CMS Announces Hospice Capitation Rates for Medicare Advantage -
The U.S. Centers for Medicare and Medicaid Services (CMS) recently released the capitation rates for hospice care through the value-based insurance design...more
Investor Interest in Health IT Expected to Remain Strong in 2020 -
After three years of strong growth in healthcare technology funding, investor interest in the space has not abated....more
During 2018, five nursing facilities sought to create a more livable space for their residents by reducing their licensed bed capacities. These changes eliminated 3-bed wards in favor of semi-private rooms and improved living...more
Digital Health Companies Look Toward IPOs as M&A Stabilizes -
Digital health funding in 2019 suggests more companies will be looking to go public or be acquired in the coming years, according to a report from seed fund and...more
News Briefs -
FDA Exempts Some Medical Devices from Premarket Review -
FDA closed out the year with the publication of a final order that exempts dozens of Class I and Class II medical devices from 510(k) premarket...more
The decisions of appellate courts often establish precedent that will have ramifications that extend far beyond the immediate parties to an appeal. ...more
The uncertainty surrounding the use of arbitration agreements in nursing homes has finally ended—at least for now. On July 16, 2019, CMS released its long-awaited final rule, which updates the requirements nursing homes must...more
AGG health care litigation partners Jason Bring, Chesley McLeod, and Jerad Rissler recently filed a friend of the court brief with the Georgia Court of Appeals on behalf of both the Georgia Hospital Association and the...more
On July 9, 2018, in United States ex rel. Polukoff v. St. Mark’s Hosp., the Tenth Circuit Court of Appeals added to the debate over the role of the False Claims Act in policing medical necessity. ...more
Medicare’s implementation of post-payment review through overly aggressive zone program integrity contractors (ZPICs) and unified program integrity contracts (UPICs), combined with an ineffective review process at the first...more
Medicare’s implementation of post-payment review through overly aggressive private contractors, combined with an ineffective review process at the first two levels of the administrative appeal process (redetermination and...more
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on April 27, 2018 to overhaul the payment system for skilled nursing facilities (SNFs). Specifically, the rule would “update the payment rates used...more
Medicare’s implementation of post-payment review through private contractors who are overly aggressive in denying payments, combined with an ineffective review process at the first two levels of administrative appeal...more
On January 11, 2018, the United States District Court for the Middle District of Florida set aside a nearly $350 million False Claims Act (FCA) jury verdict rendered in February 2017 against a group of fifty-three skilled...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs....more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
4/22/2016
/ Abbott Laboratories ,
All Natural ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Investors ,
Medicare Part B ,
Misleading Impressions ,
Natural Products ,
Personal Care Products ,
Pharmaceutical Industry ,
Prescription Drugs ,
Securities and Exchange Commission (SEC) ,
Securities Fraud
On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more
4/12/2016
/ Biotechnology ,
Board of Directors ,
Capital Raising ,
Corporate Officers ,
Disgorgement ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Misleading Statements ,
Permanent Injunctions ,
Personal Liability ,
Securities and Exchange Commission (SEC) ,
Securities Fraud
On January 7, 2016 the United States District Court for the Middle District of Florida took the rare step of dismissing (with leave to amend) the government’s Complaint in Intervention in a False Claims Act Case. This case...more
Medicare’s implementation of post-payment review through private contractors who are overly aggressive in denying payments, combined with a severe backlog of cases in queue for hearing before an Administrative Law Judge...more
11/11/2015
/ Administrative Appeals ,
Administrative Law Judge (ALJ) ,
Centers for Medicare & Medicaid Services (CMS) ,
Due Process ,
Hospice ,
Medicare ,
Medicare Provider Agreements ,
OMHA ,
RAC Audits ,
Recoupment ,
Recovery Audit Contractors (RACs)
Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more
As you likely are aware, Medicare hospice payments were reduced by two percent in accordance with a sequestration order issued March 1, 2013, pursuant to Section 251A of the Balanced Budget and Emergency Deficit Control Act....more
(...) Saving Money – The Proof is in the Empirical Data -
A recent national study concluded that arbitration awards are approximately 35% lower than recoveries in the court systems. Moreover, attorney’s fees for defending...more