Client Alert: Mandates in the Golden State: Do Not Get National

Client Alert: Mandates in the
Golden State: Do Not Get
Distracted     by   National
Mandate Mayhem
Mandates in the Golden State: Do Not Get Distracted by
National Mandate Mayhem

Last week, we provided guidance on the national vaccination
mandates, including the Healthcare Workers’ Mandate issued by
CMS, and (2) the 100-Employee Mandate issued by OSHA. After
some rapid back-and-forth decisions on the federal circuit,
the Supreme Court will hear challenges to both mandates on
January 7, 2021. Because of Omicron, we believe the Court will
act relatively quickly to render a decision. However, we
recommend that California businesses and healthcare facilities
remain focused on compliance with state mandates.

Generally, the scope of California’s Covid-19 mandates is on
parity with the federal rulings, if not more comprehensive. In
addition, California is one of 22 states that has its own OSHA
program (CAL/OSHA). As such, whenever a new federal OSHA
regulation is passed, California has a 30-day grace period to
establish an identical plan, or to adopt something similar
that will be “at least as effective.” What does this mean?

First, California healthcare personnel are already required to
get vaccinations. This was mandated for employees at general
acute care hospitals as well as other healthcare workers. All
of whom must get booster shots by February 1, 2022.        So,
whether or not the Supreme Court approves the federal
healthcare workers vaccine mandate, the Court’s decision will
have limited impact on California healthcare. In regards to
the 100-Employee mandate—targeting companies not included in

the national healthcare mandate—if that is approved as well,
CAL/OSHA will have 30 days to decide to adopt or adapt the
mandate for California businesses. The CAL/OSHA board is
scheduled to meet January 20, 2022. We expect they will decide
if new standards must be adopted by large California
corporations in order to comply with the national 100-Employee
mandate. We are monitoring the situation, and will send out
updates accordingly. In the meantime, the state mandate for
all non-healthcare employers goes into effect on January 14,
2022. By then, California employers, irrespective of their
size, will need “to establish, implement, and maintain an
effective written Covid-19 Prevention Program.” The State has
conveniently provided a fillable model program for employers.

Nelson Hardiman LLP
Healthcare Law for Tomorrow

Nelson Hardiman regularly advises clients on workplace
policies related to Covid-19. We offer legal services to
businesses at every point in the commercial stream of
medicine, healthcare, and the life sciences. For more
information, please contact us.

Authored By:

Yehuda Hausman, Law Clerk

Harry Nelson, Managing Partner

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.*

Client Alert: Ryan’s Law:
Terminally Ill Patients are
Finally Allowed Marijuana in
CA Hospitals
Ryan’s Law: Terminally Ill Patients are Finally Allowed
Marijuana in CA Hospitals

On September 28, 2021, Governor Newsom approved Senate Bill
311, better known as “Ryan’s Law.” The legislation requires
hospitals and certain health facilities to allow terminally
ill patients to use medical cannabis, subject to certain
restrictions. Governor Newsom had previously vetoed a prior
iteration of the bill (SB 305) in 2019, owing to fears that
participating hospitals or hospices might jeopardize Medicare
and Medicaid (CMS) reimbursements if they permitted medical
cannabis onsite, as marijuana remains illegal under federal
law. Sponsoring Senator Ben Hueso (D-San Diego) spoke to the
repeated setbacks facing the legislation: “It is inconceivable
to me that, in a state where medical cannabis was legalized
more than 25 years ago, those in deepest suffering receiving
treatment in our state’s healthcare facilities cannot access
this proven, effective, and prescribed treatment.”

Why Now?

A confluence of factors helped to allay fears associated with
permitting marijuana use in health facilities. Since FY2014,
congressional omnibus bills have included a rider prohibiting
the Department of Justice from using taxpayer fund to prevent
states from “implementing their own laws that authorize the
use, distribution, possession, or cultivation of medical
marijuana.” AG Merrick Garland has articulated the Biden
Administration’s “hands-off” approach with regards to state

marijuana laws. Most significantly, CMS specifically assured
California legislators that it would not pull funding for
participating hospitals without DOJ backing.

What Must Health Facilities Know

Healthcare administrators and managers should take note of
some important caveats and qualifications.

     While healthcare facilities cannot prohibit “patient use
     of medicinal cannabis due solely to the fact that
     cannabis is a Schedule I drug,” there is a safe harbor
     clause that, should federal regulatory agencies
     reinstate cannabis enforcement, healthcare facilities
     may suspend compliance with state law.
     Although a hospital must allow patient access, it need
     not procure or provide medical cannabis, or dispense
     medical marijuana from its pharmacy. This ‘arms-length’
     length approach was designed to buffer healthcare
     facilities should federal enforcement revive under a new
     administration.
     The legislation     applies    only    to   those   who   are
     “terminally ill,” that is patients with a life prognosis
     of “one year or less, should the disease follow its
     natural course.”
     State hospitals     and   chemical    dependency    recovery
     hospitals are excluded from the measure.
     The measure does not apply to emergency departments or
     patients receiving emergency care.

Required Actions

The California measure requires affected hospitals and
healthcare facilities to undertake several actions. In
summary, they must:

     Establish written guidelines for the use of medical
     cannabis on their premises.
     Provide the patient with a “locked container” to secure

the cannabis, to ensure the safety of others.
     Obtain a copy of patient’s marijuana identification card
     or a letter from attending physician stating patient’s
     need for medicinal cannabis.
     Include the use of medicinal cannabis in patient’s
     medical records.
     Prohibit smoking or vaping as methods of use.

We advise healthcare facilities to review compassionate
cannabis guidelines with their counsel before implementation.

Nelsonn Hardiman LLP

Healthcare Law for Tomorrow

Nelson Hardiman regularly advises clients on cannabis related
laws and regulations. We offer legal services to businesses at
every point in the commercial stream of medicine, healthcare,
and the life sciences. For more information, please contact
info@nelsonhardiman.com

Authored By:

Yehuda Hausman, Law Clerk

Harry Nelson, Managing Partner

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.*

Client Alert: COVID Confusion
Clarity:Federal CMS, OSHA,
and   CAL/OSHA   Vaccination
Mandates
At every level of government, the key policy question for the
second half of 2021 has been what to do about unvaccinated
Americans. The basic role of federal, state, and local
government is to promote the public welfare. At the same time,
government is responsible to preserve individual freedom and
liberty. Amidst a global pandemic, the conflict between these
values will continue to confront judges resolving legal
challenges to the growing list of vaccine mandates. In turn,
employers tasked with implementing and enforcing these
mandates in their workplaces will face their own challenges.
Below, we have analyzed the primary three Federal vaccination
mandates that directly impact private employers, as well as
the healthcare and life science industry:[1]

   1. November 4, 2021 — The Centers for Medicare and Medicaid
      Services (CMS) issued the Interim Final Rule (IFR).
   2. November 5, 2021 — The Occupational Safety and Health
      Administration (OSHA) issued (“100-Employee”) Covid-19
      Emergency Temporary Standard (ETS) .
   3. June 28, 2021 — Mid-year, OSHA also issued a Covid-19
      Healthcare ETS, tailored specifically to the Healthcare
      Industry.

Immediately following the November CMS and OSHA mandates,
plaintiffs – including 27 States – brought legal challenges
against these mandates. As these challenges move through the
courts, the Delta and Omicron Covid-19 variants continue to
spread, increasing the pressure at all levels to accelerate
the implementation vaccination requirements. Let’s first look

at the CMS mandate and then the two OSHA rulings.

The CMS Mandate
As of November 5, 2021, CMS requires specified Medicare and
Medicaid certified providers to enforce vaccination
requirements for (1) staff members & employees, (2) licensed
practitioners, (3) trainees, students, & volunteers as well as
(4) employees of outside contractors that may provide care or
other onsite services, such as cleaning or food services. As
far as vaccinations themselves, those covered by the mandate
should have received their first dose by Dec. 6, 2021 and
their second dose by January 4, 2022. Some staff may be
entitled to a legal exemption based on a medical condition or
a sincerely held religious belief. However, 100% remote
workers are not subject to the ordinance.

Penalties
Effective December 3, 2021, CMS has suspended enforcement of
this mandate because of ongoing litigation. If the CMS mandate
is reinstated, it may enforce through civil penalties, denial
of payment for new patients, and termination of
Medicare/Medicaid provider agreements. Given the threat to
federal reimbursement, providers at risk should not delay
compliance once the question of enforceability is resolved as
determined by the courts.

What Entities Are Included?
There are over 20 specific types of providers and suppliers
that are required to implement the ETS ruling. Here is the CMS
list (Source):

     Ambulatory Surgical Centers (ASCs)
     Hospices
     Psychiatric residential treatment facilities (PRTFs)
     Programs of All-Inclusive Care for the Elderly (PACE)
     Hospitals (acute care, long-term care, psychiatric
     hospitals, children’s hospitals, transplant centers,
     oncology hospitals, and inpatient rehabilitation

facilities).
     Long Term Care (LTC) Facilities, including Nursing Homes
     (SNFs & NFs)
     Intermediate Care Facilities for Intellectual
     Disabilities (ICFs-IID)
     Home Health Agencies (HHAs)
     Comprehensive Outpatient Rehabilitation Facilities
     (CORFs)
     Critical Access Hospitals (CAHs)
     Clinics, rehabilitation agencies, and public health
     agencies as providers of outpatient physical therapy and
     speech-language pathology services
     Community Mental Health Centers (CMHCs)
     Home Infusion Therapy (HIT) suppliers
     Rural Health Clinics (RHCs)/Federally Qualified Health
     Centers (FQHCs)
     End-Stage Renal Disease (ESRD) Facilities

What Healthcare Entities are Exempt?
The ruling does not apply to physician’s offices, organ
procurement companies, or portable X-Ray Suppliers. As far as
ad hoc service providers—i.e. an elevator inspector, or a
repair worker— visiting a health facility on a limited basis,
they will not need to show proof of vaccination. In addition,
companies that are not physically present at the patient
treatment site are exempt. For example, Telehealth and off-
site payroll providers are not subject to the CMS mandate.

OSHA’s Healthcare Covid-19 ETS
On June 28, 2021 OSHA issued a directive specifically
targeting Covid-19 exposures in the healthcare industry. Its
purpose was to protect healthcare workers from the
occupational hazard of contracting Covid-19. With few
exceptions, this ETS applies to all settings where any
employee provides healthcare services. This includes
hospitals, assisted living facilities, emergency responders,
home healthcare workers, as well as ambulatory caregivers

working where suspected or confirmed Covid cases are being
treated.

OSHA has published a summary of employer requirements.
Generally, employers are required to:

     Conduct a hazard assessment and implement a Covid-19
     plan for each workplace.
     Screen patients, non-employees, and any other visitors
     for symptoms of Covid-19.
     Ensure that employees where facemasks indoors, and
     provide facemasks on other PPE to protect individuals
     from exposure.
     To limit contact with suspected or confirmed COVID-19
     patients to those employees essential for treatment.
     Clean and disinfect adjacent equipment.
     Maintain 6 ft. social distancing. Utilize disposable
     barriers and fixed work spaces in areas where a 6 ft.
     separation cannot be maintained.
     Follow standard cleaning and disinfection procedures in
     accordance with the CDC.
     Provide sanitizer and accessible handwashing facilities.
     As COVID-19 spreads through airborne transmissions,
     there are requirements for HVAC systems and air filters.
     Daily screening of employees.
     Notify specific employees who may have exposed to person
     in their workplace who has tested positive with
     COVID-19.
     Remove employees who have or are suspected of having
     Covid-19
     It may be necessary to provide paid leave and benefits
     for individuals who must quarantine.
     Provide reasonable time and paid leave for vaccination,
     and recovery from vaccine side-effects.
     Train employees so they are aware of workplace Covid-19
     procedures and policies.
     Record employee cases of Covid-19.

Report work-related Covid-19 fatalities within 8 hours,
     and in-patient hospitalizations for Covid-19 within 24
     hours.

A significant number of States have already adopted or
incorporated the OSHA ruling in their own mandates. While
California, acting preemptively, issued guidance for
healthcare workers on May 16, 2021, six weeks ahead of the
federal mandate. Compliance with CAL/OSHA requirements ensures
federal compliance by default. Additionally, on December 22,
2021, Governor Newsom announced that that CA healthcare
workers will need booster shots by February 1, 2022.

OSHA’s (100-Employee) Covid-19 ETS
OSHA’s large employer mandate – covering private employers
with 100 or more employees – is the most extensive national
vaccination and testing regime to date. Entities that were
already subject to OSHA’s Healthcare-specific ETS (see
previous section) are exempt from the new Covid-19 ETS. For
life science organizations and all others with more than 100
employees, this may be the only relevant federal mandate.

Requirements 100-Employee Covid-19 ETS
In general, the ETS requires employers to:

     Develop and enforce a mandatory vaccination policy or,
     alternatively, to establish a bilateral policy allowing
     employees to either elect vaccination, or, to undergo
     weekly Covid-19 testing and to wear a mask at the
     workplace.
     Obtain proof of vaccination from employee and maintain
     records of each employee’s vaccination status.
     Provide reasonable time and paid leave for vaccination,
     and recovery from vaccine side-effects.
     Require employees to give prompt notice if they have
     contracted Covid-19.
     Remove employees from workplace if they have been
     diagnosed with Covid-19, or tested positive for

Covid-19.
     Ensure face coverings while indoors for employees who
     are not fully vaccinated.
     Inform employees in plain language writing of its
     Covid-19 policies and procedures, and provide them with
     the CDC document, “Key Things to Know About COVID-19
     Vaccines” which discusses vaccine benefits, and
     describes employee protections against discrimination
     and retaliation.
     Report work-related Covid-19 fatalities within 8 hours
     to OSHA, and in-patient hospitalizations for Covid-19
     within 24 hours.
     Make certain that employee Covid-19 are available upon
     request by the employee or a consented representative.

Employers must comply with most provisions by January 10,
2022. However, compliance with the testing provision is
extended to February 9, 2022. For California businesses,
unfortunately, the federal mandate will likely cause some
confusion. On December 16, 2022, CAL/OSHA issued its own
revised Covid-19 ETS for employers, which goes into effect
January 14, 2022. There are some significant differences:

   1. CAL/OSHA does not have a 100-employee minimum. All
      California employers, irrespective of their size, will
      need a “to establish, implement, and a maintain an
      effective written Covid-19 PreventionProgram.” They have
      conveniently provided a fillable model program for
      employers.
   2. CAL/OSHA does not have a vaccination requirement, but it
      will require employers to monitor employee vaccination
      status and make available free weekly or bi-weekly
      Covid-19 tests during paid time, whenever there is an
      “outbreak,” or “major outbreak” in the workplace.

The CAL/OSHA board is scheduled to meet January 20, 2022. We
believe they will attempt to better align state and federal
standards at that time.

Enforcement and Unemployment: Vaccine Refusers Beware!
For organizations whose employees and other onsite personnel
are providing proof of vaccinations, the primary burden of the
vaccine mandates is likely to be compliance with recordkeeping
requirements. For employers encountering reluctance and
resistance from the workforce, on the other hand, the
questions become (a) consideration of alternatives, such as
permitting weekly Covid-19 testing; (b) consideration of
requests for reasonable accommodation on medical or religious
grounds; and (c) difficult choices of termination or
suspension for employees who refuse to cooperate. For example,
in some states, the calculus will be complicated by “anti-
mandate” laws and regulations. Iowa, Florida, Tennessee, and
Kansas have recently passed legislation specifying that
workers terminated for vaccination refusal, can still receive
unemployment benefits. However, in many other states,
termination of employees refusing vaccination or testing, may
be used as grounds for denying state unemployment benefits.
Employers are well advised to seek state-specific counsel to
navigate the implementation of vaccine related rules.

Nelson Hardiman LLP
Healthcare Law for Tomorrow

Nelson   Hardiman   regularly   advises   clients   on   workplace
policies related to Covid-19. We offer legal services to
businesses at every point in the commercial stream of
medicine, healthcare, and the life sciences. For more
information, please contact Info@nelsonhardiman.com

[1] This article does not address the other two federal
mandates, which apply to federal agency employees and to
federal government contractors.
Authored By:

Yehuda Hausman, Law Clerk

Harry Nelson, Managing Partner

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.*

Client     Alert:     Genetic
Information Privacy Act: What
Do Genomics Companies (and
Everyone Else) Need to Know?
On January 1, 2022, a new privacy statute, GIPA (the Genetic
Information Privacy Act), will introduce significant
protections for California residents who undergo non-medical
genetic testing. Some 30 million people have spat in a tube
and shared their unique genetic data with prominent genealogy
companies, like Ancestry.com and 23andMe. Customers expect
their DNA will be used for tracking down distant relatives and
discovering new branches on the family tree. But very few will
study the lengthy disclosures indicating how their personal
genetic information might be sold or shared with third
parties. A broader concern is that, once genetic data is
uploaded to a digital database, it can potentially be exposed
to accidental data breach or cyber-theft, like any other
information stored in “the cloud.” As the genomics industry
continues to evolve, GIPA will hopefully protect California
residents from having their genetic data shared with third
parties without their consent or knowledge.

Industry Impact

     As of January 1st 2022, affected companies will need to
     update their customer consent forms so that they satisfy
     the “plain language” requirements of the new law.
     Specific consent forms for data transfers and sales to
     third-parties will need to identify the third-party
     recipient by name. Considering the implausibility of
     obtaining consent from users who have ceased using the
     web interface, this law may render much of these
     databases useless for remarketing to for-profit
     entities.
     In general, policies and procedures regarding the
     collection, use, and maintenance of genetic data will
     also need to be prominent and easily accessible on
     company websites, so consumers can learn how their
     information is being used.
     In addition, companies         will   need   to    create
     straightforward mechanisms allowing consumers the
     ability to delete their accounts, revoke consent, and
     request that their biological data be destroyed.

Stiff Penalties

The negligent violation of the statute can be assessed a civil
penalty of $1,000. While the penalty for intentional violation
is set between $1,000 and $10,000. As each violation is
“separate” and “actionable”, liability for a mass data breach
is immense. The statute itself stipulates that public
attorneys can prosecute actions for relief. This is in
addition to potential class-action claims.

Who is Exempt

A number of service providers and professionals are excluded
from the reach of GIPA:

     Licensed medical professionals that use biological data
     solely for diagnosing and treating patients.
     Covid-19 testing companies. (A previous iteration of the
     bill, which would have impacted pandemic testing, was
     vetoed by Governor Newsom.)
     There are also some use exclusions for “deidentified
     data,” where the genetic data cannot be matched with a
     particular person. Under certain circumstances, database
     information can be shared with an educational non-profit
     for scientific purposes.

If the Law Applies to You…

If your business is in possession of a genetic database,
transports biometric samples, or engages in genomics research
and development, there are some immediate steps to take. We
recommend the following:

     Businesses involved in marketing, selling, interpreting,
     or analyzing direct-to-consumer genetic testing should
     review and update their consent forms.
     Website information may require extensive review and
     updating so information is easily accessed and
     comprehended by consumers.
     Risk-analysis. Companies that store genetic information,
     digitally or physically, should review their security
     precautions. Even companies that maintain genetic
     databases, but do not offer DTC genetic testing, must
     comply with the new statute.

 We invite you to contact us with any additional information
you have obtained regarding this important matter.

Authored By:

Yehuda Hausman, Law Clerk

Harry Nelson, Managing Partner

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.*

Nelson     Hardiman     Adds
Chambers-Ranked,    Renowned
Corporate Finance Attorney
LOS ANGELES (PRWEB) DECEMBER 16, 2021

Moshe Kupietzky, one of the most respected corporate finance
attorneys in Los Angeles, has joined healthcare law
firm Nelson Hardiman, deepening its bench for transactional
matters. “Moshe Kupietzky has built a reputation as being on a
short list of the very best corporate finance attorneys in
Southern California and nationally, representing buyers and
sellers in complex transactions. It is a genuine privilege for
us to add an elite M&A lawyer of Moshe’s caliber to our ranks.
He brings the kind of serious expertise that our healthcare
and life science clients need,” said Managing Partner Harry
Nelson.

Kupietzky joins Nelson Hardiman from the Reed Smith law firm.
Previously, he served as head of Sidley Austin’s Los Angeles
Corporate and Finance practice for more than 20 years, and
served as managing partner of the firm’s Los Angeles office

from 2003–2009.

As reflected by over a decade of Chambers USA ranking, Moshe
is recognized as a market-leading corporate and finance
attorney. He has represented national and international
companies across a broad spectrum of industry sectors to
structure complex mergers and acquisitions, joint ventures,
private equity purchases, strategic partnerships and
consolidations, and related opportunities. Moshe also brings
deep experience in financing and M&A transactions. “Nelson
Hardiman has an exceptional reputation as a dynamic, cutting
edge law firm, which made it a seamless transition for me,”
said Moshe Kupietzky. “I look forward to contributing to the
expansion of the firm’s transactional expertise and practice.”

A graduate of Harvard Law School, Kupietzky has been
frequently recognized for his leadership and more than five
decades of professional impact and influence in the corporate
arena. Since 2007, Chambers USA has annually named him a
leading Corporate/M&A attorney, and, since 2008, also a
leading lawyer in Banking & Regulatory. He has also been named
among The Best Lawyers in America in Corporate Law each year
since 2011.

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 innovation in leadership in addressing issues in
telehealth, behavioral health, and emerging therapeutic
modalities. More information about the firm is available
at http://www.nelsonhardiman.com or at 310.203.2800.

Read Press Release

Contact Us: info@nelsonhardiman.com

Forbes: Predicting The Course
And Impact Of The Covid
Crisis In The New Year
From the article:

 The Covid-19 pandemic, which has had more ups and downs than
 a rollercoaster ride, shows no signs of ending anytime soon.
 The latest turn of events was the discovery last week of the
 Omicron variant, which scientists are scrambling to
 understand.

 This crisis reminds me of something American baseball legend
 Yogi Berra once said: “It ain’t over till it’s over.” His
 acute observation is underscored by the following predictions
 from doctors, experts and others about the coronavirus crisis
 in 2022.

 100,000 More Deaths
 Harry Nelson is the founder and managing partner of Nelson
 Hardiman, a healthcare law firm. He said, “For the
 unvaccinated…Covid-19 will remain much more of a wildcard. I

suspect we will see at least another 100,000 Americans dead
in 2022, drawn from the ranks of the unvaccinated.

“As time goes on and this stark contrast between the
respective risk levels becomes more apparent, I expect
vaccination rates to increase from the current 60% to closer
to 70% of the U.S. population,” Nelson concluded.

Another Winter Wave
Dr. Andrew Noymer is an associate professor of population
health and disease prevention with the University of
California Irvine Program in Public Health. He predicted
that, “The pandemic in 2022 will have another winter wave,
less severe and less deadly than in winter 2020-21, but
nonetheless still significant, and, in most places, more
concerning than the ‘Delta [variant] wave’ of summer 2021.

“Omicron is a variable here, but even without Omicron, there
will be a winter wave. The regulatory environment for retail
businesses (masking, vaccine verification, and so on) will
continue to vary from place to place, but in general the
pandemic will not cease but become the ‘new normal’, in an
only-slightly attenuated state from right now.”

High Rates Of Infection
Dr. Rich Parker a former medical director of Beth Israel
Deaconess Care Organization, is now a hospice physician,
medical consultant and chief medical officer of Arcadia. “I
predict that in 2022, we will still see high rates of
infection in areas with low vaccination rates. These areas
will have stressed healthcare systems with shortages of
healthcare staff and hospital beds.

“Businesses in these areas will also have more difficulty
hiring and retaining workers who do not wish to be at further
risk of contracting Covid. Therefore, businesses can prepare
for 2022 by either mandating vaccination or offering
significant incentives for employees to get vaccinated,

including the booster shots,” he advised.

A Court Ruling On Vaccine Mandate
Nannina Angioni is a labor and employment attorney and
partner of the Los Angeles-based law firm Kaedian. She said
that, “We will have a final ruling —likely from the U.S.
Supreme Court—about Biden’s vaccine mandate, which will
affect business operations nationwide.

“Businesses will also continue to grapple with local masking
and vaccine requirements, including [sometimes having]
difficult conversations with their clients and customers,”
she said.

Harder To Recruit And Keep Employees
Suky Sodhi is the president of staffing agency Professional
Selection. “I believe talent is going to be more difficult to
attract and retain,” she predicted. “Larger companies need to
be prepared for mass exits which is going to impact their
businesses, as those who refuse to get the vaccine are forced
to seek alternative employment opportunities.

“This is also a great opportunity for companies to look at
remote set-ups for existing employees, and international
talent for new vacancies, where they can utilize skills
outside of their usual reach. Companies need to think
carefully about implementing the blanket enforcement without
investigating how they can protect society while still
respecting their employee’s freedom of choice,” Sodhi
counseled.

Erratic Wait Times In Global Supply Chain
Jason Fullmer is the chief operating officer of 3D printer
company Formlabs. He that that, “In 2022, the fall out of the
Covid-19 pandemic will continue to have an impact on
manufacturing and the global supply chain. The long, erratic
wait times will not go away anytime soon, especially as more
variants emerge and potentially disrupt international travel

and shipping routes.

“To account for these disruptions, businesses will prioritize
making their supply chain and manufacturing processes more
redundant and decentralized in 2022,” he observed.

Increased Liability Risks
Daniel R. Strecker is senior counsel with the Harris Beach
law firm. “As the Covid-19 global pandemic persists into
2022, I predict businesses, real estate owners,
manufacturers, distributors, and retailers will face
continued premises and product liability risks…The situation
has become more complex in connection with a patchwork of
vaccine mandates, which has put vaccinated and unvaccinated
people into close contact.

He said that, “… awareness of potential claims and defenses,
and ongoing compliance with state and federal health
guidelines, will remain critical to avoid incidents now and
lay the groundwork for future defenses should claims
nevertheless arise.

“Plaintiffs must do more than prove someone became sick—often
they must prove negligence, notice, a product defect, or a
breach of warranty, and causation. Depending on the state law
that applies, following state and federal guidelines may
provide immunity. In others, it constitutes evidence that the
defendant was not at fault,” Strecker noted.

Advice For Business Leaders
Keep Calm
Nelson of the Nelson Hardiman law firm, said, “… the best
thing business leaders can do is be a source of calm,
spreading the message that Covid-19 is going to keep looking
more and more like the flu, and the panic is worse than the
risk (for the vaccinated).

“Leaders need to find the resources to be empathetic to
people who remain overly stressed by Covid-19 and the people

who are continuing to put themselves at risk needlessly by
forgoing vaccination.”

Monitor Data
Don Silver is the chief operating officer of Boardroom PR. He
recommended that, “Businesses have to keep a close eye on the
data and advisories from the CDC and others and maintain an
open line of communications with their workforce and
customers and to have alternative plans to help everyone stay
as safe as possible.”

Accept Reality
John Goodman of John Goodman PR said that, “Business[es] that
have not already adapted to our Covid world will be forced to
change. Flexible work schedules will become commonplace.
Companies will enhance their work/family benefits to attract
and retain employees.

“And those businesses that remain stuck in the past will
continue to lose talent to other companies that offer either
hybrid or remote work and better benefits. The bottom line:
living in our Covid world is now the new normal. And
businesses must come to that reality and pivot or else face
the consequences,” he concluded.

Read Full Article

Top Lawyers: Harry Nelson of
Nelson Hardiman On The 5

Things You Need To Become A
Top Lawyer In Your Specific
Field of Law
From the article:

The legal field is known to be extremely competitive. Lawyers
are often smart, ambitious, and highly educated. That being
said, what does it take to stand out and become a “Top Lawyer”
in your specific field of law? In this interview series called
“5 Things You Need To Become A Top Lawyer In Your Specific
Field of Law”, we are talking to top lawyers who share what it
takes to excel and stand out in your industry.

As a part of this interview series, I had the pleasure of
interviewing Harry Nelson.

Harry, the founder of Nelson Hardiman, has been called the
leading healthcare lawyer in America. Apart from his
regulatory strategy work in other areas of healthcare and life
science innovation, he developed the regulatory pathway for
telehealth companies that were acquired in 2021 for
collectively over $2 billion. His lessons from crisis response
work in the overdose crisis led to the best-selling “United
States of Opioids: A Prescription for Liberating a Nation in
Pain.” Harry’s advocacy work related to America’s healthcare
future has led to numerous awards and has produced tangible
results to improve healthcare regulations at the federal and
state levels.

Thank you so much for joining us in this interview series.
Before we dig in, our readers would love to get to know you a
bit more. What is the “backstory” that brought you to this
particular career path in Law? Did you want to be an attorney
“when you grew up”?

Igrew up in the Midwest (Detroit). My father and his father
both went to law school, but went on to the seminary and
become rabbis. I was much older before I felt the spiritual
pull, so as a teenager, I felt like I could break the family
mold by not just going to law school but actually practicing
law. Originally, I thought I would be a prosecutor. But after
a summer in college interning for a congressman on Capitol
Hill, I came away fascinated by the way government regulations
ruled over so many American industries — and how broken the
whole system was. Back then, the government was rolling back
regulations in airlines and telecom, leaving the lawyers who
specialized in those areas scratching their heads with what
they would do next. So I figured out that I wanted to become
an expert in an area that wasn’t going to be deregulated
anytime soon, which turned out to be healthcare. To me, living
in a country that spends more than anyone in the world for a
terrible system, it was simultaneously the biggest opportunity
and most broken part of our whole system.

Can you tell us a bit about the nature of your practice and
what you focus on?

My practice has 3 sides. For companies in areas of healthcare
and life science innovation, like telehealth, behavioral
health, genomic testing, stem cells, psychedelics, I function
as a regulatory lawyer and strategist, helping early stage
ventures navigate uncharted or less charted regulatory waters
from ideation to all the way to wherever they want to go. For
healthcare and life science companies in crisis due to
regulatory mistakes (fraud, patient safety, privacy violations
or other noncompliance), I help them fix what is broken —
remediating compliance issues, repairing relationships
internally, with government agencies, with insurance
companies. And for many healthcare companies, I serve as a
one- stop shop when they need outside regulatory counsel for
ongoing business needs.

You are a successful attorney. Which three character traits do

you think were most instrumental to your success? What unique
qualities do you have that others may not? Can you please
share a story or example for each?

I don’t think I would be where I am if I wasn’t driven. Life
would be more fun if I wasn’t constantly driven to work
relentlessly to produce the highest quality work product and
advice, and to be the best. I would set better boundaries. My
wife and my kids are ready to kill me sometimes because I am
rarely fully away from the work. I will be on the ski lift
with my kids and a client has an issue, and I am in the thick
of it. I get a complete separation only from Friday night to
Saturday night because we observe Shabbat, but I think that
indefatigable drive is the number one thing that separates me
from my colleagues.

I think my empathy has been a difference-maker. I once had a
doctor who kept calling me. He lived on the other side of the
country, but had gotten my name from a friend. He told me from
the beginning that he was already working with two other
lawyers I knew and respected, one of whom was nationally
renowned, but I took his calls as a courtesy and then took a
meeting with him. I kept telling him, “You’re in good hands
already. You don’t need me.” He said to me, “I did my homework
and I know I’ve hired the best people. But I also know that
you are every bit as good as they are. And the difference is,
when I talk to them, they leave me cold. But when I talk to
you, I feel you are in it with me, and my anxiety just lifts.”
It was an epiphany for me that part of my difference is that
personal bond and my ability to give clients emotional support
in a way other lawyers didn’t. He taught me not to hold back,
to lean in to the emotional side of a client’s needs.

I think that my ability to manage stress and to process things
quickly has been a key difference. I work in areas of law
where the norm for lawyers is to be super-cautious and slow,
and I know it drives clients crazy. There’s way too much
hemming and hawing because it’s stressful to stake out a

definitive position in areas where technology has outpaced the
law, and where there’s confusion and ambiguity. I have come to
the view that, as long as I am transparent about what I know
and where I am thinking out loud, I can give clients my best
advice in a way that is specific and in real-time, without
making them wait for a memo a couple weeks later. I regularly
have clients who tell me, “I spent the last six months and
tens of thousands of dollars with other lawyers getting the
run around, and you just gave me the answer on our very first
call.” It only happens because I can manage the stress of
being put on the spot constantly, process the situation, the
challenge, calibrate to the audience, and give the answer that
is needed.

Do you think you have had luck in your success? Can you
explain what you mean?

I have unquestionably had some good breaks that you could call
lucky. I was once standing in line at a hotel valet parking
waiting for my car after an event, when a lawyer I knew from
another firm walked by with a colleague and introduced me.
That introduction produced one of my biggest clients of the
past decade. I view the kindness of people on a daily basis
who happen to think of me and make connections as the greatest
kind of luck.

I’ve come to the belief that everything happens for a reason,
that we can’t understand why good things happen or why bad
things happen. All we can do is be grateful for the breaks we
get and find a way not to hold onto anger and resentment with
the ones that don’t go our way. I’ve got a way to go on that
score, but I have learned to process things quickly so that I
can move on and focus on the next thing.

Do you think where you went to school has any bearing on your
success? How important is it for a lawyer to go to a top-tier
school?

I am proud of being a Michigan alum. I think it mattered at
the beginning of my career that it was a top school. It helped
me get a clerkship with a judge in Hawaii, who maybe only gave
me an interview because he was Michigan alum. It helped with
my first job at a firm in Chicago, at a firm with other people
from elite schools, having the right markers on my resume. But
I know as many lawyers without fancy academic pedigrees who
were as or more driven than me that have killed it. It
definitely gives you a leg up in the early days of your
career, but I also think over time, it really doesn’t matter
where you went to school. And what I have seen being in Los
Angeles is that it may be just as valuable to have a network
of local alumni (be it USC or Loyola) than to have high-
ranking school without a strong presence in the community.

Based on the lessons you have learned from your experience, if
you could go back in time and speak to your twenty-year-old
self, what would you say? Would you do anything differently?

I would say a few things:

First, I would say there are times I should have been more
patient. I sold a big position out of Amazon when Webvan
cratered that I can’t even think about. Hang in there on those
bets.

Second, I would say it took me a while to really have fun with
the work, to be myself fully, to feel a sense of not just
purpose, but joy. I think my early days as a lawyer were too
focused on making the senior folks I worked for happy, to
meeting expectations, and not focusing on setting up the life
that I wanted. I worried too much about what other people
thought and not enough about what I needed. I would tell my
younger self not to waste time getting to know my interior
self and to embrace my work style, my risk tolerance, and my
passions. I would spend more time with fellow creatives and
people who are energizing.

Third, I would tell my younger self not to worry so much about
fitting in. Law is a crowded marketplace where not standing
out is basically the same as being invisible.

This is not easy work. What is your primary motivation and
drive behind the work that you do?

It constantly changes. There was a point where I was convinced
I was building an empire, a national practice and leaving a
legacy. All it took was a taste of what mercenary times these
are for so many lawyers for me to be dissuaded that that was a
worthwhile pursuit.

There is a piece that is motivated by the satisfaction of
providing for my family, of taking care of the people I love,
of having the autonomy to make my own choices.

But I think my ultimate motivation is that I feel I am living
my purpose when people bring me problems to solve, and I am
able to work them out. I feel a sense of joy in connecting
with people on the work, in learning of something new about
feeling a momentary satisfaction about a job well done —
before jumping into the next problem.

What are some of the most interesting or exciting projects you
are working on now?

I have a handful of clients that feel like multi-billion
dollar opportunities if they can work out the challenges in
front of them. I am particularly excited about two projects I
am working on at the cutting of personalized, genomic medicine
that I think is about to revolutionize medicine. I am excited
about a couple of clients who are at the forefront of
psychedelic therapy, including one that is integrating
psychedelics into telehealth to drive a transformation in how
we treat depression and PTSD. I am really excited about a
local health system client that is on the verge of rolling out
a new model of behavioral health crisis response centers that
have the potential to move the needle on overdose prevention

and also on addressing homeless mental health issues.

Where do you go from here? Where do you aim to be in the next
chapter of your career?

I am really enjoying myself these days. And I still feel
passionate and energized by the work I try to make sure I am
focusing on doing what I love, doing it well, staying on top
of the next big things.

Beyond my practice, I am working with a publisher on a new
book addressing America’s overdose crisis. I’ve been asked to
get involved in some more television projects, and am trying
to figure out a roadmap to make sure my public service
messages for America’s healthcare future are being heard. I
have gotten some informal inquiries about taking a leadership
role in some type of (appointed, not elected) public service.
I am taking interesting calls and keeping my ear to the
ground.

I haven’t figured out what the next chapter is for me. I am
trying to build up a strong cadre of colleagues who can bear
more of the “heavy lifting” in client work that I currently
do, so that I have the option to re-allocate more time to
other projects, but that is a work in progress.

Without sharing anything confidential, can you please share
your most successful “war story”? Can you share the funniest?

My favorite war stories involve jumping in at the last minute
into projects that couldn’t be resolved by other people and
taking care of business. I once got a call from the general
counsel of one of the biggest telehealth companies in the
country. He was panicked because the Medical Board of
California was about to commence a hearing against one of
their doctors. Their regular law firm handling the case had
reassured them the matter would be settled on mutually
agreeable terms, and then informed them that they were wrong,
and there was no way to prevent the case from going forward in

just over a week. The Deputy Attorney General handling the
case was an impossible, ideological person, on a mission, who
I had butted heads with before, and I knew she was never going
to give ground. So I went over her head and made a direct
appeal to the Board leadership and painted a picture of why
this case needed to be shut down. Less than 24 hours before
the case was scheduled to start, with the doctor about to
board a plane to come to California, the case was dismissed.
No explanation. Grateful client, very unhappy prosecutor.

My other favorite war story is that I had a publicly traded
client in a different area of healthcare being railroaded out
of California by a licensing agency. They had many locations,
and it was going to be a disaster for them. I decided that the
case needed a new lawyer, but that it would be better for me
to bring in another law firm so I could serve as the expert
witness. The strategy paid off when the administrative law
judge found in his decision that I was the authoritative
person on the issue in question (corporate practice medicine),
as exemplified by the number of times that the Attorney
General’s office kept citing me. He wouldn’t let them pick and
choose. It was a case with hundreds of millions of dollars at
stake for the client, and my testimony won the case. The state
agency adopted it and abandoned a multi-year battle with the
company.

The funniest story for me was the one that led me to become
the very first healthcare lawyer in the country to start doing
medical marijuana work. In 2009, the Obama Administration had
just announced it would stop raiding California’s medical
marijuana dispensaries if they complied with state guidance. I
was known for my DEA-related work, including petitioning for
DEA research permits for cannabis, so my phone started ringing
off the hook with marijuana-related clients. I said, “I don’t
really know much about medical marijuana law beyond doctors.
Let me find the right lawyer who understands dispensaries,
cultivation, product development. I called around and found

the lawyer everyone in town described as the expert. Everyone
else advising was a criminal defense lawyer, but this was the
preeminent “corporate lawyer” for cannabis in California. I
left a voicemail message for him. He called me back and we had
a nice conversation late in the day. I was getting ready to
email the people who called me his name the next day, when he
called me again. He literally had no recollection whatsoever
that we had already spoken. I realized he had been as high as
a kite in both conversations. I decided I couldn’t in good
faith give his name to anyone, so I decided to roll up my
sleeves and start learning cannabis. Within a year, we had the
biggest cannabis practice in Southern California. The lawyer
later became a client and a friend, but to this day, I credit
him with inspiring me to tackle the space.

Ok, fantastic. Let’s now shift to discussing some advice for
aspiring lawyers. Do you work remotely? Onsite? Or Hybrid?
What do you think will be the future of how law offices
operate? What do you prefer? Can you please explain what you
mean?

Personally, I like to be in the office. It’s quiet these days
(more than half of our team is still remote), but I like the
ability to bounce ideas around with my colleagues who are
there. The work is getting done, but I would say some of the
emotional support and connection we give each other is gone
when everyone is remote. I also think it is weakening our
culture and the bonds that tie us together. I already hate how
mercenary law practice has become, and I think this makes it
worse. I am trying to make the most of it personally by
traveling more, taking advantage of the ability to be
someplace else, stretching out my time away. I think it is the
future. We have 42,000 square feet of space and can function
with a fraction of it in the post-pandemic world. I would not
want to be in the commercial real estate business. Law firms
are going to get much more space efficient, and I think we are
going to see a wave of innovation in digital tools to let u

better connect remotely.

How has the legal world changed since COVID? How do you think
it might change in the near future? Can you explain what you
mean?

There have been some positive changes. I used to have many
projects that needed an in-person meeting to get going. These
days, everyone is just fine with an initial meeting or a kick-
off via Zoom. I think location matters less than ever. We are
getting new clients all over the country and also globally
more than ever. At the same time, we are competing with good
lawyers and firms all over the country, so it forces us to up
our game. As a healthcare lawyer, COVID has also brought up
many new legal issues for us to tackle, and driven the growth
of pandemic-friendly businesses, like diagnostic lab testing
and telehealth that were already sweet spots for us.

We often hear about the importance of networking and getting
referrals. Is this still true today? Has the nature of
networking changed or has its importance changed? Can you
explain what you mean?

I would be nothing without an amazing network of lawyers at
other firms and former clients who give my name out all over
the place, who vouch for me, and who sing my praises when
people need someone who does what I do. So networking is still
critical to me. The pandemic put our ability to nurture our
networks on hold, because we stopped seeing each other, and
were limited to more impersonal emails and calls. I have had a
slight advantage with regular TV appearances because I tend to
be highly visible on social media so people don’t forget about
me. But networking in person will be a big focus again with
COVID hopefully in check.

Based on your experience, how can attorneys effectively
leverage social media to build their practice?

It keeps evolving. At one point, I had massive visibility on

LinkedIn, and then they changed their algorithm, and I went
from thousands of views per day to several hundred per week. I
have had good results with Facebook, although I am still
learning. I feel like I am still at square one in learning how
to use Instagram for engagement. I think of social media as a
visibility tool which is useful for activating my network. The
work flows mostly through the network, but the social media
visibility keeps me on the network’s mind.

Excellent. Here is the main question of our interview. What
are your “5 Things You Need To Become A Top Lawyer In Your
Specific Field of Law?” Please share a story or an example for
each.

1. Research: You are dead in the water in healthcare law if
you aren’t on top of the latest regulation or pronouncement in
whatever jurisdiction you are dealing with. The ground is
constantly shifting. I’ve picked up more than a few clients
because their last lawyer missed a particular change. For
example, after Medicare announced the 36-month rule limiting
home health agency changes of ownership, I saw an influx of
work because one of our competitors had failed to advise
client that it was coming.

2. Writing: I am in the business of persuading investors or
acquirers of early stage ventures that the regulatory
compliance concerns expressed by other lawyers are not a real
problem — or that they are addressable. I am constantly
relying on my ability to write to win hearts and minds and get
deals done. Just last week, we had a national law firm ready
to kill an acquisition of one of our clients over an expressed
compliance concern. I generated a memo that convinced the
other firm’s client that they were being unduly conservative.
This work is all about the writing.

3. Speaking: There are many moments when being able to deliver
the message clearly and succinctly is the difference between
success and failure. I have been though a number of eleventh

hour conversations where being confident and firm makes the
difference as to whether the deal gets done or not.

4. Problem-Solving: So much of the work is figuring out the
best way to navigate through the puzzle. People call us when
they are stuck or confused or lost. The job comes down to
knowing the landscape and then thinking critically, thinking
creatively, and thinking quickly, because something bad is
going to happen if we don’t figure out the solution and get it
done.

5. Interpersonal: I don’t see how you can be successful if you
can’t listen, relate to clients and make them feel heard and
understood. People need to really be able to trust and rely on
their lawyer on sensitive healthcare questions.

We are very blessed that some of the biggest names in
Business, VC funding, Sports, and Entertainment read this
column. Is there a person in the world, or in the US with whom
you would love to have a private breakfast or lunch, and why?
He or she might see this.

I   get   to   interact   with   more   sports   and   entertainment
celebrities than you might think who are considering or
joining cutting edge healthcare/life science ventures, and my
job is to settle down VCs so clients can get the funds they
need. If I had to confess a fascination, I would love a chance
to schmooze with Elon Musk. I love his drive to innovation and
would like to sell him on some life science opportunities.
Slightly geekier second choice would be to pick Ray Kurzweil’s
brain. I have a lot of questions for him.

This was very inspiring. Thank you so much for the time you
spent with this. We wish you continued success and good
health!

_______________________________________

Contact: info@nelsonhardiman.com

Client Alert: MultiPlan Named
As    Central    Figure    In
Antitrust Lawsuit Alleging
Health Insurance Monopoly
Scheme
The liquidating bankruptcy trust for Verity Health System of
California recently filed a lawsuit in the Superior Court of
the State of California, County of San Francisco, against
third-party “re-pricer” MultiPlan, including its subsidiaries
Viant and Data iSight, and more than a dozen of MultiPlan’s
customers – including major commercial payers like Anthem,
United Healthcare, Aetna, Cigna, and others – alleging
antitrust claims under California’s Cartwright Act and Unfair
Competition Law.

According to the lawsuit, MultiPlan acted as an unlawful
“corporate hub” of a classic “hub, spoke, and rim” agreement
among the re-pricer and its various insurance company clients,
to “fix” the amounts that would be reimbursed to healthcare
providers on out-of-network claims. The complaint alleges that
reductions in reimbursement payments for healthcare services
rendered by providers nationwide totaled approximately $10
billion per year from 2012 to 2020, driving up profits for
MultiPlan’s insurance company clients, and also for MultiPlan
itself.

Indeed, the timing of the lawsuit is significant, as it comes