Category Archives: Medical Licensing

TELEMEDICINE IN CALIFORNIA

DOES THE LAW STRANGLE ATTEMPTS TO SAVE COSTS THROUGH TELEHEALTH?

Telehealth can take different forms.  It’s one thing to offer consultations and second opinions.  But once this useful tool is utilized for diagnosis and treatment, the rules change.

How can a compnay offer telemedicine, including diagnosis, treatment and prescriptions in California?  Does the physician have to be licensed?  How does a telemedicine company avoid the corporate practice of medicine doctrine?

THE PHYSICIAN MUST BE LICENSED IN CALIFORNIA

California’s Medical Board describes telehealth as: “Telehealth (previously called telemedicine) is seen as a tool in medical practice, not a separate form of medicine. There are no legal prohibitions to using technology in the practice of medicine, as long as the practice is done by a California licensed physician.”

Telehealth is not a telephone conversation, email/instant messaging conversation, or fax; it typically involves the application of videoconferencing or store and forward technology to provide or support health care delivery.” One statute states: Any law allowing telehealth shall not be construed to alter the scope of practice of any health care provider.

THE CORPORATE MEDICINE DOCTRINE

California prohibits the corporate practice of medicine, which among other things, requires that business or management decisions and activities resulting in control over a physician’ practice of medicine, be made by a licensed California physician and not by an unlicensed person or entity. In order to avoid the direct violation of state prohibitions on the corporate practice of medicine.  While there are legal structures that may promote non-physician investment in telehealth, (many companies use the so-called “friendly PC” model).

Enforcement by the medical board regarding the prohibition against the corporate practice of medicine generally is inconsistent.
Although there is no hard and fast rule as to when a given arrangement may be deemed to constitute corporate practice, the focus in any enforcement action likely will be on the level of control a physician exercises over the operation of the medical practice, specifically the professional judgment of licensed health care professionals. Where a high level of control exists, the arrangement may be found to be a sham intended to disguise the de facto practice of medicine by an unlicensed entity.

By Matt Kinley, Esq.

Reporting Physician Office Controlled Substance or Prescription Abuse

Physician offices often are hit with an internal crime:  employees utilize the office, its forms, the doctors DEA Number, or even the computers to write unauthorized prescriptions. The physician’s office has the obligation to make sure that forms, computers, and other tools utilized to write prescriptions are carefully safeguards.  Attorneys and malpractice carriers can be consulted for the best practices.

Health and Safety Code Section 11368 states that anyone who forges or alters a prescription or who obtains any narcotic drug by a forged, fictitious, or altered prescription may be punished by imprisonment in the county jail or state prison for not less than six months or more than one year. Since prescription forgery is considered a criminal offense, it is recommended that a report be made to the local law enforcement.

The California Medical Board provides some specific advice:

Federal law requires physicians to report theft or loss of controlled substances and official Federal Order Forms (Form 222) to a regional office of the Drug Enforcement Administration. The DEA has offices located in Los Angeles, San Diego and San Francisco and the office addresses and phone number are available through their website. In addition, the DEA has their reporting forms available online at the following link: http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html.

While neither the Medical Board nor state law requires that a report of stolen or illegal use of the physician’s DEA number be made to the Board, it is our recommendation that physicians provide the Medical Board with a written narrative of the circumstances and the actions taken by the physician so we may have this information on file. When the written narrative is received, this valuable information will be input into the Medical Board’s internal database for reference, as it is not unusual to receive complaints from pharmacists or law enforcement officers regarding concerns about physicians’ prescribing practices. If a physician has already reported that he/she has experienced a problem related to the illegal use of his/her DEA number, the Board has already been provided with background information on the problem. The written narrative should be forwarded to the Medical Board of California, Central Complaint Unit, 2005 Evergreen Street, Suite 1200, Sacramento, CA 95815.

Once the information has been processed, the physician will receive correspondence from the Central Complaint Unit containing their assigned “Conl Number,” which should be maintained for their records. A carbon copy of this correspondence will also be forwarded to the California Board of Pharmacy so they may notify pharmacies in the physician’s surrounding area of the incident. The notified pharmacies will then contact the physician to verify any prescriptions they receive on the physician’s prescription pad or using the physician’s DEA number. For additional questions or concerns regarding this issue, please contact the Central Complaint Unit through the Medical Board’s toll-free number, 1-800-633-2322.

In addition to the above, if the physician is aware of the theft or loss of the tamper-resistant prescription forms, the State Department of Justice, Bureau of Narcotic Enforcement must be notified. To report the theft or loss of the new tamper-resistant prescription forms, Form JUS MUST be completed. Please complete all applicable fields on the form and forward the form to: California Department of Justice, Bureau of Narcotic Enforcement, CURES Program, P.O. Box 160447, Sacramento, California, 95816, FAX: (916) 319-9448. If you have additional questions or concerns regarding lost or stolen tamper-resistant prescriptions forms, please contact the CURES Program at (916) 319-9062.

Matt Kinley, Esq. 

What’s the difference: Physician Assistant v. Nurse Practioner

As the need for health care has expanded, there has been an increase in demand for employees and professionals in the medical field. Therefore, there are a variety of health care jobs and careers. Two key positions in the health care field that have contributed to addressing the looming physician gap are Physician Assistants and Nurse Practitioners. Because both job descriptions have notable similarities, there can be some confusion between the differences in purpose and the roles between a Physician Assistant and Nurse Practitioner. However, there are notable differences.

In California, both Physician Assistants and Nurse Practitioners are regulated according to state regulations. The main difference between a Physician Assistant and Nurse Practitioner is the education received. Physician Assistants are trained more similarly to that of a Physician where a Nurse Practitioner skills are advanced under the nursing-centric education model. Physician Assistants get extensive training in treatment and diagnosing ailments for patients and conversely, the nursing-centric education model that Nurse Practitioners are exposed to focuses on a holistic approach to management of patients.

A Physician Assistant is a medical professional who has been authorized to practice medicine. Specifically, a Physician Assistant can conduct physical examinations, diagnose patients, provide treatment including setting broken bones, obtain medical histories, perform procedures, assist in surgery, and make regular rounds in hospitals and nursing homes. Physician Assistants must be certified to practice. Generally, masters programs for Physician Assistants are modeled on the medical school curriculum combining both classroom lectures and clinical training. Physician Assistants must be supervised by a Physician as established by Title 16 of the California Code of Regulations Section 1399.545. Moreover, a Physician Assistant may only provide medical services in which they are competent to perform and which are consistent with their education (Cal. Code Regs. tit. 16, § 1399.540).

On the other hand, a Nurse Practitioner is a registered nurse with an advanced education—usually a masters degree in nursing. A Nurse Practitioner specializes in disease prevention, promotion of health and education, and diagnosis and management of chronic diseases. Nurse Practitioners utilize a holistic approach to management of patients and overall care. Title 22 of the California Code of Regulation Section 51170.3 requires that Nurse Practitioners be licensed and certified under the Board of Registered Nursing. Moreover, Nurse Practitioners can further specialize and hold themselves out as family or pediatric Nurse Practitioners (Cal. Code Regs. tit. 22, § 51170.3). Unlike that of a Physician Assistant, in California, Nurse Practitioners do not need to be under direct supervision of a Physician.

As the demand for medical treatment grows, the importance of mid-level practitioners including Physician Assistants and Nurse Practitioners increases. It is apparent that there are overlapping skills between the two careers, however, a Physician Assistant concentrates on medical treatment whereas a Nurse Practitioner provides overall care management for patients.

CALIFORNIA MEDICAL BOARD: PHYSICIANS BEWARE OF PRESCRIPTION ABUSE

The California has posted a public service announcement video with information for physicians for prescription drug abuse.  It’s on youtube:

 

THE ACA AND NURSE PRACTITIONERS UNDER CALIFORNIA LAW

NURSE PRACTITIONERS REQUIRE SOME DUE DILIGENCE

The ACA utilizes the idea of non-physician professionals to help bridge the gap presented by having insufficient physicians to handle patients.  It is hoped that utilizing these professionals will help increase communications with patients, particularly chronic patients who could avoid hospital stays by seeing a nurse practitioner for an office visit or even email communication with a knowledgeable professional  Finally, utilizing non-physicians should lower costs.

In California, this presents some major issues.  California carefully regulates the use of such professionals, particularly nurse practitioners.    Specialists need to  pay attention to creating the right environment for such professionals.  Standardized Procedures should be updated to conform to the needs of the practice.  The California Code of Regulations (Title 16, section 1472) requires physicians to have “standardized procedures” before permitting registered nurses to perform treatments and procedures.  The purpose of the standardized procedures is to establish policies and protocols for NPs so that they are able to perform their authorized duties.  It is particularly important to update these standardized procedures because your NP will most likely be characterized as your employee, which will expand the scope of your liability for her acts.

California Code of Regulations Title 16, section 1474 establishes specific guidelines for the standardized procedures and provides that each standardized procedure must:

v    Be in writing.

v    Specify which functions the nurse may perform and under what circumstances.

v    State specific requirements to be followed by the nurse in performing specific functions.

v    Specify experience, training, and education requirements for the performance of the procedure function.

v    Establish a method for initial and continuing evaluation of the competence of the registered nurse.

v    Provide for a method of maintaining a written record of who is authorized to perform standardized procedure functions.

v    Specify the scope of supervision required for performance of standardized procedure functions.

v    Set forth specialized circumstances under which the nurse is to immediately communicate with the patient’s physician concerning the patient’s condition.

v    State the limitations on settings.

v    Specify patient record keeping requirements.

v    Provide for a method of periodic review of the standardized procedure.

 

            (a)       Furnishing Scheduled Drugs

                        Of particular importance are the standardized procedures on Furnishing Scheduled Drugs.  California law requires that you specifically list “which drugs or devices may be furnished or ordered” and “under what circumstances.”  (Bus. & Prof. Code, § 2836.1(c)(1).)  We recommend to physicians that they review the “List of Scheduled Drugs” to ensure that it is consistent with the drugs that the NP may prescribe to patients.  

            (b)       Dispensing Hormonal Contraceptives

                        California law also has strict guidelines for a nurse’s dispensation of self-administered hormonal contraceptives.  In order to administer hormonal contraceptives, your practice must have standardized procedures developed in compliance with Business and Professions Code section 2725.2.  These standardized procedures must include, but are not limited to, the following:

v    Which nurse may dispense the hormonal contraceptive.

v    Minimum training requirements regarding educating patients on medical standards for ongoing women’s preventative health.

v    Competency in providing the appropriate prior examination of checking blood pressure, weight, and patient and family health history, including medications taken by the patient.

v    List of the contraceptives that may be dispensed or administered under specific circumstances.

v    Criteria and procedure for identification, documentation, and referral of patients with contraindications for hormonal contraceptives and patients in need of a follow-up visit to a physician and surgeon, nurse practitioner, certified nurse-midwife, or physician assistant.

v    The extent of physician and surgeon supervision requested.

3.         Ensure that Your Nurse Practitioner is “Clinically Competent”

           NPs  must be “clinically-competent” to treat a particular population.  Standardized procedures should establish a method for the continuing evaluation of the competence of your NP to perform the specified procedures.

Following these procedures will help you utilize nurse practitioners to help your patients.  You will also avoid accusations of failing to follow state law in guiding the NPs to perform as if they were an extension of your care.

BY:  Matt Kinley, Esq,

ALL THE AGENCIES THAT REGULATE HEALTHCARE ALL IN ONE PLACE!

Oversight of Health Care Industry

HEALTHCARE LAW UPDATE, 2014: PHARMACISTS SEE MORE CLOUT

This is second in a series of new 2024 laws affecting healthcare in California. 

SB 493: New Authority to Pharmacists

One of the key goals of the Accountable Care Act was to to increase utilization of professionals other than doctors.  One way to do that is to expand the authority of pharmacists to perform certain tests and to administer drugs.

This new law gives pharmacists new clout as “health care providers” who can now administer drugs by injection, provide training on drug therapy and disease management and prevention, furnish contraceptives, nicotine replacement products, medications recommended for travel outside the US, order certain tests, and initiate, adjust or discontinue drug therapy (but may not interfere with “as written”).

Devolving  physician authority to other professionals, including nurse practitioners, physician assistants and pharmacists, is an experiment with some risk.  It is clear that these professionals will be able to fill some gaps left by overly busy physicians.  However, there is likely to be less quality and the overall effectiveness of healthcare may follow.  The provision regarding the administration of international travel drugs will likely the pocket books of those physicians who derive economic benefit from this part of their practice.

 

BEST PRACTICES TO AVOID PAIN KILLER ABUSE BY PATIENTS IN THE MEDICAL OFFICE

This is the third in a series of articles on
avoiding fraud and theft in healthcare professionals
offices.
The article is meant for medical professionals including physicians,
dentists, home nursing and mental health professionals. If you have any
questions about this series, feel free to contact attorney Matthew L. Kinley, a
healthcare lawyer in Long Beach, California at 562.901-3050

           Practices in California should be wary
of prescribing pain killers for their patients.
The Medical Board has told various audiences that they are reviewing
physicians who prescribe such medications, and will review patient files for
abuse.

           There is good reason for the Medical
Board to be concerned: There has been great abuse by patients who utilize pain
killers.  There has also been an epidemic
of deaths caused by such abuse.  One
estimate has it that American physicians prescribe enough pain killers to
medicate every American around the clock for a month.

           In order to avoid a visit by the
Medical Board, or to be prepared if they do visit,  and to make sure that your painkiller practice
is beneficial for patients, physician offices should adopt protocols to make
sure that patients actually need the painkillers you prescribe.  Such protocol will help keep prescribed drugs
making it on the black market.

 Action Items to Protect Your Practice:

 1. Carefully
document the patient chart.  Carefully
explain the side effects of the prescription, and for long term use, the
potential detrimental effects of potential addiction.

 2. Screen
and monitor for substance abuse and mental health problems.

 3. Be
vigilant for scams and identity theft.

 4. Prescribe
pain killers only after examining the patient.

           California Business and Professions
Code provides some guidance.  Section
2242 provides  that it is
“unprofessional conduct” to prescribe or furnishing dangerous drugs without
an appropriate prior examination and a medical indication.

 5.  Only prescribe painkillers after other treatments
have not been effective for pain.

 6.  Use legally required form. California Healt  & Safety Code section 11162.1 provides standards
for prescription forms for controlled substances. 

Limit the
number of pills prescribed. 

 7. The
quantity prescribed should be based on the expected length of pain.California
Health Safety Code section 11158 provides for limits on number of pills
(“may dispense directly to an ultimate user a controlled substance
classified in Schedule II in an amount not to exceed a 72-hour supply for the
patient in accordance with directions for use given by the dispensing
practitioner only where the patient is not expected to require any additional
amount of the controlled substance beyond the 72 hours. )

 8. Using
patient-provider agreements combined with urine drug tests for people using
painkillers long term.

 9.  Talking with patients about safely using,
storing and disposing of prescription of painkillers.  (www.cdc.gov/homeandrecrationalsafety/poisoning/preventiontips.htm)

 10.  Check the prescription monitoring programs with the California Attorney
General.

 

By Matthew L. Kinley, Esq.

 

Matt Kinley On HIPAA Final Rule: Talk before Orange County Medical Group Management Association

OCMGMA: HIPAA Update

Tuesday, June 11, 2013 (12:00 PM – 1:30 PM)

Presented by: Kathleen Stillwell, MPA/HSA, RN, CPHRM Patient Safety
Risk Management Account Executive, The Doctors Company, and Matthew
Kinley, Esq.,  Partner, Tredway Lumsdaine & Doyle, LLP

Program Information:

The new HIPAA Omnibus Rule
includes new breach notification requirements; limits for use and
disclosure of Protected Health Information (PHI), defined Business
Associates and Subcontractors, increased Patient Rights, change in the
Notice of Privacy Practice, increased fines and penalties, and other
important changes. There is a new focus on investigating and penalizing
noncompliance due to “willful neglect.”

The Office of Civil Rights will begin enforcement of the Omnibus Rule September 23, 2013.

Attend this session to learn what actions your practice must take to meet the new federal compliance regulations.

Objectives:

  • Describe new limits on uses and disclosures of PHI
  • Recognize Business Associates and Subcontractors
  • Explain increased Patient Rights
  • Outline action steps for compliance with Omnibus Rule

Kathleen Stillwell Bio       Matt Kinley Bio

RSVP to Maria Taylor at 714-937-2182 or mtaylor@osiortho.com.
Cost: Members – $25, Non-Member managers – $35, Members Vendors and
Vendors who attend the first time – $50. Other Non-Member vendors – $95.

1.0 CEU Available from ACMPE

Investigations by the California Medical License Board: What Happens and What You Can Do

The California Medical Board issues licenses which it can deny, revoke, suspend, or place on probation. 

The Board investigates complaints or reports which may involve a violation of the Medical Practices Act.  Investigations are generally conducted by investigators, in consultation with deputy attorneys general, medical consultants, and medical experts employed by the Board.  The initiation of the investigation is not evidence of guilt.  There can be numerous bases for accusations, most frequently including negligence due to patient quality of care, prescribing violations, substance abuse, sexual misconduct or from convictions of a crime. 

Board investigators have peace officer authority. California Penal Code §830.3.  This means they can subpoena documents they deem necessary for their investigation.  Board investigations often span for more than a year.  At the investigation, licensed physicians are investigated by investigators with badges, guns and Board-paid medical consultants.  Sometimes this is at the Board's office or at the doctor's office.  They may request records or for voluntary mental examinations.  These are similar to depositions and are recorded. 

If the investigation produces evidence that a physician appears to have violated the Medical Practice Act, the Board transmits the case file to the Health Quality Enforcement Section of the Office of the Attorney General.   A Deputy Attorney General drafts a formal accusation and represents the Board in any subsequent disciplinary proceedings.  When a Statement of Issues or Accusation is filed by the Attorney General's Office, the doctor must prepare to defend him or herself before an Administrative Law Judge.  The information contained in a formal accusation is public record.  Some offenses may be resolved through a public record of reprimand, citation and fine or other actions. California Bus. and Prof. Code §2233

By law, a physician has a right to a hearing when formal charges are filed.  If a physician chooses to contest the charges in an accusation, he or she may request an administrative hearing conducted by an administrative law judge.  The hearing will result in a proposed decision that is submitted to the Board for final decision.

The Board must act on the proposed decision within 90 days to either adopt it, modify it, or substitute an alternate decision.  If the Board wishes to impose a more stringent penalty, each member must read the transcript of the hearing.  Final decisions are public record. 

Prior to the hearing, the physician may be offered an opportunity to negotiate a resolution to an accusation.  If this is done, a proposed stipulated decision is prepared by the parties and submitted before the Board.  Then the Board may adopt the stipulated decision or make changes. 

Discipline of a Physician’s License by the Board is governed by California Business and Professions Code §2227.  Disciplinary action taken against a physician’s license may take any of the following forms:

“(1) Have his or her license revoked upon order of the board.

(2) Have his or her right to practice suspended for a period not to exceed one year upon order of the board.

(3) Be placed on probation and be required to pay the costs of probation monitoring upon order of the board.

(4) Be publicly reprimanded by the board. The public reprimand may include a requirement that the licensee complete relevant educational courses approved by the board.

(5) Have any other action taken in relation to discipline as part of an order of probation, as the board or an administrative law judge may deem proper.

(b) Any matter heard pursuant to subdivision (a), except for warning letters, medical review or advisory conferences, professional competency examinations, continuing education activities, and cost reimbursement associated therewith that are agreed to with the board and successfully completed by the licensee, or other matters made confidential or privileged by existing law, is deemed public, and shall be made available to the public by the board pursuant to Section 803.1.”

There are ways to reinstate a surrendered or revoked California Medical License through a petition and following certain statutory waiting periods.

What to do if you are being investigated:

It is important that if you are being investigated, you consult with an attorney to guide you on how to handle responding.  Depending upon the nature of the investigation, we may recommend to you that you enroll in a particular Board approved program to avoid a formal accusation being filed against you and communicate that to the Board initially.  If a formal accusation is filed against you, you will need to work with your attorney to prepare for a hearing and retain several experts early on to support your defenses.   

Written by Pamela Tahim