February 2009

Headline News

  • The Center for Practical Bioethics, joined by their partners the Federation of State Medical Boards and NAAG, have issued a Balanced Pain Policy Initiative Policy Brief, an outgrowth from the two Law Enforcement Roundtables that were held by the Balanced Pain Partnership Initiative. The brief suggests strategies that law enforcement personnel may use to minimize the unintended chilling effect on legitimate medical practice that the investigation and prosecution of doctors for prescription drug diversion might cause.

News from Attorneys General Offices

  1. Arizona Attorney General Terry Goddard announced the indictment of Dr. Paul Balikian on charges of healthcare fraud and illegal prescribing of controlled substances. According to the indictment, Dr. Balikian sold his medical practice to non-physician Olena Kulakova who saw patients and used Dr. Balikian’s prescription pad to order medications. Balikian returned to the clinic to practice medicine and signed off on patients’ charts despite knowing that Kulakova was not a licensed doctor.
  2. California Attorney General Jerry Brown announced the arrest of Dr. Lisa Michelle Barden on charges of illegally obtaining prescription drugs. The Riverside District Attorney’s Office filed 276 felony counts including commercial burglary, forgery, identity theft, obtaining a controlled substance by fraud, and insurance fraud. She is accused of stealing prescription pads from five local physicians and personal information from 15 of her patients. General Brown also announced last month the arrests of nursing home employees who allegedly drugged patients for the staff’s convenience.
  3. Kentucky Attorney General Jack Conway announced the guilty plea of the Letcher County Coroner John Cornett to seven counts of unlawfully obtaining a prescription for a controlled substance by fraud, commonly known as “doctor shopping.”
  4. New Jersey Attorney General Anne Milgram announced that six defendants had pled guilty to racketeering charges for their roles in a Newark-based narcotics ring that distributed millions of dollars a year in illegal prescription painkillers. General Milgram also announced that a Livingston pharmacist had pled guilty to stealing more than $11,500 in prescription drugs by creating phony prescriptions.
  5. New Mexico Attorney General Gary King announced the successful prosecution of Laurel Canyon, LLC, for abuse and neglect of a resident. The company and its owners face exclusion from participation in federally funded health care programs.
  6. Rhode Island Attorney General Patrick Lynch announced that 30 individuals were arrested and charged with being involved in various criminal activities, including illegal distribution and sell of controlled substances.
  7. Funds from the $650,000 settlement with Purdue Pharma were distributed by the former Virginia Attorney General Bob McDonnell prior to his leaving office this month. The money was given to the Appalachian Substance Abuse Coalition for Prevention and Treatment, the Department of Mines, Minerals, and Energy, and the Department of Mental Health, Mental Retardation, and Substance Abuse Services.
  8. Washington Attorney General Rob McKenna has made the issue of prescription drug abuse a priority in his office. He will join members of SAMA, Science and Management of Addictions, on March 25 for a roundtable discussion on the issue. SAMA’s Parent Advisory Council is promoting April 1 as prescription drug awareness day with the goal of encouraging consumers to regularly check their medicine cabinets for dangerous drugs just as they check their batteries in their smoke alarms.
  9. Wisconsin Attorney General J.B. Van Hollen has announced a new public education campaign to raise awareness of threats posed by unsecured prescription drugs. The Wisconsin Department of Justice is sponsoring, with the Wisconsin Broadcasters Association, both television and radio spots designed to encourage parents and family members to secure their prescriptions.

Judicial Developments

  • A Wisconsin man, Michael D. Below, has been charged with first-degree reckless homicide in the death of his two-month old daughter, Madison. His attorney argued that the medical staff at Children’s Hospital of Wisconsin took Madison off life support without following state law and, thus, the infant’s death was caused by the hospital. The circuit court rejected that argument and the state Court of Appeals upheld the circuit court judge. Below’s trial will begin on March 3.

Legislative/Regulatory Developments

  1. The American Recovery and Reinvestment Act of 2001, HR 1, includes a one-year moratorium on cuts in Medicare funding for hospice programs.
  2. Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), Food and Drug Administration (FDA) can require manufacturers to submit a risk evaluation and management strategy (REMS)when a drug first comes on the market or later if FDA becomes aware of new safety data about the drug. The FDA recently announced that it will meet with manufacturers of Schedule II narcotics on March 3 to discuss ways to reduce the problems associated with overuse of these drugs and develop a REMS for the various Schedule II drugs. Public meetings are planned for later in the spring. The FDA also announced that it was partnering with the Centers for Disease Control to support research intended to prevent unintentional drug overdoses by adults.
  3. Arizona SB 1311 would require physicians to answer questions from their terminally ill patients about palliative care options or refer them to someone who will.
  4. The Colorado legislature is considering HB 1260, the Designated Beneficiaries Bill. It would allow unmarried adults to enter into an agreement that would make each a designated beneficiary of the other. This would allow surrogate decision-making for medical purposes as well as allow inheritance through intestacy and other benefits. The form would be filled out at the County Clerk and Recorder’s office.
  5. The Georgia legislature is considering HB 273, the Georgia Prescription Monitoring Program Act.
  6. The Idaho legislature is considering SB 1114, a Texas-style futile treatment bill, titled “Witholding or Withdrawing Health Treatment ─ Voluntary Ethics Committee Review.
  7. The Illinois General Assembly is considering HB0758 that would amend the state’s Nursing Home Care Act and the Health Care Surrogate Act. It would require that all nursing home residents be given written information describing the home’s policies concerning CNR orders and that each be given the opportunity to execute a living will or power of attorney.
  8. The Kansas legislature is considering new end-of-life legislation, HB 2109.
  9. Minnesota legislators will be considering HF 804, a bill that would tighten Minnesota’s standards for guardians and conservators. The legislation would also provide more opportunities to challenge a conservator’s spending and the guardian’s annual report on a ward’s well-being.
  10. The Texas legislature is considering a bill, SB 911, which would license pain management clinics, making them submit to an annual review and renew their licenses every two years. Another bill is being drafted that would outlaw doctor shopping.
  11. The Utah House of Representatives voted down a bill, SB 117, which would have allowed physician assistants and psychologists to determine whether an adult lacks healthcare decision-making capacity. It had passed the Senate with little opposition.
  12. The Vermont Prescription Drug Monitoring System, which was approved in 2006, has now gone into effect statewide. Under the system, pharmacies are required to report their data on each controlled substance dispensed at least every seven days. More than 328,000 records had already been uploaded to the system in the first month of operation.
  13. A Vermont legislative study committee concluded that health care providers need better education about end-of-life care, pain management, and palliative care. The recommendations include requiring more training for doctors, removing insurance obstacles, and public education.
  14. Under consideration by the Washington legislature is HB 1165 that would require drug manufacturers to develop and pay for programs to take back unused medicines and dispose of the drugs in secure hazardous-waste facilities. Designed as a measure to protect the environment, the proposed legislation would also help to eliminate unused drugs in medicine cabinets from being diverted.
  15. Washington legislators are also considering SB 2639, a bill requested by Attorney General Rob McKenna, which would add new protections for vulnerable adults. The bill would require employees of financial institutions to receive training to recognize and report financial exploitation.
  16. HB 164 has passed the Wyoming House and now heads to the full Senate. The bill would undo a change in the law that softened penalties for first-time offenders and would make charging forging or altering a drug prescription a felony. The Senate Judiciary Committee added an amendment that would give local authorities discretion over how to prosecute first-time offenders.

Pain Management

  1. An article in Pediatric Blood & Cancer reported the results of a study that showed opoiod prescriptions for pediatric cancer patients while hospitalized during the last week of life vary greatly among hospitals.
  2. A panel of pain-management experts, representing the American Pain Society and the American Academy of Pain Medicine, has published a comprehensive clinical practice guideline to assist clinicians in prescribing opioid medications for patients with chronic, non-cancer pain. The report makes 25 specific recommendations.
  3. The 25th Annual Meeting of the American Academy of Pain Medicine heard a presentation from Dr. Chester Buckenmaier, stationed at Walter Reed Medical Center, regarding the treatment of pain in returning war veterans. He emphasized that private physicians will be treating these pain sufferers as they enter civilian life. His co-presenter, Dr. Norman Harden, Northwestern University Feinberg School of Medicine, discussed the long-term management of combat-related neuropathic pain and emphasized the use of multidisciplinary teams to treat such pain.
  4. The Annual Meeting also heard a presentation that highlighted two of the underlying issues that contribute to the under-treatment of pain: public perceptions about opioids and patient non-compliance in the form of diversion.

Prescription Drug Diversion

  1. The February issue of the Council of State Government’s State News magazine includes the article “Accidental Overdoses from Legal Drugs.” The article grew out of the discussions at the Centers of Disease Control and Prevention meeting on the epidemic of prescription drug overdoses last December.
  2. The Food and Drug Administration (FDA) announced in February that it would be collaborating with the Centers for Disease Control and Prevention (CDC) to support research into new efforts to prevent adults’ unintentional drug overdoses. The CDC will provide $350,000 a year for two years to be split between two grantees. The FDA will also commit money to the project although the amount has not yet been set.
  3. The James Madison University student newspaper, The Breeze, devoted an article to Adderall abuse. It reported that an informal poll of 230 students found that one-tenth of the students reported using Adderall without a prescription.
  4. State authorities arrested a Sands Point, New York, podiatrist, charging him with obtaining fraudulent prescriptions and then selling the medication on the street. Dr. William Levine has been charged with second and fifth degree criminal possession of a controlled substance, fifth degree criminal sale of a controlled substance, an second degree criminal possession of a weapon. He was arrested in a public school parking lot.
  5. Michigan physician Dr. Sohrab Shafinia has been charged in a 43-count federal indictment with illegally dispensing controlled substances.
  6. Florida physician Dr. Yong Am Park was recently arrested and charged with assisting in obtaining a controlled substance by fraud and unauthorized possession of prescription forms.
  7. Dr. Philip Astin of Carrollton, Georgia, entered a guilty plea to all 1715 counts of an indictment that charged him with illegally dispensing prescription drugs from 2002 to 2007.
  8. An Oklahoma City doctor was found guilty by a federal jury of 53 counts of illegally dispensing controlled substances, health care fraud, and obstruction of justice. Can D. Phung will be sentenced in 90 days; he faces up to 20 years in prison and a fine of up to $1 million.
  9. A federal court judge in Tampa, Florida, sentenced Dr. Juan Antonio Ibanez to 51 months imprison for distributing pain medicine through Internet web sites. His organization grossed more than $85 million between 2003 and 2007 by distributing more than 50 million hydrocodone pills nationwide. Customers accessed the various websites, filled out a short questionnaire, selected the dosage and amount of hydrocodone desired, and sometimes submitted alleged medical records. The investigation into others involved in the Internet scheme is continuing.
  10. Florida physician Dr. Robert L. Ignasiak Jr. has been sentenced to 292 months in prison and fined $1,000,000 after being found guilty of health care fraud and illegally dispensing controlled substances.
  11. A doctor from Mt. Laurel, Pennsylvania, was sentenced to over 4½ years in federal prison, fined $10,000, and 4 years of supervised release. Dr. Pravin Vasya, who practiced in the area of neurology and neuropathic pain management in New Jersey, pled guilty to charges involving selling prescriptions for the painkillers Oxycontin and Roxicodone.
  12. Acting under a Kentucky Governor’s warrant, two Nashville, Tennessee, doctors have been arrested and held awaiting extradition to Harlan County, Kentucky. Dr. Visuvalingham Vilvarajah and Dr. Mireille Lalanne have been charged with three counts: engaging in organized crime, second-degree assault, and first-degree wanton endangerment in the Harlan, Kentucky, Circuit Court. The second-degree assault charges involve the doctors’ alleged prescribing of large quantities of narcotics to a Kentucky woman who told the doctors she was pregnant. The baby was born drug-addicted. The investigation leading to the arrests was prompted by the large number of Kentucky residents, who had received prescriptions from the Nashville doctors and who then were arrested for drug trafficking in Harlan. Harlan County is a five to six hour drive from Nashville.
  13. As a result of an investigative article published in the Toronto Star, Ontario, Canada, will lead a national probe into the misuses of OxyContin. The report found that the number of OxyContin prescriptions paid for by the province’s public drug plan had tripled in five years and that, in the past five years, an estimated 464 deaths have been blamed on the drug contained in OxyContin.

Other Items of Interest

  1. The latest issue of the Journal of Emergency Medicine includes an article discussing research that was conducted among emergency medical technicians and paramedics. The article notes that there is considerable confusion regarding end-of-life wishes. Many of the emergency responders interpreted the mere existence of a “living will” as meaning they should not attempt resuscitation. More often, patients who have clearly specified that resuscitation not be attempted are, instead, resuscitated or hooked up to respirators and feeding tubes. The article prompted an op-ed in the New York Times. Washington Post readers discussed the New York Times article in an on-line blog.
  2. The emergence of capacity assessment in older adults as a distinct field of study was discussed in an article in the February issue of Focus. The authors noted the need for studies of a wide range of capacity constructs, particularly focusing on clinical markers of diminished capacity, methods to improve clinical assessment, and the intersections between law and clinical practice.
  3. JAMA, the Journal of the American Medical Association, published an informative article for primary care physicians regarding the issues that surround referring a patient to palliative care.
  4. The journal Pediatrics published an article regarding conversations between adolescents suffering from chronic illnesses and their families about end-of-life wishes. The researchers found that such conversations did not discourage hope for recovery or cause additional emotional or mental harm to the patients.
  5. The New York Times published an article in February, written by physician Pauline W. Chen on “moral distress” that afflicts both doctors and nurses. “Moral distress” can be caused by the competing demands of administrators, insurance companies, lawyers, and patients’ families. One of the persistent issues causing such distress is a family’s insistence that aggressive treatment be initiated for a patient in the last days of life.

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