News & Analysis as of

Pharmacies Policies and Procedures

Cozen O'Connor

California AG Sends Letters Reminding Pharmacies and Health Data Companies of Consumer Privacy Obligations

Cozen O'Connor on

California AG Rob Bonta issued letters to eight large pharmacy chains and five health data companies reminding the companies of their obligations to comply with California’s Confidentiality of Medical Information Act (CMIA)...more

Guidepost Solutions LLC

Navigating the DEA Registration Application Process

Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare...more

WilmerHale

FTC Brings First of its Kind Enforcement Action against GoodRx for Violating the Health Breach Notification Rule

WilmerHale on

On February 1, 2023, the Federal Trade Commission (FTC) reached a settlement with digital health platform GoodRx for sharing users’ personal health information with third parties without properly disclosing their data...more

Bass, Berry & Sims PLC

Third Circuit Ruling Allows Restrictions on 340B Contract Pharmacies

On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more

Hinshaw & Culbertson - Health Care

Laboratory Testing Presents Business Opportunities for Community Pharmacies

The role of community pharmacies in health care has evolved and expanded in recent years. Many community pharmacies now offer health and wellness services related to identifying, preventing, and monitoring acute and chronic...more

Hinshaw & Culbertson - Health Care

New California Law Prohibits Chain Community Pharmacy Productivity Quotas for Pharmacists and Pharmacy Technicians

Last year, The New York Times published an article titled "How Chaos At Chain Pharmacies Is Putting Patients At Risk." The article described how many pharmacists in large chain pharmacies "struggle to fill prescriptions, give...more

Oberheiden P.C.

The Importance of a Pharmacy Compliance Program

Oberheiden P.C. on

As federal agencies and law enforcement investigate pharmacies around the country for health care fraud and kickback schemes, pharmacies should be proactive in understanding their regulatory environment and the importance 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

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

Hinshaw & Culbertson - Health Care

California Board of Pharmacy Approves "No Pharmacist Left Alone" Regulations for Retail Pharmacy Chains

In retail pharmacy chain stores, pharmacists are sometimes left alone for long periods of time. Pharmacists at such chains—which are also known as community pharmacies—have also had to perform a number of non-pharmacist...more

Oberheiden P.C.

Pharmacy Compliance: Will Your Pharmacy’s Policies and Protocols Withstand a DEA or PBM Audit?

Oberheiden P.C. on

Compliance is a key aspect of operating a successful pharmacy in the United States. This is true for pharmacies that bill federal healthcare benefit programs (i.e. Medicare, Medicaid, and Tricare) as well as private payors,...more

Baker Donelson

HRSA Eliminates Delay in Use of 340B Drugs in New Hospital Clinic Locations

Baker Donelson on

The Health Resources and Services Administration (HRSA) has issued guidance eliminating a longstanding enforcement position that delayed the ability of hospitals participating in the 340B drug pricing program to use...more

Hinshaw & Culbertson - Health Care

Guidance for Protecting Pharmacy Staff and Customers from COVID-19

Employees concerned about their workplace safety amidst the COVID-19 pandemic recently filed a legal action against their employer (Smithfield Foods) seeking a court order that would require the company to comply with Centers...more

Akerman LLP - Health Law Rx

Managing the Healthcare Workplace During the COVID-19 Outbreak

Healthcare providers have special concerns for their employees during the Coronavirus (COVID-19) global health emergency....more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - March 2020 #5

Today was all about the numbers - State spending and revenue as well as the increasing count of Georgians diagnosed with the novel coronavirus. The House Appropriations Committee voted out its version of HB 793, the state’s...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - February 2020 #6

The cold rain in Atlanta threw no cold water on legislative action today as the General Assembly convened for Legislative Day 15. The House and Senate each took up a handful of measures on their respective floors, including...more

Smart & Biggar

CADTH releases Environmental Scan on International Policies on Use of Biosimilars

Smart & Biggar on

In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines...more

Holland & Knight LLP

CMS Releases the 2019 MPFS and QPP Final Rules

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS), which includes provisions related to Medicare physician payments as well...more

McDermott Will & Emery

OCR Enforcement Trends

On April 27, 2015, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Cornell Prescription Pharmacy (CPP) pursuant to which CPP paid a $125,000...more

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