Pharmacies, wholesalers, third-party logistics providers, outsourcing facilities, clinics, and pharmacists must obtain the California State Board of Pharmacy’s (the “Board”) approval or otherwise notify the Board about...more
9/6/2024
/ Business Entities ,
California ,
Change of Ownership ,
Compliance ,
Licensees ,
Licenses ,
Notification Requirements ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacist ,
Prescription Drugs ,
Reporting Requirements
The 340B Drug Program requires pharmaceutical manufacturers participating in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care organizations and programs, referred...more
Introduction -
Pharmacy employees at some CVS and Walgreens stores, including pharmacists, technicians, and support staff, recently walked off of their jobs to protest insufficient staffing and dangerous workloads that they...more
Federally Qualified Health Centers (FQHCs) are required to provide all required primary, preventive, and enabling health services as well as additional health services as appropriate and necessary – either directly or through...more
In OIG Advisory Opinion 22-17, the U.S. Department of Health and Human Services (H.H.S.) Office of Inspector General (OIG) analyzed a proposal whereby a regional non-profit health system would forgive debt owed by a federally...more
On July 20, 2022, the United States Department of Justice (the DOJ) announced charges against multiple defendants alleging fraudulent schemes (including telemedicine arrangements) totaling more than $1.2 billion. That same...more
8/3/2022
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
OIG ,
Telehealth ,
Telemedicine
Telehealth—the provision and coordination of healthcare remotely by means of telecommunications technology—is now an essential tool in the delivery of health care services. The COVID-19 pandemic created an incentive for...more
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
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
Family Health Centers of San Diego (Health Center) operates a federally qualified health center (FQHC) that has 49 locations throughout San Diego County, California, and provides a comprehensive range of primary and...more
Federally Qualified Health Centers (FQHCs) deliver care to some of the nation's most vulnerable individuals and families, including federal Medicare and Medicaid health care program beneficiaries. As safety net providers,...more
2/23/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Digital Health ,
FQHC ,
Gifts ,
Health Care Providers ,
New Guidance ,
OIG ,
Safe Harbors ,
Value-Based Care
The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more
1/7/2021
/ Administrative Proceedings ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Filing Requirements ,
Final Rules ,
HRSA ,
Manufacturers ,
Office of Pharmacy Affairs (OPA) ,
Pharmacies ,
Section 340B
Compliance with prescription drug controlled substances prescribing and dispensing rules is essential for pharmacies and prescribers, as penalties for non-compliance are severe and can result in State Board of Pharmacy and...more
11/20/2020
/ Business & Professions Code ,
Controlled Substances ,
DEA ,
Department of Justice (DOJ) ,
Electronic Prescribing ,
Health and Safety ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reporting Requirements
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
As detailed in a press release from the U.S. Department of Health and Human Services (HHS), "Metropolitan Community Health Services, doing business as Agape Health Services (Metro), has agreed to pay $25,000 to the U. S....more
8/27/2020
/ Compliance ,
Compliance Monitoring ,
Corrective Action Plans (CAPs) ,
Covered Entities ,
Electronic Protected Health Information (ePHI) ,
Failure To Implement ,
FQHC ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
OCR ,
Risk Assessment ,
Risk Management ,
Settlement
On July 20, 2020, the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued the OPA Program Update 2020. In addition to adopting new Covered Entity registration and recertification...more
8/18/2020
/ Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Health Clinics ,
Hospitals ,
HRSA ,
Medicaid ,
Medicare ,
Office of Pharmacy Affairs (OPA) ,
Office of Pharmacy Affairs Information System (OPAIS) ,
Pharmacies ,
Prescription Drug Coverage ,
Recertification ,
Registration Requirement ,
Section 340B
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
5/18/2020
/ Centers for Disease Control and Prevention (CDC) ,
Contact Tracing ,
Coronavirus/COVID-19 ,
Employee Training ,
Employer Liability Issues ,
Employment Litigation ,
Health Care Providers ,
Infectious Diseases ,
OSHA ,
Personal Protective Equipment ,
Pharmacies ,
Policies and Procedures ,
Public Safety ,
Risk Mitigation ,
Sick Customers ,
Sick Employees ,
Social Distancing ,
Telehealth ,
Virus Testing ,
Workplace Decontamination ,
Workplace Safety
The Drug Enforcement Agency (DEA) recently published guidance relating to the COVID-19 public health emergency, including the ability to prescribe controlled substances via telemedicine without a prior in-person exam;...more
On March 24, 2020, Health Resources & Services Administration (HRSA) released newly updated Novel Coronavirus (COVID-19) Frequently Asked Questions (FAQs), which outline multiple COVID-19 related issues for federally...more
The Coronavirus Preparedness and Response Supplemental Appropriations Act (the "Act") includes a provision allowing the U.S. Department of Health and Human Services (HHS) to waive certain Medicare telehealth payment...more
In response to the federal and state declarations of public health emergencies surrounding the COVID-19 pandemic, the California State Board of Pharmacy has issued the following waivers to California Board of Pharmacy...more
A HIPAA Business Associate ("Business Associate") is an individual or entity who performs or furnishes activity or service for or on behalf of a HIPAA Covered Entity ("Covered Entity") involving the use or disclosure of...more
The Centers for Medicare & Medicaid Services (CMS) recently revised regulations (the "Regulations") for the Programs of All-Inclusive Care for the Elderly (PACE), making significant changes to ownership restrictions,...more
The California Department of Managed Health Care (the "DMHC"), which regulates Health Care Service Plans, recently adopted a regulation regarding general licensure requirements for health care providers ("Entities") that...more
State Boards of Pharmacy are responsible for protecting the health, safety and welfare of the public by regulating the legal distribution of prescription drugs in their respective states, and ensuring the quality of all drugs...more