Health Care

You might have missed it but Congress averted a government shutdown last week. While several appropriations bills passed on time for the first time in years, several agencies, including the FDA, were funded on a continuing resolution (CR). The CR provides funding until December 7th and will need to be addressed again by that time. However, the House is now in recess and won’t be back in town until after the midterm elections. So the lame duck session will have a few ‘must dos’ on the list.

On August 27, 2018 the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued a request for information (RFI) seeking comment on the anti-kickback statute (AKS) and the beneficiary inducement prohibition to the civil monetary penalties (CMP) as potential barriers to coordinated and value-based care. The August 27 RFI was the second RFI issued as part of HHS’s “Regulatory Sprint to Coordinated Care,” an ongoing effort to accelerate the transition from fee for-service to a value-based system that emphasizes care coordination.

Medicare Advantage Organizations (MAOs) have been hailing a federal judge’s recent ruling to vacate the 2014 Overpayment Rule. But, how did we get here? And what does it really mean for MAOs?

This week, Congress and the White House need to finalize a government spending bill in order to avoid a shutdown. While all signs point to a deal being reached, it is widely expected that several agencies will be operating on a continuing resolution for the first couple months of fiscal year 2019. While the Departments of Labor, HHS, and Education are expected to receive a full appropriation prior to September 30th, the FDA, which is funded through the Department of Agriculture, is expected to be funded through the continuing resolution, which will go through December 7th.

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has proposed a number of changes to the DoN Regulations (105 CMR 100.000, et. seq.). Program Director Nora Mann presented the proposed revisions, together with an informational briefing memorandum, to the Massachusetts Public Health Council at its September 12, 2018 meeting. The proposal reflects administrative lessons learned in implementing the regulations, which, as reported in a previous post, DPH redrafted and promulgated in January 2017.

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.

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.

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. 

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. 

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.

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: