ASCRS, the AAO and the Ophthalmic Community Work to Provide Continued Access to Compounded Moxifloxacin from Bulk Substances from 503B Outsourcing Facilities
On September 11, ASCRS, the AAO, and the ophthalmic community sent a letter to the FDA requesting the retention of moxifloxacin as Category 1 for outsourcing facility use (503B), because there is a demonstrated clinical need for the medication as a bulk substance. This was as a result of concerns initially raised by ASCRS regarding the importance of the continued availability of the most common concentration (5mg/ml) used for antibiotic prophylaxis of endophthalmitis following cataract surgery. The letter references the ASCRS 2019 Clinical Survey regarding the use of intracameral antibiotics and cites several clinical opinions also provided by ASCRS.
The U.S. Food and Drug Administration (FDA), in its effort to promote the use of approved products as the basis for compounded products, is proposing to remove moxifloxacin from the list of bulk products that 503B outsourcing facilities may use. The FDA is instead suggesting that commercially approved topical moxifloxacin products be used to formulate intraocular solutions. However, these were never labelled for intraocular use, and there are potential concerns with dosage, pH toxicity, inactive components, and particulate contamination for intraocular use.
FDA recently issued an alert to health care professionals citing several adverse events associated with the use of intraocular use of compounded moxifloxacin. We question whether these events have been associated with the quality of product from 503B outsourcing facilities, because some of these reports appear to be associated with physician dosing errors or the use of topical Moxeza as a formulation source.
Because there is no approved commercial intraocular moxifloxacin formulation, we stress that compounded solutions are a primary source of intracameral moxifloxacin used by American ophthalmologists. Most are supplied to ASCs and Hospital Outpatient Facilities from 503B facilities, which have greater FDA oversight. We raise the point that should moxifloxacin be removed from the Category 1 503B bulk substance list, the intraocular injection could shift to being compounded by 503A pharmacies or by individual surgeon’s preparation of their own intracameral product. Therefore, we believe that public safety will be impacted by loss of access to bulk moxifloxacin. Several additional ophthalmology sub-specialty societies have co-signed the letter.
ASCRS, in Conjunction with Surgical Coalition and the Larger Provider Coalition, is Working to Prevent the Medicare Physician Payment Proposed Cuts Scheduled to Take Effect Jan. 2021; Members of Congress Need to Hear from You
ASCRS, in working with the Surgical Coalition and the broader Provider Coalition, is continuing efforts to prevent the Medicare physician payment proposed cuts scheduled to take effect January 1, 2021. We are meeting with members of the key committees of jurisdiction in the Senate and the House, as well as with committee staff, with the goal of developing a legislative solution that is acceptable to Congress that would be included in the appropriate legislative vehicle, including a possible Continuing Resolution (CR). We are also working on a possible sign-on letter from the members of the key committees to the House and Senate leadership stressing the urgency of a legislative fix before the end of the year.
Therefore, we need your help in reaching out to your members of Congress. The ASCRS grassroots effort has generated over 500 letters to members of Congress, and we thank you for participating and taking the time to tell your representative and senators how these proposed cuts will impact you, your practice, and your patients. For those of you who have not, please take the time to go to our ASCRS Grassroots Action Center. After you log in and provide your zip code – a letter will be generated to your representative and two senators on this issue from you. You may personalize the letter prior to sending it. Please contact Nancey McCann, ASCRS Director of Government Relations, at nmccann@ascrs.org if you have any questions.
Senate GOP COVID Bill Fails to Advance
On Thursday, September 10, the Senate Democrats blocked the narrow GOP COVID-19 bill. Senators voted 52-47 on the roughly $650 billion Republican bill. Senator Rand Paul (R-KY) was the only Republican to vote against the bill, and no Democrats voted for the bill. It failed to get the 60 votes necessary to proceed.
The bill provides $300 per week in federal unemployment benefits through Dec. 27, another round of Paycheck Protection Program (PPP) funding, more money for testing and schools, and liability protections from coronavirus-related lawsuits.
GOP leadership knew this vote would fall short of the 60 votes, however they were facing pressure to vote on something weeks before the election to help their vulnerable incumbents in key states. At this point, there is no sign that congressional Democrats or the White House is willing to break the stalemate. The House is scheduled to return next week, and it is unclear whether the stalled negotiations will resume.
Mnuchin, Meadows, Schumer, and House Speaker Nancy Pelosi (D-CA) remain far apart on the price, but also on significant policy issues including unemployment insurance and additional money for state and local governments.
MedPAC Discusses Expansion of Telehealth in Medicare
During its September 3-4, 2020 virtual public meeting, the Medicare Payment Advisory Committee (MedPAC), which is an advisory agency to Congress on Medicare, discussed the expansion of telehealth in Medicare in addition to COVID-19 and Medicare, as well as the solvency of the Medicare Trust Fund.
As you are aware, telehealth has been an important tool used by providers during the COVID-19 public health emergency (PHE), and ASCRS and the medical community have supported its expansion permanently. Before the pandemic, Medicare covered a limited set of telehealth services in rural locations. During the public health emergency, those services were expanded temporarily including providing services to patients in homes and non-rural settings.
MedPAC staff presented potential options for recommendations to expand telehealth after the PHE, including permitting expanded flexibilities for providers participating in advanced alternative payment models while recommending limited expansions for fee-for-service providers. While commissioners generally agreed that telehealth has an important role to play in expanding care, they raised several concerns regarding quality of care, potential fraud and abuse, and increases in overall Medicare spending.