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.

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For Inquiries Contact: [email protected]


Client Alert: Biden Healthcare Proposal Faces Uncertain Future

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 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

Client Alert: Telehealth Waivers – Where are we now?

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.
[2] Acting Secretary of HHS Letter to the Governors dated January 22, 2021.
[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.
[5] Id.
[7] CMS Newsroom Press Release, cited above.
[8] Id. For a state-by-state breakdown of PHE waivers during COVID-19, see
[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.
[10] Text of H.R. 133 “Consolidated Appropriations Act of 2021” dated December 21, 2020.
[11] Id.
[12] Center for Connected Health Policy, The National Telehealth Policy Resource Center, “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.
[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.
[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.
[22] Cision PR Newswire, “Leading Health Innovators Launch Alliance To Advance Care In The Home” dated March 3, 2021.
[23] Id.

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

For More Info Contact: [email protected]

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

Client Alert: Is Your Professional Information Being Sought From Your Licensing Agency? Do You Know Your Rights?

California Court of Appeal Decision in Board of Registered Nursing v. Superior Court of Orange Draws A Line In the Sand:  Health Care Professionals Must Be Notified When Their Professional Information Is Sought From An Administrative Body

Stemming from California’s ongoing legal battle against pharmaceutical companies for deceptive marketing schemes in relation to the opioid epidemic (think Purdue), the issue of health care professionals’ privacy rights came to the forefront when the State of California subpoenaed administrative records (including disciplinary records) and investigatory files (including complaints) about these professionals from their licensing boards, including the Medical Board, Nursing Board, Pharmacy Board, and Department of Justice.

In Board of Registered Nursing v. Superior Court, January 15, 2021, ___ Cal.App.5th ___ [2021 WL 140983], the administrative and governmental agencies referenced above took the position that the subpoenas issued by the State, demanding a broad swath of documents, were invalid because the State failed to provide notices to consumer (i.e., health care professionals) that their professional information was being sought. The agencies further maintained that the scope of categories demanded was protected by the official information privilege, deliberative process privilege, and constitutional right to privacy.

When the trial court ordered the agencies to produce documents in response to the State’s subpoenas, despite the arguments above, the agencies sought and were granted writ relief by the Court of Appeal.

The Court of Appeal made the following findings, among others:

  • Health care professionals (doctors, nurses, pharmacists, etc.) whose identities would be disclosed in an agencies’ administrative records, investigatory files, and coroners report must be given notice of the subpoena.

The Court of Appeal denied the State’s argument that the Information Practices Act of 1977 (IPA) allowed administrative and governmental agencies to comply with subpoenas without providing notice to consumer. Instead, it held that, because the subpoenas sought “the personal information of investigated or disciplined health care professions, without redaction, [the State] was required to provide notice to these persons.”

  • Requests for complete administrative records, investigatory files, and CURES data absent notice to consumer (i.e., health care professionals) was a violation of the constitutional right to privacy and the statutory official information and deliberative process privileges.

The Court of Appeal held that the private and public interest in confidentiality of the requested materials (which included investigatory files, administrative records, and CURES data) is substantial. “The health care professionals named in the investigatory files and disciplinary proceedings have a legally protected privacy interest in their personal information reflected in the records…This right to privacy is especially salient for those professionals who were investigated but never accused of wrongdoing…”

Take Away:

The arguments and assertions made by the administrative and governmental agencies in Board of Registered Nursing v. Superior Court in response to the State’s subpoenas are the very same arguments and assertions that can and are raised when the same agencies issue similar requests/subpoenas to health care professionals. Health care professionals must keep a close eye on whether these administrative and governmental agencies are providing notice to consumer, whether the consumer is a health care professional or a patient, before turning over any records.

When you receive a subpoena or similar request, even if it is for your own administrative records or investigatory file, notice to consumer needs to be provided. If you did not receive notice or if you received notice, but do not know how to respond, contact an attorney immediately to discuss how to best protect your privacy rights. Statutory deadlines require a quick response to subpoenas or similar requests, so time is of the essence.

If you have any questions or would like to discuss how to protect your privacy interests, the attorneys at Nelson Hardiman are here to answer your questions. Feel free to contact Sara Hersh or Miriam Mackin at 310-203-2800.

Contact Us

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.

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!

Client Alert: Certain “Just-in-Time” Inventory Practices Overruled for General Acute Hospitals; Hospitals Required to Maintain Stockpile of Personal Protective Equipment under AB 2537


Cal OSHA and OSHA regulations mandate that health care workers be protected from hazards at the workplace in hospitals, but these requirements merely address the general need “to furnish employment and a place of employment that was safe and healthful” and “to have an effective injury prevention program in place.” As such, hospitals were free to manage their inventory of personal protective equipment (“PPE”) much as any other inventory, including the ‘just-in-time’ practice of prior day delivery of supplies for cost controls.

These minimal inventory practices, while cost-effective, proved disastrous in the pandemic.

While common sense in normal operations might prevail to increase PPE supplies over time against the reoccurrence of a pandemic, the California legislature has stepped in and passed AB 2537, that requires hospitals to have ready stockpiles of PPE for their workers exposed to hazards, including infectious disease.

Specifically, AB 2537 requires both private and public employers operating general acute hospitals to supply PPE to health care workers who provide direct patient care or provide services that directly support patient care in areas exposed to potential hazard. Hospitals are also required to conduct periodic training in the use PPE.

Additionally, beginning on April 1, 2021, the hospitals must maintain a supply of specified equipment (respirators, particulate filters or cartridges, surgical masks, isolation gowns, eye protection, and shoe coverings) in quantities equal to three months of normal consumption. Hospitals must document the management of this stockpile, including written policies and procedures for periodically reviewing and adjusting the par levels of inventory for all types of equipment to meet the three-month requirement.

A list of the Hospital’s PPE stockpile (with par levels) and a copy of its written policies and procedures must be provided to the Division of Occupational Safety and Health upon request. Failure to maintain the required stockpile may come with a civil penalty of up to $25,000 per violation. Please note that these obligations extend to all hospital facilities, and responsibilities fall on owners, operators, and management companies.

On or before January 15, 2021, general acute care hospitals (with the exception of hospitals under the jurisdiction of the State Department of State Hospitals) must also be prepared to report to the Department of Industrial Relations, under penalty of perjury, their highest 7-day consecutive daily average consumption of PPE during the 2019 calendar year.

If you have any questions about this new PPE Stockpile law, please contact Nelson Hardiman attorneys Miriam Mackin, Lara Compton, or Rob Fuller for further advice (310)203-2800.

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.

Major Payers Slow to React to AMA Attack on High-Deductible Plans

Partner Rob Fuller was interviewed by health payer specialist to discuss the nation’s leading payers high-deductible health plans in the aftermath of the American Medical Association’s indictment of the products and the growing crisis of affordable coverage.

From the article:

Because they are designed to have consumers pay between $1,400 to $7,000 for medical care before insurance kicks in, these types of plans can be “a very bad trap for the unwary,” says Rob Fuller, attorney with Nelson Hardiman in Los Angeles and co-author of the book From ObamaCare to TrumpCare.

Fuller says that the plans exploded in popularity over the past 15 years as employers started asking for a lower-cost benefi. But the crisis of affordability, rendered more sharply by the pandemic, is leading to calls for change.

Read Full Article: Major-Payers-Slow-to-React