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Covered Entities Centers for Medicare & Medicaid Services (CMS)

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

King & Spalding

Medicare Advantage Payors Have Not Redressed 340B Underpayments

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CMS recently published its remedy in response to the Supreme Court’s decision that CMS’s 340B outpatient drug payment policy violated the Medicare statute. Many hospitals that are 340B covered entities will now receive tens...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

Foley & Lardner LLP

CMS Proposes Remedy for 340B-Acquired Drug Payment Policy for CY 2018-2022

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Along with its calendar year (CY) 2024 Medicare Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) have also published the long-awaited proposal to remediate the...more

McDermott Will & Emery

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

Foley & Lardner LLP

The Future of the 340B Program: 2023 Key Decisions

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Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...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

BakerHostetler

Dobbs Triggers Significant Healthcare and Privacy Law Concerns and Confusion

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To help guide entities through the significant confusion and changes that will be evolving for the next several years, BakerHostetler has assembled the Dobbs Decision Task Force (DDTF), led by attorneys in five major areas...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

Foley Hoag LLP - Medicaid and the Law

Supreme Court Will Hear Several Health Care Cases in 2022 Term

Recently, my colleague Regina DeSantis told you about the ongoing saga involving disputes between 340B contract pharmacies and pharmaceutical manufacturers.  We often write about the 340B program on our blog because of the...more

Hinshaw & Culbertson - Health Care

Change is on the Horizon for 340B Pharmacy Program's Administrative Dispute Resolution Process

The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more

K&L Gates LLP

340B Update: Appellate Court Upholds 340B Payment Reduction as CMS Proposes Further Reductions for 2021

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In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more

McDermott Will & Emery

GAO Recommends CMS, HRSA Improve 340B Duplicate Discount Oversight

On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...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

Foley Hoag LLP - Medicaid and the Law

CMS Issues Guidance to States on 340B Duplicate Discounts

Late last year, we noted that the Massachusetts Medicaid program had proposed regulations to address issues related to the prohibition on duplicate discounts in the 340B program. The Massachusetts solution was relatively...more

McDermott Will & Emery

2020 Starts Off with Two Government Publications Critical of 340B Program Oversight

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Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...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

Snell & Wilmer

HHS to Start Randomly Selecting Health Plans for HIPAA Compliance – Are You Ready?

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The CMS Division of National Standards, on behalf of HHS, is launching the Compliance Review Program (the “Program”) to ensure compliance among covered entities with HIPAA Administrative Simplification rules for electronic...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

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