Pharmacies

News & Analysis as of

NJ Project Medicine Drop

DCA Notice Regarding Drug Take Back Programs Must be Given When Dispensing CDS Prescriptions in NJ - New Jersey P.L. 2015, c.66, which became effective on January 1, 2016, requires prescribers and pharmacies to provide a...more

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

Arizona Passes Biosimilar Automatic Substitution Law

Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic. Arizona continues the recent trend of states enacting biosimilar...more

SC Public Policy Update - June 2016

What's New - SENATE - The Senate spent the final three days of the legislative session debating the remaining House bills on the calendar as well as bills returned from the House. Members worked late into the night...more

Recent New York Medicaid Settlement with Pharmacy Shows Importance of Checking Excluded Provider List Prior to Filling...

A New York pharmacy has agreed to pay approximately $500,000 to the State of New York for improperly billing New York Medicaid for prescriptions written by a physician who had been excluded from the Medicaid program. This...more

Seventh Circuit Finds that Pharmacy Discount Programs Are Not Exempt from the Definition of “Usual and Customary”

Created in 2006, Medicare Part D is a government program that subsidizes the cost of prescription drugs to Medicare beneficiaries. The program is run through “Plan Sponsors” – private entities that receive a fixed monthly...more

Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound...more

SC Public Policy Update - May 2016 #3

What's New - SENATE - It was another busy week in the Senate as members continued to work through various bills on the lengthy Senate Calendar. The Senate spent the day on Wednesday taking up the Governor’s veto on...more

Prohibition on Pharmacy Inducements Beyond College of Pharmacists’ Authority

In Sobeys West Inc v. Alberta College of Pharmacists, 2016 ABQB 232, the Alberta Court of Queen’s Bench held that amendments to the College of Pharmacists’ Codes of Ethics and Standards of Practice prohibiting inducements to...more

Key Takeaways from FDA's New Guidance for Prescription Drug Compounders

On April 15, 2016, the Food and Drug Administration (FDA) released draft guidance that describes the FDA's interpretation of drug compounding standards under Sections 503A and 503B of the Food Drug & Cosmetic Act (FD&C Act)....more

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

FDA Issues Three Draft Guidance Documents For Drug Compounders

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding

If you read one thing... - FDA interprets the FDCA not to permit compounding for “office use” under Section 503A; compounding pharmacies must receive a valid prescription for an individually identified patient before...more

Florida’s Adoption of Federal Exemptions for Wholesale Drug Distribution May Benefit Pharmacies, Practitioners and Hospitals

The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act...more

Fighting Prescription Drug Abuse Gets a Little Easier for Florida Providers, Pharmacists

Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements. Florida established its Prescription Drug Monitoring...more

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is intended to improve quality of care and deliver better value for Medicare Part...more

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

Massachusetts Adopts Comprehensive Legislation To Curb Opioid Abuse

On March 14, 2016, Massachusetts Governor Charlie Baker signed comprehensive legislation designed to curb opioid addiction. The legislation reflects growing concern for the “dangers in the medicine cabinet” (i.e., risks...more

Massachusetts Legislature Reaches Compromise on Opioid Legislation

On March 10, the Senate voted unanimously to pass a bill that offers long-awaited measures aimed at tackling the state’s growing opioid abuse crisis. After House approval the previous day and seven weeks of conference...more

What Does the Health Care Industry Do Now When Disposing "Hazardous Waste" Pharmaceuticals?

Potentially affected health care facilities should evaluate current management practices, evaluate best management practices for regulated facilities, and develop a plan to prepare for and manage a regulatory inspection....more

CMS Doubles Down on Targeting Part D Enrollee Prescription Drug Abuse, But Will Stakeholders Agree?

With the release of its 2017 draft call letter, CMS continues its push to curb opioid dependence, overdose and death among Medicare Part D enrollees. To that end, CMS proposes that Part D plan sponsors edit their benefit...more

Health Law Alert: Pharmacies and Prescription Drug Dispensers...Are You Ready for The March 1, 2016 DSCSA Compliance Deadline?

In order to improve drug security throughout the supply chain, and to facilitate drug recalls and to address drug importation, diversion, and counterfeiting, Congress passed the Drug Supply Chain Security Act (the "DSCSA")....more

CMS Notifies States of AMP Rule Requirements: 340B Providers Should Take Note

Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and...more

King of Pain: FDA Plans to Re-Review Its Opioid Policies

The Food and Drug Administration announced recently that it intends to re-evaluate its policies on opioid medications, designed “at reversing the epidemic, while still providing patients in pain access to effective relief.”...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

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