Capsule: Antitrust, Privacy Hot Topics Ahead of Halloween

Welcome to Capsule, where we’ll give you your weekly dose of what to watch out for in the health-care space. Let Ayanna Alexander and Valerie Bauman get you prepped for this week’s hottest health-care topics.

We’re jumping into the Halloween spirit this week with some spooktacular subjects—including antitrust, privacy, and costly health care!

Valerie: Antitrust issues are increasingly important in the pharmaceutical sector. That’s truer than ever given a high-stakes lawsuit against many generic drug makers over alleged price-fixing and growing questions about what kind of physician or provider compensation qualifies as a “kickback.”

I’ll be learning more about trends in that area this week at a conference organized by Dechert LLP in Philadelphia. Watch for my live tweets on Wednesday.

I’m expecting to hear about mergers in the pharmaceutical industry—and what companies are doing as those deals come under growing scrutiny. The event will feature officials from the U.S. and Europe, including Gail Levine, deputy director of the Bureau of Competition at the Federal Trade Commission, and Paul Csiszar, a member of the Directorate Generale for Competition at the European Commission in Brussels.

Speaking of antitrust issues, Oct. 24 will be one year since the Eliminating Kickbacks in Recovery Act of 2018 took effect as part of a federal initiative to take on the nation’s opioid epidemic.

The law was passed to address concerns about patient referrals to substance use-disorder treatment facilities—and to prevent a system where facilities received kickbacks or “finder’s fees” for referring people into treatment beds while charging private insurance companies top dollar for the services.

Rebekah Plowman, a health-care partner at Arnall Golden Gregory LLP, described it as “hastily crafted legislation,” that “swept up” laboratories in its application, making it harder for them to pay employees for connecting patients with legitimate services expressly allowed under the federal Anti-Kickback Statute.

While lawmakers have promised a fix on the issue, none has emerged, leaving many questioning whether it is safe for laboratories to pay sales staff commissions for patients—whether or not they are in addiction treatment.

Some argue that the statute is written so broadly that many laboratories could be subject to its penalties of up to $200,000 in fines and/or 10 years in jail per occurrence.

Neither the attorney general nor the secretary of health and human services have offered any regulations or guidelines to clarify the issue.

As the law enters its second year, we’ll be watching to see if any laboratories face enforcement actions over previously legal compensation practices.

Ayanna: In the same safety and security vein, the privacy industry must wrap up comments on Thursday on the National Institute of Standards and Technology’s preliminary draft of the privacy framework, which will help companies beef up their their security and assess risks.

Remember, this is the same research lab that has issued multiple frameworks since 2016 to help the medtech industry maintain and mitigate cybersecurity risks before and after devices and other medical products hit the market.

NIST applied its knowledge on cybersecurity to identify, assess, and prepare for any privacy dangers, hazards, and other potentials for disaster.

What Else We’re Watching

Value-based is clearly a major topic this week inside the Beltway.

Insurers, providers, federal agencies, and lawmakers are gathering Monday and Tuesday in Arlington, Va., to discuss the best practices in network and value-based contract design and management. Attendees will also look into ways organizations including Anthem and Blue Cross Blue Shield improve outcomes and lower costs by using options like bundled payments with value-based incentives and payment structures.

The Council for Affordable Health Coverage is hosting a panel on Capitol Hill Wednesday to look at health-care trends in hospitals, how that care varies state-by-state and across hospital systems, and how value-based care will improve outcomes and lower costs.

A $30 donation to Bernie Sanders may not disqualify Gaurov Dayal, an executive at primary-care provider ChenMed, from leading the office that implements President Donald’s Trump’s health priorities. However, the donation made in 2016 through ActBlue has caught the eyes of the White House and may be enough to tip the balance in favor of Brad Smith, former CEO of palliative care provider Aspire Health and aide to former Sen. Bob Corker (R-Tenn.), as new head of the Center for Medicare & Medicaid Innovation, sources tell reporter Shira Stein.