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1
HHS Files Brief In D.C. Circuit Supporting Drug Pricing Transparency Rule
As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court's
United States
8 Oct 2019
2
ML Strategies Health Care Preview: Government Shutdown Looming?
Congress returns to session this week with days to pass a continuing resolution (CR) to keep the government open
United States
7 Oct 2019
3
Compounding Pharmacy And Private Equity Firm Owner Agree To $21 Million Settlement To Resolve FCA Allegations
The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic
United States
26 Sep 2019
4
Greater Access To Mental Health Care Is On The Horizon
Employers and retail giants alike are increasingly inserting mental health into the broader, public conversation around individual health care and employee benefits.
United States
24 Sep 2019
5
ML Strategies Health Care Preview: Surprise Billing Issue Heats Up
This week, Congress is working towards passage of a continuing resolution that would fund the government through the middle of November.
United States
23 Sep 2019
6
Key Takeaways From CMS's Final Rule Requiring The Disclosure Of Affiliates During Provider Enrollment
The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the "Final Rule") that is designed to increase ...
United States
19 Sep 2019
7
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
8
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
9
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
10
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
11
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
12
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
13
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
14
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
15
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
16
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
17
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
18
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
19
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
20
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
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