S.1001/A.1619 – PrEP No Prior Authorization

This legislation, S.1001/A.1619, would prohibit health insurers from applying prior authorization or step therapy protocols for coverage for pre-exposure prophylaxis (PrEP) used for the treatment or prevention of HIV infection. The New York Health Plan Association (HPA) opposes this legislation, as restrictions on prior authorization undercut health plan efforts to promote safe, coordinated health care that will increase the cost of coverage for consumers, employers, and the state. This bill is also unnecessary as protections already exist to ensure patients have appropriate access to PrEP.

Health plans support and promote the use of evidence-based, best practices. In order for PrEP to be effective, and protect the patient and others, timely and ongoing testing is necessary to verify that the PrEP patient remains HIV-negative.  Federal Centers for Disease Control (CDC) guidance requires HIV testing every three months for individuals taking oral PrEP, and HIV testing after the first month and then bimonthly thereafter for those receiving PrEP injections.  The testing requirement are the reason plans perform prior authorization (PA) on these critically important medications.

Also, in addition to the requirement for an ongoing negative HIV test once a patient has begun taking PrEP, multiple other tests and screenings are recommended prior to initiation of PrEP, including but not limited to assessments of a patient’s renal function and screening for other sexually-transmitted infections (STIs).  Health plans require  prior authorization to ensure that these patient safety protocols have been followed, not to slow initiation of the medication. PA also helps plans verify that patients are adhering to medication requirements and are connected to other medical services, including additional services they may need if they stop taking PrEP.  In regard to PrEP,  prior authorization is critical to support the safety of the patient and others.

Prior authorization is an important tool to protect patients from unnecessary and potentially harmful care. For example, it is utilized to help ensure that medications are safe, effective, and provide value for specific populations or subpopulations who may be affected differently by a medication, and to make sure that a medication is not co-prescribed with another medication that could have dangerous interactions. Additionally, it ensures that the clinician providing the care has the appropriate training to deliver the care being requested. Further, prior authorization enables health plans to improve care coordination by making sure care management supports are in place as members navigate the system and help with follow-up care and other services that help the member succeed in recovery. Prohibiting the use of prior authorization would remove critical protections for patients and undercut efforts to ensure that the care they receive is safe, effective and affordable.

When developing prior authorization policies, health plans review information on the use of inappropriate treatments, practice variation for specific services, the extent to which providers deliver care consistent with evidence, safety concerns, and other relevant factors to determine what services or drugs should be subject to prior authorization. Health plans regularly review the medical services and prescription drugs that are subject to prior authorization and make changes based on new evidence, adherence to recognized standards of care, or, in the case of new and emerging therapies, limited available evidence or safety concerns. These reviews are conducted by Pharmacy and Therapeutics committees with relevant clinical expertise.

State measures already exist to protect patients, making S.1001/A.1619 unnecessary. In December 2017, the Department of Financial Services (DFS) issued a circular letter reminding health plans that prior authorization requirements cannot create an unacceptable barrier to coverage for individuals who would otherwise benefit from PrEP. In its circular letter, DFS noted the requirement that health plans must provide coverage for PrEP, and that in making coverage determinations they must do so in a non-discriminatory manner and that they “use appropriate written clinical review criteria when reviewing for medical necessity.”  In December 2022, Governor Hochul signed legislation requiring insurance coverage for PrEP and PEP to prevent HIV infection.

For all these reasons, HPA OPPOSES S.1001/A.1619.