As 2021 winds down, I reflect on the achievements the rheumatology community has had in the realm of advocacy throughout the year. And there were many: Seven states signed accumulator program bans into law, five states reformed the use of step therapy protocols, Texas passed an innovative “gold carding” law to reduce the burden of prior authorization, and West Virginia passed a rebate pass-through law to directly assist patients with high out-of-pocket costs – the first of its kind in the nation.
Dr. Madelaine Feldman
Of course, the close of another year also means gearing up for the year ahead. The majority of state legislatures are getting ready to open legislative sessions in the New Year. This means a year of new opportunities and new challenges. As a community, there are some key areas rheumatology will need to focus on during the course of the upcoming year as policy makers return to the business of policy making.
Many in the rheumatology community are aware that the buy and bill acquisition system has come under threat in recent years, mainly from payer mandates to use the alternative white bagging model. In some cases, payers have gone as far as to mandate the practice of “brown bagging,” or home infusion. These practices can endanger patient safety and overall quality of care. A study led by Matthew Baker, MD, of Stanford (Calif.) University found that biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care; specifically, home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after infusion, compared with facility infusions, and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. Additionally, site-of-care research by Paul Fronstin, PhD, at Employee Benefit Research Institute clearly shows that in-office infusion with physician supervision is far more cost effective than hospital and, in some cases, home infusion as well.
Further, the metastasis of these payer mandates is likely to severely limit availability of and access to care. It is unclear whether outpatient infusion, especially in private rheumatology practices, will prove sustainable in a world of white bagging. The net result of an expansion of the white-bagging requirements may well be broad access challenges that inconvenience patients deeply and irresponsibly.
The expansion of these mandates has not come without pushback, and rheumatologists should be prepared to advocate for policy that prohibits payers from mandating the use of white bagging, brown bagging, and home infusion. It is abundantly clear that arguments of safety and cost effectiveness are sufficient grounds for policy makers to curtail the mandatory use of these practices.
Similar to white bagging, another key issue in the year ahead is formulary construction based on the rebate system and proposed policies to address its attendant problems. Propagated by pharmacy benefit managers (PBMs), the rebate-based, or kickback, system of formulary construction often rewards higher-priced drugs with preferred placement regardless of whether they are the best and most affordable medications for our patients. A few states are beginning to address the affordability issue by mandating that the rebate/kickback acquired by the PBM be passed back to the patient at the point of sale. West Virginia passed a first-of-its-kind law to ensure that patients who generate drug rebates benefit from them by requiring that their cost shares are reduced by an amount equivalent to the rebate received by a health plan. This policy does not get at the root of the formulary construction problem, but if it is adopted more broadly across the country, it will deliver direct relief to patients who are struggling with out-of-pocket costs associated with prescription drugs. I anticipate that this will be a prominent issue nationwide during the upcoming year with opportunity for rheumatologists to lend their voices.
Many of the rheumatology community’s longstanding issues persist, and while progress has been made, more work remains to be done. Whether it’s accumulator programs, prior authorization, nonmedical switching, or step therapy, there will be opportunities in almost every state to engage in improving our ability to provide excellent care to our patients.
We tend to be motivated into action when one of these individual issues appear in our own state’s legislature; however, consistency of engagement is also important. While it is important to talk to your legislators when you need them to vote a certain way on a certain bill, scheduling a meeting with them or sending them a message detailing some of the issues that the rheumatology community faces before legislatures return in full swing is equally important to establish the relationship.
By making “rheum for action” now, you’ll have more impact when legislation relevant to our daily work does appear in the state legislatures. You can find your state representatives at the Coalition for State Rheumatology Organization’s Action Center.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.