Recent News and Industry Developments

FOURTH ROUND OF UPDATES TO THE FDA GUIDANCE FOR CLINICAL TRIAL RESEARCHERS AMID COVID-19 PANDEMIC
Advisories | News | FOURTH ROUND OF UPDATES TO THE FDA GUIDANCE FOR CLINICAL TRIAL RESEARCHERS AMID COVID-19 PANDEMIC

September 23, 2020 THE U.S. FOOD AND DRUG ADMINISTRATION (“FDA”) AGAIN SUPPLEMENTS ITS MARCH 18 GUIDANCE ENTITLED “CONDUCT OF CLINICAL TRIALS OF MEDICAL PRODUCTS DURING COVID-19 PUBLIC HEALTH EMERGENCY” The… Read more »

DOL NARROWS FFCRA “HEALTH CARE PROVIDER” EXEMPTION IN REVISED REGULATIONS EFFECTIVE SEPTEMBER 16, 2020
Advisories | News | DOL NARROWS FFCRA “HEALTH CARE PROVIDER” EXEMPTION IN REVISED REGULATIONS EFFECTIVE SEPTEMBER 16, 2020

September 14, 2020 On Friday, September 11, 2020, the U.S. Department of Labor’s Wage and Hour Division (DOL) announced revisions to the regulations that govern paid sick leave and expanded… Read more »

Election Update-September
Articles | News | Election Update-September

Virginia will elect a new Governor, Lt. Governor and Attorney General on November 2, 2021.  Candidates are lining.  Please see an updated list of candidates below: ************************************************************************************* GOVERNOR: Republican: Amanda… Read more »

A GRADUAL RETURN TO NORMAL: CMS ISSUES GUIDANCE ON THE EXPANSION AND PRIORITIZATION OF SURVEY ACTIVITES AND RESOLVING ENFORCEMENT CASES
Advisories | News | A GRADUAL RETURN TO NORMAL: CMS ISSUES GUIDANCE ON THE EXPANSION AND PRIORITIZATION OF SURVEY ACTIVITES AND RESOLVING ENFORCEMENT CASES

August 19, 2020 On August 17, 2020, CMS issued revised guidance (QSO-20-35-ALL) for survey activities and enforcement actions for long-term care facilities, non-long-term care facilities, and laboratories. The memorandum updates… Read more »

CMS UPDATES ABN FORM
Advisories | News | CMS UPDATES ABN FORM

August 6, 2020 The Office of Management and Budget renewedthe Centers for Medicare and Medicaid Services’ (CMS) instructions and Advance Notice of Noncoverage (ABN), Form CMS-R-131, which is distributed by… Read more »

CMS SET TO RESTART MEDICAL REVIEW ACTIVITY
Advisories | News | CMS SET TO RESTART MEDICAL REVIEW ACTIVITY

July 24, 2020 The Centers for Medicare and Medicaid Services (“CMS”) announced that it plans to resume pre-payment and post-payment medical review activity on August 3, 2020, regardless of the… Read more »

New COVID-19 Emergency Temporary Standard Becomes Effective Week of July 27th
Advisories | News | New COVID-19 Emergency Temporary Standard Becomes Effective Week of July 27th

July 23, 2020 On Friday, June 12, the Virginia Department of Labor and Industry (DOLI) published a draft emergency temporary standard (ETS), 16 VAC 25-220, that applies to all employers… Read more »

DOJ UPDATES GUIDANCE ON THE EVALUATION OF CORPORATE COMPLIANCE PROGRAMS
Advisories | News | DOJ UPDATES GUIDANCE ON THE EVALUATION OF CORPORATE COMPLIANCE PROGRAMS

June 10, 2020 On June 1, 2020, the US Department of Justice (“DOJ”) issued updated guidance on the “Evaluation of Corporate Compliance Programs” (2020 Guidance) designed to assist prosecutors on… Read more »

Virginia Candidates for Governor, Lt. Governor and Attorney General
News | Virginia Candidates for Governor, Lt. Governor and Attorney General

July 7, 2020 Please see a list of current declared and potential candidates for Governor, Lt. Governor and Attorney General in Virginia.  The election will take place on November 2,… Read more »

THIRD ROUND OF UPDATES TO THE FDA GUIDANCE FOR CLINICAL TRIAL RESEARCHERS AMID COVID-19 PANDEMIC
Advisories | News | THIRD ROUND OF UPDATES TO THE FDA GUIDANCE FOR CLINICAL TRIAL RESEARCHERS AMID COVID-19 PANDEMIC

July 7, 2020 THE U.S. FOOD AND DRUG ADMINISTRATION (“FDA”) AGAIN SUPPLEMENTS ITS MARCH 18 GUIDANCE ENTITLED “CONDUCT OF CLINICAL TRIALS OF MEDICAL PRODUCTS DURING COVID‑19 PUBLIC HEALTH EMERGENCY” The… Read more »

CMS ENDS BLANKET WAIVER OF NURSING HOME STAFFING DATA SUBMISSION REQUIREMENT, REQUIRES DATA SUBMISSION BY AUGUST 14, 2020
Advisories | News | CMS ENDS BLANKET WAIVER OF NURSING HOME STAFFING DATA SUBMISSION REQUIREMENT, REQUIRES DATA SUBMISSION BY AUGUST 14, 2020

July 6, 2020 On June 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it is ending its waiver of the requirement for nursing homes to submit… Read more »

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