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Articles by Bryan Murray
CMS Proposes Steep Reductions to Medicare Reimbursement for 340B-Acquired Drugs | JD Supra
On July 2, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intending to substantially reduce Medicare Part B payment rates for drugs acquired through the federal 340B Drug Pricing Program. Specifically, CMS proposes that beginning January 1, 2027, 340B Program drugs be reimbursed by Medicare Part B at the Average Sales Price (ASP) minus 33.4%.
CMS Proposes Steep Reductions To Medicare Reimbursement For 340B-Acquired Drugs
Dinsmore & Shohl are most popular: within Government, Public Sector, Intellectual Property and Real Estate and Construction topic(s) with readers working within the Technology, Metals & Mining and Law Firm industries On July 2, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule intending to substantially reduce Medicare Part B payment rates for drugs acquired through the federal 340B Drug Pricing Program.
CMS Changes to Off-Campus Provider-Based Status Requirements | JD Supra
Medicare-participating hospitals and their off-campus provider-based departments will soon face substantial new compliance obligations under the recently adopted Consolidated Appropriations Act of 2026 (“CAA”).
HRSA Announces Pilot Program for 340B Rebate Models | JD Supra
On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the launch of a one-year 340B Rebate Model Pilot Program (the Pilot Program).
HRSA Announces Pilot Program for 340B Rebate Models
On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the launch of a one-year 340B Rebate Model Pilot Program (the Pilot Program).
D.C. District Court Declines Manufacturers’ Unilateral Efforts to Move Forward with Proposed 340B Rebate Models | JD Supra
Last month, the United States District Court for the District of Columbia (the “District Court”) evaluated Motions for Summary Judgment concerning drug manufacturers’ efforts to unilaterally pay 340B Program discounts in the form of a rebate.
D.C. District Court Declines Manufacturers’ Unilateral Efforts to Move Forward with Proposed 340B Rebate Models
Last month, the United States District Court for the District of Columbia (the “District Court”) evaluated Motions for Summary Judgment concerning drug manufacturers’ efforts to unilaterally pay 340B Program discounts in the form of a rebate.
[Webinar] Don't Be the Next Change Healthcare: How to Avoid a Breach and Prepare Your Response Plan - October 29th, 12:00 pm - 1:30 pm ET | JD Supra
This program is only virtual. You will receive the link with a calendar reminder upon registration. During the first half of this webinar, Jen Mitchell, Bryan Murray and Laura Fryan, will focus on practical tips and pointers on avoiding a HIPAA breach and what lessons you can take away from the Change Healthcare breach.
Offshore wind and wave energy can reduce total installed capacity required in zero-emissions grids - Nature Communications
Abstract As the world races to decarbonize power systems to mitigate climate change, the body of research analyzing paths to zero emissions electricity grids has substantially grown. Although studies typically include commercially available technologies, few of them consider offshore wind and wave energy as contenders in future zero-emissions grids.
Kentucky Senator Introduces Legislation to Combat Discrimination in the 340B Drug Program | JD Supra
State efforts to address the 340B Drug Program[1] continue to ramp up in 2024. Early this January, Kentucky Senator Stephen Meredith introduced Senate Bill 27 ("SB-27"), which intends to address a number of purchasing restrictions drug manufacturers unilaterally imposed on health care providers participating in the 340B Program.
Best Meal Delivery Services and Kits for Busy Households
If the thought of planning for, purchasing, and preparing healthy, home-cooked meals every day feels overwhelming, a meal delivery service might be just the life assist you need. From in-depth specialty meals for the adventurous at-home cook to quick, simple heat-up meals, and even meals that cater to weight-loss goals and ultra-restrictive diets, there’s a service for you. Plus, since the ingredients are pre-measured, meal delivery services can help reduce food waste.
Another Voice: The illicit market is the biggest obstacle to New York's legal cannabis program
As frustration mounts over the slow rollout of New York’s legal adult-use cannabis market, cannabis licensees and stakeholders are understandably anxious. However, infighting amongst the state’s current and prospective cannabis licensees risks missing the bigger picture – the illicit market is winning. There has been concern over the state’s medical operators (formally known as “registered organizations” or “ROs”) entering the adult-use market after a delay of more than two years.
Modernization of Cosmetics Regulation Act Passed
Thursday, February 23, 2023 On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023.
Cosmetic Regulations Get a Facelift
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023.
Pennsylvania Rescinds New Policy Impacting 340B Savings - Workgroup Will Convene To Discuss Further Changes To The 340B Program in Pennsylvania
As previously discussed in our January 5, 2023 legal alert, the Pennsylvania Department of Human Services (“Pennsylvania DHS”) issued a Medical Assistance Bulletin (the “Bulletin”) in late December, 2022 that had the potential to put 340B savings at risk in Pennsylvania.
D.C. District Court Rules HHS Will be in Charge of OPPS Repayments
Thursday, January 19, 2023 On January 10, the United States District Court for the District of Columbia issued a long-awaited opinion which will allow the U.S. Department of Health and Human Services (HHS) to determine the means by which it will repay inappropriate cuts it levied against 340B participating hospitals’ Medicare reimbursement.[i] The District Court’s decision comes on the heels of the United States Supreme Court’s unanimous decision in American Hospital Association v.
D.C. District Court Rules HHS Will be in Charge of OPPS Repayments
On January 10, the United States District Court for the District of Columbia issued a long-awaited opinion which will allow the U.S. Department of Health and Human Services (HHS) to determine the means by which it will repay inappropriate cuts it levied against 340B participating hospitals’ Medicare reimbursement.[i] The District Court’s decision comes on the heels of the United States Supreme Court’s unanimous decision in American Hospital Association v. Becerra, 142 S.
Commentary: U.S. government must remove cannabis obstacles
This is because federal law prohibits financial institutions from providing banking services to cannabis businesses — even ones that are state-licensed. Most banks are hesitant to risk federal prosecution, which could shut smaller financial institutions down completely. Every problem has a solution, though, and thankfully, the federal government holds the key to solving this predicament through a commonsense piece of bipartisan legislation called the SAFE Banking Act.
340B Hospital Payment Cuts Unanimously Overturned By Supreme Court
On June 15, 2022, the Supreme Court of the United States released its long-awaited decision in American Hospital Association v. Becerra in which it unanimously held that the United States Department of Health and Human Services (HHS) overstepped its statutory authority by cutting 340B-related reimbursement to hospitals.
Small tax fix is big step forward for New York's cannabis industry
Buried in the recently approved 2022-23 budget is a seemingly small change that will have a big impact as New York seeks to establish one of the nation's most equitable cannabis programs.
Opinion: CT municipalities should opt-in to cannabis legalization Original
Connecticut has a proud tradition of home rule, deeply appropriate to The Constitution State. When leaders in Hartford finally removed the outmoded, top-down, state-level prohibition of adult cannabis use last year, Nutmeggers’ clear preference for direct, local control was reflected in the law their representatives passed. Today, the decision about where cannabis is accessed by adults 21 and older has been left to individual municipalities.
Opinion: CT municipalities should opt-in to cannabis legalization
Connecticut has a proud tradition of home rule, deeply appropriate to The Constitution State. When leaders in Hartford finally removed the outmoded, top-down, state-level prohibition of adult cannabis use last year, Nutmeggers’ clear preference for direct, local control was reflected in the law their representatives passed. Today, the decision about where cannabis is accessed by adults 21 and older has been left to individual municipalities.
CMS Plans to Regulate Pharmacy Benefit Manager DIR Fees
Legal Disclaimer You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
The Death of Chevron? Supreme Court Hears Oral Arguments on Medicare Cuts to 340B Reimbursement
Tuesday, December 7, 2021 On Nov. 30, 2021, the U.S. Supreme Court heard oral arguments from a coalition of hospital plaintiffs who are challenging Medicare’s nearly 30% reduction in outpatient drug reimbursement rates for 340B Program-participating hospitals.
Drug Enforcement Administration and Telepharmacy Practices
November 18, 2021 President Biden Nominates Andre B. Mathis to the Sixth Circuit by: Litigation Group Squire Patton Boggs Driving Value Before an M&A Transaction by: Robert L. Macklin A Shot in the Arm: Navigating the Evolving Federal Vaccine... by: Karen D. Adinolfi and Ericka L. Adler Corporate Transparency Act Expands Anti-Money Laundering Burden... by: Craig N. Landrum New Law Regulating Health Care Benefit Managers in Washington State by: Steven L.
HRSA Refers Six Drug Manufacturers to OIG for Possible 340B-Related Civil Penalties
September 22, 2021 Regulatory Fees for Unlicensed Users and Large Technology Companies? by: Laura A. Stefani Class Action Waivers Redux: Ninth Circuit Upholds Arbitration... by: Anna S. McLean and Michael A. Lundholm Top Five Labor Law Developments for August 2021 by: Jonathan J. Spitz and Richard F. Vitarelli Biden Administration Announces Changes to COVID-19 Travel Bans by: John F. Quill NO EVIDENCE PRECLUSION HERE: Court Allows Late Submission of Critical... by: Erin M.
Interagency Fraud Enforcement Action Highlights Telepharmacy Compliance Risks
February 03, 2021 Interagency Fraud Enforcement Action Highlights Telepharmacy... by: Bryan P. Murray and Todd W. Collis Congressional Investigations Preview for The 117th Congress: Unified... by: Barry M. Hartman and David C. Rybicki FERC Directs RTOs and ISOs to File Reports on Hybrid Resources by: Stephen Hug and Taylor M. Stuart WHD Releases Six New FLSA Opinion Letters in January 2021 Addressing... by: Carly Baratt and Adriana S.
HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts
Legal Disclaimer You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
HRSA Publishes Long-Awaited 340B Program Administrative Dispute Resolution Procedures
Tuesday, December 15, 2020 The U.S. Health Resources and Services Administration (HRSA) recently released a draft final rule (Final Rule) that establishes a binding administrative dispute resolution (ADR) process concerning drug costs under the Federal 340B Drug Discount Program (340B Program). As per its terms, the Final Rule will be formally published on Dec. 13, 2020 and will take effect on Jan. 13, 2021.
340B COVID-19 Updates: HRSA COVID-19 Resources and Regulatory Flexibility
Tuesday, March 31, 2020 As U.S. hospitals and health clinics continue preparing for novel coronavirus (COVID-19) patient surges, federal regulatory agencies are developing resources to help health care providers comply with myriad regulatory requirements.
Pennsylvania Health Insurers Must Cover Medication Synchronization Services Beginning July 2020
January 10, 2020 ESMA Issues SFTR Guidelines by: John Ahern and Carolyn H. Jackson Pennsylvania Health Insurers Must Cover Medication Synchronization... by: Bryan P. Murray 2019 Year in Review: Notable Changes in Law, Policy, and Enforcement... by: Vinay Bhupathy and Daniel R. Eliav Breaking TCPA News- It’s Happening! Supreme Court to Review TCPA on... by: Eric J. Troutman Fifth Money Laundering Directive Becomes Operational by: John Ahern and Carolyn H.
CMS Releases Bulletin Discussing Best Practices for Avoiding 340B Duplicate Discounts in Medicaid
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
Kentucky Proposed 340B Policy and Procedures Manual
Thursday, October 10, 2019 The Federal 340B Drug Discount Program (the “340B Program”) is a budget-neutral drug-pricing program that allows certain hospitals and clinics (“Covered Entities”) to buy discounted medication from drug manufacturers.1 Established in 1992, the 340B Program has grown to become a critical financial resource for safety-net health care providers across the United States, including disproportionate share hospitals, critical access hospitals, and sole community hospitals,...
Kentucky Proposed 340B Policy and Procedures Manual | Lexology
The Federal 340B Drug Discount Program (the “340B Program”) is a budget-neutral drug-pricing program that allows certain hospitals and clinics (“Covered Entities”) to buy discounted medication from drug manufacturers.1 Established in 1992, the 340B Program has grown to become a critical financial resource for safety-net health care providers across the United States, including disproportionate share hospitals, critical access hospitals, and sole community hospitals, as well as federally...
Pennsylvania Issues Pharmacy Compounding Regulations
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
FDA Targeting Increasing Regulations in Dietary Supplement Industry
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
340B Drug Ceiling Prices Now Available
Jennifer is a Partner in the Health Care Practice Group and leads the firm’s HIPAA Privacy and Security practice and initiatives. In her HIPAA practice, she works with clients to minimize the risk of privacy and data security issues, assisting with all aspects of HIPAA privacy and security compliance, governance, audits/investigations, breach analyses, training and strategic planning.
FDA Releases Medical Device De Novo Pathway Proposed Rule
You are responsible for reading, understanding and agreeing to the National Law Review's (NLR’s) and the National Law Forum LLC's Terms of Use and Privacy Policy before using the National Law Review website. The National Law Review is a free to use, no-log in database of legal and business articles. The content and links on www.NatLawReview.com are intended for general information purposes only.
FDA Proposes Changes to Clinical Trial Informed Consent Rules
Thursday, November 15, 2018 On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects.
Manufacturer CMP and 340B Ceiling Price Rule to Become Effective on January 1, 2019
Today the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (NPRM) that will end HRSA’s delays in implementing a January 5, 2017 final rule concerning 340B drug price calculations and civil monetary penalties (CMPs) against manufacturers who knowingly and intentionally overcharge 340B covered entities for 340B drugs (the Final Rule).
CMS Proposes to Reduce Medicare CoPs and CfCs Burdens
Proposed rule could eliminate many Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) On September 17, 2018, the Centers for Medicare and Medicaid Services (CMS) released an advance copy of a proposed regulation which aims to eliminate some of the Medicare Program’s Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) for certain Medicare providers.
OIG Considering Changes to Anti-kickback Statute and CMP Law
On August 27, 2018, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a request for information that seeks public input on aspects of the Federal Anti-kickback Statue (AKS) and Civil Monetary Penalties law (CMP) which may act as barriers to coordinated care and value-based health care services.
For a Woman Intent on Helping Others, Help Through Hard Days
In Haiti, where she spent her youth, she often fought peers and schoolmates who bullied her younger siblings. “My childhood was kind of hard. My parents were very strict, and worked all the time,” Ms. Laporte recalled. “Growing up, I would fight a lot, for my sisters and brothers, when we were very young.” Ms. Laporte, whose father was a carpenter and whose mother was a shop worker, also fought to keep her family afloat, cooking meals and caring for her siblings while her parents worked.
A Son’s Illness and a Mother’s Aspirations
Shiniqua Scott with her sons David Smith-Daye, left, 8, and Jolae Smith-Daye, 5. David has a rare genetic disease that requires chemotherapy and 25 pills a day. Five pills in the morning. Five pills at night. And 15 pills in the afternoon. That is the daily routine for Shiniqua Scott, 27, in caring for her oldest son, who is severely ill. Ms. Scott is a single mother of two boys, Jolae Smith-Daye, 5, and David Smith-Daye, 8, and lives with her four siblings and her mother in an apartment in the Bronx.
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