News & Analysis as of

Department of Health and Human Services (HHS) Policy Statement

Stinson LLP

CMS Says That EMTALA Overrides State Law in Pregnancy Emergencies

Stinson LLP on

On July 11, 2022, United States Secretary of Health and Human Services, Xavier Becerra, issued a letter to hospitals stating that the Federal Emergency Medical Treatment and Active Labor Act (EMTALA) requires physicians and...more

Nelson Mullins Riley & Scarborough LLP

HHS Issues Reminder about EMTALA Obligations to Pregnant Women Post-Dobbs

The Secretary of the Department of Health and Human Services (“Secretary”) issued a letter to healthcare providers ("Letter") and associated guidance on July 11, 2022, reminding applicable providers of their EMTALA...more

Hogan Lovells

FTC reinforces breach notification duties for health apps and connected health and wellness devices

Hogan Lovells on

A new Policy Statement from the US Federal Trade Commission places companies that offer consumer-facing health apps and connected health and wellness devices on notice that they may be covered by a Health Breach Notification...more

Benesch

Warning from FTC Regarding Scope of Health Breach Notification Rule

Benesch on

As the collection and use of health data drastically expands, the agency issued a recent guidance to officially put health apps and connected medical devices “on notice.” On September 15, the Federal Trade Commission...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Morgan Lewis

HHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During COVID-19 Pandemic

Morgan Lewis on

The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more

Ruder Ware

Waiver Amounts Owed For Telehealth Services During The 2019 Novel Coronavirus (COVID-19) Outbreak

Ruder Ware on

The Health and Human Services (HHS) Office of Inspector General (OIG) issued a Policy Statement on March 17, 2020 regarding the waiver of amounts owed by beneficiaries for services provided by telehealth. Recognizing the...more

Seyfarth Shaw LLP

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

Seyfarth Shaw LLP on

On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...more

Bass, Berry & Sims PLC

Waiver of Patient Cost-Sharing Obligations for Telehealth Services During COVID-19 Pandemic

Bass, Berry & Sims PLC on

On March 17, 2020, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued a Policy Statement addressing the ability of physicians and other practitioners to reduce or waive patient...more

King & Spalding

HHS OIG Updates Its Interpretation of “Nominal Value” Under CMP to $15 Per Item or $75 Per Patient Per Year

King & Spalding on

On December 7, 2016, HHS OIG issued a “General Policy Statement Regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries” (Policy Statement). In the Policy Statement, OIG announced that it is changing its...more

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