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Health Care Providers Pharmaceutical Industry Final Rules

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Manatt, Phelps & Phillips, LLP

Changes to the Substance Use Disorder Confidentiality Regulation: Implications for Stakeholders

Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more

Polsinelli

New SAMHSA Rule Expands Access to Medications for the Treatment of Opioid Use Disorder

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On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes...more

McDermott Will & Emery

Trending in Telehealth: January 4 – 15, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McGuireWoods Consulting

Washington Healthcare Update - September 2023 #2

This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to...more

McDermott Will & Emery

CMS Issues Broad-Ranging Medicare Advantage and Part D Proposed Rule

On December 14, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding Contract Year 2024 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - November 2021

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Drug Pricing Initiatives: Late on Nov. 5, 2021, the House of Representatives passed H.R. 3684 (the Infrastructure Investment and Jobs Act). This $1 trillion infrastructure bill, which was passed earlier by the Senate, is part...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Wiley Rein LLP

Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?

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In part two, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander continue their discussion of the Most-Favored Nations (MFN) Rule and the Rebate Rule and look at the potential impacts of these Final...more

Wiley Rein LLP

Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?

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In part one, Wiley Health Care Practice partners Dot Powell-Woodson and Rachel Alexander break down the background, substance, and procedural issues of the two Final Drug Pricing Rules released on November 30, 2020: the...more

Katten Muchin Rosenman LLP

FDA Reduces Regulatory Uncertainty with New Finalized Rule Defining "Biological Product" under BPCIA to Include Insulin and Other...

Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more

King & Spalding

HHS Issues Final Rule Requiring Disclosure of Partial Refills of Prescriptions to Help Curb Opioid Abuse

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On January 23, 2020, HHS issued its final rule adopting a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D.0, National Council for Prescription Drug Programs...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Manifesting Non-Creditable Hazardous Waste Pharmaceuticals/New Four Character Code: U.S. Environmental Protection Agency RCRA...

The United States Environmental Agency (“EPA”) released December 19, 2019 interpretive guidance titled: Manifesting Non-Creditable Hazardous Waste Pharmaceuticals – New Four Character Code (“Guidance”) - The document...more

K&L Gates LLP

K&L Gates Triage: Looking Ahead to 2020: Developing Issues in Pharmacy Law and the 340B Drug Pricing Program

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In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more

Sheppard Mullin Richter & Hampton LLP

340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information...

Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”),...more

Polsinelli

CMS Issues New Final Rule on Pricing Transparency

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On November 15, CMS issued the Price Transparency Requirements for Hospitals to Make Standards Charges Public Final Rule (“Final Rule”), as directed by President Donald Trump’s Executive Order on Improving Price and Quality...more

Polsinelli

CMS Delays Price Transparency, Doubles Down on Site-Neutral and 340B Payment Policies in CY 2020 OPPS Final Rule

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Late last week, the Centers for Medicare & Medicaid Services (“CMS”) released the CY 2020 Hospital Outpatient Prospective Payment System (“OPPS”) final rule [CMS-1717-FC]. While many hospitals had hoped for relief from recent...more

K&L Gates LLP

K&L Gates Triage: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

K&L Gates LLP on

In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more

Epstein Becker & Green

State Implementation of New EPA Standards for Maintenance of Hazardous Waste Pharmaceuticals: Drug Supply Chain Implications

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Earlier this year, the Environment Protection Agency (“EPA”) adopted a final rule imposing new standards for the management of hazardous waste pharmaceuticals (“HWPs”) that goes into effect on August 21, 2019 (“Final Rule”)....more

Holland & Knight LLP

Healthcare Law Update: July 2019

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CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

Mintz - Health Care Viewpoints

ML Strategies Health Care Preview - May 2019 #4

We are a few legislative days from the Memorial Day recess with the trajectory of issues like drug pricing and surprise medical billing still emerging. The House has passed several drug pricing bills in the past month, with...more

Holland & Hart LLP

New EPA Pharmaceutical Hazardous Waste Rule Finalized

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On February 22, 2019, EPA published its final rule governing standards for the management of pharmaceutical hazardous wastes in the Federal Register (Final Rule). The Final Rule’s publication in the Federal Register sets...more

K&L Gates LLP

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

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As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

Sheppard Mullin Richter & Hampton LLP

340B Drug Pricing Program Litigation Update: Court Rejects CMS Drug Pricing Cuts

On December 27, 2018, the U.S. District Court for the District of Columbia issued an opinion that ruled against the Trump Administration in its plan to cut funding from the 340B Drug Pricing Program (“340B Program”). ...more

Foley & Lardner LLP

Medication or Hazardous Waste? EPA Creates Significant New Requirements for Managing Unused Pharmaceuticals

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On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent...more

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