August is always a quiet time on Capitol Hill because both congressional chambers “recess” and Members of Congress return home for several weeks. The time just before and after the August recess, however, tends to be extremely active – and this year’s been no exception. Below is a high-level overview of the highlights and RNS’ activities. Please get in touch with us () if you have questions or would like more information!
Federal Reform of Utilization Management Remains a Top Priority
RNS remains heavily engaged in federal reform of insurance issues, including utilization management reform and protection of patients’ ability to access the full value of copay assistance. On these issues, we have developed strong working relationships with a number of coalitions. For example, RNS is an active participant in the Safe Step Act Coalition, which is entirely devoted to enactment of legislation to reform the use of step therapy in employer-sponsored coverage. At the time of this writing, that legislation has over 100 House cosponsors and 35 Senate cosponsors. When legislation has over one third of all Senators listed as cosponsors, that is a positive indicator of its chances of enactment. In fact, the question isn’t whether there is bipartisan support for the policy, since it’s very clear there is. Rather, the question will be: what’s the “vehicle” for enactment? Very few bills get standalone votes on the Senate Floor, so the Safe Step Act will likely need to be “attached” to a bigger bill. There seems to be momentum behind attaching the Safe Step Act to broader reform of the pharmacy benefit manager (PBM) industry: the Senate HELP Committee incorporated the bill via amendment into its PBM reform package, which advanced out of Committee back in May. Heading into the fall, RNS will continue to engage via the Coalition to seek out “moving vehicles” into which the Safe Step Act can be incorporated.
RNS Weighs in on Implementation of “Maximum Fair Price” Mechanism
The Inflation Reduction Act (IRA) was a sweeping piece of legislation touching a wide range of policy issues, including healthcare. Within its healthcare provisions, the IRA included a provision requiring Medicare to – for the first time – directly establish prices for certain selected Part B and D drugs. The program starts with Part D drugs first, so in August, the Centers for Medicare and Medicaid Services (CMS) issued its first list of ten selected Part D drugs. That announcement kicks off a back-and-forth between the affected drug company and CMS on each of the ten products to arrive at a “maximum fair price” (MFP), which would ultimately become effective in 2026. The first list of ten includes Enbrel and Stelara, two commonly used medications in rheumatology. CMS has provided the public an opportunity to weigh in with the agency on the selected drugs, and RNS decided to take advantage of that opportunity. Specifically, we wanted to ensure that the agency keeps in mind the unique situation of Stelara, which, unlike the other drugs on the list, has both a provider-administered and a self-administered version. Accessing the provider-administered version of Stelara has become very challenging for Medicare beneficiaries because Medicare Administrative Contractors (MACs) have excluded the drug from Part B coverage and will only cover it in Part D. Not only does that create financial barriers for patients, it also leaves beneficiaries who cannot self-administer without access to the medication. These access issues have gotten so severe that CMS is currently reevaluating the process by which the MACs exclude medications in this situation from Part B coverage. In our submission to CMS about the MFP list (read the submission), we focused entirely on this unique situation surrounding Stelara, urging the agency to ensure that implementation of an MFP for this medication in Part D does not exacerbate the existing challenges for beneficiaries who need the provider-administered version.
Key Senate Committee Advances Healthcare Workforce Legislation
At the end of July, the Chairman of the Senate Health, Education, Labor & Pensions (HELP) Committee, Senator Bernie Sanders of Vermont, announced that the Committee would consider the Primary Care and Health Workforce Expansion Act the following week, just before leaving town for August. The underlying legislation included provisions that virtually all provider groups – including RNS – support, including prior authorization reforms and, as the bill title suggests, primary care workforce investments. With regard to the latter, the bill proposed investments in two-year registered nursing program enrollment, as well as in the NURSE Corps scholarship and loan repayment program. Of course, these provisions require federal government spending, which means that they also require a “pay-for” to offset that spending. Unfortunately, the “pay-fors” is where legislation often falls apart and, here too, the pay-fors included in the bill generated heartburn for several stakeholders.
Most relevant to the world of rheumatology, the bill proposed to entirely eliminate the standard of “interchangeability” for biosimilars. Going forward, all biosimilars approved by the FDA would be “deemed” interchangeable and, therefore, fully switchable with the brand/reference product. There were other pay-for provisions that caused concern for the hospital and provider communities. We closely monitored the stakeholder input provided on the legislation, which ultimately resulted in Chairman Sanders pulling the bill from the Committee’s calendar. Instead, he committed to reworking the bill on a bipartisan basis throughout August, with the goal of rescheduling consideration of the bill in September.
On Thursday September 21, the Committee did exactly that. Although many of the positive workforce investment provisions were retained, the language striking the interchangeability standard was removed. For our part, we strongly support workforce initiatives for advanced practice providers, but have concerns with lowering standards at FDA for the complex medications our patients use, so removal of the interchangeability provision greatly improved the legislation from our perspective. The bill was voted out of Committee, providing the perfect example of how quick stakeholder activation can help shape legislation for the better at critical moments.
RNS Hosts FDR at Town Hall Series “Breaking Down Biosimilars”
On September 28, RNS hosted the fourth session of our virtual town hall series entitled “Breaking Down Biosimilars.” This particular session focused on biosimilar pathways, and what’s to come. We were honored to have as our guest Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars at the Food and Drug Administration (FDA). Joining Dr. Yim for a live streamed conversation were Kevin D. Lyons, RNS Executive Director, and RNS Board Member Barbara Kienzle, BSN, RN. The discussion was wide-ranging, touching on a variety of topics related to biosimilars, including of course FDA’s regulatory approach to these products, as well as the market response to them. As an example of the latter, where insurers used to cover just one biosimilar, now the covered list tends to be much longer, which requires clinicians to choose among various biosimilars. Dr. Yim stressed the fact that each of the biosimilars in the same product class (i.e., sharing the same brand reference product) cannot have meaningful clinical differences as compared to the original biologic. When FDA reviews a biosimilar application, they know that patients may be switched among different products in the marketplace, so they have to be – and are – very confident before they approve any biosimilar. There is never a product that stands out as “suspicious” in terms of patients’ ability to tolerate being switched to it, because if that were the case, that product would never have been approved in the first place. When it comes to pharmacovigilance, biosimilars are treated no different than any other biologic, meaning that FDA’s Office of Surveillance and Epidemiology reviews every MedWatch report and watches the literature for signals. The conversation also touched on why some biosimilars are approved for only some of the brand’s indications but not others, and tackled the most debated issue in biosimilars policy at the moment: is the interchangeability standard still necessary? If you missed it, it’s worth watching: click below to do so.Watch the Video
We Need You for our Advocacy Program!
In August, we hosted our annual Conference in Austin, Texas, which included a presentation entitled, “From Policy to Practice: Enhancing Rheumatology Nursing Through Legislative Engagement.” The talk provided an overview of how to effectively engage in outreach and advocacy to policy makers. Whether or not you were able to attend, we’d love to recruit you for our advocacy efforts!
The easiest, quickest way to get involved with our legislative outreach is to visit the RNS Action Center.
COMING SOON: 2024 RNS Advocacy Summit & Hill Day
Additionally, we’ll soon finalize the dates for our annual in-person RNS Advocacy Summit in Washington D.C. in the early spring of 2024, and we hope to see many of you there. Although visiting the Congress may seem intimidating, we will take care of all the logistical details and—most importantly—provide you with all the talking points you need to ensure successful visits with your congressional delegation.