Archive for category Kentucky “Pill Mill Bill”

Complying with KASPER

The Kentucky General Assembly passed House Bill 1, also known as the “pill mill bill” in 2012. Following its enactment, the Cabinet for Health and Family Services and various licensure boards issued regulations implementing its requirements. It was soon realized that the law would need some refinement to address concerns raised by the provider community and stakeholders. In 2013, House Bill 217 amended portions of House Bill 1 to address some unintended consequences of the original legislation. One of those amendments was giving an exemption to hospitals, long-term care facilities and approved researchers from the law’s requirement to report controlled substances administered directly to patients through the state’s description drug monitoring system, KASPER. However, for those licensees not exempt from the reporting, it remains a stringent requirement that a KASPER report is filed within one day of dispensing a controlled substance. (See more on HB 217 here.)

Complying with KASPER can be tedious, to say the least. But, there are some common sense tips that, when utilized, can make the system run more smoothly. Here are some pointers for prescribers:[1]

1. Distinguish yourself.

If you work alongside multiple prescribers and the prescription pad is pre-printed with the names and DEA numbers of everyone in the practice, you will need to specify who is actually prescribing. You can do this by circling your name and DEA number in the pre-printed area or by clearly printing your name, DEA number and/or state license number alongside your signature.

2. Identify the patient.

It goes without saying that the patient’s name should be on the prescription, but double-check to make sure you are including their full name and any suffixes (Sr., Jr., III, etc.). Any incident of fraud can be further reduced by including the patients’ date of birth, address and Social Security Number. The more information, the better.

3. Do not pre-sign or post-date.

Title 21 in the Code of Federal Regulations §1306.05(a) clearly directs that “all prescriptions for controlled substances shall be dated as of, and signed on, the day when issued…”. An office staff member cannot complete a pre-signed or post-dated prescription at a later time.

4. Clarify acetaminophen strength.

Manufacturers have until January 14, 2014 to remove prescription medications containing more than 325mg of acetaminophen per tablet/capsule from the market, in line with the Food and Drug Administration’s directive. Combination products are now hitting the market, with various strengths of acetaminophen under the 325mg limit. If you prescribe one of these combination products, include the strength of the acetaminophen. Failure to do so will lead to a phone call requesting the correct mg.

There are many state and federal statutes and regulations that govern controlled substances. If you have a question about any of these, you can always call your licensing board, DEPPB, or the DEA. You can also contact one of the health care attorneys at McBrayer. If you have ever received a KASPER report and been perplexed about some of the information included therein, check back on Thursday and I’ll offer some tips for decoding it.


[1] This guidance was originally provided in the Fall 2013 Kentucky Board of Medical Licensure Newsletter by Amanda J. Ward of the Drug Enforcement and Professional Practices Branch.

Chris Shaughnessy

 

 

 

 

 

 

 

Christopher J. Shaughnessy is an attorney at McBrayer, McGinnis, Leslie & Kirkland, PLLC.  Mr. Shaughnessy concentrates his practice area in health care law and is located in the firm’s Lexington office.  He can be reached at cshaughnessy@mmlk.com or at (859) 231-8780. 

This article is intended as a summary of federal and state law activities and does not constitute legal advice. 

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House Bill 1 Revisited: Kentucky General Assembly Amends the Pill Mill Bill

In a 2012 Special Session, the Kentucky General Assembly passed House Bill 1, also known as the “pill mill bill,” to reign in the overprescribing of prescription drugs and the diversion of prescription drugs.  Following the enactment of House Bill 1 and it being signed into law by Governor Beshear, the Cabinet and various licensure boards issued regulations implementing House Bill 1’s requirements.  After emergency regulations were promulgated, Governor Beshear’s office held a series of stakeholder meetings to address the concerns of health care providers and other stakeholders to address some of the compliance and logistical issues that were being raised by stakeholders.  Both Governor Beshear’s office, as well as various licensure boards, recognized that House Bill 1 and the implementing regulations would require amendment and refinement to address concerns raised by the provider community and other stakeholders.  During the 2013 Regular Session of the General Assembly, some of these concerns were addressed in House Bill 217 which amended portions of House Bill 1 to address some of the compliance and other issues raised by health care providers and other stakeholders.

House Bill 217 requires state licensing boards to issue regulations requiring practitioners to query the KASPER system prior to the initial prescribing or dispensing of any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone.  However, House Bill 217 provides that the practitioner only is required to query all available data on the patient for the twelve (12) month period immediately preceding the patient encounter and then utilize that data in the evaluation and treatment of the patient.

House Bill 217 also authorizes state licensing boards by regulation to exempt, in whole or in part, compliance with mandatory diagnostic, treatment, review of treatment plans, and other protocols and standards governing the prescribing of controlled substances in certain situations.  For example, licensing boards may provide an exemption from these mandatory standards for a licensee prescribing or administering a controlled substance immediately prior to, during or within fourteen (14) days following an operative or invasive procedure or a delivery if the prescribing or administering is medically related to the operative or invasive procedure or the delivery and the medication usage does not extend beyond the fourteen (14) days.  Likewise, House Bill 217 allows licensing boards by regulation to exempt from compliance with the mandatory prescribing standards a licensee prescribing or dispensing a controlled substance as part of the patient’s hospice or end-of-life treatment, for the treatment of pain associated with cancer or with the treatment of cancer, or in a single dose to relieve the anxiety, pain, or discomfort experienced by a patient submitting to a diagnostic test or procedure.

In addition to authorizing licensing boards to provide exemptions to compliance with mandatory diagnostic, treatment and other protocols and standards governing the prescribing of controlled substances in the circumstances specified in the bill, House Bill 217 gives licensing boards broad authority to carve out additional exemptions if specific procedures are followed.  Prior to promulgating administrative regulations providing for additional exemptions beyond those set forth in House Bill 217, a state licensing board must:

1.         Notify the Kentucky Office of Drug Control Policy that it is considering a proposal to promulgate an administrative regulation authorizing supplemental or additional exemptions and invite the Kentucky Office of Drug Control Policy to participate in the board meeting at which the proposal will be considered;

2.         Make a factual finding based on expert testimony as well as evidence or research submitted to the board that the exemption demonstrates a low risk of diversion or abuse and is supported by the dictates of good medical practice; and

3.         Submit a report to the Governor and the Legislative Research Commission of its actions, including a detailed explanation of the factual and policy basis underlying the board’s action, a copy of which shall be provided to the regulations compiler.

House Bill 217 goes a long way toward providing the needed regulatory flexibility that was lacking in House Bill 1.  Undoubtedly, as the provider community continues to deal with the requirements of House Bill 1, licensing boards will now be given the flexibility to address specific scenarios encountered by the provider community that may warrant less stringent regulatory requirements.

Chris Shaughnessy

 

 

 

 

 

 

 

Christopher J. Shaughnessy is an attorney at McBrayer, McGinnis, Leslie & Kirkland, PLLC.  Mr. Shaughnessy concentrates his practice area in health care law and is located in the firm’s Lexington office.  He can be reached at cshaughnessy@mmlk.com or at (859) 231-8780. 

This article is intended as a summary of state law activities and does not constitute legal advice. 

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THE PERILS OF PRESCRIBING CONTROLLED SUBSTANCES

As the Kentucky Board of Medical Licensure’s (“KBML”) implementing regulations for House Bill 1 are now effective on an emergency basis for the next six months, physicians, nurse practitioners, and other licensed prescribers have specific statutory and regulatory requirements establishing when and how they may prescribe controlled substances.  These rules must be followed or physicians and others may face serious consequences that include criminal misdemeanor offenses, loss of prescribing privileges, and disciplinary actions against professional licenses. All practitioners must pay careful attention to these rules because even minor violations may create problems. Because the KBML’s regulations are more comprehensive than the requirements of House Bill 1, a great deal of confusion exists concerning what physicians and practitioners are required to do and when. Recognizing that compliance with its emergency regulations may mean major changes in the way physicians practice medicine, the KBML has announced that it expects full compliance by October 1, which creates a welcome grace period.   While the ambiguities and details will be worked out over the course of the next six months, physicians should take heed and incorporate these things into their practices.

  • Assess your practice to assure that it is not an unintentional pain management facility that must register with the Cabinet or the KBML

The definition of a pain management facility is so broad that it may cover private physician practices in unexpected ways.  House Bill 1 defines a pain management facility to be a facility where the majority of the patients receiving treatment from the practitioners at the facility are provided treatment for pain that includes the use of controlled substances, and (i) the facility’s practice primary component is the treatment of pain; or (ii) the facility advertises in any medium for any type of pain management services.  This means that even though a physician’s specialty practice may be something other than pain management, if more than 50% of the patients are treated for pain and prescribed controlled substances for pain, then the practice may constitute a pain treatment facility regardless of whether the practice is an urgent treatment center, an internal medicine practice, or other medical practice.  Neither the statute nor the KBML’s regulation is clear about whether a subspecialty practice like orthopedic surgery would constitute a pain treatment facility in the event that a majority of its patients present seeking treatment for pain or painful conditions.  If the practice advertises that it treats pain, then it qualifies as a pain treatment facility. 

Pain treatment facilities must register with the Cabinet for Health and Family Services and obtain a license if the ownership of the entity includes only non-physicians or with the KBML if the ownership of the entity consists of physicians.  The KBML has noted on its website that the deadline for registration is September 1, 2012.

Major exceptions to the classification as a pain treatment facility exist for hospitals which include hospital clinics and the offices of their employed physicians; educational institutions; hospice programs; ASCs; and long term care facilities.  Physicians should know that failure to register when required may constitute a misdemeanor and result in disciplinary action.  

  • Register for KASPER

House Bill 1 contains strong requirements that every physician who holds a DEA permit must register to use KASPER.  In addition, the KBML requires physicians to register within three days of receipt of DEA permit.   In fact, the KBML regulations state that to lawfully prescribe controlled substances, a physician must have the DEA permit and register with KASPER.  

  • Make a KASPER inquiry every time a controlled substance is prescribed

House Bill 1 and the KBML establish different standards for prescribing controlled substances and requirements for KASPER inquiries.  House Bill 1 applies to Schedule II controlled substances and Schedule III controlled substances containing hydrocodone.  The KBML’s regulations on the other hand apply to all Schedule II and Schedule III controlled substances and selected Schedule IV and V controlled substances that have been determined to be highly addictive.  These Schedule IV and V medications include Ambien, Anorexics, Ativan, Klonopin, Librium, Nubain, Oxazepam, Phentermine, Soma, Stadol, Stadol NS, Tramadol, Valium, Versed, and Xanax.   While House Bill 1 only requires KASPER inquiries when Schedule II drugs and Schedule III drugs containing hydrocodone are prescribed, the KBML requires that a physician request and review a KASPER report before prescribing any of the controlled substances listed above.

Exceptions to the requirement for KASPER inquiries exist for hospice or end of life patients, cancer patients, residents of a long term care facility, and for patients experiencing an emergency.  Interestingly, the requirements for physicians to obtain KASPER reports for hospital patients differ between House Bill 1 and the KBML regulations.  House Bill 1 states that an admitting physician should query KASPER and then make the report part of the patient’s medical record.  An inpatient’s subsequent physicians satisfy the KASPER inquiry requirement when they review the report in the medical record prior to prescribing controlled substances and prior to discharging the patient with a prescription for no more than a 72 hour supply of controlled substances.

Both House Bill 1 and the KBML regulations have mandatory requirements for KASPER inquiries.  Because of the penalties associated with a failure to adhere to the requirements, physicians should establish a KASPER inquiry process as part of the routine practice of medicine even if this means making inquiries that may be unnecessary. Regulators have promised that the KASPER inquiry system will be quick and convenient for users. 

  • Implement the prescribing standards for controlled substances into the routine practice of medicine

Both House Bill 1 and the KBML regulations establish prescribing standards for controlled substances that must be followed and have the potential to subject a physician to serious disciplinary action for violations. In fact, the KBML has also revised its disciplinary regulations to create new standards to make it easier to issue emergency orders restricting physicians from prescribing or practicing. The standards for prescribing are complicated and vary based upon the timing of the prescribing.

  • Initial Prescribing

For initial prescribing of controlled substances, a physician must verify the patient’s ID, perform a history and focused physical that is documented; obtain and review a KASPER report; make a deliberate decision to prescribe controlled substances that is medically appropriate after weighing the risks and benefits; prescribe only the amount of medication necessary to treat a specific medical complaint for a definite, pre-determined time period; not prescribe long-acting or controlled release opioids for acute pain; and explain to the patient the need to discontinue the medication when the patient’s condition is resolved.

  • Prescribing for more than 3 months

 If a physician intends to prescribe any controlled substance for a period more than three months, the physician shall perform and document a thorough history  that includes patient and family history of abuse, dependence and psychosocial history; perform and document a comprehensive physical exam; obtain medical records from other physicians who have previously treated the patient’s complaint if necessary to justify the long-term prescribing of controlled substances; establish and document a working diagnosis; formulate a treatment plan with specific and measureable goals; screen the patient for abuse, dependence and psychiatric or psychological conditions that may create a diversion risk and make appropriate referrals; obtain a baseline urine drug screen and not prescribe controlled substances if the test indicates improper use; obtain the patient’s’ informed consent to the long term use of controlled substances; and try non-controlled substances treatments prior to prescribing.

  • Long Term Prescribing

When a physician decides to prescribe controlled substances beyond the initial 3 month period, the KBML emergency regulations require: seeing the patient once a month until medication is titrated and not causing side effects and that sufficient monitoring is in place; evaluating the patient and reviewing the working diagnosis; reviewing functional goals and obtaining consent to speak with others; managing breakthrough pain by identifying the triggers and attempting non-controlled medications; performing or assuring that the patient’s primary care physician has performed an annual preventive health screening or exam; reviewing KASPER reports at least every three months and taking action immediately if the report indicates that the patient is not taking the medication or diverting medications and reporting it to law enforcement; stopping or tapering prescribing; performing random urine drug screens; performing random unannounced pill counts; and discontinuation of treatment and to refer an addiction specialist when there is no improvement, significant adverse effects of drug-seeking behavior or diversion.

Additional standards have been promulgated for physicians who prescribe within the emergency department.

  • Documentation Requirements

Physicians must document all relevant information in the patient’s medical record in sufficient detail to provide for (1) a meaningful diagnosis and treatment; (2) the safe and medically appropriate assumption of care by another physician at any given time; and (3) the KBML to determine whether the physician is conforming to professional standards for prescribing.

  • Patient Education Requirements 

In addition to the professional standards for prescribing controlled substances, the KBML has declared that it is the acceptable and prevailing medical practice to educate patients on the following matters about controlled substances through verbal or written counseling including proper use; impact on driving and work safety; effect of use during pregnancy; potential for overdose and appropriate response to overdose; and safe storage and proper disposal of controlled substances.  This, of course, means that a physician must provide educational consultation or materials to patients or risk finding that

 Conclusion 

House Bill 1 and the KBML’s emergency regulations change how physicians must operate on a daily basis and interact with their patients.  The Governor’s Office has announced that public hearings on the KBML regulations will be held on September 26th and 27th, 2012 in Frankfort.  These meetings will provide an opportunity for comments on the KBML regulations.  House Bill 1, on the other hand, has become law, is incorporated into Kentucky’s statutes, and is not subject to anything but legislative change.  Regardless concern about the ability of physicians to perform all the tasks are required by the emergency regulations, the KBML’s regulations are now effective even though a grace period for enforcement exists.  Good luck! 

 

 

 

 

 

 

Lisa English Hinkle is a Partner of McBrayer, McGinnis, Leslie & Kirkland, PLLC.  Ms. Hinkle concentrates her practice area in health care law and is located in the firm’s Lexington office.  She can be reached at lhinkle@mmlk.com or at (859) 231-8780. 

This article is intended as a summary of newly enacted federal law and does not constitute legal advice. 

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The New Business of Prescribing Controlled Substances

Out of the heated debate between the Attorney General representing law enforcement and the Kentucky Medical Association representing physicians, the Legislature enacted Kentucky’s “Pill Mill Bill,” which is  sweeping legislation designed to combat prescription drug abuse through increased regulation of pain clinics and greater scrutiny of prescribing practices by various agencies of state government.  The Pill Mill Bill becomes effective on July 20, 2012 and imposes requirements not just for doctors practicing pain medicine, but for all practitioners who prescribe controlled substances.  In addition to placing significant limits on who can own a pain clinic and how a pain clinic is operated, the legislation requires Kentucky’s licensing boards, including the Kentucky Board of Medical Licensure and the Kentucky Board of Nursing, to enact new regulations that impose standards for physicians, nurses and other practitioners when a Schedule II or Schedule III controlled substance is prescribed. Because the Pill Mill Bill imposes sweeping changes for pain clinics and prescribing practices, all health care providers and their patients will  face new challenges as procedures change.  Regardless of whether the legislation stops the shifting pattern of drug abuse from illicit to prescription drugs, physicians are at the center of the Pill Mill Bill and are now required to reduce the risk of diversion and abuse of prescription drugs when treating a patient’s pain. Whether the collateral effect of the Pill Mill Bill is the serious under treatment of pain is yet to be seen.

  • Pain Clinics

One of the most important public health trends of the last ten years is the shifting pattern of drug abuse from heroin, cocaine, and marijuana to prescription drugs that are opioid based.  Kentucky’s Pill Mill Bill was specifically designed to target “pill mills” and pain clinics. By defining a pain clinic as a facility where the majority of patients of the practitioners at the facility are provided treatment for pain that includes the use of controlled substances, or where the clinic’s primary practice component is the treatment of pain, or where the facility advertises in any medium for any type of pain management services, the legislation is meant to cover any practice that holds itself out as treating chronic pain.  For these clinics that meet the definition, the legislation requires that  a physician having a full and active license to practice medicine in Kentucky shall have an ownership or investment interest in a pain management facility. The legislation, however,  “grandfathers” non-physician owned pain management facilities that were operating before the legislation was signed by Governor Beshear unless there is an administrative sanction or criminal conviction related to controlled substances imposed on the facility or any person employed by the facility for an act or omission done within the scope of the facility’s licensure or the person’s employment.

Regardless of the ownership of the facility, beginning on July 20, 2012, all pain management facilities must meet strict staffing requirements.  The legislation requires at least one of the owners of the facility or an owner’s designee (who is a physician, such as a medical director who is employed by and under the supervision of the owner) to be physically present practicing medicine in the facility for at least fifty percent (50%) of the time that patients are present in the facility.  More importantly, the physician owner or owner’s designee must meet specific specialty or sub-specialty certification requirements or have completed an accredited residency or fellowship in pain management. The aim of these requirements is to assure that a pain clinic has a physician who is trained and certified in pain medicine present when patients are treated.  This means that a pain clinic may not be staffed with mid-level practitioners without the presence of a physician at least half the time the clinic is open.

  • New Requirements for Prescribing Controlled Substances

In addition to regulating pain clinics, the Pill Mill Bill imposes specific clinical and documentation standards on all practitioners prescribing any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone, irrespective of whether the practitioner is practicing in a “pain management facility” as defined by the legislation. Now, by statute, a practitioner who prescribes any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone is required to (1) obtain a complete medical history and conduct a physical examination of the patient and document the information in the patient’s medical record; (2) perform a Kentucky All Schedules Prescription Electronic Reporting (“KASPER”) system search for all available data on a  patient; (3) make a written treatment plan stating the objectives of the treatment and diagnostic examinations required; (4) discuss the risks and benefits of the use of controlled substances with the patient, the patient’s parent, or a legal guardian that  include the risk of tolerance and drug dependence; and (5)obtain written consent for the treatment.  The legislation further requires the practitioner to review the course of treatment at reasonable intervals and provide any new information about the treatment to the patient.  As part of the review of the course of treatment, a practitioner is required to query the KASPER system not less than once every three (3) months for all available data on the patient and review that data before issuing any new prescription or refills for the patient for any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone.

The legislation even goes so far as to dictate the required content of a patient’s medical record  who receives controlled substances.  The legislation requires a  practitioner who prescribes any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone to keep accurate, readily accessible, and complete medical records that  include medical history and physical examination results; diagnostic, therapeutic, and laboratory results; evaluations and consultations; treatment objectives; discussion of risks, benefits, and limitations of treatments; treatments; a list of medications, including date, type, dosage, and quantity prescribed or dispensed; instructions and agreements; and conduct of periodic review of the patient’s file.

  • Requirements for Licensing Boards

State licensing boards are now required to promulgate administrative regulations governing prescribing standards and to take enforcement actions involving improper prescribing practices.  The legislation requires state licensing boards that include the Kentucky Board of Medical Licensure, the Kentucky Board of Nursing, the Kentucky Board of Dentistry, the Kentucky Board of Optometric Examiners and the State Board of Podiatry to issue regulations by no later than September 1, 2012 that address the following:  mandatory prescribing and dispensing standards for controlled substances; prohibiting practitioners from dispensing greater than a forty-eight (48) hour supply of any Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone unless the dispensing is done as part of a licensed narcotic treatment program; a procedure for temporarily suspending, limiting or restricting a license where a substantial likelihood exists that the unrestricted practice by the licensee would constitute a danger to the health, welfare or safety of patients or the public; and a procedure for the expedited review of complaints filed against licensees for prescribing or dispensing of controlled substances that is designed to start an investigation within seven (7) days of a complaint being filed and  produce a charging decision on the complaint within one-hundred twenty (120) days, unless an extension for a definite period of time is requested by a law enforcement agency due to an ongoing criminal investigation.

Kentucky’s Pill Mill Bill has made clinical standards for prescribing controlled substances the law, which  will require not only pain management facilities but all practitioners prescribing controlled substances to make changes to conform their policies, procedures and operations to the requirements of the law as well as the regulations which will follow. With only a few exceptions, practitioners will have to gather KASPER reports before prescriptions for controlled substances will be issued to patients.  Because of the potential liability with licensing boards, practitioners may decide that prescribing pain medications creates too much risk. Consequently, risk also exists that pain will be under-treated.    With the strict enforcement climate in Kentucky, all practitioners will need to incorporate the new requirements for prescribing into the their practices.  Now, more than ever, compliance efforts must include prescribing practices.

 

 

 

 

 

 

Lisa English Hinkle is a Partner of McBrayer, McGinnis, Leslie & Kirkland, PLLC.  Ms. Hinkle concentrates her practice area in health care law and is located in the firm’s Lexington office.  She can be reached at lhinkle@mmlk.com or at (859) 231-8780. 

This article is intended as a summary of newly enacted state law and does not constitute legal advice. 

 

 

 

 

 

 

 

Christopher J. Shaughnessy is an attorney at McBrayer, McGinnis, Leslie & Kirkland, PLLC.  Mr. Shaughnessy concentrates his practice area in health care law and is located in the firm’s Lexington office.  He can be reached at cshaughnessy@mmlk.com or at (859) 231-8780. 

This article is intended as a summary of state law enforcement activities and does not constitute legal advice. 

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