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Article | 102 KY. L. J. ONLINE 2 | Oct. 27, 2013
Peter P. CohronFN1
Prescription pain pill abuse and misuse is a substantial problem in Kentucky.FN2 In the Commonwealth, over one thousand deaths per year are attributable to drug overdoses.FN3 This figure is the sixth highest in the country and represents more deaths than those caused by automobile accidents. Additionally, Kentucky ranks as the fourth most medicated state in the United States, though it ranks twenty-sixth for population.FN4 Governor Steve Beshear has acknowledged the problem, “We have an epidemic in Kentucky that we cannot ignore….We are losing lives. We are losing families, and we’ve got to aggressively attack that problem.”FN5 Much of the state’s drug problem was the result of pain pill mills, alleged pain management clinics where patients were prescribed controlled substance (narcotic) prescription medication following either a cursory examination or no examination by the physician on site. The phrase “pill mill” is nomenclature used by local and state police investigators most often to describe a physician or clinic, and occasionally a pharmacy, that is prescribing or dispensing controlled substance narcotics inappropriately or for non-medical reasons.FN6 However, the Governor’s call to arms was not solely aimed at these so-called clinics. Governor Beshear sought comprehensive legislation that would address all of the concerns regarding the prescribing and use of controlled substances including properly organizing and running pain management facilities, properly training physicians prescribing these dangerous drugs, balancing the interests to provide a watchful but not overly intrusive eye on the patient consumer of these drugs, and providing authority for the proper administrative boards and the necessary police powers to act in cases of prescribing regulations. In a demonstration of the importance of this issue, Governor Beshear called a special session of the Kentucky Legislature to provide for a solution.
House Bill 1 (KRS 218A.172)
The Legislature responded with House Bill 1 (HB1).FN7 House Bill 1 recognized the necessity of having properly managed and maintained pain management clinics. Therefore rather than banning such facilities outright, HB1 sought to achieve quality care by instituting standards for opening and running such a clinic. The Legislature attempted to balance the need for regulation due to the prevalence of the misuse of these medications leading to dependence and violence with the privacy concerns of the prescription pill user. HB1 attempted to strike this balance by limiting scope of the bill to Schedule IIFN8 controlled substances and other controlled substances containing hydrocodone.FN9 However, in promulgating administrative regulations pursuant to this bill, under KRS 218A.172, which is also limited to these drugs, the Kentucky Board of Medical Licensure relied on KRS 218A.205, a statue regarding reports of improper, inappropriate, or illegal prescribing or dispensing of controlled substances. As a result, the regulation promulgatedFN10 was not limited to Schedule II controlled substances and controlled substances containing hydrocodone, but included all controlled substances except Schedule V.FN11 A primary issue addressed by the regulation is the physician’s decision to prescribe a controlled substance to a patient for pain. Under this regulation, in order to prescribe controlled substances, a physician must meet certain professional standards. Prior to prescribing, the physician must obtain an “appropriate medical history relevant to the medical complaint,”FN12 obtain a KASPER report on the patent,FN13 make a “deliberate decision” to prescribe a controlled substance after weighing the benefits of the drug against the risks,FN14 and counsel the patient regarding how to take the drug and when to stop the treatment.FN15 As many of the patients at pain management facilities, legitimate and otherwise, are chronic controlled substance users, the regulation sets forth additional standards for prescribing for this patient population. These standards apply to all patients over the age of sixteen who are being treated with controlled substances for longer than 3 months.FN16 Before prescribing and regularly afterwards, the prescribing physician must obtain a history of the illness or condition, a past medical history, including any relevant family history and any history of past substance abuse, and a psychosocial history.FN17 To ensure a first time face-to-face meeting between patient and physician, there must be an appropriate physical examination that supports the patient’s claim of chronic pain,FN18 and a baseline assessment that establishes starting measurements by which to gauge future progress or decline in the condition.FN19 If this screening indicates any propensity or indication of substance abuse, the physician is required to refer the patient to an appropriate treatment center or provider.FN20 If the patient shows an indication or risk of diverting the prescribed drugs, the physician shall employ the use of a prescribing agreement, or pain management contract.FN21 Where there is any indication of either behavior, prior to the prescribing of controlled substances, the physician must perform a baseline drug screen.FN22 Once a patient begins long term continuing treatment for pain, the physician must meet additional requirements. The patient must be re-evaluated on a monthly basis by the physician and then at appropriate intervals.FN23 If improvement is expected and does not occur, the physician must refer the patient to an appropriate physician for consultation.FN24 The patient is also required to have an annual physical examination.FN25 The physician also must obtain follow-up KASPER reports at least every 3 months.FN26 Frequently when pharmacies deny filling pain mill prescriptions these patients present in hospitals’ emergency departments complaining of pain. In order to deter this behavior, the regulation placed limits on emergency doctors’ ability to prescribe these medications. Under the new law, emergency doctors were prohibited from administering IV controlled substances,FN27 replacing a lost or stolen prescription for a controlled substance,FN28 replacing a methadone Subutex or Suboxone dose for a patient in a drug treatment program,FN29 prescribing controlled release products such as Oxycontin,FN30 or prescribing more than a 7 day supply of a controlled substance.FN31 For the treatment of other conditions (excluding pain), the same standards apply. In the case where the patient has a psychiatric complaint, an appropriate psychiatric examination must be performed prior to prescribing controlled substances.FN32 If the on-site physician is, or feels, unqualified to perform a psychiatric examination, the patient must be referred to an appropriate physician or facility.FN33 In seeking to establish its authority and determine its scope, HB1 defined a pain management facility as a facility where the majority of patients are treated for pain with controlled substances, and 1) the primary practice component is pain treatment, or 2) the clinic advertises any type of pain management services.FN34 HB1 regulated the ownership of such pain management facilities by requiring that only a fully licensed physician may own or have an investment interest in a pain clinic, though clinics in existence before July 20, 2012 were grandfathered in.FN35 Additionally, one physician owner must be on-site at least 50% of the time the facility is open and he must be engaged in the practice of medicine at the site.FN36 This physician must hold a current American Board of Medical Specialties (ABMS) subspecialty certification, American Osteopathic Association Bureau of Osteopathic Specialties (AOABOS) certification in pain management, or a current ABMS or AOABOS certification in hospice or palliative care, or hold board certification by the American Board of Pain Medicine or American Board of Interventional Pain Physicians, or have done a residency or fellowship in pain management.FN37 In another move to legitimize treatment for those truly in pain, HB1 addressed the issue of payment. Prior to enactment of HB1, unscrupulous physicians were preying on those in chronic pain by accepting cash as the only form of payment, thus obfuscating the facility’s records. HB1 required that pain management facilities accept private health insurance and payment only from the patient, responsible caregiver, and/or insurance.FN38 After HB1 was implemented with relevant administrative regulations physicians, while agreeing that prescription drug abuse was “an out of control issue in Kentucky” and a very serious problem, criticized HB1.FN39 The critics were not limited to physicians, as hospitals and patients also claimed that “HB 1 in its present form restricts too many drugs in too many clinical settings, needlessly complicating medical care.”FN40 Because of HB1, many patients incurred costs for drug testing that their insurance would not cover.FN41 For these reasons, the bill seemed to, in effect, punish the patient in more ways than it was aiding in the fight against pill mills.
House Bill 217
In response to these criticisms, Governor Beshear signed into law House Bill 217 (HB217) on March 5, 2013. This bill was designed to address and eliminate the problems created by HB1.FN42 The purpose of this new bill was to remove onerous requirements from both physician and patient, while continuing to address the widespread drug abuse problem in Kentucky and seeking to provide adequate medical care and treatment for those patients truly in pain, acute or chronic. The all-encompassing sweep of HB1 had previously required that every entity in the Commonwealth be covered by HB1. To remedy this scope issue, HB217 exempted hospitals, long term care facilities, hospices, and end-of-life care centers that prescribe controlled substances and research facilities from the reporting and prescribing requirements.FN43 These facilities and prescribers were determined to only contribute slightly to pain pill abuse and therefore their inclusion under HB1 was deemed unduly burdensome. HB217 also addressed HB1’s requirement that each facility whose primary function or business was pain management have some kind of certification in pain control or management. Critics argued that this requirement, though reasonable, was problematic as it forced the closure of businesses until their physicians could comply with the certification. HB217 amended this requirement to allow facilities without such certification to stay open if they were “making reasonable progress toward completing or holding, a certification.”FN44 Next, the bill revised the KASPER requirement of HB1. Under the previous bill, KASPER checks were not limited to a specific time period prior to treatment. Therefore, KASPER reports had to be sought as far back as obtainable. Critics argued that this was an unnecessary administrative burden and that it created an impediment to establishing effective treatment plans.FN45 Additionally, there was concern that patients who had successfully completed a drug addiction treatment program would be characterized incorrectly by reference to their past records. HB217 addresses these concerns by limiting the scope of the KASPER check to twelve months previous to the day of the examination or prescription for controlled substances.FN46 However, HB217 requires that if treatment extends beyond ninety days, then the KASPER query be repeated every three months.FN47 The major criticism from physicians of HB1 was that requiring a physical examination and a medical history review prior to prescribing a controlled substance was an undue burden, repetitive, and time-consuming. To attempt to balance all of the interests involved, HB217 removed the word “complete” from the legislation so that physicians, in the exercise of professional judgment, could limit the scope of the examination to those facets important to the medical complaint. Second, the requirement for an examination was changed and required now only when “appropriate to the patient’s medical complaint.”FN48 This requirement relieves the physician from completing a physical examination, especially in circumstances where the physician is already well acquainted with the patient’s condition, and additionally relieves the patient of the costs of unnecessary testing. Even with the changes implemented by HB217, critics continue to have concerns. Critics worry that physicians, faced with significant oversight, may treat pain too cautiously or not at all. The fear continues to be that legitimate patients in extreme pain will still have substantial obstacles to obtaining the medication that they need.FN49
The impact of the legislation was largely seen prior to the enactment of HB217. When HB1 had been in force for less than three months, ten pain management pill mills in the Commonwealth of Kentucky had closed. Prescriptions for the pill mill “cocktail”FN50 have dropped dramatically. The number of KASPER subscribers had tripled, and KASPER is handling, on average, more than 18,000 requests a day (of which over 90% are responded to in less than fifteen minutes).FN51 With the passage of HB1 and HB217, the Kentucky Legislature has taken a strong and serious step towards ending the epidemic of drug abuse widespread in the Commonwealth. The willingness of the Legislature to flexibly and quickly address issues with the initial bill emphasizes its concern for this issue. However, HB1 and HB217 merely address only one of the root causes of the drug problem in Kentucky. Therefore neither the citizenry nor the Legislature should celebrate the accomplishments made by these bills, but instead, they should swiftly seek out other effective ways to help significantly address and substantially eliminate the drug problem in Kentucky.
FN1. Peter P. Cohron is a graduate of the University of Kentucky colleges of Pharmacy and Law. He practices in both professions, as a pharmacist for a major retail chain and as an attorney in private practice mainly dealing with pharmacy related issues.
FN2. The definition of drug or substance abuse is the use of a drug for a result unintended by the prescriber, e.g., getting high. Misuse is defined as the use of a drug for an intended result but taken in a manner or dose not prescribed. Abuse
, The Free Dictionary.com, http://medical-dictionary.thefreedictionary.com/abuse
(last visited September 15, 2013).
FN7. H.R. 1A, 2012 Gen. Assemb., 1st Spec. Sess. § 1(1)(A) (Ky. 2012) (hereinafter HB1).
FN8. Schedule II controlled substances are defined in Ky. Rev. Stat. §§ 218A.060–070 (LexisNexis 2013).
FN9. Hydrocodone is a Schedule III controlled substance, defined in Ky. Rev. Stat. §§ 218A.080–090 (LexisNexis 2013) and referenced as “dihydrocodeinone,” a synonym for hydrocodone that is marketed under such brand names as Lortab, Vicodin, and Norco.
FN10. Professional Standards for Prescribing and Dispensing Controlled Substances, 201 Ky. Admin. Reg. 9:260 (September 2013).
FN11. Id. at § 1(2)(g).
FN12. Id. at § 3(1).
FN13. Id. at § 3(2). KASPER, Kentucky All Security Prescription Electronic Record, is a monitoring system for all controlled substance prescriptions dispensed in the Commonwealth of Kentucky.
FN14. Id. at § 3(3).
FN15. Id. at §§ 3–5.
FN16. Id. at § 4(1).
FN17. Id. at § 4(2)(a).
FN18. Id. at § 4(2)(b).
FN19. Id. at § 4(2)(c).
FN20. Id. at § 4(2)(h)(2).
FN21. Id. at (4)(2)(h)(3). These agreements or contracts may limit who may prescribe controlled substances to the patient, state the pharmacy where the patient must fill his prescriptions, and/or require random pill counts and drug tests.
FN22. Id. at § (4)(2)(h)(4).
FN23. Id. at § (5)(2)(a)(1).
FN24. Id. at § (5)(2)(e).
FN25. Id. at § (5)(2)(h).
FN26. Id. at § (5)(2)(i).
FN27. Id. at § (6)(1).
FN28. Id. at § (6)(2).
FN29. Id. at § (6)(3).
FN30. Id. at § (6)(4).
FN31. Id. at § 7(1)(a).
FN32. Id. at § (6)(6).
FN33. Id. at § (7)(1)(a)(1)-(2).
FN34. H.R. 1A, 2012 Gen. Assemb., 1st Spec. Sess. § 1(1)(A) (Ky. 2012) (hereinafter HB1).
FN35. Id. at § 1(2).
FN36. Id. at § 1(3).
FN38. Id. at § 1(4).
FN43. H.R. 217, 2013 Gen. Assemb., Reg. Sess. § 1(4) (Ky. 2013) (hereinafter HB 217).
FN44. Id. at § 2(3)(f).
FN45. Kentucky “Pill Mill Bill” Amended by House Bill 217, supra note 41.
FN46. HB217 at § 1(1)(b).
FN47. Id. at § 1(2)(b)(1).
FN48. Id. at § 1(1)(a).
FN50. Usually a pain pill mill cocktail includes prescriptions for carisoprodol, alprazolam, and either hydrocodone or oxycodone-containing painkillers.