As we reach the last quarter of 2015, it’s worth taking a look at some of the important regulatory changes that will affect health insurers next year and in 2017.
Earlier this year, the Department of Health and Human Services released the Notice of Benefit and Payment Parameters for 2016 final rule, which contains a number of provisions that will not only impact insurers, but may lead to changes for independent review organizations (IROs).
Exceptions process and deadline. Plans must have a process in place that allows enrollees (or their designee or prescribing healthcare provider) to request clinically appropriate drugs that aren’t covered by the plan, also called an “exceptions process.” For plan years starting in 2016, the plan must notify the other party of its decision about the coverage within 72 hours of receiving the request.
As before, plans must also have a process for handling expedited reviews in exigent situations (like when the patient’s life or functional ability is at serious risk). In these situations, a plan must inform the other party of its determination within 24 hours of the request.
Plans that make standard exceptions must continue to cover the non-formulary drug for the duration of the prescription, including refills. In case of exigent circumstances, plans must cover the non-formulary drug for the duration of this situation. “IRO’s can certainly assist in this review process,” notes Lousine Alpern, MD, vice president of clinical services at Advanced Medical Reviews (AMR), “and AMR already handles this for many clients.”
Role of independent review organizations. If plans deny a request for a standard or expedited exception, they must have a process in place for the other party to request an external review from an IRO.
The plan must provide its determination on the request within the same time frame (72 hours for a standard exception request or 24 hours for an expedited exception request). This ruling also applies to plan years starting in 2016.
As AMR’s Lousine Alpern explains, “Although this change has been on the horizon for a while the amount of reviews required could be onerous to many health plans. This is where IRO’s can be invaluable. AMR is URAC accredited to perform internal reviews and with our state-of-the-art technology, review handling expertise and the breadth of our specialist network we are well equipped to assist those health plans that may need to outsource these types of reviews.”
Pharmacy and Therapeutics (P&T) committees. Health plans must create P&T committees to develop drug formularies for plan years beginning in 2017, Health Affairs noted. Committees, which must meet at least quarterly, are required to:
- “Develop and document procedures to ensure appropriate drug review and inclusion.”
- “Base clinical decisions on the strength of scientific evidence and standards of practice, including assessing peer-reviewed medical literature, pharmacoeconomic studies, outcomes research data, and other such information as it determines appropriate.”
- “Ensure the issuer’s formulary drug list: (1) Covers a range of drugs across a broad distribution of therapeutic categories and classes and recommended drug treatment regimens that treat all disease states, and does not discourage enrollment by any group of enrollees; and (2) Provides appropriate access to drugs that are included in broadly accepted treatment guidelines and that are indicative of general best practices at the time.”
These committees should include chronic disease experts, as well as experts on caring for individuals with disabilities. The majority of members must be practicing pharmacists, physicians and other healthcare providers. At AMR, the value of not only having a variety of reviewers, but also reviewers in active practice is reflected in our network of reviewers and puts us in a special position to assist plans and provide expertise as needed.
Advanced Medical Reviews continues to stay current with health coverage changes by having our own dedicated compliance department that works hard to stay ahead of health plan coverage changes as they continue to roll out with the ACA. This gives us the ability to be proactive with these changes, get our own internal technology ready to process new turnaround times and be proactive with our clients needs.