Mazina Law

California pharmacies sue OptumRx

By Natalia Mazina

September 22, 2020

Last week, California pharmacies filed a legal action against OptumRx alleging patient steering and violations of California law by paying low reimbursement rates. Independent pharmacies allege that OptumRx is paying them substantially less than to chain pharmacies and Optum’s mail-order pharmacy for the same prescriptions. Pharmacies also complain that OptumRx reimburses them below acquisition cost. Mark Cuker from Jacobs Law Group represents the pharmacies. This is not the first case filed by Mark, in which…

Pharmacy & Healthcare Legal Blog

When applying manufacturer’s coupons could get a pharmacy in trouble

By Natalia Mazina

September 16, 2020

It is not uncommon for pharmacies to apply manufacturer’s coupons to assist patients with high deductibles. But when applied incorrectly, the pharmacy may face recoupments, audits/investigations, and large settlements as recent cases illustrate. The U.S. Attorney’s Office has recently reached a $3.5 million settlement with specialty pharmacy Advanced Care Scripts, Inc. (ACS), to resolve allegations that it conspired with Teva for paying kickbacks to Medicare patients taking Copaxone (a Teva drug approved for treatment of…

Pharmacy & Healthcare Legal Blog

Manufacturers exiting 340b program

By Natalia Mazina

September 9, 2020

Since the inception of the 340b program, drug manufacturers have been attempting to curtail it to avoid offering discounts or to prevent double discounts (which occurs when a 340b drug is billed to a Medicaid program). This year, however, there were multiple coordinated attempts by manufacturers to exit the program. For example: AstraZeneca will stop offering 340b discounts to on-site hospital pharmacies starting October 1, 2020. Eli Lilly will no longer offer 340b discounts on…

Pharmacy & Healthcare Legal Blog

Federal law now allows pharmacies to vaccinate children

By Natalia Mazina

August 31, 2020

The U.S. Department of Health and Human Services (HHS) has issued an amendment to the Public Readiness and Emergency Preparedness Act (PREPA) allowing pharmacies to perform vaccination to children ages three through 18 as per ACIP’s standard immunization schedule. In July, 2020, Centers for Disease Control and Prevention (CDC) conducted a survey to assess the capacity of pediatric health care practices to provide immunization services to children during the COVID-19. The survey showed that 21.3…

Pharmacy & Healthcare Legal Blog

Executive order on ensuring essential medicines are made in the U.S.

By Natalia Mazina

August 24, 2020

This month, President Trump signed an executive order mandating that certain drugs and medical supplies purchased by federal agencies are U.S.-manufactured. The objective of the order is to reduce our dependence on foreign manufacturers for “Essential Medicines, Medical Countermeasures, and Critical Inputs” to ensure sufficient and reliable long-term domestic production of these products. The order is apparently aimed at plugging gaps in the medical supply chain that have been revealed during the coronavirus crisis. (By…

Pharmacy & Healthcare Legal Blog

Importance of accurately reporting Usual and Customary Drug Prices

By Natalia Mazina

August 19, 2020

Recently, we have seen many cases filed by whistleblowers against pharmacies for not properly reporting their Usual-and-Customary Drug Prices (U&C). The cases are usually filed under the False Claims Act (FCA) for manipulating U&C to receive greater reimbursements from government payors. First of all, what is U&C? There is no uniform definition. Instead, third-party payor contracts and Medicaid state statutes define U&C, which is usually the lowest net price a cash patient would have paid…

Pharmacy & Healthcare Legal Blog

When pharmacy’s attempts to make money result in big trouble.

By Natalia Mazina

August 11, 2020

Due to low reimbursement rates, many pharmacies are struggling to maintain their profit margins. Some turn to specialty medications, some convert into veterinary pharmacies, and some close their doors to retail patients and start working with long-term care facilities. And there is a category of pharmacies that step into the murky waters of adjusting patient therapies in favor of their bottom lines. Such practices, however, may cost more in the long run than any potential…

Pharmacy & Healthcare Legal Blog

New proposed DEA rules. Increased registration fees and a 15-day reporting requirement.

By Natalia Mazina

August 3, 2020

Last week, DEA proposed two new rules regarding (1) reporting theft or significant loss of controlled substances and (2) registration fees. 1. 15-day requirement for reporting drug loss or theft. This proposed rule would amend DEA regulations regarding Form-106, used by the registrants to report thefts or significant losses of controlled substances, to clarify that all such forms must be submitted electronically. In addition, the proposed rule would add new requirements for the form…

Pharmacy & Healthcare Legal Blog

Unverified licensure could cost your pharmacy millions of dollars

By Natalia Mazina

July 28, 2020

While this is not a new case, nevertheless it must be revisited to remind the importance of verifying all licensure, credentials, and records of pharmacy employees. This straightforward and easy step could potentially save pharmacies millions of dollars, as this case and many enforcement actions illustrate. Earlier this year, Walgreens agreed to pay $7.5 million to resolve a lawsuit contending that the company allowed an unlicensed employee to handle over 745,000 prescriptions. For over 15…

Pharmacy & Healthcare Legal Blog

Does a Medicare-Part-B Contract Add Value to my Pharmacy?

By Natalia Mazina

July 20, 2020

Many pharmacy owners wonder if contracting with Medicare directly (as a Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (“DMEPOS”) provider) adds value to a pharmacy business. The answer depends on whether the sale of the pharmacy is structured as an asset or a stock purchase. Asset purchase To become a DMEPOS provider under Medicare Part B, a pharmacy must obtain accreditation, post a surety bond, and obtain a Medicare contract by filing form CMS-855S. (The…

Mazina Law

Mazina Law Blogs

Blog Authors

California pharmacies sue OptumRx

When applying manufacturer’s coupons could get a pharmacy in trouble

Manufacturers exiting 340b program

Federal law now allows pharmacies to vaccinate children

Executive order on ensuring essential medicines are made in the U.S.

Importance of accurately reporting Usual and Customary Drug Prices

When pharmacy’s attempts to make money result in big trouble.

New proposed DEA rules. Increased registration fees and a 15-day reporting requirement.

Unverified licensure could cost your pharmacy millions of dollars

Does a Medicare-Part-B Contract Add Value to my Pharmacy?

Stay Connected

Company

Products

Support

New to the Network

Mazina Law Blogs

Blog Authors

Latest from Mazina Law