News & Analysis as of

Pharmacies

Corporate Actors Held Individually Accountable in Recent False Claims Act Settlement

The Department of Justice (“DOJ”) has sent a clear message that individuals cannot hide behind the corporate shield in its recent settlement with Med-Fast Pharmacy, Inc. and the charges brought against its associated...more

Pharmacy Chain Not Required To Reasonably Accommodate Needle-Phobic Pharmacist

by Farrell Fritz, P.C. on

Trypanophobia—the fear of needles—played a significant role in a case brought against Rite Aid Pharmacy under the Americans with Disabilities Act (ADA). In Stevens v. Rite Aid Corp., the Second Circuit overturned a jury...more

CMS Completes Final Medicare Part D Reconciliation for 2016

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more

HRSA delays 340B CMP and Ceiling Price Rule to July 1, 2018 and intends to reopen rulemaking

by Hogan Lovells on

Last week, the Health Resources and Services Administration (HRSA) issued a Final Rule delaying the effective date and the enforcement date of the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties Rule (the...more

Pharmacy Chain's Benefit Program Gets OIG Approval in Advisory Opinion 17-05

by Baker Ober Health Law on

The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more

OIG Signs Up for Customer Loyalty Program

by BakerHostetler on

In Advisory Opinion 17-05, posted by the U.S. Department of Health and Human Services Office of Inspector General (OIG) on September 7, 2017, the OIG approved a pharmacy’s customer loyalty/discount program (Benefit Program)....more

FDA Clarifies Trading Partners Under the DSCSA

by Reed Smith on

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with...more

OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program...

by Dorsey & Whitney LLP on

On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more

OIG Issues Advisory Opinion to Pharmacy

On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid...more

Summer Is Over...Time For Connecticut Health Care Providers To Get Up To Speed On Recent Changes

by Murtha Cullina on

Although much of the latest Connecticut legislative session focused on the budget, and while fewer health care bills passed than we have grown accustomed to in recent years, we still ended up with a number of public acts...more

Specialty Pharmacy's Antitrust Claim against Humana Fails

by Baker Ober Health Law on

On August 9, District Judge Susan Wigenton (D. NJ) issued a ruling in Prime Aid Pharmacy v. Humana, Civ. No. 16-2104, granting Humana's motion to dismiss the plaintiff's Second Amended Complaint, finding that the plaintiff...more

Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse

by Arnall Golden Gregory LLP on

On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The...more

Opioid Epidemic Declared a National Emergency; Proposed Law Calls for Mandatory E-Prescribing of Controlled Substances to Curb...

by Dorsey & Whitney LLP on

Today, in a move that is widely supported by those in both political parties and across the country, President Trump declared the opioid epidemic a national emergency. Doing so will allow for additional resources to be used...more

Compounding Pharmacies Should Expect Greater Scrutiny as Government Healthcare Budgets Get Squeezed

by Blank Rome LLP on

As Congress continues to grapple over healthcare reform, there are many uncertainties. However, one thing is clear: as government healthcare funding shrinks, federal and state enforcement agencies will continue to target...more

Italy opens the door to corporate ownership of pharmacies – a revolution for the Italian Pharma distribution

by Hogan Lovells on

By Law passed today, August 2nd, 2017 (Law for the improvement of the competition on the market), further to a recommendation of the Italian Competition Authority (“ICA“), the Italian legislature enacted provisions for the...more

A Candidate Named Sue (or Maybe Regina)? Tread Carefully With the Litigious Job Applicant

When is it safe to take action against an employee (or a former employee) who filed an EEOC charge against you? As the 7th Circuit just found in Baines v. Walgreen Co., you can never –REPEAT, NEVER – take action because an...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

DOJ and OIG Focus on Opioid Abuse: Medical Professionals Who Overprescribe May Be Targets

by Foley & Lardner LLP on

Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal...more

As Feds Talk, States Act: A Survey of Recent State Actions to Rein in Drug Prices

by Faegre Baker Daniels on

While Congress and the White House continue to make statements about the need to rein in drug costs, several states are enacting legislation or regulations that offer the greatest opportunity to remake practices that are...more

New Maine Law Limits Manufacturer and Wholesaler Interactions with Health Care Professionals

by McDermott Will & Emery on

Maine recently amended its Pharmacy Practice Act to prevent licensed manufacturers or wholesalers and their agents from offering or giving certain gifts to practitioners. The bill’s sponsor tied the issue of gifts from...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Public Act 17-241 — An Act Concerning Fairness in Pharmacy and Pharmacy Benefits Manager Contracts

by Robinson & Cole LLP on

Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and...more

Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online...more

New Mexico Wrongful Conduct Rule Shuts Down Opioid Case Against Pharmacist

by Reed Smith on

New Mexico is called the Land of Enchantment, but when it comes to law it is the Land of You Can’t Make this Up. You might think it weird that New Mexico’s state constitution (Article VII, section 1) specifies that idiots...more

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update,...

by Jones Day on

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget ("OMB") Director Mick Mulvaney prompting him to work with the Department of...more

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