Nelson Hardiman LLP is proud to announce that, after two years of peer review, including a judicial review panel, an internal appeal, and a writ of mandamus in the Superior Court, the firm’s client – a world renowned academic medical center’s medical staff – prevailed.

Nelson Hardiman represented the medical staff in a peer review action taken against a seasoned physician based upon his violations of patient privacy, HIPAA, CMIA and Medical Center policy. The physician exerted his authority over trainees to obtain medical record numbers in order to review a patient case of interest. He did so without authorization or consent. He discussed the case with an outside physician (who was not a medical staff member) and even brought that physician to the patient floor and directed the trainees to open the electronic medical record (EMR) for review by the outside physician. 

The subject physician argued that the HIPAA healthcare operations exemption applied, and that his actions were designed to improve patient care and safety. He lost at the JRC level, the internal appeal level, and petitioned the court. The court disagreed and denied the physician’s writ petition. 

For questions regarding medical staff representation and peer review matters, please contact Sara Hersh and Miriam Mackin.

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.

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

For Inquiries Contact: [email protected]

Partner Zachary Rothenberg interviews Peter Walstrom, Founder of Walstrom & Associates to discuss the Revenue Cycle and in particular Quality of Earnings.

“A View from Legal Street” is a series created by attorneys Zachary Rothenberg and John A. Mills. These videos serve to showcase a “nuts and bolts” approach to maximize success in obtaining reimbursement for services rendered. Watch Episode 1: Essential Documentation.

Have a topic you would like covered? Contact Us!

Phone: 310.203.2800 For more information visit: https://www.nelsonhardiman.com​

Zachary Rothenberg
[email protected]

​An attorney-client relationship is not created by watching this video. The information in this video is for informational purposes only, and should not be taken as legal advice. Any individual or entity viewing this information should consult an attorney for their particular situation.

Healthcare is a top policy agenda item for President Biden.  In his first week in office, he issued executive orders aimed at making Medicaid and ACA plan coverage more accessible to Americans, including institution of a special open enrollment period and a reinstatement of HealthCare.gov as a working portal.  The President went on to propose a $1.9 trillion infrastructure bill last month, which included $400 billion for support of aging at home through expanding home-based care and community services that allow seniors to receive care in the home setting.  The legislation so far lacks detail and doesn’t specify how the $400 billion in additional funding would be spent.  The spending proposal was accompanied by progressive labor policies for home care workers, with the Administration offering that the new law would provide in-home workers “a long-overdue raise, stronger benefits and an opportunity to organize or join a union.”  (This healthcare portion of the infrastructure legislation has drawn strong opposition from Republicans, and some Democrats, as being too amorphous, and not constituting true any infrastructure or investment.)

Even while the Congress debates the landmark infrastructure investment legislation, the White House has signaled a follow-on bill, the American Families Act, which will specifically address President Biden’s core health care initiatives.

During the campaign, Biden proposed high-level health care policy to advocate for four legislative initiatives: (i) reinstate the individual mandate under the Affordable Care Act, (ii) add a public-option, Medicare-like health program for non-seniors, (iii) limit net cost to consumers of insurance coverage under the ACA programs to 8.5% of adjusted income, and (iv) address prescription pharmacy costs.  The campaign proposal is undergoing some revision, as the President recently indicated that the healthcare policies are subject to further change and negotiation.  It now appears that the 8.5% limitation on insurance costs is a non-starter in the eventual package that will be sent to Congress.  Senior congressional leaders are also advocating additional health care proposals not currently backed by the Administration, including (i) increasing subsidies for low income ACA plan participants, (ii) reducing Medicare age to 60,  and (iii) expanding regular Medicare to include dental and vision services.

Handicapping where healthcare policy initiatives will end up is difficult.  The lack of unity within the Democratic party at this point on policy initiatives is one factor, as is the strong opposition to ‘soft’ infrastructure proposals, and the attendant costs and tax implications of the infrastructure bill.  We believe that these pressures will likely result in the aging at home initiatives being dropped from the infrastructure bill, as a way to lower the price tag to try to gain passage in the Senate.

Thus we foresee that the policies behind Americans aging in the home and needing support to do so are likely to be rolled into the American Families Act expected later this Spring.  These particular policies have a decent chance of success, as they are arguably in part a cost-saving measure; it is pretty clear that supporting people in their homes is cheaper than providing institutional care.  With better definition of the spending priorities (and toning down of the progressive labor initiatives) the aging at home proposals may have some legs.

Additionally, the pharmaceutical cost control initiatives also seem to have a pathway for passage. Biden’s plan would repeal existing law that currently bans Medicare from negotiating lower prices with the pharma industry. The plan would also limit price increases “for all brand, biotech and abusively priced generic drugs” and control prices for drugs that do not have competition.  The Biden Administration’s proposal to negotiate drug prices directly with pharmaceutical manufacturer’s is not dissimilar to ones floated in the Trump Administration.  The ‘hands-off’ pharma policy currently followed by Medicare was a result of the ACA negotiations; it was a policy that the Obama Administration had to concede in order to bring an important stakeholder to the table to support passage of the ACA.  Eleven years later, pharma billing practices are seen as a huge cost driver of health care in the US, and the Biden Administration needs to reverse the Obama-era stance with respect to the pharma industry if it wants to advance the overall interests of keeping Medicare and Medicaid costs in line.  At some level, a bi-partisan pharma bill would seem to be possible.

We see a much harder path to success of the other health policy initiatives in their current versions.  The individual mandate is a firewall for the Republicans, calling it the gateway to socialized medicine.  While it doesn’t have a particularly significant price tag, it is an easily turned political hot potato from a messaging standpoint.

Another complicating factor for each of the coverage expansion initiatives is that they add to the federal cost burden, with the public-option for Medicare carrying the additional baggage as a stepping stone for Medicare for all.  Also, while the Biden Administration is concurrently grappling with immigration issues, it has proposed to open federal health programs to undocumented immigrants (but not subsidies).  This crossover issue, while supportive of the immigration policy path, complicates the ability of the Administration to gain approval of health initiatives when they are tied into immigration policy.

At bottom, some expansion of the ACA coverages might be possible in a well-defined aging at home and pharma cost control package, if the net financial effect was kept neutral or better to the federal budget.  Given that we are one heart attack away from the Senate flipping back to Republican control, congressional politics becomes very hard in the current era.  ‘Single-issue’ Democratic senators can hold up the process with the current leverage being the party needs 100% of its votes.  We see the progressive policy initiatives embedded in increased federal healthcare spending as unattractive to middle-of-the-road Democrats from swing States, let alone Republicans.  And the trades and compromises that might otherwise be available will be made more difficult by whatever process the infrastructure legislation takes and whatever political scar tissue that process leaves.

So for the moment, we think that, while the messaging on the progressive policy future for healthcare is strong, the actual legislative pathway is too uncertain to envision success.  We predict that there will be changes in federal healthcare policy, but from a legislative perspective they will be more like marginal changes to the existing ACA-dominated structure, and not a full revamp of federal initiatives.

We also view healthcare policy as subject to significant change through Executive Branch innovation in pilot programs under the existing ACA structure. These HHS-lead trial innovations are likely to be more significant, at least in the short to intermediate term, than healthcare legislative action.

For further discussion of how these policy pathways may impact your business or your investments, please reach out to Nelson Hardiman, LLP, the leading healthcare boutique law firm in the West and a prominent thought leadership center.

For more information about this client alert, contact:

Rob Fuller

E: [email protected]

P: (310)203-2800

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

For More Information Contact: [email protected]

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]

Exactly one year ago, in March 2020, Founding Partner Harry Nelson gave a webinar on the telehealth waivers issued by the Centers for Medicare and Medicaid (CMS) which were followed shortly thereafter by parallel telehealth coverage expansions from individual and group insurers in response to the critical need for access to care during the COVID-19 pandemic.[1]

Although the CMS waivers for Medicare beneficiaries, summarized here, are still in effect through April 21, 2021, they are due to expire at the end of the year in which the federally declared public health emergency (PHE) ends, likely December 31, 2021.[2] The Department of Health and Human Services (HHS) has promised to provide State Governors with at least 60 days’ notice prior to termination of the PHE.[3]

Despite the embrace of telehealth offerings by healthcare providers and patients alike and a dramatic increase in utilization, uncertainty surrounds the future of telehealth coverage beyond the PHE. To date, no federal legislation has been proposed that would extend the telehealth waivers or otherwise expand telehealth reimbursement. Understandably, providers are wondering what to expect and to what extent they can count on the continued coverage for telehealth beyond the PHE.

This Client Alert addresses some of the questions about the future of telehealth. In reviewing industry, executive and congressional actions being taken to maintain and advance telehealth beyond COVID-19, several key trends are discernible.
_______________________________________________________________

Specifically, there have been several recent developments in which the Government and key stakeholders have indicated a need to overhaul the current healthcare system in favor of the expansion of telehealth services beyond the PHE.

In December 2020, CMS released the annual Physician Fee Schedule (PFS) final rule, adding more than 60 services to the Medicare telehealth list that will continue to be covered beyond the end of the PHE.[4] One significant and newly covered benefit is the permanent code (HCPCS code G2252) describing 11-20 minutes of medical discussion to determine the necessity of an in-person visit, which can be conducted via audio only technology and is similar to a virtual check-in.[5] The code is limited to a qualified healthcare professional who can report evaluation and management (E/M) services to the patient, has an established relationship with the patient, and has not provided the related E/M service in the past 7 days or within the next 24 hours or soonest available appointment. [6]

Notably, CMS limited these telehealth additions to Medicare beneficiaries in rural areas who are in a medical facility (such as a hospital or physician’s office), as CMS lacks statutory authority to reimburse for telehealth outside of rural areas or for services in a beneficiary’s home.[7] Without legislative authority, CMS cannot permanently extend telehealth coverage more broadly as it has done by interim action during the PHE. In addition, CMS lacks authority to control state licensing laws for the physicians and other practitioners who are federally qualified to provide telehealth services.[8]

Currently, about 144 services are covered by CMS waivers, and about one-third of those are certain to end with the end of the PHE, as CMS lacks sufficient data to support permanent adoption.[9] There are an additional 50 or so telehealth services in which CMS could, but has not yet decided, to approve for reimbursement by end of year 2021 or in the years that follow.

Another significant federal development is the enactment of the Consolidated Appropriations Act of 2021, which allows Medicare beneficiaries to utilize telehealth for purpose of diagnosis, treatment, or evaluation of mental health disorders without geographic restrictions.[10] The new law also permits Medicare beneficiaries to receive treatment in the home.[11] Previously, these services were available only to patients receiving treatment for substance use disorders with or without a co-occurring mental health condition, under the 2018 SUPPORT for Patients and Communities Act.[12]

Last month, the California Department of Health Care Services (DHCS) announced its support for broad and permanent changes to Medi-Cal covered benefits and services involving telehealth modalities across all delivery systems, when clinically appropriate.[13] The DHCS proposal enhances telehealth coverage via synchronous and asynchronous telehealth, as well as other virtual communication systems, including remote patient monitoring.[14] The only services that DHCS recommends be discontinued are certain payment modalities for telephone/audio-only telehealth and PHE flexibilities for Tribal 638 clinics.[15]

Earlier this month, the House Energy and Commerce Subcommittee on Health held a hearing to address “The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care”[16] during which Representatives heard testimony from Harvard, Stanford, the American Medical Association, among others, and set forth priorities for removing the following barriers to telehealth:

1. Originating Site Requirements – not reimbursing telehealth services provided to the beneficiary while at home unless the beneficiary qualifies for one of CMS’s special programs (including Accountable Care Organizations and Medicare Advantage plans) or otherwise are addressed by separate legislation.[17]
2. Audio and Visual Capabilities (two-way) – not covering virtual check-ins, remote monitoring, or audio-only services.[18]
3. Specified Set of Practitioners – limiting telehealth services to physicians, nurse practitioners, physician assistants, nurse midwives, clinical nurse specialists, certified registered nurse anesthetists, clinical psychologists, clinical social workers, or registered dietitians.[19]
4. Specified Set of Services – amending the reimbursable list of services on an annual basis through the Physician Fee Schedule (PFS).[20]

As part of the congressional hearing, the American College of Physicians submitted a Statement for the Record summarizing clinical evidence and articles in support of the continuation of CMS waivers for the following: (1) pay parity for audio-only telehealth, (2) geographic site restriction waivers, (3) telehealth cost-sharing waivers, (4) flexibilities for direct supervision by physicians in teaching hospitals, (5) revised policies for remote patient monitoring and (6) interstate licensure flexibility for telehealth and promotion of state-level action.[21]

The next day, a new coalition of healthcare providers called “Moving Health Home” announced that it will push for federal and state policy changes to make the home a permanent site for care for telehealth and remote patient monitoring.[22] According to Moving Health Home, the COVID-19 pandemic “exposed the untapped potential of home-based clinical care, and the opportunity for a robust set of services ranging from primary care to hospital-level treatment.”[23]

All of the foregoing reflect significant momentum for permanent expansion of telehealth in government programs, with commercial and employer-sponsored plans expected to follow suit. The expanded coverage parallels a dramatic increase in direct-to-consumer telehealth resources and utilization. Taken together, these developments reflect that the expansion in telehealth during the pandemic is unquestionably a permanent transformation in U.S. healthcare. Under the circumstances, we anticipate a new federal bill in the near future making permanent expanded telehealth coverage in Medicare and other government programs.

For more information on how the expansion of telehealth services affects your practice or how to participate in advocacy efforts related to telehealth, please reach out to [email protected] for further information and/or resources.
_____________________________________________________
[1] CMS issued guidance to the individual and group market indicating that insurers could make mid-year modifications to expand coverage for telehealth services, without fear of federal enforcement action. https://www.healthsystemtracker.org/brief/how-private-insurers-are-using-telehealth-to-respond-to-the-pandemic/.
[2] Acting Secretary of HHS Letter to the Governors dated January 22, 2021. https://ccf.georgetown.edu/wp-content/uploads/2021/01/Public-Health-Emergency-Message-to-Governors.pdf.
[3] Id.
[4] CMS Newsroom Press Release “Trump Administration Finalizes Permanent Expansion of Medicare Telehealth Services and Improved Payment for Time Doctors Spend with Patients” dated December 1, 2020. https://www.cms.gov/newsroom/press-releases/trump-administration-finalizes-permanent-expansion-medicare-telehealth-services-and-improved-payment.
[5] Id.
[6] https://hcpcs.codes/g-codes/G2252#
[7] CMS Newsroom Press Release, cited above.
[8] Id. For a state-by-state breakdown of PHE waivers during COVID-19, see
https://www.fsmb.org/siteassets/advocacy/pdf/states-waiving-licensure-requirements-for-telehealth-in-response-to-covid-19.pdf.
[9] At present, the research demonstrates that telehealth is beneficial for specific uses and patient populations, such as remote home monitoring for chronic conditions, communicating and counseling patients with chronic conditions, and for psychotherapy services. Memorandum from Chairman Pallone to the Subcommittee on Health dated February 26, 2021. https://energycommittee.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Briefing%20Memo_HE%20Hearing_2021.03.02.pdf.
[10] Text of H.R. 133 “Consolidated Appropriations Act of 2021” dated December 21, 2020. https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-116HR133SA-RCP-116-68.pdf.
[11] Id.
[12] Center for Connected Health Policy, The National Telehealth Policy Resource Center, “Telehealth and Medicare.” https://www.cchpca.org/telehealth-policy/telehealth-and-medicare.
[13] State of California Health and Human Services Agency, Department of Health Care Services, “Post-COVID-19 Public Health Emergency Telehealth Policy Recommendations: Public Document” dated February 2, 2021. https://www.dhcs.ca.gov/services/medi-cal/Documents/DHCS-Telehealth-Policy-Proposal-2-1-21.pdf.
[14] Id.
[15] Id.
[16] Hearing on “The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care” dated March 2, 2021. https://energycommerce.house.gov/committee-activity/hearings/hearing-on-the-future-of-telehealth-how-covid-19-is-changing-the.
[17] Memorandum from Chairman Pallone to the Subcommittee on Health, cited above.
[18] Id.
[19] Id.
[20] Id.
[21] American College of Physicians Statement for the Record, Hearing before the House Energy and Commerce Subcommittee on Health, “The Future of telehealth: How COVID-19 is Changing the Delivery of Virtual Care” dated March 2, 2021. https://www.acponline.org/acp_policy/testimony/acp_statement_for_the_record_to_the_house_energy_and_commerce_committee_on_telehealth_during_covid-19_march_2021.pdf.
[22] Cision PR Newswire, “Leading Health Innovators Launch Alliance To Advance Care In The Home” dated March 3, 2021. https://www.prnewswire.com/news-releases/leading-health-innovators-launch-alliance-to-advance-care-in-the-home-301239624.html.
[23] Id.

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

For More Info Contact: [email protected]

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.

Read Full Press Release