How Will Seniors Be Impacted by the Trump Administration's Medicare Policy?

As part of the Trump Administration’s plan to lower drug prices by introducing more negotiation and competition, in early August, CMS announced that one of the protocols used by many health insurance providers to control costs and limit drug access—step therapy—can now be implemented by Medicare Advantage (MA) health plans on new Part B prescriptions. Given that Part B medications are those that need to be administered in a provider’s office or in a hospital setting, older adults with arthritis and other chronic autoimmune diseases are effectively targeted by this policy.

The announcement may benefit biosimilar access (which is one of the administration’s main priorities to reduce healthcare costs), but it does so at the expense of shared decision making by providers and their patients. These important treatment decisions will now be made by insurers and their rigid protocols.

It can take months or even years before people living with arthritis or chronic disease find the therapy that works for them. Once the treatment is identified, medication stability becomes the gold standard for treatment, as it can prevent symptoms from flaring and reduce the risk of complications from disease progression.

While there is reason for physicians to try medications in succession, using a “fail-first” approach for nonmedical reasons, when the payer insists on a specific order only to save the system money, is misguided. For example, some plans will require a patient to try and fail on 1 or more prescription drugs—sometimes for more than 3 months—before covering the originally prescribed medication.

CMS requires the Part B MA plans to disclose their new policy, but merely informing patients of change isn’t the same as actually protecting them. Instead, they may even be surprised by higher out-of-pocket costs.

Despite claims from some health insurance providers, there is no evidence that savings stemming from step therapy protocols are passed on to the patients. However, everyone would welcome reduced costs if patients experienced savings (or better access), too. We believe that the policy ought to be clarified to reflect this goal.

Patients First, Savings Second

First, the CMS policy will be immediately improved if MA health plans are specifically prohibited from attempting to nonmedically switch patients to less expensive prescriptions if they are stable on their current treatments. Switching a patient’s medication can result in a patient getting sicker if they do not respond well, and certainly, addressing symptoms and complications is more expensive than leaving a stable patient on a therapy that works.

Second, science, not cost, should lead prescribing. Step therapy protocols need to be developed within the framework of credible data demonstrating efficacy and safety while understanding that individual patient response varies. There is no reason to insist that a patient fail on multiple drugs in the same class, but this is often the patient experience when 1 class of drugs is cheaper than another.

Third, it is vital that CMS monitor, police, and enforce its policy across the Part B MA plans. Likely, this objective can be accomplished with little headache if it is linked to insurers’ existing software that tracks prescriptions.

Biosimilars Top of Mind

With regard to biosimilars in the CMS announcement, MA plans are encouraged to start newly diagnosed seniors on “a cost-effective biosimilar before progressing to a costlier drug therapy.” This statement is concerning because if patients only gain access to these medications because they are known as being cheaper alternatives, it could negatively impact patient confidence in these options. When patients have confidence in their physicians, they typically report that they have better health outcomes, fewer symptoms, and a higher quality of life.¹ If a patient’s treatment becomes dependent more on the cost of their treatment, rather than the decisions made by their physicians, it could have an adverse effect on their treatment outcomes.

We believe that patients should have greater access to biosimilars not only because they may be the most cost-effective option, but because patients and their provider believe that these treatments are as effective as the reference drug. Period. But, if cost is the deciding factor, then patients should share in cost savings.

Since its inception, one of the best features of public and private Medicare Part B has been that patients are able to access their treatments without delay. That’s why healthcare providers, in collaboration with the patient, should be the primary treatment decision-makers. “Fail-first” policies prevent patients from receiving the right medication at the right time, and seniors can’t live with delays or risk disease destabilization.

While it may be too late to eliminate the practice of step therapy in the private healthcare market, it’s important to continue to speak out about how to improve the system to focus on 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.

Learn more about our efforts to advocate for people with chronic disease at www.50statenetwork.org.

Reference

1. Birkhäuer J, Gaab J, Kossowsky J, et al. Trust in the health care professional and health outcome: a meta-analysis. PLoS One. 2017;12(2): e0170988. doi: 10.1371/journal.pone.0170988.