CDC Approves Moderna and J&J COVID-19 Booster Shots,
Allows for Mix-and-Match

The CDC has endorsed the Advisory Committee on Immunization Practices (ACIP) recommendation for a booster shot of Moderna and Johnson & Johnson COVID-19 vaccines for certain populations following the FDA amendment of emergency use authorizations (EUAs). For individuals who received a Pfizer-BioNTech or Moderna COVID-19 vaccine, the following groups are eligible for a booster shot at 6 months after the initial series: 1) 65 years and older; 2) 18+ who live in long-term care settings; 3) 18+ who have underlying medical conditions; and 4) 18+ who work or live in high-risk settings. For individuals who received the Johnson & Johnson COVID-19 vaccine, booster shots are also recommended for those 18 and older who were vaccinated 2 or more months ago. CDC has also approved heterologous booster dosing—eligible people may choose a different booster from the vaccine they originally received. Additional information is available in the CDC media statement released following the ACIP meeting on October 21.

NCPA Provides Testimony on Patient Steering

This week, NCPA Director of State Government Affairs Matt Magner provided virtual testimony before an Oklahoma House interim study committee. The committee is studying SB 821, a bill that addressed PBM abuses, including patient steering. SB 821 was passed by the legislature earlier this year, but Gov. Kevin Stitt (R) vetoed it. NCPA provided information related to patient steering nationwide, including data from states finding that PBMs steer patients to their own pharmacies and reimburse those pharmacies at higher rates than independent pharmacies.

CMS Study Finds Improved Adherence
Created Billions in Medicare Savings

A recent Centers for Medicare & Medicaid Services (CMS) study found that medication use is improving among seniors and vulnerable beneficiary populations. Better adherence to medicines used to treat common chronic conditions such as high cholesterol, high blood pressure and diabetes is estimated to have saved the Medicare program $27-$46.6 billion in avoided health care costs from 2013- 2018.

CMMI Briefs Stakeholders on Long Term Strategy
for the Agency

On October 20, 2021, CMMI hosted a brief for interested stakeholders to update on the agency’s strategy following the release of the “CMMI Strategy Refresh White Paper.” The agency plans to reduce the number of models tested and concentrate on disparate projects where the impact can be accurately assessed. Additionally, CMMI described potential options for models on Medicare Part B covered drugs, stating that CMMI is considering small scale, mandatory models informed by the Health and Human Services (HHS) Drug Pricing Plan. NCPA will continue to communicate with CMMI on changes to models which impact patient access and quality of care at the pharmacy.

NCPA Presents at CPA and PCCA Meetings

NCPA SVP of Policy and Pharmacy Affairs Ronna Hauser provided an update this week during the Connecticut Pharmacists Association Fall CE Series on “Updates on DIR Reform: What's Next for Pharmacies and Their Patients.” NCPA also participated in a panel discussion at PCCA’s International Seminar 2021. The session “Industry Panel: Regulatory Update with PCCA, NCPA and APC” highlighted the compounding industry’s efforts to work collaboratively, advocating to Congress, FDA and state boards of pharmacy the vital role of compounding. NCPA appreciates these opportunities to interact with our members and partners and educate on the importance of pharmacy advocacy.

NCPA Provides Comments to the National Advisory
Committee on Rural Health and Human Services

This week, NCPA provided initial comments for the National Advisory Committee on Rural Health and Human Services which is scheduled to meet from October 25-27. The Committee is under the umbrella of HRSA and advises the Secretary of HHS on health care challenges in rural America. For this meeting, the Committee is set to discuss a new rural provider designation for hospitals as directed by Congress. NCPA took the opportunity to focus on informing the Committee on the ongoing work on pharmacy deserts and importance of pharmacy in addressing patient needs in rural areas – particularly with adherence to prescription regimes producing favorable outcomes. NCPA will continue to work with the Committee as they explore policies which address the needs of rural patients.

Make Sure to Join Us: Life After Rutledge Webinar

Make sure you’re registered for a free webinar, Tuesday November 16th, with Attorney Rob Smith, partner at Katten, Muchen, Rosenman, LLP who most recently argued on behalf of the state of North Dakota before the Eighth Circuit in defense of two North Dakota laws regulating PBMs (in PCMA v. Wehbi), and Matt Walker, Executive Director of the West Virginia Independent Pharmacy Association. Smith and Walker, in a follow-up to their presentation at the 2021 NCPA Annual Convention, will help to explain how last year’s unanimous 8-0 decision in Rutledge changed the legal landscape and how pharmacists can work to push for new PBM regulations at the state level.

During the webinar, you’ll have the opportunity to contribute to NCPA’s Legislative/Legal Defense Fund, which funds expenses related NCPAs multiple ongoing federal lawsuits. Your donation to the LDF through this webinar is critical as our webinar sponsor, RxSafe, will MATCH your individual contributions to the LDF dollar for dollar. You can register for the webinar here. Learn more about NCPA’s Legislative/Legal Defense Fund here.

NCPA Attends NABP District Meeting

This week, NCPA attended the National Association of Boards of Pharmacy (NABP) District IV virtual meeting hosted by the Ohio State University College of Pharmacy and the Ohio Board of Pharmacy. District IV includes Boards of Pharmacy from states in the upper Midwest: Wisconsin, Michigan, Illinois, Indiana, and Ohio. Presentations from students and staff at the Ohio State University College of Pharmacy featured topics on pharmacy education, the challenges of pharmacist burnout from the increased workload during the pandemic and their lobbying efforts in the passage of Ohio’s provider status bill in 2018. All but one state, Michigan, within District IV have extended immunization authority to pharmacists and pharmacy interns and technicians under specific authority to administer flu, COVID-19, and other CDC & FDA approved vaccines for most individuals.

FDA Releases Updated Draft Guidance on Hospital
and Health System Pharmacy Compounding

Earlier this month, the FDA released draft guidance for 503A compounding pharmacies in hospitals and health systems. These updated documents remove the one-mile limit proposed in earlier versions and adds a potential exemption to the prescription requirement (office use) for these entities – which does not exist for community compounding pharmacies. The guidance states the FDA does not intend to take action in the following circumstances:

• The compounded drug products are administered only to patients within the hospital or health system;
• The compounded drug products are used or discarded within 24 hours of transfer out of the pharmacy;
• The drug products are compounded in accordance with all other applicable requirements of the FD&C Act and FDA regulations (e.g., the drug products are not made under insanitary conditions (section 501(a)(2)(A)) or misbranded (e.g., section 502(g)).

This guidance is still in draft form and the FDA is currently accepting comments on the proposal. NCPA will be advocating FDA to prevent the implementation of different standards for 503A facilities based upon the pharmacy model.

USP Announces Open Forums on Compounding Changes

With the announcement of proposed changes to chapters <795> and <797>, USP is hosting open forums and permitting public observation of the Compounding Expert Committee meetings from now until January 31, 2022 – when stakeholder comments are due. The CEC is meeting on November 2, 2021, with additional dates following. Even if you are not a member of USP, you can sign up to observe here. Also, the USP is hosting Open Forum sessions to discuss questions on the changes. You can participate in sessions and discuss questions with the CMP EC on for <795> on January 12th, 2022, 10:00 a.m. – 12:00 p.m. ET and for <797> on January 19th, 2022, 10:00 a.m. – 12:00 p.m. ET. NCPA staff will be observing and participating in these forums as we begin to formulate comments in response to the suggested changes of the chapters.

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.