News & Analysis as of

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

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

Third Time’s a Charm: Governor Bentley and Legislature Reach Budget/Tax Compromise

Summary - Governor Robert Bentley called a second special session of the Alabama Legislature on Tuesday, September 9 at 5 p.m. to address the FY 2016 General Fund budget and associated revenue measures. After meeting for...more

Discriminating Tastes: Court Puts Long-running Robinson-Patman Act Case To Rest

Described as the Rodney Dangerfield of the antitrust laws, the Robinson-Patman Act—which prohibits anticompetitive price discrimination—gets no respect. The Justice Department and the Federal Trade Commission unapologetically...more

Avoiding the Costly “Robo No-No”

The Telephone Consumer Protection Act (“TCPA”) was enacted to protect consumers from intrusive robocalls, but Congress probably did not foresee that it would result in a windfall for plaintiff’s lawyers. Virtually every...more

Prosecuting Doctors for Medicare Fraud

Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more

Pain Clinic Raids: Blocking and Tackling Drills for Physician Practices

Every day, medical providers are asked to serve a population that largely expects their healthcare to be free, and that everything they want is covered by insurance or government. Providers want to serve these wants and...more

UCLA cleared in lawsuit alleging breach as to sexually transmitted disease information

UCLA was absolved by a California judge last week in a suit filed by a patient of a UCLA affiliated doctor’s group, who alleged that a temporary worker in the doctor’s office used the doctor’s username and password to get...more

340B Guidance: Eight Key Points Covered Entities Should Consider

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

EPA’s New Draft Hazardous Waste Rules Promote Flexibility, but Devil is in the Details

On August 31, 2015, EPA released two proposed hazardous waste rules under the Resource Conservation and Recovery Act (RCRA) that will be soon be available for public comment after they are published in the Federal Register....more

GAO Calls for Expanded State Reporting on Medicaid Prescription Drug Fraud Controls

In light of continuing indicators of potential prescription-medication fraud and abuse in state Medicaid programs, the Government Accountability Office (GAO) has reviewed federal and state pharmacy-related policies and...more

KMART Settles False Claims Act Allegations for $1.4 Million

The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

HRSA Issues 340B Program Omnibus Guidance

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

EPA Says “Stop” – Don’t Dump Those Drugs Down the Drain

The U.S. Environmental Protection Agency this week released a pre-publication copy of a proposed rule on pharmaceutical hazardous wastes in healthcare and related industries that will significantly affect our healthcare...more

EPA Proposes New Standards for Hazardous Waste Pharmaceuticals

The Environmental Protection Agency (EPA) released its proposed Management Standards for Hazardous Waste Pharmaceuticals Rule. If finalized, it will create an entirely new subpart in the Resource Conservation and Recovery Act...more

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

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