Take 5 before Taking the Fifth

On Friday, June 22, 2018, a Florida Appeals Court handed down its decision in Omulepu v. Department of Health Board of Medicine.  The case involved a doctor’s appeal from a decision by the Florida Department of Health, Board of Medicine to revoke a plastic surgeon’s right to practice medicine.  The main issue on appeal was the effect of the doctor’s invocation of his Fifth Amendment right not to incriminate himself.

In criminal proceedings, a defendant’s invocation of his Fifth Amendment privilege cannot be used against him.  Juries are instructed in criminal cases that they cannot draw any inference from a defendant’s refusal to testify.  Indeed, jury selection in a criminal case often focuses on ensuring a jury can and will follow this important safeguard.

But the issues are less cut and dried in the civil and administrative contexts.  Generally in civil cases, invocation of the Fifth Amendment results in an adverse inference against the invoker.  See Baxter v. Palmigiano, 425 U.S. 308 (1976), and its progeny.  To be sure, as warned in the concurring opinion in Omulepu, this is an inference only.  It must be combined with other evidence for a sustainable result and cannot serve as the sole basis for a verdict or decision.  But the inference is a powerful one nonetheless.

In Omulepu, the doctor claimed no such inference should have been permitted in his license revocation proceeding.  The Florida appeals court disagreed, and noting the existence of other evidence against the doctor, deemed the adverse inference both proper and probative.

Omulepu serves as a reminder to doctors facing administrative hearings and board suspensions, and lawyers counseling them, to factor carefully the pros and cons of an invocation of the Fifth Amendment. Often, the overarching concerns leading a doctor to invoke his right are simply too great, no matter the adverse inference or its consequences. But at the margins, there may be reasons to take 5 before taking the Fifth, and game out the consequences first.

 

 

 

2018 Bipartisan Budget Act Revises Stark Law Regulations – Part II

This is the second installment of a two-part series on the Bipartisan Budget Act. Part I discussed the Bipartisan Budget Act’s effect on Medicare Advantage health plans.

The Bipartisan Budget Act of 2018 (the “Act”), signed into law on February 9, 2018, contains an amendment that should cause physicians and healthcare providers to take note. Section 50404 of the Act, titled “Modernizing the Application of the Stark Rule under Medicare,” codifies recent Centers for Medicare and Medicaid Services (“CMS”) regulations and corresponding preamble that went into effect on January 1, 2016 (“2016 Final Rule”). These new provisions provide greater authority to the Secretary of Health and Human Services to grant waivers or exceptions under the law.

BRIEF BACKGROUND ON THE STARK LAW

The Stark Law prohibits a physician from referring Medicare patients for certain “designated health services” (“DHS”) to DHS providers if the physician (or an immediate family member) has a direct or indirect financial relationship with the DHS provider, unless one or more exceptions apply to the arrangement. The Stark Law also prohibits DHS providers from submitting claims to Medicare if the service was provided as a result of a prohibited referral.   Additionally, the Stark Law mandates that all entities furnishing services for which payment may be made under Medicare submit information on their reportable financial relationships to CMS or to the OIG.

Over the last few decades, the federal government and many state governments have increasingly scrutinized the financial relationships between health care facilities and physicians who refer patients or business to them.  Such relationships are prone to fraud and abuse because a physician may be more likely to make unnecessary referrals or otherwise over-utilize services if the relationship monetarily incentivizes him or her to do so.  Over-utilization not only results in higher costs to patients and payors, but also may adversely affect patient care.

THE ACT EASES STARK LAW REQUIREMENTS

Previously, arrangements between physicians and providers that were well-structured to comply with the Stark Law’s substantive requirements have nevertheless failed on technicalities—not being written or signed by the parties. With the passing of this Act, Congress aims to ease some of the burdens imposed by these technical requirements and, in turn, lower the instances of over-payments and self-reporting of violations to the government.

Specifically, the Act revised the Stark Law to indicate the following:

  1. The Writing Requirement. The writing requirement of various Stark Law compensation exceptions can be satisfied “by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties involved.” Previously, CMS had only indicated in a preamble to the 2016 Final Rule that a collection of documents could be relied upon to meet the writing requirement. This was not set forth in regulatory text. Now that this language is in the Stark Law statute, physicians and providers can more comfortably rely on a collection of documents to satisfy the exceptions’ requirements (such as appointment letters, time cards, pay stubs, copies of checks, etc.) to evidence a course of conduct between the parties, rather than formal written contracts.
  2. The Signature Requirement. If parties to an arrangement do not obtain the required signatures before the compensation arrangement is effective, they may do so within 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant (without regard to whether any referrals occur or compensation is paid during such 90-day period) and the compensation arrangement otherwise complies with all criteria of the applicable exception. This 90-day grace period is available for use only once every three years with respect to the same referring physician. This statutory language now aligns with the regulatory language in the 2016 Final Rule.
  3. Holdover Leases for Office Space, Rental of Equipment, and Personal Services Arrangements. Congress additionally offers relief for expired lease and personal services arrangements, providing that they may indefinitely meet the applicable Stark Law exceptions if the immediately preceding arrangement (a) expired after a term of at least one year, (b) met all the requirements of the exception when it expired, (c) continues on the same terms and conditions as the immediately preceding arrangement, and (d) continues to satisfy the conditions of the applicable exception. The corresponding regulatory language was updated in the 2016 Final Rule, which previously only permitted holdovers for up to six months.

Please see Part I of our installment which pertains to Medicare Advantage health plans.

 

2018 Bipartisan Budget Act: Greater Access, Innovation, and Technology in the Administration of Medicare Advantage Plans – Part I

This is the first installment of a two-part series on the Bipartisan Budget Act. Part II will discuss the Bipartisan Budget Act’s effect on the federal Stark Law.

Prior to adjourning for spring recess, Congress passed and the President signed into law on March 23, 2018, omnibus appropriations legislation that funds the government for the remainder of the fiscal year – through September 30. As part of the earlier negotiations to reach the budget deal, Congress passed and the President signed into law on February 9, 2018, the Bipartisan Budget Act, which included dozens of provisions to extend and modify a variety of health care measures.

Several of the provisions modify Medicare Advantage plans, specifically allowing for continued access to special needs plans for vulnerable populations; adapting benefits to meet the needs of chronically ill enrollees; expanding supplemental benefits for the chronically ill; increasing convenience through telehealth; and, changes to the calculation of star ratings for consolidated plans.

Here are summaries of the five sections of the Bipartisan Budget Act pertaining to Medicare Advantage Plans[1]:

TITLE III – CREATING HIGH-QUALITY RESULTS AND OUTCOMES NECESSARY TO IMPROVE CHRONIC (CHRONIC) CARE

Subtitle B – Advancing Team-Based Care

Section 50311. Providing continued access to Medicare Advantage special needs plans for vulnerable populations. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA; P.L. 108-173) established a new Medicare Advantage (MA) coordinated care plan to provide services for individuals with special needs. Special needs plans (SNPs) are permitted to target enrollment to one or more types of special needs individuals, including those who are (1) institutionalized, (2) dually eligible for both Medicare and Medicaid, or (3) living with severe or disabling chronic conditions. Among other changes, the Affordable Care Act extended SNP authority through December 31, 2013, and temporarily extended authority through the end of 2012 for dual eligible SNPs without contracts with state Medicaid programs to continue to operate, but in their current service areas. After 2012, dual eligible SNPs, new and renewing, were required to have contracts with state Medicaid agencies. Several subsequent laws have extended SNP authority without interruption; most recently, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA, P.L. 114-10) extended SNP authority through December 31, 2018.

In this section, the Medicare-Medicaid Coordination Office would be directed to serve as a dedicated point of contact for states to assist with Medicare and Medicaid integration efforts, and the Secretary would be required to work through this office to establish a unified grievances and appeals process for individuals enrolled in a D-SNP. This section would permanently authorize the I-SNP, D-SNP and C-SNP, if certain requirements are met. By 2021, a D-SNP contract would be required to have a unified grievances and appeals procedure in place, and by 2021, a D-SNP would be required to integrate Medicare and Medicaid long-term services and supports and/or behavioral health services by meeting one of three requirements. Failure to meet one of the three integration requirements would result in suspension of enrollment. MedPAC, in consultation with MACPAC, would be required to conduct a study and report to Congress on the quality of D-SNPs. Beginning in 2020, a C-SNP would be required to meet additional requirements to improve care management for the beneficiaries with severe or disabling chronic conditions enrolled in the plan. By January 1, 2022, and every five years thereafter, the Secretary would be required to update the list of chronic conditions eligible for participation in a C-SNP. The updated list must include HIV/AIDS, end-stage renal disease, and chronic and disabling mental illness. The Secretary may consider implementing the quality star rating system at the plan level for SNPs and all MA plans. GAO would be instructed to conduct a study and report on state-level integration between D-SNPs and Medicaid within two years of enactment.

Subtitle C – Expanding Innovation and Technology

Section 50321. Adapting benefits to meet the needs of chronically ill Medicare Advantage enrollees. Under Medicare Advantage (MA) private health plans are paid a per-person monthly amount to provide all Medicare-covered benefits (except hospice) to beneficiaries who enroll. Unlike original Medicare, where providers are paid for each item or service provided to a beneficiary, an MA plan receives the same capitated monthly payment regardless of how many or few services a beneficiary actually uses. The plan is at-risk if aggregate costs for its enrollees exceed program payments and beneficiary cost sharing; conversely, in general, the plan can retain savings if aggregate enrollee costs are less than program payments and cost sharing. Currently, an MA plan must offer the same benefit package to all of its enrollees. The Centers for Medicare and Medicaid Innovations (CMMI) is currently testing a model to allow greater flexibility for an MA plan to meet the needs of chronically ill enrollees. CMS has also proposed a regulation that would permit MA plans to offer a benefit package that includes different cost-sharing requirements or benefits to help MA plans better serve the most vulnerable enrollees.

This section would expand the testing of the CMMI Value-Based Insurance Design (VBID) Model to allow an MA plan in any state to participate in the model by 2020 (during the testing phase) to determine whether savings are achieved without negatively impacting quality.

Section 50322. Expanding supplemental benefits to meet the needs of chronically ill Medicare Advantage enrollees. All Medicare Advantage (MA) plans must offer required Medicare benefits (except hospice) and may offer additional or supplemental benefits. Mandatory supplemental benefits are covered by the MA plan for every person enrolled in the plan and are paid for either through plan rebates, a beneficiary premium, or cost sharing. Optional supplemental benefits must be offered to all plan enrollees, but the enrollee may choose to pay an additional amount to receive coverage of the optional benefit; optional benefits cannot be financed through plan rebates.

An MA plan must adhere to specific rules regarding the supplemental benefits that it can offer. First, the MA plan cannot design a benefit plan that is likely to substantially discourage enrollment by certain MA eligible individuals. Further, supplemental benefits (a) may not be Medicare Part A or Part B required services, (b) must be primarily health related with the primary purpose to prevent, cure, or diminish an illness or injury, and (c) the plan must incur a cost when providing the benefit. Items that are primarily for comfort or are considered social services would not qualify as supplemental benefits. Examples of supplemental benefits include the following:

  1. Additional inpatient hospital days in an acute care or psychiatric facility,
  2. Acupuncture or alternative therapies,
  3. Counseling services,
  4. Fitness benefit,
  5. Enhanced disease management, and
  6. Remote Access Technologies (including Web/Phone based technologies).

CMS proposed a regulation that would allow MA plans greater flexibility to offer targeted supplemental benefits.

This section would allow an MA plan to offer a wider array of supplemental benefits to chronically ill enrollees beginning in 2020. These supplemental benefits would be required to have a reasonable expectation of improving or maintaining the health or overall function of the chronically-ill enrollee and would not be limited to primarily health related services. The section would allow an MA plan the flexibility to provide targeted supplemental benefits to specific chronically ill enrollees.

Section 50323. Increasing convenience for Medicare Advantage enrollees through telehealth. Telehealth is the use of electronic information and telecommunications technologies to support remote clinical health care, patient and professional health-related education, and other health care delivery functions. While Medicare beneficiaries may receive telehealth services in a variety of settings, under current law (SSA Section 1834(m)), the Medicare program recognizes and pays for only certain Part B telehealth services. These services must be either (1) remote patient and physician/professional face-to-face services delivered via a telecommunications system (e.g., live video conferencing), or (2) non face-to-face services that can be conducted either through live video conferencing or via store and forward telecommunication services in the case of any Federal telemedicine demonstration program in Alaska or Hawaii. Typically, Medicare coverage for remote face-to-face services includes payments (1) to physicians or other professionals (at the distant site) for the telehealth consultation, and (2) to the facility where the patient is located (the originating site).

An MA plan may provide basic telehealth benefits as part of the standard benefit; for example, telemonitoring and web-based and phone technologies can be used to provide telehealth services. Medicare Advantage Prescription Drug (MAPD) may choose to include telehealth services as part of their plan benefits, for instance, in providing medication therapy management (MTM). However, while there is nothing to preclude Medicare Advantage (MA) from providing telemedicine or other technologies that they believe promote efficiencies beyond what is covered in the traditional Medicare program, those services and technologies are not separately paid for by Medicare and plans must use their rebate dollars to pay for those services as a supplemental benefit.

This section would allow an MA plan to offer additional, clinically appropriate, telehealth benefits in its annual bid amount beyond the services that currently receive payment under Part B beginning in 2020. The Secretary would be required to solicit comments on: what types of telehealth services, including but not limited to those provided through supplemental health care benefits, such as remote patient monitoring, secure messaging, store and forward technologies, and other non-face-to-face communication; and the requirements for furnishing those benefits. If an MA plan provides access to a service via telehealth, the MA plan must also provide access to that service through an in-person visit, and the beneficiary would have the ability to decide whether or not to receive the service via telehealth.

TITLE XII – OFFSETS

Section 53112. Preventing the artificial inflation of star ratings after the consolidation of MA plans offered by the same organization. In recent years, CMS has encouraged MA organizations to consolidate their MA plans into fewer contracts. An unintended consequence of contract consolidation can be an artificial increase in star ratings, and therefore, quality bonus payments. Earlier this year, CMS proposed new rules related to how contract consolidations affect star ratings to more accurately reflect performance of the surviving and consumed contracts. This section would direct CMS to calculate a weighted average of star ratings across contracts that have been consolidated to more accurately reflect quality and mitigate unwarranted quality bonus payments.

[1] The summaries are provided in the Section-by-Section Summary of the Bipartisan Budget Act located at https://schrader.house.gov/uploadedfiles/summary_of_bipartisan_budget_act.pdf.

 

 

Now is the Time – Commit to a Sexual Harassment Free Workplace

Unfortunately, 2017 will most likely be remembered as the Year of Sexual Harassment. Notwithstanding that AB 1825 mandated harassment prevention training in California in 2004, the statute was amended to require training on bullying and abusive conduct in 2015 (AB 2053), and recently to require training in 2018 on gender identity, gender expression, and sexual orientation (SB 396), sexual harassment continues to permeate the work place.  Given the profound impact sexual harassment has on individuals and workplaces, it is time for change.

As a new year begins, this is an excellent time for employers to reassess their sexual harassment prevention policies and training ~ not only to ensure that they are legally complaint but also effective and embraced by everyone.  It is also an excellent time to reaffirm your company’s commitment to maintaining a workplace free of sexual harassment (as well as any other harassment and discrimination) where everyone feels safe and respected and understands that retaliation is unlawful.  Continue Reading

Abrupt Closure of SynerMed Shakes Up Medical Management Industry

SynerMed, a Southern California-based physician management company, will be shutting down, per an email from its CEO earlier this month. Recently, the company had come under increasing scrutiny by health plans and California state regulators, including an investigation by the Department of Managed Health Care.

According to the company-wide email, audits conducted by health plans had found “several system and control failures within medical management and other departments.” Additionally, the California Department of Managed Health Care’s investigation has been publicly acknowledged, although the details of such investigation remain confidential.

SynerMed has played an important role, coordinating services between health plans and physician practices, as well as insurance contracting, payment of claims and other administrative tasks for independent practices. The unwinding will begin immediately, with the company transitioning clients to another management firm within the next 180 days. As more information emerges from the investigation and audits, SynerMed’s abrupt closure will provide important lessons for medical management companies and Department of Managed Health Care-regulated entities.

“Always a bridesmaid, never a bride” Might Work for Stark Liability but Not the Anti-Kickback Statute

Last Thursday, a jury in federal district court in St. Louis handed down a verdict in a False Claims Act (“FCA”) case that presents a laundry list of the challenges which can arise in a FCA case.  This one includes kickback allegations, Stark issues, both state and federal claims, individual liability, civil-criminal cooperation, a criminal indictment (later dropped), and even family law.  The defendants are neurologist, Dr. Sonjay Fonn, and his fiancee of nine years, Deborah Seeger, as well as their respective medical practice and medical device distributorship.

The verdict found them liable for conspiracy and FCA violations under the Anti-kickback Statute for arrangements under which Dr. Fonn purchased nearly all of his neurology devices and implants from the distributor owned and operated by his fiancée, Deborah Seeger.  The allegations included Dr. Fonn increasing his use of devices and participating in the distributorship’s negotiations with manufacturers.  Conspicuous consumption (including a yacht, plane and $230,000 entertainment center) may have contributed to the local relators, including physicians, filing the FCA suit.

The civil suit was stayed for a year in order for criminal prosecutors to pursue an indictment handed down by a grand jury.  At the request of prosecutors, the court dismissed the indictment, which led the civil case to resume and go to trial earlier this month.  The judgment amount is pending and could approach $5 million against Dr. Fonn and Ms. Seeger for the 228 Medicare and Medicaid claims presented at trial.

Incidentally, their nine-year marriage engagement may be attributed to the Stark law’s rule of equating a spouse with the referring physician (for which no Stark exception appears available in this case) and Missouri not being a common law marriage state.  A law school professor would be hard-pressed to write an exam question with more issue-spotting than the saga of Dr. Fonn and Deborah Seeger!

Is Your Hospital Compliant With the Revised Joint Commission Standards for Pain Assessment and Management?

On January, 1, 2018, The Joint Commission’s (“TJC”) new and revised pain assessment and management standards go into effect for TJC accredited hospitals. The changes to the standards stem from a review commenced by The Joint Commission in 2016 to bring the preceding accreditation standards into alignment with leading practices in pain assessment and management, and the safe use of opioids. In light of these standards, hospitals and their medical staffs should review their current policies, protocols, and procedures to ensure their practices comply with the new TJC requirements.

Among the revised standards are requirements for:

  • Identifying a leader or leadership team that is responsible for pain management and safe opioid prescribing.
  • Screening of patients for pain during emergency department visits and at time of admission
  • Identifying and monitoring patients at risk for adverse outcomes related to opioid treatment.
  • Establishing criteria to screen, assess, and reassess pain that are consistent with the patient’s age, condition, and ability to understand.
  • Involving patients in the developing of their treatment plans through setting realistic expectations and measurable goals and discussing objectives used to evaluate treatment progress.
  • Developing pain treatment plans based on evidence-based practices and the patient’s clinical condition, past medical history, and pain management goals.
  • Assessing and managing the patients’ pain and minimizing the risks associated with treatment.
  • Providing nonpharmacologic pain treatment modalities.
  • Involving the medical staff in pain assessment, pain management, and safe opioid prescribing through participation in the establishment of protocols and quality metrics, and review of performance improvement data.
  • Educating staff and licensed independent practitioners on resources and programs regarding pain assessment, pain management, and the safe use of opioid medications based on the identified needs of the patient population.
  • Acquiring equipment needed to monitor patients who are at high risk for adverse outcomes from opioid treatment.
  • Identifying opioid treatment programs that can be used for patient referrals.
  • Providing information to staff and licensed independent practitioners on available services for consultation and referral of patients with complex pain management needs.
  • Educating patients and their families on discharge plans related to pain management including, side effects of pain management treatment, and the safe use, storage, and disposal of opioids.
  • Collecting and analyzing data on pain assessment and pain management, including types of interventions and effectiveness.
  • Conducting performance improvement activities focusing on pain assessment and management to increase safety and quality for patients (e.g., tracking adverse events).
  • Facilitating practitioner access to Prescription Drug Monitoring Program databases.

The full text of the new and revised requirements is posted on The Joint Commission website and will be reflected in the Fall 2017 E-dition Standards and 2018 hard copy publication. Standards affected include: LD 04.03.13 (Eps 1-7), MS 03.01.03, MS.05.01.01 (EP 18), PC.01.02.07 (EPs 1-8), PI.01.01.01 (EP 56), and PI.02.01.01 (Eps 18 and 19).

Additional post related to pain and opioids:

Medical Board of California Circulates Opioid Prescriber Guidance

Don’t Forget HIPAA’s “Minimum Necessary” Rule When Making Health Information Disclosures

When Covered Entities or Business Associates or their counsel analyze whether a particular disclosure of Protected Health Information (or “PHI,” as defined in HIPAA) is permissible, they should be sure also to analyze whether the disclosure complies with HIPAA’s Minimum Necessary Rule (“MNR”), which is oft forgot. This issue arises when disclosing PHI in response to subpoenas, which HIPAA permits as long as the disclosing party receives satisfactory assurances that the requesting party has made reasonable efforts to obtain a protective order or to notify the individual(s) who is/are the subject of the disclosure and provide them with an opportunity to object. 45 CFR 164.512(e).

Set forth at 45 CFR § 164.502(b)(1), the MNR states:

When using or disclosing protected health information or when requesting protected health information from another covered entity or business associate, a covered entity or business associate must make reasonable efforts to limit protected health information to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.

The MNR does not apply in situations where it either does not protect the individual (such as when the disclosure is to the patient herself or to the OCR for investigatory or compliance purposes) or where the burden of compliance is outweighed by the purpose of the disclosure (such as when the disclosure is for treatment purposes). None of the MNR exceptions (the complete list is at 164.502(b)(2)) is implicated in the routine subpoena/court order context.

This means that a Covered Entity (or its counsel) should not simply copy the entire patient record pertaining to the issue before the court without ensuring that it only includes information minimally necessary to accomplish the intended purpose of the disclosure, which here would be to comply with the subpoena by disclosing the requested records, provided they are relevant. So, in one sense, the general relevance standard in litigation and the MNR are the same, and ordinarily if the information disclosed includes strictly relevant information, including PHI, the MNR should be satisfied.

On the other hand, unlike the general relevance standard, which does not prohibit a party from disclosing irrelevant information, the MNR explicitly prohibits disclosure of irrelevant PHI because such would not further the intended purpose of the disclosure. Therefore, under certain circumstances, it would seem that a Covered Entity responding to a subpoena could risk HIPAA sanctions by running afoul of the MNR for disclosing certain irrelevant PHI, but not be at risk of consequences related to breaching the plaintiff’s privacy. For example, in the routine slip-and-fall case, what if the treating physician recorded in the “social history” section of the history and physical examination that the plaintiff has a history of alcoholism, substance abuse or mental illness, all of which turns out to be responsive to the subpoena, but ultimately is determined to be irrelevant to the litigation. If the Covered Entity hospital had not redacted those references, the plaintiff will not likely be able to successfully sue the hospital for breach of privacy or emotional distress for improperly disclosing the PHI because it did so properly in response to the subpoena. For the same reason, the plaintiff could not succeed with a private right of action under state law (HIPAA not having a private right of action). However, the Covered Entity has probably violated the MNR and could face OCR scrutiny and possible penalties.

You can imagine how this could play out where, say, the defendant in the slip-and-fall case, a convenience store owner, happens to be a family friend, employer, neighbor or worse—an enemy—of the patient. If the store-owner’s attorney gave appropriate notice to the patient/plaintiff, she could not object because she filed a suit about which her health condition is now at issue, and she probably would not object anyway because she probably would not be thinking about that information being in her record or that her friend or enemy might see it. Or perhaps the subpoenaing attorney obtained a protective order. Either way, the hospital would provide the records to him, and his client could then easily learn about the plaintiff’s embarrassing social history, and she would have little recourse for damages other than the satisfaction of learning about whatever penalties the OCR may ultimately assess against the hospital.

How would you handle it?


Additional posts related to HIPAA

Press Release Mistake Leads to $2.4 Million HIPAA Penalty for Health System
OCR Issues $475,000 Fine for Untimely Reporting of HIPAA Breach

 

Medical Board of California Adopts New Regulations for Midwife Assistants

On September 21, 2017, the Medical Board of California adopted new regulations related to the training of midwife assistants, the administration of midwife assistant training, and the requirements for approved, midwife assistant certifying organizations. The Board took this action to implement and interpret Senate Bill 408 (2015), which added new requirements and prohibitions to the Licensed Midwifery Practice Act of 1993 under Business & Professions Code § 2516.5.

SCOPE OF PRACTICE

Business and Professions Code § 2516.5(a)(1) defines “midwife assistant” as:

A person, who may be unlicensed, who performs basic administrative, clerical, and midwife technical supportive services in accordance with this chapter for a licensed midwife or certified nurse-midwife, is at least 18 years of age, and has had at least the minimum amount of hours of appropriate training pursuant to standards established by the board for a medical assistant pursuant to Section 2069. The midwife assistant shall be issued a certificate by the training institution or instructor indicating satisfactory completion of the required training. Each employer of the midwife assistant or the midwife assistant shall retain a copy of the certificate as a record.

Section 2516.5 authorizes a midwife assistant to perform certain assistive activities under the supervision of a licensed midwife or certified nurse-midwife, including the administration of medicine, withdrawing of blood, and midwife technical support services. Midwife assistants are permitted to perform the following midwife technical support services under § 2516.5(b)(3):

(A) Administer medications orally, sublingually, topically, or rectally, or by providing a single dose to a patient for immediate self-administration, and administer oxygen at the direction of the supervising licensed midwife or certified nurse-midwife. The licensed midwife or certified nurse-midwife shall verify the correct medication and dosage before the midwife assistant administers medication.

(B) Assist in immediate newborn care when the licensed midwife or certified nurse-midwife is engaged in a concurrent activity that precludes the licensed midwife or certified nurse-midwife from doing so.

(C) Assist in placement of the device used for auscultation of fetal heart tones when a licensed midwife or certified nurse-midwife is engaged in a concurrent activity that precludes the licensed midwife or certified nurse-midwife from doing so.

(D) Collect by noninvasive techniques and preserve specimens for testing, including, but not limited to, urine.

(E) Assist patients to and from a patient examination room, bed, or bathroom.

(F) Assist patients in activities of daily living, such as assisting with bathing or clothing.

(G) As authorized by the licensed midwife or certified nurse-midwife, provide patient information and instructions.

(H) Collect and record patient data, including height, weight, temperature, pulse, respiration rate, blood pressure, and basic information about the presenting and previous conditions.

(I) Perform simple laboratory and screening tests customarily performed in a medical or midwife office.

Section 2516.5(c) specifically prohibits midwife assistants from administering local anesthetic agents or performing any clinical laboratory test or examination for which the assistant is not authorized. Finally, section 2516.5(d) prohibits a midwife assistant from being employed for inpatient care in a licensed general acute care hospital as defined in Health and Safety Code § 1250(a).

CERTIFICATION AND TRAINING REQUIREMENTS

Among the new regulatory requirements, midwife assistants must maintain current certification in Neonatal Resuscitation from the American Academy of Pediatrics (Bus. & Prof. Code § 1379.02) and Basic Life Support from the American Heart Association or the American Safety and Health Institute (Bus. & Prof. Code § 1379.03), as well as training in infection control from the CDC (Bus. & Prof. Code § 1379.04).

Specific minimum hourly training requirements under § 1379(a) include:

(1) Five (5) clock hours of midwifery didactic training.

(2) Two (2) clock hours of training in administering oxygen by inhalation.

(3) Ten (10) clock hours of satisfactory demonstration of immediate newborn care.

In order to perform certain services, the following minimum training hours are required under § 1379(b):

(1) Five (5) clock hours of training on the device used for auscultation of fetal heart tones and ten (10) demonstrations of satisfactory placement of the device used for auscultation of fetal heart tones during labor or by stimulation.

(2) Ten (10) clock hours of training administering injections and performing skin tests, and satisfactory performance of ten (10) each intramuscular, subcutaneous, and intradermal injections, and skin tests.

(3) Ten (10) clock hours of training in venipuncture and skin puncture for the purpose of withdrawing blood, and satisfactory performance of ten (10) each of venipunctures and skin punctures for the purpose of withdrawing blood.

Organizations that certify midwife assistants must obtain Board approval, be not-for-profit, and meet specific standards listed under § § 1379.07-1379.09.

LexBlog