Our Advocacy Issues

Increase Step Therapy Guardrails

The issue

Step therapy is a utilization management practice whereby health plans or Pharmacy Benefit Managers mandate patients try less expensive medication options before “stepping up” to more expensive medications, if necessary. Step therapy is also known as “fail first” because patients must fail on the mandated medication before the patient can perceive the doctor-prescribed medication. For people with bleeding disorders, failing on a medication could lead to spontaneous and uncontrolled bleeding into joints, muscles ot other organs, potentially causing permanent damage, chronic pain, or even life-threatening emergencies.

A 2021 Tufts University study of the 17 largest commercial payers found 38.9% of policies had step therapy, 55.6% of step therapy rules were more strict than clinical guidelines, and 33.4% of the time patients were required to step up through more than one medication. Step therapy protocols were found to be included in 77.3% of health insurance policies for people with complex, chronic diseases like multiple sclerosis and Hepatitus C.

What is being done:

S,1267/A.901 “ An act to amend the insurance law and the public health law, in relation to requiring a utilization review agent to follow certain rules when establishing a step therapy protocol,” has been passed in the Senate but remains in committee in the Assembly.

Under S.1267/A.901:

· Patients can’t be required to try an off-label medication

· Patients can’t be required to try and fail on more than one medication

· Patients can’t be required to try a medication for more than 30 days

· Patients can’t be required to try and fail on a medication if they were already covered for a doctor-prescribed medication in the previous year

· Patients can’t be required to try a medication if they already failed on it (even on a different plan)

· Patients can’t be forced to try other medications if they’re already taking a covered medication and a plan/PBM changes their formulary

· Plans/PBMs must accept letters of medical necessity from a prescribing doctor

· Step therapy overrides granted by a plan/PBM ust be honored for 12 months

· Failure to follow these guardrails constitutes grounds for the patient to receive an automatic override of a step therapy ruling.

S.1267/A.901 balances cost concerns with medical principles. Health plans and PBMs will still be able to apply step therapy and patients will be protected from unsound step therapy policies. S.1267 passed the Senate in 2022. It passed again in 2023 by a vote of 59-3. We are now working with the Assembly to secure more co-sponsors and passage this session.

PriorAuthorization Reforms

The issue:

Prior Authorization is a practice by payers (health insurance plans and Pharmacy Benefit Managers – PBMs) that requires a patient, doctor, or pharmacy to seek special permission from the payer to provide a patient with a treatment already covered by the patient’s health plan. Prior authorization rules are set by the payer and differ for each payer. The rules may require a patient, doctor, or pharmacy to submit additional information and receive approval before providing the medication or treatment. The original purpose of prior authorization was to limit unnecessary and potentially fraudulent insurance claims.

Differing prior authorization rules, the extra information required, and the extra time needed to meet these requirements and receive authorization can cause several problems. Patients, doctors, and pharmacists may have trouble understanding the extra requirements. The extra work involved increases costs to payers, doctors, and pharmacists. It can also delay patients from receiving necessary care, which can harm the patient’s health and lead to complications (which require additional treatment).

A growing problem for people with chronic medical conditions is the requirement to get prior authorization for every medication refill. Many people with bleeding disorders regularly use clotting medication to control bleeding and may