DEA Proposed Rulemaking on Electronic Prescribing of Controlled Substances

September 24 , 2008

 

Drug Enforcement Administration

Attention: DEA Federal Register Representative/ODL

8701 Morrissette Drive

Springfield, VA  22152

 

 

Re:  Comments on Electronic Prescriptions for Controlled Substances Docket No. DEA-218

 

Dear Sir or Madam:

 

The American Academy of Physician Assistants (AAPA) is the only national professional society representing physician assistants (PAs) in all specialties. AAPA appreciates the opportunity to submit comments on the proposed rule to enable practitioners to electronically write prescriptions for controlled substances as published in the June 27, 2008 Federal Register (Volume 73, Number 125). 

 

AAPA supports the proposed changes to voluntarily permit practitioners, including physician assistants, to electronically write prescriptions for controlled substances. The Academy believes that the projected enhancements will improve patient access to care, reduce medical errors, and assist DEA in its ongoing efforts to identify and minimize prescription controlled substance abuse and diversion. However, AAPA requests that the Administration reconsider some provisions of the proposed rule.1  As a matter of context, our comments are in relation to state law provisions. 

 

Section 1311.105 Electronic prescription system requirements: Identity proofing

Paragraph (a) of this section of the proposed rule requires service providers to obtain documentation that has been prepared by an entity authorized to conduct in-person identity proofing indicating each of the state licenses and DEA Certificates of Registration a practitioner possesses should he or she wish to prescribe controlled substances in more than one state. Further, subsection (4)(i) of the same paragraph provides that this documentation must contain the name of the state licensing authority and state licensing number of the practitioner whose identity is being verified.  Lastly, to ensure that only those who have registered with the DEA are granted access to the electronic prescription system and to protect against identity theft, the proposed rule requires service providers to check with each state to determine that a practitioner’s state “license to practice medicine” is current and in good standing.

 

The use of the word “State”

Physician assistants are authorized to practice in all 50 states, the District of Columbia, the Commonwealth of the Northern Mariana Islands, Guam, and the United States Virgin Islands.

 

AAPA requests that clarification be made to the proposed rule to indicate the inclusion of these jurisdictions and others that may later authorize physician assistant practice.  If such an amendment to the proposed rule were to be considered the following language could be employed:

 

§ 1300.03 Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances.

 

State means any of the 50 States and other United States territories or jurisdictions including: the District of Columbia, the Commonwealth of the Northern Mariana Islands, Guam, the United States Virgin Islands, the Commonwealth of Puerto Rico, the Canal Zone, and American Samoa.

 

The use of the phrases “state license,” “state licensing authority,” and “state license number”

All states (and the aforementioned jurisdictions) authorize and regulate physician assistant practice.  Historically, states have used three regulatory terms for PAs: certification, registration, and licensure.  Although most states issue licenses to PAs, six states—Maryland, Massachusetts, Minnesota, New York, Ohio and Vermont—still certify or register physician assistants.  Consequently, these regulatory bodies are neither necessarily designated as a state “licensing” authority nor do they inherently issue a “state license number.” Regardless of whether a state issues a license, certificate or registration, different numerical identifiers are issued by each. Some states issue “registration numbers” or “provider identifier numbers,” while others simply issue “identification numbers.” AAPA is concerned that: (1)  practitioners who practice in a state that uses a regulatory term other than “licensure” for physician assistants, (2) does not have a state “licensing” authority, or (3) does not issue state license numbers will be unintentionally excluded from Section 1311.105.  AAPA requests that clarification be made to the proposed rule to indicate the inclusion of practitioners who may have a level of regulation other than licensure.  If an amendment to the proposed rule were to be considered, the following language could be employed:

 

§ 1300.03 Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances.

 

State license means a license, certification, registration, or other equivalent issued by a state regulatory body which authorizes a practitioner to practice a profession.

 

State licensing authority means the state regulatory body that governs the professional practice of a practitioner.

 

State license number means any numeric identifier issued by a state regulatory authority to identify a practitioner.

 

The use of the phrase “license to practice medicine”

The use of the phrase “license to practice medicine” as used in this section presents another unique circumstance for PAs. Although PAs are trained in the medical model, the definition of a “physician assistant” and the medical services they are authorized to provide by law vary greatly across jurisdictions. Although some laws and regulations, consistent with AAPA Model Legislation for Physician Assistants, define a physician assistant as a health professional who is “licensed to practice medicine” with physician supervision, others do not. Some authorize PAs to “perform medical services,” “provide patient services,” or “perform medical acts, tasks and functions” with physician supervision.  AAPA requests that clarification be made to the proposed rule to indicate the inclusion of practitioners who are authorized by

 

 

law to provide medical services that are inherent to the practice of medicine. If an amendment to the proposed rule were to be considered the following language could be employed:

 

§ 1311.105 Electronic prescription system requirements:  Identity proofing.

 

(c) For each practitioner seeking to issue electronic controlled substances prescriptions, the service provider shall do the following:

              (1) Check with each State to determine that the practitioner’s State license to practice medicine is current and in good standing.

 

Section 1311.115 Electronic prescription system requirements:  Prescription contents

This section of the proposed rule enumerates the required data elements that must be included for an electronic prescription for a controlled substance to be valid.  Paragraph (c) provides that the DEA registration number for the practitioner issuing the prescription is the only one that may be associated with the prescription; multiple DEA registration numbers may not be associated with a prescription. 

 

AAPA understands the Administration’s desire to ensure that only the registration number and practitioner information for the prescribing practitioner appear on electronic controlled substance prescriptions. However, because of the unique relationship between physician assistants and their supervising physicians, this requirement directly conflicts with several state laws—Alaska, Hawaii, New Jersey, and Texas—which require the DEA number of both the supervising physician and the PA to be included on a controlled substance prescription in order for it to be valid.

 

While the Academy neither desires nor expects the Administration to devise an electronic system which centers on the specific needs of physician assistants, we do feel that it is incumbent upon us to bring such concerns to the DEA’s attention. The electronic system requires flexibility in addition to the other facets DEA proposes. Elements of the suggested rule such as this one cannot be uniformly applied nor presently achieved by all professions.  Although the AAPA is committed to helping states amend their current laws and regulations to bring them into compliance with this requirement should it be adopted, such efforts will take an indeterminate amount of time to accomplish. 

 

 

Section 1311.120 Electronic prescription systems requirements:  Creating a controlled substance prescription

This portion of the proposed rule sets the requirements for creating an electronic prescription consistent with current regulations governing paper prescriptions.  Once a practitioner or his agent has entered the prescription information into the system, the system must display certain information related to the controlled substance prescription, including the patient’s name and address, the name of the drug prescribed, the dosage strength and form, etc.  The Academy is concerned that many physician assistants will not be able to participate in the use of the proposed e-prescribing technology unless the system can include all of the information that is currently required for paper controlled substance prescriptions to be valid under individual state law requirements.  For example, the overwhelming majority of state laws require that the name of the supervising physician appear on a prescription for a controlled substance.

Other states have very unique language statements that a PA must sign or handwrite on the prescription or that must appear generally on the prescription for it to be valid; pharmacists are prohibited from filling prescriptions that fail to meet these requirements.2,3,4

Section 1311.125 Electronic prescription system requirements:  Signing the prescription

This section of the proposed rule sets the requirements for signing an electronic prescription. Paragraph (b) includes a declaration that the prescribing practitioner whose name and DEA registration number appears on the controlled substance prescriptions being transmitted must agree to in order for the prescription to be successfully transmitted. If the practitioner fails to indicate agreement to this statement, the controlled substance prescriptions shall not be transmitted.  The statement reads, “I, the prescribing practitioner whose name and DEA registration number appear on the controlled substance prescription(s) being transmitted, have reviewed all of the prescription information listed above and have confirmed that the information for each prescription is accurate…”  Consistent with the rationale outlined in our comments on Section 1311.115, physician assistants prescribing in states that require the DEA registration number of both the supervising physician and the PA will not be able to meet this proposed requirement while simultaneously adhering to state controlled substance prescription validity requirements.  Again, AAPA is not advocating for a physician assistant centered resolution. We recognize the unique circumstances presented by state laws which require both the supervising physician’s and PA’s DEA registration numbers on controlled substance prescriptions. However, a “one size fits all approach” will not be feasible for requirements such as this. While we are more than willing to work with state agencies to change this requirement, we cannot confirm that this could be accomplished prior to the implementation of the electronic system.

 

Overall costs

Physician assistants play an important role in ensuring high quality and accessible health care.  The profession is committed to providing care in underserved communities, such as inner cities and rural areas. AAPA is concerned that the costs associated with the adoption of the proper hardware and software required to facilitate the electronic prescribing of controlled substances may prevent professionals serving communities such as these or other small practices from participating in writing prescriptions for controlled substances electronically.  Although the proposed regulations attempt to address cost issues, the actual costs of implementation are certain to vary depending on several factors, including the complexity of the prescriber’s practice, adoption of electronic health records and the level of existing electronic prescription systems.  The Academy encourages the DEA to develop and implement systems that are as cost effective as possible.

 

Thank you for the opportunity to submit comments on electronic prescriptions for controlled substances. Should you have any questions on the AAPA, the PA profession, or these comments, please do not hesitate to contact Ann Davis, AAPA’s Director of State Government Affairs at 703-836-2272, extension 3201, or ann@aapa.org.

 

Sincerely,

William F. Leinweber

Executive Vice President/Chief Executive Officer

 

 

1. To be most helpful and effective we have provided citations to relevant state laws and regulations. These citations are not meant to be an exhaustive list of every state that will be affected by the proposed rule. Instead, they are intended to provide the DEA with an understanding of the unique physician-PA team relationship and physician assistant prescribing authority.

2. Ga. Code Ann. § 43-34-103(e.1) (3):  The physician's assistant shall only be authorized to exercise the rights granted under this subsection using a prescription drug or device order form which includes the name, address, and telephone number of the prescribing supervising physician, the patient's name and address, the drug or device prescribed, the number of refills, and directions to the patient with regard to the taking and dosage of the drug. Such form shall be signed by the physician's assistant using the following language:
         This prescription authorized through: (the prescribing supervising physician) (M.D. or D.O.) by (the physician's assistant) PHYSICIAN'S ASSISTANT.

The name of the prescribing supervising physician shall be handwritten in the appropriate space by the physician's assistant on the prescription drug or device order form. Any form containing less information than that described in this paragraph shall not be offered to or accepted by any pharmacist who is duly licensed under Title 26.

 

3. N.J. Stat. Ann. § 45:9-27.19:  Controlled dangerous substances may be ordered or prescribed, if among other things, the prescription states whether it is written pursuant to protocol or specific physician direction.

 

4. Wy. Rules & Regs. AI PDSC Ch. 6 § 4:  Effective January 1, 2007, all controlled substance prescriptions written by a Wyoming practitioner shall be issued on security paper. Any controlled substance prescriptions written by a Wyoming practitioner issued on non-security paper may not be dispensed by a pharmacist if signed after January 1, 2007. Any written, typed or computer generated prescription issued by a Wyoming practitioner for a schedule II-V controlled substance except those issued as a medication order for administration in a long-term care facility or institutional facility shall meet the following requirements: (i) Shall be printed on security paper, which includes the following features: (A) If scanned or copied, "void" is displayed prominently throughout the front side of the document; (B) Erasure protection on green or blue background is utilized on the front side; (C) Clear instructions printed on the paper indicating the front and bacfk sides; and (D) Security warning list on the blank.




 

 

Last Revised: 9/24/08