BILL ADDRESSES PRIOR AUTHORIZATION
The “Improving Seniors’ Timely Access to Care Act of 2021” aims to remove hurdles for physicians and patients.
BY JULIE GREENBAUM, ASSOCIATE EDITOR
In October, a prior authorization relief bill reached a significant milestone with more than one-half of the U.S. House of Representatives co-sponsoring the bipartisan legislation, positioning it for swift passage in Congress. The bill — H.R. 3173, the “Improving Seniors’ Timely Access to Care Act of 2021” — may provide some major relief for ophthalmologists, their staff and patients in 2022 and beyond.
Introduced by Reps. Suzan DelBene (D-WA), Mike Kelly (R-PA), Ami Bera, MD (D-CA) and Larry Bucshon, MD, (R-IN), the legislation would help protect seniors from unnecessary delays in care by streamlining and standardizing prior authorization under the Medicare Advantage (MA) program, providing oversight and transparency of health insurance for Medicare beneficiaries.
ELIMINATING UNNECESSARY BARRIERS
According to George Williams, MD, ophthalmologist and senior secretary for advocacy of the AAO, the bill would provide much needed relief at the right time for physicians and their patients.
“What we hope this bill will do and what it’s designed to do is diminish the practice burdens on ophthalmologists,” he says. “Increasingly, physicians are encountering difficulties obtaining what they believe, in their best judgement, is the best for their patients.”
In the ophthalmology space, this is particularly burdensome when it comes to treatment since MA plans require a form of prior authorization known as step therapy or fail-first therapy.
“It becomes difficult to get approval from insurance providers for anti-VEGF drugs or drugs like Eylea (Regeneron), Lucentis (Genentech) and Beovu (Novartis),” Dr. Williams explains. “The physician and the patient are then forced to use the off-label treatment — even though a physician believes that the off-label drug is a poor choice.”
Dr. Williams adds that when a physician believes that the off-label drug is a poor choice, the prior authorization process becomes that much more cumbersome.
BENEFITS OF THE BILL
Based on a consensus statement on prior authorization reform adopted by leading national organizations representing physicians, medical groups, hospitals, pharmacists and health plans, the Improving Seniors’ Timely Access to Care Act of 2021 would:
- Establish an electronic prior authorization (ePA) program and require MA plans to adopt ePA capabilities.
- Require the Secretary of Health and Human Services to establish a list of items and services eligible for real-time decisions under an MA ePA program.
- Standardize and streamline the prior authorization process for routinely approved items and services.
- Ensure prior authorization requests are reviewed by qualified medical personnel.
- Increase transparency around MA prior authorization requirements and their use.
- Protect beneficiaries from any disruptions in care due to prior authorization requirements as they transition between MA plans.
ADMINISTRATIVE BURDEN OF PRIOR AUTHORIZATION
While ophthalmologists may have a dedicated, full-time staff to handle prior authorization requests, the process can be difficult to navigate. Even within the same Medicare Advantage company, there are different contracts, and each contract has different requirements as to how to obtain prior authorization.
“I work in a large practice, we have three people that only handle prior authorization requests. That’s a significant administrative burden and cost,” Dr. Williams says. “In our experience, when we finally do get to speak to someone, they are completely unqualified to make any clinical decision. This bill will ensure that prior authorization reviewers are qualified Medicare personal.”
MEETING URGENT MEDICAL NEEDS
Being able to address the urgent healthcare needs of patients is another key issue that this bill will address, establishing a criteria for when there is a relative medical urgency.
“Currently, Medicare Advantage programs don’t have to respond for up to 72 hours — and that’s business days,” says Dr. Williams. “So, if a patient has a problem on a Friday afternoon, the practice might not hear back about prior authorization until Wednesday. The issues are significant in how they obstruct access to care.”
Dr. Williams also points out that the process becomes further difficult for patients if they decide to change plans. For example, if a patient obtains prior authorization from one Medicare Advantage provider and is doing well on a drug but switches plans, they will have to start all over.
On Oct. 20, further progress on the bill was made when it was introduced in the Senate, and at press time, more than 300 national and state patient, physician, health-care professional and other health-care stakeholder organizations have endorsed this legislation.
“I am very optimistic that the bill will improve access to care, improve the quality of care and will allow physicians and ophthalmologists to make the best clinical decisions,” Dr. Williams says. “In the long run, it will certainly be best for patients.” OM
QUICK NOTES
Allergan, an AbbVie company, received FDA approval of VUITY (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia. VUITY is the first FDA-approved eyedrop to treat presbyopia. The daily, prescription eyedrop works in as quickly as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision.
Bausch + Lomb and Clearside Biomedical received FDA approval for XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation. XIPERE is the first medicine to be approved in the United States for delivery via suprachoroidal injection, a method designed to facilitate targeted delivery of therapeutic agents to the retina and choroid.
The FDA approved Genentech’s Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet AMD who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. It is the first FDA-approved treatment for wet AMD that offers as few as two treatments per year. Susvimo will be available in the United States in the coming months.
Oyster Point Pharma announced the approval of TYRVAYA (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease (DED). TYRVAYA is the first nasal spray approved for the treatment of the signs and symptoms of DED and is designed to activate the trigeminal parasympathetic pathway, resulting in increased production of basal tear film.
Luminopia has been granted de novo premarket approval by the FDA for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye). Luminopia One is indicated for improvement in visual acuity in children with amblyopia, aged 4-7, associated with anisometropia and/or with mild strabismus. Luminopia One allows patients to watch therapeutically modified TV shows and movies to improve their vision within a virtual reality headset.
Ocular Therapeutix received FDA approval for a supplemental new drug application for Dextenza (dexamethasone ophthalmic insert), which adds an additional indication for the treatment of ocular itching associated with allergic conjunctivitis.