Alphonso David, Esq.

Counsel to the Governor

State Capitol, Executive Chamber

Albany, NY 12224

RE: A.2834-D (TITONE)/S.3419-C (YOUNG) - AN ACT to amend the insurance law, in relation to the regulation of step therapy policies 

Dear Mr. David:

We are writing to you to urge that you recommend that the Governor sign into law the above-referenced legislation that would better assure that patients will have coverage for necessary prescription drug therapies that are recommended by their treating physician, by defining the criteria and time frames for a health insurer to consider a request for an override of any “fail first” or “step therapy” drug protocol that may otherwise be required.   

The ability of patients to receive needed prescription medications is an essential component to assuring recovery from or managing a particular illness or condition.   Too often, however, decisions regarding coverage for prescription drugs provided under health insurance company formularies are compromised by the companies’ and PBM concerns regarding profits for their shareholders.    Insurance companies impose significant restrictions ranging from higher co-payments and coinsurance to burdensome bureaucratic approval requirements such as pre-authorization, or other requirements that require a patient to “fail first” on a particular medication before taking a medication that the physician believes is most appropriate for treating the patient’s condition. 

While these policies can be helpful in some cases to reduce unnecessary spending of limited premium dollars, these restrictions can also sometimes go too far and hinder patients’ ability to initially receive or remain stabilized on prescription medications that their physician has determined to be most suitable to treat their particular condition.  Among the patients most adversely impacted by these step therapy restrictions are patients suffering very serious medical conditions such as mental illness, multiple sclerosis, lupus, arthritis and cancer.   We also frequently hear complaints from physicians regarding their patients being forced to switch ACE inhibitors and/or statins when they switch insurance coverage despite the patient’s high blood pressure or cholesterol being stabilized on a particular medication.  As set forth in recent medical journal articles, developing and complying with an insurer step therapy protocol presents ethical concerns regarding the proper balance between cost control and the ability of patients and clinicians to tailor care to the needs of the individual patient.[1]

[1] Nayak & Pearson, The Ethics Of ‘Fail First’: Guidelines And Practical Scenarios For Step Therapy Coverage Policies, Health Affairs, October 9, 2014

This legislation would better enable a patient’s treating physician to quickly request an override of health plans’ and PBMs’ use of “fail first” protocols that prevent or delay patients from receiving medications believed by the treating physician to be most beneficial for the patient.  Recent surveys by MSSNY and the New York State Academy of Family Physicians detail the extent to which these “fail first” protocols delay and adversely affect patient care, are challenging and time consuming and limit clinical judgment in determining what medication will be most effective for patients.  For example, 90% of physicians indicated that step therapy protocols at least “sometimes” adversely affected their patients and 46% indicated that it “frequently” adversely affected patients.  The surveys also found that 94% of respondents support the concept of requiring insurers to provide an expedited process to exempt patients from step therapy protocols when the drug they prescribed is medically necessary.   These surveys clearly demonstrate why legislation is needed to assure our patients can get the medications they need without having to needlessly wait weeks or months to comply with insurance company protocols.  This important legislation would not prevent insurers from imposing step therapy protocols, but instead define a process and criteria for which insurers must override the protocol where the physician can demonstrate the following of the step protocol is not in the best interests of the patients’ health.

For all the above-stated reasons, the Medical Society of the State of New York supports this bill and urges its enactment.



cc: Axel Bernabe, Esq.