FBI Reaches Out For Victims Of Subsys Scheme

In an unusual move, the FBI is reaching out publicly to patients who were prescribed the powerful narcotic medication Subsys, which federal agents allege was improperly dispensed by practitioners across the country, including a nurse in Derby. In a posting on its Victim Assistance Program website, the FBI asks people who were prescribed Subsys between March 2012 and December 2016 to complete a brief questionnaire that will assist in a federal probe of Insys Therapeutics, the company that makes Subsys. The appeal follows the indictments in December of six top executives and managers of Insys on charges they led a nationwide conspiracy to bribe doctors and nurses to prescribe Subsys, which is approved for treating cancer patients suffering episodes of breakthrough pain. In exchange for bribes and kickbacks, the practitioners wrote large numbers of prescriptions for patients, most of whom were not diagnosed with cancer, the indictments allege. One of the practitioners named in the indictments is Heather Alfonso, formerly an advanced practice registered nurse (APRN) at the Comprehensive Pain and Headache Treatment Center in Derby. She has pleaded guilty to accepting kickbacks from Insys through a sham “speakers’ program,” in exchange for prescribing Subsys.

Ten prescribers wrote more than 23 percent of the state's Medicare spending on opioids in CT.

Handful Of Prescribers Responsible For Large Share Of Opioids

Ten Connecticut prescribers, including a Derby nurse who is at the center of a federal kickback probe, were responsible for more than 23 percent of the state’s Medicare spending on opioids in 2014, suggesting that the largest share of those prescriptions is concentrated among a small number of clinicians. 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. 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.

Drug Company Falsely Claimed Patients Had Cancer, Feds Allege

 A former executive of Insys Therapeutics has been criminally charged for leading a special “reimbursement unit” at the company that defrauded insurers into paying for a potent opioid pain medication by falsely claiming patients had cancer and other conditions needed for pre-approval. Elizabeth Gurrieri, a former manager of reimbursement services for Arizona-based Insys, was charged with wire fraud conspiracy in a criminal complaint filed in federal court in Boston. The complaint sheds light on a Connecticut case involving a Derby nurse who has been charged with taking kickbacks from Insys in exchange for prescribing the company’s fentanyl spray, Subsys. The nurse, Heather Alfonso, has been cooperating with investigators in Boston and Connecticut in an ongoing probe of Insys’ sales tactics. The complaint against Gurrieri notes that patients needed prior authorizations from insurance companies to cover the costs of Subsys, an expensive drug approved by the Food and Drug Administration in 2012 for the management of breakthrough pain in patients with cancer who already were receiving opioid pain treatment.

Derby Nurse Pressured By Drug Company To Boost Sales

A Derby nurse who admitted taking kickbacks from a drug company that makes the powerful painkiller Subsys was pressured by sales representatives to increase her prescribing “so that the Subsys numbers would also increase,” according to court documents. In a hearing transcript recently made public, federal prosecutors charged that Heather Alfonso “continued to increase her prescribing of Subsys and to find more patients for whom she could prescribe the drugs” in exchange for a series of $1,000 kickbacks, totaling $83,000, from the company, Insys Therapeutics. Although the potent narcotic is approved only for cancer patients, some of the patients given Subsys by Alfonso “did not have a cancer diagnosis,” which would have meant that Medicare and private insurers would have refused to pay claims, federal prosecutors said. But “prior authorizations” submitted on behalf of patients falsely represented that they had cancer, misleading insurers into paying for the drug. It is not clear in the testimony who was involved in submitting the false authorizations to Medicare and insurers.

Blumenthal, Grassley Call For Expanded Drug Company Reporting

US Sen. Richard Blumenthal (D-Conn.) and U.S. Sen. Chuck Grassley (R-Iowa) have introduced legislation that would require drug companies and medical device manufacturers to start reporting their payments to nurse practitioners and physician assistants, as they do for physicians. “Requiring companies to disclose gifts and payments made to other health care providers – not just doctors – is absolutely essential,” Blumenthal said in a statement Tuesday. “The Provider Patient Sunshine Act will rein in dishonorable behavior by increasing transparency and accountability across the entire healthcare industry.”

Grassley added: “It makes sense to apply the sunshine (provisions) to anyone who prescribes medicine.”

The proposed Provider Payment Sunshine Act, would require drug companies and device makers to publicly disclose payments to nurse practitioners and physician assistants for promotional talks, consulting and other services. The companies already report such payments to physicians in a national Open Payments database, under prior legislation co-authored by Grassley. The payments to nurse practitioners and physician assistants would be added to that database. Nurse practitioners and physician assistants write a significant number of prescriptions in the federal Medicare program, data show.

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Highest Prescribers Of Cancer Drug Paid As Speakers

Eight of the top 10 prescribers of a potent narcotic used for cancer pain were paid more than $870,000 in speaking fees by the drug maker in 2013 and 2014 — indicating that Derby nurse Heather Alfonso was not the only high prescriber compensated by the company. Alfonso, an advanced practice registered nurse (APRN) who worked at the Comprehensive Pain and Headache Treatment Center in Derby, pleaded guilty last month to accepting $83,000 in kickbacks from 2013 to March 2015 from the drug company Insys Therapeutics, which has heavily marketed a painkiller called Subsys, a sublingual fentanyl spray approved only for cancer patients. Alfonso was paid to speak about Subsys at more than 70 “dinner programs,” but most of those programs were attended only by her and a sales representative for Insys, or by Alfonso’s colleagues and friends who had no authority to prescribe the drug, according to the U.S. Attorney’s Office for Connecticut. Alfonso faces a maximum prison term of five years and a fine of up to $250,000 on the charge of receiving kickbacks in connection with a federal healthcare program. In pleading guilty, she admitted that the money she was paid influenced her prescribing of Subsys, often to non-cancer patients, federal investigators said.

Case Against Derby Nurse Involves Potent Painkiller

Federal charges against Derby nurse Heather Alfonso center on a powerful and addictive painkiller called Subsys, which has been heavily marketed by the Arizona-based manufacturer Insys Therapeutics, federal officials confirmed Wednesday. Alfonso, 42, of Middlebury, pleaded guilty Tuesday in U.S. District Court in Hartford to receiving $83,000 in kickbacks from January 2013 until March 2015 from a pharmaceutical company that makes a drug used to treat cancer pain. In pleading guilty, Alfonso admitted that the money she was paid influenced her prescribing of the drug, according to the U.S. Attorney’s Office for Connecticut, which is prosecuting the case. Receiving kickbacks in exchange for billing charges to a federal health care program is illegal. While the company and drug are not named in the indictment, a prosecutor revealed in court Tuesday that the case involves Subsys and Insys Therapeutics.