The U.S. Department of Defense (“DOD”) claims that fraud and abuse is inhibiting the ability of the Defense Health Agency (“DHA”), the agency responsible for administering TRICARE, to support and deliver “integrated,...more
5/6/2019
/ Civil Monetary Penalty ,
Comment Period ,
Criminal Investigations ,
Department of Defense (DOD) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Fraud and Abuse ,
Government Agencies ,
Health Care Providers ,
Medicaid ,
Medicare ,
Military Service Members ,
Proposed Regulation ,
Proposed Rules ,
Public Comment ,
TRICARE
On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge...more
Federal prosecutors announced yesterday the Government’s settlement with electronic health records (“EHR”) vendor Greenway Health, LLC (“Greenway”) of False Claims Act (“FCA”) allegations for a payment of $57.25 million and...more
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
2/7/2019
/ Criminal Investigations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Risk Mitigation ,
U.S. Attorney ,
Warning Letters
I. Introduction -
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, seeks to prohibit...more
1/9/2019
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Investors ,
Kickbacks ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse
In a key case being watched by the industry, Judge Collyer of the United States District Court for the District of Columbia issued an opinion today granting UnitedHealthcare’s Motion for Summary Judgment in UnitedHealthcare...more
Medicare Part C and Part D Star Ratings are used by CMS to measure the quality of and reflect the experiences of beneficiaries in Medicare Advantage (“MA”) and Prescription Drug Plans (“PDPs”). Below is a summary of CMS’...more
On November 2, 2017, CMS published its final rule (the “Final Rule”) on the 2018 Quality Payment Program (“QPP”), authorized by the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”). This final rule adopted many...more
As we reported last month, CMS’ proposed rule updating MACRA’s Quality Payment Program (“QPP”) for CY 2018 would extend and expand exceptions that would allow many practitioners to avoid participating in its Merit-based...more
In our July 10, 2017 post regarding telemedicine prescribing, we wrote about the seven exceptions to the Haight Act’s requirement that a provider and patient have an-person visit before a prescriber/practitioner can prescribe...more
On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online...more
7/11/2017
/ Controlled Substances ,
Electronic Prescribing ,
Health Care Providers ,
Internet ,
New Legislation ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Ryan Haight Act ,
Substance Abuse ,
Telehealth ,
Telemedicine
On Friday, October 14, 2016, CMS released the much-anticipated final rule (the “Final Rule”) implementing the Quality Payment Program (QPP), mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). ...more
In 2010, the Affordable Care Act (“ACA”) enacted new rules governing overpayments made by the Medicare and Medicaid programs. Under these rules, providers have 60 days from the date that the overpayment has been identified to...more
7/14/2016
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Health Care Providers ,
Medicaid ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Overpayment Recovery Time Limits ,
Universal Health Services Inc v United States ex rel Escobar
On June 16, 2016, the Supreme Court issued its opinion (“Op.”) in Universal Health Services v. U.S. ex rel. Escobar (“Escobar”), a case testing the viability and scope of the implied certification theory of False Claims Act...more
6/20/2016
/ Conditions of Payment ,
Failure To Disclose ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Pleading Requirements ,
Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Mental Health ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers