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Centers for Medicare & Medicaid Services (CMS) Office of the Inspector General

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

King & Spalding

OIG Audit Finds Medicare Overpaid Hospitals an Estimated $79 Million for Enrollees Who Had Received Mechanical Ventilation

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On August 12, 2024, OIG announced the results of an audit of payments made to hospitals for inpatient claims with the Medicare Severity Diagnosis-Related Groups (MS-DRGs) that require ninety-six hours of consecutive...more

Foley & Lardner LLP

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

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Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

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

Health Care Compliance Association (HCCA)

[Event] Healthcare Enforcement Compliance Conference - November 18th - 20th, Arlington, VA

Is your compliance strategy aligned with current enforcement priorities? Hear first-hand from government enforcement leaders about regulatory changes, expectations, and key areas of concern. Gain insight into current...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

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The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

McCarter & English, LLP

More Roadblocks For Information Blocking: HHS Finalizes Rule Establishing Disincentives for Hospitals, Clinicians, and ACOs

On July 31, 2024, the Department of Health and Human Services (HHS) final rule, 89 FR 54662, establishing disincentives for certain healthcare providers that have committed information blocking, will become effective. This...more

Faegre Drinker Biddle & Reath LLP

Long-Awaited Disincentives Rule for Providers Gives the Information Blocking Rule Teeth

On June 24, 2024, the Department of Health and Human Services (HHS) finalized the Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking (Disincentive Rule) under the 21st Century...more

McGuireWoods Consulting

CMS Finalizes Rule to Prevent Blocking of Electronic Health Information

On June 24, 2024, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final rule that disincentivizes healthcare providers from...more

BakerHostetler

Healthcare Providers Beware: Finalized Disincentives Sharpen the Teeth of Information Blocking Rule

BakerHostetler on

On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...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

Greenbaum, Rowe, Smith & Davis LLP

HHS Finalizes Rule Establishing Significant Financial Penalties for Information Blocking by Healthcare Providers

On June 24, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule establishing stringent financial penalties, referred to as “disincentives,” for healthcare providers found to have committed...more

McDermott Will & Emery

HHS Issues Provider Information Blocking Disincentives Final Rule

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

Arnall Golden Gregory LLP

HHS Finalizes Healthcare Provider Disincentives for Information Blocking

Recently, the United States Department of Health and Human Services (“HHS”), Centers for Medicare & Medicaid Services (“CMS”), and Office of the National Coordinator for Health Information Technology (“ONC”) announced the...more

Holland & Knight LLP

HHS Is Primed to Enforce Information Blocking Conduct

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The U.S. Department of Health and Human Services (HHS) continued its commitment to timely and full access to health records on June 24, 2024, through the finalization of its information blocking disincentives rule for...more

McDermott+

HHS Institutes Information Blocking Disincentives for Healthcare Providers

McDermott+ on

The long-awaited final reg is upon us! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final regulation earlier this week...more

King & Spalding

OIG Report Details Weaknesses in Enforcement of Two-Midnight Rule

King & Spalding on

CMS estimates that between 2017 and 2021, Medicare Part A improperly paid $23.9 billion for inpatient hospital stays, with $7.8 billion attributable to short stays that did not qualify for Medicare Part A. On June 13, 2024,...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024

This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B...more

Husch Blackwell LLP

Increasing Hospital Reimbursement by Paying to the Upper Payment Limit

Husch Blackwell LLP on

This post is the first in a series dedicated to Colorado’s Medicaid finance and payment systems, challenges faced by those programs, and opportunities for expansion. The Colorado Healthcare Affordability and Sustainability...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #4

This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal...more

Alston & Bird

Health Care Week in Review: Senate Finance Committee Releases Plan to Address Workforce Shortages, Court Sides with Manufacturers...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: May 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

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