Archives: Pharmaceutical

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Ohio Expands Prescriptive Authority for Certain Advanced Practice Registered Nurses

On May 17, the Ohio Board of Nursing (the Board) adopted a new formulary which expands the prescriptive authority for certain of Ohio’s advanced practice registered nurses (APRNs). Specifically, this new “exclusionary” formulary applies to Ohio’s certified nurse practitioners, clinical nurse specialists and certified nurse midwives.  The new formulary was adopted pursuant to Ohio’s House … Continue Reading

Lawyer Misconduct Dooms FCA Suit

A fraudulent survey of doctors sponsored by attorneys for a qui tam relator doomed a False Claims Act (FCA) complaint against a pharmaceutical company. In a forceful opinion, United States District Judge Dennis Saylor IV, District of Massachusetts, found violation of ethical rules, excised more than 100 paragraphs of the complaint as a sanction, and … Continue Reading

FDA Considers Regulating Refurbishers and Other Third Parties

The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products.  However, manufacturers may not be able … Continue Reading

Healthcare Facilities Face New Rules for Disposing Pharmaceuticals

On August 31, 2015, the Environmental Protection Agency (“EPA”) Administrator signed the proposed Management Standards for Hazardous Waste Pharmaceuticals rule outlining management and disposal standards for hazardous waste pharmaceuticals that are generated specifically by healthcare facilities. Additionally, this rule “clarif[ies] the regulation of the reverse distribution mechanism used by healthcare facilities for the management of … Continue Reading

CMS Finalizes Medicare Part C and Part D Program Changes for Contract Year 2015: Moderate Deviations from Proposed Rule

On January 8, 2014, we noted several proposed changes to the Medicare Part C and D programs as delineated in CMS’ January 8th proposed rule (hereinafter “Proposed Rule”). On Monday, May 19, 2014, CMS issued the final rule, titled Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare … Continue Reading

Florida Proposes Pharmacy Audit Rights Legislation

The Florida legislature is currently considering proposed legislation that may affect the way in which managed care organizations, insurers, third-party payors, pharmacy benefit managers and other entities audit pharmacies in Florida.  The Florida House of Representatives, Health Innovation Subcommittee, is reviewing HB 745, which proposes to create a “Pharmacy audit bill of rights.”  The Health … Continue Reading

Michigan Proposes Legislation to Regulate Compounding Pharmacies

Michigan’s Attorney General, Republican State Senator Joe Hune, and Steve Arwood, Director of the Michigan Department of Licensing and Regulatory Affairs announced that they would collaborate on a Michigan bill to tighten regulations on compounding pharmacies.  Over the past two years, compound pharmacies have been the subject of increasing controversy as these pharmacies create medications … Continue Reading

Is CMS Having Second Thoughts About Preferred Pharmacy Networks?

In January of 2005, the Centers for Medicare and Medicaid Services (“CMS”) finalized its regulation permitting Medicare Part D plans to establish networks of “preferred” and “non-preferred pharmacies,” meaning that the plans may offer lower cost-sharing to enrolled Medicare beneficiaries who receive items or services from a preferred pharmacy.  70 Fed. Reg. 4194 (Jan. 28, … Continue Reading

Article Shines Spotlight on Pharma Payments to Physicians

An article published today in the Columbus Dispatch shines a spotlight on physicians receiving payments from pharmaceutical companies for speaking and consulting engagements.  The article identifies several central Ohio physicians who have received hundreds of thousands of dollars in fees from drug companies from 2009 through 2012.  The Dispatch’s analysis, taken from data gathered by … Continue Reading
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