US Department of Health and Human Services Archives - Page 3 of 9

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

by Gregory Fosheim, Jacob Mattinson, Todd Solomon and Moyosore Koya | Aug 18, 2022 | Benefit Controversies, Employee Benefits, Health and Welfare Plans

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.

Monkeypox Declared a National Public Health Emergency

by McDermott Will & Emery | Aug 12, 2022 | Employee Benefits, Health and Welfare Plans

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.

Read more here.

Navigating Data Privacy Questions Post-Dobbs

by Scott Weinstein, Jayda Greco, David Quinn Gacioch, Daniel F. Gottlieb and Carolyn Metnick | Aug 10, 2022 | Digital Health, Employee Benefits, Health and Welfare Plans

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.

Read more here.

Hospitals Shouldn’t Expect Quick Pay Despite 340B Win

by Emily J. Cook | Aug 2, 2022 | Benefit Controversies, Employee Benefits, Health and Welfare Plans

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.

Access the article.

HHS Announces New Guidance on Reproductive Healthcare

by McDermott Will & Emery | Jul 18, 2022 | Employee Benefits, Health and Welfare Plans

On July 8, President Biden signed an executive order for abortion access. In this order, the US Department of Health and Human Services (HHS) pledged to take steps to ensure that all patients have access to the full rights and protections for emergency medical care afforded under the law. Currently, medical providers and hospitals are required by the Emergency Medical Treatment and Labor Act to provide stabilizing treatment for patients with emergency medical conditions. On July 11, the Biden administration reiterated, through new guidance from HHS, that medical providers must offer abortion services if the life of a mother is at risk and that procedures conducted under such circumstances would be protected regardless of state law. The state of Texas has already filed a lawsuit challenging the Biden administration on this new guidance on the grounds that it violates the rights of physicians who oppose providing abortions and violates a state’s right to invoke its own policies.

Additionally, the Office of Civil Rights released guidance for retail pharmacies on access to reproductive healthcare services. The guidance, directed toward the nation’s 60,000 retail pharmacies, directed that pharmacists must provide medications related to reproductive healthcare as directed and prescribed by providers. This includes abortion pills, birth control and other reproductive care treatments. The agency cited reports outlining instances in which women were denied certain medications because the drugs may be linked to abortion or the drugs have ingredients like those used for medication abortion, for example Methotrexate, which is sometimes used to treat certain types of cancer, psoriasis and rheumatoid arthritis, but can also be used off-label to end ectopic pregnancies.

Read more here.

See What’s Next with McDermott+Consulting’s 340B Ligitation Tracking Tool

by Emily J. Cook and Rodney Whitlock | Jun 17, 2022 | Employee Benefits, Health and Welfare Plans

The 340B program landscape is constantly shifting. Wednesday’s US Supreme Court American Hospital Association v. Becerra decision is of critical importance to hospitals that participate in the 340B program. The Court held that the US Department of Health and Human Services (HHS) improperly imposed a payment cut of almost 30% on 340B drugs paid by Medicare. Yet, while this decision is significant, it is not the end of the litigation surrounding the payment cut. The case has been remanded for further deliberation, which will include a determination of the remedies.

McDermott+Consulting has launched the 340B Litigation Tracking Tool, an up-to-date resource following the 30+ state and federal 340B program legal challenges. No more searching online or sorting through your newsfeed for updates on important case developments. This tracker, available 24/7 and routinely monitored by our team, delivers concise updates to help you make informed risk analyses on what’s next for your business in the evolving 340B landscape.

View the 340B litigation tracking tool here.

Safe Harbor Issued for Reporting Healthcare Prices Under Transparency Rules

by McDermott Will & Emery | May 17, 2022 | Employee Benefits, Health and Welfare Plans

The US Departments of Labor, Health and Human Services, and the Treasury recently released Frequently Asked Questions (FAQs) regarding the implementation of certain reporting provisions of the Affordable Care Act (ACA). The FAQs were released to provide clarity on the required drug price disclosures identified in the Transparency in Coverage final rule (the Rule) issued on October 29, 2020. As described in this SHRM article, employers are responsible for making sure that these disclosures are ready and available.

Read more here.

Four Discrimination Questions Employers Have About COVID-19

by Lindsay Ditlow | Feb 25, 2022 | Employee Benefits, Employment, Health and Welfare Plans, Labor

As the world enters the third year of the COVID-19 pandemic, employers have gained a greater understanding about the virus’ relationship with US anti-discrimination laws. With the inevitable rise of future variants and long-haul COVID-19 cases, however, businesses are still navigating murky waters. In this Law360 article, McDermott Partner Lindsay Ditlow offers perspective about worker accommodation requests and what they mean for employers.

Access the article.

Agencies Clarify How Employers Can Charge COVID-19 Vaccine Premium Incentives

by Sarah Raaii and McDermott Will & Emery | Feb 24, 2022 | Employee Benefits, Employment, Health and Welfare Plans, Labor

US employers have grown increasingly interested in identifying incentives that increase COVID-19 vaccination among employees. The US Departments of Labor, Treasury and Human and Human Services recently issued guidance regarding the application of the Health Insurance Portability and Accountability Act (HIPPA) wellness rules to vaccine-related premium surcharges and discounts, clarifying that employers may charge vaccine premium incentives if they adhere to the requirements of activity-only health-contingent programs. In this Employee Benefit Plan Review article, McDermott Partner Judith Wethall and McDermott Associate Sarah G. Raaii outline what this HIPPA guidance means for employers.

Access the article.

Saga and Legal Challenges Continue Despite Vaccine Requirement for Healthcare Workers

by Sandra M. DiVarco | Feb 23, 2022 | Employee Benefits, Employment, Health and Welfare Plans, Labor

The US Supreme Court’s January ruling allowing the Centers for Medicare & Medicaid Services to enforce its COVID-19 mandate is likely to continue to face challenges. Nevertheless, in this article published by the Health Care Compliance Association, McDermott Partner Sandra DiVarco said that the Supreme Court’s decision wasn’t a surprise.

“Many of [the CMS] providers may have slow-walked their compliance and now in theory need to be fully compliant,” DiVarco noted.

Access the article.