Turn Up the Heat on Your Member of Congress in August

Congress’ August in-district work period is just weeks away, and that is an opportune time to invite them to visit your pharmacy. There’s no better way for them to see what you do and how important your pharmacy is to the community you serve. Check out this video of Rep. Buddy Carter (R-Ga.) and NCPA Vice President Michael Kim discussing how to effectively host a legislator in a pharmacy. We’re asking all community and LTC pharmacists to participate in our Month of Action and turn up the heat on our elected officials.

Congressional schedules are filling up for August so don’t delay! Please let us know of your interest in participating by completing this interest form or by emailing Michael Rule and submit your invites to your legislators by July 15.

FDA Includes Pharmacists in Revised
Paxlovid Prescribing Authority

This week, after months of advocacy from NCPA and other pharmacy organizations, the FDA revised the EUA for Paxlovid, authorizing state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing. “The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said in a press release. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.” This action allows pharmacists to prescribe Paxlovid with certain limitations as described in the FDA press release. Read the FDA press release here.

Senate Democrats Release Drug Pricing Language
for Potential Reconciliation Bill

Senate Democratic leadership released legislative text on Wednesday detailing their updated drug pricing plans to revive the sweeping Build Back Better reconciliation bill that fell apart last year. While the new language mirrors the agreement forged on drug pricing last November, Democrats tweaked the proposal to boost targeted drugs for Medicare negotiations and move timelines for implementation and the Medicare redesigns. Next, the parliamentarian will review the proposed text to make sure it abides by the Senate's reconciliation rules, while Majority Leader Charles Schumer (D-N.Y.), Sen. Manchin (D-W.Va.), and the caucus continue to negotiate tax and climate provisions.

Florida is Re-evaluating State PBM Contracts

Florida Gov. Ron DeSantis (R) announced plans to sign an executive order that would hold PBMs accountable and provide drug cost transparency. Under the order, state agencies will be directed to re-evaluate their contracts with PBMs to ensure “that costs to the state of Florida are justified.” The Agency for Health Care Administration (AHCA), which oversees the state’s Medicaid program, and the Department of Management Services will audit the PBMs they work with to determine whether cost-saving measures are in place. The announcement comes just weeks after AHCA issued a “request for information” on ways to improve the Medicaid managed care program, including ways to protect patient access to community-pharmacist services. Community pharmacy advocates, including NCPA, weighed in by pointing out that PBMs’ inherent conflicts of interest limit patient access to pharmacy services while driving up costs for taxpayers.

Rep. Carter and NCPA’s Matt Seiler Discuss PBM Reform
on Pharmacy Podcast

A new edition of the Pharmacy Podcast features Rep. Buddy Carter (R-Ga.), NCPA General Counsel Matthew Seiler, and host Todd Eury discussing PBM reform. They talk about the real harm that PBMs do as well as the Pharmacy Benefit Manager Transparency Act of 2022 that seeks to incentivize “fair and transparent” PBM practices, prohibit spread pricing and clawbacks of payments to pharmacies, and empower the FTC and state attorneys general to enforce “unfair and deceptive” PBM business practices. Carter notes that we’ve reached a point that is no longer sustainable. “It’s like squeezing a balloon,” he says. Also, in the podcast, Carter emphasizes the importance of inviting your member of Congress to your pharmacy. Great advice, learn more about NCPA’s August Month of Action here.

Help Educate Policymakers on the Importance
of Community Pharmacy

If you are a pharmacy owner, please take a few moments and complete NCPA’s Census Survey. This survey takes about ten minutes to complete and your responses help us communicate community pharmacy’s story to legislators, regulators, the media, and patients. Data from the pharmacy profiles also helps NCPA bring new opportunities to community pharmacies. There are no financial questions that should require referencing of other documents for answers, and you can take the census on your mobile phone, tablet, or desktop computer. Multiple-store owners can complete the survey for one store and then complete the survey for each additional store by clicking "Take the survey for another store" at the end of the survey.

NCPA Submits Follow Up Comments
to Medicare Part D Final Rule

Last week, NCPA submitted technical comments in follow up to the Medicare Part D final rule. NCPA’s comments were in response to CMS seeking feedbackon proposed updates to the Prescription Drug Event (PDE) file size and layout. The expansion of the PDE file is the first increase in file length since the PDE file structure was implemented in 2006. PDE is the summary record that a prescription drug plan sponsor needs to submit to CMS after every time a beneficiary fills a prescription under Medicare Part D. The PDE data are not the same as individual drug claim transactions but are summary extracts using CMS-defined standard fields.

FDA Issues Guidance Documents on DSCSA

This week, the FDA issued two guidance documents on DSCSA implementation. The first guidance document includes standards necessary for pharmacies that are authorized trading partners under the DSCSA to facilitate adoption of secure, interoperable, electronic data exchange for DSCSA implementation on Nov. 23, 2023, including enhanced drug distribution security requirements, electronic only methods, and product tracing and verification of product at the package level. This draft guidance recommends that authorized trading partners use GS1’s Electronic Product Code Information Services (EPCIS) standard to provide and maintain the electronic data associated with transaction information and transaction statements. FDA is soliciting comments on this guidance document, which are due to FDA by Sept. 6.

The second guidance document includes a re-iteration of the “5 percent rule,” namely that FDA generally does not consider a licensed retail pharmacy that sells drugs to a licensed practitioner for office use in minimal quantities at or below such 5 percent threshold to be subject to the wholesale distributor requirements under the DSCSA based on those sales alone. However, such a licensed retail pharmacy may still be considered a wholesale distributor based on other activities. The guidance also discusses that dispensers are not required to provide product tracing information if the product is dispensed to a patient or if it is a sale by a dispenser to another dispenser to fulfill a “specific patient need.” Additionally, the guidance spells out specific requirements for dispensing pharmacies to be considered authorized trading partners under the DSCSA. FDA is soliciting comments on this second guidance document, which are due to FDA by Sept. 6.

NCPA State Legislative Activity Update

NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Click each issue for a report of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached report. Bills that have moved this week are listed at the top in the “Recently Updated” section.

NCPA’s Advocacy Center Update provides a weekly detailed summary of recent and breaking legislative, regulatory, and state developments impacting independent community pharmacy and NCPA’s efforts to affect policies benefitting its membership and the industry. The weekly update is distributed to NCPA leadership, steering committees, allied organizations/stakeholders and major contributors to the NCPA LDF and PAC. The weekly update is intended exclusively for the recipient and is not for external distribution.