NEW DRUG THERAPY MANAGEMENT RULES
In October 2005, the Colorado Board of Medical Examiners (CBME) adopted Rule 900, “Regarding the responsibilities of a physician who engages in drug therapy management with a Colorado licensed pharmacist” (effective Nov. 30, 2005). While there are more than 20 other states with rules allowing pharmacists to participate in drug therapy management, CBME is the first medical board in the country to enact corresponding rules for physicians who choose to enter into drug therapy management agreements.
The drug therapy management rule adopted by the Colorado Board of Pharmacy (Rule 6.00.30) allows pharmacists who have agreements with physicians to modify, per protocol, medication orders for patients. A physician must still order changes in medications or new prescriptions. A typical example of drug therapy management would be adjusting coumadin levels based on current INR values according to a written protocol.
CBME’s Rule 900 mirrors the pharmacy board rule in defining when drug therapy management may be used: only after a initial diagnosis by the doctor, only with a doctor’s order for drug therapy management, and only when there is a written agreement between the doctor and the pharmacist that includes the management protocol and defines the interaction between the involved individuals.
Only physicians with active, unrestricted licenses are permitted to participate in drug therapy management agreements (except in very rare cases where CBME may grant a waiver), and then only for therapies within the scope of their current practice, education, training and experience. A participating pharmacist must also have an unrestricted license and meet additional qualifications determined by the pharmacy board.
Rule 900 outlines protocol requirements, specifying specific elements to be included. Protocols must be evidence-based; that is, based on current, objective, published medical evidence, and must be reviewed and revised as necessary by the physician upon changes in the accepted standards of medical care and at least annually. CBME can require the physician provide the written protocol for board review.
The rule also outlines the requirements for the written agreements between physicians and pharmacists who choose to participate in drug therapy management. It allows for general agreements for physicians practicing in inpatient settings or in group model, integrated closed model HMOs, and outlines in detail the elements required for agreements outside of these settings. These elements include the doctor’s and pharmacist’s names and signatures, the specific diagnoses covered under the agreements, the protocols to be used, what the pharmacist will and won’t do under the agreement, details of reporting to the physician, time requirements for notification of the physician of modifications to drug therapy (not to exceed 24 hours during regular week days), an agreement for physician review and documented acceptance of any modification within 72 hours, a provision that allows the physician to override any action by the pharmacist, a provision for when care is provided by more than one physician for the designated medical condition, an agreement that the pharmacist agrees to maintain liability insurance of at least one million dollars (per occurrence), and the effective date of the agreement.
Any general authorization plan or written agreement must allow for either the physician or the pharmacist to withdraw from the plan or agreement within a specified period of time.
Finally, the rule requires that physicians engaging in drug therapy management obtain and review, in a timely manner, copies of the pharmacist’s records for each patient. CBME feels these corresponding rules provide the necessary safeguards for the provision of care to patients in Colorado when drug therapy management is provided through agreements between physicians and pharmacists. You can review the complete rule, including the appendix that outlines the required elements for protocols, on the CBME website.
PERFORMANCE ASSESSMENTS AND THE REVISED PHYSICIAN ASSISTANT RULE 400
In a recent revision to Medical Board Rule 400, Physician Assistants were placed in three distinct categories, based on the practice experience of the PA.
New Physician Assistant Graduates
This PA has recently graduated from an accredited PA program and has been employed for six months or less as a PA, with less than 500 patient encounters as a licensed PA.
This PA requires onsite supervision for the first 1,000 hours and all charts must be reviewed and signed within seven days.
A performance assessment must be completed by the Primary Supervising Physician at the end of six months and then quarterly for the first two years, twice a year thereafter.
Experienced Physician Assistants new to a practice
This PA is new to the place of employment but has previously worked as a PA for the two-year period required of new graduates.
This PA does not require onsite supervision, but must have adequate means for communication with the physician supervisor (primary or secondary) by either telephone, radio, pager or other telecommunication device.
A performance assessment must be completed by the Primary Supervising Physician at the end of six months and then twice a year thereafter.
All other Physician Assistants
There is no requirement for chart signature or onsite supervision, as long as they have adequate means for communication with the physician supervisor (primary or secondary) by either telephone, radio, pager or other telecommunication device.
A performance assessment must be completed by the Primary Supervising Physician twice a year.
New to this rule is the requirement of the Performance Assessment. The board has chosen not to dictate a specific format for the assessment. However, the assessment must include but is not limited to the following:
The medical competency of the PA;
The review and initializing of selected charts;
Referrals and consultations made by the PA; and
The ability of the PA to take a medical history and perform an exam.
The Primary Supervising Physician is required to document and maintain the performance assessment records for each PA supervised. These records are not required to be submitted to the Board, but are subject to audit by the Board and should be maintained by the Primary Supervising Physician as a part of the PA’s employment file in the event of the Board request. The Colorado Academy of Physician Assistants (CAPA) has developed sample assessment forms that may be used by PAs and their supervising physicians. To obtain copies of the sample forms, please contact CAPA at (303) 770-6048 or www.coloradopas.org.
Reprinted from the Colorado Board of Medical Examiners website.
THE NCMB POLICY COMMITTEE CONTINUES REVIEW OF POSITION STATEMENTS, OFFERS RESULTS OF RECENT REVIEW
The Policy Committee of the North Carolina Medical Board regularly reviews the board’s various position statements. The board’s licensees and others interested in the subjects dealt with by the statements are invited to offer comments on any statement in writing to the chair of the Policy Committee by e-mail (email@example.com) or regular mail (PO Box 20007, Raleigh, NC 27619). Comments will be collected over time and considered when the relevant statement is reviewed. The Policy Committee discusses the position statements in public sessions during regularly scheduled meetings of the board. The results of each review are published on the board’s website and in the Forum before consideration by the board, allowing for further written comments to assist the Policy Committee in preparing the final version for board action.
Action Taken on Five Position Statements
During the past few months, recommendations of the Policy Committee resulting from the Committee’s review of four position statements have moved forward and a new statement has been proposed.
The position statement titled “Prescribing Legend or Controlled Substances for Other Than Valid Medical or Therapeutic Purposes, with Particular Reference to Substances or Preparations with Anabolic Properties” will not be changed. It will be marked “Reviewed March 2006.”
The following position statement was amended and formally approved by the board. It now reads as follows.
Sale of Goods from Physician Offices
Inherent in the in-office sale of products is a perceived conflict of interest. On this issue, it is the position of the North Carolina Medical Board that the following instructions should guide the conduct of physicians or licensees. Sale of practice-related items such as ointments, creams and lotions by dermatologists, splints and appliances by orthopedists, spectacles by ophthalmologists, etc., may be acceptable only after the patient has been told those or similar items can be obtained locally from other sources. Any charge made should be reasonable.
Due to the potential for patient exploitation, the board opposes licensees participating in exclusive distributorships and/or personal branding, or persuading patients to become dealers or distributors of profitmaking goods or services.
Licensees should not sell any non-health-related goods from their offices or other treatment settings. (This does not preclude selling of such low-cost items on an occasional basis for the benefit of charitable or community organizations, provided the licensee receives no share of the proceeds and patients are not pressured to purchase.)
All decisions regarding sales of items by the physician or his/her staff from the physician’s office or other place where health care services are provided must always be guided by what is in the patient’s best interest. (Adopted March 2001, Amended March 2006)
The following new position statement is being considered for final action by the board.
Competence and Reentry to the Active Practice of Medicine
The ability to practice medicine results from a complex interaction of knowledge, physical skills, judgment, and character tempered by experience leading to competence. Maintenance of competence requires a commitment to lifelong learning and the continuous practice of medicine, in whatever field one has chosen. Absence from the active practice of medicine leads to the attenuation of the ability to practice competently.
It is the position of the North Carolina Medical Board, in accordance with GS 90-6(a), that practitioners seeking licensure, or reactivation of a North Carolina medical license, who have had an interruption, for whatever reason, in the continuous practice of medicine greater than two years must reestablish, to the board’s satisfaction, their competence to practice medicine safely.
Any such applicant must meet all the requirements and complete an application for a regular license. In addition, fullscale assessments, engagement in formal training programs, supervised practice arrangements, formal testing, or other proofs of competence may be required.
The board will cooperate with appropriate entities in the development of programs and resources that can be used to fulfill the above requirements, including the issuance, when necessary and appropriate, of a time or location limited and/or restricted license (e.g., residency training license).
It shall be the responsibility of the applicant to develop a reentry program subject to the approval of the board.
The following position statements are proposed revisions of existing statements and are being considered in their new form for final action by the board.
Availability of Physicians to Their Patients
It is the position of the North Carolina Medical Board that once a physician-patient relationship is created, it is the duty of the physician to provide care whenever it is needed or to assure that proper physician backup is available to take care of the patient during or outside normal office hours.
The physician must clearly communicate to the patient orally and provide instructions in writing for securing after-hours care if the physician is not generally available after hours or if the physician discontinues after-hours coverage.
Referral Fees and Fee Splitting
Payment by or to a physician solely for the referral of a patient is unethical. A physician may not accept payment of any kind, in any form, from any source, such as a pharmaceutical company or pharmacist, an optical company, or the manufacturer of medical appliances and devices, for prescribing or referring a patient to said source. In each case, the payment violates the requirement to deal honestly with patients and colleagues. The patient relies upon the advice of the physician on matters of referral. All referrals and prescriptions must be based on the skill and quality of the physician to whom the patient has been referred or the quality and efficacy of the drug or product prescribed.
It is unethical for physicians to offer financial incentives or other valuable considerations to patients in exchange for recruitment of other patients. Such incentives can distort the information that patients provide to potential patients, thus distorting the expectations of potential patients and compromising the trust that is the foundation of the patient-physician relationship.
Furthermore, referral fees are prohibited by state law pursuant to N.C. Gen. Stat. Section 90-401. Violation of this law may result in disciplinary action by the board.
Except in instances permitted by law (NC Gen Stat §55B-14(c)), it is the position of the board that a physician cannot share revenue on a percentage basis with a non-physician. To do so is fee splitting and is grounds for disciplinary action.
Reprinted from the Number 1, 2006, issue of Forum, published by the North Carolina Medical Board.
DIVORCED PARENTS AND THEIR CHILDRENS’ MEDICAL RECORDS
Many physicians treat children of divorced parents, in which custody is shared or full custody is given to one parent. At times, questions arise as to who has access to a child’s medical records. West Virginia State Law (West Virginia Code §48-9-601. Access to a child’s records.) states:
Each parent has full and equal access to a child's medical records absent a court order to the contrary. Neither parent may veto the access requested by the other parent. If necessary, either parent is required to authorize medical providers to release to the other parent copies of any and all information concerning medical care provided to the child which would otherwise be properly released to either parent.
If the child is in the actual physical custody of one parent, that parent is required to promptly inform the other parent of any illness of the child which requires medical attention.
Each parent is required to consult with the other parent prior to any elective surgery being performed on the child, and in the event emergency medical procedures are undertaken for the child which require the parental consent of either parent, if time permits, the other parent shall be consulted, or if time does not permit such consultation, the other parent shall be promptly informed of the emergency medical procedures: Provided, That nothing contained herein alters or amends the law of this state as it otherwise pertains to physicians or health care facilities obtaining parental consent prior to providing medical care or performing medical procedures.
Reprinted from Volume 10, Issue 1, of the West Virginia Board of Medicine Quarterly Newsletter, published by the West Virginia Board of Medicine.
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