News & Analysis as of

Department of Health and Human Services (HHS) Exemptions

Troutman Pepper

FOIA Exemption Questions on Redacted HHS Cannabis Letter

Troutman Pepper on

The principle of open government is foundational to a healthy democracy, and the availability of government records upon request from the public is one of its chief cornerstones. Originally published in Law360 - January 5,...more

Bradley Arant Boult Cummings LLP

Vax Requirement Sacked in TN: Medicare Providers Lose Exemption from COVID-19 Laws

The federal government says healthcare employers can soon stop requiring employees to get the COVID-19 vaccine. Yes — the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) is...more

Holland & Knight LLP

Trucking Industry Group Seeks to Conduct Drug Screening Utilizing Hair Testing

Holland & Knight LLP on

The Federal Motor Carrier Safety Administration (FMCSA) has requested public comment on an application for exemption submitted by The Trucking Alliance that would allow trucking companies to use hair testing in addition to...more

King & Spalding

FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)

King & Spalding on

Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more

Greenbaum, Rowe, Smith & Davis LLP

New Jersey Enacts Legislation Imposing Annual Community Service Contributions On Nonprofit Hospitals

On February 22, 2021, New Jersey Governor Phil Murphy signed into law new legislation (A1135/S357) that clarifies and preserves the statutory property tax-exemption historically afforded to nonprofit hospitals under N.J.S.A....more

Hogan Lovells

HHS Publishes Final SUNSET Rule With New Exemptions and Timelines

Hogan Lovells on

On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...more

Hogan Lovells

HHS proposal to exempt medical devices from 510(k) process halted

Hogan Lovells on

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

Arnall Golden Gregory LLP

The COVID-19 Vaccine and Healthcare Employers: To Mandate or Not to Mandate?

With COVID-19 vaccines now being distributed to healthcare facilities, including hospitals, long-term care, and other healthcare providers, employers in these industries are faced with an immediate decision: whether to...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Benesch

HHS Proposes Changes to Stark Law and Federal Anti-kickback Regulations to Advance Value-Based Care and Coordination of Care

Benesch on

On October 9, 2019, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General for the Department of Health and Human Services (“OIG”) announced proposed changes to modernize and clarify the...more

Chambliss, Bahner & Stophel, P.C.

Push for Medicaid Work Requirements Encounters Headwinds

Efforts by the federal government and some states to require certain Medicaid beneficiaries to work in order to maintain eligibility for benefits has run into a series of obstacles, both in the courts and in state...more

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

Holland & Knight LLP on

On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Judges Halt Expanded Exemption From ACA Contraceptive Mandate

In back-to-back decisions, two federal district court judges have blocked implementation of a Trump administration rule that would exempt more employers from the Patient Protection and Affordable Care Act (ACA) requirement...more

Baker Donelson

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

Baker Donelson on

On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more

Dechert LLP

DC Circuit shuts down effort to limit TCPA liability for communicating health information

Dechert LLP on

The U.S. Court of Appeals for the D.C. Circuit, on March 16, 2018, struck a blow to healthcare industry efforts to exclude certain communications subject to the Health Insurance Portability and Accountability Act (HIPAA) from...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Is the New Moral Exemption From ACA Contraceptive Coverage a Game Changer?

Any privately held, for-profit company could potentially be exempt from the Affordable Care Act’s (ACA) requirement to provide comprehensive contraceptive coverage without cost-sharing based on the company’s “sincerely held...more

Mintz - Health Care Viewpoints

Seven Takeaways from the ABA National Institute On Health Care Fraud

On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with...more

Foley & Lardner LLP

Prescribing Controlled Substances Without an In-Person Exam: The Practice of Telemedicine Under the Ryan Haight Act

Foley & Lardner LLP on

Editor’s Note: This article is the second in a series addressing telemedicine prescribing and controlled substances, designed to give some much needed practical guidance and orientation to established healthcare providers,...more

Baker Donelson

OIG Approves Transportation Assistance Program

Baker Donelson on

On October 3, 2016, the U.S. Department of Health & Human Services, Office of the Inspector General (OIG), issued an advisory opinion approving a local health care district’s proposal to cooperate with another district to...more

McDermott Will & Emery

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

Mintz - Health Care Viewpoints

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

Manatt, Phelps & Phillips, LLP

Manatt on Health Reform: Weekly Highlights - August 2015

Increased plan choice on HealthCare.gov is linked to lower premium growth; Arizona seeks changes to Medicaid expansion; and California and New York release detailed Marketplace and Medicaid enrollment reports....more

Bergeson & Campbell, P.C.

EPA Gets Closer To Issuing Final Rule On Revisions To Minimum Risk Exemption For Pesticides

On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

IRS Notice 2015-43 Addresses Expatriate Health Coverage

New guidance from the Internal Revenue Service (IRS) leaves in place the limited Affordable Care Act (ACA) exemptions set out in the Expatriate Health Coverage Clarification Act of 2014 (EHCCA). IRS Notice 2015-43 (Notice)...more

McCarter & English, LLP

Health Law Insights Newsletter - April 2014

In This Issue: - Federal Updates - State Updates - HIPAA Updates - Excerpt from Centers for Medicare & Medicaid Services Issues Guidance for Meaningful Use Hardship Exception: The Centers...more

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