News & Analysis as of

Reporting Requirements Department of Health and Human Services (HHS)

Health Care Compliance Association (HCCA)

Privacy Briefs: September 202

The HHS Centers for Medicare & Medicaid Services (CMS) and Wisconsin Physicians Service Insurance Corporation (WPS) are notifying 946,801 people whose protected health information or other personally identifiable information...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 5, June 2024

We are pleased to announce that several of the firm’s practice groups and attorneys were recognized in the 2024 edition of Chambers USA, a directory of leading law firms and attorneys. Chambers and Partners annually...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

Husch Blackwell LLP

Massachusetts Public Health Council Approves Hospital Occupancy Reporting Requirements

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On Friday, May 3, 2024, Massachusetts’s Public Health Council (PHC) approved emergency amendments to 105 CMR 130.000 requiring hospitals to report occupancy data to the Department of Public Health. This requirement extends...more

Holland & Knight LLP

Finalized HTI-1 Interoperability and Information Blocking Updates Have Taken Effect

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The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) published its Health Data, Technology, and Interoperability: Certification Program Updates,...more

Alston & Bird

HHS Final Rule Brings Sweeping, Complex Changes for Substance Use Records

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A new HHS Final Rule overhauls the federal Part 2 regulations on the confidentiality of substance use disorder (SUD) records. Our Heath Care Health Care and Privacy, Cyber & Data Strategy Groups unpack how the changes will...more

Davis Wright Tremaine LLP

LEAP, Don't Run, to Make this YEAR's Deadline: HIPAA Small Breach Notifications Due February 29

February 29, 2024, is the date by which HIPAA-covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR) of all "small" breaches of unsecured protected health information that...more

Gardner Law

CMS Auditing Companies for Sunshine Compliance: Are You Ready?

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As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

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On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

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On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more

Rivkin Radler LLP

New HHS Rule for Nursing Home Ownership and Manager Disclosure

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A new rule will require nursing homes enrolled in Medicare or Medicaid to make disclosures about certain facility ownership, management and other operational information. The U.S. Department of Health and Human Services (HHS)...more

Mintz - Health Care Viewpoints

HHS Proposes Appropriate Disincentives for Health Care Providers That Commit Information Blocking

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more

Snell & Wilmer

2023 End-of-Year Plan Sponsor “To Do” Lists (Part 1) Health and Welfare

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We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate Employee Benefits Updates. This Part 1 covers year-end health and welfare plan issues....more

Akin Gump Strauss Hauer & Feld LLP

Research Security: New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks & Research Data With the U.S. Prime...

On September 15, 2023, the National Institutes of Health (NIH) moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

BakerHostetler

Are You Complying with ClinicalTrials.gov Reporting Obligations?

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Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials...more

McDermott Will & Emery

Special Report - A Million Reasons to Share: OIG’s Final Rule on Information Blocking Enforcement

McDermott Will & Emery on

On July 3, 2023, the US Department of Health and Human Services Office of Inspector General (OIG) published its long-awaited final rule implementing the 21st Century Cures Act provisions authorizing OIG to investigate claims...more

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

Bipartisan legislative activity related to pharmacy benefit manager (PBM) oversight is at an all-time high in both the House and Senate. As we noted last week, several bills that address PBM activities are moving through the...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases Updates to Hospital Pricing Transparency Rule

On April 26, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a fact sheet on Hospital Price Transparency Enforcement Updates (the “Fact Sheet”) under the Hospital Price Transparency Rule (the “Rule”)....more

Mintz - Health Care Viewpoints

Pharmacy Benefit Managers are on the Federal Government’s Radar: Senate, House, and Agency Proposals Seek to Increase PBM...

In conjunction with the surge in state legislative efforts to regulate the pharmacy benefit manager (PBM) industry, Congress and federal agencies have ramped up PBM oversight efforts as part of the ongoing battle to lower...more

Verrill

Gag Clauses – New Guidance and Litigation Will Inform Compliance

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Certain provisions of the Transparency in Coverage Final Regulations and the Consolidated Appropriation Act, 2021 (“CAA”) require group health plans and/or their vendors to report information to federal agencies. On December...more

Arnall Golden Gregory LLP

GAO Report Focuses on Expert Recommendations to Improve Nursing Home Infection Prevention and Control

A roundtable of 13 experts convened by the Government Accountability Office (“GAO”) has made several recommendations for improving infection prevention and control (“IPC”) efforts in nursing homes. The recommendations are...more

Foley & Lardner LLP

Child Labor: 9 Key Strategies to Mitigate Risk of Child Labor in the Supply Chain

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Since 2018, the U.S. Department of Labor has seen a 69 percent increase of children being employed illegally by companies. Last month, the U.S. Department of Labor (“DOL”) and Department of Health and Human Services (“DHHS”)...more

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