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Department of Health and Human Services (HHS) Social Security Act

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

OIG Approves Arrangement Regarding Drug Cost Subsidies for Certain Low-Income Medicare Enrollees

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...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

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...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

Harris Beach PLLC

The End of the Public Health Emergency is Near

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President Biden announced that the COVID-19 national emergency and public health emergency (PHE) will expire on May 11, 2023. During the PHE, federal agencies were permitted to grant blanket waivers for certain health care...more

Foley & Lardner LLP

DOJ Antitrust Division and HHS OIG Enter into Partnership to Increase Coordination and Enforcement in Health Care

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On December 9, 2022, the U.S. Department of Justice Antitrust Division (DOJ) and Office of Inspector General of the U.S. Department of Health and Human Services (OIG) announced they had entered a Memorandum of Understanding...more

Venable LLP

Return to "Normalcy" - Bracing for the End of the Public Health Emergency

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In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more

King & Spalding

HHS Says Hospitals Must Provide Abortions When an Emergency Medical Condition is Found to Exist; Texas Files Lawsuit in Response

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HHS released guidance on July 11, 2022, stating that the Emergency Medical Treatment and Active Labor Act (EMTALA)—which requires hospitals and physicians to provide emergency medical treatment when an emergency medical...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

Mintz - Health Care Viewpoints

OCR RFI: Have You Implemented Your Recognized Security Practices?

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) to obtain industry feedback and inform potential future rulemaking regarding information...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

Foley & Lardner LLP on

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

OIG Updates COVID-19 Administrative Enforcement FAQs With Question Regarding Ambulance Providers’ Waiver or Discount of Certain...

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On May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...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

King & Spalding on

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

White & Case LLP

Elimination of Medicaid Rebate Cap in the Latest COVID-19 Relief Package—The First Legislative Action on Drug Pricing Under the...

White & Case LLP on

The American Rescue Plan Act of 2021, the US$1.9 trillion stimulus package expected to be passed by Congress and signed into law by President Biden by March 14, 2021, contains the first drug pricing legislative action being...more

White and Williams LLP

HITECH Act Amendment Offers New Incentive to Reduce Fines and Other Remedies

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Just in case your office or company is in the process of compiling a “to-do” list for 2021, here is one item that should have your full attention. On January 5, 2021, an amendment to the HITECH Act (H.R.7898) was signed into...more

Holland & Knight LLP

HITECH Act Amended to Give Businesses Brownie Points for Certain HIPAA Security Programs

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On Jan. 5, 2021, the President signed into law H.R. 7898, which provides even more incentive for Health Insurance Portability and Accountability Act (HIPAA)-covered entities and business associates to develop robust security...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

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Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

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