NCPA Releases Summary and Will Host Webinar
on CMS’ Final Part D Rule
Join NCPA on Tuesday, May 17, at 8 p.m. ET for a webinar to provide an analysis of CMS’ Final Part D Rule addressing pharmacy DIR fees and what it means for independent community pharmacies. Pharmacy DIR reform has been NCPA’s top priority for years and this webinar will provide an overview of what this rule does and doesn’t do. NCPA has also created this summary of the final rule to help answer immediate questions surrounding the rule.
Senate Hearing Focuses on Abusive PBM Business Practices
This week, the U.S. Senate Commerce Committee’s Subcommittee on Consumer Protection, Product Safety, and Data Security held a hearing titled “Ensuring Fairness and Transparency in the Market for Prescription Drugs.” Chairman Richard Blumenthal (D-Conn.) and Ranking Member Marsha Blackburn (R-Tenn.) were joined by Sen. Maria Cantwell (D-Wash.), Chairwoman of the full committee, in aggressive questioning of PBM’s anticompetitive business practices and called for greater oversight and enforcement authority for the Federal Trade Commission (FTC). NCPA submitted a statement for the record calling for greater transparency and reform while detailing how PBMs harm the marketplace and patients with practices including patient steering, discriminatory reimbursement, and overly broad audits, among others. The statement encourages passage of S. 1388, the Prescription Pricing for the People Act, and S.298, the Pharmacy Benefit Manager Accountability Study Act. NCPA also reiterated that the FTC should proceed with conducting a 6(b) study on PBMs’ commercial activities for better insight into their drug pricing practices and their contracts with pharmacies. View NCPA’s press release here and Sen. Cantwell's press release here.
Senators Seek Clarity for Pharmacists
as Regulatory Flexibilities Wind Down
This week, Sens. Charles Grassley (R-Iowa), Robert Casey (D-Pa.), Sherrod Brown (D-Ohio), John Barrasso (R-Wyo.) and Ben Ray Luján (D-N.M.) sent a letter to CMS seeking clarification on the flexibilities that will be granted to pharmacists once the COVID-19 public health emergency designation ends. The bipartisan group is seeking a smooth transition for pharmacists that ensures regulatory flexibility. See the full press release on the letter here.
PCMA Appeals District Court Ruling in PCMA v. Mulready
to Tenth Circuit
This week, the Pharmaceutical Care Management Association (PCMA) announced plans to appeal the PCMA v. Mulready decision issued by the U.S. District Court for the Western District of Oklahoma to the Tenth Circuit. The district court found that ERISA preempted none of the challenged provisions of Oklahoma’s Patient’s Right to Pharmacy Choice Act, thus reinforcing the state’s broad authority when it comes to regulating PBM practices in Oklahoma. PCMA claimed the law is preempted by both Medicare Part D and ERISA.
Share Your Examples of PBM Harms with the FTC
The FTC is seeking examples of patient and consumer harm caused by PBMs. Please take a few moments and share your examples of patient harms with the FTC, using this template as a guide. It is important that you personalize this with your own examples and let the FTC know how your patients will continue to be harmed if PBMs are not addressed and be sure to remove anything from the template that may not pertain to you. Once your comment is ready, you can submit it here. Make sure and do so by May 25.
Rep. Donald Payne (D-N.J.) Visits E and M Pharmacy
This week, Rep. Donald Payne (D-N.J.) visited E and M Pharmacy in Orange, N.J. Owner Prakash Maddali reported the visit went well. “We were glad that he made it. The congressman was very receptive to current health care and small business challenges.” Maddali worked with NCPA on materials for the visit and officials from Garden State Pharmacy Owners Association were also in attendance. Contact Michael Rule at NCPA for assistance if you are interested in hosting a pharmacy visit.
FDA Finalizes Guidance on Compounding Animal Drugs
from Bulk Ingredients
FDA recently released a final guidance for industry (GFI) on the legality of compounding animal drugs from bulk ingredients. The GFI describes FDA’s current thinking about compounding animal drugs from bulk drug substances, identifies FDA’s enforcement priorities with respect to drugs compounded from bulk drug substances, and describes circumstances under which FDA generally does not intend to take action against veterinarians or pharmacists who compound animal drugs from bulk drug substances. To see a member summary of the guidance, click here. NCPA will be working with our compounding stakeholder partners to address concerns from the guidance.
FDA’s Pharmacy Compounding Advisory Committee
to Meet June 8
This week, the FDA announced that its Pharmacy Compounding Advisory Committee will meet on June 8. The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione. NCPA will coordinate a presentation on glutathione, a substance NCPA nominated, for the June 8 meeting.
NCPA Joins TPA, Other Pharmacy Organizations
on Letter to Tennessee Governor
NCPA joined the Tennessee Pharmacists Association and other pharmacy advocacy groups on a letter to Tennessee Gov. Bill Lee (R) urging him to sign SB 2458/HB 2661 into law. The bill has passed both chambers and is awaiting the governor’s signature. The bill would require PBMs to adopt reimbursement methods that accurately reflect actual acquisition costs and protect patients from being forced to use PBM-owned pharmacies.
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.