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Penalties Health Care Providers

Holland & Hart LLP

FMV for Provider Contracts: Regulatory Standards

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As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...more

Holland & Knight LLP

Five Red Flags in De-identification and Data Monetization for Healthcare Companies

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Healthcare providers running on thin margins or just seeking new (and in the case of tax-exempt providers, permissible) revenue sources may jump at the chance when third party vendors offer to help them monetize their patient...more

Davis Wright Tremaine LLP

21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more

King & Spalding

FTC Announces Final Rule Sweeping Consumer Digital Health Tech Under the Health Breach Notification Rule

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On April 26, the Federal Trade Commission (FTC) approved its Final Rule revising the Health Breach Notification Rule (HBNR) (“Final Rule”) by a 3-2 vote. The HBNR requires vendors of personal health records (PHR) and related...more

Holland & Hart LLP

Avoiding HIPAA Penalties: A Checklist for Covered Entities

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The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Husch Blackwell LLP

Federal Court Reduces FCA Penalties by 82 Percent Because of Excessive Fines Clause Concerns

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Husch Blackwell’s False Claims Act team previously covered the results of a rare False Claims Act (FCA) trial in which a federal jury found that a surgical product distributor was liable for paying kickbacks to physicians....more

Burr & Forman

Proposed Penalties for Information Blocking Violations

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On October 30, 2023, the Department of Health and Human Services (HHS) released a proposed rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century...more

Holland & Hart LLP

Business Associate Agreements: Requirements and Suggestions

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The HIPAA Privacy and Security Rules generally require covered entities (including most healthcare providers) to execute written agreements (“business associate agreements” or “BAAs”) with their business associates before...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...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)

Revised Privacy Rule May Not Emerge for Two Years; Info Blocking Penalty Regulation Published

Report on Patient Privacy Volume 23, no 7 (July 2023) In two public talks this spring, Melanie Fontes Rainer, director of the HHS Office for Civil Rights (OCR), said completing the 2021 proposed regulation extensively...more

King & Spalding

Illinois House Passes Legislation to Increase State Oversight of Healthcare Consolidation

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On March 24, 2023, the Illinois House of Representatives passed HB 2222. If passed by the Illinois Senate and signed by Illinois’ Governor, HB 2222 would amend the Illinois Antitrust Act (the Act) to add reporting...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

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On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Snell & Wilmer

HHS Proposed Changes To Part 2 Rules To Align With HIPAA Privacy Rules

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On November 28, 2022, the U.S. Department of Health and Human Services (“HHS”) proposed sweeping changes to the rules that govern use and disclosure of protected health information (“PHI”) about patients receiving substance...more

Foley & Lardner LLP

Compliance Officers Lookout! DOJ and OIG Tag Team Corporate Integrity Agreements

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The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...more

Nelson Mullins Riley & Scarborough LLP

Comparison of Three Federal Fraud and Abuse Laws

In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of...more

Foley & Lardner LLP

Postponement in the Massachusetts Patients First Act Penalties

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On July 5, 2022, the Commonwealth of Massachusetts re-extended the implementation and enforcement date for the “Patients First Act”, sometimes referred to as the Massachusetts No Surprises Act, to January 1, 2025. As...more

Oberheiden P.C.

Medicare TPE Audits: 6 Things You Need to Know

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Targeted Probe and Educate (TPE) audits have recently become a common tool used by both law enforcement and private insurers in the Medicare program. While they focus on educating Medicare providers about proper billing...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

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Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Robinson+Cole Data Privacy + Security Insider

New Jersey Settles with Cancer Center Over Business Email Compromise

One of the challenging things about HIPAA (Health Insurance Portability and Accountability Act) enforcement is the fact that both the Office for Civil Rights and State AGs have jurisdiction to assess fines and penalties for...more

ArentFox Schiff

2022 HOPPS Final Rule Addresses Hospital Price Transparency

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New Rule Finalizes Penalties for Violating the 2021 Price Transparency Rule - On November 2, 2021, CMS published the 2022 Hospital Outpatient Prospective Payment System Final Rule that addressed its previously-proposed...more

McDermott Will & Emery

CMS Will Finalize Heightened Penalties, Additional Requirements Under Hospital Price Transparency Rule

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On November 2, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it will implement increased penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1,...more

Nelson Mullins Riley & Scarborough LLP

[Event] 2021 South Florida Health Forum - November 2nd, Fort Lauderdale, FL

Please join Nelson Mullins Riley & Scarborough for the 2021 South Florida Health Forum. We look forward to reconnecting with you after a year away from our annual event....more

Mintz - Health Care Viewpoints

FTC Personal Health Records Breach Rule Applies to Health App and Connected Device Developers

On September 15, 2021, in response to the “proliferation of apps and connected devices that capture sensitive health data” the Federal Trade Commission (FTC) issued a Policy Statement (the Statement) offering guidance on the...more

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