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This week, Congress is off and running with two emerging priorities to complete before members head off to campaign. With the midterms just 50 days away, the longer issues like opioids and appropriations remain unsolved the more likely they are to get punted until after the midterms.
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Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the Breakthrough Devices program in the 21st Century Cures Act and the Software Precertification pilot program in the FDA’s Digital Health Innovation Action Plan. Others have been less trumpeted but are still significant developments for device manufacturers.
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ACA plans scored a major victory last week when a federal court held that health plans participating on the ACA exchanges are entitled to unpaid cost sharing reduction (CSR) payments from the federal government. 
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Congress continues to make progress towards funding the government despite having only seven business days remaining with both chambers in town prior to the September 30 deadline. 
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We have continually provided updates on the application and approvals of Medicaid 1115 waivers that include work requirements. One such approved waiver is the Arkansas Works Program. As we previously noted, Arkansas became the first state to implement work requirements for Medicaid eligibility.
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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
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.
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.
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.
On August 9, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to overhaul the Medicare Shared Savings Program (MSSP).
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.
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:
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. 
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.
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. 
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.”
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