News & Analysis as of

Final Rules Compliance Healthcare

Katten Muchin Rosenman LLP

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Saul Ewing LLP

Trump on Transparency: Making America Healthy Again Through Executive Order 14221; How Plan Sponsors Can Respond

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One mandate under the PPACA required health care providers, non-grandfathered health insurance issuers and self-insured group health plans to provide consumers with access to information about the cost of services before they...more

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

McDermott Will & Emery

ASTP Final Rule Codifies Requirements for TEFCA-Qualified Health Information Networks

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On December 16, 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

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

Harris Beach Murtha PLLC

"No Surprises Act" Ruling Favors Regulators, Insurers

Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act (the...more

Ankura

Is there room for AI in the ICU? Guiding Principles and Compliance Considerations

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Artificial Intelligence (AI) offers unprecedented opportunities to enhance patient care, streamline clinical documentation, and support medical decision-making processes. More and more healthcare professionals find themselves...more

Holland & Hart LLP

Are You Ready for It? Section 1557's Upcoming Deadlines

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The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) published its final rules implementing the anti-discrimination provisions under Section 1557 of the Affordable Care Act (“Final Rule”) on May...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

Health Care Compliance Association (HCCA)

What does the HIPAA final rule regarding reproductive health information mean for your organization?

On April 26, 2024, the U.S. Department of Health and Human Service Office for Civil Rights issued a final privacy rule to support reproductive health privacy. The rule does not allow the sharing of reproductive health...more

ArentFox Schiff

OCR Finalizes HIPAA Privacy Rule to Support Reproductive Health Care Privacy

ArentFox Schiff on

On April 26, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Final Rule that adds protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule...more

Health Care Compliance Association (HCCA)

Defensibility of a fair market value analysis

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Health Care Compliance Association (HCCA)

[Event] 2020 Virtual Columbus Regional Conference - May 1st, Columbus, OH

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Robinson & Cole LLP

CMS Makes Significant Changes to Stage 2 Meaningful Use and Finalizes Stage 3

Robinson & Cole LLP on

On October 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) that streamlines Stage 2 and finalizes Stage 3 of the Medicare and Medicaid electronichealth record (EHR) Incentive...more

Fisher Phillips

USDOL "Companionship", "Live-In Domestic" Enforcement Coming

Fisher Phillips on

The U.S. Labor Department has now announced that, beginning on November 12, it will start enforcing its revised regulations governing the Fair Labor Standard Act's Section 13(a)(15) "companionship" exemption and Section...more

Foley & Lardner LLP

MSSP Final Rule ACO Eligibility Requirements, Application and Renewal Process

Foley & Lardner LLP on

This is the second post in Health Care Law Today’s series on the final rule. This post addresses Eligibility Requirements, and the Application and the Renewal Process. ACO Eligibility Requirements - Under the...more

McDermott Will & Emery

HIPAA Omnibus Final Rule Compliance Date Is Only Two Months Away

McDermott Will & Emery on

The compliance date for the omnibus final rule amending the privacy, security, breach notification and enforcement regulations under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information...more

Morgan Lewis

CMS Rule Complicates Long-Term Care Facility and Hospice Relationships

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Final rule aims to improve the quality and consistency of care between long-term care facilities and hospice providers but may increase conflict between facility and provider staff. ...more

Bradley Arant Boult Cummings LLP

Final Rules on Wellness Programs under the Affordable Care Act

Plan sponsors should review wellness programs for compliance with recently issued final rules, which among other things increase the maximum permissible award for certain wellness programs. On May 29, the Internal Revenue...more

Saul Ewing Arnstein & Lehr LLP

Highlighting Transparency Through The Federal Sunshine Act Regulations

The final regulations implementing the Physician Payments Sunshine Act take effect April 9, 2013. Pharmaceutical manufacturers, group purchasing organizations, academic medical centers and physicians need to be ready to...more

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