5673159 Health, Department of- Notice of Proposed Rulemaking- for Collaborative Practice Agreements Between Physicians and Pharmacists

DEPARTMENT OF HEALTH

 

NOTICE OF PROPOSED RULEMAKING

 

The District of Columbia Boards of Pharmacy and Medicine (the “Boards”) jointly, pursuant to the authority set forth under Section 2(b)(2) of the Collaborative Care Expansion Amendment Act of 2012, effective October 22, 2012 (D.C. Law 19-0185; 59 DCR 9454, (August 10, 2012)) (the “Act”), hereby gives notice of their intent to adopt the following new Chapter 100, entitled “Collaborative Practice Agreements Between Physicians and Pharmacists” of Title 17 (Business, Occupations, and Professionals) of the District of Columbia Municipal Regulations (DCMR).

 

The adoption of Chapter 100, which had until now been reserved, is necessary to implement the Act, which permits physicians and pharmacists licensed in the District of Columbia to enter into collaborative practice agreements.

 

The Boards give notice of their intent to adopt these rules as final, in not less than thirty (30) days after publication of this notice in the D.C. Register.

 

Title 17 DCMR, BUSINESS, OCCUPATIONS, AND PROFESSIONALS, is amended by adding a new Chapter 100 to read as follows:

 

CHAPTER 100         COLLABORATIVE PRACTICE AGREEMENTS BETWEEN PHYSICIANS AND PHARMACISTS

 

10000              General Provisions

10001              Requirements for Participation in a Collaborative Practice Agreement

10002              Use of a Collaborative Practice Agreement and Required Content

10003              Signed Authorization

10004              Informed Patient Consent and Withdrawal of Participation

10005              Termination or Alteration of the Collaborative Practice Agreement

10006              Approval of Protocols Outside the Standard of Care

10007              Recordkeeping

10008              Disapproval and Revocation of Collaborative Practice Agreements

10099              Definitions

 

10000              GENERAL PROVISIONS

 

10000.1           Participation in a collaborative practice agreement shall be voluntary, and no licensed physician, pharmacist or institution shall be required to participate.

 

10000.2           Neither a pharmacist nor physician shall provide economic incentives to the other for the purpose of entering into a collaborative practice agreement.

 

10000.3           A physician shall not be employed by any pharmacist or pharmacy for the sole purpose of collaborative practice.

10000.4           Patient entry into a collaborative practice arrangement shall be initiated by an authorizing protocol that includes coverage of the patient(s), or a written referral from the licensed physician to the pharmacist for a specific patient.

 

10000.5           When patient entry is initiated by the pharmacist, the pharmacist shall:

 

(a)                Instruct the  patient to follow up with the authorizing physician within the time period established in the collaborative practice agreement;

 

(b)               Notify the authorizing physician of the encounter in writing within twenty-four (24) hours or one (1) business day; and

 

(c)                Obtain a referral from the authorizing physician before providing further collaborative practice services to the patient.

 

10000.6           A pharmacist who is a party to a collaborative practice agreement shall utilize an area for in person, telephonic or other approved electronic consultations relating to the management of drug therapy that ensures the confidentiality of the patient information being discussed.

 

10000.7           Nothing in these regulations shall be construed or interpreted to allow a pharmacist to accept delegation of a physician’s authority outside of or beyond the scope of the pharmacist’s practice.

 

10001              REQUIREMENTS FOR PARTICIPATION IN A COLLABORATIVE PRACTICE AGREEMENT

 

10001.1           A pharmacist shall only participate in a collaborative practice agreement in accordance with this chapter.

 

10001.2           A licensed physician shall have a valid patient-physician relationship with a patient that he or she refers to a pharmacist for participation in a collaborative practice agreement under this chapter.

 

10001.3           For purposes of this chapter, an internet based or telephone consultation or questionnaire evaluation is not adequate to establish a valid patient-physician relationship unless and except as otherwise specifically permitted by District law.

 

10001.4           The licensed physician and pharmacist who are parties to a collaborative practice agreement shall hold an active license in good standing in the District of Columbia.

 

10001.5           The Boards may deny approval of a physician or pharmacist to participate in a collaborative practice agreement if the physician or pharmacist has:

(a)                A final order by the governing Board disciplining the physician or pharmacist's license for a practice issue within the five (5) years immediately preceding the formation of the agreement; or

 

(b)               Limitations placed on the physician or pharmacist's license by the governing board.

 

10001.6           The collaborative practice agreement shall be within the scope of the licensed physician's current practice.

 

10001.7           To be eligible to participate in a collaborative practice agreement, a pharmacist:

 

(a)        Shall possess relevant advanced training as indicated by one of the following:

 

(1)               Certification as a specialist by:

 

(i)                 The Board of Pharmaceutical Specialties;

 

(ii)               The Commission for Certification in Geriatric Pharmacy; or

 

(iii)             Another credentialing body approved by the Board of Pharmacy; or

 

(2)               Successful completion of:

 

(i)                 A residency accredited by the American Society of Health-Systems Pharmacists, a body approved by the Board of Pharmacy or offered by a body accredited by the Accreditation Council for Pharmacy Education; or

 

(ii)        A certificate program approved by the Board of Pharmacy; and

 

(b)        Shall have successfully completed:

 

(1)               A minimum of three (3) years of relevant clinical experience, if the pharmacist holds an academic degree of Doctor of Pharmacy; or

 

(2)               A minimum of five (5) years of relevant clinical experience, if the pharmacist holds an academic degree of Bachelor of Science in Pharmacy; and

 

(c)        Shall have documented training related to the area of practice covered by the collaborative practice agreement.

10002              USE OF COLLABORATIVE PRACTICE AGREEMENTS AND REQUIRED CONTENT

 

10002.1           The management of drug therapy pursuant to a collaborative practice agreement shall be initiated by an authorizing protocol that includes coverage of the patient(s) or a written referral from the licensed physician to the pharmacist for a specific patient.

 

10002.2           When a patient encounter is initiated through an authorizing protocol, the pharmacist shall notify the authorizing physician in writing within twenty-four (24) hours or one (1) business day.

 

10002.3           The authority granted by the physician to the pharmacist must be within the scope of the physician’s practice.

 

10002.4           The collaborative practice agreement may allow the pharmacist, within the pharmacist’s scope of practice, to conduct activities approved by the physician pursuant to the agreement and within the authority established by the law and regulations.

 

10002.5           The collaborative practice agreement shall not prohibit the pharmacist from providing other pharmaceutical services that are within the pharmacist's scope of practice.

 

10002.6           A collaborative practice agreement shall be based upon treatment protocols that are generally accepted as the clinical standard of care within the medical and pharmacy professions, or approved by the Boards of Medicine and Pharmacy in accordance with §10006 of this chapter, and shall include:

 

(a)                Identification of the physicians(s) and pharmacist(s) who are parties to the agreement;

 

(b)               The location(s) where the pharmacist(s) and physician(s) may provide services under the collaborative practice agreement;

 

(c)                The name, address, and telephone number of the person(s) who are to  receive correspondence from the Boards related to the collaborative practice agreement;

 

(d)       A detailed description of the disease state or condition, drugs or drug categories, drug therapies, devices, and any necessary incidental tests, authorized by the physician, and the activities allowed in each case;

 

(e)        A detailed description of the methods, procedures, decision criteria, and plan the pharmacist is to follow when conducting allowed activities;

 

(f)        A detailed description of the activities and procedures that the pharmacist is to follow, including documentation of decisions made, and a plan or appropriate mechanism for communication, feedback, and reporting to the physician activities and results concerning specific decisions made;

 

(g)        The conditions under which the pharmacist may initiate, modify, or discontinue a drug therapy;

 

(h)        Directions concerning the monitoring of a drug therapy, including the conditions that would warrant a modification to the dose, dosage regime, or dosage form of the drug therapy;

 

(i)                 The frequency and the manner in which the pharmacist conducts the management of drug therapy;

 

(j)         A method for the physician to monitor compliance with the agreement and clinical outcomes and to intercede where necessary;

           

(k)        A description of the continuous quality improvement efforts used to evaluate effectiveness of patient care and ensure positive patient outcomes;

 

(l)         A provision that allows the physician to override a collaborative practice decision made by the pharmacist whenever he or she deems it necessary or appropriate;

 

(m)       A provision that allows either party to cancel the collaborative practice agreement by written notification;

 

(n)        An effective date; and

 

(o)        The signatures of all collaborating pharmacists and physicians who are party to the collaborative practice agreement, as well as dates of signing.

 

10002.7           In addition to the requirements set forth in the collaborative practice agreement, documentation of each intervention, including changes in dose, duration or frequency of medication prescribed, shall be recorded in the pharmacist’s prescription record, patient profile, a separate log book, or in some other appropriate system.

 

10002.8           Documentation of allowed activities must be kept as part of the patient’s permanent record and be readily available to other health care professionals providing care to that patient and who are authorized to receive it.  Documentation of allowed activities shall be considered protected health information.

10002.9           Oral communications between the physician and pharmacist shall be summarized in the documentation maintained by the pharmacist and forwarded to the physician.

 

10002.10         Unless an alternative time period is stated in the collaborative practice agreement, the pharmacist shall inform the physician within forty-eight (48) hours if the pharmacist modifies the drug dose or agent.

 

10002.11         Unless an alternative time period is stated in the collaborative practice agreement, the pharmacist shall inform the physician within twenty-four (24) hours if the pharmacist detects an abnormal result from an assessment activity.

 

10002.12         Amendments to a collaborative practice agreement must be documented, signed, and dated, and for collaborative practice agreements containing approved protocols outside the generally accepted clinical standard of care, the amendments must be approved by the Boards before they are implemented.

 

10002.13         At a minimum, the collaborative practice agreement shall have a documented review and, if necessary, be revised every year.

 

10003              SIGNED AUTHORIZATION

 

10003.1           The signatories to a collaborative practice agreement shall be a District of Columbia licensed physician involved directly in patient care and a District of Columbia licensed pharmacist involved directly in patient care.

 

10003.2           The physician may designate alternate physicians, and the pharmacist may designate alternate pharmacists, provided that the alternates meet the educational, licensure, and training requirements of this Chapter, and are involved directly in patient care at a single, physical location where patients receive services.  Nothing in this Section shall be construed as prohibiting the practice of telemedicine if it is otherwise permitted by District law.

 

10004              INFORMED PATIENT CONSENT AND WITHDRAWAL OF PARTICIPATION

 

10004.1           Documented informed consent from the patient shall be obtained by the physician who authorizes the patient to participate in the collaborative practice agreement or by the pharmacist who is also a party to the collaborative practice agreement.

 

10004.2           For purposes of this section, documented informed consent shall mean either written consent signed by a patient, or its electronic equivalent, maintained in a patient’s record.

 

10004.3           The patient may decline to participate or withdraw from participation at any time.

10004.4           Prior to obtaining a patient’s consent to participate in a collaborative practice agreement, the physician or pharmacist, or both, shall inform a patient:

 

(a)                Of the procedures that will be utilized for drug therapy management under the collaborative practice agreement, and such discussion shall be documented in the patient record;

 

(b)               That the patient may decline to participate or withdraw from participating in the drug therapy management at any time; and

 

(c)                That neither the physician nor the pharmacist has been coerced, given economic incentives, excluding normal reimbursement for services rendered, or involuntarily required to participate.

 

10005              TERMINATION OR ALTERATION OF THE COLLABORATIVE PRACTICE AGREEMENT

 

10005.1           The collaborative practice agreement may be terminated at any time upon written notice by the pharmacist, physician, or the patient.  Notice of termination shall be provided to all parties to the collaborative practice agreement and the patient within fourteen (14) days of termination.

 

10005.2           A physician may override the collaborative practice agreement whenever he or she deems such action necessary or appropriate for a specific patient.

 

10005.3           If either the physician or the pharmacist who is a party to the collaborative practice agreement has a change of practice location, employer, or ownership, that person shall notify the other party and all patients who are participants in the collaborative practice agreement.

 

10006              APPROVAL OF PROTOCOLS OUTSIDE THE STANDARD OF CARE

 

10006.1           If a physician and a pharmacist intend to manage or treat a condition or disease state for which there is not a protocol that is generally accepted as the clinical standard of care, the physician and pharmacist shall apply for approval. The Boards shall receive and review the proposed treatment protocol and jointly approve or disapprove.

 

10006.2           Any procedure outside generally accepted clinical practice shall be approved by the Boards, and any changes to a protocol for procedures outside the generally accepted clinical practice shall be approved by the Boards before they are implemented.

 

10006.3           Application and approval are not needed for treatment of conditions for which there is a generally accepted clinical standard of care, but for which the physician wants to increase the monitoring and oversight of the condition over what the protocol recommends.

 

10006.4           In order to apply for approval of a protocol outside the generally accepted clinical standard of care, the physician and the pharmacist shall jointly submit:

 

(a)                An application on the required form and the required fee;

 

(b)               A copy of the proposed protocol; and

 

(c)                Supporting documentation that the protocol is safe and effective for the particular condition or disease state for which the physician and the pharmacist intend to manage or treat through a collaborative practice agreement.

 

10006.5           To apply for approval to make changes to an approved protocol outside of the generally accepted clinical standard of care, the physician and the pharmacist shall jointly submit:

(a)                An application on the required form and the required fee;

 

(b)               A copy of the proposed changes to the protocol; and

 

(c)                Supporting documentation that the change(s) to the protocol is safe and effective for the particular condition or disease state for which the physician and the pharmacist intend to manage or treat through a collaborative practice agreement.

 

10007              RECORDKEEPING          

 

10007.1           Signatories to a collaborative practice agreement shall keep a copy of the agreement on file at their primary places of practice.

 

10007.2           The referral of a patient from the physician authorizing the implementation of drug therapy management pursuant to the collaborative practice agreement shall be noted in the patient's medical record and kept on file by the pharmacist.

 

10007.3           The patient's documented informed consent shall be retained by the parties to the                          collaborative practice agreement.

 

10007.4           A copy of the collaborative practice agreement, any amendments to the agreement, and the subsequent termination of any such agreement, if applicable, shall be available as follows:

 

(a)        At the practice site of any physician who is a party to the collaborative practice agreement;

(b)        At the practice site of any pharmacist who is a party to the collaborative practice agreement;

 

(c)        At the institution or facility where a collaborative practice agreement is in place;

(d)               Upon request, to any patient who is being managed under the collaborative practice agreement; and

 

(e)        Upon request, to representatives of the Boards of Pharmacy and Medicine.

10007.5           Documentation of activities performed under a collaborative practice agreement or the physician's specific instructions shall be maintained in such a manner that it is accessible to the:

 

(a)                Physician;

 

(b)               Pharmacist; and

 

(c)        The Boards of Pharmacy and Medicine upon request.

10007.6           Documentation may be maintained in written or electronic form.

 

10007.7           A pharmacist or physician who is a party to the collaborative practice agreement shall have access to the records of the patient who is the recipient of the management of drug therapy.

 

10007.8           A patient's records related to the management of drug therapy under a collaborative practice agreement may be maintained in a computerized recordkeeping system which meets all requirements for Federal and State certified electronic health care records.

 

10007.9           The handling of all patient records by the pharmacist providing the management of drug therapy must comply with the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191, 110 Stat. 1936).

 

10007.10         The Boards may conduct random audits to ensure compliance with the provisions of the Act and this chapter.

 

10008              DISAPPROVAL AND REVOCATION OF COLLABORATIVE PRACTICE AGREEMENTS

 

10008.1           The Board of Pharmacy and the Board of Medicine may disapprove or revoke a collaborative practice agreement if the Boards find:

 

(a)                Inadequate training, experience, or education of the physician(s) or Pharmacist(s) to implement the protocol or protocols specified in the physician-pharmacist agreement;

 

(b)               The collaborative practice agreement fails to comply with the requirements of this chapter or the Act;

 

(c)                The collaborative practice agreement is intended to manage or treat a condition or disease state for which there is not a protocol that is generally  accepted as the clinical standard of care, or which is not approved by the Boards; or

 

(d)               Either party to the agreement has been formally disciplined by any health professional licensing          board in any jurisdiction, or is otherwise no longer licensed in good standing in the District of Columbia.

 

10099              DEFINITIONS

 

10099.1           As used in this Chapter, the following terms have the meanings ascribed:

 

Act- the Collaborative Care Expansion Amendment Act of 2012, effective October 22, 2012 (D.C. Law 19-0185; 60 DCR 7591 (May 31, 2013)).

 

Collaborative practice agreement-   a voluntary written agreement between a licensed pharmacist and a licensed physician that has been approved by the Board of Pharmacy and the Board of Medicine, or between a licensed pharmacist and another health practitioner with independent prescriptive authority licensed by a District health occupation board, that defines the scope of practice between the licensed pharmacist and licensed physician, or other health practitioner, for the initiation, modification, or discontinuation of a drug therapy regimen.

 

Physician- a person holding a degree in medicine (MD) or osteopathy (DO).

 

Standard of Care- the course of action that other prudent and well-trained health professionals in the same field of practice would customarily take under the same or similar circumstances.

 

 

All persons desiring to comment on the subject matter of this proposed rulemaking action shall submit written comments, not later than thirty (30) days after the date of publication of this notice in the D.C. Register, to Phillip Husband, General Counsel, Department of Health, Office of the General Counsel, 899 North Capitol Street, N.E., 5th Floor, Washington, D.C. 20002.   Copies of the proposed rules may be obtained between the hours of 8:00 a.m. and 4:00 p.m. at the address listed above, or by contacting Angli Black, Administrative Assistant, at [e-mail], [phone].