Access to Part B, Prescription and Compounded Drugs

What We Told You Early This Year

The Academy was hard at work addressing drug-price spikes and shortages, while weighing in with federal regulators on their proposed changes to compounding regulations and how physicians are reimbursed for Part B drugs.

What's Happening Today

Drug supply and cost issues are the talk of the town in Washington, D.C. Lawmakers continue to seek solutions that they can pass through Congress to reduce costs for prescription drugs on patients' behalf. And nationwide shortages continue to plague our profession, with Avastin being the most recent and glaring example.

The Academy is leading on all fronts, engaging with the White House and Congress on legislative ideas and providing ophthalmologists with the information you need as you contend with difficulties obtaining important treatments. We're also active in securing better policies on how compounded treatments are produced and regulated, including testimony before the Food and Drug Administration on why timely access to office-use treatments is critical for our patients.

Part B Drug Payment Reform

A highly anticipated demonstration by the U.S. Department of Health and Human Services to test changes to how physicians are reimbursed for administering Part B drugs is in a state of limbo right now. Sources tell the Academy that administration officials are considering not unveiling this transformative demonstration program until later this year.

The demonstration's exact configuration is unknown for now. But HHS Secretary Alex Azar suggested it would move physicians from the "buy and bill" process. Physicians' drug payments would no longer be related to the price of the drug. Instead, physicians would be paid a flat rate by Medicare for storage and handling of drugs, a strategy that the Centers for Medicare & Medicaid Services hopes will keep physicians on firm ground financially.

The funds for the first year of this flat-rate payment would come from a pool of money that would be based on the previous year's claims data. It would be calculated on the average sales price plus 6%, rather than 4.3%.

Additionally, the amount Medicare would pay for these drugs would be based on an international index of what other countries currently reimburse for the same treatments.

That said, many questions remain as we engage with CMS on this key issue for ophthalmology.

In comments that the Academy submitted to the CMS in January, we stressed the necessity of making such a program voluntary. We also urged CMS to carefully define its expectations of its vendors who would now purchase and deliver the drugs.

The Academy objects to CMS' intent to make this program mandatory for physicians and patients because previous attempts to establish similar competitive acquisition programs failed due to delivery issues.

We also continue to seek protections for physicians who are outside of the regions that CMS designates for this demonstration.

The Academy believes that any experiment with lower, international pricing index-based payments for drugs must not affect average sales price-based payments to physicians in regions where the demonstration is not taking place.

Access to Compounded Treatments

We've been busy. The Academy continues to engage regulatory agencies on the issue. We also are mustering support for legislation that would let traditional compounding pharmacies distribute compounded drugs for office-use without a patient-specific prescription in states that allow office-use compounding.

In May, the Academy joined the American Society of Retina Specialists and American Society of Cataract and Refractive Surgery at an FDA stakeholder meeting as the only physician groups to testify on the agency's 2018 revised draft guidance for 503B facilities.

Our comments are in response to recent draft guidance from the FDA that the agency hopes will encourage more compounding pharmacies to become outsourcing facilities.

Academy Secretary for Federal Affairs David B. Glasser, MD, made a case that the FDA should establish more limited exceptions that will allow traditional, 503A facilities to serve the market's needs for compounded drugs for office use.

Dr. Glasser highlighted the Academy's ongoing concerns that due to economic constraints, new 503B outsourcing facilities are unwilling to provide low-volume compounded drugs for office-use, including some compounded antiviral and antibiotic drugs. Dr. Glasser reiterated to FDA that these drugs are used to treat patients appearing in the office with infections needing immediate treatment.

Rep. Kurt Schrader, D-Ore., right, briefs Mid-Year Forum 2019 attendees on his efforts to address rising prescription drug costs at the federal level.

The revised 503B draft guidance proposes less restrictive testing requirements that would better enable outsourcing facilities to produce small batches of drugs for office use. This is a major issue for ophthalmologists. In these cases, the drugs ophthalmologists need immediately for patients with sight-threatening conditions may not be available.

Meanwhile, our allies in Congress are also getting involved. A bipartisan proposal in the U.S. House of Representatives would help improve access to compounded, office-use treatments. The bill is authored b Reps. Morgan Griffith, R-Va., and Henry Cuellar, D-Texas. It would let traditional compounding pharmacies distribute these drugs without a patient-specific prescription in states where office-use compounding is allowed.

Ask your congressional lawmaker to co-sponsor this proposal.

In our letter of support for the legislation, we reiterate that ophthalmologists continue to face challenges getting certain antibiotic and antiviral drugs for office use. We reiterate that these drugs are used to treat patients facing urgent care needs as a result, delays in care can lead to vision loss or blindness.