Included in this newsletter
- Prime Therapeutics Medicare Prescription Payment Plan Pharmacy Certification
- Iowa Pharmacists Are Now Considered Practitioners
- Long-Term Care (LTC) at Home Policies and Procedures
- Pharmacy-Based Immunization Administration by Pharmacy Technicians
- FDA Determines that Semaglutide Shortage Is Over
- FDA Issues Class-Wide Labeling Changes for Testosterone Products
- Enforcement
- Policy & Procedure Updates
Prime Therapeutics Medicare Prescription Payment Plan Pharmacy Certification
Prime Therapeutics has been notifying pharmacies concerning their “Medicare Prescription Payment Plan (M3P) Pharmacy Certification”.
The Medicare Prescription Payment Plan is a voluntary enrollment for Part D patients. There is no savings for the patient but it allows payments to be spread out over the plan year. There is a form, CMS-10882 (Spanish version), that should be provided to the patient by their Part D Sponsor or the pharmacy that explains the plan and how to sign up for it.
Prime Therapeutics requires the pharmacy to complete a Medicare Prescription Payment Plan Pharmacy Certification Form indicating that there are policies and procedures in place for the Medicare Prescription Payment Plan which include providing a copy of the CMS-10882 form to Part D patients, staff training on the plan, and oversight measures to ensure adherence to the plan.
Note: From CMS Part Two Guidance FAQs Item #5 – “The name “Medicare Prescription Payment Plan” should be used in any guidance and communications by Part D sponsors related to this program. CMS is not using “M3P,” “MPPP,” or any other acronym as approved terms for the program and encourages Part D sponsors to use the CMS-developed fact sheet as the basis of their materials for the 2025 plan year.”
Iowa Pharmacists Are Now Considered Practitioners
Congratulations to Iowa pharmacists for becoming the third state to recognize them as Practitioners! Iowa joins Alaska and Idaho, where pharmacists can expand their pharmacy to become medical providers. Let’s hope this trend will continue.
Long-Term Care (LTC) at Home Policies and Procedures
By request of several clients and organizations, R.J. Hedges is creating an LTC @ Home program that has just finished step one of our peer review process. Stay tuned for additional information. In preparation, if your pharmacy has not fully implemented a Medication Adherence Program (Sync), please begin in earnest. Both programs work well with each other, and this will increase the pharmacy’s EQuiPP Scores and Star Rating, which will increase your reimbursement.
Pharmacy-Based Immunization Administration by Pharmacy Technicians
American Pharmacist Association is announcing that pharmacy technicians should expand their expertise with the Pharmacy-Based Immunization Administration training on Friday, March 21, from 8:00 am – 12:00 pm CT https://www.pharmacist.com/Education/Certificate-Training-Programs/Technician-Immunizations
FDA Determines that Semaglutide Shortage Is Over
The Food and Drug Administration has determined the shortage of semaglutide injection products is resolved and that it does not intend to take action against: See More…
- Pharmacies compounding under section 503A, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved product until April 22, 2025.
- Outsourcing facilities compounding under 503B, distributing or dispensing semaglutide injection products that are essentially a copy of an FDA-approved drug product until May 22, 2025.
- There are several lawsuits filed in Texas and other states to delay the FDA’s decision. However, a U.S. District court in Texas has permitted Novo Nordisk to enter the lawsuit where they are stating their manufacturing can not meet the demand for their GLP-1s. We strongly suggests not to dispense past the deadline of April 12th (503A) and May 22nd (503B). See More…
FDA Issues Class-Wide Labeling Changes for Testosterone Products
FDA announced new labeling changes for testosterone products following a review of clinical trial data and post-market ambulatory blood pressure monitoring (ABPM) studies. The updated language will include findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) study on all testosterone products; retain "Limitation of Use" language for age-related hypogonadism and remove language from the boxed warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products. See More…
Enforcement
- NY Pharmacists Convicted for Illegal Oxycodone Distribution Face Up to 60 Years
- HHS Office for Civil Rights Imposes a $1,500,000 Civil Money Penalty Against Warby Parker in HIPAA Cybersecurity Hacking Investigation
- Walgreens Ordered to Pay $987 Million In COVID-19 Test Contract Case
- In addition, Walgreens is being sold to the capital investment company Sycamore Partners, which will break up Walgreens into three different companies. Many pharmacies are closing, and employee layoffs have begun. Read more…
- Felony Charges Filed Against Former Paxton Pharmacist
New and Updated Policies & Procedures and Forms
None this month
