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Well-Intended House Bill 1 Imposes Onerous Requirements on Practitioners. Louisville Bar Association's Bar Briefs, November, 2012

Well-Intended House Bill 1 Imposes Onerous Requirements on Practitioners

This article was originally published in the November 2012 issue of Bar Briefs, the monthly publication of the Louisville Bar Association. It is reprinted here with permission.

Scope of the Problem

According to the Centers for Disease Control (CDC), overdose rates due to prescription drug use have reached epidemic proportions. Since 1990, drug overdose rates have tripled, with three out of four drug overdoses involving prescription pain medicines.

In 2010, an estimated two million people used prescription painkillers for nonmedical reasons for the first time. The CDC reported that more than three out of four prescription drug abusers received drugs that were prescribed to other persons. In that report, 55 percent of those who abused prescription drugs obtained them free from a friend or relative, 11.4 percent purchased them from a friend or relative, and 4.8 percent took them from a friend or relative without asking.

A 2008 report indicated that Kentucky had one of the highest drug overdose death rates in the country, at 17.9 per 100,000 people—ranking sixth highest in the nation.

Armed with this data on the prescription drug abuse epidemic, Kentucky legislators pushed hard to pass House Bill 1—an act that would amend existing sections and add new sections to the Kentucky Controlled Substances Act (KRS 218A). Although stalled at the end of the General Legislative Session in March of 2012, the bill was presented and passed during the special session taking place in April 2012 and went into effect July 20, 2012.

House Bill 1

House Bill 1 (HB 1) is a comprehensive piece of legislation that seeks to address the prescription drug abuse problem by limiting the availability of certain controlled substances through increased regulation and oversight. The law includes requirements aimed at doing just that by defining what a pain management facility is, requiring physician ownership of such facilities opening after July 20, 2012, and issuing oversight requirements in these facilities. Such oversight requirements include: (1) A physician must be on-site practicing medicine for at least 50 percent of the time that the office is seeing patients; and (2) Each facility must have a medical director who is board certified in pain management, interventional pain, or hospice and palliative medicine.

For the first time, the Cabinet for Health and Family Services—responsible for enforcement of Kentucky-All-Schedule-Prescription-Electronic-Monitoring (KASPER) provisions—became authorized to proactively use the data contained in the system to identify inappropriate or illegal prescribing or dispensing practices. Additionally, the law provides for the sharing of electronic dispensing data between the KASPER system and registries in Kentucky’s bordering states, as well as the development of an interstate compact to permit sharing of electronic monitoring data between the states.

One new provision requires medical examiners to test blood for the presence of controlled substances when the cause of death is unclear and to report the findings, along with the name of the practitioner who prescribed the controlled substance, to the Registrar of Vital Statistics and the Kentucky State Police. Other sections established reporting requirements for pharmacists related to controlled substances theft, or instances where shipped controlled substances fail to arrive at their intended destination.

Prior to HB 1, use of the KASPER system was voluntary. HB 1 makes use of the KASPER system required of each dispensing pharmacist and each practitioner who prescribes controlled substances in the Commonwealth and has a Drug Enforcement Administration (DEA) certificate. Further, pharmacists and practitioners must register for and maintain a KASPER account during the period of their licensure.

The law also changed the standards relating to the disclosure of KASPER reports. Previously, KASPER reports could not be shared with patients, nor could they be placed in the patient’s record. Now, KASPER reports may be shared with the patient and be placed in the medical record. Once in the record, the KASPER report is deemed part of the medical record and subject to disclosure on the same terms and conditions as an ordinary medical record. Thus, by increasing usage of the KASPER database and requiring direct oversight of pain management facilities by specialists, a great portion of HB 1 appears to address key components contributing to the prescription drug abuse epidemic in Kentucky.

Statutory Prescribing & Dispensing Standards

The law has caused great concern in the healthcare community, however, due to the two sections of the bill pertaining to the prescribing practices of practitioners throughout the state. Specifically, one section, codified at KRS 218A.172, requires that prior to the initial prescription of any Schedule II controlled substance, or a Schedule III controlled substance containing hydrocodone, a practitioner must (1) perform an H&P; (2) query the KASPER system for patient-specific data; (3) write a treatment plan; and (4) obtain written informed consent for the use of the controlled substances, including the risk of tolerance and dependence.

Of note is that KRS 218A.010(35) defines the term “prescription” broadly as a “written, electronic, or oral order for a drug or medicine . . . signed or given or authorized by a [practitioner] … and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . .” Thus, although purportedly unintentional, the law extends into treatment of patients within hospitals and long-term care facilities where these drugs are ordered and subsequently directly administered to patients.

Several exceptions are included in the statute, such as where an anesthetic or controlled substance is administered immediately prior to or during surgery; where a covered controlled substance is administered to treat an “emergency situation” at the scene of an emergency, in an ambulance, the ER or the ICU; where a controlled substance is prescribed for a hospice patient enrolled in a hospice program or on a hospice inpatient unit; where an optometrist prescribes a Schedule III controlled substance pursuant to KRS 320.240; or where a dentist who has performed oral surgery prescribes a three-day supply of a Schedule III controlled substance.

Adding further confusion is use of the term “administering” in the “emergency situation” and “during surgery” exceptions, because the prescribing practitioner is usually not the person administering the drug and the ability of another licensee to administer a drug is tied to the receipt of an “order” by the prescribing practitioner. Following the initial prescription of one of these controlled substances, practitioners are thereafter required to re-query KASPER at least every three months for patients receiving continued prescriptions for these controlled substances.

Impact of Statutory Prescribing Standards

At first blush, many of these requirements look reasonable. However, on closer examination they are unnecessarily onerous. Of grave concern to hospitals, nursing homes and long-term care facilities is that the new prescribing requirements must occur before a practitioner can provide an initial order for needed pain medicines to patients in these settings—resulting in inadequate or delayed care to patients.

Prior to HB 1, practitioners responsible for admitting patients in the night hours could provide care orders to the nursing staff in these facilities over the telephone. Under HB 1, the practitioner must now either come into the facility to perform the tasks, or prescribe a class of drug that isn’t covered by HB 1 (and may not be as effective in adequately treating the patient’s pain). And this same scenario doesn’t just exist in the middle of the night—it exists when the practitioner is with another patient, in the office, in surgery, or otherwise not physically present and immediately able to come to the patient’s bedside.

Further, the exceptions listed in the statute are narrow and do not account for a variety of common patient care situations. For example, an exception to HB 1’s requirements exists for prescribing to treat a hospice patient with controlled substances; however, this exception does not extend to other patients in similar situations, such as cancer patients who are not enrolled in hospice, or end of life patients with any origin of disease.

Consider the family of a patient who has experienced a devastating stroke and the family has made the decision to initiate comfort care and to allow the patient to die a natural death. A Schedule II controlled substance is frequently initiated as part of the comfort care treatment plan. HB 1 requires that the ordering physician complete certain tasks, such as obtaining informed consent from the patient for the use of controlled substances, including the risks of tolerance and dependence. In the situation described above, this may be wholly inappropriate, but is nonetheless statutorily required.

Reporting into the KASPER System

Hospital and long-term care facility pharmacies had previously been exempted from the requirement in the Controlled Substances Act (CSA) that each dispenser of a controlled substance report certain data into the KASPER system. This is because there had been a specific statement in the CSA that provided that these dispensers need not report doses of dispensed controlled substances that were directly administered to patients.

HB 1 altered that exception by requiring that all dispensers report doses of Schedule II controlled substances and Schedule III controlled substances containing hydrocodone—even where directly administered to patients—within seven days until July 1, 2013, at which time the report must be submitted within one day.

The law makes it a misdemeanor to intentionally fail to report to KASPER as required. In addition to the fact that hospital pharmacies do not have the infrastructure to report into the KASPER system, the requirement does not serve the purpose of reporting into KASPER at all—which is to track controlled substances dispensed to patients in the community, where the potential for abuse and diversion exists.

What purpose could a report of each and every controlled substance administered to a patient in a hospital or long-term care facility serve? The inclusion of the millions of line items of data of controlled substances directly administered to patients in these settings—that would be added to the KASPER system—would merely detract from a prescribing practitioner’s ability to determine if the potential for abuse or diversion is occurring.

Licensing Board Regulatory Prescribing Standards

In addition to the statutory prescribing standards discussed above, HB 1 imposed even more regulatory control over the prescription of controlled substances by mandating that the respective licensing boards issue regulations by September 1, 2012 addressing mandatory prescription and dispensing standards for “controlled substances.” Included in those regulations is the mandate that there be a prohibition on the dispensing by practitioners of a covered controlled substance in a volume greater than needed to treat a patient for 48 hours—unless the dispensing occurs as part of a licensed narcotic treatment program. For reasons that remain unknown, the licensing boards issued these emergency prescribing and dispensing regulations on July 20, 2012—adding chaos, confusion, and even more burdensome requirements on practitioners, particularly physicians.

The Kentucky Board of Medical Licensure (KBML) issued ten emergency regulations, including its 26-page Prescribing and Dispensing regulation (201 KAR 9:260E). The prescribing regulations were in response to the statutory mandate issued to the licensing boards in HB 1 to promulgate mandatory prescribing and dispensing standards for “controlled substances,” as opposed to the narrower class of Schedule II controlled substances and Schedule III controlled substances containing hydrocodone, addressed in KRS 218A.172.

The KBML provided certain exceptions to its regulations, largely in response to feedback from key interest groups regarding the problems with HB 1’s limited exceptions. Unfortunately, the exceptions section of the regulation expressly stated that these exceptions did not apply to HB 1’s statutory prescribing standards for Schedule II controlled substances and Schedule III controlled substances containing hydrocodone. The result? Two separate and distinct laws, each with its own exceptions—one applying to all controlled substances, the other to Schedule II controlled substances and Schedule III controlled substances containing hydrocodone; one law applicable in hospitals and nursing homes, the other not; and both, as a general rule, applicable to prescribing in the physician’s office—in sum, an overreaching morass of mandates that force physicians to go through a series of mental gymnastics to attempt to avoid violating the laws.

Even standing alone, the KBML regulations are unduly burdensome. ER physicians are “strongly discouraged” from certain practices, such as the prescribing of IV/IM controlled substances to patients experiencing acute exacerbations of chronic pain. They are likewise “strongly discouraged” from prescribing more than a three-day supply of a medication to a discharged patient.

What if the patient is unable to get an appointment with his or her doctor within three days? If it would be an initial prescription of a Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone, the follow-up physician must physically see the patient to perform an H&P and obtain written informed consent before issuing such a prescription. Unfortunately, the patient, who may legitimately need pain medication, is forced to endure without until they can be seen in follow-up.

Outside of the ER, any time a physician issues an initial prescription for a controlled substance—among other things—he must run a KASPER query to review the patient’s previous controlled substances use. If the patient is prescribed “chronic” or “long-term” controlled substances (defined as greater than three months), the physician must perform a host of tasks. Those tasks include conducting a baseline urine drug screen, and screening for substance abuse and dependence, psychiatric/psychological conditions and diversion risk.

If the physician determines that there is a reasonable likelihood that the patient suffers from one of these issues, he is required to refer the patient for consultation with an appropriate specialist, and obtain that specialist’s recommendation prior to issuing further prescriptions. In many communities, access to such specialists is limited, and it is not unusual that there be a thirty day waiting period to get in to see a specialist. Again, the patient is left to endure without adequate pain relief until the specialist can see him and report recommendations back to the referring physician.

And that’s not all. If the physician continues to prescribe those controlled substances to a patient in the long-term, the requirements continue—including random urine drug screens and random pill counts, where appropriate. KASPER reports must be run every three months, and physicians are required to report to law enforcement if it appears that a patient has obtained controlled substances from other physicians without that physician’s knowledge and approval.

Relief in Sight?

Since July 20, 2012, when the laws went into effect, there has been much discussion about their problems and unintended consequences. The House Bill 1 Implementation Oversight Committee—consisting of a panel of legislators—has heard testimony from various key interest groups. These interest groups have requested that the statutory prescribing standards be removed from the CSA and have also requested that the licensing boards be permitted to continue drafting guidelines for practice, as opposed to mandatory regulations.

Alternatively, several groups requested that the statutory licensing board mandate be narrowed to the class of drugs originally addressed in HB 1’s prescribing standards, rather than all controlled substances. In parallel, the governor’s office has coordinated a stakeholder’s group. The intent of this group is to identify and address potential solutions to the many identified problems with the statute and regulations, through regulation and prior to the next legislative session. Stakeholders have provided feedback and have proposed solutions that both meet the intent of HB 1 in addressing the prescription drug abuse epidemic while supporting patient care practices and the professional judgment of the Commonwealth’s practicing physicians. Although the group is collaborating well, to date there has been very little final action to address the concerns.

All parties agree that something has to be done about the prescription drug abuse epidemic in Kentucky. HB 1 went a long way in addressing Kentucky’s prescription drug abuse epidemic; however, it extended its reach to practitioners and patients in an overly burdensome manner. Some legislators have been heard to say that a “clean up” bill is needed to address the concerns—others have stated that they believe all of the problems can be addressed through regulation. What will be the end result? Stay tuned, as all eyes and ears will be on the General Assembly this next legislative session, to determine just that!

Rosalind Cordini is an attorney with Wyatt, Tarrant & Combs and a member of the LBA Health Law Section.