Massachusetts state laws and regulations that affect your medical practice
I UNLICENSED PHYSICIAN AIDES
1. What tasks may a physician direct his or her unlicensed employee to administer?
The following activities may be delegated provided it is done in compliance with State regulation:
B. Collection, reporting, and documentation of simple data; and
C. Activities which meet or assist the patient in meeting basic human needs, including but not limited to nutrition, hydration, immobility, comfort, socialization, rest, and hygiene.
244 MA ADC 3.05
The following activities may not be delegated:
A. Nursing activities requiring nursing assessment and judgment during implementation;
B. Physical, psychological, and social assessment requiring nursing judgment, intervention, referral, or follow-up;
C. Formulation of the plan of nursing care and evaluation of the patient's response to the care provided; and
D. Administration of medications.
2. May a physician bill for the services rendered by an unlicensed assistant?
While there is no specific State law addressing this issue, physicians are encouraged to contact third party payors and get written confirmation prior to billing for such services. For self-pay patients, physicians should establish written financial policies which address billing for services rendered by unlicensed personnel in accordance with State law.
II. LICENSED PHYSICIAN ASSISTANTS
1. What qualifications must an assistant have to be licensed as a physician assistant?
The Board of Physician Assistants (Board) will issue a physician assistant license to an applicant if the following requirements are met. The applicant must:
A. Be of good moral character;
B. Be a graduate of an approved program;
C. Possess a Bachelor's Degree;
D. Have graduated from a Physician Assistant program approved by the Commission on Accreditation of Allied Health Education Programs;
E. Have taken and passed the National Commission for Certification of Physician Assistants examination;
F. Agree to register biennially with the Board; and
G. Ensure that any continuing education requirements have been completed as are required under the law.
263 MA ADC 3.02
2. Who may employ a physician assistant?
A physician assistant may be employed by a physician, a health care facility or institution.
3. What regulations must the employer of a physician assistant follow?
A. A physician must supervise the activities of a physician assistant. A supervising physician may supervise no more than two physician assistants at a time. A supervising physician must provide supervision adequate to assure that:
1. the physician assistant provides medical services in accordance with accepted medical standards (Note that Massachusetts does not require the physical presence of the supervising physician whenever a physician assistant renders medical services.)
2. the physician assistant, except in life-threatening emergencies and when no physician is available, informs each patient that he or she is not a physician and that a physician assistant renders medical services only under the supervision of a physician.
3. the physician assistant wears a name tag which identifies him or her as a physician assistant.
4. the supervising physician reviews diagnostic and treatment information, as agreed upon by the supervising physician and the physician assistant, in a timely manner consistent with the patient's medical condition.
5. on follow-up care, hospital visits, nursing home visits, attending the chronically ill at home, and in similar circumstances in which the supervising physician has established a therapeutic regimen or other written protocol, the physician assistant checks and records a patient's progress and reports the patients's progress to the supervising physician. Supervision is adequate under this subsection 5 if it permits a physician assistant who encounters a new problem not covered by a written protocol or which exceeds established perimeters to initiate a new patient care plan and consult with the supervising physician.
6. in an emergency, the physician assistant renders emergency medical services necessary to avoid disability or death of an injured person until a physician arrives.
B. When a supervising physician is unable or unavailable to be the principal medical decision maker, another licensed physician must be designated to assume temporary supervisory responsibilities of a physician assistant. The name and scope of responsibility for the physician providing the temporary supervision must be readily ascertainable from the records kept in the ordinary course of business which are available to patients. he supervising physician(s) of record is ultimately responsible for insuring that each task performed by a physician assistant is properly supervised.
243 MA ADC 2.08
C. A physician who supervises a physician assistant engaged in prescriptive practice must do so in accordance with written guidelines mutually developed and agreed upon with the physician assistant, and signed by both parties. uch guidelines must be reviewed annually, and dated and initialed by both the supervising physician and the physician assistant at the time of each review. he guidelines may be altered at any time upon agreement by the supervising physician and physician assistant; any such changes must be initialed and dated by both parties.
In all cases, the written guidelines must:
1. identify the supervising physician;
2. include a defined mechanism for the delegation of supervision to another physician including, but not limited to, duration and scope of the delegation;
3. specifically describe the nature and scope of the physician assistant's practice;
4. identify the types and classes of medication(s) to be prescribed, specify any limitations on medications to be prescribed, indicate the quantity of any medications including initial dosage limits and refills, and describe the circumstances in which physician consultation or referral is required;
5. include a defined mechanism to monitor prescribing practices, including documentation of review by the supervising physician at least every three months;
6. include protocols for the initiation of intravenous therapies and Schedule II drugs;
7. specify the frequency of review of initial prescriptions or changes in medication of controlled substances; any prescription or medication order issued by a physician assistant for a Schedule II controlled substance must be reviewed by his supervising physician, or by a temporary supervising physician within 96 hours after its issuance;
8. specify the types and quantities of Schedule VI medications which may be ordered by the physician assistant from a drug wholesaler, manufacturer, laboratory or distributor for use in the practice setting in question;
9. identify and specify any limitations on the initiation and/or renewal of prescriptions which are not within the ordinary scope of practice for the specific work setting in question, but which may be needed to provide appropriate medical care; and
10. conform to the regulations of the Massachusetts Department of Public Health.
243 MA ADC 2.08; 263 MA ADC 5.05
4. What duties may a physician assistant perform?
A. Those services which are within the competence of the physician assistant as determined by the supervising physician's assessment of his or her training or experience and within the scope of services for which the supervising physician can provide adequate supervision to insure that accepted medical standards are followed;
B. Approaching patients of all ages and with all types of conditions;
C. Eliciting histories;
D. Performing examinations;
E. Performing and interpreting diagnostic studies;
F. Performing therapeutic procedures, instruct and counsel patients regarding physical and mental health issues;
G. Responding to life-threatening situations; and
H. Facilitating the appropriate referral of patients consistent with his or her supervising physician's scope of expertise and responsibility and delegated to him or her by the supervising physician.
I. Where major invasive procedures are involved, such procedures must be identified and undertaken under specific written protocols, available to the Board upon request, developed between the supervising physician and the physician assistant, which, inter alia, must specify the level of supervision the service requires, e.g., direct (physician in room), personal (physician in building), or general (physician available by telephone).
243 MA ADC 2.08
5. What is a physician assistant prohibited from doing?
A physician assistant may not:
A. Give general anesthesia;
B. Perform procedures involving ionizing radiation; or
C. Render a formal medical opinion on procedures involving ionizing radiation.
243 MA ADC 2.08
III. NURSE PRACTITIONER
1. What qualifications must an individual have to be a nurse authorized to practice in the expanded role (NP)?
The Massachusetts Board of Registration in Nursing (Nursing Board) will issue a nurse practitioner (NP) license to an applicant if he or she:
A. Is of good moral character;
B. Holds a current State license as a registered nurse by :
1. graduating from a school of nursing approved by the Nursing Board; and
2. passing a licensing examination.
In lieu of State licensure, the applicant may show proof of satisfactory completion of a formal educational program for registered nurses which has been approved by a national professional nurses accrediting body which the Nursing Board recognizes as such;
3. having advanced nursing knowledge and clinical skills acquired through an appropriate nursing education program (the Nursing Board will accept in satisfaction of this requirement only those educational programs whose attendance and training requirements are the equivalent of at least one academic year); and
4. having a current certification by a nationally recognized accrediting body approved by the Nursing Board for nurse practitioners.
MGLA 112 §74, 80B; 244 MA ADC 4.13; 244 MA ADC 2.010
2. What duties may be performed by a NP?
An NP may do the following:
A. Diagnose and treat illnesses and injuries;
B. Perform physical examinations;
C. Order and interpret diagnostic tests; and
D. Provide counseling and education.
E. A NP may engage in prescriptive practice if he or she has:
1. authorization to practice in the expanded role;
2. a minimum of 24 contact hours in pharmacotherapeutics which are beyond those acquired through a generic nursing education program; and
3. valid registration(s) to issue written or oral prescriptions or medication orders for controlled substances from the Massachusetts Department of Public Health and, where required, by the U.S. Drug Enforcement Administration.
244 MA ADC 4.05; 244 MA ADC 4.13
3. What are the requirements for issuing prescriptions and orders; dispensing medications?
A. All NPs who seek prescriptive authority must register with the Massachusetts Department of Public Health- Drug Control Program (DPH-DCP).
B. All NPs who prescribing controlled substances in Schedules II - V, must also obtain a Drug Enforcement Administration (DEA) registration number. To be eligible for a DEA number an NP must have a state Controlled Substance Registration Number or have an application pending for it from the DPH-DCP.
C. The supervising physician and NP must develop written guidelines which address which drugs may be prescribed.
D. The supervising physician must review the NP's prescribing practice at least every three (3) months with the exception that initial prescription of Schedule II drugs must be reviewed within 96 hours. Prescribing guidelines must also include how frequently the nurse and supervising physician will review initial prescriptions issued by the nurse, how this will be done, and how it will be documented.
243 MA ADC 2.10; 244 MA ADC 4.0
E. A prescription made by a nurse practitioner must include the following:
1. the registration number of the practitioner;
2. date of issuance of the prescription;
3. name, dosage, and strength per dosage unit of the controlled substance prescribed, and the quantity of dosage units;
4. name and address of the patient, except in a veterinary prescription;
5. directions for use, including any cautionary statements required; and
6. the name of the physician with whom the prescribing NP has developed and signed mutually agreed upon agreement or guidelines.
M.G.L.A. 94C 9; 105 MA ADC 721.02
4. What are the standards for joint protocols (guidelines) between NP and collaborating physicians?
A. All NPs must practice in accordance with written guidelines developed in collaboration with and mutually agreeable to the NP and physician who has the appropriate training or experience in the NP's area of practice in the case of the nurse in the physician's office and in private practice.
B. A supervising physician must sign prescriptive practice guidelines only with those nurses for whom he/she is able to provide supervision, taking into account factors including, but not limited to geographical proximity, practice setting, volume and complexity of the patient population, and the experience, training and availability of the supervising physician and the nurse(s).
C. A supervising physician must not enter into guidelines with an NP, unless the NP has professional malpractice liability insurance with coverage of at least $100,000.00 per claim, with a minimum annual aggregate of not less than $300,000.00. This requirement does not apply in circumstances where guidelines limit the NP to engage in prescriptive practice in or on behalf of federal, state, county or municipal health care facilities.
243 MA ADC 2.10; 244 MA ADC 4.22
D. In all cases, the guidelines must:
1. be in writing;
2. identify the supervising physician;
3. include a defined mechanism for the delegation of supervision to another physician including, but not limited to duration and scope of the delegation;
4. specifically describe the nature and scope of the nurse's practice;
5. identify the types of medication(s) to be prescribed, specify any limitations on medications to be prescribed, and describe the circumstances in which physician consultation or referral is required;
6. describe the use of established procedures for the treatment of common medical conditions which the nurse may encounter;
7. include provisions for managing emergencies;
8. include a defined mechanism to monitor prescribing practices, including documentation of review by the supervising physician at least every three months;
9. include protocols for the initiation of intravenous therapies and Schedule II drugs; and
10. specify the frequency of review of initial prescription of controlled substances; the initial prescription of Schedule II drugs must be reviewed within 96 hours.
243 MA ADC 2.10; 244 MA ADC 4.22
5. What is the penalty for failure to establish and implement joint protocols consistent with the standards set forth by the Board?
Any violation of the guidelines by the NP or physician may be deemed professional misconduct or other grounds for disciplinary sanction by his or her respective licensing board.
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.