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1
Evolution & Revolution: Device Policy Priorities At FDA In 2019
This post is the first in a series of three in which we recap the Food and Drug Administration's somewhat difficult year
United States
9 Dec 2019
2
Key Vote In FDA Commissioner Confirmation Process Set For December 3rd
The Senate Health, Education, Labor and Pensions (HELP) Committee is set to vote on Dr. Stephen Hahn, the Trump administration's nominee to head the Food and Drug Administration (FDA)
United States
4 Dec 2019
3
HHS Proposes Sweeping Changes To AKS And Stark Law, Part 5: Proposed Changes To Key Stark Law Requirements And Numerous Stark Law Exceptions
As we previously reported, the Department of Health & Human Services (HHS) recently issued two proposed rules intended to reduce the regulatory burden associated with the Anti-Kickback Statute ...
United States
27 Nov 2019
4
CMS Finalizes Changes Expanding The Scope Of The Open Payments Program
On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule.
United States
22 Nov 2019
5
CMS Ignores The Courts: 2020 Hospital Outpatient Prospective Payment System Final Rule Includes 340B Rate Cuts Already Ruled Unlawful
The Centers for Medicare and Medicaid Services (CMS) recently published the 2020 Hospital Outpatient Prospective Payment System (OPPS) rule, ...
United States
21 Nov 2019
6
HHS Proposes Sweeping Changes To AKS And Stark Law, Part 4: Modifications To Key Stark Law Terminology And A New Stark Law Exception
This post is the fourth installment of our blog series on significant, proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) ...
United States
21 Nov 2019
7
The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy And Puts Industry On Notice Of Further Regulatory Pressure
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years...
United States
7 Nov 2019
8
HHS Proposes Sweeping Changes To AKS And Stark Law, Part 3: Personal Services And Management Contracts, Outcomes-Based Payments, And Warranties
This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the...
United States
5 Nov 2019
9
HHS Proposes Sweeping Changes To AKS And Stark Law, Part 2: Cybersecurity Technology And Electronic Health Records
On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) ...
United States
4 Nov 2019
10
New York Seeks To Add Greater Protections Against Surprise Bills
Last week, the New York State Department of Financial Services released a proposed amendment to the regulations promulgated under the state's Emergency Medical Services and Surprise Bills...
United States
24 Oct 2019
11
HHS Proposes Sweeping Changes To Anti-Kickback Statute And Stark Law
On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) ...
United States
22 Oct 2019
12
FDA Updates Digital Health Guidances To Align With 21st Century Cures Act
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act ("Section 3060 Changes Guidance") – Final
United States
21 Oct 2019
13
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
14
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
15
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
16
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
17
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
18
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
19
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
20
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
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