Dr. Ralph Alvarado’s medical practice has prescribed controlled substances to 1,800 patients in central Kentucky over the past three years. But he and other doctors in the practice decided to put down their pens four weeks ago.
That’s because, he says, the standards imposed under a new Kentucky law designed to crack down on prescription drug abuse are so strict and complex that he would go bankrupt in a month — or worse — if he were to continue prescribing controlled substances.
“I’m not going to be threatened with jail time or criminal charges and lose my career,” the Winchester doctor said, instead referring patients to specialists to get pain-pill prescriptions.
Proponents argue that the law, which took effect July 20, is intended only to root out pill mills and crooked doctors and should not hamper legitimate physicians or prevent patients from receiving needed drugs.
But some doctors contend the legislation is excessive, confusing and time-consuming, and across Kentucky, many have been seeking advice from attorneys about following the law, and warning patients about potential cutbacks to common drugs for pain, anxiety and other conditions.
Some doctors are even talking about leaving the state or, like Alvarado, tearing up their prescription pads for controlled substances, according to industry groups.
Others say they have sent patients home in tears or in pain because they lack the time and resources to comply with the law.
“Patients who have never been a problem are bound up in all of this,” said Greg Hood, Kentucky chapter governor of the American College of Physicians. “There are so many unintended consequences.”
The College of Physicians and the Kentucky Medical Association are trying to determine how many clinics are declining to write prescriptions, but neither is advocating that approach.
According to state offices of the Drug Enforcement Administration, only three in-state doctors have voluntarily surrendered their DEA registration — required for prescribing controlled substances — in recent weeks for reasons related to the new law.
Still, the Greater Louisville Medical Society held a meeting with about 200 members recently in which attorneys tried to explain the law’s details. Doctors cited nearly two dozen areas of concern stemming from what they call vague and ambiguous legal language, the group reported.
Law spurred new rules for doctors
The new prescribing standards are the result of House Bill 1, passed by the 2012 General Assembly in hopes of combating an epidemic of drug abuse that kills nearly 1,000 Kentuckians each year . e
Th measure increases regulation of pain management clinics and requires doctors to use the state’s prescription drug tracking system known as Kentucky All Schedule Prescription Electronic Reporting, or KASPER.
It also called on state licensing boards that oversee the medical industry to write regulations for prescribing controlled substances.
The boards submitted emergency regulations — which Gov. Steve Beshear has signed — as well as proposed long-term regulations that require a public hearing and must pass through two committees before becoming final.
Among the emergency regulations from the Kentucky Board of Medical Licensure are 25 pages of standards for prescribing and dispensing controlled substances, including a requirement to run KASPER reports on a patient’s drug history before prescribing new medicine.
In instances of chronic treatment, the regulations call on doctors to perform detailed evaluations that include drug screenings, inquiries into the patient’s risk for substance abuse and development of long-term drug management plans. Doctors must also obtain a formal diagnosis of what is causing the patient’s condition, even if that requires help from other physicians or consultants.
State officials are giving doctors until Oct. 1 to come into compliance but said doctors have been running 20,000 KASPER reports each day since the law took effect. That compares with 3,000 a day a year ago.
Officials say 93 percent of reports are processed in fewer than five seconds.
Even so, medical organizations and some physicians say the rules are already changing treatment protocol, particularly for patients with chronic conditions.
Kathy Nieder, a family practice doctor with Baptist Medical Associates in Louisville, said she has an 88-year-old patient with spine problems who now must submit to urine screening and regular office visits to receive hydrocodone for back pain.
In another case, she was unable to prescribe five Xanax pills — an anti-anxiety medication — to a patient who called in and requested them for an annual plane flight. The regulations require a physical exam, but the patient wasn’t able to get to the office before the trip. Nieder said she has treated both patients for 10 years, and neither shows signs of risk for drug abuse or diversion.
Hood, from the College of Physicians, reported that an outof state patient tearfully left his office without a prescription for the sleep aid Ambien because she couldn’t get her prescription filled in Kentucky.
Alvarado, who practices internal medicine and pediatrics, said he has notified the local school board that 187 of his patients could be returning this academic year without drugs for attention deficit hyperactivity disorder.
Although there are some exceptions for prescribing the drugs to ADHD kids initially, doctors still must follow through on several steps under the law to treat the chronic condition.
“These laws treat medicine like it is black and white, and in reality there are so many shades of gray,” he said. “There are so many nuances and situations that the law is incredibly vague on.”
Another doctor, James Murphy, owner of the Murphy Pain Center in Louisville, said he may try to move some patients to his Indiana clinic, but he believes most pain specialists will figure out ways to continue prescribing.
The regulations provide some exceptions for certain patients, such as end-of-life care, children with ADHD and patients in the emergency room. But critics argue that those exemptions are illdefi ned and confounding.
Doctors question regulations
According to the College of Physicians, attorneys and doctors have cited confusion or concern over aspects of the regulations, including nighttime admissions to hospitals, Medicare payments, conflicts with informed consent and KASPER access. For instance, if no doctor is at a hospital when a patient is admitted and needs morphine, there is a question as to whether the patient can receive the drug, physicians say.
They also say the rules aren’t clear on how to respond in situations where multiple doctors treat a single patient, or when a patient in serious pain has a questionable drug history.
Some doctors also worry that clerical errors and mistakes in documenting prescriptions could lead to criminal penalties and say they often don’t have time to perform all the work mandated under the standards.
Supporters say the scope of Kentucky’s drug problem makes the changes necessary.
Beshear released a statement this month that the state must focus on the big picture. He added that most doctors are providing thoughtful care and following the law.
“So when a fraction of practitioners complain that the new regulations to drive out drug abusers are ‘too burdensome’ on the medical community, I am confounded not only by their immediate rejection of a simple, commonsense step to better track these drugs, but also by their utter lack of a reasonable alternative to curb prescription diversion and abuse,” he said.
Others argue that most of the concerns will decrease as the rules become more familiar.
Van Ingram, executive director of the Office of Drug Control Policy, said he has spoken with medical practitioners from across the state who use KASPER for every patient. “If they can do it, I don’t understand why others cannot,” he said.
Lloyd Vest, general counsel for the Kentucky Board of Medical Licensure, said standards when prescribing drugs have been in place for decades — even though not in regulation form — and much of the anxiety is due to misinformation and potential penalties.
Doctors can face misdemeanor charges under the new law, while Vest said violations of the board’s standards can only lead to an action against a doctor’s license.
Board President Preston Nunnelley released a letter early this month saying that the board understands the concerns and is working to calm physicians’ fears.
“It is important to point out … that nothing in HB 1 … precludes any licensed physician from prescribing any controlled substance to a patient that the physician believes is medically necessary or appropriate,” he wrote.
Legislators hear complaints
The governor’s emergency regulations expire after six months, and the proposed permanent regulations are subject to a public hearing and comment period in September.
An oversight task force on the bill met Wednesday to hear opinions from the medical industry, and doctors hope to prompt revisions to both the regulations and the statute under HB 1.
Kentucky Medical Association President Shawn Jones spoke before the committee and presented a set of proposed solutions to the industry’s concerns.
Because of time constraints, not all the doctors who went to Frankfort to voice concerns were able to speak, so another hearing will be scheduled.
Rep. John Tilley, D-Hopkinsville, co-chair of the committee, said he believes some of the concerns are based in miscommunication over the intent of the law. But he said he expects the legislature will need to make revisions next year.
Other lawmakers, who also have reported hearing complaints, have said they are open to changes. And some — including House Speaker Greg Stumbo, DPrestonsburg, the bill’s sponsor — have expressed concern that the regulations exceed the bill’s original intent.
That’s a point that critics may seize on since the regulatory process does not allow regulations to “fix” a statute.
Rep. Tom Burch, DLouisville, chairman of the House Health and Welfare Committee, said lawmakers need to wait a few months to find the bill’s bugs.
But the measure could become a hot political issue if patients can’t get their drugs, said Sen. Julie Denton, R-Louisville, chairwoman of the Senate Health and Welfare Committee. Denton voted against the bill.
For now, some doctors are encouraging patients to call lawmakers with complaints.
Source: The Courier-Journal, Louisville