Just days after a landmark prescription drug abuse law took effect, Governor Steve Beshear joined lawmakers and medical providers to report the law has already effected changes in the medical field and positioned Kentucky as a national leader in battling prescription abuse.
House Bill 1 (HB1), sponsored by House Speaker Greg Stumbo, passed in a special legislative session this spring. The bill included multiple elements to prevent the abuse and diversion of prescription drugs and to enhance law enforcement's tools to investigate illegal prescribing practices.
"The enforcement of this bill began just a couple of days ago, and yet we already know that four "pain management clinics' in Kentucky have waved the white flag and notified us they will shut their doors," said Gov. Beshear. "We know that more than 9,000 medical providers have signed up for electronic prescription monitoring just since this law passed in April -- more than doubling the number registered. The word is out. Kentucky is deadly serious about stopping this scourge of prescription drug abuse, and now we have some of the strongest tools in the country to make that happen."
Gov. Beshear was joined by Attorney General Jack Conway as well as representatives from medical licensure boards, advocacy groups and law enforcement organizations, for today's announcement.
HB1 expands the Kentucky All Schedule Prescription Electronic Reporting (KASPER) system, the state's prescription monitoring system, by requiring all prescription providers of controlled substances to register. It requires pain management clinics to be owned by a licensed medical practitioner, and requires professional licensure boards to investigate prescribing complaints immediately. The legislation allows for better coordination between health regulators and law enforcement to address problems of abuse. Finally, elements of HB1 will help prevent Kentucky from becoming a source state for prescription pills.
According to Kentucky's Drug Control Policy Office, nearly 1,000 Kentuckians die every year from drug overdoses -- an annual fatality rate that exceeds deaths from car accidents. More than 5,000 overdose patients are admitted to hospitals annually.
"Let's be very clear -- if you need a prescription for a controlled substance for a legitimate medical condition, you have nothing to fear. You'll get your medicine. For doctors who worry their ability to prescribe will be compromised, you have nothing to fear. The law is built to protect valid prescribing," said Gov. Beshear. "But if you're doctor-shopping, buying extra pills for recreational use, or prescribing pills for cash, you'd better change your vocation or change your location, because we're coming after you."
"Prescription drug abuse is killing Kentuckians. Three people will die today from prescription drug overdoses. I believe the provisions in House Bill 1 will save the lives of our friends, our neighbors and our family members," said Attorney General Jack Conway. "The provisions in this law will help shut down rogue clinics and providers who are poisoning people. I appreciate those in the medical community who have joined with us as responsible providers to be a part of the solution instead of part of the problem."
"House Bill 1 and the emergency regulations will help stop tragic loss of life to drug abuse. We are working closely with medical professionals to ensure that legitimate pain management cases are not adversely affected," said Speaker Stumbo. "The joint Implementation and Oversight Committee will be alert to any needed corrections, and we will make sure that all concerns are addressed."
Lawmakers praised the cooperation of the Cabinets, agencies, and boards who worked together to create new regulations, educate patients and medical providers, and build the necessary computer infrastructure to support the implementation of the law.
HB1 Impact -- KASPER enhancements
Effective July 20, all medical practitioners who prescribe controlled substances must register to use KASPER and run a KASPER report before prescribing a patient a controlled substance such as Oxycontin or Xanax.
When the law passed in April, KASPER had 7,911 registered accounts. Since then, another 9,137 providers have signed up for the program, a 115 percent increase.
According to the Cabinet for Health and Family Services (CHFS), which oversees KASPER, 90 percent of all KASPER reports are completed within 15 to 30 seconds. The reports show medical providers what other controlled substances have been prescribed to a patient and in what amount.
"Some providers worried that running a KASPER report would be cumbersome or time consuming, but 9 times out of 10, it will take as much time as measuring a patient's blood pressure or recording their insurance information," said Mary Begley, CHFS Inspector General. "It's a very short investment of time that will become as routine as taking a patient's temperature. A report can provide crucial information that not only may flag a problem user, but may also warn a provider of otherwise unforeseen complications from drug interactions."
KASPER's cache of prescription information will grow more robust as more users add records. Supporters say patient care will become more precise as medical providers review patient prescription history and know more about existing prescriptions.
A 2010 CHFS poll of KASPER users noted that 94 percent of medical providers said that the program is an effective tool in tracking an individual's prescription history, and nearly 94 percent reported satisfaction with the tool. Nearly 9 in 10 KASPER users reported denying a prescription for a controlled substance to a patient based on information provided by a KASPER report.
To accommodate the steep increase in KASPER use, CHFS has hired additional staff, implemented system upgrades and expanded capacity.
Existing regulations provide that all dispensers (usually pharmacists) report to KASPER when any Schedule II through Schedule V controlled substances are dispensed. For the first time, new regulations provide that all prescribers must request a KASPER report before Schedule II, III and some IVs are prescribed.
HB1 Impact: Shared Investigative Information
HB1 requires that when a complaint about prescription abuse is lodged with any of several investigative agencies -- the Attorney General, Kentucky State Police (KSP), CHFS, or any of the professional licensure boards -- that complaint must be shared with the remaining agencies.
Previously, if KSP was investigating a possible pill mill, the agencies that licensed that clinic were not required to be notified, nor would they be compelled to contribute information to the case.
The Attorney General, KSP, CHFS and the six professional licensure boards have signed a memorandum of understanding to notify the other agencies of prescription complaints within three days of receipt. This will allow the investigators to share information quickly.
The six professional boards -- Medical Licensure, Nursing, Dentistry, Pharmacy, Podiatry and Optometry -- are required to share reports with the Attorney General, KSP and CHFS but not required to share among each other. This alleviates concerns that the professional organizations would be forced to report information to other boards that have no jurisdiction over the complaint.
HB1 Impact: Regulations Squeeze Offenders, Offer Grace Period for Providers
Regulations for the implementation of HB1 were filed on July 20, the effective date of HB1. These regulations, which interpret how the law is carried out by each agency, board, or office, uphold the intent of HB1 -- to reduce the abuse and diversion of prescription drugs.
New regulations mandate that all pain management clinics must be owned by a licensed medical provider or employ a medical director in good standing with one of the professional licensure boards. Clinics will have some time to meet those requirements, but CHFS administrators say that already, four of the state's pain clinics not owned by physicians have reported that they will close their doors. Another 9 have not yet contacted CHFS regarding licensing, and will be investigated to determine if they are operating illegally.
"Not all pain management clinics are abusing their prescribing authority -- many of them are meeting legitimate patient needs," said CHFS Secretary Audrey Tayse Haynes. "However, these regulations are designed to make it very, very difficult to stay in business if your clinic is a pill mill, prescribing high volumes of powerful drugs to people who are addicted."
Each of the professional license boards has also created an educational period for practitioners through October 1st. Much like other laws such as the seat belt law, providers will have a few months to get accustomed to the new practices before any disciplinary action will take place.
"We don't want the medical community to be afraid of immediate repercussions if they make an error this early in the process," said Preston Nunnelley, chair of the Board of Medical Licensure. "We'll have a few months to learn how the new policies will work, and we'll be able to correct and guide providers along the way, instead of punishing people for unintentional errors."