ASCRS, Medical Community Oppose Administration Proposal to Expand Physician Assistants’ and Nurse Practitioners’ Scope of Practice; ASCRS and Alliance of Specialty Medicine Maintain Opposition to Pay Parity for Non-Physicians
This week, ASCRS joined with the medical community in a letter to CMS opposing the Administration’s proposal to expand physician assistants’ (PAs) and nurse practitioners’ (NP) scope of practice. The letter is in response to a request for information issued in conjunction with the recent executive order Protecting and Improving Medicare for Our Nation’s Seniors that required CMS, as a means of expanding patient access to primary care services, to explore how PA and NP’s scope of practice could be expanded, including paying them at the same rate as physicians. In the letter, we argue that care teams should continue to be led by physicians since their education and training is significantly longer and more intensive than PAs or NPs, whose training requirements can vary by state. In addition, the letter argues that patient access may not improve since studies show patients prefer to see physicians rather than non-physicians. Following the release of the executive order last October, ASCRS joined with the Alliance of Specialty Medicine in a letter on the executive order that opposed expanding scope of practice and argued that there should not be pay parity for PAs and NPs with physicians because of their lower level of education. The Alliance letter also opposed other provisions in the order, such as pegging Medicare Part B payments to Medicare Advantage rates.
MedPAC Finalizes Recommendation to Maintain 2021 0% Payment Update for Physicians, Eliminate ASC Payment Update
This week, the Medicare Payment Advisory Commission (MedPAC) met and voted on its recommendations for Medicare payment updates in 2021. Despite data indicating payments are not keeping pace with inflation, MedPAC’s surveys found that Medicare beneficiaries do not have difficulty accessing care. Therefore, the commission voted to recommend that physician payment be updated in accordance with current law, which is 0% for 2021 based on the MACRA statute. ASCRS and the medical community continue to advocate for positive payment updates to the conversion factor.
For ASCs, MedPAC reaffirmed its long-standing recommendation that ASCs be required to report cost data. Citing the lack of cost data, MedPAC voted to recommend that there not be a payment update for ASCs in 2021.
As a reminder, MedPAC is an advisory body to Congress and its recommendations do not have the force of law.
FDA Drug Center Director Highlights 2020 Priorities, Includes Compounding and Drug Shortages
This week, Janet Woodcock, MD, Director of the FDA’s drug division, laid out the agency’s drug-related priorities for 2020. Among the priorities, Dr. Woodcock listed compounding and noted that the newly created Compounding Quality Center of Excellence will be the lead on compounding issues and will target working with outsourcing facilities to improve quality. In addition, she said FDA will build off its recently released report on drug shortages and work with Congress and industry to implement its recommendations. Other issues she highlighted for 2020 include addressing opioid abuse and sunscreens.
CMS Aims at Reposting Medicare 2020 Physician Fee Schedule Next Week
The 2020 Medicare physician fee schedule remains unavailable online while it makes the necessary adjustments for geographic differences. CMS said this week that it hopes to have the fee schedule re-posted next week. If you experience delays in payments after it is reposted, please contact your local Medicare administrative contractor (MAC) for information.
ASCRS and Ophthalmic Community Send Letter of Support for “Mitigating Emergency Drug Shortages (MEDS) Act”
This week, ASCRS joined the ophthalmic community in a letter to U.S. Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN) in support for S.2723, the “Mitigating Emergency Drug Shortages (MEDS) Act,” that would help increase the supplies of vital drugs needed to treat or prevent a wide variety of diseases, illnesses, and conditions. Specifically, the MEDS Act would give the FDA additional authority to help address drug shortages by increasing manufacturer transparency and developing market-based incentives, such as prioritizing review of supplements and abbreviated new drug applications (ANDAs) for generic drugs as well as inspections. We believe this legislation is a strong first step to addressing drug shortages.
FDA Issues Two Recalls: Surgical Gowns, Compounded Products for Axia Pharmaceuticals
This week, the FDA issued two recalls that may affect ophthalmologists.
- Surgical gowns and packs by Cardinal Health; potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs. Customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include the surgical gowns because the manufacturer cannot provide assurance the products are sterile. Customers with questions about whether their own inventory is affected should contact Cardinal Health directly. Visit the FDA website for more information.
- All sterile drug products within expiry by AXIA Pharmaceutical due to a lack of assurance of sterility. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines. Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening. To date, AXIA Pharmaceutical has not received any reports of adverse events related to this recall and is recalling all sterile products out of an abundance of caution. Click here for a full list of recalled products. Additional information is available on the FDA website.
If you have any additional questions, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.
CMS Updates Open Payments Data
This week, CMS announced it has updated its Open Payments database with changes to its dataset that have occurred since its last update in June of 2019. The refreshed Open Payments data includes:
- Record Updates: Changes to non-disputed records that were made on or before November 15, 2019, are published.
- Disputed Records: Dispute resolutions completed on or before December 31, 2019 are displayed with the updated information. Records with active disputes that remained unresolved as of December 31, 2019 are displayed as disputed.
- Record Deletions: Records deleted before December 31, 2019 were removed from the Open Payments database. Records deleted after December 31, 2019, remained in the database, but will be removed during the next data publication in June 2020.
As a reminder, the Open Payments database tracks payments and transfers of value of more than $10 between manufacturers and physicians or academic institutions. If you need additional information, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.