By Dina Inverso
March 15, 2017
Managing the cost of prescription drugs is a major economic challenge. As a result, prior authorization requirements are more demanding than ever. And, for doctors and patients, navigating the maze of regulations and restrictions can be frustrating at best. At worst, patient access to lifesaving therapies sometimes hangs in the balance.
A paradigm shift is required for people with rare medical conditions who require chronic care with medicines that are life-sustaining. This is a cost for life, and payers should focus on lifetime management cost. But instead, from the reimbursement coverage perspective, the process has become more granular and we are seeing more and more hurdles being created.
A paradigm shift is required for people with rare medical conditions…
One of these hurdles has to do with whether a patient has the right lab values. Patients with common variable immune deficiency, whose lab results indicate decreased immunoglobulin levels, may be denied coverage because the levels aren’t “low enough,” even though their doctor has prescribed the medicine and determined that their patient needs it. Prescriptions are also frequently held up when insurers ask for additional and cumbersome amounts of documentation.
Laura Rohe is a registered nurse with Allergy, Asthma and Immunology Associates who has seen firsthand the increasing difficulty in obtaining prior authorization from insurance companies for immune globulin for primary immunodeficiency (PI) patients. Laura says that in the last six months, she has seen an increase in denials for this life-saving therapy, and it keeps getting worse every year.
Many payers require a magic number that a patient must hit before they are approved.
“Many payers require a magic number that a patient must hit before they are approved for intravenous or subcutaneous immunoglobulin, regardless whether they have suffered with chronic, severe or life threatening infections,” says Laura. “I have seen a patient with PI denied treatment even though her immunoglobulin G (IgG) level was less than 500 milligrams per deciliter. While we were appealing the denial she developed bronchitis and pneumonia.”
According to Laura, her office has submitted a third-level appeal for this patient, something they never had to do before. Not only are payers requesting a low IgG level for approval, she says she is seeing more denials if the doctors try and increase the grams due to increased infections or low trough levels.
“On top of that,” Laura adds, “if insurance companies see that a patient is still getting sinus infections they will deny treatment because they assume it must not be working. Unfortunately, they do not comprehend that these patients may still get sinus infections, just not severe, life-threatening ones such as sepsis and pneumonia.”
Doctors are being hit hard by the amount of medical documentation they are now required to provide. Some of them spend as much as 30 to 60 minutes on the phone with the medical director at an insurer justifying why they want to use a particular drug with a patient. This reduces clinical time the doctor could be spending with patients.
These types of administrative barriers function as obstacles to people getting the therapy they need. This heightens their risk of falling between the cracks. Making matters even more confusing, prior authorization requirements change from payer to payer for the same therapy. Cigna may have one set of requirements and Aetna another set for the same product.
As part of our promise to patients, we are working hard to reduce the confusion healthcare providers experience while documenting their patients’ therapeutic needs. Our reimbursement field team assists patients across the United States with navigating the voluminous paperwork that is required and, hopefully, take as much of the “worry” out of the process as possible.
Healthcare providers should include as much documentation as possible during the first submission.
Toward this end we developed a Prior Authorization Toolkit, based on research of major plans and policies, to help traverse insurers’ prior authorization requirements for immunoglobulin therapies. Our goal is to be proactive and to help navigate authorization requirements in the most expedient way possible. Healthcare providers should include as much documentation as possible during the first submission to minimize unnecessary churn.
We also created a Know Your Benefits: Patient Guide to help patients understand a benefits investigation, and determine their out-of-pocket expenses for the treatment of a primary immunodeficiency. The guide describes the most commonly requested codes and what they mean, and includes space for patients to fill in their own information.
We know how challenging it can be for people living with a rare disease, which is why we help patients become effective advocates when they interact with insurers. We also go the extra mile for patients. As an example, Lynne Szott on our reimbursement team helped the mother of two 19-year-old sons with hemophilia who had passed the maximum age eligible for coverage under the Florida State Children’s Health Insurance Program (SCHIP). As a result, they were covered through the Medicaid cost share program, for which they were required to qualify every month.
Under the cost share plan, a certain amount of medical bills must be incurred each month before Medicaid is approved.
Under the cost share plan, a certain amount of medical bills must be incurred each month before Medicaid is approved. This poses a risk for specialty pharmacies because of the longer time frame for payment and the possibility that from one month to the next, a patient could be denied coverage. Hemophilia patients in Florida are left with the option of either using Medicaid cost share, which is based on monthly income minus the monthly Medicaid income limit, or being classified as disabled by Medicaid, in which case they are extremely limited in the amount of income they can earn.
Lynne intervened on behalf of the family. She verified ineligibility through SCHIP and asked a representative why the brothers were not transitioned to the Affordable Care Act (ACA) plan. Next she met with the family and called the insurance exchanges on their behalf. Through Lynne’s efforts, the mother was able to enroll her sons in the ACA plan and receive a subsidy.
We will continue to do everything we can to prevent patients from falling between the cracks.
We will continue to do everything we can to prevent patients from falling between the cracks. But ultimately, we will need to make a paradigm shift in our approach to treating people with chronic conditions by managing the lifetime cost of treating their condition, and helping them stay healthy and out of the hospital, which represents the lion’s share of healthcare spending.
In order to do this we are working to persuade payers to think more long-term, which isn’t easy because they’re trying to save money today. We communicate with payers about their business model, the nature of the diseases we have therapies for, and seek to understand what they are trying to accomplish as an organization. When we are able to establish a relationship and common ground with a payer, the likelihood of a satisfactory outcome on the patient’s behalf increases.
Dina Inverso is CSL Behring’s US Leader Reimbursement and Patient Engagement