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Social Security Act Centers for Medicare & Medicaid Services (CMS) Department of Health and Human Services (HHS)

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Arnall Golden Gregory LLP

Proposed Legislation Focuses on Private Equity and REITs in Healthcare

Efforts to draw attention to and, in some instances, dissuade private equity investment in healthcare have been on the rise. For example, in late 2023, the Centers for Medicare & Medicaid Services finalized a rule increasing...more

Baker Donelson

What the Supreme Court's "Chevron Deference" Ruling Could Mean for Health Care Law

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Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more

Mintz - Health Care Viewpoints

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more

King & Spalding

CMS Issues IPPS and LTCH PPS Final Rule for FY 2024

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On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more

King & Spalding

Federal District Court Grants Injunction Barring CMS from Implementing New Policy on Medicaid Funding Designed to Prevent...

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On June 30, 2023, the United States District Court for the Eastern District of Texas (the Court) granted the State of Texas’ preliminary injunction motion, enjoining CMS from implementing and enforcing its Informational...more

Akin Gump Strauss Hauer & Feld LLP

Supreme Court Upends Medicare 340B Drug Payment Policy

Key Points - The Supreme Court invalidated 2018 and 2019 cuts to Medicare reimbursement rates for hospital outpatient drugs acquired through the 340B Drug Pricing Program, effectively reinstating the default rate of ASP...more

Morgan Lewis - Health Law Scan

OIG Launches New Resource Page Featuring Telehealth

Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured...more

Foley & Lardner LLP

How does the Federal No Surprises Act Impact Telemedicine Providers? Part Two

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In this second installment of this blog series on the No Surprises Act interim regulations (NSA) we discuss: i) notice and consent requirements for out of network providers providing services at participating health care...more

King & Spalding

HHS Rescinds Medicaid Work Requirements for Ohio, South Carolina, and Utah, and Reopens Comment Period for Tennessee

King & Spalding on

On August 10, 2021, CMS notified Ohio, South Carolina, and Utah that it is withdrawing its prior approval of the Medicaid demonstration projects in these states, which had established work requirements as a condition for...more

Chambliss, Bahner & Stophel, P.C.

HHS and Other Agencies Issue Interim Final Rule on Surprise Billing

Earlier this month, the U.S. Department of Health and Human Services, Department of Labor, Department of the Treasury, and the Office of Personnel Management issued an interim final rule with a comment period on the issues of...more

King & Spalding

King & Spalding Represents Medicaid Beneficiaries in a Suit to Challenge the Approval of the TennCare III Medicaid Demonstration...

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On April 22, 2021, thirteen Medicaid beneficiaries, represented by the National Health Law Program, the Tennessee Justice Center, and King & Spalding, filed a complaint in the U.S. District Court for the District of Columbia...more

King & Spalding

HHS Revokes Arkansas and New Hampshire Medicaid Work Requirements

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On March 17, 2021, HHS notified Arkansas and New Hampshire officials that it was withdrawing its approval of demonstration projects which had permitted those states to impose work requirements as a condition for eligibility...more

King & Spalding

He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform

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On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more

Manatt, Phelps & Phillips, LLP

HHS Renews the COVID-19 Public Health Emergency Through January 20, 2021

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days, beginning on October 23 (the date the...more

Manatt, Phelps & Phillips, LLP

End-of-Term Retrospective on the Trump Administration’s 1115 Waiver Priorities

Section 1115 of the Social Security Act permits states to waive certain Medicaid statutory requirements through demonstration projects that advance state policy priorities and test innovations in their Medicaid programs....more

King & Spalding

Executive Order Looks to Extend Access to Telemedicine Beyond the Pandemic and Increase Access to Care in Rural Communities

King & Spalding on

On August 3, 2020, President Trump signed an Executive Order that could potentially extend the easing of restrictions on telemedicine that were put in place during the COVID-19 public health emergency (PHE) beyond the...more

Manatt, Phelps & Phillips, LLP

HHS Renews COVID-19 Public Health Emergency, Extending Flexibilities and Funding for Another 90 Days

On Thursday, July 23, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days through October 22. This update...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

Holland & Knight LLP on

Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

Foley & Lardner LLP

Telehealth in the Wake of COVID-19

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On March 13, 2020, the President of the United States issued a proclamation that the 2019 Novel Coronavirus (previously referred to as 2019-nCoV, now as COVID-19) outbreak in the United States constitutes a national emergency...more

Mintz - Health Care Viewpoints

A Review of the Affordable Care Act at 10 Years, Part 2: Medicaid Expansion

This post is the second installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA) and will examine Medicaid expansion under the ACA. Medicaid is joint federal-state program that...more

Foley & Lardner LLP

COVID-19: Washington Becomes the Second State Approved For 1135 Medicaid Waiver – Key Takeaway

Foley & Lardner LLP on

On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more

Foley & Lardner LLP

COVID-19: Washington Becomes the Second State Approved For 1135 Medicaid Waiver – Key Takeaways

Foley & Lardner LLP on

On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more

Sheppard Mullin Richter & Hampton LLP

Bringing Clarity to Section 1135 and Other Waivers amid the COVID-19 Emergency

On a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic. As the federal government works to respond to the COVID-19 pandemic, guidance from HHS...more

Robinson+Cole Health Law Diagnosis

HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19)...

Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of...more

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