The final rule that would allow Part B Medicare Advantage health plans to implement step therapy and other drug-limiting programs was announced by the Center for Medicare & Medicaid Services (CMS) on May 16, 2019. You can read about it this press release entitled “CMS empowers patients with more choices and takes action to lower drug price.” This rule is part of the Trump Administration’s plan to lower drug prices by introducing more negotiation and competition.

The problem is that these “fail first” programs will adversely affect people with arthritis and other chronic illnesses. Here’s why.

What are Part B medications?

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, as well as many other chronic disorders, are often forced to use medications covered under Medicare Part B. This is because of the complexity and progression of their disease on other types of treatments.

It should be clear, therefore, that policies like this have the effect of targeting people with chronic diseases.

The initial proposed rule described in the press release (above) had many patient organizations worried, including the Global Healthy Living Foundation (GHLF). However, the final rule appears to have taken public comments into consideration.

It implements a number of safeguards that patient groups can support. This is because these new components of the regulation seem to ensure that these programs are put in place with the patient at the center of all discussions.

Let’s dive into some of the ways in which these safeguards may accomplish that.

Don’t fail first, succeed first

Step therapy, or “fail-first”, protocols are a one-size-fits-all cost-saving practice that requires patients to try and fail on one or more prescription drugs before accessing the more costly prescription drug their doctor has prescribed. Sometimes the drug trial may last for as long as 130 days.

This drug trial must take place 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 first. This delays or sometimes even overrides a treatment plan created by a doctor and patient. These medically unnecessary practices undermine physicians’ ability to effectively treat patients. They also lower the quality of care. This can cause setbacks and disease progression in some cases.

Change in Step Therapy Protocols

Many of us in the patient community were concerned that the decision to allow these policies into Medicare Advantage plans would disrupt the coverage of some of the most vulnerable patients in our community. However, in an effort to alleviate these concerns in the final ruling, CMS determined that step therapy protocols can only apply to when patients begin a new medication. In other words, beneficiaries who are actively taking a Part B drug are exempt from going through the step therapy requirement.

Stabilization – No Sudden Changes

This addressed one of our major concerns by ensuring that patients who are currently stable on their medications are not subjected to a sudden change in treatment. 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. We prefer to see patients succeed first, not fail first. This change in the CMS’ final rule seems to do that.

Put the Patient First

Another important issue is that despite claims from some insurers, there is no evidence that savings from these drug limiting programs are passed on to the patients. CMS optimistically expects health plans will put the patient first. And, they expect that savings will be passed on to them. However, 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 these expectations.

Monitor and Enforce Regulations?

Prior to the final rule coming out, CMS attempted to address this concern by stating that Medicare Advantage plans are subject to penalties if they do not spend at least 85% of their revenue on healthcare services and quality improvement activities.

While we would have liked to see instructions that more explicitly state that this 85% directly benefits patients, we appreciate that CMS is attempting to address these concerns in a general manner.

However, we still believe that monitoring health plans and proper enforcement of these regulations is key. Luckily, this can be done semi-automatically if the insurer’s existing software is able to track prescriptions.

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One Size Doesn’t Fit All

We understand the administration’s attempt to lower drug prices for Medicare patients. We also appreciate their attempt to ease some of the concerns of the patient community between the initial rule and the final rule.

However, 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. Particularly because easy tweaks can save money and ensure healthy seniors.

Without further tweaks to the system, the elderly patient community faces potentially dangerous delays in access to treatment. Of course, they are the beneficiaries 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.

Patient-Focused Decisions

GHLF believes a patient’s healthcare provider should have the ultimate authority to make treatment decisions. But ‘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 health care market. However, our organization and others that represent patients and providers will continue to fight for sensible patient-focused decisions. We will continue to advocate for an easier appeal process that allows patients to access the treatment outlined by their provider before any damage occurs.

We invite chronic disease patients concerned about the CMS policy to learn more at www.50statenetwork.org.

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