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Covered Entities Health Care Providers Centers for Medicare & Medicaid Services (CMS)

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Bricker Graydon LLP

AI and Healthcare: Decoding the Latest 1557 Non-Discrimination Regulations

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Section 1557 of the Affordable Care Act (ACA) prohibits providers and health plans that receive reimbursement from the federal government from discriminating against individuals in the Covered Entities’ health programs. Such...more

Venable LLP

Looming CTA Disclosure Requirements and Healthcare Providers

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The Federal Corporate Transparency Act (the CTA), 31 U.S.C. §5336, will soon require certain entities to disclose to the U.S. Treasury's Financial Crimes Enforcement Network (FinCEN) certain pieces of identifying information...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

McDermott Will & Schulte

This Week in 340B: May 2023 #4

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Bricker Graydon LLP

Are you regulated under HIPAA? Ensure your website or app’s user tracking is HIPAA compliant

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On December 1, 2022, the Centers for Medicare and Medicaid Services’ Office of Civil Rights (OCR) issued new guidance to covered entities and business associates regarding website and application user data tracking and how...more

BakerHostetler

HHS Proposes Rule Strengthening Section 1557 Protections Against Nondiscrimination in Health Activities

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​​​​​​​On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more

Williams Mullen

Physician Group Monitoring of “Open Payments”

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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

Bond Schoeneck & King PLLC

CMS Tool for HIPAA Compliance

The pandemic has accelerated the U.S. healthcare system’s ascent into the digital age – and privacy standards are along for the ride. Recognizing this, the Federal Centers for Medicare and Medicaid Services (CMS) of the U.S....more

Fisher Phillips

Medicare and Medicaid Participants Face Sweeping New Workplace Vaccination Rule: A 5-Step Survival Guide

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Note: This CMS Rule refenced in this Insight is separate and distinct from the OSHA ETS that was issued on November 4. Thus, although the CMS Rule could also be challenged in court, the November 6 court order blocking...more

Arnall Golden Gregory LLP

AGG Talks: Technology - In the Balance: Interoperability and Security

Our podcast series features AGG attorneys and guests discussing challenges they’ve encountered when assisting clients on business and legal issues related to the Technology industry. While all topics will have a legal...more

K&L Gates LLP

K&L Gates Triage: 340B Update: CMS Issues Guidance for Avoiding Duplicate Discounts in Medicaid

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In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more

Mintz - Health Care Viewpoints

CMS Takes Another Swing at 340B Reimbursement Cuts. Will It Be Strike Three?

The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications, CMS took another swing at cutting Medicare Part B reimbursement...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

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This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Fox Rothschild LLP

Feeling Lucky? You Could Be One Of The Nine Covered Entities Selected For HIPAA Compliance Review This Month

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If you are a covered entity health plan or clearinghouse, you may be among the nine (un)lucky entities randomly chosen this month for review into compliance with HIPAA’s Administrative Simplification rules governing...more

Foley & Lardner LLP

Court Rules Against 340B Hospitals, Allows Medicare Reimbursement Cuts to Go Forward

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On Friday, December 29, 2017, the U.S. District Court for the District of Columbia dealt a blow to hospitals participating in the 340B Drug Pricing Program. By participating in the 340B program, eligible public and...more

Polsinelli

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

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In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

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