FTC Seeks Comments on Anticompetitive Contracts
The Federal Trade Commission (FTC) is requesting public comments on contract terms that may be harmful to fair competition. NCPA will be sending out a template to members early next week that will aid them in providing comments if they wish. Additionally, NCPA has included a FTC link and example of anticompetitive contract terms on Twitter should members wish to use that pathway.
FDA Extends Time for States to Sign MOU By One Year
In a win for NCPA members, on August 6, 2021, the FDA published a notice in the Federal Register extending the time period for states to decide whether to sign the final standard memorandum of understanding (MOU) between States and the FDA on human compounded drugs before FDA intends to begin enforcing a 5 percent limit on distribution of products out of the states which do not sign the agreement. NCPA has advocated for such an extension and the FDA will now allow states until October 27, 2022 to sign. States may sign the final standard MOU at any time, including after FDA begins enforcement. This extension gives States and their Board of Pharmacy more time to consider the MOU and make any necessary changes to existing state law for compliance. However, the FDA does not address any of the underlying issues raised by NCPA or other stakeholders such as resolving the dispense versus distribute definition or affect the ongoing litigation over the authority of FDA to issue the MOU. NCPA will continue to advocate for the FDA to make the necessary changes to make the MOU a more workable framework for compounding pharmacies.
NCPA Participates in HHS Drug Pricing Listening Session
This week, Ronna Hauser, NCPA Senior Vice President of Policy and Pharmacy Affairs, participated in an HHS Listening Session to provide recommendations to the drug pricing report HHS is preparing in response to the Biden Executive Order. NCPA spoke on the need for the report to look at lowering out of pocket drug costs via pharmacy DIR fee reform and realigning incentives in Part D. NCPA also discussed other community pharmacy priorities, including the importance of banning spread pricing in Medicaid managed care and allowing any willing pharmacy to participate in Part D preferred networks.
Pharmacy Technicians and Interns Authorized
to Administer Seasonal Flu Vaccines
HHS Secretary Xavier Becerra has issued an amendment to the federal Public Readiness and Emergency Preparedness (PREP) Act, extending PREP Act coverage to and authorizing pharmacy technicians and interns with proper training (similar to previous requirements to administer COVID-19 and childhood vaccines) to administer seasonal flu vaccines to adults. Effective August 4, qualified pharmacy technicians and pharmacy interns (under the supervision of a State-licensed pharmacist and licensed or registered by their State board of pharmacy) can administer seasonal influenza vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons aged 19 and older according to ACIP’s standard immunization schedule. This is in addition to previous PREP Act authorizations for pharmacists, pharmacy technicians, and pharmacy interns to administer ACIP-recommended vaccines to persons ages three through 18 and COVID-19 vaccines to persons ages three or older.
Senate Introduces Bipartisan Infrastructure Bill
A bipartisan $1 trillion infrastructure bill called the Infrastructure Investment and Jobs Act was released earlier this week. Among other things, the bill includes new federal investments for roads and bridges, broadband internet, public transit and electric utilities. A delay to the “rebate rule” was used as a so called “pay for” for this infrastructure package. This would delay the prohibition on the massive rebates received by PBMs. The Senate is expected to take up a key vote this weekend to end debate. Should this vote be successful it will clear the way for a final vote in the Senate early next week.
Bipartisan Bill Seeks to Shift Patients from Nursing Homes
to Home Health Care
Last Thursday, Senators Debbie Stabenow (D-Mich.) and Todd Young (R-Ind.) introduced legislation, S.2562, the Choose Home Care Act of 2021, to provide Medicare beneficiaries with post-acute care, including daily living support, at home. The current Medicare benefit offers part-time nursing services, in-home therapies, social services, and medical supplies for 60 days. However, beneficiaries are not eligible for home health care if they need more than intermittent skilled nursing services. NCPA will continue to advocate for the explicit inclusion of medical at home pharmacy services in any legislation modifying or expanding home health care moving in Congress.
NCPA Co-Hosts Briefing on Long-Term Care
Pharmacy Definition Act of 2021
Last Thursday, Premier, NCPA, ASCP, and SCPC hosted a briefing with Senators Tim Scott (R-S.C.) and Mark Warner (D-Va.) on their legislation, S. 1574, the Long-Term Care Pharmacy Definition Act of 2021. The legislation establishes a definition of LTC pharmacy to ensure continued patient access to essential medications and pharmacy services. If you wish to view the opening remarks from the Senators along with broader discussion by a panel of invested stakeholders on why a definition for long-term care pharmacies is so important, you can do so here.
Invite Your Legislator to Visit Your Pharmacy
During the August Recess
Congress is currently scheduled to be in recess July 31-September 8 for the annual August recess. This is an ideal time to invite your member of Congress to tour your pharmacy and urge their support for pro-pharmacy and pro-patient legislation such as for S. 1909/H.R. 3554, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act. Click here for tips on scheduling a pharmacy visit or contact Michael Rule at mrule@ncpa.org for assistance.
Help Patients Fight Back Against PBM Steering
NCPA developed materials that you can use in your pharmacy to help your patients fight back against PBM steering. These materials direct your patients to the resources available to them on Fight4Rx. Encourage your patients to take advantage of these resources, particularly a tool that helps them customize their own letter. Contact Michael Rule with any questions.
New Resource on Biosimilars Interchangeability
Cardinal Health has released a new, interactive Biosimilars Interchangeability State Laws resource. This state-by-state resource was developed in partnership with regulatory advisors to help you navigate your state’s specific guidelines and support patients with biosimilar adoption. As a reminder, the FDA approved the first interchangeable biosimilar insulin product on July 28 (press release here)—Semglee (insulin glargine-yfgn) is both biosimilar to and interchangeable with its reference product Lantus (insulin glargine).
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.
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.