FDA Grants Full Approval to Pfizer Vaccine

This week, the FDA granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, making it the first COVID-19 vaccine to gain full approval. The Pfizer vaccine will be marketed as Comirnaty and will remain under emergency use authorization for 12-to-15-year-olds. Moderna has applied for full approval; no word on when that might happen, and Johnson & Johnson is expected to apply for full approval soon.

Oral Arguments Set for
North Dakota PBM Regulations Lawsuit

Oral arguments for PCMA v. Wehbi have been scheduled for September 1, 2021 at 3:00 ET. Earlier this year the U.S. Supreme Court vacated a ruling by the U.S. Circuit Court of Appeals for the 8th Circuit in the case formerly known as Wilke v. PCMA. Last August the 8th Circuit struck down North Dakota PBM regulations due to ERISA preemption issues. The Supreme Court determined that the 8th Circuit’s ruling could not stand in light of the recent unanimous ruling in Rutledge v. PCMA, and it was sent back for the circuit court to reevaluate North Dakota’s law under the Rutledge decision. NCPA, along with nine state pharmacy associations, filed a friend of the court (amicus curiae) brief in the 8th Circuit of the U.S. Court of Appeals defending North Dakota’s right to regulate PBMs. The public can listen to oral arguments by dialing into 1-888-363-4749; Access Code 442356. A recording of the arguments will also be posted here. Read more about the case here.

House Passes Budget Resolution
Opening Path to Reconciliation

This week, the House of Representatives voted 220-212 to advance a resolution to unlock the reconciliation process. With this vote, a group of moderate Democrats were also able to secure a commitment from Speaker Pelosi (D-Calif.) to vote on the Senate-passed bipartisan infrastructure deal on or before September 27, 2021. House committees will now begin their work to draft and mark-up their respective policy areas of the $3.5 trillion reconciliation package with the goal of sending them back to the Budget Committee to be compiled by a non-binding deadline of September 15th.

NCPA Urges DOJ, HHS to Defend Price Transparency Rule

This week, NCPA urged HHS and the Department of Justice to defend a rule that would create transparency in the murky prescription drug pricing system that is now under assault by the powerful PBM lobby. PCMA sued recentlyto block a federal regulation that would force PBMs to disclose the historical net prices they negotiate with pharmaceutical manufacturers. That information would be made available to the public. Read NCPA’s press release here.

CMS Expands Vaccine Access,
Changes Payment for At-home Patients

This week, CMS announced. new guidelines for administering COVID-19 vaccinations in patient homes and certain other locations, and a change in the number of additional payments per visit. Effective August 24, 2021, Medicare will pay the additional payment amount (approximately $35 per dose administered) for up to a maximum of five administration services per home unit or communal space within a single group living location, but only when fewer than 10 Medicare patients receive a COVID-19 vaccine dose on the same day at the same group living location.

Alert—Be on the Lookout for
Scammers Diverting Insulin and Diabetes Testing Supplies

Scammers have been increasingly targeting pharmacies to unlawfully divert insulin and diabetes testing supplies. Some scammers obtain legitimate prescriptions for insulin and other diabetes testing supplies, pick up their prescription, after which they immediately contact PBMs posing as the pharmacy to reverse the claim, with the pharmacy only finding that the claim has been reversed when they receive their remittance statement. Other schemes involve scammers obtaining pharmacy account information to place orders with distributors, which then send shipments to a pharmacy, at which point the scammer contacts the pharmacy, impersonating the distributor to inform pharmacy staff that the shipment was made in error and that it will be retrieved by someone posing as a courier. Take the time to verify all open orders with distributor partners and only release a return after you receive a proper, designated return authorization from your distributor partner and that the only couriers that should be permitted to pick up returns should be your pharmacy’s regular, contracted distributor driver. Principal states where pharmacies have been targeted include: Arkansas, California ,Florida, Georgia, Hawaii, Louisiana, Missouri, New Jersey, New Mexico, New York, Ohio, South Carolina, Texas, and Utah.

NCPA Joins Letter Supporting the
Patient Access to Urgent-Use Pharmacy Compounding Act

This week, NCPA was one of forty signatories on a letter to Reps. Henry Cuellar (D-Texas) and Morgan Griffith (R-Va.) supporting HR 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act. The signatories noted “that the recent pandemic has shown, there are patient access gaps in our health care system that occur when critical drugs go into shortage, including those needed for administration to patients in hospitals and other clinical settings.” This legislation would address the gaps and improve patient care.

FDA Compounding Quality Center of Excellence Offers
2021 Virtual Conference

The Center of Excellence is extending an invite to the annual virtual conference to be held on September 14-15, 2021, as well as a pre-conference session on the 13th. The conference will bring together outsourcing facilities, compounders interested in becoming outsourcing facilities, regulators, and other stakeholders to learn and engage on key topics and best practices. This event includes a variety of speakers and informational sessions on quality compounding best practices. Space is limited and the FDA is reviewing registration requests on a rolling basis. Please contact the  CompoundingQualityCoE@fda.hhs.gov

Deadline Extended:
FTC Seeks Comments on Anticompetitive Contracts

This week, the Federal Trade Commission (FTC) extended the deadline to September 30 for submission of public comments on contract terms that may be harmful to fair competition. If you have not done so, please take a few moments to send a comment letter to the FTC urging them to investigate unfair terms in PBM contracts and inform them of your own experiences of how these terms harm patient choice and competition. Be sure to add your comment to the more than 2,300 that have been submitted through this link.

Join Us in Charlotte, N.C. for the NCPA
2021 Annual Convention

If you have not yet done so, register for the in-person NCPA 2021 Annual Convention in Charlotte, N.C. from Oct. 9-12. Don’t miss the chance to reconnect with your colleagues for four days of best-in-class business education, networking opportunities, and a little fun in Charlotte. We look forward to seeing you there.

CA Patient Steering Bill Passes Major Hurdle

This week, CA SB 524, a patient protection bill, was voted out of the Assembly Appropriations Committee despite major opposition by the PBMs. This bill protects patients and community pharmacies from PBM conflicts of interest by prohibiting insurers and PBMs from steering customers to insurer and PBM-affiliated pharmacies. SB 524 will help ensure patients have the authority to make decisions that are in the patient’s best interest, instead of what’s in the insurer or PBM’s best interest. NCPA has been proud to work with our partner, the California Pharmacists Association on this important legislation. Great job CPhA! Please see NCPA’s letter of support.

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.