New Law Alert
No. 13 
August 2005
California edition

• “Keepsake” fetal ultrasounds
• Detecting congenital heart defects
• Physician assistants and Schedule II drugs
• Nurse practitioners furnishing drugs or devices
• Retired physicians with “active” status
• Pharmacists and physicians can now furnish hypodermic needles
• Complementary and alternative medical treatment or advice
• MBC Claims Investigation
• Pharmacists who prescribe
• Podiatrists’ scope of practice expanded
• To reach MIEC

The California Legislature recently enacted a number of new laws affecting physicians, nonphysician clinicians, pharmacists, and patients. Effective January 1, 2005 (unless noted otherwise): keepsake ultrasounds for entertainment purposes must include a written disclosure; sonographers must comply with certification or training criteria; physician assistants can order Schedule II drugs under certain circumstances; nurse practitioners can furnish drugs in health facilities; retired physicians who volunteer may be due a refund from the MBC; pharmacists and physicians can furnish hypodermic needles; physicians’ CAM advice must meet criteria; MBC requires physicians’ timely response; and more.

Fetal ultrasound as “keepsake”  

Newly enacted Health & Safety Code §123620 requires that a person or facility that offers fetal ultrasound, or a similar procedure, for a “keepsake” or for entertainment purposes must disclose in writing the following statement: “The federal Food and Drug Administration has determined that the use of medical ultrasound equipment for other than medical purposes, or without a physician’s prescription, is an unapproved use.”
[Article 4.5 (commencing with Section 123620) is added to Division 106, Chapter 2, Part 2 of the Health & Safety Code]

Sonography to detect congenital heart defects

Effective July 1, 2006, sonographers who perform ultrasounds to detect congenital heart defects in a health facility licensed to do so must be in compliance with one of the following certifications or training criteria:

(1) American Registry for Diagnostic Medical Sonography (ARDMS) obstetrical ultrasound certification;

(2) Cardiovascular Credentialing International (CCI) cardiac sonography certification; 

(3) American Registry of Radiologic Technologists (ARRT) sonography certification; or

(4) have a minimum of two years full-time work experience as a prenatal ultrasound sonographer and have obtained, or be in the process of obtaining, thirty (30) continuing medical education credits over a three-year period in ultrasound.

The work must be performed under the supervision of a licensed physician or surgeon.
[Health & Safety Code §1264]

Physician assistants and Schedule II drugs

Business & Professions (B&P) Code §3502.1 outlines under what circumstances physician assistants (PA) can order or furnish Schedule II drugs.

Before a PA can provide any prescription, the supervising physician and surgeon must “prepare and adopt ... a written, practice-specific, formulary and protocols that specify all criteria for the use of a particular drug or device, and any contraindications for the selection.” [B&P Code §3502.1(a)(2)] The drugs listed will constitute the physician’s formulary and can include only medicines appropriate to the doctor’s or surgeon’s type of practice. The law clearly states that physician assistants are acting on behalf of the supervising physician and surgeon, and are their agents.

“A PA may not administer, provide or issue a drug order for Schedule II through Schedule V controlled substances without advanced approval by a supervising physician and surgeon for the particular patient.” A supervising physician and surgeon must counter-sign and date within seven (7) days the medical record of a patient for whom a PA issues a Schedule II drug order, a change from the previous law that required physician co-signatures for all Schedule II - V drug orders issued by these nonphysician clinicians. [B&P §3502.1(c)(2) and (e)] 

Nurse practitioners: Furnishing drugs or devices

Newly amended B&P Code §2836.1 expands the list of “health facilities” where nurse practitioners (NP) may furnish or order drugs or medical devices for patients. Primary, community, and free clinics were the principle venues until the recent amendment to the Code. Health and Safety Code §1250 defines “health facilities” as, “... any facility, place or building that is organized, maintained, and operated for the diagnosis, care, prevention and treatment of human illness, physical or mental, including convalescence, and rehabilitation ... care during and after pregnancy ... .” Facilities include: general acute care hospitals, acute psychiatric hospitals, skilled nursing facilities, intermediate care facilities, residential homes, and more.

The amended B&P Code also permits nurse practitioners to furnish or order drugs or devices in accordance with a standardized procedure or protocol developed by the NP and the supervising physician and surgeon “when the drugs or devices ... are consistent with the practitioner’s educational preparation or for which clinical competency has been established and maintained.” [B&P Code §2836.1(a)]

The law continues to require:

(a) A standardized procedure or protocol that defines which nurse practitioners may furnish drugs or devices, which drugs, under what circumstances, the extent of the physician and surgeon’s supervision, periodic review of the NP’s competence, and review of the protocol. The standardize procedure must also define when Schedule II controlled substances can be furnished.

(b) Physician and surgeon supervision.

(c) Limitation of four nurse practitioners per supervising physician and surgeon.

(d) Agreement between the physician and NP as to what Schedule II through V controlled substances may be furnished in accordance with a patient-specific protocol.

(e) A nurse practitioner’s completion of a course in pharmacology covering the drugs or devises to be furnished or ordered, and at least six months of physician and surgeon-supervised experience in furnishing or ordering drugs or devices.

(f) Continuing medical education, including a course that reviews Schedule II drugs.

Retired physicians with “active” status: The MBC may owe you money!

In November 2004, MIEC advised retired California policyholders:

“... physicians with ‘retired’ license status can no longer practice medicine in the state of California. If you want to volunteer, you must apply for a ‘volunteer’ license. A holder of a ‘volunteer’ license is exempt from annual licensing fees unless his/her medical license is currently delinquent. If delinquent, the applicant must pay all accrued renewal fees, delinquent fee, and penalty fee when submitting the application for a volunteer license. You also must fulfill continuing medical education (CME) requirements, unless the Medical Board of California (MBC) grants you a waiver. If you receive any money at all for the services you provide, you must maintain an ‘active’ license, pay licensing fees, and fulfill CME requirements. [Business & Professions Code §§2439 and 2442]”

The law requiring that all retired doctors switching to “active” status pay full licensing fees at the time they changed their license status has changed. Business & Professions §2439 has been amended to read, in part,

“(b) If a physician and surgeon has applied to convert from retired status to active status on or after January 1, 2004, but prior to January 1, 2005, the fee to change license status shall be waived, unless the change ... coincides with the physician and surgeon’s license renewal date. The board shall refund any fees paid by a physician and surgeon to change from retired to active status after January 1, 2004, and before January 1, 2005, unless the change in status coincides with the physician and surgeon’s license renewal date.” [emphasis added]

For more information about a possible licensing fee refund, contact the MBC’s Division of Licensing at 916/263-2382 or go to the website www.medbd.ca.gov.

Pharmacists and physicians to furnish hypodermic needles

Health and Safety Code (commencing with §121285) establishes the Disease Prevention Demonstration Project (DPDP), a collaboration between pharmacies that register for the project, and local and state health officials. DPDP was developed to evaluate the long-term “desirability of allowing licensed pharmacists to furnish or sell nonprescription hypodermic needles or syringes to prevent the spread of blood-borne pathogens, including HIV and Hepatitis C.”

Amended Business and Professions (B&P) Code §4145 allows a physician or pharmacist, without a prescription or permit, to furnish hypodermic needles or syringes to a person known to the furnisher “... and the furnisher has previously been provided a prescription or other proof of a legitimate medical need requiring a hypodermic needle or syringe to administer a medicine or treatment.” It is also permissible under this B&P Code for a pharmacist who works for a pharmacy registered with the DPDP to furnish or sell 10 or fewer hypodermic needles or syringes to a person 18 years of age or older.

DPDP registered pharmacies must certify that they will provide written information or oral counseling at the time they furnish or sell the needles or syringes. The education must include how to: access drug treatment; access testing and treatment for HIV and Hepatitis C; and how to dispose of sharps waste. For the latter, the pharmacies are required to provide one or more of the following disposal options:

(a) An onsite safe needle and syringe collection and disposal program.

(b) Mail-back sharps disposal containers (furnished or available for purchase) approved by the US Postal Service, and tracking forms to verify destruction at a certified disposal facility.

(c) Furnish or make available for purchase personal sharps disposal containers (furnished or available for purchase) that meet state and federal standards for disposal of medical waste.

The State Department of Health Services will evaluate the effects of the DPDP and provide a report to the Governor and Legislature on or before January 15, 2010.

Complementary and alternative medical treatment or advice

A physician and surgeon who provides complementary and/or alternative medical treatment or advice cannot be subject to a disciplinary action if treatment or advice meets all of the following conditions:

(a) It is provided after the doctor and patient have an informed consent discussion and the physician has performed a good-faith examination. A medical indication must be present for the treatment or advice, or it is “provided for health or well-being.”

(b) The physician and surgeon has given the patient information about conventional treatment and described his/her education, experience, and credentials related to complementary or alternative medicine.

(c) The treatment or advice does not cause delay in, or discourage, the traditional diagnosis of the patient’s condition.

(d) It does not cause death or serious bodily injury to the patient. [Business and Professions Code §2234.1]

MBC claims investigation: Contact MIEC immediately

In 2002, the California Legislature, under B&P Code §2220.1, allowed the appointment of an Enforcement Program Monitor, who was to “... monitor and evaluate the disciplinary system and procedures” of the Medical Board of California (MBC). After two years of observation, the monitor published her initial report in November 2004, in which she made sixty-five (65) recommendations for improvement to the Board’s Enforcement Program and Diversion Program. The Board reviewed the recommendations, two of which were implemented immediately in January 2005.

B&P Code §2319 set as a goal for the MBC, a six (6) month interval from the filing of a complaint with the Board to the completion of the investigation. The monitor found that it took an average of about sixty-six (66) days to obtain medical records and another sixty (60) days to schedule an interview with the physician, two activities that consumed two-thirds of the 180-day goal for completion of the MBC investigation.

B&P Code §2225.5 clearly states that when the MBC sends a physician a request for records, accompanied by the patient’s signed authorization for the release of records, the doctor has fifteen (15) days (30 for hospitals) within which to respond to the request or be assessed a civil penalty of $1000 per day for every day that the documents are not produced. Unless there is “good cause” for the delay, the MBC will pursue the civil penalties.

The monitor also found undue delay when a physician is asked to come to an MBC district office for an interview in conjunction with the MBC investigation; it took an average of sixty (60) days. As of January 2005, when the MBC contacts a physician to schedule an interview, the physician has 72 hours to respond. The interview must take place within 15 days. According to the MBC Action Report, January 2005, “If the physician fails to respond within 72 hours of the investigator’s call or fails to keep the scheduled appointment, a subpoena will be served to compel the physician to attend an interview at a time and date of the board’s choosing.”

MIEC advises California policyholders to immediately call the MIEC Claims Department in Oakland at 510/428-9411 or toll free at 800/227-4527 when contacted by the MBC. Do not delay.

Pharmacists to register for a DEA number

Recently amended B&P Code §§4040, 4053, 4060, 4061 and 4076, along with Health & Safety Code §§1150, now allow pharmacists to register for a DEA number and initiate or adjust a controlled substance or drug therapy, pursuant to the conditions prescribed in the existing law. 

Existing law also authorizes pharmacists to furnish, transmit and administer prescription medication; perform routine drug therapy-related patient assessment procedures, including temperature, pulse and respiration, ordering drug therapy-related lab tests; administer drug and biologicals by injection; and furnish emergency contraception drug therapy after completing a training program on emergency contraception drug therapy.

Pharmacists are also allowed to initiate or adjust the drug regimen of a patient as authorized by the patient's prescriber under express policies, procedures and protocols, or when functioning as part of a multidisciplinary group in a clinic setting, under a physician's supervision. Specially qualified pharmacists can initiate and adjust prescription drug therapies under protocols jointly developed by physicians and pharmacists. This authority applies to both controlled and non-controlled substances.

Podiatrists’ scope of practice expanded

Amended B&P Code §2472 clarifies the scope of practice for doctors of podiatric medicine. The Code, in part, authorizes them to perform limited amputations (without removing the entire foot) and treat ulcers or wounds of the lower leg related to conditions of the foot or ankle. 

We thank Phillip J. Goldberg, Esq., and Dexter B. Louie, Esq., of Hassard Bonnington, LLP, San Francisco, California, for their contribution, review, and advice for this edition of New Law Alert.

To reach MIEC