|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…
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…
►MONEY, MAT TO STEM OPIOID CRISIS
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.
►REDUCING OOPS IN TIME FOR MIDTERMS
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:
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.
►CALI DATA BILL SPELLS TROUBLE FOR CLINICAL TRIALS
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,