Fall is officially here, marking week three of the NFL season (we’ve got some Browns fans in the house), the rapid approach of the midterm elections, and the kickoff of the socially acceptable window for ordering pumpkin spice lattes. Although temperatures are starting to cool down, healthcare news remains hot, so let’s get to the week’s recap, which saw an abundance of payer-focused news…

  • $52B Pound Gorilla? The DOJ has given its imprimatur to Cigna’s $52 billion acquisition of Express Scripts. Payer mega-mergers have been a hot topic in recent years, with UnitedHealth buying Catamaran and Aetna joining forces with CVS. Of course, fewer payers means less leverage for pharma with respect to formulary inclusion—that is, unless the President’s Blueprint does away with rebates…

  • ICERed Out: CVS is backing away from a plan to allow clients to use ICER assessments to exclude coverage of drugs exceeding $100K/QALY. The decision follows significant pushback from patient advocate who argue that QALYs discriminate against sicker and disabled patients. CVS execs have responded by trying to find middle ground: while they insist that cost-effectiveness evaluations are here to stay, they are delaying this QALY-based plan until 2019 and remain open to “reasonable solutions” that would value all covered lives equally. Sounds like a tough balancing act.

  • Whooda? It’s Ooda: No, it’s not a boy band-inspired owl trio (yes, that is a thing). Ooda is a new start-up backed by big-name insurers and HCP groups aimed at streamlining billing. Ooda pays providers immediately, then works with health plans to sort out coverage, eliminating the need for health providers to follow up with patients to get paid. More significantly, Ooda joins the trend of startups—like those we profiled in our recent Comcast coverage—looking to reinvent health plan services. Maybe we start a disruptor of the year pool?

  • Cover Your Apps: The ACA’s much-disputed coverage mandate for contraception took a digital twist as the FDA approved contraceptive app Natural Cycles. According to many, the app falls under HRSA’s definition of “the full range of contraceptive methods for women,” but now that it is approved, no one is sure what triggers mandatory coverage—or how a subscription-based app would get reimbursed. We also wonder how the binary world of health coverage (medical vs. pharmaceutical) will start to integrate apps—and whether they will be considered as part of formulary step-edits…

See—we told you there’s a lot happening on the payer front! But this week saw significant legislative and regulatory action, too, so keep reading…


Last week, the Senate passed one of this year’s few bipartisan pieces of legislation: a package of bills intended to address the opioid crisis. The legislation is wide-ranging, with provisions that address illegal drugs in the mail system, babies born in withdrawal, and funds to develop non-addictive painkillers, among many others. The House version of the legislation, currently being reconciled with the Senate package, features some potentially contentious differences, including whether to partially overturn an old rule prohibiting federal Medicaid reimbursements of substance abuse treatment for patients in larger inpatient facilities whose primary diagnosis is severe mental illness. And lest we forget that it’s election season, activity around the legislation is playing out against a wave of campaign ads politicizing the opioid epidemic.

While funding is a big part of the conversation around slowing the opioid epidemic, so is access to medication-assisted treatment (MAT), which is limited in part due to special DEA licensing and training requirements for providers to be able to prescribe buprenorphine products, which limit cravings. HHS has suggested that telemedicine could play a major role in supporting access to MAT, which also requires ongoing counseling, and even commercial insurers like Blue Cross Blue Shield have publicly supported better access to MAT. To address prescribing limits, the Senate would allow physicians prescribe buprenorphine to more patients (physicians are currently capped at the number of patients they are allowed to treat) and grant nurse practitioners and physician assistants permanent prescribing authority—a provision also included in the House bill. Regardless of how Congress goes about increasing access to MAT, it’s clear that current laws are out of step with public policy needs—something we expect to be a major point of discussion for manufacturers and advocates alike at ICER’s upcoming public meeting on opioid use disorder.


In the current populist environment, healthcare out-of-pocket costs (OOPs) continue to drive headlines and influence elections as we count-down to the mid-terms. Last week alone, we saw three significant stories around limiting OOPs for patients:
  • First, a group of senators drafted legislation that prohibits balance billing for emergency care, meaning that patients pay normal cost-sharing amounts, while insurers pick up the tab for 125% of the in-network rate.
  • The Senate passed a ban on gag clauses, which currently forbids pharmacists from telling customers when paying cash for a prescription would be a cheaper option than their insurance co-pay.
  • As backlash around copay accumulators has increased, some plan sponsors are moving to copay maximizers, which evenly spread manufacturer's copayment support throughout the year. The end result is less profitable for plans and manufacturers, but significantly better for patients.

As midterms near, politicians recognize healthcare to be a prime voting issue—and are acting accordingly, passing a spate of bills that aim to keep more healthcare dollars in voters’ pockets. At the same time, drug companies have been expanding support programs to insulate patients against high-deductible plans, accumulator policies, and formulary changes that are driving up patient contributions to prescription coverage. In the current environment where drug costs are both scrutinized and politicized, we advise our clients to be mindful about communicating value. Of course, value-based agreements and paying for outcomes are certainly important approaches and demonstrate confidence in the impact of novel therapies. But, don’t focus on value to payers alone. It’s critical for drugmakers to communicate their understanding of patient cost-sharing and myriad ways they are working to make treatments affordable to patients.


In June, legislative bellwether state California enacted the Consumer Privacy Act, which empowers consumers find out what personal information companies have collected, demand that the information be deleted, and block the sharing of that information with third parties. Sounds great—unless you’re a pharma company running clinical trials. Legislators failed to exempt clinical trial data from the law, meaning that trial participants could potentially ban researchers from using their data or unblind a study to determine whether they are in the active or the placebo arm of a trial. Life sciences trade groups have responded with a bill that prevents patients from accessing and deleting certain information with the goal of protecting the integrity of clinical studies.

At least 8,000 clinical trials are running or recruiting patients in California, which means that unblinding clinical trial participants could have a major effect on trials outside the state. While the California law presents new concerns, challenges with protecting the integrity of clinical trials has been an ongoing struggle in the age of social media. For example, we’ve seen patients both accidentally and intentionally unblind studies when sharing their trial experiences online.  While we expect legislators to tighten up the Cali law before scheduled enactment in 2020, we continue to advise drug makers that education and communication is key to clinical trial integrity. Trial participants are volunteers—they enter intro trials wanting to help themselves and other patients. It’s critical to empower them with information, clearly outlining not only the clinical risks and benefits, but explaining  the trial design, the importance of confidentiality and objectivity, and best practices for communicating about their experience while protecting study integrity—and providing them with resources if they have questions or concerns during the trial.

 Until next week,
  • The Reputation & Risk Management Practice

About the Author:

We are a team of healthcare communicators, policy-shapers and crisis response specialists. Drawing upon professional experiences from Congress, CMS, HHS, hospitals, and health technology—and our collective work in rare disease, oncology, diabetes, gene therapy, pain management and infectious disease—we provide unique solutions to the evolving messaging challenges in today’s healthcare industry. We support our clients with evidence-based approaches to preventing pricing pushback, protecting brands from modern activism, establishing and communicating clear policies surrounding expanded access to medicines, and a proactive approach to value frameworks. Our offerings also include product safety, litigation, regulatory risks, ex-U.S. considerations and policymaker investigations.