Health Care

Last week, Governor Andrew Cuomo unveiled his proposed $168 billion budget for fiscal year 2019, which proposes several changes to New York’s healthcare landscape.

Last week, Mintz released an Advisory reminding holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) of the February 14, 2018, deadline to submit data to the U.S. Food and Drug Administration (FDA).

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates. 

Today is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. 

Congress has four days to fund the government. The emerging spending deal could include any number of legislative priorities. We will wait and see for signs that a spending deal is close before we start envisioning what a short-term continuing resolution might look like.

On January 11, 2018, CMS released a Letter to Medicaid Directors outlining guidance that work requirements can be used as a basis for eligibility for certain adult Medicaid beneficiaries through 1115 waivers.

On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in HHS, first as general counsel to HHS and then as deputy secretary.

The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of neurosurgeons who perform spinal fusion surgeries at the hospital.

This week, Congress returns to D.C. with 11 days to pass a government funding bill that may touch on issues such as CHIP, the minibus, DACA, and disaster relief. How this all comes together by January 19th will start to play out this week.

In both civil and criminal enforcement proceedings, 2017 was perhaps most notable for the cases brought against individual health care providers and small physician practice owners. 

2017 was an eventful year for health care, and now we can all sit back and relax with very little concern that major health policy will be on the table in 2018. Right? Not so fast. Talks of entitlement reform, upcoming regulatory action in Medicare, Medicaid, FDA and the Marketplace, and let's not forget the still lingering health care minibus. Lots to do in 2018 and we are just getting started.

Throughout 2017, the lower courts built upon the standard for determining immateriality under the False Claims Act (FCA) established by the U.S. Supreme Court in Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016) (“Escobar”).

The U. S. Department of Justice (DOJ) issued a memo dated January 4, 2018 regarding federal marijuana enforcement policy, directing all U.S. Attorneys to enforce the laws enacted by Congress and to follow well-established principles when pursuing prosecutions related to marijuana activities.

Like prior years, 2017 saw large government recoveries and a high volume of False Claims Act (“FCA”) cases, which remain the government’s primary health care enforcement tool.

The volume of health care–related qui tam litigation under the False Claims Act (FCA) remained robust in 2017. Based on our review of the data in Mintz Levin's Health Care Qui Tam Database, we identified over 150 qui tam lawsuits that were unsealed in the twelve months ended November 30, 2017. 

Happy New Year and welcome to 2018! Our first weekly preview of the year dives into the issues left unresolved in 2017. Where does CHIP and the minibus fit into the developing government funding bill, which Congress will have to finalize or pass another continuing resolution by January 19th.

This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments pertain to FDA actions on drugs and biologics, this post will address developments related to “traditional” medical devices and diagnostics (i.e., not software devices).

As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance that lasts the whole year through.