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Department of Health and Human Services (HHS) Regulatory Requirements

Holland & Knight LLP

HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations

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The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

McDermott Will & Emery

New Fact Sheet Highlights ASTP’s Concerns About Certified API Practices

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On October 29, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP) released a fact sheet titled “Information Blocking Reminders Related to API Technology.” The fact...more

Vorys, Sater, Seymour and Pease LLP

Action Required for HIPAA Covered Entities Regarding Reproductive Health Care Compliance

On April 22, 2024, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (Final Rule)....more

Bass, Berry & Sims PLC

HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare

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As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The...more

Bass, Berry & Sims PLC

HHS’ Office of Inspector General Announces New Strategic Plan: What Contractors Should Know

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On October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan for improving oversight of public grants and contracts “to strengthen compliance with HHS award...more

Health Care Compliance Association (HCCA)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

Bass, Berry & Sims PLC

Compliance Deadlines for New Section 1557 Nondiscrimination Rules Approaching, Includes Application to Medicare Part B Recipients

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In April 2024, the Department of Health and Human Services (HHS) finalized revised regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (ACA). The new, final Section 1557 regulations (2024...more

Health Care Compliance Association (HCCA)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

McDermott Will & Emery

OIG Recommends Additional Oversight of Remote Monitoring Services

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On September 24, 2024, the Office of Inspector General (OIG) at the US Department of Health and Human Services issued a report recommending additional oversight of remote physiologic monitoring (RPM) services furnished to...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

McDermott+ on

Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

Bass, Berry & Sims PLC

HHS Proposed Rule Seeks to Align Health IT Procurement Standards to Leverage Interoperable Data

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On August 9, the Department of Health and Human Services (HHS) published a proposed rule that seeks to amend and update the Health and Human Services Acquisition Regulation (HHSAR) to align health IT procurement requirements....more

McDermott Will & Emery

ASTP’s HTI-2 Proposed Rule Would Add and Expand Information Blocking Exceptions

On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Baker Donelson

Information Blocking: Disincentives Established for Health Care Providers

Baker Donelson on

The United States Department of Health and Human Services (HHS) has now established disincentives for certain health care providers if found by the Office of Inspector General (OIG) to have committed information blocking...more

McDermott+

HHS Institutes Information Blocking Disincentives for Healthcare Providers

McDermott+ on

The long-awaited final reg is upon us! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final regulation earlier this week...more

McDermott Will & Emery

Federal Court Invalidates Key Part of HHS OCR Bulletin Regarding Application of HIPAA to Online Tracking Technologies

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In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled in American Hospital Association...more

Manatt, Phelps & Phillips, LLP

Preparing for the Future of Health Care Antitrust Scrutiny

Now, more than ever, health care organizations are facing complex antitrust issues as their mergers/acquisitions, hiring, contracting, and private funding are being scrutinized by the federal and state governments.  Proper...more

Proskauer - Health Care Law Brief

Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA...

In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

McDermott Will & Emery

Nondiscrimination on the Basis of Disability

McDermott Will & Emery on

For the first time in nearly 50 years, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has finalized revisions to regulations implementing Section 504 of the Rehabilitation Act of 1973,...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

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On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Health Care Compliance Association (HCCA)

‘I Will Not Rest’; ‘I Am All In’: Remarkable Breach Hearing Sees Pledges by UHG CEO, Sen. Wyden

United Healthcare Group (UHG) CEO Andrew Witty was in a board meeting on Feb. 21 when officials interrupted with the news that Change Healthcare—a clearinghouse UHG subsidiary Optum had purchased for $1.3 billion in October...more

Sheppard Mullin Richter & Hampton LLP

Bridging the Gap: Cannabis Rescheduling to Align Policy with Research

In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...more

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