News & Analysis as of

Patients Prescription Drugs

Napoli Shkolnik

What Is Polypharmacy And Why Should You Care?

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Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more

Dentons

Ep. 4 - Ozempic, Wegovy, and the New Compliance Risks for Providers

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Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

Epstein Becker & Green

In Genesis Case, South Carolina District Court Scraps HRSA Interpretation of “Patient” Under 340B Statute

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On November 3, 2023, the United States District Court for the District of South Carolina issued its decision in the long-running dispute between Genesis Health Care Inc., a federally qualified health center and 340B-covered...more

Smart & Biggar

PMPRB publishes scoping paper for consultation on guidelines, and invites stakeholder feedback

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As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more

McDermott Will & Emery

This Week in 340B: November 2023

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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 of more than 50 340B cases to provide you with a quick...more

Quarles & Brady LLP

District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling

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In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

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On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Troutman Pepper

Georgia to Become First State in the Nation to Allow Medical Marijuana in Pharmacies

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The Georgia Board of Pharmacy has begun accepting applications from independent, licensed pharmacies for authorization to dispense authorized medical marijuana products, and nearly 120 pharmacies reportedly have agreed to...more

McDermott Will & Emery

This Week in 340B: September 2023 #3

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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 of more than 50 340B cases to provide you with a quick...more

Sheppard Mullin Richter & Hampton LLP

PBM Practices Receive Increased Federal Scrutiny

Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers...more

McDermott Will & Emery

This Week in 340B: February 2023

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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

Bass, Berry & Sims PLC

Federal District Court Vacates Copay Accumulator Adjustment Rule: Programs Remain the Same for Now

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On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more

McDermott Will & Emery

HRSA Filings in Genesis Shed Light on Definition of “Patient” for 340B Covered Entities

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A recent case before the US Court of Appeals for the Fourth Circuit addressed the issue of which persons qualify as “patients” of a 340B program participating entity (covered entity). Court-ordered filings in ongoing...more

Faegre Drinker Biddle & Reath LLP

Ninth Circuit Asks California Supreme Court to Clarify the Causation Standard Applicable When the Learned Intermediary Doctrine...

How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff...more

Foley Hoag LLP - Medicaid and the Law

Oregon’s New Waiver Request to Exclude Accelerated Approval Drugs from Medicaid Coverage

Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the...more

Bass, Berry & Sims PLC

Kentucky Federal Court Temporarily Bars CVS from Imposing Block on Interventional Pain Doctor’s Prescriptions

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In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more

Baker Donelson

OIG Allows Pharmaceutical Manufacturer to Provide Financial Assistance for Travel, Lodging and Other Expenses to Certain Patients...

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A pharmaceutical manufacturer has received a green light from the Office of Inspector General (OIG) to provide financial assistance for travel, lodging and other expenses to certain patients prescribed the manufacturer's...more

Sheppard Mullin Richter & Hampton LLP

Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts...more

Sheppard Mullin Richter & Hampton LLP

The Next in the Series of Executive Orders Affecting the Pharmaceutical Industry

On Sunday, September 13, 2020, President Trump signed an Executive Order, the next in a series of Executive Orders targeting the pharmaceutical industry, which aims to lower prescription drug prices in the United States (the...more

Steptoe & Johnson PLLC

FDA Recommends Naloxone Prescription for Patients Receiving Opioids or Medications Used to Treat Substance Use Disorder

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In an attempt to reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (“FDA”) issued a Drug Safety Communication recommending that providers discuss the availability of Naloxone, the opioid...more

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

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In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Robinson+Cole Health Law Diagnosis

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more

Robinson+Cole Health Law Diagnosis

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

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