August 24, 2016

Derby Pain Clinic’s High Prescribing Of Cancer Drug Extends Beyond Nurse

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Four nurses, all of them affiliated with a Derby pain clinic, were responsible for nearly all of the state’s 2014 Medicare spending on the powerful opioid painkiller Subsys, which is at the center of a kickback probe.

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.

C-HIT-Subsys-Graphic-2016-08---v3-smallThe 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

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.

 

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