Recent News and Industry Developments

CMS Announces Primary Cares Initiative
Advisories | News | CMS Announces Primary Cares Initiative

May 17, 2019 On April 22, 2019, CMS announced the CMS Primary Cares Initiative, a set of five new payment models available to primary care practices and other providers under… Read more »

DOJ RELEASES NEW GUIDELINES FOR COOPERATION CREDIT IN FALSE CLAIMS ACT CASES
Advisories | News | DOJ RELEASES NEW GUIDELINES FOR COOPERATION CREDIT IN FALSE CLAIMS ACT CASES

May 9, 2019 On May 7, 2019, the U.S. Department of Justice (DOJ) released new guidance on how targets of False Claims Act (FCA) investigations may receive “credit” for proactively… Read more »

Act Now to Clean-Up Medicare Enrollment Records to Avoid Denied Claims After July 1
Advisories | News | Act Now to Clean-Up Medicare Enrollment Records to Avoid Denied Claims After July 1

April 26, 2019 Starting July 1, 2019, CMS will reject Medicare claims for services performed at a hospital’s off-campus provider-based department if the department’s address listed on the claim is… Read more »

DOL PROPOSES MAJOR CHANGES TO OVERTIME CALCULATION AND ELIGIBILITY
Advisories | News | DOL PROPOSES MAJOR CHANGES TO OVERTIME CALCULATION AND ELIGIBILITY

APRIL 9, 2019 In a span of four weeks, the U.S. Department of Labor (the “DOL”) has issued two regulatory proposals that may affect the wages of millions of American… Read more »

90% of FCA Recoveries in FY 2018 Came from Health Care Industry
Advisories | News | 90% of FCA Recoveries in FY 2018 Came from Health Care Industry

January 22, 2019 The Department of Justice (DOJ) recovered more than $2.8 billion in settlements and judgements from civil cases involving fraud and false claims in FY 2018.  Nearly 90… Read more »

DOJ’s Health Care Fraud Unit Sees Growth and Notable Results in FY 2018
Advisories | News | DOJ’s Health Care Fraud Unit Sees Growth and Notable Results in FY 2018

January 10, 2019 The U.S. Department of Justice (DOJ) Criminal Division recently released its Fraud Section Year in Review for 2018.  The Fraud Section runs three litigating units, including the… Read more »

THE VIRGINIA PRESCRIPTION MONITORING PROGRAM AS A TOOL OF ENFORCEMENT
Advisories | News | THE VIRGINIA PRESCRIPTION MONITORING PROGRAM AS A TOOL OF ENFORCEMENT

December 19, 2018 The Virginia Prescription Monitoring Program (“PMP”) is a statewide electronic database with information on dispensed controlled substances included in Schedule II, III and IV; those in Schedule… Read more »

FDA Announces Exclusion of Three Substances from its Section 503B Bulk List
Advisories | News | FDA Announces Exclusion of Three Substances from its Section 503B Bulk List

November 5, 2018 Drug compounding is the process of combining (two or more drugs), mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.[1]… Read more »

PROTECT INITIATIVE: ADVANCING CHILDREN’S MEDICATION SAFETY
Events | News | PROTECT INITIATIVE: ADVANCING CHILDREN’S MEDICATION SAFETY

Elizabeth Whalley Buono will be presenting “Federal and State Responses to the Opioid Epidemic” at the Center for Disease Control’s (CDC) Annual meeting of The Prevention of Overdoses and Treatment… Read more »

FDA APPROVES FINAL OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY WITH A FOCUS ON EDUCATION OF BOTH PROVIDERS AND PATIENTS
Advisories | News | FDA APPROVES FINAL OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY WITH A FOCUS ON EDUCATION OF BOTH PROVIDERS AND PATIENTS

October 25, 2018 This past week, as part of the U.S. Food and Drug Administration’s (FDA) goal of reducing serious adverse outcomes resulting from inappropriate prescribing and misuse and abuse… Read more »

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 »

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