News & Analysis as of

Department of Health and Human Services (HHS) Compliance

Foley & Lardner LLP

Final Mental Health Parity Rules – Top Five Changes to the Status Quo

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The Mental Health Parity and Addiction Equity Act and its implementing regulations and guidance (MHPAEA) prohibit health insurance policies and group health plans that cover mental health and substance use disorder (MH/SUD)...more

BCLP

Action Items as a Result of HIPAA Privacy Rule Modifications

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On April 22, 2024, the U.S. Department of Health and Human Services (“HHS”) issued new regulations under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) that impose new restrictions on the use and...more

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

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On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

Foley & Lardner LLP

Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV

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Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Health Care Compliance Association (HCCA)

Overlapping surgeries: Time for a compliance checkup?

Overlapping surgeries is a practice that has been used for many years by healthcare providers (such as hospitals and surgical centers). This practice generally refers to situations where one lead attending surgeon is...more

Foley & Lardner LLP

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

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On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

Saul Ewing LLP

HIPAA Security Rule Settlement Results in $950,000 Payment by a Mid-Atlantic Health System

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On July 1, 2024, the U.S. Department of Health and Human Services (“HHS”) Office For Civil Rights (“OCR”) announced a $950,000 settlement with Heritage Valley Health System (“Heritage Valley”) and a three-year Corrective...more

Health Care Compliance Association (HCCA)

A partnership with HHS OIG

This year’s annual Compliance Institute (CI) provided a strong reminder of just how fortunate we are to have such a strong relationship with the U.S. Department of Health and Human Services Office of Inspector General (OIG)....more

ArentFox Schiff

Providers Face HIPAA Compliance Questions After Change Healthcare Cyberattack

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Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more

Ankura

OIG Testimony Puts a Spotlight on Clinical Documentation and Payer Risk

Ankura on

In recent testimony before the United States House Committee on Energy and Commerce Subcommittee on Oversight and Investigations, Christi A. Grimm, Inspector General of the Department of Health and Human Services (HHS)...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

Health Care Compliance Association (HCCA)

In This Month’s E-News: June 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Holland & Hart LLP

New ACA 1557 Non-Discrimination Rules: Checklist For Healthcare Providers

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On May 6, 2024, the Department of Health and Human Services (HHS) published its final rule revamping the non-discrimination regulations issued under § 1557 of the Affordable Care Act.  The revised rules apply to all...more

Oberheiden P.C.

Ultimate Guide to the Anti-Kickback Statute

Oberheiden P.C. on

All healthcare providers and other businesses in the healthcare industry need to comply with the Anti-Kickback Statute (AKS). The AKS imposes criminal penalties for knowing and willful violations, and even inadvertent...more

Skadden, Arps, Slate, Meagher & Flom LLP

AI-Enabled Compliance: Keeping Pace With the Feds

The potential for artificial intelligence (AI) to transform business has commanded enormous attention over the past year. Little noted, however, is the U.S. government’s increasing — and increasingly sophisticated — use of AI...more

Holland & Knight LLP

What HIPAA Security Rule Surprises Await Healthcare Providers for the Second Half of 2024?

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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has, as part of its mandate, the responsibility to enforce the Health Insurance Portability and Accountability Act (HIPAA) Security Rule....more

Baker Donelson

How to Comply with HHS' New Nondiscrimination Compliance Infrastructure Requirements in Your Facility

Baker Donelson on

The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services and Office of the Secretary (collectively, HHS) released on May 6, 2024, the agencies' Final Rule governing the implementation of...more

Bass, Berry & Sims PLC

Is Your Compliance House In Order? Tips for Ensuring Private Equity and Portfolio Company Compliance in the Wake of the Recent...

The recent Request for Information by the Federal Trade Commission (FTC), Department of Justice (DOJ) and Department of Health and Human Services (HHS) seeking input on the effects of private equity (PE) investment in the...more

Epiq

Healthcare Organizations Can Meet New HHS Cybersecurity Goals with the Help of Tabletop Exercises

Epiq on

In today’s digital age, securing sensitive healthcare data is paramount. With the rise in cyber threats targeting healthcare organizations, the Department of Health and Human Services (HHS) has taken proactive steps to...more

Saul Ewing LLP

HHS OCR Issues Post-Dobbs Final Rule to Address Reproductive Health Care Privacy Protections

Saul Ewing LLP on

On April 22, 2024, the U.S. Department of Health & Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a final rule to support reproductive health care privacy (the “Reproductive Rule”). According to the HHS OCR...more

Health Care Compliance Association (HCCA)

OHRP FY 25 Budget Request Lacks Prior Plea For Funding, Staff Increases; Plans Are Modest

In December 2022, Julie Kaneshiro—then deputy director of the HHS Office for Human Research Protections (OHRP)—disclosed that the agency had 32 positions but that only 20 were filled, leaving 12 vacant or “on hold,” due to...more

Husch Blackwell LLP

Confidentiality of Substance Use Disorder Records: HHS Finalizes Changes to Part 2 Rule

Husch Blackwell LLP on

On February 8, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) finalized long-awaited modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at...more

Latham & Watkins LLP

US Regulators Announce Inquiry Into Healthcare Consolidation

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Companies should prepare for increased regulatory scrutiny into healthcare transactions and increased emphasis on compliance programs. The Federal Trade Commission (FTC), the Department of Justice (DOJ), and the...more

Health Care Compliance Association (HCCA)

An international standard for healthcare quality management

In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more

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