By Ronnie Ellis
CNHI News Service
Revised regulations implementing a wide-ranging new law to rein in prescription drug abuse seem to have quelled the most vociferous objections to the law.
House Bill 1, which attempts to combat prescription painkiller abuse and “pill mills,” went into effect last summer but initial emergency regulations governing prescribing procedures and tracking of use and prescription of the drugs caused widespread alarm among physicians, hospitals and patients with legitimate need for the drugs.
But amendments to those regulations presented Wednesday to a legislative oversight committee appear to have alleviated most, if not all, of the concerns.
“I think we’re fairly comfortable now, but that’s not to say there won’t be additional concerns and we’re going to continue to work until we get it right,” said Rep. John Tilley, D-Hopkinsville, who sponsored the bill and co-chairs the oversight committee. “But I think this is a good step in the right direction.”
Physicians and patient advocates had complained that the initial regulations exceeded the intent of the bill by lumping many non-pain killer medications under the regulations.
They feared a requirement to run reports for each patient at the time of prescribing with the state’s electronic prescription and drug tracking system, KASPER, would interfere with prompt care for patients with legitimate pain issues such as cancer or trauma injuries.
There was also concern about requirements for physical exams and urine tests which would be expensive and unnecessary for long-time patients, some of whom are elderly and suffer from chronic conditions. Others complained the regulations covered drugs for children under 16 who suffer from conditions like attention deficit-hyper activity disorder or ADHD.
But Dr. Preston Nunnelley, chairman of the Kentucky Medical Board of Licensure, said revised regulations now exempt Schedule V drugs which are used often by elderly patients and aren’t prescribed for pain will no longer require such tests nor will drugs for children under the age of 16.
“We listened to the various groups and we tried to address their issues,” said KMBL General Counsel Lloyd Vest.
Nunnelley said the revised regulations focus on prescribing for long-term pain over 90 days and excludes patients under 16. For any controlled substance for treatment of conditions other than pain, the regulations require only one, initial KASPER report.
The board also made some changes to regulations requiring pain clinics to be owned by physicians, though physician ownership is still required. It lowered fees for registering clinics and grandfathers in those clinics already operating in compliance with the law when HB 1 was passed.
Nunnelley said the board is working with the University of Kentucky to establish training for pain treating physicians and will make training available online for those unable to attend scheduled training sessions.
Nunnelley said if physicians for some reason cannot access KASPER they may still prescribe the needed medication and if they document the time and problem, the KBML will not consider the failure to access KASPER as a violation.
The committee seemed pleased with the changes, posing few questions and those which were asked were mostly for clarification.
“We want to stop prescription drug abuse,” Tilley told Nunnelley when commending the KMBL for the changes. “But we don’t want to stop legitimate pain management.”
The Cabinet for Health and Family Services which operates KASPER also revised a number of its original regulations. One change will now allow hospitals and other licensed health facilities to dispense controlled substances without reporting to KASPER before July 1 of next year.
The new regulations will also allow physicians to authorize hospitals to designate delegates to run KASPER reports. The regulations establish standards for those prescribing pain medications in clinics and how those clinics are to be regulated.
Mary Begley, inspector general for the cabinet, told the committee there were 44 pain clinics in Kentucky when HB 1 was passed. Of those, 18 have closed.
Medical prescribers with KASPER registered accounts have increased from about 7,500 in Dec. 2011 to 23,000 at the end of last month and daily reports have increased from 3,300 before HB 1 to 17,665 last month.
She said KASPER is up and operating 97 percent of the time and the number of complaints about slow responses have fallen to only three in November. The average time for a KASPER report to be returned has decreased to 15 seconds to one minute.
Tilley said after the meeting he thinks there remain some unintended consequences of the bill which may require legislative action. He expects if any such legislation is filed he or another member of the oversight committee will sponsor bill.
“I still stand by the proposition that the vast majority of concerns can be handled through the regulatory process and that’s what you saw today: a great simplification of the process from where we were,” Tilley said.
Ronnie Ellis writes for CNHI News Service and is based in Frankfort. Reach him at email@example.com. Follow CNHI News Service stories on Twitter at www.twitter.com/cnhifrankfort.