News & Analysis as of

Physicians Health Care Providers Pharmacies

Marshall Dennehey

Pharmacy Staffed by Pharmacist Provided by an Employee Leasing Agency is a Provider as Defined by Section 109 of the Act. When a...

Marshall Dennehey on

700 Pharmacy v. Bureau of Workers’ Compensation Fee Review Hearing Office & SWIF; No. 660 C.D. 2020; No. 617 C.D. 2020; filed May 16, 2024; President Judge Cohn-Jubelirer - In this case, 700 Pharmacy filed five Fee Review...more

Epstein Becker & Green

The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care

Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q2 2023

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There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023.  Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

Womble Bond Dickinson

[Webinar] First Annual Health Care Fraud Symposium - March 14th, 12:00 pm - 1:30 pm ET

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Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more

Bass, Berry & Sims PLC

Healthcare Transactions Q2 2022

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With some exceptions, healthcare M&A activity is down this year compared to the record-breaking highs of 2021. Those exceptions include the hospital sector, which is still seeing fewer but significantly larger (i.e., billion...more

Bass, Berry & Sims PLC

Summary of Medicare Drug Negotiation Program in Inflation Reduction Act and Impact on Pharmacies and Providers

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The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - December 2021

In this season of goodwill, gratitude, and giving, it's worth considering that both friends and strangers can have medical needs that we can ease with little pain or inconvenience to ourselves. Here's a sampling of five ways...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 21, Number 6. Privacy Briefs: June 2021

Report on Patient Privacy 21, no. 6 (June 2021) - Scripps Health in San Diego experienced what it called “an information technology security incident” from ransomware that was detected May 1, forcing some of its operations...more

Patrick Malone & Associates P.C. | DC Injury...

U.S. ends confusion and expands prescribing of opioid-fighting medication

Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine,...more

McDermott Will & Emery

340B in 2021: What Covered Entities and Their Partners Need to Know Now

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Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

McDermott Will & Emery

[Webinar] 340B in 2021: What Covered Entities and Their Partners Need to Know Now - March 18th, 2:00 pm - 3:00 pm ET

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This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow. Our...more

Oberheiden P.C.

Eight Keys to Developing an OIG Compliance Program for Hospitals

Oberheiden P.C. on

The Office of Inspector General is a division of the U.S. Department of Health and Human Services that is tasked with combating fraud committed against Medicare, Medicaid, and other federally funded government programs. The...more

ArentFox Schiff

February 2021 Update: California Department of Consumer Affairs Extends and Issues Additional Healthcare Professional Licensing...

ArentFox Schiff on

This is the latest in a series of articles discussing selected updates to the Department of Consumer Affairs’ (DCA) waivers issued in response to Governor Newsom’s March 30, 2020 Executive Order N-39-20, which authorized the...more

Patrick Malone & Associates P.C. | DC Injury...

Consultant to pay $573.9 million as consequence of its sketchy opioid advice

The opioid abuse and drug overdose crisis has tarred yet another of the nation’s business titans: McKinsey, a globally renowned consulting firm, has discovered that providing corporate clients sketchy advice about addictive,...more

Bass, Berry & Sims PLC

Key Takeaways from Bass, Berry & Sims Connect During the Annual J.P. Morgan Healthcare Conference

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For the fifth consecutive year, the Bass, Berry & Sims Healthcare Private Equity Team hosted BBS Connect, a forum to connect healthcare dealmakers during the annual J.P. Morgan Healthcare Conference. Over three days –...more

Epstein Becker & Green

Finalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge

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On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more

Patrick Malone & Associates P.C. | DC Injury...

U.S. suit accuses Walmart of fueling deadly opioid crisis via its pharmacies

The stain of the nation’s opioid abuse and drug overdose crisis has spread now to Bentonville, Ark., as federal prosecutors have sued Walmart, accusing the nation’s largest retailer of improperly allowing its pharmacists to...more

Epstein Becker & Green

HHS’s Efforts to Reduce Prescription Drug Prices and Transition to Value-Based Care – Part 1: CMS and OIG Issue a Series of Final...

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In a completely unexpected move, on November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) published advance...more

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

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On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

Health Care Compliance Association (HCCA)

CMS Hikes Payment for COVID-19 Inpatients Treated With New Drugs, Links it to 20% Bonus

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Regional Healthcare Compliance Conference - Indianapolis, IN - September 25th, 8:30 am - 4:30 pm EDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Smart & Biggar

Health Canada amends Drug Sampling Laws and issues Guidance (effective July 1, 2020)

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Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more

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