International travel is getting easier — except for the unvaccinated – Harry Nelson Interview by CNBC

Founder and Managing Partner Harry Nelson was interviewed by CNBC regarding loosening entry requirements for vaccinated travelers as there is a growing list of countries reducing or eliminating quarantine and Covid-19 testing requirements for those who have been fully vaccinated while keeping restrictions in place for those who haven’t.

From the interview:

Phuket, Thailand, and Greece have indicated less restrictive vaccine-based protocols are in the works.

Such policies make “perfect sense,” said Harry Nelson, the founder of Los Angeles-based health care law firm Nelson Hardiman.

“My anticipation is that this will eventually be the rule in the vast majority of countries and that, at some point in the future … we will see some countries shift to a vaccination requirement,” he said.

Are these policies fair? No, said Nelson, “but the complaints about fairness are, in my view, ridiculous.”

He cited long-standing precedents for countries imposing proof of vaccinations for visitor entry, particularly with yeIlow fever. He said that the ongoing threat of Covid-19 variants makes it “fully reasonable for countries to impose vaccination requirements.”

“Fair is a concept that is irrelevant when it comes to controlling a highly infectious virus that is transmitted around the world,” he said.

Full Article

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Robert Fuller on KTLA5 News – Johnson Johnson Vaccines Halted Following Reports of Rare Blood Clots


Partner Robert Fuller on KTLA5 News: Johnson Johnson Vaccines Halted Following Reports of Rare Blood Clots.

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Harry Nelson on KTLA5 News – Blue Shield Vaccines: Money & Politics


Managing Partner Harry Nelson interviewed on KTLA5 Morning News to discuss the California Blue Shield Vaccine Contract as well as Money & Politics.

For More Information Contact: [email protected]


Commercial Insurers Hitting More and More Behavioral Providers with Audits, Repayment Requests

Partner Zachary Rothenberg was interviewed by Behavioral Health Business to discuss the growing risk private payers are posing for behavioral health providers.

From the Article:

As government enforcement action in behavioral health heats up, providers who work with commercial insurers may think they’re in the clear. But that’s not the case.

Private payers can pose just as big of a threat and financial burden for behavioral health providers. And in fact, that risk is growing, according to lawyers who work in the behavioral health care space.

While commercial insurers don’t have the FCA at their disposal, they have other tools. As of late, audits and retrospective reviews are among their most commonly used, according to Zachary Rothenberg, a partner at Nelson Hardiman LLP.

“In the past year or so, it has really heated up and become a bigger and bigger part of my practice,” Zachary Rothenberg, a partner at Nelson Hardiman LLP, told BHB. “I’m dealing with these retrospective reviews all the time.”

Based in California, Nelson Hardiman is a specialty healthcare law firm that serves clients across the U.S. Behavioral health is one of its main focuses, especially for Rothenberg, who said he spends about 25% of his time working with behavioral health providers on commercial audit issues specifically.

It usually works like this: An insurance company will request a sample set of documents from a provider. After reviewing the documents, the insurer will tell the provider that it has been billing incorrectly. Then, the payer often extrapolates those findings and asks for repayments.

“It’s often millions of dollars,” Rothenberg said. “And that obviously is a huge stressor for clients, which are not always massive businesses. They are sometimes mom-and-pop operations being asked to refund all of the money they’ve ever received from a particular payer.”

Rothenberg frequently works with clients to help negotiate those repayments down, but the amount is always substantial, he said. If providers want to continue working with said insurer, denying the repayment request altogether isn’t really an option.

“If [providers] don’t agree and they don’t write that check, they will remain flagged with the payer,” Rothenberg said. “They will basically never get paid for treating that payer’s members.”

In an industry marked by slim margins and small businesses, that kind of financial strain can ruin providers. In fact, in the past year since Rothenberg began to notice an uptick in commercial insurers auditing behavioral health providers, he said he’s watched providers go out of business. However, he stopped short of attributing closures solely to these recoupments.

“Whether you can tie it directly and exclusively to these retrospective reviews, as opposed to the pandemic or other issues, I don’t know,” he said. “What I can tell you, though, is that it has been awfully painful, and the reviews certainly contributed to financial hardship for these businesses.”

Rothenberg isn’t the only lawyer to take notice of the commercial insurance audit trend. Polsinelli shareholder Asher Funk told BHB it’s becoming increasingly common for commercial payers to take issues with claims they’ve already paid.

“A classic example of this is the Florida model, where treatment providers put together an outpatient [offering] and a housing component to create something like residential care,” Funk said. “Payers paid for the outpatient level of care and were content enough to pay that lower reimbursement rate for a period of time. Then they turn back and say, … ‘That looked a lot more like residential care. … Please send us back all of that money.’”

Meanwhile, Rothenberg said he’s seen retrospective reviews fall into a number of categories. Those include step-down billing issues similar to the one Funk described, in which providers bill insurers for a less expensive, lower level of care; admission issues related to initial intake, assessments, individualized treatment plans and care acuity; services-related issues, which frequently focus on oversight by licensed clinicians and non-evidence-based care; and documentation issues like missing hours and notes that don’t have enough detail.

Protections for providers
In light of this trend, the obvious question becomes: How can providers protect themselves?

First and foremost, compliance planning is key. Providers should commit time, money and people toward preparing and implementing their compliance plan, which could have the seven elements outlined by the Office of Inspector General (OIG) for Health and Human Services (HHS).

Those include policies and procedures; a compliance infrastructure; effective education and training; effective communication; effective auditing and monitoring; effective investigation into violations; and a consistent disciplinary process.

It’s not enough to just have the plan, though. Providers also have to put it into practice.

“I would really encourage providers to do regular audits of their own paperwork,” Rothenberg said.

Additionally, he recommends providers proactively check with payers to make sure the payers approve of the provider’s program offerings. Plus, he says folks should prepare for the worst case scenario, rather than looking for loopholes.

“You’ve got to go into it thinking, ‘I’m going to do this the right way no matter what, and if I can’t … then I just won’t do that line of business,’” he said. “That’s as opposed to, ‘I’m going to move forward in this line of business one way or another, and if I have to take my chances, I’ll take my chances. That’s what gets people into trouble.”

Still, even providers with robust compliance programs can fall victim to audits from commercial insurers. And if that happens, it’s time to call a lawyer.

“Once a provider is in the zone of scrutiny or having one of these issues, they benefit from engaging competent counsel to make the best case they can and provide the best protection,” Funk said. “Just because allegations were made doesn’t mean they’re true.”

Full Article

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With 3 New Additions, Nelson Hardiman Adds to the Leading Healthcare and Life Sciences Law Firm in Los Angeles

Nelson Hardiman, LLP, is proud to announce that three experienced healthcare attorneys, is proud to announce that three experienced healthcare attorneys, Daniel R. Eliav, Joshua G. Singer, and Ariella (Cohen) Coleman have joined the firm, securing Nelson Hardiman’s position as the premier specialty healthcare and life sciences law firm in Los Angeles.

Daniel R. Eliav joins the firm after working at two Am Law 100 firms. Prior to joining Nelson Hardiman, Daniel also served as Covered California’s lead attorney for several program areas related to consumer assistance. In that role, he was responsible for drafting agreements and regulations impacting the success of health reform in California. In addition, Daniel worked extensively to develop and implement a privacy program for the entire organization. Daniel has served a wide variety of clients from start-ups to some of the largest public and private entities in the country, and has extensive experience on a wide variety of healthcare/life sciences mergers, acquisitions, joint ventures, matters involving corporate finance, and other types of investments. Representative clients include telehealth ventures, hospitals, managed care organizations, medical groups, behavioral health providers, and other healthcare entities in regulatory and transactional matters. With hands-on experience working in institutions such as large academic medical centers, state government, hospitals, non-profit clinics, and laboratories, Daniel is uniquely positioned to advise and represent clients in the healthcare industry. Daniel has extensive experience representing clients with multi-state practices and tailoring business arrangements to comply with the corporate practice of medicine and fraud abuse laws of each state. In addition, Daniel has provided counsel on compliance with the Health Information Portability and Accountability Act (HIPAA), reimbursement issues under Medicare and Medicaid, the Emergency Medical Transfer and Labor Act (EMTALA), the Clinical Lab Improvement Amendments (CLIA), physician advertising, and consent issues. “We are thrilled with the wealth of experience that Daniel brings advising different types of healthcare clients, and our clients are already reaping the benefits of his deep understanding of healthcare infrastructure,” said Managing Partner Harry Nelson.

Joshua G. Singer joins Nelson Hardiman with deep experience advising and guiding the cannabis industry on regulatory and related business issues, as well as related healthcare and life science matters. Josh guides companies of all sizes in navigating the complex maze of state laws and municipal regulations, drawing as well on his experience in corporate transactional matters, licensing, and regulatory compliance. Josh has spent years of focus on the regulations that govern cannabis licensing and compliance in California and nationally. He has been personally responsible for securing hundreds of cannabis and other licenses for clients. He also counsels clients on managing the conflicts that exist between federal and state laws and municipal ordinances for cannabis manufacturers, cultivators, retailers, distributors, investors, and ancillary services around finance and tax issues. Josh is intimately familiar with the nuances of California law governing the multi-million dollar legalized cannabis industry, particularly in the Greater Los Angeles area. Josh also brings valuable experience advising on corporate transactions and ensures regulatory compliance for other regulated substances, including psychedelics, and other innovative health products. His knowledge and experience make Josh a trusted advisor assisting a wide range of clients through the complex license process, adhering to local and state cannabis regulations, and providing legal counsel on business operations, corporate transactions, and tax laws. “Nelson Hardiman has always been a pioneer in emerging areas of healthcare and life sciences, and Josh’s regulatory and transactional legal skill and experience in the cannabis industry, made him a compelling addition to our team to continue to serve our client’s needs,” said Managing Partner Harry Nelson.

Ariella (Cohen) Coleman brings to Nelson Hardiman a blend of a regulatory background with strong experience in healthcare law and policy including a focus on products regulated by the Food Drug Administration (FDA) under the Food Drug and Cosmetics Act (FDCA) and related compliance issues arising from innovation. Leveraging her legislative and policy experience with FDA-regulated products and compliance, Ariella works closely with clients in developing regulatory strategy and the pathway for new products and services, including emerging diagnostics and therapeutic technologies. In addition to her FDA regulatory focus, Ariella has a strong working knowledge of transfusion medicine and biotherapies. Ariella has advised clients on multi-state business and regulatory compliance with Medicare requirements and bankruptcy requirements. “We are excited to add someone that brings a new dimension to our practice in providing support to emerging healthcare technologies in the heavily regulated arena of direct-to-consumer products and services,” said Managing Partner Harry Nelson. “We have been at the forefront of pandemic-driven acceleration of telemedicine, and Ariella will be a welcomed addition to assist our clients in developing regulatory strategy and the pathway for new products and services.”

“The additions of Daniel, Josh, and Ariella are exciting on multiple levels,” commented Partner Mark Hardiman. “Healthcare and life sciences continue to be arenas of transition, innovation, and growth. Daniel, Josh, and Ariella help expand and deepen our roster of specialized talent. They are just the latest evidence that the firm continues to lead the way and that the pathway for healthcare and life sciences innovation runs through Nelson Hardiman.”

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’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.

*Ariella (Cohen) Coleman is admitted in Pennsylvania, New Jersey and District of Columbia; Ariella (Cohen) Coleman is not admitted to practice in California.

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Harry Nelson on Spectrum News 1: CDC Relaxing Social Distancing Guidelines for Younger Children


Founding Partner Harry Nelson interviewed on Spectrum News 1 Regarding CDC Relaxing Social Distancing Guidelines for Younger Children.

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Unhappy AGs Have Options In Latest Purdue Ch. 11 Plan – Harry Nelson Interview by LAW 360

Co-Founder and Managing Partner Harry Nelson was interviewed by Law 360 over Purdue Pharma’s restructuring proposal which allocates a $4.38 billion opioids settlement. Harry discusses the details of the company’s Chapter 11 bankruptcy plan, and the accountability and remedies for the deadliest drug crisis in the nation’s history.

From the interview:

“Still, there are larger questions of what amount of money, if any, could fully recompense for the lives lost due to the opioid crisis, which has only grown worse during the coronavirus pandemic.”

“What do justice and fairness look like when the company profited so much from manufacturing and selling these drugs with the knowledge of the profound suffering that they were causing?” Harry Nelson of health care boutique Nelson Hardiman LLP said. “It doesn’t seem like the public anger is anywhere near sufficiently addressed, given the legal cases that are still alive and putting the [Sackler] family at risk.”

Full Article


HIPAA: To Preserve and Protect

Senior Counsel Alan J. Sedley was recently interviewed by SFVBA Valley Lawyer Magazine to provide an overview of HIPAA and the standards for the protection of certain sensitive personal health information.

From the Article:

Alan J. Sedley, senior counsel with the Nelson Hardiman firm in Los Angeles, notes that “Every byte of personal, individual identif able data, such as that stored at banks, schools, places of employment, and online merchant services–name, address, social security number, date of birth, bank account numbers, employers, and the identity of family members, for example–could, with a simple send command and without adequate safeguards in place, effortlessly become the source of exploitation, monetization, and even personal humiliation.”

Full Article – SFVBA Valley Lawyer Magazine


8 Nelson Hardiman Attorneys Named to the 2021 Southern California Super Lawyers List

Nelson Hardiman is proud to announce that Attorneys Rob Fuller, Mark Hardiman, Sara Hersh, John A. Mills, Harry Nelson, Jonathan Radke, Zachary Rothenberg, and Alan J. Sedley were named to the 2021 Southern California Super Lawyers list. Each candidate is evaluated on 12 indicators of peer recognition and professional achievement. Only 5% of attorneys in Southern California receive this distinction.

2021 marks the 11th consecutive year that Co-Founder and Managing Partner Harry Nelson has been named as one of Southern California’s Super Lawyers.

Congratulations to all for the selection to this prestigious list!