Nelson Hardiman Successfully Defends Medical Board Charges Brought Against Physician Client

Nelson Hardiman Successfully
Defends Medical Board Charges
Brought Against Physician
Client
Nelson Hardiman LLP successfully represented a physician
client following a complaint filed against him by the Medical
Board of California. The complaint alleged, among other
charges that the client violated the California prohibition
against the corporate practice of medicine pursuant to
Business and Professions Code § 2052. The firm successfully
defended the arrangement between a Management Services
Organization (MSO) and the client’s professional corporation
(PC) through an in-depth and comprehensive review of
organizational and transactional documents between the
entities. After a thorough review, the MBC declined to proceed
with the case and closed the investigation without action,
effectively conceding that there was no violation of corporate
practice of medicine.

For questions regarding Medical Board inquiries and health
professional licensure issues please contact Alan J. Sedley at
asedley@nelsonhardiman.com.

About Nelson Hardiman

Nelson Hardiman LLP is the premier healthcare and life
sciences firm in Los Angeles, serving healthcare providers,
investors, and organizations that need a hard-to-find level of
quality advice on the most sensitive industry issues. The
firm’s litigation practice specializes in defending fraud and
abuse and whistleblower actions, government investigations,
reimbursement disputes, and other complex business disputes.
Nelson Hardiman regularly serves as outside counsel for

healthcare system clients and medical staff representation.
Nelson Hardiman’s transactional group handles healthcare
organization acquisitions, sales, investment, and financings,
and Nelson Hardiman’s regulatory team advises on compliance
with licensing, operational, and reimbursement issues across
the full continuum of healthcare industry sectors, with
expertise on Medicare and Medicaid requirements, privacy and
data security, FDA, and many more matters. The firm has earned
a singular position reputation nationally for its leadership
in addressing issues in behavioral health. More information
about the firm is available at www.nelsonhardiman.com or at
310.203.2800.

Nelson   Hardiman Advises
Lemonaid Health in Merger
with 23-and-Me
Nelson Hardiman served as healthcare regulatory counsel to
Lemonaid Health in connection with its $400 million
merger with 23-and-Me. The merger brings together the ground-
breaking innovation of 23-and-Me, in direct-to-consumer DNA
testing and biotech, and Lemonaid, in direct-to-consumer
telemedicine and prescription drug delivery.

“We are grateful for the regulatory counsel of Harry Nelson
and the Nelson Hardiman team in this transaction,” said
Lemonaid CEO Paul Johnson. “Their advice has been invaluable
throughout our growth.”

Los Angeles-based Nelson Hardiman LLP specializes in
healthcare and life sciences regulatory strategy, and is known
for its pioneering work in telehealth innovation. Firm

founder Harry Nelson has served as lead regulatory counsel to
Lemonaid Health since its launch in 2014 and counseled the
company through its growth on compliance with laws related to
telemedicine, corporate practice of medicine, pharmacy,
marketing, privacy, and data security. Nelson commented: “It
has been a genuine privilege to advise Lemonaid Health, both
on this deal and throughout its history. The Lemonaid
leadership have been visionaries as to the future of U.S.
healthcare. We appreciate the trust they have placed in us.”

In addition to Harry Nelson, the Nelson Hardiman team advising
Lemonaid, included Regina Trainor, Aviva Morady, and Daniel
Eliav, with Daniel Eliav’s leadership of the deal team. Nelson
Hardiman’s work on the merger included assistance with
healthcare regulatory due diligence, advice on structuring to
address health care laws and regulations, drafting of
healthcare-related provisions of transaction documents, and
ongoing compliance advice.

More information on the transaction is available via 23-and-
Me’s press release.

About Nelson Hardiman
Nelson Hardiman LLP is the premier healthcare and life
sciences firm in Los Angeles, serving healthcare and life
science providers, investors, and organizations that need
experts on the most difficult questions with deep industry
knowledge and relationships. The firm’s litigation practice
specializes in defending fraud and abuse and whistleblower
actions, government investigations, and other complex business
disputes. Nelson Hardiman’s transactional group handles
healthcare organization acquisitions, sales, investment, and
financings, and Nelson Hardiman’s regulatory team advises on
compliance with licensing, operational, and reimbursement
issues across the full continuum of healthcare industry
sectors, with expertise on Medicare and Medicaid requirements,
privacy and data security, FDA, and other regulatory matters.
The firm has earned a singular position reputation nationally

for its leadership in addressing issues in behavioral health,
telehealth, corporate practice of medicine, and emerging
therapeutic modalities. More information about the firm is
available    at  https://www.nelsonhardiman.com       or   at
310.203.2800.

Read Press Release

Contact Us: info@nelsonhardiman.com

Fight to Free Britney Spears
Highlights ‘Toxic’ Side of
Conservatorsh
The legal arrangements are meant to protect people unable to
make their own decisions. A burgeoning movement sees it as a
vehicle for abuse.

Read Full Article

For questions please contact: marketing@nelsonhardiman.com

*This article is provided for educational   purposes only and is
not offered as, and should not be relied    on as, legal advice.
Any individual or entity reading this        information should
consult an attorney for their particular    situation.*

Harry Nelson on Spectrum News
discussing how CA lawmakers
are considering a program
that would pay drug addicts
to stay sober.
Harry Nelson on Spectrum News discussing how CA lawmakers are
considering a program that would pay drug addicts to stay
sober.

Email: info@nelsonhardiman.com

Website: https://www.nelsonhardiman.com

twitter: @nelsonhardiman

linkedin: https://www.linkedin.com/company/nelsonhardiman

Debate on vaccine mandates
leaves     mental    health
providers conflicted
Mental Health Weekly interviewed Partner Rob Fuller regarding
the decision on whether to mandate COVID-19 vaccination for
staff members and the public health concerns against the
reality of workforce shortages.

Read Full Article

For questions please contact: Rob Fuller

*This article is provided for educational   purposes only and is
not offered as, and should not be relied    on as, legal advice.
Any individual or entity reading this        information should
consult an attorney for their particular    situation.*

California    sets   Vaccine
Mandate    For    Healthcare
Workers and Visitors
Order broadly applicable to hospitals of all kinds, skilled
nursing, adult day health centers, ambulatory surgery centers,
doctors offices and clinics, residential substance abuse
facilities, and others.
California issued orders over the past week (i) mandating
healthcare workers become vaccinated, and (ii) mandating all
hospital and long-term health facility visitors show proof of
vaccination or recent negative Covid test. The implications
of these orders for health care enterprises are wide-ranging,
requiring additional human resources processes and front door
processes to address the new demands to check vaccination
status of workers and visitors.

I.           Vaccinations Required for Workers in Healthcare
Facilities

California Department of Public Health (“CDPH”) issued an
order on August 5th, requiring healthcare workers who provide
services in or have the potential for direct or indirect
exposure to patients in hospitals, skilled nursing facilities,
and other healthcare facilities to be vaccinated no later
than September 30, 2021.

A.   Facilities covered by the order

The order applies to “healthcare facilities” and “workers.”
These definitions are broad. “Healthcare facilities” covers
acute, subacute, and behavioral health facilities, including:

       General Acute Care Hospitals
       Skilled Nursing Facilities
       Intermediate Care Facilities
       Acute Psychiatric Hospitals
       Adult Day Health Care Centers
       Program of All-Inclusive Care for the Elderly Centers
       Ambulatory Surgery Centers
       Chemical Dependency Recovery Hospitals
       Clinics & Doctor Offices
       Congregate Living Health Facilities
       Dialysis Centers
       Hospice Facilities
       Pediatric Day Health and Respite Care Facilities
       Residential Substance Use Treatment and Mental Health
       Treatment Facilities

B.    Workers covered by the order

Similarly, “Workers” is an all-inclusive definition, not
limited to just employees, covering employees, contractors,
vendors, and volunteers, who are physically present wherever
care is given or wherever patients have access in a healthcare
facility.   Workers include all people who are indoors who
share space covered by common air handling, covering
clinicians of all types, technicians, therapists, students,
trainees, contractors not employed by but present in the
healthcare facility, and persons not directly involved in
patient care, but who are present in patient care and patient
access areas, such as clerical, clergy, dietary, environmental
services, laundry, security, engineering, facilities
operations, administrative, billing, vendor, and volunteer
personnel.

C.   Limited exemptions

There are limited exceptions based on bona fide religious
beliefs and medical reasons. Exemption from the vaccination
mandate may be sought through the worker submitting, in the
case of the religious belief exemption, a signed form
declaring opposition to the vaccine based on religious
beliefs, or, in the case of medical exemption, a letter from a
physician documenting that the worker has a “Qualifying
Medical Reason” for not receiving the vaccine. To be eligible
for a Qualifying Medical Reason exemption, the worker is
required to provide the physician’s letter stating that the
worker qualifies for the exemption under the terms of the
order, but not necessarily documenting the underlying medical
condition that constitutes the Qualifying Medical Reason. The
letter should also state anticipated duration of the worker’s
inability to receive the vaccine or whether the duration is
permanent.

Employers who accept the exemptions must ensure that exempt
workers are (i) screened for fever and other symptoms when
reporting to work, (ii) tested weekly or biweekly for
COVID-19, and (iii) required to wear a surgical mask or
respirator at all times while at work. Testing may be either
polymerase chain reaction or antigen tests. Testing is
required twice weekly for exempt workers in acute health care
and long-term care facilities, and once weekly for all other
healthcare settings.

D.   Facility recordkeeping requirements

Facilities subject to the order are required to make and
retain a record of workers’ vaccination pursuant to CDPH
guidelines                                        (available
at: https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/V
accine-Record-Guidelines-Standards.aspx).    These guidelines
require the facility to record (i) Worker’s name and date of
birth; (ii) date of vaccinations and vaccine manufacturer; or,

if not vaccinated, (iii) documentation supporting the
exemption and the ongoing lab test results. Such records
should be treated as Personal Health Information maintained on
a confidential basis. Local or state Public Health Officers
or their designees are empowered to review and audit such
records which must be provided promptly upon request (no later
than one business day).

E.   Interaction with prior order

The CDPH August 5 order does not replace or supersede its
earlier July 26 order, that allowed testing and masking as an
alternative to vaccination. The requirements of the July 26
order remain in place until September 30 (including
vaccination status checks and periodic testing unvaccinated
workers or workers whose status is uncertain), at which time
the ‘test and mask’ alternative to vaccination will no longer
be an option.

II.         Vaccinations required for Hospital and Long-term
Care Facility Visitors

Effective as of August 11 th , a separate CDPH August 5 order
prescribed strict limitations on visitors to hospitals and
long-term care facilities. The order is applicable to general
acute care hospitals, skilled nursing facilities, and
intermediate care facilities. The order covers only indoor
visitation.

The facilities covered by the order must either: (i) verify
visitors are fully vaccinated, or (ii) for unvaccinated or
incompletely vaccinated visitors, verify documentation of a
negative COVID test within the prior 72 hours. Facilities must
track visitors in the facility, and record and retain
documentation of the vaccination record or negative test.

There is a limited exception where the visitor has neither

proof of vaccination or negative test, when the visitor is
seeking to visit a patient in critical condition, “when death
may be imminent.”     Such exempt visitors are required to
physically distance and wear PPE.

III.      Impact of Recent Orders

From a practical standpoint, these orders impose significant
recordkeeping, monitoring, and human resources requirements on
covered facilities.

Under applicable CDPH and CalOSHA orders, entry screening
continues to be required for all employees and visitors, and,
in addition, covered facilities must provide a mechanism for
visitors to submit their vaccination and/or negative test
results, and record such documentation. These requirements
for visitors start on August 11. Facilities must also have a
mechanism for monitoring visitors as they enter and transit
through the facility, including prominent identification that
they are a visitor and their intended destination within the
facility. Employees should be trained to address any visitor
in areas not their intended destination or in transit thereto.

Human resources departments, in conjunction with employee
health in larger facilities, must establish secure processes
to obtain and maintain records of all employee vaccination and
exemption records.    More problematic is addressing which
internal entity should be responsible for establishing similar
processes for contractors, vendors, and volunteers.       Most
larger facilities will establish protocols for human resources
expand their operations to cover such non-employees in order
to have a centralized record of vaccination status and/or
exemption and test results. Whichever department(s) is/(are)
established to collect the data, a centralized, secure data
base or filing system should be created to allow for ease of
response in the event of an audit by the public health
authorities.

Administration, human resources, and security departments must
develop plans and protocols for addressing non-compliant
employees, contractors, vendors, and volunteers. Whether an
employee is terminated for non-compliance or placed on
administrative leave pending completion of vaccination or
exemption process should be considered on a case-by-case basis
to ensure compliance with employment laws and/or union
agreements. But it is clear that non-compliant persons of any
type must be denied entry into the facility until they become
compliant or are terminated.

If you have any questions about the recent orders, or the
issues they raise in your operations, please contact
us (310)203-2800.

Authored By:

Rob Fuller

VIEW CLIENT ALERT

*This article is provided for educational purposes only and is
not offered as, and should not be relied on as, legal advice.
Any individual or entity reading this information should
consult an attorney for their particular situation.

Toward A New Normal
From the article:

In May, America was celebrating progress. COVID-19
hospitalization and mortality numbers that spiked in January
had plummeted and seemed to be flat. The availability of the
Pfizer and Moderna vaccines seemed to have led to turning the
corner on the pandemic. The prevailing assumption was that we

were on a trajectory back to “normal.”

Fast forward two months and the Delta variant has upended that
assumption, stirring anxiety, confusion, anger and concern.
Masks are back indoors and in schools for the coming year.
After the summer of 2020 was hampered by restrictions,
questions again are swirling around the safety of summer camps
and travel. COVID-19 cases — and hospitalizations — are up.
What’s happening and how should we think about?

Delta, a SARS-CoV-2 mutation that originally was identified in
India, appears to be significantly more infectious than
previous variants that have spread across the world. Even
Israel, with a vaccination rate approaching 60% of the
population (one of the highest in the world), has seen an
uptick in COVID-19 cases as the Delta variant spreads.
Although the primary concern has been the risk for
unvaccinated people (including children under the age of 12
for whom vaccine use has not been cleared), Delta also has
highlighted the prevalence of “breakthrough” infections, in
which people who previously had COVID or are fully vaccinated
are nonetheless getting infected.

The short-term impact of the Delta variant is not good news —
but also not terrible. Although Delta is leading to more
COVID-19 infections, the early picture suggests that it is not
driving up mortality rates, at least for vaccinated people
(now over 60% of Californians) or for unvaccinated children.

Although the Delta variant is leading to more COVID-19
infections, the early picture suggests that it is not driving
up mortality rates, at least for vaccinated people (now over
60% of Californians) or for unvaccinated children.

While California hospitals are seeing an increase in
hospitalization rates, it does not appear that we are likely
to see hospitals overwhelmed — given the numbers of vaccinated
people. The early data show that the Pfizer-BioNTech mRNA

vaccine continues to be 80% to 90% effective against the Delta
variant. As a result, in the vast majority of “breakthrough”
cases, vaccinated people are testing positive but either are
asymptomatic or only mildly symptomatic. Consequently, for the
vaccinated, the Delta variant warrants precautions, but not
panic. The overwhelming majority of hospitalizations are of
unvaccinated people, which should motivate ambivalent and
reluctant vaccine holdouts to get vaccinated.

The bigger takeaway, though, is the long-term significance of
the Delta variant. In 2020, we heard a lot about the goal of
“herd immunity,” where so many people have antibodies, whether
by vaccination or previous infection, that there are too few
vulnerable hosts for a virus to spread. Increasingly, however,
the consensus — articulated by Christopher Murray, the
director of the Institute for Health Metrics and Evaluation at
the University of Washington — is that low vaccination rates
worldwide, coupled with COVID-19’s frequent mutation, mean
that herd immunity is likely to be unattainable.

A more realistic way to think of the Delta variant (like the
U.K. variant that predominated in April and May) is as just
the latest of an ongoing stream of COVID-19 strains that will
be with us for the foreseeable future, much like the flu. As
with the flu, people at greater risk will get an annual
vaccine updated from time to time to address the evolution of
the viral strain. The Delta variant may predominate for the
next several months, but eventually it will peter out … until
the next variant spreads.

Although vaccination is the best way to reduce the
availability of hosts for the virus, the reality is that we
are still years away from global vaccination. Much of the
developing world still lacks access to vaccines, meaning new
variants will continue to develop. Although many are
rightfully frustrated with those around us who have ready
access to vaccines and could be vaccinated but are refusing
(the “willfully unvaccinated”), even without them, we will

continue to see new strains and “breakthrough” re-infections
from the rest of the world for years to come.

Although vaccination is the best way to reduce the
availability of hosts for the virus, the reality is that we
are still years away from global vaccination.

The challenge ahead is the many public and private decisions
about other public health measures. Many people are
questioning whether business closures or travel restrictions
are worth the economic costs of harming and potentially
closing down more businesses. Increasingly, the consensus
appears to be that these steps are not likely to alter the
trajectory of the surge, and carry collateral costs that are
too high to justify. Meanwhile, vaccinated people similarly
are questioning why they should be burdened with returning to
mask-wearing, when the real risk is to the willfully
unvaccinated.

We can take some comfort in the growing chorus of pro-
vaccination messaging coming from former anti-vaxxers who
learned the price of their poor decision-making after being
hospitalized with COVID. The numbers of hardcore anti-vaxxers
is likely to keep shrinking with new variants and with more
employers and universities ultimately likely to mandate
vaccination.

Personally, I suspect that support for “vaccine passports”
will continue to grow as a requirement for entry to stadiums,
concerts and private venues. The future is likely to be one in
which the willfully unvaccinated will continue to have the
right not to be vaccinated, but may face limits in their
access to employment or recreational opportunities based on
the right of everyone to avoid unnecessary exposure to risk.

Welcome to the “new normal.”

READ ENTIRE ARTICLE

If you have any questions regarding this article please
contact: info@nelsonhardiman.com

Spectrum News turns to health
law expert Harry Nelson for
answers   on   legality    of
vaccine mandate
Spectrum News turns to health law expert Harry Nelson for
answers on legality of the vaccine mandate.

Email: info@nelsonhardiman.com

Website: https://www.nelsonhardiman.com

twitter: @nelsonhardiman

linkedin: https://www.linkedin.com/company/nelsonhardiman

Nelson Hardiman Successfully
Resolves Medi-Cal Recoupment
Litigation    for    Medical

Supplies Client
Nelson Hardiman LLP successfully represented a client in a
Medi-Cal Recoupment litigation. Nelson Hardiman’s client filed
a lawsuit seeking an injunction against the California
Department of Health Care Services, to prevent the Department
from recoupment in excess of $7,000,000 in alleged
overpayments made to Nelson Hardiman’s client, in connection
with reimbursement rate reductions introduced with the passage
of AB 97. In filing its lawsuit, Nelson Hardiman’s client, a
national medical supplies company, sought to reduce the amount
of the total recoupment and to modify the recoupment process.
Nelson Hardiman was able to negotiate a favorable resolution
that accommodated its client’s concerns.

For questions regarding Medi-Cal Recoupment please contact
Zachary Rothenberg.

About Nelson Hardiman

Nelson Hardiman LLP is the premier healthcare and life
sciences firm in Los Angeles, serving healthcare providers,
investors, and organizations that need a hard-to-find level of
quality advice on the most sensitive industry issues. The
firm’s litigation practice specializes in defending fraud and
abuse and whistleblower actions, government investigations,
reimbursement disputes, and other complex business disputes.
Nelson Hardiman regularly serves as outside counsel for
healthcare system clients and medical staff representation.
Nelson Hardiman’s transactional group handles healthcare
organization acquisitions, sales, investment, and financings,
and Nelson Hardiman’s regulatory team advises on compliance
with licensing, operational, and reimbursement issues across
the full continuum of healthcare industry sectors, with
expertise on Medicare and Medicaid requirements, privacy and
data security, FDA, and many more matters. The firm has earned
a singular position reputation nationally for its leadership

in addressing issues in behavioral health. More information
about the firm is available at www.nelsonhardiman.com or at
310.203.2800.