Pharmacies

News & Analysis as of

Guest Post - Just the Fax, Ma’am

While Bexis is on vacation, here is a guest post to take up some of the slack. Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith's Chicago office. This one's a little different. It's about the impace of...more

Emerging State Biosimilar Laws – Reference Chart and Five Issues to Watch

As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more

The Supreme Court Addresses Scope of Section 11 Liability for Statements of Opinion

As the Supreme Court recently explained in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S. Ct. 1318 (2015), that distinction is significant when it comes to liability under Section 11 of...more

Also In The News - Health Headlines - July 2015

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

Medicaid Managed Care Update: A Middle Ground for Network Adequacy Standards

This article is part of a series that takes an in-depth look at several proposals that would affect managed care organizations, health care providers and other industry stakeholders participating in, and contracting with...more

2015 Florida Legislative Post-Session Report

Carlton Fields Jorden Burt’s Government Law and Consulting Practice Group released its 2015 Florida Legislative Post-Session Report detailing significant bills that passed during the 2015 Regular Session of the Florida...more

Health Law Wire: CMS Proposes Major Overhaul of LTC Survey Regulations (7/15)

On July 16, 2015, CMS filed over 400 pages of regulatory comment and proposed revisions to the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. CMS stated that these...more

Government Finalizes Religious Accommodation, But What About Health Plans, TPAs and PBMs?

In a set of rules published last week, the government finalized a July 2010 interim final rule (“IFR”) related to coverage of certain preventive services and an August 2014 IFR regarding the definition of an eligible...more

Connecticut Updates its Data Security Laws, Imposing Stringent New Requirements

On June 30, 2015, the Governor of Connecticut signed into law S.B. 949, “An Act Improving Data Security and Agency Effectiveness." The new law updates Connecticut’s data security laws, including by adding a 90-day hard...more

The Sixth Circuit Further Defines “Advertisement” Under the Telephone Consumer Protection Act

Last month, in a case of first impression, the Sixth Circuit Court of Appeals issued an opinion finding that unsolicited faxes intended strictly for informational purposes were not “advertisements” and therefore not...more

Recent Legislative Developments Affecting Florida Pharmacies

Florida’s 2015 Legislative Session ushered in two new laws affecting pharmacies: One addressing pharmacist immunizations (HB 279) and the second clarifies that veterinarians are authorized to dispense compounded drugs and...more

The Elephant in the Room in Alabama

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and...more

Health Alert (Australia) - July 6, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. 26 June 2015 - Northern Health v Kuipers [2015] VSCA 172 - The Victorian Supreme Court has allowed an appeal...more

The Compounding Regulations Surrounding Drug Compounding

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in...more

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

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

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