The United States Supreme Court’s review of the Affordable Care Act dominates the news and is on the minds of health care attorneys across the country. The constitutional fate of the Act will be decided when the Supreme Court releases its opinion in June, an event all health care providers will anticipate as the landscape of American health care awaits its fate.
Yet, there are still local developments to report that affect Delaware practitioners. In recent months the Delaware Board of Medical Licensure and Discipline has grappled with the degree to which a practitioner must demonstrate clinical competency in order to obtain a license, particularly when the applicant has been away from clinical practice for an extended period of time. The Board’s focus on this issue has been reflected in two recent written decisions.
So it was no surprise that earlier this month, the Board published notice of a proposed rule that amends “outdated” requirements for license renewal and for examination of practitioners out of clinical practice for three or more years seeking initial licensure in the State. Under the proposed rule, practitioners seeking initial licensure, but who have been out of clinical practice for three or more years, must demonstrate clinical competency. The proposed rule will require such practitioners to complete an approved “clinical and didactic” practice assessment program and demonstrate that the applicant has kept current with BMLD CME requirements.
The proposed rule indicates that a list of approved practice assessment programs will be posted on its website. Nothing has been posted yet and it will be interesting to see the list. From our experience, the availability of clinical and didactic practice assessment programs is somewhat limited, with the most prominent programs located in Colorado and California. We are also aware that a similar program is underway in Pennsylvania.
The proposed rule also seeks to make important procedural changes to the license renewal process. For any provider who fails to renew a license within one year after it expires, the renewal process will not be available. Instead, the practitioner will be required to seek licensure under the same conditions that govern applicants for new licensure and the requirements that govern reentry to practice.
Additionally, all applicants seeking renewal of a license after it has expired must certify that he or she has not practiced in Delaware while the license has expired.
A public hearing on the proposed rule will be held on April 3, 2012. More information on the hearing and the text of the proposed rule can be found at http://regulations.delaware.gov/register/march2012/proposed/15%20DE%20Reg%201293%2003-01-12.htm.
Showing posts with label Delaware Board of Medical Licensure and Discipline. Show all posts
Showing posts with label Delaware Board of Medical Licensure and Discipline. Show all posts
Thursday, March 29, 2012
Thursday, February 2, 2012
New Regulation Imposes Strict Requirements on Medical Practitioners who Prescribe Controlled Substances for Treatment of Chronic Pain
On October 14th, we posted on the Delaware Health Law Blog that the Board of Medical Licensure and Discipline had proposed a rule regarding the use of controlled substances for the treatment of pain. A public hearing was held on November 1, 2011 without comment in opposition to the rule. On February 1st, Rule 32 was adopted as proposed and will go into effect on February 11, 2012. The Rule is designed to assist practitioners by providing them with the minimum requirements for meeting the necessary standard of care in prescribing controlled substances for the treatment of pain. In order to demonstrate that your practice has met the standard of care, you must be vigilant in documenting specific aspects of care and medical decision-making.
This new regulation is likely to change the way most medical practitioners treat chronic pain patients and it imposes significant documentation requirements.
What is Required
The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. The key to the standard of care is to document a diagnosis with unrelieved pain and the sound clinical judgment to prescribe controlled substances. Additional specific requirements are listed below.
Evaluation of Patient
A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The following must be documented in the evaluation:
• One or more recognized medical indications for the use of a controlled substance
• Etiology, the nature, and intensity of pain
• Current and past treatments for pain
• Underlying or coexisting diseases or conditions
• The effect of the pain on physical and psychological function
• History of substance abuse
Treatment Plan
A written treatment plan is required, and must outline the goals and objectives that will be used to determine treatment success. The plan should note all diagnostic evaluations and any planned alternative treatments. Importantly, the plan must note whether other treatment modalities or rehabilitation programs are necessary.
Informed Consent
You must discuss the risks and benefits of treatment with controlled substances with the patient and document that discussion, including the patient’s informed consent.
Pain Treatment Agreement
You must use a written treatment agreement only if the patient is at “high risk” for medication abuse or has a history of substance abuse. The agreement must include required medication level screenings upon request, the number and frequency of prescription refills, the reasons drug therapy will be discontinued, and the requirement that the patient receive prescriptions from one physician and one pharmacy, where possible.
Periodic Review
The course of drug therapy must be periodically reviewed and documented, including any new information about the etiology of the pain and the patient’s state of health. A periodic review must include whether the treatment should be continued or modified, whether the patient’s pain has improved, and whether the patient has an increased level of function or improved quality of life. If not, it should be noted that the practice has considered the appropriateness of continued drug therapy or alternative modalities. A periodic review must also consider all objective evidence of improved or diminished function, including information from family members or other caretakers.
Consultation
During the course of treatment, the practitioner must refer the patient as necessary for additional evaluation and treatment in order to meet the goals and objectives of treatment. “The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder requires extra care, monitoring, documentation and may require consultation with or referral to an expert in the management of such patients.” Importantly, the rule states that “practitioners who regularly treat patients for chronic pain must educate themselves about the current standards of care applicable to those patients.”
Records must be maintained in an accessible manner. The record should also include documentation appropriate for each visit’s level of care, including interim history, vital signs, an assessment of progress, and the continued medication plan.
With the final rule becoming effective in ten days, it is important make sure that new documentation meet these standards. Notes used for initial and follow-up visits should be scrutinized to ensure that each of these new requirements is achieved in order to meet the these regulatory requirements.
This new regulation is likely to change the way most medical practitioners treat chronic pain patients and it imposes significant documentation requirements.
What is Required
The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. The key to the standard of care is to document a diagnosis with unrelieved pain and the sound clinical judgment to prescribe controlled substances. Additional specific requirements are listed below.
Evaluation of Patient
A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The following must be documented in the evaluation:
• One or more recognized medical indications for the use of a controlled substance
• Etiology, the nature, and intensity of pain
• Current and past treatments for pain
• Underlying or coexisting diseases or conditions
• The effect of the pain on physical and psychological function
• History of substance abuse
Treatment Plan
A written treatment plan is required, and must outline the goals and objectives that will be used to determine treatment success. The plan should note all diagnostic evaluations and any planned alternative treatments. Importantly, the plan must note whether other treatment modalities or rehabilitation programs are necessary.
Informed Consent
You must discuss the risks and benefits of treatment with controlled substances with the patient and document that discussion, including the patient’s informed consent.
Pain Treatment Agreement
You must use a written treatment agreement only if the patient is at “high risk” for medication abuse or has a history of substance abuse. The agreement must include required medication level screenings upon request, the number and frequency of prescription refills, the reasons drug therapy will be discontinued, and the requirement that the patient receive prescriptions from one physician and one pharmacy, where possible.
Periodic Review
The course of drug therapy must be periodically reviewed and documented, including any new information about the etiology of the pain and the patient’s state of health. A periodic review must include whether the treatment should be continued or modified, whether the patient’s pain has improved, and whether the patient has an increased level of function or improved quality of life. If not, it should be noted that the practice has considered the appropriateness of continued drug therapy or alternative modalities. A periodic review must also consider all objective evidence of improved or diminished function, including information from family members or other caretakers.
Consultation
During the course of treatment, the practitioner must refer the patient as necessary for additional evaluation and treatment in order to meet the goals and objectives of treatment. “The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder requires extra care, monitoring, documentation and may require consultation with or referral to an expert in the management of such patients.” Importantly, the rule states that “practitioners who regularly treat patients for chronic pain must educate themselves about the current standards of care applicable to those patients.”
Records must be maintained in an accessible manner. The record should also include documentation appropriate for each visit’s level of care, including interim history, vital signs, an assessment of progress, and the continued medication plan.
With the final rule becoming effective in ten days, it is important make sure that new documentation meet these standards. Notes used for initial and follow-up visits should be scrutinized to ensure that each of these new requirements is achieved in order to meet the these regulatory requirements.
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