US Department of Health and Human Services Archives

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.

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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.

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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.

Are Out-of-Pocket Costs on Their Way Out? At-Home COVID-19 Testing and Expanded Preventative Healthcare for Women and Children

by Jacob Mattinson and Teal Trujillo | Jan 14, 2022 | Employee Benefits, Employment, Health and Welfare Plans

In response to a directive from the White House, based on provisions of the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security (CARES) Act that eliminated cost sharing for COVID-19 diagnostic testing, three federal government departments—the US Department of Health and Human Services (HHS), the US Department of Labor (Labor) and the US Department of the Treasury (Treasury)—issued guidance in the form of frequently asked questions (FAQs) that states group health plans and insurers must also cover over-the-counter (OTC) COVID-19 diagnostic testing. This guidance is effective beginning January 15, 2022.

In addition, the Health Resources and Services Administration (HRSA) updated the Affordable Care Act’s (ACA) comprehensive preventive care and screening guidelines for women and children to cover additional services and supplies without a copay or deductible, effective 2023.

COVID-19 AT-HOME TESTING COVERAGE

On January 10, 2022, HHS, Labor and the Treasury together issued FAQs that elaborated on prior guidance and indicated that group health plans and insurers are required to cover OTC COVID-19 diagnostic tests without cost sharing. Because of the recent spike in COVID-19 cases resulting from the rapid spread of the Omicron variant, the guidance will continue for the duration of the public emergency.

Most consumers with private health coverage will be able to buy OTC COVID-19 tests and either have the cost covered upfront or be reimbursed later by submitting a claim to their health plan. The new requirement only applies to “diagnostic” OTC COVID-19 testing. It does not include the treatment of COVID-19 or testing that is for employment purposes.

The guidance provides that health plans and insurers must cover at least eight OTC COVID-19 diagnostic tests per covered individual per a 30-day period. Insurers will be able to set up networks of preferred suppliers to provide OTC COVID-19 tests directly to participants without upfront costs. Insurers must still reimburse OTC COVID-19 tests purchased outside the direct coverage program, however, the reimbursable amount is limited to $12 per test if the health plan also provides tests through its preferred pharmacy network and through a direct-to-consumer shipping program without upfront costs.

Besides the risk of increasing the average cost of OTC COVID-19 tests, the new initiative raises concerns over fraud and abuse. For health plans and insurers to protect themselves, the FAQs provide several examples of permissible activities to prevent fraud and abuse, like requiring proof of purchase or an attestation that the test was purchased for proper purposes (i.e., is being used by the covered individual, is not being reimbursed by another source, is not being resold and is not for employment purposes).

HRSA UPDATES ACA PREVENTIVE HEALTHCARE GUIDELINES

On January 11, 2022, HRSA announced that it updated the preventive health and screening guidelines for women, infants, children and adolescents. Under the ACA, certain group health plans and insurers must provide coverage with no out-of-pocket costs for preventive health services within these HRSA-endorsed comprehensive guidelines.

HRSA accepted the updates recommended by the Women’s Preventative [...]

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