Regulations governing the prescription of certain medications are expected to change next month following criticism from physicians and patients of House Bill 1, a recently enacted law that targets so-called “pill mills” and doctors who over-prescribe addictive painkillers and other drugs.
Officials, including Gov. Steve Beshear, have lauded HB1 for shuttering 10 pain management clinics, reducing the number of prescriptions of commonly abused medications and increasing the number of investigations into suspicious prescribing patterns since it went into effect July 20.
However, doctors and patients alike have voiced concerns to legislators over regulations set by the Kentucky Board of Medical Licensure, such as drug screens prior to and during certain prescriptions for long-term treatment that generally cost about $100 each, as well as the potential criminal and civil implications of failing to follow the law.
“The legal ramifications of punitive tone intertwined with the complexity of these laws renders a physician reluctant to ever prescribe controlled meds for pain,” Dr. Bill Bryant, patient safety officer with Owensboro Medical Health System, told the Interim Joint Committee on Health and Welfare Wednesday.
“I feel I need a lawyer with me every moment of the day to confirm that I am fulfilling every requirement of this law.”
Dr. Preston Nunnelley, chairman of KBML, acknowledged the concerns of the medical community during meetings of the health and welfare and HB1 Implementation and Oversight committees Wednesday.
The law has had a “tremendous impact” thus far, he said, but it remains a work in progress.
“Just the shutdown of the pill mills has taken thousands of pills off the market,” Nunnelley said. “It’s a good bill; we just need to make sure that we get the regulations right, and we’re going to do that. It’s just going to take a little time.”
Nunnelley said KBML has been working on proposed changes to its emergency regulations after numerous meetings with physicians and others in the health field. Though specifics won’t be available until next month, he said many of the changes won’t be major.
For example, doctors will be given more discretion over drug screens during the course of certain long-term controlled substance prescriptions, though initial tests will likely remain, he said. Regulations will also be different for mental health patients and in pediatrics, he said.
Some attention-deficit disorder medications require drug screens over long-term care under current requirements.
“Does a 6-year-old who’s been on medication for ADD for some period of time, do you need to go through and do a urine screen on him? Well, no,” Nunnelley said after the HB1 oversight committee meeting. “Do you need to run a KASPER (Kentucky All Schedule Prescription Electronic Reporting) on him? Generally, no.”
Certain drugs, such as the sleep aid Ambien, could also be removed from the list of medications included in KBML’s regulations, he said.
Mandatory participation in and use of the KASPER system when prescribing medications in most cases will likely remain, Nunnelley said. Doctors will be able to designate a staff member to query KASPER and document the findings, he added.
KBML has given doctors a grace period to further understand the new emergency regulations, Nunnelley said. He and others say while some changes are needed, misinterpretations of HB1 have created confusion on the new law.
“I do want to say this: I think there is a whole lot of misinformation about what can or cannot be done,” said Senate Majority Floor Leader Robert Stivers, R-Manchester, during the HB1 oversight committee meeting. “I do appreciate (KBML’s) hard work on trying to rectify those bits and pieces of information that are wrong or correcting them.”
However, others say while HB1 helps the state deal with pill mills and prescription drug abuse, certain pieces are burdensome and potentially costly.
Bill Doll, a lobbyist for the Kentucky Medical Association, said doctors are leery of potential changes to KBML’s emergency regulations, especially since those currently in place aren’t completely clear.
The medical community has also been “vilified” throughout the process of passing and implementing HB1, he said.
“We’ve got a real, serious substance abuse problem in this state,” Doll said. “There’s no denying that. The goal of addressing it is certainly laudable. The process that we’ve gone through thus far to take on that task, with the exception of running off the pill mills and dealing with KASPER, has been very, very unfortunate.”
Some legislators on the health and welfare committee called for HB1 to be completely overhauled or repealed entirely in the upcoming legislative session.
“I just want to emphasize that today we’ve heard from a practicing physician, and I think you can see by this bill and the supporting regs how much we are encumbering our physicians and how we’re deterring their ability to practice good medicine,” said Sen. Joe Bowen, R-Owensboro, adding that provisions of the law make Kentucky unattractive for future physicians.
Sen. Julie Denton, a Louisville Republican and co-chair of the joint committee, said HB1 and the corresponding regulations has “gone far, far beyond” targeting commonly abused opioid drugs. She said some doctors in Louisville have moved their practices across the river to Indiana since the law went into effect.
“I really, really want to recommend that unless the goal is repeal of the whole bill, that you use (a simple) method and you target in on the opioids and you leave the rest the heck out of it,” Denton said during the meeting.