Archives: Other HHS Developments

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HHS to prohibit discrimination on the basis of sexual orientation and gender identity

On May 10, 2021, the Department of Health and Human Services (“HHS”) announced that— consistent with the Supreme Court’s decision in Bostock v. Clayton County, 140 S. Ct. 1731 (2020), and Title IX of the Education Amendments of 1972—HHS’s Office of Civil Rights (“OCR”) will interpret and enforce the prohibition on discrimination on the basis … Continue Reading

What happens when the clock strikes midnight: A Primer on “Midnight Regulations”

With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to closely monitor and track which of the outgoing Trump administration’s “midnight regulations” will survive past the early months of the Biden administration. But for those less familiar with the topic … Continue Reading

President Biden implements policies to expand access to health care and coverage

On January 28, 2021, the White House issued President Biden’s Executive Order on Strengthening Medicaid and the Affordable Care Act (the “Executive Order”), which seeks to increase access to affordable health insurance and strengthen Medicaid and the Affordable Care Act, particularly in light of the ongoing COVID-19 pandemic.  In addition to this Executive Order, the … Continue Reading

Long-Awaited issuance of Section 340B ADR final rule

In 2010, the Affordable Care Act (ACA) directed the Secretary of Health and Human Services to issue regulations to establish an administrative dispute resolution (ADR) process for certain claims between Section 340B covered entities and pharmaceutical manufacturers (e.g., claims of overcharging by manufacturers and claims of covered entities taking duplicative discounts or diverting Section 340B … Continue Reading

New Executive Order seeks to address COVID-19 impact on mental health

On October 5, 2020, the White House issued President Trump’s Executive Order on Saving Lives Through Increased Support for Mental- and Behavioral-Health Needs (the “Executive Order”), which seeks to provide federal support to address mental and behavioral health concerns arising from the COVID-19 pandemic. The Executive Order acknowledges the exacerbating effects that the COVID-19 pandemic … Continue Reading

Patient access to health information at the forefront of government initiatives and scrutiny

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information. In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability … Continue Reading

HHS announces another round of CARES Act funding for Medicaid and CHIP providers as well as Safety Net Hospitals

On June 9, 2020, the U.S. Department of Health and Human Services (HHS) announced additional distributions from the CARES Act Provider Relief Fund to several groups of providers, totaling approximately $25 billion. $15 billion of these funds is targeted towards eligible Medicaid and Children’s Health Insurance Program (CHIP) providers participating in state Medicaid and CHIP … Continue Reading

CDC Offers Guidance to Health Providers on ICD-10 Coding for Coronavirus/COVID-19 Encounters

The Centers for Disease Control and Prevention (CDC) recently released official diagnosis coding guidance for health care encounters and deaths related to the 2019 novel coronavirus (COVID-19), potentially in anticipation of more frequent cases in the United States. The guidance identifies specific ICD-10-CM codes to be used to code encounters. CDC advises that patients presenting … Continue Reading

Potential Tensions Lie Ahead Between Federal and State Authorities Over the Application of CDC Quarantine Powers

According to the U.S. Centers for Disease Control and Prevention (CDC), although there have been imported cases of Covid-19 detected in the United States, “at this time, the virus is NOT currently spreading in the community in the United States.”[1]  However, on Tuesday, February 25, 2020, Nancy Messonier, the CDC’s Director of National Center for … Continue Reading

Analysis:  Navigating US federal and state rules during the novel coronavirus public health emergency

The novel coronavirus (2019-nCoV, also known as “SARS-CoV-2”) has been declared a public health emergency (PHE) by the U.S. Department of Health and Human Services (HHS).  This designation authorizes HHS to direct funding to: (1) enable the dissemination of information about the virus; (2) encourage research and development of diagnostic and treatment techniques; (3) improve … Continue Reading

HHS Continuing to Reduce Medicare ALJ Appeals Backlog under Court Order; Senators Reintroduce Legislation Striving to Improve Efficiency of Medicare Appeals Process

The Department of Health and Human Services (HHS) is ahead of schedule to reduce its Medicare Administrative Law Judge (ALJ) appeals backlog, as required by court order, but lawmakers are still looking for ways to improve the efficiency of the Medicare appeals process. Following a November 1, 2018 federal district court order in American Hospital … Continue Reading

HHS “Quality Summit” to Focus on Overhauling Federal Quality Programs

The Department of Health and Human Services (HHS) has announced plans to hold a “Quality Summit” to foster dialogue between government leaders and health care industry stakeholders on how HHS quality programs “can be further evaluated, adapted, and ultimately streamlined to deliver a value-based care model focused on improving outcomes for American patients.”  Ultimately, the … Continue Reading

HHS Deputy Secretary Hargan Names Innovation/Investment Summit Participants; First Meeting Scheduled for December 18, 2018

Health and Human Services Deputy Secretary Eric Hargan has selected 15 health industry and investment professionals to participate in the Deputy Secretary’s Innovation and Investment Summit (DSIIS), which will hold its inaugural meeting on December 18, 2018.  As previously reported, this initiative is intended to provide a forum for private sector and government experts to … Continue Reading

Healthcare Investors, Innovators Wanted for HHS Summit – Nominations Due October 3, 2018

HHS Deputy Secretary Hargan has announced the creation of the “Deputy Secretary’s Innovation and Investment Summit” (DSIIS), which will provide a forum “to discuss the innovation and investment landscape within the healthcare sector, emerging opportunities, and the government’s role in facilitating more investment and accelerated innovation.”  The DSIIS will involve quarterly meetings between healthcare innovation … Continue Reading

Reed Smith Analysis: Trump Administration’s Drug Pricing Blueprint

As previously reported, the Trump Administration has released its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.”  Many of the recommendations in the Blueprint were previously made in President Trump’s fiscal year 2019 budget proposal, while numerous others are framed as open-ended questions rather than policies.  While the near-term impacts on drug pricing based … Continue Reading

Trump Administration Releases Drug Pricing “Blueprint” and Request for Comments on Reducing Drug Costs

The Trump Administration has launched a high-profile initiative aimed at reducing prescription drug prices, including release of a blueprint containing a series of short- and long-term policy proposals and a request for public comments on additional reforms. First, on May 11, 2018 the Department of Health and Human Services released its “Blueprint to Lower Drug … Continue Reading

New HHS Advisors Appointed to Develop Strategy on Drug Pricing, Opioid Policy

HHS Secretary Alex Azar has appointed two advisors to help advance Department strategy to address prescription drug pricing and the opioid crisis. Daniel M. Best, the new Senior Advisor to the Secretary for Drug Pricing Reform, is charged with leading the HHS initiative to lower the cost of prescription drugs. He recently served as Corporate … Continue Reading

Azar Sworn in as HHS Secretary

Alex Azar was sworn in as Secretary of Health and Human Services on January 29, 2018.  He fills the position left by former Secretary Tom Price, M.D., who resigned last fall in the wake of a controversy over his travel expenses.… Continue Reading

ONC Proposes Trusted Exchange Framework for Health Information Networks

The Office of the National Coordinator (ONC) for Health Information Technology has released a draft trusted exchange framework that proposes policies, procedures, and technical standards to further Congressionally-mandated efforts to establish a nationwide, interoperable health system under the 21st Century Cures Act of 2016.  Currently, there are dozens of Health Information Networks (HINs) that operate … Continue Reading

HHS Creates Conscience and Religious Freedom Division within OCR

On January 18, 2018, HHS announced it has established a new Conscience and Religious Freedom Division within the HHS Office for Civil Rights (OCR).  The Division will focus on enforcement of (1) existing protections for health care providers who refuse to perform certain health care services on religious or moral grounds, and (2) laws that … Continue Reading

HHS Announces New Appeals Settlement Initiatives

The HHS Departmental Appeals Board (DAB) is inviting the public to submit recommendations for precedential Medicare Appeals Council (Council) decisions that will be binding on all CMS, HHS, and Social Security Administration components that adjudicate matters under CMS jurisdiction. The designation of precedential decisions was authorized by regulations adopted earlier this year; the DAB will … Continue Reading

Update: Now it’s Wright out, Hargan in at HHS

President Trump has named Eric Hargan to serve as Acting HHS Secretary, replacing Don Wright (who was just named to the post on September 29, 2017).  The HHS Secretary vacancy was created when Tom Price, MD resigned the post September 29.  Hargan, an attorney who served at HHS during the George W. Bush Administration, was … Continue Reading

Price Out, Wright In at HHS (for Now)

In the wake of the resignation of former Secretary Tom Price, MD over concerns about his travel expenses, President Trump has named Don Wright, MD, MPH, as Acting Secretary of the Department of Health and Human Services (HHS). Wright previously served as Acting Assistant Secretary for Health.  The Administration has not yet indicated who will … Continue Reading
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