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Monkeypox Declared a National Public Health Emergency

On August 4, 2022, the Biden administration declared monkeypox a public health emergency (PHE), a step that will allow the federal government to work with more agility to combat the spreading outbreak, including via expedited vaccine distribution and expanded testing.

The PHE declaration follows the recent appointment of federal officials to head up the monkeypox response team, including Robert Fenton of the Federal Emergency Management Agency as White House national monkeypox response coordinator, and Dr. Demetre Daskalakis of the US Centers for Disease Control and Prevention as White House national monkeypox response deputy coordinator.

The administration also began holding what will be a recurring weekly briefing with congressional staff on August 4. A press release from the US Department of Health and Human Services (HHS) on the PHE declaration can be found here.

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Navigating Data Privacy Questions Post-Dobbs

The US Supreme Court’s recent decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization has raised many questions about potential efforts by law enforcement agencies to obtain data from healthcare and other service providers to detect the performance of a possibly unlawful abortion. For example, data collected by period-tracking apps, patients’ self-reported symptoms, or diagnostic-testing results might be used to establish the timeframe in which an individual became pregnant, and then demonstrate that a pregnancy was terminated, as part of investigative or enforcement efforts against individuals or organizations allegedly involved in such termination.

On June 29, 2022, the office within the US Department of Health and Human Services (HHS) that is responsible for enforcing the Health Insurance Portability and Accountability Act (HIPAA), the Office for Civil Rights (OCR), issued guidance addressing how HIPAA limits disclosures by covered entities and business associates to law enforcement agencies in the absence of a court order or other legal mandate. The guidance provides helpful insight on how OCR may use HIPAA enforcement to discourage unauthorized disclosures of protected health information (PHI) to law enforcement officials in the wake of new state laws outlawing abortion. The guidance also implicitly confirms, however, that HIPAA does not provide a complete shield against law enforcement and litigation-driven requests for abortion-related information.

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No Surprises Act to Prevent Millions of Surprise Bills

Effective January 1, 2022, the No Surprises Act protects healthcare consumers from surprise medical billing under certain circumstances. 

Two health insurance advocacy organizations recently surveyed more than 80 commercial health insurance companies and received responses from 31 companies, which collectively represent 115 million commercial health plan members. These companies reported receiving 600,000 claims covered by the No Surprises Act (NSA) in January and February 2022. However, based on claims experiences from prior years and factoring in processing delays this year, the two organizations estimate the true number of NSA-eligible claims in the first two months of 2022 was actually more than 2 million. The two organizations project that the No Surprises Act could prevent more than 12 million surprise bills in 2022 alone.

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US House Passes Telehealth Extension Through 2024

The US House of Representatives approved a bipartisan bill that would extend Medicare telehealth flexibilities through the end of 2024; immediate US Senate action on the bill is unlikely, however.

On July 27, 2022, the US House of Representatives approved the Advancing Telehealth Beyond COVID-19 Act (H.R. 4040) by a wide bipartisan margin of 416–12. This bill would extend Medicare telehealth flexibilities through the end of 2024, including geographic and originating site flexibilities, expanded eligible practitioners, reimbursement for federally qualified health centers and rural health clinics, delay of the in-person telemental health requirement, continued use of audio-only telehealth and flexibility to use telehealth to satisfy Medicare face-to-face requirements.

Immediate US Senate action on H.R. 4040 is not likely, as the Senate is working on other priorities heading into the August recess. In addition, given the limited number of legislative days on the calendar before the midterm elections, additional action on telehealth extensions is more likely to occur during Congress’s lame-duck session at the end of the year. These same provisions were extended for 151 days beyond the end of the public health emergency (PHE) through the enactment of the Consolidated Appropriations Act of 2022, making it less urgent for Congress to act on an extension before the end of the year—although this bill has significantly increased chances of Congress doing so.

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Manchin Agrees to Expanded Reconciliation Deal

Senators Schumer and Manchin announce a bill that includes drug pricing and an extension of the advance premium tax credits, the amount individuals pay for monthly health insurance premiums when they buy health insurance on the Marketplace.

On July 27, 2022, Senate Majority Leader Schumer and Senator Manchin announced a surprise agreement to move forward with an expanded reconciliation bill titled the Inflation Reduction Act (summary here). The tentative deal includes drug pricing and expands upon a previous “healthcare-only” version of the reconciliation package that focused solely on drug pricing and a two-year extension of the advance premium tax credits (APTCs). The deal would raise an estimated $739 billion, with revenues going toward climate and healthcare initiatives, as well as reducing the federal deficit.

Leader Schumer and Senator Manchin released a joint statement outlining the agreement, which contains two key healthcare policy items: allowing Medicare to negotiate prescription drug prices and a three-year extension of APTCs. The three-year extension is one year longer than had been widely expected and reported in the previous version of the bill. The Biden-Harris Administration has also announced support for the bill. The package must go before the Senate Parliamentarian for Byrd Rule challenges before it can go to the Senate floor. It is expected to garner the Democratic support necessary to pass both the House and the Senate, and will move quickly from this point. The caveat to this is the impact of COVID-19. Several senators are already out, and Senator Dick Durbin (D-IL) announced July 28 that he has COVID-19 as well.

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Monkeypox in the Workplace: Key Considerations for Employers

As of July 26, 2022, there are 3,591 confirmed cases of monkeypox in the United States, according to US Centers for Disease Control and Prevention (CDC) data, and the World Health Organization (WHO) Director-General has declared the multi-country monkeypox outbreak a Public Health Emergency of International Concern (PHEIC). With much about the potential impact and scope of monkeypox still unknown, employers should consider taking proactive steps now, as may be appropriate for their workforce, to enhance and reinforce the safety protocols already in place from the COVID-19 pandemic.

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EEOC Potentially Limits Employer’s Right to Mandate COVID-19 Testing

On July 12, 2022, the US Equal Employment Opportunity Commission (EEOC) revised its guidance on compliance with disability discrimination law during the COVID-19 pandemic. While previous guidance, initially published on December 14, 2021, provided that COVID-19 viral testing was permissible for on-site employees and did not run afoul of the Americans with Disability Act (ADA) due to health and safety priorities of the pandemic, the recent EEOC updates now only permit screening and viral testing measures when such measures are job-related and consistent with business necessity, holding COVID-19 testing to the same standard as other workplace medical tests. The July 12 update “makes clear that going forward employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify viral screening of employees to prevent workplace transmission of COVID-19,” the EEOC said.

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Hospitals Shouldn’t Expect Quick Pay Despite 340B Win

340B hospitals should not expect to receive withheld program funds anytime soon despite a recent US Supreme Court ruling. According to this Becker’s Hospital Review article, the Court reversed a 2020 federal appeals court ruling that found that the US Department of Health and Human Services (HHS) had the authority to make a $1.6 billion annual reimbursement cut to the program under its Medicare Outpatient Prospective Payment System (OPPS). McDermott Partner Emily J. Cook said that the ruling will not result in any immediate changes to Medicare payments for 340B drugs nor require that HHS restore the full payment rates for the drugs.

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Fired for Having an Abortion? Unlikely, but It’s Complicated

Could a worker be fired for having an abortion? According to this Insider article, workplace laws would likely protect pregnant people from discrimination. McDermott’s Sarah Raaii said employers should make sure abortion health plan coverage does not conflict with federal laws.

“Incorporating abortion benefits into an employer’s existing health plan might help mitigate worker privacy concerns,” Raaii said, “since health plans are subject to the Health Insurance Portability and Accountability Act (HIPAA).”

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Abortion Questions Swirl Over Health Lawyers in Post-Roe World

Following the US Supreme Court’s decision to overturn Roe v. Wade, health lawyers have been busy making sense of the legal implications of the court’s landmark ruling. In this Law360 article, McDermott Partners Stacey Callaghan and David Gacioch offer insight into the myriad of questions they’ve received from hospitals, pharmacies, telemedicine platforms, investors and other players in the industry.

“The field against whom [abortion restrictions] can be enforced becomes so much broader,” Gacioch said. “It’s such a sea change.”

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