Health Care

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion.

A New Jersey district court recently denied a motion to dismiss Talone, et. al. v. The American Osteopathic Association, an antitrust class action. The suit alleges that the physician association violated the Sherman Act by illegally tying osteopaths’ board certification to association membership.

Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court ("SJC") ruled that local government approval is not required for the operation of a private needle exchange program and that the Town of Barnstable cannot bar such a program from operating.

Our colleagues at ML Strategies have provided a Health Care Weekly Preview.  This week’s preview describes health insurers' marketplace applications as well as the American Health Care Act (AHCA).

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported.

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks.  As cybersecurity remains a pressing concern for health care entities, these guidance documents are a useful reminder of best practices that health care entities should have in place in case of a cybersecurity incident.

In an opinion written by Judge Posner, the Seventh Circuit on Friday, June 9, 2017, affirmed OSF Saint Francis Medical Center’s summary judgment win in a $300 million antitrust suit brought by a smaller competitor alleging unlawful exclusive dealing and attempted monopolization.

As we gear up for a busy week in Washington, D.C., our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week's preview describes upcoming hearing on safety net health programs and prescription drug costs along with the progress of the American Health Care Act.

Earlier this month, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) published its Semiannual Report to Congress covering the period from October 1, 2016 to March 31, 2017. The report describes OIG’s work and accomplishments during the 6-month reporting period.

Earlier this week, my colleagues Bruce Sokler, Robert Kidwell, Dionne Lomax, and Farrah Short published an alert about the federal district court for the Eastern District of Michigan’s recent decision to deny both the government’s and defendant hospital’s respective motions for summary judgment in a suit filed by the Department of Justice and the Michigan Attorney General in 2015.

Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry's cybersecurity challenges. That Task Force--a combination of public and private participants--released a report last week describing U.S. healthcare cybersecurity as being in "critical condition."

In addition to yesterday's post on the June session of Congress, our colleagues at ML Strategies have provided another weekly preview of Congressional activity for the week of June 5, 2017. The preview includes the upcoming schedule of the House and Senate, along with the looming issues of the American Health Care Act, the health care minibus, and tax reform.

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by as much as $1.27 billion, “far more” than the announced-but-never-confirmed or finalized $465 million DOJ settlement with Mylan.

Congress returns from its Memorial Day recess to four full weeks of legislative activity. The drama of the American Health Care Act (AHCA) now hangs over the Senate. The House will return to its regular work once they advance the FDA User Fee Reauthorization, with the Senate also having to schedule floor time for the package.

In a recent post, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program. In this post we will go into detail on the background and outlook for outpatient therapy caps.This is part of our ongoing series on the potential riders on a health care minibus.

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a "Drug Competition Action Plan" that it will unveil in upcoming weeks and months.

Our colleagues on the Employment Matters blog recently analyzed a budget proposal by the Massachusetts Senate that would authorize the Governor to collect additional funds from employers to offset increasing MassHealth costs.

On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud.  I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with colleagues from all sides of the aisle.  And I always come away with a few nuggets to share with those who did not attend.

Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending.

On May 23, the White House released its 2018 budget proposal, outlining its priorities for the upcoming fiscal year. In health care, the President has proposed cuts to several agencies and programs. The Administration’s annual budget is seen as a statement of policy, not necessarily a legislative proposal certain to become law.