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Centers for Medicare & Medicaid Services (CMS) Penalties

WilmerHale

2024 CMS Audit and Enforcement Report

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On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more

Jones Day

CMS Finalizes The Increasing Organ Transplant Access Model

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The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more

ArentFox Schiff

The 2025 Final Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need to...

ArentFox Schiff on

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now...more

Fenwick & West LLP

California’s SB 1120 Regulates AI in Health Plan Utilization Review and Management Activities Starting in January

Fenwick & West LLP on

On September 28, California Gov. Gavin Newsom signed Senate Bill 1120 Health Care Coverage: Utilization Review into law, amending § 1367.01 of the Health and Safety Code and § 10123.135 of the state’s Insurance Code....more

Holland & Hart LLP

FMV for Provider Contracts: Regulatory Standards

Holland & Hart LLP on

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

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

Gardner Law

CMS Audits on the Horizon: Prepare for Increased CMS Audits Under the Sunshine Act

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Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...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

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

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The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Harris Beach Murtha PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Mintz - Health Care Viewpoints

Mintz IRA Update — A Deeper Dive into Other Controversies of the IRA’s Medicare Drug Price Negotiation Program

The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more

King & Spalding

CMS Announces Increased Scrutiny for Poor-Performing Nursing Facilities

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On October 21, 2022, CMS announced new actions to increase accountability and scrutiny on nursing homes in the Special Focus Facilities Program (SFF Program), an oversight program for the poorest performing nursing homes in...more

Oberheiden P.C.

Medicare TPE Audits: 7 Common Questions Answered

Oberheiden P.C. on

The Centers for Medicare and Medicaid Services (CMS) and its audit contractors have recently increased their use of Targeted Probe and Educate (TPE) audits to target providers suspected of improperly billing Medicare. While...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

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

Arnall Golden Gregory LLP

Is There a Constitutional Limit to Excessive Fines in False Claims Act Cases? Eleventh Circuit Says a Million Dollar Fine for a...

In late December, the U.S. Circuit Court of Appeals for the Eleventh Circuit issued its decision in Yates v. Pinellas Hematology & Oncology, P.A. The appellate court affirmed the district court’s imposition of damages and...more

Miller Canfield

OSHA Issues Emergency Temporary Standard Requiring Mandatory Vaccination or Testing of Private Sector Workers for COVID-19

Miller Canfield on

On November 4, 2021, the Occupational Safety and Health Administration (OSHA) revealed its Emergency Temporary Standard (ETS) on COVID-19 Vaccination and Testing, which has been published in the Federal Register and is...more

ArentFox Schiff

2022 HOPPS Final Rule Addresses Hospital Price Transparency

ArentFox Schiff on

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 & Schulte

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

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

Ogletree, Deakins, Nash, Smoak & Stewart,...

HHS Proposes Air Ambulance Reporting Details Beginning in 2022

Employer-sponsored health plans can add air ambulance claims reporting to the list of required disclosures that will go into effect in the next several years. Under proposed regulations published September 16, 2021, by...more

K&L Gates LLP

CMS Proposes to Increase Penalties for Hospital Price Transparency Noncompliance

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On 19 July 2021, the Centers for Medicare & Medicaid Services (CMS) released the 2022 Outpatient Prospective Payment System/Ambulatory Surgery Center Payment System proposed rule (OPPS Proposed Rule),1 which includes a...more

McDermott Will & Schulte

CMS Proposes Heightened Penalties and Additional Requirements under the Hospital Price Transparency Rule

On July 19, 2021, President Joseph R. Biden’s administration released a proposed rule that would increase penalties for hospitals that do not comply with the Hospital Price Transparency Rule, effective January 1, 2022. The...more

ArentFox Schiff

Physician Fee Schedule Proposed Rule for 2022 Released: What Pharmaceutical Manufacturers Need to Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more

Baker Donelson

CMS Amps Up Penalties on Long Term Care Facilities for Failing to Report COVID-19 Data and Mandates Staff Testing for the Virus

Baker Donelson on

Effective September 2, 2020, the Centers for Medicare and Medicaid Services (CMS) implemented an interim final rule with comment period to bolster its regulatory authority in addressing a number of issues relating to CMS's...more

Baker Donelson

Federal District Court Upholds CMS Hospital Price Transparency Rule, Reporting to Begin January 1, 2021

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On June 23, 2020, a federal district court upheld a Centers for Medicare and Medicaid Services (CMS) regulation that requires hospitals to publicly report information regarding their standard charges, including privately...more

King & Spalding

CMS Issues New Nursing Home Survey Requirements and Penalties in Light of COVID-19 Pandemic

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On June 1, CMS issued guidance to states on new requirements for nursing homes in light of the COVID-19 pandemic. Since March 6, 2020, CMS has relied on State Survey Agencies to perform Focused Infection Control surveys of...more

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