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HHS Issues Proposed Rule Under Section 1557 of the Affordable Care Act: Nondiscrimination in Health Programs and Activities

On August 4, 2022, the US Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM or proposed rule) to reinterpret section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of race, color, national origin, sex, age or disability in a health program or activity, any part of which is receiving federal financial assistance. The proposed rule restores and strengthens certain civil rights protections under federally funded health programs and HHS programs which were limited following the 2020 Trump-era version of the rule, specifically regarding discrimination on the basis of sex, including sexual orientation and gender identity, and returns certain protections for individuals with limited English proficiency (LEP). Additionally, the proposed rule bolsters protections against discrimination in healthcare by clarifying that funds received under several federal healthcare programs, including Medicare Part B, are included in the definition of federal financial assistance under the law. As such, under the proposed rule, the list of entities expected to comply with the nondiscrimination measures outlined in Section 1557 of the ACA is significantly expanded, in many ways aligning with the 2016 Obama-era version of the rule. The NPRM also proposes to expand the applicability of the post-Bostock interpretation of “on the basis of sex” to Medicaid, Children’s Health Insurance Programs (CHIP) and Programs of All-Inclusive Care for the Elderly (PACE). For now, portions of the 2020 Final Rule not discordant with Bostock continue to apply.

Read more here.




How Can Employers Protect Workers Who Seek Abortion Care?

As US states seek to reduce abortion access in the wake of the overturning of Roe v. Wade, how can employers protect workers who seek abortion care? In this Fortune article, McDermott’s David Gacioch, Sarah Raaii and Ellen Bronchetti offer insight into what the US Supreme Court’s decision means for employee healthcare data, employee benefits and Title VII.

“Any employer who doesn’t already have an assessment of what the end of Roe means for its operations and workforce…needs to get in front of this,” Gacioch said.

Access the article.




CMS Recommends Cost Savings Be Passed Along to Medicare Part B Beneficiaries

The US Centers for Medicare & Medicaid Services (CMS) recently released a report recommending that cost savings from lower-than-expected Medicare Part B spending be passed along to individuals with Medicare Part B coverage in the calculation of the 2023 Part B premium.

CMS’s recommendations are based upon the development of the Part B premium and the potential effects of factors that have changed since a premium was announced on a drug used for the treatment of Alzheimer’s disease. CMS builds in a reserve to ensure the Medicare Supplementary Medical Insurance (SMI) Trust Fund remains adequately financed for the year. In 2021, CMS built in a reserve to ensure the SMI Trust Fund could cover the potential costs of the Alzheimer’s disease drug and similar drugs.

Read McDermott’s latest Healthcare Regulatory Check-Up newsletter here.




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.

Read more here.




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.

Read more here.




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.

Read more here.




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.

Read more here.




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