Pharmacies

News & Analysis as of

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

EPA Proposes RCRA Rules Easing Standards For Pharmaceutical Wastes And Revising Generator Standards

The U.S. Environmental Protection Agency (EPA) on August 31, 2015, proposed two rules under the Resource Conservation and Recovery Act (RCRA) that would alter fundamentally the hazardous waste regulatory program. One rule...more

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

A summary and analysis of HRSA's proposed 340B program guidance

On August 28, 2015, the US Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published its long-awaited, if still only proposed, 340B program guidance (Proposed Guidance). 80 Fed....more

Colorado Medical Board Adopts New Telehealth Policies

On August 20, 2015, the Colorado Medical Board (the Board) adopted Policy 40-27, which sets forth important new guidelines for providers delivering healthcare services via telehealth technologies, including the ability to...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

Marginal Evidence of Customer Diversion Won’t Support a Price Discrimination Claim

In Cash & Henderson Drugs, Inc v. Johnson & Johnson, Case No. 12-4689 (2nd Cir. Aug. 27, 2015), the Second Circuit upheld a summary judgment in favor of defendant pharmaceutical manufacturers accused of price discrimination....more

OIG Approves Limited, Free Drug Program

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more

Will NYSDEC's Audit Agreement for Retail Pharmacies Provide a Path to Increased Compliance?

Federal and state hazardous waste handling and disposal requirements, which were established to address issues related to industrial waste generators and disposal facilities, are often a complicated and awkward fit for retail...more

GAO Issues Report on Medicaid Prescription Drug Fraud Controls

In July 2015, the U.S. Government Accountability Office (GAO) issued a report concerning Medicaid pharmacy-related program integrity efforts. GAO explained that this review was pursued due to the substantial amount of funds...more

OIG Issues Two Favorable Advisory Opinions

OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

OIG Will Not Impose Sanctions on Entities for Program That Provides Free Drugs to Patients Experiencing Delayed Insurance...

On August 5, 2015, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG) issued Advisory Opinion No. 15-11 (the “Opinion”) in response to a request by pharmaceutical manufacturers that...more

340B Program Change on the Horizon? OMB Completes Review of the 340B Omnibus Guidance

Safety-net providers, manufacturers, members of Congress, and other stakeholders have been tracking the status of the Health Resources and Services Administration’s (“HRSA”) draft 340B Omnibus Guidance closely as it promises...more

Blog: HHS OIG Approves Drug Company Program Providing Free Cancer Treatment Drugs

On Tuesday, the Health and Human Services (HHS) Office of Inspector General (OIG) issued an Advisory Opinion regarding a program to provide a 30-day supply of cancer drugs free of costs to patients who experience an insurance...more

Washington Healthcare Update

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

HIPAA Enforcement On The Rise

The number of claims filed under the Health Insurance Portability and Accountability Act (HIPAA) have skyrocketed in recent years. The latest figures from the U.S. Department of Health and Human Services (DHS) highlight a...more

Religious Institutions: August 2015

The decision by the United States Supreme Court on same-sex marriage has been greeted with praise and disdain by different corners of the country. The faith-based community has been especially outspoken. This is not...more

Private Equity Investment in Healthcare: 15 Healthcare Investment Niches – A Review of Key Sectors for 2015

Private equity investment in healthcare continues to grow considerably. This article provides thoughts, observations and insights on 15 investment niches. It also provides some initial thoughts on the market as a whole....more

RLUIPA Round-Up

After a brief summer hiatus, RLUIPA Defense is back with another edition of the Round-Up.  What better way to kick things off than with news about the Satanic Temple of Detroit, which recently unveiled “The Satanic Temple...more

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

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