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Last week, Bruce Sokler and Farrah Short from Mintz’s Antitrust practice group published a detailed alert regarding the Third Circuit’s reinstatement of an antitrust suit brought by medical device manufacturer LifeWatch Services, Inc. (“LifeWatch”) against the Blue Cross Blue Shield Association and five of its member insurance plan administrators: LifeWatch

ML Strategies Health Care Preview – Week of September 4th

September 4, 2018 | Blog | By Eli Greenspan

Congress is back in session with several high-profile hearings and looming deadlines. The Senate will begin consideration of the nomination of Brett Kavanaugh to the U.S. Supreme Court and will begin its work with the House on conferencing a number of appropriations bills.

New Jersey Regulates Out-Of-Network Billing

August 31, 2018 | Blog | By Bridgette Keller, Nili Yolin, Hope Foster

News alert for all New Jersey health care providers! A new law went into effect yesterday (August 30, 2018) that changes billing requirements for out-of-network services in New Jersey.

House and Senate Opioid Packages Comparison

August 28, 2018 | Blog | By Emma Zimmerman

The opioid epidemic has driven significant legislation this session.  To help our readers track the pending opioid legislation, ML Strategies has created a chart to analyze various provisions of House and Senate bills and their overlap.
Viewpoint General
On August 9, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to overhaul the Medicare Shared Savings Program (MSSP).

Arkansas 1115 Medicaid Waiver: August 2018 Status

August 21, 2018 | Blog | By Emma Zimmerman

In January 2018, CMS issued new guidance allowing states to impose work requirements as a condition of Medicaid eligibility through the use of Section 1115 Medicaid demonstration waivers. These waivers allow states to test new approaches in Medicaid that differ from federal rules.

Amended FCA Complaint Cannot Cure A First-to-File Violation

August 17, 2018 | Blog | By Mackenzie Queenin

The Second Circuit Court of Appeals recently held that a False Claims Act (FCA) relator could not evade the FCA’s first-to-file bar by filing an amended complaint after two earlier-filed FCA suits alleging similar conduct had been dismissed.
As a continuation of the recent drug pricing developments tied the Trump Administration’s American Patients First Blueprint, beginning January 1, 2019, Medicare Advantage plans will be able to apply step therapy for physician-administered and other Part B drugs in an effort that CMS hopes will lower drug costs and improve the quality of care for Medicare beneficiaries.
Employers with workers in Massachusetts will have a lot to do between now and October 1, 2018, when reforms to Massachusetts non-compete laws go into effect.
Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 46 health care-related False Claims Act qui tam cases unsealed in February and March 2018 and the trends they reflect:

New Jersey’s Pending 1332 Reinsurance Waiver

August 10, 2018 | Blog | By Emma Zimmerman

At the end of July, CMS approved two Section 1332 State Innovation Waivers submitted by Wisconsin and Maine for the purpose of establishing state reinsurance programs. There has been a flurry of 1332 waiver activity recently as states have sought to stabilize their individual insurance markets through reinsurance programs.

OCR Warns Providers About Securely Disposing Electronic Devices

August 10, 2018 | Blog | By Sarah Beth Kuyers

The July 2018 cyber security newsletter issued by the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) reminds health care providers and their business associates of the importance of properly disposing and destroying electronic devices and/or media that are no longer needed or that will be repurposed. 
On Wednesday, August 8, CMS filed a proposed rule clearing the way for the federal government to continue making payments under the ACA’s risk adjustment program for the benefit year 2018. 

Recent 1332 Waiver and Reinsurance Activity

August 2, 2018 | Blog | By Emma Zimmerman

States are increasingly looking for ways to improve stability in their individual insurance marketplaces. One way is through reinsurance programs – systems in which multiple insurance companies share risk by purchasing insurance policies from another party to limit the total loss the original insurer would experience in case of unusually high claims.
The first statistic comes from a recently published study by the Ponemon Institute, with sponsorship from IBM Security, entitled “2018 Cost of a Data Breach Study: Global Overview.”
Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the “Proposed Rule”) released by CMS earlier this month.

ML Strategies Weekly Health Care Preview – July 30, 2018

July 30, 2018 | Blog | By Eli Greenspan

This week, the Senate is in session while the House is out on its August recess. The Senate could move the ball on opioids, but it is more likely that it focuses on nominations.
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.

Biosimilars Action Plan Update: Public Hearing Scheduled

July 24, 2018 | Blog | By Joanne Hawana

As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.”

ML Strategies Weekly Health Care Preview – July 23, 2018

July 23, 2018 | Blog | By Eli Greenspan

This week, the House is looking at advancing several health care tax proposals, including permanent repeal of the medical device tax. They will also consider a proposal to delay the health insurance tax by two years.
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