News & Analysis as of

Massive Fraud Alleged by Camarillo Pharmacist

Russell Reitz, a Camarillo pharmacist, with a modest prescription-filling service, R&O Pharmacy, sold his business to Philidor Rx Services, a mail-order pharmacy, for $350,000. Reitz stayed on as manager, only to see an...more

Congressional Hearing Examines Competition in the PBM Industry

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s...more

OMNICARE and its Implications

In the spring of this year, the Supreme Court issued its long-awaited decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 135 S.Ct. 1318 (2015), resolving a circuit split regarding the...more

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

Effective November 1, 2015: New Jersey Expands Scope of Prescription Monitoring Program

In July, New Jersey Governor Chris Christie signed legislation that expands the access, registration, and utilization of the New Jersey Prescription Monitoring Program (NJPMP). The legislation, Senate Bill 1998 (S-1998), is...more

Health Alert (Australia) - October 26, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Queensland 22 September 2015 - Metro South Hospital and Health Service & Leighton v Luthje [2015] QCATA...more

Privacy Tip #5 — Retail store reward cards

Many retail pharmacies, supermarkets and other retailers offer rewards cards that offer discounts on certain items to be purchased in the store. They give you the cards that contain a bar code in regular size, which looks...more

PharMerica Corporation Settles Anti-Kickback Allegations by Paying Over $9 Million to Government

On October 7, 2015, the Department of Justice announced that PharMerica Corporation (“PharMerica”), the nation’s second-largest nursing home pharmacy, agreed to pay $9.25 million to resolve allegations that it received...more

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

The Next Rx: New Medicare Part D Initiative Advances Role of Medication Management in Reform

Medicare Part D’s Medication Therapy Management (MTM) program intends to optimize clinical benefits and avoid drug-related problems among eligible beneficiaries. MTM services—involving pharmaceutical and clinical...more

News from Second and State

As promised last week, on Wednesday the House of Representatives held a vote on a portion of Governor Wolf’s budget proposal. The proposal was not a General Appropriations or “revenue spending bill”; it was a legislative...more

FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public

Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more

Massachusetts Legislature Takes Action on Opioid Crisis

Amid a recent surge in opioid-related deaths in Massachusetts, with over 1,200 accidental deadly overdoses last year, the Senate passed legislation on Thursday, October 1, that is designed to fight the epidemic on various...more

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Health Alert (Australia) - October 5, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. Epichealth Pty Ltd v Yang [2015] VSC 516 The Supreme Court has granted an interlocutory...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

New Licensing and Regulatory Requirements for Pharmacy Benefit Managers in Ohio

House Bill 64 recently amended Ohio Revised Code Chapter (ORC) 3959. The relevant code sections amended by House Bill 64 are ORC 3959.111 and ORC 3959.12 and these changes took effect on September 29, 2015. Pursuant to...more

West Coast States Bolster Momentum for Pharmacist Provider Status Reforms

In recent years, legislative reforms have been introduced that recognize pharmacists as reimbursement-eligible providers under government-funded health care programs. While these efforts have attracted significant media and...more

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

Illinois Federal Court “Sanctions” Fraudulent Joinder of Pharmacies

We learned a new word the other day while watching TV: Autoantonym. An autoantonym is a word that means one thing, but it also means the opposite. The word is its own antonym, and it is remarkably easy to think of examples...more

CMS Issues Proposed Rule Significantly Modifying the Requirements for Long-Term Care Facilities Participating in the Medicare and...

On July 16, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule comprehensively updating and extensively revising the requirements for participation for long term care (“LTC”) facilities...more

EPA Proposes Hazardous Waste Rule for Pharmaceuticals

A pre-publication draft of a proposed rule by EPA may clarify hazardous waste requirements for obsolete or defective pharmaceuticals. EPA proposes a new Subpart P entitled “Hazardous Waste Pharmaceuticals” to 40 CFR Part 266...more

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