesiologist who is medical director of the privately run pain center, housed in Griffin Hospital, did not respond to messages seeking comment. Asked about Alfonso’s Medicare prescribing rate in 2012 – the most recent year for which data is available — a spokeswoman at the pain center said only, “We are a very large practice for pain management, and with our patients’ (complex) diagnoses, those are factors.”

Connecticut officials have been working to stem an increase in opioid prescribing and overdoses. In January, the Connecticut Hospital Association joined the state Department of Public Health and two physicians’ groups in endorsing a set of “voluntary guidelines” aimed at reducing opioid prescribing in hospital emergency departments. The guidelines discourage emergency clinicians from providing “replacement prescriptions” for lost or stolen medications, and recommend dispensing small amounts of opioids to patients who have acute injuries, such as fractures.

This month, Gov. Dannel Malloy proposed several initiatives designed to stem substance use and opioid overdose, including one that would require any prescriber supplying more than a 72-hour supply of a controlled substance to first review the patient’s record in a statewide prescription database. All pharmacies would be required to report prescriptions for controlled substances immediately – rather than weekly – through the state’s prescription monitoring program, to help ensure that prescribers have real-time data for treatment decisions. The legislation also would require education on opioid prescribing for medical professionals, as part of the license-renewal process.

Malloy’s proposals stop short of initiatives in some other states which have health agencies and medical boards using prescription data to spot problem prescribing, mandate drug screening for patients on long-term opioid treatment, or impose special regulations on pain management clinics.

William Gerrish, spokesman for the state Department of Public Health, said the DPH and the state medical board do not monitor the prescription database, which is maintained by the Department of Consumer Protection’s drug control division. “We can only access the database when there is a complaint (or) referral,” he said. The consumer protection agency is empowered to notify law enforcement or regulatory agencies of any improper prescribing activity.

In the past several years, a number of Connecticut physicians have been charged with illegal prescribing of controlled substances. Last July, for example, a long-term Drug Enforcement Administration investigation, which included the use of undercover agents, led to the arrest of a Fairfield doctor, Dr. John Katsetos, on charges he wrote prescriptions for large quantities of controlled substances to patients addicted to the drugs, outside the scope of legitimate medical practice.

Gary Mendell, founder and CEO of Shatterproof, a Norwalk-based organization dedicated to combating addiction, applauded the governor’s proposals, but said more work is needed to educate both prescribers and consumers about the risks of opiates and the potential for abuse. He said state regulators should be reviewing the statewide prescription database regularly to identify clinicians with unusually high rates of prescribing.

In addition, Mendell said, prescribers and pharmacies should be better educating consumers about the safe keeping of controlled substances and programs to dispose of excess pills.

“There’s too large a supply of these medications and too little education about them,” he said.

The federal Centers for Medicare & Medicaid Services (CMS) has been slow to police high prescribers. The agency adopted regulations last year that will allow it to remove providers from the program – starting in mid-2015 — if it finds a pattern of prescribing that is “abusive,” or if a state suspends or revokes a provider’s ability to prescribe.

Alfonso was reprimanded last July by the state Board of Examiners for Nursing for providing narcotic pain medications to a non-cancer patient seven times without personally examining the patient, instead “inappropriately” relying on an unlicensed assistant to examine the patient, state records say. She paid a $2,000 fine and took courses in safe prescribing and delegating work duties. She was allowed to continuing practicing without restrictions.

There is no indication in the records that the state DPH or the medical board had reviewed her level of prescribing.

Medicare records from 2012 show that 94 percent of Alfonso’s patients received at least one prescription for a potent Schedule II medication. Other nurse practitioners in Connecticut wrote such prescriptions rarely or not at all, according to the federal data compiled by ProPublica. Alfonso issued an average of 18 prescriptions per patient – double the average for nurse practitioners – the data show.

Until 2014, APRNs in Connecticut could only practice and prescribe in collaboration with a licensed physician. A change in law now allows them to work independently after a three-year collaboration with a physician.

Comprehensive Pain & Headache Treatment Centers advertises itself as using “state of the art procedures” to help control patients’ pain. “Today there are many options other than oral narcotics to give a chronic pain sufferer back the quality of life that they are craving,” its website says.

Thimineur had fewer Medicare prescriptions for controlled substances than Alfonso; he was the third-highest prescriber among pain medicine specialists in the state in 2012, data show. Like Alfonso, most of his prescriptions were for Schedule II drugs, defined as those with a high potential for addiction and abuse.

Thimineur was cited in a 2009 workers’ compensation case brought by the wife of state corrections officer Anthony Sapko, who died in 2006 of “multiple drug toxicity” due to excessive doses of oxycodone (20 times higher than the therapeutic dosage) and Seroquel (more than five times higher). Thimineur treated Sapko for back pain, prescribing at least eight drugs, including oxycodone, records say. The Comprehensive Pain & Headache Center “counseled the decedent on the proper use of the drugs prescribed for pain control and required the decedent to participate in a ‘controlled substances agreement,’” according to records of the compensation review board. The center’s treatment was not questioned in the case.

In 2014, Connecticut emergency departments had nearly 1,900 visits related to opioid overdose – a 50 percent increase over 2011. Close to 500 state residents died from accidental drug overdoses in 2013, a 38 percent increase from 2012, a state report shows. While 257 of those deaths were from heroin overdoses, the rest were from oxycodone, morphine and other prescription drugs.