Kathleen Peterson

Kathleen Peterson

Cooley LLP

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Blog: HHS OIG Releases Annual Solicitation for New and Modified Anti-Kickback Safe Harbors and for New Special Fraud Alerts

On December 29, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released its annual solicitation (the “Solicitation”) for proposals and recommendations for developing new and modifying...more

12/30/2014 - Anti-Kickback Statute Healthcare Healthcare Fraud HHS OIG Safe Harbors Solicitation

Blog: OIG Report Encourages States to Explore Alternate Methods for Calculating Medicaid Supplemental Rebates

On December 12, 2014, the U.S. Department of Health & Human Services Office of Inspector General (OIG) published a report titled: “States’ Collection of Offset and Supplemental Medicaid Rebates” (OEI-03-12-00520). ...more

12/19/2014 - Affordable Care Act CMS MCOs Medicaid OIG Prebate Program

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more

12/18/2014 - FDA Health Care Providers Healthcare Information Sharing PHI Prescription Drugs Proposed Regulation

Blog: HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more

11/4/2014 - Affordable Care Act Audits Healthcare Facilities HHS Hospitals HRSA Investigations Medicaid Medical Devices Medicare Medicare Part A Medicare Part B Medicare Part C Medicare Part D OIG Pharmacies Work Plans

Blog: Phrma Challenges HRSA Interpretative Rule On Orphan Drugs In The 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive...more

10/13/2014 - HRSA Orphan Drugs Pharmaceutical Manufacturers PHRMA Prescription Drugs Section 340B

Blog: 9th Circuit Upholds Alameda County Manufacturer-Funded Drug Disposal Ordinance

On September 30, 2014, the U.S. Court of Appeals for the 9th Circuit unanimously upheld a lower court’s finding that a California county ordinance requiring prescription drug manufacturers to operate and finance certain drug...more

10/9/2014

FDA Releases Five New Compounding Pharmacy Policy Documents

Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s...more

7/3/2014 - DQSA Draft Guidance Drug Compounding FDA Final Guidance Pharmaceutical pharmacie Proposed Regulation

340B Drug Discount Program Orphan Drug Rule Vacated: ACA “New” Covered Entity Types No Longer Authorized to Purchase Orphan Drugs...

The D.C. District Court permanently enjoined the U.S. Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan...more

5/27/2014 - 340B Affordable Care Act Covered Entities FFDCA HHS HRSA Orphan Drugs Pharmaceutical Manufacturers

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