Head of FDA’s COVID-19 Vaccine Review Team Shares Insights With ASHP

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Here’s the latest from ASHP’s Government Relations Team

Head of FDA’s COVID-19 Vaccine Review Team Shares Insights With ASHP

This week, ASHP was pleased to host a webinar with Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA), who shared the latest details on the COVID-19 vaccine clinical trials and actions that the FDA is taking to make safe, effective, and transparent decisions about COVID-19 vaccine candidates.

Dr. Marks spoke with Tom Kraus, ASHP’s vice president of government relations and former FDA chief of staff, to answer questions from ASHP’s members about the vaccine review process and expected timelines, safety and efficacy information, plans for gathering additional data related to special populations, durability of the vaccine(s), and expected side effects, among other topics.

If you missed the webinar, ASHP highly recommends that you consider listening to this critical discussion with FDA’s leadership. It is now available on demand and offers continuing education credit designated as an immunization-related topic.

Listen to ASHP’s Election Impact Podcast

Tom Kraus, ASHP’s vice president of government relations, Doug Huynh, director of federal legislative affairs, and Jillanne Schulte Wall, senior director for health and regulatory policy, discuss the outcome of the 2020 election and how it will impact pharmacy.

ASHP Calls on Health Systems and Healthcare Organizations to Urge Biden Transition Team and COVID-19 Advisory Board to Make Telehealth Flexibilities Permanent

Over 100 health systems and professional organizations joined ASHP this summer to urge the Centers for Medicare & Medicaid Services (CMS) to make telehealth flexibilities for virtual supervision permanent. CMS has allowed physicians to supervise clinical staff virtually during the pandemic. This virtual supervision flexibility had allowed expansion of pharmacist-led telehealth. ASHP has been working with the current administration and now we are educating the transition team that is reviewing these policies on behalf of President-elect Joseph Biden about this issue. ASHP and others are urging the Biden transition team to make this rule change permanent by signing on to a joint letter addressing the issue. If your organization is interested in signing on to this letter, please fill out this survey. Please only sign form if you are authorized to do so on behalf of your organization.

CMS Releases OPPS CY 2021 Final Rule

CMS has released the hospital Outpatient Prospective Payment System (OPPS) final rule for CY 2021. ASHP submitted comments on the proposed OPPS rule in October 2020. We were extremely disappointed that CMS finalized both its proposal to extend cuts to 340B reimbursement, dropping the rate to ASP minus 22.5% from ASP plus 6%, and its proposal to continue implementation of site neutral payment changes that would slash hospital outpatient department payments for the most commonly used code, G0463. Both the 340B and site neutral policies have been the subject of ongoing litigation, and appeals courts recently found in favor of CMS in both cases, paving the way for new cuts that threaten patient access and services. Safeguarding the 340B program and the services it supports remains one of ASHP’s highest priorities, and we are actively exploring every possible option to protect it.

ASHP Comments on HHS’s Request for Information on Vaccines National Strategic Plan

ASHP submitted comments to the Department of Health and Human Services (HHS) in response to the Vaccines National Strategic Plan. ASHP applauds the plan’s commitment to eliminate vaccine-preventable diseases through safe and effective vaccination. The comments submitted included lessons learned throughout the development of the SARS-CoV2 vaccine and reinforced ASHP’s longstanding advocacy effort pertaining to pharmacists’ role in supporting public health by increasing patient access to immunizations.

CMS Releases Final PFS Rule with Pharmacist-Provided E/M Coding Changes

CMS has released the Physician Fee Schedule (PFS) CY 2021 final rule, with policy changes in a number of areas, including appropriate reimbursement for incident-to services, the Medicare Diabetes Prevention Program, Medicare Part B Opioid Treatment Programs, and quality metrics. ASHP has published a full issue brief detailing ASHP’s comments on the proposed rule and CMS’s responses in its final rule. ASHP is pleased that CMS extended virtual supervision of incident-to services until at least Dec. 31, 2021, but we will continue to push for this flexibility to be permanent. We are, however, extremely concerned about CMS’s clarification of evaluation and management (E/M) coding for pharmacist-provided incident-to services, which allows billing at only the 99211 level for these services. CMS indicated that in making the decision, they were bound by statutory authority, and expressed support for pharmacist services and for the creation of new codes that capture pharmacist contributions. ASHP, with member input, will develop a slate of codes to present to CMS. We will also pursue all other potential regulatory and legislative solutions to ensure that pharmacists’ services are reimbursed at a level commensurate with the complexity and duration of the services provided.

Pennsylvania Enacts Pharmacy Testing and Technician Registration Bill

Pennsylvania Governor Tom Wolf signed HB 770 on Nov. 30. For the first time, all pharmacy technicians and technician trainees will be required to register with the Pennsylvania Board of Pharmacy. Additionally, the bill also loosens restrictions on conducting pharmacy-based diagnostic testing for COVID-19, influenza, and streptococcal infections. ASHP congratulates the Pennsylvania Society of Health-System Pharmacists and its members on their legislative win.

Florida Governor Appoints Dorinda Segovia to Board of Pharmacy

Gov. Ron DeSantis announced the appointment of Dorinda Segovia to serve a four-year term on the Florida Board of Pharmacy. Segovia is vice president of pharmacy services at Memorial Healthcare System in Miramar and chair of the Florida Society of Health-System Pharmacists’ (FSHP) Legal and Regulatory Council. ASHP congratulates FSHP and Segovia for her well-deserved appointment.

Additional COVID-19 Resources

ASHP is committed to supporting you in the response to the COVID-19 pandemic. Our COVID-19 Resource Center is updated regularly and includes open-access, evidence-based resources and tools for pharmacists and healthcare professionals. Our COVID-19 Community on Connect serves as a forum for any healthcare providers to ask questions, share experiences, post resources, and more. Thank you for all that you are doing for your patients and your community.