On August 7th, the Centers for Medicare & Medicaid Services (CMS) announced that Part B Medicare Advantage health plans are now able to implement step therapy  and other drug-limiting programs – on new prescriptions for medications that many people with arthritis take. This is part of the Trump Administration’s plan to lower drug prices by introducing more negotiation and competition. While the new policy requires plans disclose these practices to patients, that’s small comfort to chronic disease patients who rely on these drugs and are merely warned by CMS that there may be instances where enrollees will experience higher out-of-pocket costs. This is not good for patients and does not represent lower costs to them. With a few tweaks, however, the program can protect patients from paying more.
Part B medications are treatments that need to be administered in a provider’s office or in a hospital setting. Patients with rheumatoid arthritis and other autoimmune diseases are often forced to use medications covered under Medicare Part B because of the complexity and progression of their disease. Therefore, this policy has the effect of targeting chronic disease patients.
Don’t Fail First. Succeed First.
Step therapy, or “fail-first”, protocols are a one-size-fits-all, cost-saving practice which requires patients to try and fail on one or more prescription drugs — sometimes for as long as 130 days — before coverage is provided for the medication originally chosen by the patient’s health care provider. Sometimes physicians endorse fail-first for medical reasons, but when it is used solely to save the system money, it can be misused. Using step therapy, insurance companies save money by starting patients on older, less expensive medications, thereby delaying or even overriding a treatment plan created by a doctor and patient. These unnecessary practices undermine physicians’ ability to effectively treat patients and lower the quality of care, potentially resulting in setbacks and disease progression.
Further, despite claims from some insurers, there is no evidence that savings are passed on to the patients.
This is what’s most concerning about the CMS plan. It doesn’t save the patient money, but equally important, the policy could be expanded to everyone using Part B and stabilized on their medication to fail on other medicines before getting back to the one that works for them. We prefer to see patients succeed first, not fail first, and we think CMS does, too.
Three tweaks to help ensure patients succeed
The tweaks that will help ensure patients succeed first are simple. First, put the patient first. Patients who are stabilized on their drugs need to be left alone. It can take a long time to find the right drug or drugs to combat serious autoimmune diseases, so the successful patient needs to be protected. Destabilizing a patient doesn’t save money, it costs money.
Second, the actual procedure for trying different drugs needs to be scientifically rigorous, not just economically expedient. We don’t see any reason to force a patient to fail on drugs in the same class, but this is what can happen when one class of drugs are the cheapest. In this case, the insurer is favored, not the patient.
CMS optimistically expects health plans will put the patient first and that savings will be passed on to them, but this doesn’t generally happen. Insurers are in business to make money. Without providing any specific form of policing, there is no way to ensure that these health plans are following through on those expectations. The third tweak is monitoring and enforcement. Luckily, this can be done nearly automatically with insurer’s existing software that tracks prescriptions.
The downside to “fail-first”
In Massachusetts, the Global Healthy Living Foundation (GHLF) and a coalition of more than 30 patient advocacy groups have, for the past two years, educated legislators about the downside to patients of “fail-first”. Some health plans force patients to use and fail on up to three medications before they might have access to the treatment their provider originally prescribed based on a professional assessment of a patient’s individual need. CMS can learn from Massachusetts’ mistakes, save money, and have healthier seniors.
For example, Susan D-P. (pseudonym for privacy), a volunteer patient advocate with the Global Healthy Living Foundation’s grassroots advocacy arm, the 50-State Network, witnessed her husband, Neal, progress through “fail-first” protocols to treat an infected leg wound. Frustratingly, his doctor correctly predicted that the first medicine in the step therapy protocol would likely be ineffective, but the insurance company refused to cover a more expensive treatment despite the infection spreading over time. After several months of calling and fighting, Susan was able to get her husband’s original medication covered, but not before he had to get treatment five times a week in a hyperbaric chamber so the infection in his leg didn’t spread even more. CMS can learn from this and make sure “fail-first doesn’t cost more than succeeding first.
This past session, bills that would have prevented that from occurring in Massachusetts failed to gain enough support and patients remain subject to these dangerous practices. By allowing step therapy to be used in Medicare Advantage plans, more seniors will be forced to fight, just like Susan, to get their prescribed treatments.
Easy tweaks can save money and keep seniors safe
While we understand and appreciate the administration’s attempt to lower drug prices for Medicare patients, we do not believe that inserting the one-size-fits-all model of step therapy into Part B Medicare Advantage plans is the way to do it when easy tweaks can save money and ensure healthy seniors.
Without these tweaks, potentially dangerous delays in access to effective treatments will face a mostly elderly patient population that can ill afford these types of setbacks. Since its creation, one of the best features of Medicare Part B, even the privately managed Medicare Advantage plans, has been that patients are able to access their treatments without delay. Seniors can’t live with delays.
GHLF believes a patient’s health care provider should have the ultimate treatment decision-making capability for their patients. “Fail-first” stands in the way of patients receiving the right medication at the right time. It may be too late to completely eliminate the practice in the private healthcare market, but our organization and others that represent patients and providers will continue to fight for sensible patient-focused decisions as well as an easier appeal process so that patients can access the treatment outlined by their provider before any damage occurs.
We’re inviting chronic disease patients concerned about the CMS policy to learn more at www.50statenetwork.org.
 “CMS empowers patients with more choices and takes action to lower drug prices” Press release. https://www.cms.gov/newsroom/press-releases/cms-empowers-patients-more-choices-and-takes-action-lower-drug-prices