Recent News and Industry Developments

ANNUAL FDA INTER-GOVERNMENTAL WORKING MEETING REVIEWS REGULATORY PROGRESS AND ANNOUNCES NEW GUIDANCE FOR COMPOUNDING INDUSTRY
Advisories | News | ANNUAL FDA INTER-GOVERNMENTAL WORKING MEETING REVIEWS REGULATORY PROGRESS AND ANNOUNCES NEW GUIDANCE FOR COMPOUNDING INDUSTRY

October 2, 2018 On Sept. 24, 2018, the U.S. Food and Drug Administration (FDA) convened its seventh inter-governmental working meeting as part of its commitment to maintaining close communication with… Read more »

IMPORTANT REVISIONS REGARDING CREDENTIALING REIMBURSEMENT
Advisories | News | IMPORTANT REVISIONS REGARDING CREDENTIALING REIMBURSEMENT

9/25/2018 Credentialing physicians is frequently an arduous process that takes several months to complete and involves hours of paperwork detailing every certification, academic experience and personal background. Thankfully, for Virginia… Read more »

OPIOID BILLS WILL LIKELY RESULT IN SIGNIFICANT CHANGES IN THE WAY OPIOIDS ARE PRESCRIBED, DISPENSED AND PACKAGED
Advisories | News | OPIOID BILLS WILL LIKELY RESULT IN SIGNIFICANT CHANGES IN THE WAY OPIOIDS ARE PRESCRIBED, DISPENSED AND PACKAGED

September 21, 2018 On Monday September 17, 2018, with almost unanimous support, the Senate passed a package of 70 bills that collectively seek to address the myriad of challenges posed… Read more »

Virginia Impact Investing Forum and Social Entrepreneurship
Events | News | Virginia Impact Investing Forum and Social Entrepreneurship

Elizabeth Whalley Buono will be presenting Scaling the Health Economy at the “Virginia Impact Summit” hosted by the Office of Governor Northam, the Virginia Impact Investing Forum & Social Entrepreneurship… Read more »

What’s Happening in the Medicare Advantage World
Advisories | News | What’s Happening in the Medicare Advantage World

August 23, 2018 The Medicare Advantage sector is experiencing steady growth. From the increasing number of enrolled beneficiaries, to health insurers investing in this privatized version of traditional Medicare, to… Read more »

MALPRACTICE POINTERS WHEN PRESCRIBING DRUGS FOR OFF-LABEL USES
Advisories | News | MALPRACTICE POINTERS WHEN PRESCRIBING DRUGS FOR OFF-LABEL USES

August 21, 2018 Unlike the regulatory prohibitions against drug and device manufacturers advertising and/or promoting use of their products off-label, doctors are free to responsibly use FDA-regulated products outside of… Read more »

New OIG Report Highlights Risk of Fraud and Abuse at Compounding Pharmacies and Recommends the Launch of Further Investigations
Advisories | News | New OIG Report Highlights Risk of Fraud and Abuse at Compounding Pharmacies and Recommends the Launch of Further Investigations

August 13, 2018 The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released a new report  this month highlighting its concern with the enormous increase… Read more »

VIRGINIA BOARD OF MEDICINE UPDATE: NEW LICENSURE BY ENDORSEMENT REGULATIONS, LEGISLATIVE ACTIONS, AND FINAL OPIOID AND BUPRENORPHINE REGULATIONS
Advisories | News | VIRGINIA BOARD OF MEDICINE UPDATE: NEW LICENSURE BY ENDORSEMENT REGULATIONS, LEGISLATIVE ACTIONS, AND FINAL OPIOID AND BUPRENORPHINE REGULATIONS

August 8, 2018 On September 5, 2018, the Virginia Board of Medicine’s (“BOM”) “Licensure by Endorsement” regulations will become effective.  These regulations, published in the Virginia Register on August 8,… Read more »

PREPARING FOR NEW JOINT COMMISSION ACCREDITATION AND CERTIFICATION STANDARDS: IMPLICATIONS FOR HOSPITALS AND HOME CARE ORGANIZATIONS ENGAGED IN STERILE MEDICATION COMPOUNDING
News | PREPARING FOR NEW JOINT COMMISSION ACCREDITATION AND CERTIFICATION STANDARDS: IMPLICATIONS FOR HOSPITALS AND HOME CARE ORGANIZATIONS ENGAGED IN STERILE MEDICATION COMPOUNDING

July 30, 2018 As part of its new series of monthly updates entitled “4-1-1 on Survey Enhancements” the Joint Commission has identified sterile medication compounding as its first high-risk area… Read more »

FLORIDA FEDERAL COURT RULES DECLARATORY JUDGMENT ACTION AGAINST HHS REGARDING THE PSQIA CAN PROCEED
Advisories | News | FLORIDA FEDERAL COURT RULES DECLARATORY JUDGMENT ACTION AGAINST HHS REGARDING THE PSQIA CAN PROCEED

July 25, 2018 A Florida federal district court has held that Tampa General Hospital’s declaratory judgment action against the Secretary of the Department of Health and Human Services can proceed. … Read more »

ILLINOIS APPELLATE COURT RECOGNIZES PSQIA PROTECTIONS, OVERTURNING ORDER TO PRODUCE AND PRIOR CONTEMPT FINDING
Advisories | News | ILLINOIS APPELLATE COURT RECOGNIZES PSQIA PROTECTIONS, OVERTURNING ORDER TO PRODUCE AND PRIOR CONTEMPT FINDING

July 2, 2018 An Illinois hospital has successfully appealed a trial court order requiring it to produce confidential and privileged Patient Safety Work Product (“PSWP”) documents and finding it in… Read more »

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