News & Analysis as of

Reporting Requirements Department of Health and Human Services (HHS) Health Care Providers

Sheppard Mullin Richter & Hampton LLP

New York State Releases Much Anticipated Guidance on Reporting Requirements for Material Healthcare Transactions as Budget...

On August 1, 2023, the New York State’s Department of Health (the “DOH”) began implementation of Public Health Law Article 45-A, the State’s new statutory requirement for advance notice and public disclosure of certain...more

Nelson Mullins Riley & Scarborough LLP

Senate Bill 316: An Overview for North Carolina Hospitals

Earlier this week, Senate Bill 316 (the “Bill”) was filed in the North Carolina state legislature. The Bill covers a large swathe of healthcare-related issues, and the additional regulatory elements of the Bill would likely...more

Foley & Lardner LLP

Colorado: Proposed Expanded Medical Care Transaction Oversight - What Providers and Investors Need to Know

Foley & Lardner LLP on

On March 5, 2025, two Senators and one Representative introduced SB 25-198 (the Bill), designed to enhance transparency in transactions involving health care entities. The Bill seeks to impose notification and reporting...more

BakerHostetler

Trump Signs Price Transparency Executive Order

BakerHostetler on

On Tuesday, Feb. 25, President Donald Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the Executive Order)....more

Stevens & Lee

Urgent Care Centers Must Now Comply With Pennsylvania Newborn Safe Haven Law

Stevens & Lee on

Pennsylvania’s Safe Haven Law, also known as the Newborn Protection Act (the Act), allows parents to surrender their infants at hospitals, EMS providers and police stations without criminal liability, but for a few...more

McDermott Will & Emery

Human Trafficking Monitoring for Telehealth Providers

Telehealth providers are uniquely positioned to monitor for human trafficking when interacting with patients. Survivor records indicate that health services are among the most common points of access to help trafficked...more

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

McCarter & English, LLP

New Jersey Regulatory Update Part I - January 2025

Below is Part I of our New Jersey Regulatory Update focusing on regulations that were finalized in 2024 by various New Jersey agencies that impact healthcare. The final regulations range from additional transparency...more

Gardner Law

LDT Compliance: Countdown to May 2025

Gardner Law on

We previously reported on the FDA’s laboratory-developed test (LDT) rule published on May 6, 2024, which classifies LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This shift marks the end...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

Holland & Knight LLP

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

Holland & Knight LLP on

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

Alston & Bird on

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

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

BakerHostetler on

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

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

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

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

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

McGuireWoods LLP

Provider Relief Fund Reporting Guidance: Provider Relief Fund Late Reporting Requests for Extenuating Circumstances Accepted April...

McGuireWoods LLP on

Two Weeks Left: Approaching Deadline to Report Period 4 Provider Relief Fund Payments - Most healthcare providers received Provider Relief Fund (PRF) funding (as described in greater detail in a previous McGuireWoods...more

Bass, Berry & Sims PLC

Payment Due: HRSA Seeks Repayment of Provider Relief Funds for Non-Compliance

Bass, Berry & Sims PLC on

The Health Resources and Services Administration (HRSA) is seeking repayment of Provider Relief Fund (PRF) payments from providers who failed to submit the required report(s) on their use of the funds. Recipients were...more

Health Care Compliance Association (HCCA)

Compliance Today - December 2022. Intersection of ESG, health equity, and 501(r) compliance

Compliance Today - December 2022 - We are at a critical moment of change when it comes to truly addressing health inequities in this country. With the intersection of environmental, social, and governance (ESG) reporting and...more

McGuireWoods LLP

Provider Relief Fund Reporting Guidance: Provider Relief Fund Late Reporting Requests for Extenuating Circumstances Accepted April...

McGuireWoods LLP on

May 18 Deadline to Request Late Reporting for Provider Relief Fund Period 2 - The U.S. Department of Health and Human Services (HHS) announced a deadline extension for providers that received $10,000 or more in the second...more

Williams Mullen

Physician Group Monitoring of “Open Payments”

Williams Mullen on

Is your physician group monitoring the Open Payments database? Each June, the Centers for Medicare and Medicaid Services (CMS) releases data showcasing the payments made by reporting entities to physician groups and other...more

McDermott Will & Emery

HHS Announces Provider Relief Fund Late Reporting Pathway

McDermott Will & Emery on

Beginning on April 11, 2022, providers that failed to satisfy Provider Relief Fund (PRF) Period 1 or Period 2 reporting deadlines may apply to submit a late report based on one of six extenuating circumstances, including...more

Tucker Arensberg, P.C.

HHS Requesting Physician COVID Relief Payback of $100 Million

Tucker Arensberg, P.C. on

HHS sent notices to noncompliant physicians and facilities on March 10, 2022 giving them 30 days to return funds paid to healthcare providers who have not complied with the agency’s reporting requirements....more

McGuireWoods LLP

Provider Relief Fund Reporting Guidance: Looming Deadlines to Report Provider Relief Fund Period 2 Payments and COVID-19 Vaccine...

McGuireWoods LLP on

Looming Deadlines to Report Provider Relief Fund Period 2 Payments and COVID-19 Vaccine Claims - The U.S. Department of Health and Human Services (HHS) reporting portal remains open only through March 31, 2022, at 11:59...more

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