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California COVID-19 State of Emergency Ends Today

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February 28 marks the end of California’s COVID State of Emergency, almost three years since California Gov. Gavin Newsom declared COVID-19 a public health emergency, giving his administration broad power to issue mandates and use state funds to fight the virus.

It also enabled the governor to enter into nearly $12 billion dollars worth of no-bid emergency response contracts with testing facilities, personal protective equipment suppliers and temporary workforce agencies. Some of those contracts were with untested vendors who failed to deliver services.

Newsom has extended the state of emergency five times over the course of the pandemic, most recently last June.

The duration of the state of emergency has been controversial among state Republican leaders who attempted to overturn the governor’s power during a Senate emergency meeting last March. The resolution to terminate the state of emergency was voted down 8-4, with senators voting along party lines.

The SMARTER plan’s rollout has been a key component in eliminating the need for emergency provisions, officials said.

Last year the administration unveiled the SMARTER plan, its $3.2 billion long-term strategy for combating COVID-19. The strategy outlined preparedness measures such as stockpiling 75 million masks, increasing testing capacity to half a million tests per day and investing in the health care workforce and local community health organizations.

But some disagree it’s the right time to end the state’s emergency powers. Carmela Coyle, head of the California Hospital Association, told The New York Times earlier this month that February was “a terrible time to end the public health emergency,” because of ongoing strain on California’s hospitals.

In January, the White House announced that the federal state of emergency for COVID will end on May 11 – over two months after California ends its own. And to complicate matters a little more, there are actually two federal emergencies ending May 11: the national emergency, and the public health emergency.

California has recently enacted several laws that force insurers to keep covering COVID care even after the state and federal states of emergency wind down.

Senate Bill 510 requires insurers in California to keep covering COVID costs like testing and vaccination after the national emergency ends. On the national level, the White House’s COVID-19 Response Coordinator Dr. Ashish K. Jha has promised that COVID vaccines will remain free in the U.S. for insured people as a preventive service covered under the Affordable Care Act of 2010.

Meanwhile, another California law – Senate Bill 1473 – requires insurers to not only keep covering the costs of COVID therapeutic treatments like Paxlovid, but also to keep reimbursing their members for the costs of up to eight over-the-counter COVID tests a month. But this law only keeps the current situation in place until six months after the end of the federal emergency on Nov. 11.

San Francisco had its own Public Health Emergency Declaration for COVID in effect, and several programs for San Francisco residents. San Francisco officials announced that the city’s public health emergency would be coming to an end at the same time as the state’s, on Feb. 28.

And on Feb. 3 the California Department of Health finally announced that the state’s schoolkids would not now have to get a COVID vaccine, and that the department was “not currently exploring emergency rulemaking to add COVID-19 to the list of required school vaccinations,” adding, “but we continue to strongly recommend COVID-19 immunization for students and staff to keep everyone safer in the classroom.”

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DEA Proposed Rules for Permanent Telemedicine Prescribing

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The Drug Enforcement Administration announced proposed permanent rules for the prescribing of controlled medications via telemedicine, expanding patient access to critical therapies beyond the scheduled end of the COVID-19 public health emergency. The public will be able to comment for 30 days on the proposed rules.

The proposal would reverse a policy enacted during the coronavirus pandemic that allowed doctors to prescribe these medications through telehealth appointments. The move will make it more difficult for Americans to access some drugs used for treating pain and mental health disorders.

The rules aim to maintain expanded access to telehealth, which has been crucial for millions of patients, particularly those living in rural areas, while also balancing safety.

The proposed rules – developed with the U.S. Department of Health and Human Services and in close coordination with the U.S. Department of Veterans Affairs – propose to extend many of the flexibilities adopted during the public health emergency with appropriate safeguards.

The proposed rules do not affect:

– – Telemedicine consultations that do not involve the prescribing of controlled medications.
– – Telemedicine consultations by a medical practitioner that has previously conducted an in-person medical examination of a patient.

The proposed rules also would not affect:

– – Telemedicine consultations and prescriptions by a medical practitioner to whom a patient has been referred, as long as the referring medical practitioner has previously conducted an in-person medical examination of the patient.

The proposed rules would provide safeguards for a narrow subset of telemedicine consultations – those telemedicine consultations by a medical practitioner that has: never conducted an in-person evaluation of a patient; AND that result in the prescribing of a controlled medication. For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe:

– – a 30-day supply of Schedule III-V non-narcotic controlled medications;
– – a 30-day supply of buprenorphine for the treatment of opioid use disorder

without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws. The proposed rules are explained in further detail for patients and medical practitioners on DEA.gov.

“DEA is committed to ensuring that all Americans can access needed medications,” said DEA Administrator Anne Milgram. “The permanent expansion of telemedicine flexibilities would continue greater access to care for patients across the country, while ensuring the safety of patients. DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”

“Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives,” said HHS Secretary Xavier Becerra. “We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in-person. At HHS, we are committed to working with our federal partners and stakeholders to advance proven technologies and lifesaving care for the benefit of all Americans.”

The proposed telemedicine rules also further DEA’s goal of expanding access to medication for opioid use disorder to anyone in the country who needs it. “Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by helping people achieve and sustain recovery, and also prevent drug poisonings,” said DEA Administrator Milgram. “The telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder.”

The full text of the proposals may be found here and here. The public has 30 days to review and comment on the proposals, which DEA will then consider before drafting final regulations. DEA is appreciative of the public’s feedback.

Additional resources for practitioners can be found here:

– – Proposed Rules Summary Telemedicine Rules Summary.pdf (dea.gov)
– – Proposed Rules Highlights for Medical Practitioners Telehealth Highlights Medical Practitioners.pdf (dea.gov)

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Amazon closes $3.9B Buyout of Health Company One Medical

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Amazon has closed its multibillion-dollar deal to buy One Medical to further its ambitions to offer medical services and expand its growing healthcare business to employers.

The tech giant officially announced the closing of the deal last Wednesday morning. The news comes as The Wall Street Journal reported that the Federal Trade Commission (FTC) won’t sue in time to block the $3.9 billion deal, including debt.

The deal expands Amazon’s reach into primary care as it now officially operates 188 clinics in 29 markets. The deal also gives Amazon rapid access to the lucrative employer market as One Medical works with 8,000 companies and has a trove of member health data.

One Medical, which is not yet profitable, launched in 2007 and markets itself as membership-based, tech-integrated, consumer-focused primary care platform.

At the end of 2022, One Medical had 836,000 members with the bulk of those, 796,000 among consumer and enterprise members and 40,000 at-risk members. The company reported 2022 revenue of $1.046 billion, up 68% from 2021 and fourth-quarter revenue came in at $274.2 million, up 19%, according to its 2022 earnings report.

Amazon predicts that ‘If you fast forward 10 years from now, people are not going to believe how primary care was administered. For decades, you called your doctor, made an appointment three or four weeks out, drove 15-20 minutes to the doctor, parked your car, signed in and waited several minutes in reception, eventually were placed in an exam room, where you waited another 10-15 minutes before the doctor came in, saw you for five to ten minutes and prescribed medicine, and then you drove 20 minutes to the pharmacy to pick it up – and that’s if you didn’t have to then go see a specialist for additional evaluation, where the process repeated and could take even longer for an appointment,” said Amazon CEO Andy Jassy. “Customers want and deserve better, and that’s what One Medical has been working and innovating on for more than a decade. Together, we believe we can make the health care experience easier, faster, more personal, and more convenient for everyone.”

Amazon says One Medical sets a high bar for human-centered primary care experiences: Access to primary care where, when, and how people prefer, with:

– – Around-the-clock access through the One Medical app, giving people more control of how they seek care and the ability to do so from home or on-the-go
– – On-demand virtual care services, like 24/7 video chats and easy in-app messaging, which are included in membership at no extra cost; for other services, such as in-office appointments, One Medical accepts most major insurance health plans
– – Same and next-day in-office or remote visits, so people can quickly get the care they need
– – Thoughtfully designed and welcoming One Medical offices, offering care close to where people work, live, and shop
– – Walk-in availability for on-site laboratory services, making it easy to get lab work done where and when it’s most convenient

A comprehensive approach to make health care easier to navigate by offering:

– – A health care home base with primary care providers that help manage a person’s full health picture; from preventive and acute care needs, to chronic disease and mental health concerns
– – Pediatricians and family care providers available in a growing number of locations, serving children and families
– – Providers trained to address both physical and mental health needs, which may include lifestyle recommendations, medications, or referrals to appropriate specialists
– – Clinical and digital integrations with leading hospital networks across the U.S. for more seamless access and coordinated care across primary and specialty care services
– – Easy access to vaccine and medical records, prescription renewals, specialty referrals, and lab results in the One Medical app
– – Outstanding care for seniors in a growing number of locations, with teams specialized in serving people on Medicare

A more human health care experience enabled by:

– – Highly engaged clinicians focused on meeting the whole needs of people, thinking about health care comprehensively, and taking time to treat people as people and not solely as diagnoses
– – More time in appointments to engage with providers for more personalized and comprehensive health care
– – Proactive app reminders for follow-up care and referral needs, facilitating better prevention and coordination of care so the dots are better connected for people to get and stay healthier
– – A human-centered and technology-powered approach, offering an easy-to-use app and innovative clinician tools to simplify the experience for both the patient and the provider

FTC spokesman Douglas Farrar told the WSJ that the commission “will continue to look at possible harms to competition created by this merger as well as possible harms to consumers that may result from Amazon’s control and use of sensitive consumer health information held by One Medical.”

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Interpreter Must Show Evidence of Fees in Same Geographic Area

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Robert Caballero Cruz was a dishwasher Benu LLC DBA Monsieur Benjamin in at San Francisco, when he injured his his chest and abdomen.

After the case was resolved by compromise and release, Bay Area Interpreting filed a petition for costs for the unpaid balance of $75 for the bill for translating at the signing of the compromise and release agreement on June 26, 2019, along with a claim of interest, attorneys’ fees and costs. The case proceeded for two days of trial on the cost petition.

Based on the witness testimony, the documentary evidence and applicable law, the WCJ issued a Findings of Fact, Order and Opinion on Decision finding that cost petitioner did not meet her burden of proof of market rate entitling her to additional payment for her services on June 26, 2019, and that cost petitioner was not entitled to any recovery on the February 2, 2022 petition for costs for penalties, interest and attorneys’ fees in connection with that petition for costs.

Reconsideration was denied for the reasons stated in the WCJ’s report, which were adopted and incorporated in the panel decision of Cruz v Benu LLC DBA Monsieur Benjamin – ADJ10995520 (February 2023)

In this case, the only dispute is that cost petitioner is entitled to the balances of her charges for the June 26, 2019 invoice, which she alleges is the market rate for that service.  It contends on reconsideration that it met their burden in establishing the market rate for interpreting services, and that defendant acted in bad faith in objecting to the disputed portion of the invoice at issue, and therefore penalties, interest, costs and attorneys’ fees were warranted.

To recover charges for interpreter services, the interpreter has the burden of proving, among other things, that the fees charged were reasonable. (Guitron v. Santa Fe Extruders, 76 Cal. Comp. Cases 228, 34 (WCAB en banc 2011)

The interpreter shall establish the market rate for the interpreter’s services by submitting documentation to the claims administrator, including a list of recent similar services performed and the amounts paid for those services. (Title 8, California Code of Regulations section 9795.3(b)(2).)

To determine the reasonableness of an interpreter’s services, the WCAB has looked at the factors outlined in the 2002 en banc case of Kunz v. Patterson Floor Coverings, Inc, (67 Cal. Comp. Cases 1588 )which include “1) the usual fee accepted (not charged) by the provider, 2) the usual fee accepted by other medical providers in the same geographical area, 3) other aspects of the economics of the medical provider’s practice that are relevant, and 4) any unusual circumstances in the case.

Even though Kunz discusses what medical providers need to prove in order to prove the reasonableness of their charges, the WCAB has specifically applied the same requirement to provide the usual fee accepted by the provider, as well as other providers in the same geographical area, to interpreters. (See, Better Resource v. Workers’ Comp Appeals Bd. (2008) 73 Cal. Comp. Cases 1071, 1075 (writ denied); Guitron, Supra, 76 Cal. Comp. Cases at 247.)

Cost petitioner submitted approximately 40 invoices for various interpreting services performed in June, 2019. All of the submitted invoices were only from cost petitioner Bay Area Interpreting.

As cost petitioner did not submit any evidence of the usual fee accepted by other interpreters in the same geographical area, cost petitioner failed to establish the market rate for her services. As defendant paid cost petitioner more than what Regulation 9795.3(b)(2) assumes is reasonable for an interpreter to bill for services other than appearances at hearings trials or arbitrations or depositions, cost petitioner was not entitled to any further payment for the interpreting services performed on June 26, 2019.

As defendant timely paid the undisputed portion of the invoice and contested the remaining balance, there was no basis to award costs and attorney fee.

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Section 111 Claim Reporting – Civil Monetary Penalty Rulemaking Delayed

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Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) added mandatory reporting requirements with respect to Medicare beneficiaries who have coverage under group health plan (GHP) arrangements as well as for Medicare beneficiaries who receive settlements, judgments, awards, or other payment from liability insurance (including self-insurance), no-fault insurance, or workers’ compensation.

Non-Group Health Plan reporting entities have been waiting for over a decade for clarification on when and how civil monetary penalties (CMPs) for non-compliance with the Section 111 reporting guidelines will be assessed. The proposed rule that will specify how and when CMS must calculate and impose CMPs was published on February 18, 2020.

On February 17, 2023, CMS announced that they will be extending the time for publication of the final rule until February 18, 2024. In sum, it was noted that additional data analysis and predictive modeling need to be done to better understand the economic impact of the rule on different insurer types. The official announcement for the delay will be published in the Federal Registrar on February 22, 2023.

And according to an article on this topic written by attorney and former nurse Ciara Koba, one of the nation’s foremost authorities on Medicare Mandatory Insurer Reporting, this undoubtedly allowed Responsible Reporting Entities (RREs) to take a breath and focus on continuing to improve and streamline processes to ensure they are compliant.

She said that “It was a relief that there has been an acknowledgement of how grave the potential economic impact could be if the max penalties were to be imposed.”

For illustrative purposes, she pointed out that “if an RRE failed to report 100 claims for a period of 90 days. The proposed penalty could reach a staggering $9,000,000 without even accounting for the inflationary daily penalty which would be closer to $1,200 per day per claim.”

With this new timeframe in mind, she went on to say that it is important for responsible reporting entities to pay close attention to any guidance that CMS distributes and take this extra year to implement any necessary improvements to Section 111 reporting systems and processes. On December 6, 2022, CMS presented a webinar on Section 111 reminders and best practice, additional resources and allowed for an open question and answer session.

CMS uses the term TPOC to refer to the dollar amount of the total payment obligation to, or on behalf of, the injured party in connection with the settlement, judgment, award, or other payment in addition to/apart from Ongoing Responsibility for Medicals (ORM). CMS stressed that accurate Section 111 reporting of TPOCs and ORM assists CMS and their contractors with accurate recovery.

CMS discussed how to calculate the TPOC and what is included with specific focus on the fact that indemnity only settlements do not get reported. Logically, this makes sense because the injured Medicare beneficiary is not being compensated for medical damages, and as such, the indemnity only settlement is not reportable because CMS cannot assert a recovery claim for conditional payments against an indemnity only settlement.

CMS also discussed the Event Table contained in Section 6.6.4 of Chapter 4 of the NGHP User Guide for Section 111 reporting. This Event Table can be useful to reporting entities when trying to determine when, what and how to report a particular beneficiary and their claim data. It covers a wide array of event scenarios and CMS reviewed two common issues and reviewed the appropriate action per the User Guide. The second scenario CMS reviewed is as follows:

ORM ends for one body part due to TPOC, but ORM continues for another body part for the same claim. The recommended action for this scenario is to send an update record for the open ORM report (Action Type 2) and remove the diagnoses codes for the body parts that have settled. Then the reporting entity should send an Add record to report the TPOC for the body part that settled.

The solution proposed by CMS is logical if you are working in a system where this is something that is possible. For example, what if the RRE has their TPA reporting their claims for them and the only way to submit an “Add” record in this scenario is to open a new claim for which the RRE will be charged a fee by the TPA.

There are a lot of RREs that are unable to open multiple claims in their systems when all of the action for the claim is really under one claim/policy number in their system. As such, The Medicare Secondary Payer Network (MSPN) has been discussing possible solutions to this issue that will allow CMS to obtain the information that they need for recovery efforts and that will allow the RREs to do the reporting accurately without having to open additional claims to report multiple TPOCs and/or ORM timeframes for different body parts/injuries.

CMS also released the top 10 error codes that they have received from July 1, 2022 through October 7, 2022. This data was very interesting, and RREs should pay particularly close attention to this data.

If you would like to analyze your data but don’t know where to start, please reach out to Ciara Koba at info@allankoba.com.

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So.Cal. Chiropractor and NBA Players Sentenced for Healthcare Fraud

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Former NBA players Keyon Dooling and Alan Anderson were sentenced to 30 months and 24 months in prison this month, for their roles in a scheme to defraud the National Basketball Association Players’ Health and Welfare Benefit Plan. Co-defendant Terrence Williams orchestrated the scheme to defraud the Plan. Williams has pled guilty to conspiracy to commit wire and health care fraud and aggravated identity theft and is awaiting sentencing.

The Plan is a health care plan providing benefits to eligible active and former players of the NBA. Since Dooling and Anderson both played in the NBA and were eligible to receive reimbursements from the Plan for legitimate, qualifying medical expenses. Williams, Dooling, and Anderson recruited other former NBA players to defraud the Plan, including by offering to provide them with false invoices to support their fraudulent claims.

Williams provided the other former NBA players fake invoices from a chiropractic office in California, run by co-defendant Patrick Khaziran a/k/a “Dr. Pat,” which were created by individuals working with Williams. Khaziran pled guilty to conspiracy to commit health care fraud and was sentenced to 30 months in prison on February 7, 2023 .

In addition, Williams obtained fraudulent invoices from a dentist affiliated with dental offices in Beverly Hills, California, run by co-defendant Aamir Wahab, and from a doctor at a wellness office in Washington State.

According to a report by the Los Angeles Times, the scandal enmeshed 17 other ex-NBA players including former Lakers guard Shannon Brown and former Clippers players Darius Miles, Glen Davis, Ruben Patterson and Sebastian Telfair.

The fraud began when Williams submitted a false $19,000 invoice in 2017 that looked like a legitimate claim from Khaziran’s office. The claim was billed to the NBA players’ health and welfare benefit plan.

The invoice netted him $7,672.55 – enough to whet his appetite for more. Williams recruited more players with the help of Dooling and another former NBA player, Alan Anderson.

The subsequent fraudulent invoices purported to document that Anderson, other co-defendants, and, in some cases, members of their families, had been recipients of expensive medical and dental services, but the defendants had not received the medical or dental services described in the invoices Williams provided them.

In many instances, the defendants were not even located in the vicinity of the service providers on the dates the invoices stated they received medical or dental services. In particular, GPS location information and documentary evidence, such as flight records, show that the defendants were in locations other than the vicinity of the medical or dental offices falsely claimed as the providers of services.

Dooling received approximately $363,000 in fraudulent reimbursements, and he is responsible for facilitating the fraudulent claims filed by other defendants, who received approximately $194,295 in fraudulent proceeds from the plan.

Anderson also recruited multiple former NBA players to the fraud scheme. When co-conspirators encountered difficulties in obtaining reimbursements for fraudulent claims, Anderson encouraged them to submit forged letters of medical necessity to substantiate those claims. When those letters were unsuccessful, Anderson arranged for the co-conspirators to visit a Las Vegas doctor, after-hours, to further attempt to justify the fraudulent claims.

Anderson himself submitted approximately $121,000 in fraudulent claims to the Plan. Anderson is also responsible for recruiting and facilitating the fraud of additional defendants who sought approximately $710,000 in fraudulent claims.

The scheme widened with more health professionals, including a Washington state physician, Dr. William Washington, and a Beverly Hills cosmetic dentist Aamir Wahab – whose practice, the Unforgettable Smile, pitches itself as a home for celebrities.

In addition to their prison terms, Dooling, 42, of Orlando, Florida, was ordered to forfeit $449,250.50 and pay restitution of $547,495; and Anderson, 40, of Las Vegas, Nevada, was ordered to forfeit $121,000 and pay restitution of $121,000.

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Companies May Now Use Federal Voluntary Self-Disclosure Policy

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The U.S. Attorney’s Office for the Northern District of California has implemented the new United States Attorney’s Offices’ Voluntary Self-Disclosure Policy released earlier today.

The policy, which is effective immediately, details the circumstances under which a company will be considered to have made a voluntary self-disclosure (VSD) of misconduct to a United States Attorney’s Office (USAO), and provides transparency and predictability to companies and the defense bar concerning the concrete benefits and potential outcomes in cases where companies voluntarily self-disclose misconduct, fully cooperate and timely and appropriately remediate.

The goal of the policy is to standardize how VSDs are defined and credited by USAOs nationwide, and to incentivize companies to maintain effective compliance programs capable of identifying misconduct, to expeditiously and voluntarily disclose and remediate misconduct, and to cooperate fully with the government in corporate criminal investigations.

The policy was developed pursuant to the Deputy Attorney General’s September 15, 2022 memorandum, “Further Revisions to Corporate Criminal Enforcement Policies Following Discussions with Corporate Crime Advisory Group” (Monaco Memo), which directed each Department of Justice (DOJ) component that prosecutes corporate crime to review its policies on corporate voluntary self-disclosure and, if there was no formal written policy to incentivize self-disclosure, draft and publicly share such a policy.

Under the new VSD policy, a company is considered to have made a VSD if it becomes aware of misconduct by employees or agents before that misconduct is publicly reported or otherwise known to the DOJ, and discloses all relevant facts known to the company about the misconduct to a USAO in a timely fashion prior to an imminent threat of disclosure or government investigation.

A company that voluntarily self-discloses as defined in the policy and fully meets the other requirements of the policy, by – in the absence of any aggravating factor – fully cooperating and timely and appropriately remediating the criminal conduct (including agreeing to pay all disgorgement, forfeiture, and restitution resulting from the misconduct), will receive significant benefits, including that the USAO will not seek a guilty plea; may choose not to impose any criminal penalty, and in any event will not impose a criminal penalty that is greater than 50% below the low end of the United States Sentencing Guidelines (USSG) fine range; and will not seek the imposition of an independent compliance monitor if the company demonstrates that it has implemented and tested an effective compliance program.

The policy identifies three aggravating factors that may warrant a USAO seeking a guilty plea even if the other requirements of the VSD policy are met: (1) if the misconduct poses a grave threat to national security, public health, or the environment; (2) if the misconduct is deeply pervasive throughout the company; or (3) if the misconduct involved current executive management of the company. The presence of an aggravating factor does not necessarily mean that a guilty plea will be required; instead, the USAO will assess the relevant facts and circumstances to determine the appropriate resolution. If a guilty plea is ultimately required, the company will still receive the other benefits under the VSD policy, including that the USAO will recommend a criminal penalty of at least a 50% and up to a 75% reduction off the low end of the USSG fine range, and that the USAO will not require the appointment of a monitor if the company has implemented and tested an effective compliance program.

In cases where a company is being jointly prosecuted by a USAO and another DOJ component, or where the misconduct reported by the company falls within the scope of conduct covered by VSD policies administered by other DOJ components, the USAO will coordinate with, or, if necessary, obtain approval from, the DOJ component responsible for the VSD policy specific to the reported misconduct when considering a potential resolution. Consistent with relevant provisions of the Justice Manual and as allowable under alternate VSD policies, the USAO may choose to apply any provision of an alternate VSD policy in addition to, or in place of, any provision of its policy.

The Attorney General’s Advisory Committee (AGAC), under the leadership of United States Attorney for the Southern District of New York Damian Williams, requested that the White Collar Fraud Subcommittee of the AGAC, under the leadership of United States Attorney for the Eastern District of New York Breon Peace, develop policies in response to the Deputy AG’s memo.

The policy announced today was prepared by a Corporate Criminal Enforcement Policy Working Group on which U.S. Attorney Hinds sits. In addition to U.S. Attorney Hinds, the Working Group is comprised of U.S. Attorneys from geographically diverse districts, including U.S. Attorney Peace, U.S. Attorney for the Eastern District of Virginia Jessica Aber, U.S. Attorney for the District of Connecticut Vanessa Avery, U.S. Attorney for the District of Hawaii Clare Connors, U.S. Attorney for the Eastern District of North Carolina Michael F. Easley, Jr., U.S. Attorney for the Western District of Virginia Christopher Kavanaugh, and U.S. Attorney for the District of New Jersey Philip Sellinger. Assistant U.S. Attorney Amanda Riedel, White Collar Crimes Coordinator for the Executive Office for U.S. Attorneys, also participated in the development of the policy.

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SCOTUS Clarifies FLSA’s Salary-Basis Test for Highly Paid Worker

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The U.S. Supreme Court sided 6-3 with an oil rig supervisor, who sued for overtime pay even though his daily rate already earned him up to a quarter-million dollars a year.

Michael Hewitt worked for Helix Energy Solutions Group as a “toolpusher” on an offshore oil rig. Reporting to the captain, Hewitt oversaw various aspects of the rig’s operations and supervised 12 to 14 workers. He typically, but not invariably, worked 12 hours a day, seven days a week – so 84 hours a week – during a 28-day “hitch.” He then had 28 days off before reporting back to the vessel.

Helix paid Hewitt on a daily-rate basis, with no overtime compensation. The daily rate ranged, over the course of his employment, from $963 to $1,341 per day. His paycheck, issued every two weeks, amounted to his daily rate times the number of days he had worked in the pay period. So if Hewitt had worked only one day, his paycheck would total (at the range’s low end) $963; but if he had worked all 14 days, his paycheck would come to $13,482. Under that compensation scheme, Helix paid Hewitt over $200,000 annually.

In 2017 Helix fired Hewitt for performance issues. Hewitt responded by filing an action against his employer seeking overtime pay under the Fair Labor Standards Act of 1938, which guarantees overtime pay to covered employees when they work more than 40 hours a week.

Helix claimed that Hewitt was exempt from the FLSA because he qualified as “a bona fide executive.” 29 U. S. C. §213(a)(1).

The District Court agreed with Helix’s view that Hewitt was compensated on a salary basis, and accordingly granted the company summary judgment. The Court of Appeals for the Fifth Circuit, sitting en banc, reversed that judgment, deciding that Hewitt was not paid on a salary basis and therefore could claim the FLSA’s protections.

The decision of the Court of Appeals was affirmed by the Supreme Court of the United States in the case of Helix Energy Solutions Group, Inc v Hewitt – No. 21-984 (February 2023)

The Fair Labor Standards Act of 1938 (FLSA) guarantees that covered employees receive overtime pay when they work more than 40 hours a week. But an employee is not covered, and so is not entitled to overtime compensation, if he works “in a bona fide executive, administrative, or professional capacity,” as those “terms are defined” by agency regulations.

The FLSA, however, exempts certain categories of workers from its protections, including the overtime-pay guarantee. The statutory exemption relevant here applies to “any employee employed in a bona fide executive, administrative, or professional capacity . . . (as such terms are defined and delimited from time to time by regulations of the Secretary [of Labor]).”

Under applicable regulations, an employee is considered a bona fide executive excluded from the FLSA’s protections if the employee meets three distinct tests: (1) the “salary basis” test, which requires that an employee receive a predetermined and fixed salary that does not vary with the amount of time worked; (2) the “salary level” test, which requires that preset salary to exceed a specified amount; and (3) the job “duties” test..

The Secretary of Labor has implemented the bona fide executive standard through two separate and slightly different rules, one “general rule” applying to employees making less than $100,000 in annual compensation, and a different rule addressing “highly compensated employees” (HCEs) who make at least $100,000 per year. 29 CFR §§541.100, 541.601(a), (b)(1).

The general rule considers employees to be executives when they are “[c]ompensated on a salary basis” (salary-basis test); “at a rate of not less than $455 per week” (salary-level test); and carry out three listed responsibilities – managing the enterprise, directing other employees, and exercising power to hire and fire (duties test). §541.100(a).

The HCE rule relaxes only the duties test, while restating the other two.As litigated in this case, whether Hewitt was an executive exempt from the FLSA’s overtime pay guarantee turns solely on whether Hewitt was paid on a salary basis.

The question here is whether a high-earning employee is compensated on a “salary basis” when his paycheck is based solely on a daily rate – so that he receives a certain amount if he works one day in a week, twice as much for two days, three times as much for three, and so on.

The Supreme Court concluded that Hewitt was not paid on a salary basis, and thus is entitled to overtime pay.

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SCOTUS Rejects J&J’s Appeal of $302M Deceptive Marketing Penalty

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The U.S. Supreme Court denied an appeal by Johnson & Johnson of a ruling requiring the company to pay $302 million in penalties to California for deceptive marketing of pelvic mesh implants that can cause serious vaginal pain and physical damage.

Since the late 1990s, Ethicon has manufactured, marketed, and sold pelvic mesh products intended to treat two conditions that can affect women stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

In 2008, the U.S. Food and Drug Administration (FDA) issued a public health notification alerting health care providers about complications from pelvic mesh implants used to treat SUI and POP. And in 2011, the FDA issued an update to its public health notification.

In 2012, the FDA ordered Ethicon to conduct postmarket surveillance studies for one of its SUI devices (TVT-Secur) and three of its POP devices (Prolift, Prolift-M, and Prosima). Instead of conducting these postmarket surveillance studies. Ethicon stopped selling the products commercially.Ethicon’s competitors continued to sell pelvic mesh products for transvaginal repair of POP, even after Ethicon stopped selling most of its POP devices.

However, in April 2019, the FDA concluded there was not a reasonable assurance of safety and effectiveness for any commercially available pelvic mesh products intended for transvaginal repair of POP. Therefore, the FDA ordered all remaining manufacturers of surgical mesh intended for transvaginal repair of POP to stop selling and distributing such products.

During the relevant timeframe, Ethicon disseminated three categories of communications giving rise to the violations at issue here: (1) instructions for use (IFUs); (2) marketing communications directed to California doctors; and (3) marketing communications directed to California patients.

In 2016, the California Attorney General filed an enforcement action against Johnson & Johnson on behalf of the People of the State of California. The case stemmed from a multistate investigation into J&J subsidiary Ethicon Inc’s marketing of pelvic mesh devices.

The operative complaint alleged Ethicon disseminated deceptive advertisements relating to its pelvic mesh products and violated the unfair competition law (UCL) (Bus. & Prof. Code,[1] § 17200 et seq.) and 121,844 violations of the false advertising law (FAL) (§ 17500 et seq.). It requested injunctive relief, civil penalties of $2,500 for each UCL violation occurring on or after October 17, 2008, and civil penalties of $2,500 for each FAL violation occurring on or after October 17, 2009.

After a nine-week bench trial, the trial court issued an extremely thorough, 128-page statement of decision finding Ethicon liable for 153,351 UCL violations and 121,844 FAL violations.

Johnson & Johnson, Ethicon, Inc., and Ethicon US, LLC (collectively, Ethicon), appealed an adverse judgment following a bench trial. The trial court levied nearly $344 million in civil penalties against Ethicon for willfully circulating misleading medical device instructions and marketing communications that misstated, minimized, and/or omitted the health risks of Ethicon’s surgically implantable transvaginal pelvic mesh products.

Ethicon’s primary contention on appeal was that the trial court applied the wrong legal standards under the UCL and FAL Ultimately the California Court of Appeal decided that substantial evidence supported the findings regarding Ethicon’s written marketing communications, but not its oral marketing communications in the published decision of The People v Johnson and Johnson e.al. 77 Cal.App.5th 295 (April 2022).

The judgment was modified, and the civil penalties awarded to the People are reduced from $343,993,750 to $302,037,500. The judgment was affirmed as modified. The parties are to bear their own appellate costs.

The U.S. Supreme Court denied Johnson & Johnson’s Petition For a Writ Of Certiorari of this $302 million judgment on February 21, 2023. J&J had argued to the Supreme Court that state consumer protection laws like California’s are too vague, exposing companies to unpredictable state lawsuits.

JNJ said the Supreme Court’s rejection of the case will lead to continued “uneven, unclear, and unfair enforcement that harms consumers and businesses.”

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Expanded Authority for Nurse Practitioners Effective on January 1

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California faces a statewide shortfall for primary care providers. Mid-range forecasts indicate the state would need about 4,700 additional primary care clinicians in 2025 and about 4,100 additional primary care clinicians in 2030 to meet demand.

One of the top recommendations to solve this problem from the California Health Workforce Commission, representing thought leaders from business, health, employment, labor and government, after it spent a year looking at how to improve California’s ability to meet healthcare workforce demands, was to allow full practice authority for Nurse Practitioners.

The California Legislature responded in 2020 by passing AB 890 which was signed by Governor Gavin Newsom. This law created two new categories of Nurse Practitioners (NPs) that can function within a defined scope of practice without standardized procedures. These new categories of NPs are:

– – 103 NP – Works under the provisions outlined in Business and Profession Code Section 2837.103. This NP works in a group setting with at least one physician and surgeon within the population focus of their National Certification
– – 104  NP – Works under the provisions outlined in Business and Professions Code Section 2837.104. This NP may work independently within the population focus of their National Certification.

Previously, although Nurse Practitioners have had more clinical independence than Registered Nurses, California law limited their extended scope of practice to implementation of standardized procedures with physician oversight.

AB 890 required that the California Board of Registered Nursing pass appropriate implementation regulations before the law would go into full effect. The Board conducted widespread outreach and engagement prior to developing the proposed regulatory language to implement AB 890. Extensive and frequent input was received from Board members, advisory committee members, and community stakeholders.

The regulatory language to implement AB 890 has been approved by the Office of Administrative Law on December 30, 2022, and went into effect January 1, 2023. While they do not significantly extend or alter the current NPs scope of practice, the new categories do have additional authority to work without standardized procedures.

All NPs who wish to practice without standardized procedures, must apply to the BRN for a special certification before they can do so. This new authority is not automatically granted to all NPs in California on January 1st.

The law requires a licensee to first work as a 103 NP in good standing for at least 3 years prior to becoming a 104 NP. Consequently, the Board is only able to certify 103 NPs at this time and will not be able to certify 104 NPs until 2026.

According to Business and Profession Code Section 2837.103, the following criteria must be met to become a 103 NP:

– – Has been certified as an NP by the California Board of Registered Nursing.
– – Holds a National Certification in a recognized population focus consistent with 16 CCR 1481 by a national certifying body accredited by the National Commission for Certifying Agencies or the American Board of Nursing Specialties and recognized by the Board.
– – Has completed a transition to practice within the category of their National Certification in California of a minimum of three full-time equivalent years of practice or 4600 hours within 5 years of the date of an application.

An estimated 20,000 nurse practitioners will be eligible to apply for the first phase of expanded authority Nurse Practitioners who meet the requirements for either pathway under AB 890 will have the authority to undertake the following specified functions:

– – Conduct an advanced assessment;
– – Order, perform, and interpret diagnostic procedures;
– – Order diagnostic radiologic procedures and utilize the findings or results in treating a patient;
– – Establish primary and differential diagnoses;
– – Certify disability after physical examination;
– – Delegate tasks to a medical assistant; and
– – Prescribe, order, administer, dispense, procure, and furnish therapeutic measures, including controlled substances, among other pharmacological and non-pharmacological interventions.

The legislation elevates the need to reexamine intersecting statutes, regulations, payer policies, clinical agency operations, interprofessional team structures, health care finance, and employment relationships and align them to fully realize the goals and intent of AB 890.

Accordingly, the California Health Care Foundation published its study: Aligning Nurse Practitioner Statutes in California. The research team reviewed a comprehensive, but not exhaustive, list of California statutes that govern heal- ing arts practitioners and identified opportunities for better alignment between existing laws and new leg- islation or regulatory action.

Labor Code § 3209.10 (a). authorizes NPs functioning pursuant to standardized procedures and acting under the review or supervision of a physician and surgeon, to provide medical treatment in the workers’ compensation insurance program.

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