Step Therapy Reform Passes in Ohio Legislature
As the whirlwind of activity in this year’s “lame duck” legislative session continues, the OSMA is excited to report that physician and patient advocates have achieved a major victory with step therapy reform passing through the Ohio Legislature. For the OSMA, this success comes on the heels of passage of tort reform legislation (HB 7) earlier this month.
Step therapy is the process by which a health insurer can deny coverage of a prescribed medication, requiring that the patient first try a different medicine. This is usually done as a cost savings tool for the insurer. A physician may originally prescribe a certain medication for a patient, but the patient must "fail first" on a drug chosen by the insurer.
The OSMA worked for several years to support step therapy reform legislation (SB 56/HB 72) with a large coalition of groups representing the medical community and patients. This month, SB 56 passed out of committee in the Ohio Senate, and was then amended into another health care-related bill.
By late last Thursday, the amended proposal had subsequently passed through both chambers of the legislature. The bill is expected to be sent to Governor John Kasich soon to be signed into law in Ohio.
Step therapy reforms included in this legislation will apply to health benefit plans issued or renewed on and after January 1, 2020. The bill's requirements will also apply to the Medicaid program, adapted slightly but functionally the same as the requirements applied to health plan issuers.
The new law will usher in a safer and more effective step therapy process for physicians and patients alike by imposing requirements on health plan issuers that implement a step therapy protocol with regard to prescription drugs. Specifically, it will:
• Require a step therapy protocol utilized by a health plan issuer to be based on clinical practice guidelines or scientific evidence;
• Require health plan issuers to provide a clear, accessible, and convenient process by which a provider can request a step therapy exemption; and,
• Require health plan issuers to make disclosures with regard to a step therapy protocol.
Additionally, this legislation specifies circumstances in which a health plan issuer must grant a step therapy exemption, which will be as follows:
• The required prescription drug is contraindicated for that specific patient, according to the drug’s United States Food and Drug Administration (USFDA) prescribing information;
• The patient has tried the required prescription drug while under their current, or a previous, health benefit plan, or another USFDA approved AB-rated prescription drug, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event; or,
• The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration, regardless of whether or not the drug was prescribed when the patient was covered under the current or a previous health benefit plan.
The bill also imposes deadlines by which a step therapy exemption request or appeal must be either granted or denied by the health plan issuer:
• Within ten calendar days of receiving the request; or,
• Within 48 hours for urgent care services.
Should a request not receive approval or denial within this allotted time period, it will be considered approved. Upon granting a step therapy exemption, the issuer will be required to authorize coverage of the prescription drug in question.
An appeal of a denied step therapy exemption request will be handled between the prescribing provider and a clinical peer (health care practitioner in the same or similar specialty that typically manages the medical condition, procedure, or treatment under review).
The OSMA is pleased that years of hard work with the Ohioans for Step Therapy Reform coalition have resulted in this success, and that Ohio is set to enact meaningful reforms to the step therapy process. Step therapy protocol utilized by insurers in our state will be easier, safer, and more efficient, resulting in more positive health outcomes.