News & Analysis as of

Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) Covered Entities

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2025

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

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

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 & 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

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

BakerHostetler on

​​​​​​​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

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

McDermott Will & Schulte

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

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 & Schulte

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

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

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Mintz - Health Care Viewpoints

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

K&L Gates LLP

What a Trump Administration Could Mean for the 340B Drug Program

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A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

King & Spalding

New ICD-10 Compliance Date Set for October 1, 2015

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On July 31, 2014, CMS issued a final rule moving the ICD-10 compliance date from October 1, 2014 to October 1, 2015, and requiring HIPAA covered entities to continue to use ICD-9 through September 30, 2015. The final rule...more

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