NCPA Advocacy Update

Week ending July 23

Author: APCI Staff/Monday, July 26, 2021/Categories: Legislative Affairs

NCPA CEO Doug Hoey Elected President
of World Pharmacy Council

National Community Pharmacists Association CEO B. Douglas Hoey, pharmacist, MBA has been elected to simultaneously serve as president of the World Pharmacy Council, an international group with a mission of building international recognition of community pharmacy and its role, policies, and value to citizens around the world. In addition to the U.S., the WPC represents community pharmacy organizations in the United Kingdom, Ireland, Spain, Portugal, Denmark, Australia, and New Zealand. Read NCPA’s news release here.


NCPA Provides Response to Executive Order on Competition

This week, NCPA responded both to HHS and the White House on details contained within President Biden’s Executive Order on Promoting Competition in the American Economy. As HHS develops a plan to address rising drug costs within the 45-day window requested by the EO, NCPA reiterated the necessity to address pharmacy DIR fees in any regulatory or policy proposal. Additionally, NCPA provided comments to the White House on the ongoing anticompetitive behaviors of the PBMs as well as the requirements for the development of any workable potential drug importation policy. NCPA looks forward to continuing to work with the Biden Administration to implement policies and guidelines to enable small businesses to remain competitive in the marketplace.


Invite Your Legislator to Visit Your Pharmacy
During the Upcoming 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.


COVID-19 Public Health Emergency Declaration Extended

Effective July 20, 2021, HHS Secretary Xavier Becerra issued the latest renewal of the COVID-19 public health emergency (PHE), extending the declaration for an additional 90 days. As with the original PHE declaration and previous extensions, it affects telemedicine and other waived requirements for federal health care programs, including Medicare Part D flexibilities related to refill-too-son edits, extended day’s supply, home or mail delivery, prior authorization, signature log requirements, and in-person audits. Note that pharmacists’ (and other qualified persons such as pharmacy technicians and interns) ability to provide COVID-19 testing, administer vaccines, and protection from liability claims are authorized by the federal Public Readiness and Emergency Preparedness (PREP) Act declaration, and will remain in effect through 2024 (more information here). Be sure to visit NCPA’s Coronavirus Advocacy page for more information on federal, state, and local developments related to the PHE that affect pharmacists.


NCPA Provides Comments to RFI on Reporting
on Pharmacy Benefits and Prescription Drug Costs

This week, NCPA provided comments to a request for information from four Executive agencies, including HHS, regarding a requirement for the reporting of data for expenditures for prescriptions in the Consolidated Appropriations Act for health insurance plans – but not Medicare Part D. The comments focused on how to best structure the reporting of data for the expenditures and increases of prescriptions as well as price concessions, rebates, and other information related to drug costs. NCPA stressed that PBMs are the best situated to report this data and will continue to advocate for greater transparency for price concessions.


NCPA Provides Comments to Post FDA Listening Session
on Compounding

NCPA provided additional comments to the FDA following aJune 22, 2021 Listening Session. During the forum, NCPA provided feedback to the including the MOU, adverse event reporting, drug shortages, and office use – among others. The additional comments reflect and reiterate several issues – following up on the PCAC decision to permit compounding for methylcobalamin, the MOU, as well as the ability of pharmacists to address drug shortages. NCPA will continue to advocate for the ability of compounding pharmacists to continue to provide safe and effective drugs to patients.


DEA Clarification Regarding Supplier’s Registration Number
on Form 222

The Drug Enforcement Administration (DEA) issued a direct final rule to amend DEA regulations to clarify that either the purchaser or the supplier may enter a supplier’s DEA registration number on the Single-Sheet DEA Form 222, which is the form that allows DEA registrants to order and transfer Schedule I and Schedule II controlled substances. This is effective on October 18, 2021 unless DEA receives significant adverse comments, in which case it will publish a withdrawal of the rule by September 20, 2021. We will continue to monitor the situation and notify you in the event of a withdrawal or reminderas the effective date approaches.


Upcoming iPLEDGE Program Changes

The iPLEDGE Program will be updated beginning in December 2021 to remove the Risk Evaluation and Mitigation Strategy (REMS) Pharmacy Network Connectivity (“switch”), which means that pharmacies will no longer be able to obtain a Risk Management Authorization (RMA) for isotretinoin through the switch. Beginning December 1, 2021, pharmacies that dispense isotretinoin will only be able to obtain an RMA via the iPLEDGE Program website or the Interactive Voice Response System (IVRS). The iPLEDGE Program sponsors are hosting an information session on July 29, 2021 at 2:00 pm ET to review this change with pharmacy stakeholders—if you are interested in attending, please register here.


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 reformscope 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.

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