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.” This conclusion, while disheartening, shouldn’t be surprising to readers of this blog. We’ve blogged about a range of cybersecurity issues affecting health care, from the potential hacking of medical devices with deadly consequences, to ransomware attacks that threaten to shut down hospitals.  Continue Reading HHS Task Force Says Healthcare Cybersecurity is in “Critical Condition”

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.

To understand what the latest news means in the ongoing saga over EpiPen Medicaid Drug Rebates, it is important to understand how we got here.   And why at the end of the day, the information Senator Grassley included in the May 31, 2016 release may be less important than the information he hinted at but omitted from the release. Continue Reading The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

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.  Stayed tuned for more upcoming previews and blog posts from the ML Strategies team!

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. Also on our radar this month will be the date June 21st– the date in which insurers decide if they will participate in the Obamacare Marketplace for 2018. This could play a role in the Administration’s ongoing discussions regarding cost-sharing reductions, as well as how the Senate approaches its version of the AHCA. Continue Reading Congress Returns for June Session to Face AHCA, User Fees and More

shutterstock_573245464In 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. The “minibus” refers to a handful of policy provisions tied together in one piece of legislation. This minibus will carry a number of provisions into law, although the number of riders onboard the minibus and when the minibus leaves the station remain to be seen.

Future posts will review additional details of other potential riders on the minibus. Continue Reading Therapy Caps: A Minibus Rider

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. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical companies for the high prices of their products but has done little to advance concrete policies in this area.

Dr. Gottlieb has been consistent over the years, including during his recent confirmation process, in his view that FDA should take a more active role in fostering competition and reducing unnecessary regulatory barriers. So it was not surprising when he was selected by Trump to lead the Agency, nor when he received a relatively warm welcome from Senators concerned about the direction prices have been going in recent years. Continue Reading FDA Commissioner Hints at Drug Pricing-Related Initiatives

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.  MassHealth, Massachusetts’s Medicaid program, offers low-cost, benefit rich coverage to low-income individuals.   Eligible individuals sometimes forgo employer coverage in lieu of MassHealth coverage, a trend that is unsustainable for the Commonwealth.

In Governor Baker’s fiscal year 2018 budget, he called on Massachusetts employers to help pay for the increasing Medicaid costs.  To support this initiative, the Senate recently introduced a proposal that would allow the Governor to select from two options to offset these rising costs: (1) a “play-or-pay” option that would impose a per employee assessment on companies that do not offer their workers health plans, or (2) an across the board increase in the Employer Medical Assistance Contribution (or “EMAC”).  The Employment Matters post analyzes how the increase in the EMAC may be more administratively feasible for the Commonwealth, while the “pay-or-play” option is potentially preempted by the Employee Retirement Income Security Act of 1974 (ERISA).

Check out their full analysis here.

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. This score is significant as it marks the first time that CBO has concluded that providing enhanced Medicare coverage for telehealth services would be budget neutral and clears the path for Congress to pass the legislation in a tough political climate.  Continue Reading CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act

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.

Here are my seven top takeaways from this year’s Institute. Continue Reading Seven Takeaways from the ABA National Institute On Health Care Fraud

Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an allegation that the Clinic violated the Stark Law by compensating twelve Clinic physicians in a manner that took into account the volume and value of the physicians’ referrals to the Hospital’s infusion center.  The U.S. contended that the defendants’ Stark Law violations caused their reimbursement claims to Medicare for infusion services to violate the False Claims Act. Continue Reading Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated the Stark Law