- Senate Democrats Reach New Reconciliation Deal
- 207 Organizations Voice Support for S. 4293
- Turn Up the Heat in August’s Month of Action
- What to Know Before Prescribing Paxlovid
- Pharmacists Immunization Authority Across the States
- FDA Issues Proposed Rule Standardizing NDCs, Revising Drug Product Barcode Labelling Requirements
- NCPA Sends Follow-Up Letter with APC Expressing Concerns with Animal Drugs Compounding GFI 256
- APC Asks NCPA Members to Get Physicians Prescribing Compound Hormones to Sign Letter to FDA
- NCPA State Legislative Activity Update
Senate Democrats Reach New Reconciliation Deal
After months of negotiations, Sen. Joe Manchin (D-W.Va.) and Senate Majority Leader Chuck Schumer (D-N.Y.) announced a surprise deal this week on a reconciliation bill that was presumed to be dead after Manchin walked away from negotiations over inflation concerns. In a joint statement, the two said the legislation, now known as The Inflation Reduction Act of 2022, will be on the Senate floor next week. It includes roughly $370 billion in energy and climate spending, $300 billion in deficit reduction, three years of subsidies for Affordable Care Act premiums, Medicare price negotiations and other prescription drug reforms, and significant tax changes for large corporations. The bill currently includes a provision that the Secretary of Health and Human Services will establish a discount program with manufacturers, and the agreement will establish procedures to ensure that the pharmacy or mail order service is reimbursed for an amount equal to the difference between the negotiated price (including dispensing fee and any applicable vaccination administration fee) and discounted price of the applicable drug. It remains to be seen if insulin reform will be included, and if there will be capped insurance copays for insulin. Senator Schumer announced yesterday that democrats would be seeking to add insulin measures into the bill. NCPA is closely monitoring this legislation and advocating on behalf of our members to Senate offices and staff as the process to passage is still very fluid with potential changes to current language.
207 Organizations Voice Support for S. 4293
This week, NCPA and 206 other pharmacy, consumer, patient, and business organizations sent a letter to Sens. Maria Cantwell (D-Wash.) and Charles Grassley (R-Iowa) to voice strong support for S. 4293, the PBM Transparency Act. The organizations further urged Sens. Charles Schumer (D-N.Y.) and Mitch McConnell (R-Ky.) to quickly bring the bill up for a vote in the full Senate.
Take a moment and urge your Senators to cosponsor this important legislation and to voice their support to Senate leadership by clicking here.
Turn Up the Heat on Your Member of Congress in August
Congress’ August in-district work period is right around the corner, 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. We’re asking all community and LTC pharmacists to participate in our Month of Action and turn up the heat on our elected officials. Additionally, NCPA members Nasir Mahmood, Nate Rockers, and Stacey Swartz also have tips for hosting a legislator and effectively communicating with them. 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 as soon as possible.
What to Know Before Prescribing Paxlovid
Recent updates to the Paxlovid Emergency Use Authorization give state-licensed pharmacists authority to prescribe the COVID-19 antiviral drug under certain circumstances. Before you write your first Paxlovid prescription make sure your workflow accounts for the documentation, billing, and space requirements of the clinical service that differ from dispensing workflow. This Assessment by a Pharmacist billing handout calls out the information needed for the assessment, three care plans, and billing pathways plus considerations for offering telehealth if your space is limited or you want to limit potential virus exposure in the pharmacy. More information about offering or locating COVID-19 therapeutics is on the NCPA website. NCPA members can also email covid@ncpa.org.
Pharmacists Immunization Authority Across the States
NCPA advocates for states to adopt laws and regulations that allow pharmacists to independently administer FDA-approved vaccines to ages 3 and older, mirroring the PREP Act authorities that will expire in 2024. This one-pager shows the immunization authorities by state where pharmacists have prescriptive authority along with states where they must be administered through prescription or within a collaborative practice.
FDA Issues Proposed Rule Standardizing NDCs, Revising
Drug Product Barcode Labelling Requirements
This week, the FDA published a proposed rule that will amend its regulations governing the format of the National Drug Code (NDC). The NDC is an FDA standard for uniquely identifying drug products marketed in the United States. This action, if finalized, will standardize the format of all NDCs. Specifically, all NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits. Additionally, FDA is proposing to revise the drug product barcode label requirements to permit the use of other data carriers that meet certain standards. Comments are due to FDA by November 22, and NCPA will be submitting comments.
NCPA Sends Follow-Up Letter with APC Expressing Concerns
with Animal Drugs Compounding GFI 256
This week, NCPA and the Alliance for Pharmacy Compounding (APC) sent a joint letter to the Center for Veterinary Medicine at FDA regarding our ongoing concerns and additional questions we had with the framework and implementation of the GFI #256, “Compounding Animal Drugs from Bulk Drug Substances – Guidance for Industry” (April 22, 2022). This is in follow up to a previous, shorter letter by NPCA, APC, the American College of Veterinary Pharmacists, the American Pharmacists Association, and the Society of Veterinary Hospital Pharmacists asking FDA to postpone any enforcement of the GFI until Fiscal Year 2024. NCPA and APC re-iterated the ask to postpone enforcement in the more recent letter.
APC Asks NCPA Members to Get Physicians Prescribing
Compound Hormones to Sign Letter to FDA
Do you compound hormones, or know physicians who prescribe compounded hormones? The Alliance for Pharmacy Compounding (APC) is requesting NCPA members to send prescribing physicians a sign-on letter for them to send to FDA Commissioner Robert Califf (with copies going to congressional leaders) urging the Commissioner to not restrict compounded hormone therapy based on a discredited report it commissioned, and instead to base any decision about compounded hormones on solid evidence. APC’s letter also calls on FDA to avoid any action that might impede patient access to life-enhancing compounded hormones. For more information, and to see the letter, click here. The deadline for physician sign on is August 15, so please act now!
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.