Pharmacies

News & Analysis as of

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

A “Too Old” OTC Product Does Not A Class Action Make

This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy. We volunteered to photograph the event, because the usual photographer was not able to attend. And...more

The Deeper Dive: C-Suite to Prison Pipeline

In recent years, the U.S. Department of Justice (DOJ) has been criticized for failing to prosecute executives for fraud, particularly in the financial sector. In response, the DOJ has begun to more heavily emphasize...more

Health Update - June 2015

Examining Fee Splitting Statutes in the Context of Value-Based Healthcare - Editor’s note: One of the goals of the Affordable Care Act (ACA) is to align incentives among provider communities and their patients and...more

Health Alert (Australia) - June 22, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria. Inquest Into the Death of Baby Chloe Lee Kellett - The Victorian Coroner investigated an infant's death from...more

News from Second and State

The week started out a little sluggishly. While the typical cache of committees met on Monday – Senate Appropriations, Senate Rules, House Appropriations – the floor was relatively quiet. However, things picked up on Tuesday,...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

Dentists Who Write Prescriptions Must Make a Decision: Enroll in Medicare or Opt-Out

If you are a dentist who writes prescriptions to Medicare beneficiaries for drugs covered under Medicare Part D, this article contains important information for you and your patients regarding your new enrollment requirements...more

OIG Work Plan Midyear Update Adds Activities Related to Medicare Part D and Medicaid Rebates

The update to the Fiscal Year 2015 Annual Work Plan includes new initiatives that may affect pharmaceutical companies and Medicare Part D payors and pharmacies. Annually, the Department of Health and Human Services...more

News from Second and State

On Monday, the House Children and Youth Committee sent H.B. 1276 (Watson, R-Bucks) to the House floor for a vote. The bill would remedy some of the issues arising as county and state agencies implement last year’s amendments...more

News from Second and State

Monday marked one month until a state budget must be passed. While it’s hard to say whether we’re any closer to enactment of a balanced state spending plan, there was some budget-related activity in the state legislature this...more

Doing Business In Connecticut? There's A New Data Security Law You Should Get To Know

This week the Connecticut House of Representatives passed Senate Bill 949, "An Act Improving Data Security and Agency Effectiveness," (the "Act") which includes new or modified State requirements concerning the security of...more

Pharmacy Board Proposed Regulations: The Next Step for Telemedicine in North Carolina

The future of telemedicine has become a hot topic in the health care industry nationwide, and the momentum seems to be in telemedicine’ s favor. Indeed, the North Carolina Medical Board recently issued revised policy...more

Health Alert (Australia) - May 25, 2015

In This Issue: Judgments; Legislation; and Reports & Publications. Excerpt from Reports: Australian Medical Association (AMA) - 19 May 2015 - $19 billion pharmacy deal sign of skewed health...more

Healthcare Fraud Initiatives in 2015

In order to predict what 2015 will look like in the war against health care fraud, it is necessary to quickly review what happened in 2014. In 2014, the government’s health care fraud prevention and enforcement efforts...more

Court Report - May 2015 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Pharma, Inc. et al. v. Actavis Laboratories FL., Inc. et al. 3:15-cv-03322; filed May 13, 2015 in the District...more

OCR Announces Settlement and Corrective Action Plan with Pharmacy Stemming from Alleged Violations

On April 24, 2015, the HHS Office for Civil Rights (“OCR”) once again stressed the importance of properly disposing of protected health information (“PHI”) when it announced its settlement and corrective action plan with...more

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more

Compounding Pharmacies Protected by Medical Liability Act

In a court decision holding that a compounding pharmacy is entitled to certain protections against medical malpractice claims, the Supreme Court of Texas established a precedent that may well prove valuable to pharmacists...more

CMS Issues Interim Final Rule Reaffirming Requirements for Prescribers of Part D Drugs

The Centers for Medicare & Medicaid Services (CMS) on May 6, 2015, published an interim final rule with comment period (Interim Rule) modifying the regulatory requirement that health care professionals enroll in or opt out of...more

Pharmacy Settles HIPAA Investigation for $125,000

On April 22, 2015, the Office for Civil Rights (OCR) entered into its first HIPAA violation settlement in 2015. The settlement requires Cornell Prescription Pharmacy, a small pharmacy located in the Denver area to pay the OCR...more

CMS Amends Medicare Part D Program Integrity Regulations to Facilitate Beneficiary Access and Expand Coverage for Pharmacist...

On May 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule with comment period (“IFC”) that amends Medicare program integrity regulations requiring prescribers to either enroll in...more

Changes to the regulation of pharmaceutical business in Kazakhstan: implications for pharmaceutical companies

A significant number of amendments have been introduced to the Healthcare Code* of the Republic of Kazakhstan on 6 April 2015 by the adoption of the Law On Introduction of Amendments and Additions to Certain Legal Acts of the...more

Health Alert (Australia) - May 4, 2015

In This Issue: Judgments; Legislation; and Reports & Publications. Excerpt from Reports & Publications: Queensland. Office of the Health Ombudsman 24 April 2015 - Health Ombudsman releases third...more

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