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Eleventh Circuit Rules In AseraCare Case That Disagreements In Clinical Judgment, Without Objective Falsity, Do Not Prove Fraud Under The FCA
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc..
United States
16 Sep 2019
Part 2 Proposed Rule Brings Clarity And Reduces Regulatory Burdens For Substance Use Disorder Providers, But Challenges Remain
On August 22, the Substance Abuse and Mental Health Services Administration ("SAMHSA") announced a new proposed rule (the "Proposed Rule") amending 42 CFR part 2
United States
4 Sep 2019
Telemedicine Platform Recalled Over Failure To Obtain Pre-Market Clearance Or Approval From FDA
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc.
United States
30 Aug 2019
GAO Studies Use Of PBMs In Medicare Part D
GAO recently released a report analyzing the use of pharmacy benefit managers ("PBMs") and efforts to manage drug spending and use in the Medicare Part D program
United States
28 Aug 2019
HHS Drug Pricing Disclosure Rule: Chance At A Renewed Life Following District Court Appeal?
Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court.
United States
28 Aug 2019
Aaron Josephson Weighs In On Debate Over FDA Data Falsification Rule With FDA Week
Our ML Strategies colleague Aaron Josephson was quoted extensively in an August 16 FDA Week article (FDA Week is a focused newsletter from InsideHealthPolicy)
United States
27 Aug 2019
DOJ Seeks Dismissal Of FCA Qui Tam Case To Escape Onerous Discovery Obligations
On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator's qui tam suit because of the defendant's burdensome discovery
United States
26 Aug 2019
CMS Takes Another Swing At 340B Reimbursement Cuts. Will It Be Strike Three?
The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications
United States
15 Aug 2019
Open Payments Program Expansion
On July 30, 2019, the Centers for Medicare & Medicaid Services ("CMS") announced more proposed changes to the Open Payments Program.
United States
13 Aug 2019
In Policy Reversal, HHS And FDA Propose Plan To Import Foreign Drugs
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan
United States
12 Aug 2019
Three Things To Learn From Delaware Supreme Court's Opinion On Board Of Director Oversight Duties (Marchand v. Barnhill)
In June 2019, the Delaware Supreme Court issued a decision reaffirming director liability where there is no board-level reporting process for essential compliance matters.
United States
8 Aug 2019
The OIG Urges CMS To Implement Solutions To Reduce Fraud In Medicare Part C And Part D
Recently, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") issued its 2019 "Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs
United States
6 Aug 2019
FCC Seeks Big Role In Telemedicine With New Fund
$100 million in federal funds may soon become available to help health care providers cover the costs of broadband and connected care services
United States
6 Aug 2019
Senate Finance Committee Passes Drug Pricing Bill
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest
United States
5 Aug 2019
ML Strategies Health Care Preview - Week Of July 29, 2019
This week, the Senate is expected to consider the House-passed two-year budget deal that will also suspend the debt limit for two years.
United States
2 Aug 2019
FDA Invites Compounding Outsourcing Facilities' Comments To Understand Industry Challenges And Opportunities
On July 29, 2019, the Food and Drug Administration (FDA) published a notice to the Federal Register (84 Fed. Reg. 36609).
United States
2 Aug 2019
OIG Reports Focus On Hospice Quality Of Care
Earlier this month, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) released two reports regarding its concerns and recommendations
United States
31 Jul 2019
Another Chance For HIPAA And Part 2 Harmony?
There are reports that HHS plans to issue a proposed rule next month, which would again amend 42 CFR Part 2 ("Part 2") and modify how the medical records of patients
United States
26 Jul 2019
CMS Proposes Changes To The Home Health Agency Prospective Payment System
On July 11, 2019, the Centers for Medicare and Medicaid Services (CMS) issued its Home Health Prospective Payment System proposed rule for 2020.
United States
25 Jul 2019
ML Strategies Health Care Preview - Week Of July 15, 2019
This week, the House is scheduled to vote on a repeal of the Cadillac tax, which is a forty percent tax on high-cost health plans.
United States
24 Jul 2019
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