NYS-S3419C/A.2834D passed in the New York State Senate and New York State Assembly- signed by Governor Cuomo
SIGNED BY GOVERNOR
Governor Cuomo Signed The Expedited Utilization Review of Prescription Drugs Bill.
As part of LI TRIO’s legislative and advocacy efforts in New York State, our volunteers met in person with elected officials, placed phones calls and sent letters to our Senators and Assembly Members in Albany. The New York State Senate subsequently passed S.3419C and The NYS Assembly passed A.2834D. The bills amend the insurance law and the public health law in relation to insurance carriers responding to appeals with respect to prescription drugs not necessarily included in the insurance carrier’s formulary. The bill still needed to be signed by Governor Cuomo by the deadline which was December 31, 2016. Congratulations to all Long Island TRIO volunteers. This bill has become law in New York State.
LI TRIO was part of over 60 support groups, patient organizations and provider organizations statewide and across the nation that supported and advocated for this important legislation.
The law will finally deal with “fail first” policies. With fail first policies, the physician is told to prescribe and the patient is told to try one or more less expensive drugs on the formulary instead of the medication that the physician feels he or she needs to prescribe in the patient’s best interest. If those medications failed to address the original issue, an appeal would have been made and the original prescription for the more expensive medication would be considered and might have been approved by the insurance company.
If a New Yorker’s physician wants to prescribe an immunosuppression medication for example, in some cases insurance companies were able to utilize a “step process” where the physician was told that a less expensive different immunosuppression medication would have to be tried first and if it failed, there would be an appeal and the physician’s original choice of medication could be available for the patient.
Now, insurance carriers and HMO’s will have to consider evidenced based and peer reviewed clinical data that is appropriate for the patient’s medical condition. This data will be considered as part of an appeal and going forward, appeals are permitted to be submitted immediately. The law requires that insurance companies consider these types of appeals in a timely fashion and the patient and his or her physician must receive an expedited response to the appeal. The insurance company must provide an answer to the appeal within 72 hours. If the insurance company fails to provide an answer or any response whatsoever within 72 hours, the physician and patient automatically win the appeal.
It’ a fact that in the past, patients were forced to try less expensive medications, and only after it was confirmed that the less expensive medication “failed”, the originally prescribed medication had a chance of being approved by the insurance company. This certainly was not in the interest of physicians and patients.
This bill was passed by both houses in Albany and although the law will not ban all fail first policies, it will provide an effective process and path to appeal the insurance carrier’s decision. Other states such as Indiana, West Virginia, Illinois and Missouri recently passed similar laws.
In December, we asked that our chapter’s volunteers call Governor Cuomo at 518.474.8390 and request that he sign S3419C by December 31st. I’m pleased to report that the bill was successfully signed into law right at the deadline. This law went into effect on January 1, 2017 and applies to health insurance and health benefit plans delivered or renewed after January 1st.
Here’s to a healthy 2017 and once again thank you to all Long island TRIO volunteers.
Details of bill:
An act to amend the insurance law and the public health law, in relation to expedited utilization review of prescription drugs
Purpose of bill:
The purpose of this bill is to regulate insurance companies, health maintenance organizations (HMOs), and utilization review agents who impose step therapy protocols on patients and to provide for an expedited appeals process for patients and their health care professionals to override such protocols.
Summary of provisions:
Sections 1 and 2 amend Section 3217-a (b)(10) and Section 4324 (b) (10) of the Insurance Law to require health insurance companies to provide patients and health care professionals with specific written information on their clinical review criteria relating to a decision made to utilize a step therapy protocol for a particular patient.
Section 3 amends Section 4900 of the Insurance Law to define key terms such as “Step therapy protocol override determination” and “Step therapy protocol.”
Step therapy protocol means a policy, protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition are approved for a particular patient. Step therapy protocol override determination means a determination made by a utilization review agent to override a step therapy protocol.
Section 4 amends Section 4902 (a) of the Insurance Law by adding a two new subdivisions (10) and (11). Subdivision 10 requires a utilization review agent to utilize evidenced-based and peer reviewed clinical review criteria that is appropriate for a patient’s medical condition when establishing a step therapy protocol. Subdivision 11 requires a utilization review agent to utilize evidence-based and peer reviewed clinical review criteria that is appropriate to a particular patient and such patient’s medical condition when making a determination about whether to override a step therapy protocol.
Section 5 adds three new subsections (c-a), (c-b) and (c-c) to the Insurance Law to provide an expedited process for patients and health care providers to override a step therapy protocol. A determination must be made within 24 hours of the receipt of all information from the patient and/or health care provider in emergency cases. This section establishes standards for an override determination. Upon a determination that the step therapy protocol should be overridden, the health plan must authorize immediate coverage for the prescription drug prescribed by the patient’s treating health care provider.
Section 6 amends Section 4902 (a) of the Insurance Law to provide that if an insurance company or utilization review agent fails to respond within the required timeframes, the appeal shall be deemed granted in favor of the patient.
Sections 7, 8, 9, 10 and 11 make identical amendments as those
described above to the Public Health Law to regulate step therapy or
fail first protocols imposed by HMOs.
An amendment is made to the Unconsolidated Laws to provide that the
bill shall not be construed to prevent: a health care plan,
utilization review agent, or pharmacy benefit manager from requiring a
patient to try an AB-rated generic equivalent prior to providing
coverage for the equivalent branded prescription drug; or a health
care provider from prescribing a prescription drug that is determined
to be medically appropriate.
Section 11 provides for an effective date of January 1, 2017
applicable to health insurance and health benefit plans delivered,
issued for delivery, or renewed after such date.
Justification of bill:
The Legislature makes the following findings:
(1) Health insurance plans are increasingly making use of step therapy
or “fail first” protocols under which patients are required to try one
or more prescription drugs before coverage is provided for a drug
selected by the patient’s health care provider.
(2) Step therapy protocols, where they are based on well-developed
scientific standards and administered in a flexible manner that takes
into account the individual needs of patients, can play an important
role in controlling health care costs.
(3) In some cases, requiring a patient to follow a step therapy
protocol may have adverse and even dangerous consequences for the
patient who may either not realize a benefit from taking a
prescription drug or may suffer harm from taking an inappropriate
(4) Without uniform policies in the State for step therapy protocols,
all patients may not receive the equivalent or most appropriate
(5) It is imperative that step therapy protocols in the State preserve
the health care provider’s right to make treatment decisions in the
best interests of the patient.
(6) Therefore, it is a matter of public interest to require health
insurance companies and utilization review organizations to base step
therapy protocols on appropriate clinical practice guidelines or
published peer review data developed by independent experts with
knowledge of the condition or conditions under consideration; that
patients be exempt from step therapy protocols when inappropriate or
otherwise not in the best interest of the patients; and that patients
have access to a fair, transparent and independent process for
requesting an excep- tion to a step therapy protocol when the
patients’ physician deems appropriate.
The following states have enacted strong laws to prohibit or limit
step therapy or fail first practices: Connecticut, Kentucky,
Louisiana, Maryland, Mississippi, Indiana and Washington. Patients in
New York currently subject to step therapy or fail first practices
require similar protections.
2015: S.3419-A Referred to Insurance
2013/2014: S. 2711A Referred to Insurance
2012: S.6464/A.9397 Referred to Insurance