Harshbarger: Congress Must Include PBM Reforms
in Any Drug Pricing Bill
This week, Rep. Diana Harshbarger (R-Tenn.) spoke on the House floor about the need for PBM reform to reduce drug costs and ensure patient access to community pharmacies. Harshbarger is the pharmacist owner of Premier Pharmacy in Kingsport, Tenn.
She said, in part: “The virtually unchecked powers of PBMs have enabled them to: No. 1, charge drug manufacturers hefty rebates for preferred placement on formularies. The higher the list price, the higher the rebates, but no one knows where these rebates go.”
You can view her floor speech here.
NCPA Urges Congress Not to Leave Pharmacy DIR Reform
and Spread Pricing Ban Out of Reconciliation
Ahead of expected congressional action on government spending legislation, NCPA expressed disappointment that the House version of the reconciliation bill leaves out provisions to eliminate retroactive pharmacy DIR fees and PBM spread pricing games in Medicaid managed care programs. NCPA has pushed negotiators to include these important provisions, repeatedly emphasizing that pharmacy DIR fee reform would save seniors an estimated $7-9 billion while a ban on Medicaid managed care spread pricing and a move to fair and transparent pharmacy reimbursement would save the federal government over $1 billion. There is still a long road ahead and NCPA remains hopeful that these provisions will be included in the final bill.
Check to See if You’re Impacted
by the Federal Vaccine Mandates
As reported previously, the Biden Administration has issued two regulations that may impact your community or LTC pharmacy—please read on to check what the impact will be on your pharmacy.
If your pharmacy has more than 100 employees company-wide it will be required to implement a mandatory COVID-19 vaccination policy or require weekly testing and use face coverings at work per the recently released OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard. Specific details on the requirements, which will need to be implemented as early as December 5, can be found here. Note that if your pharmacy has fewer than 100 employees and you provide testing or administer vaccines, you must adhere to the previous health care ETS requirements (see here for a summary of the health care ETS).
The second regulation that may impact your pharmacy is a CMS rule that requires anyone that provides treatment or other services to health care facilities that participate in Medicare or Medicaid programs, such as skilled nursing facilities (SNFs), to be vaccinated. All individuals who physically enter or are in close proximity to LTC or SNF staff or patients, including pharmacy staff, must have received their first dose of a two-dose or a one-dose COVID-19 vaccine prior to providing any care, treatment, or other services by December 5, with full vaccination by January 4, 2022. More information can be found in this CMS press release, and a list of frequently asked questions is available here.
NCPA continues to analyze these rules to determine any additional impact on community and LTC pharmacies, so please stay tuned.
NCPA Recommendations to Overcome Barriers
to Ordering and Dispensing Oral Antivirals
In a joint letter to HHS, NCPA and other pharmacy groups provided recommendations to overcome current barriers that may prevent Medicare and Medicaid beneficiaries from accessing COVID-19 therapeutics from their pharmacist. Although the 9th amendment to the COVID-19 PREP Act Declaration provides liability immunity to and expands the scope of authority for licensed pharmacists to order and administer COVID-19 therapeutics (and for pharmacy technicians and pharmacy interns to administer COVID-19 therapeutics), no payment mechanism currently exists for the Medicare program to reimburse pharmacists for patient assessment services necessary to order appropriate COVID-19 treatments, undermining patient access to oral antivirals for COVID-19. NCPA and others are working with HHS to address this issue.
GAO Cites NCPA in Vaccines Report
This week, GAO released a report titled , COVID-19: HHS Agencies’ Planned Reviews of Vaccine Distribution and Communication Efforts Should Include Stakeholder Perspectives (GAO-22-104457). The report cited NCPA in its findings on federal efforts to distribute, administer, and communicate about COVID-19 vaccines. The full report can be viewed here.
CDC Approves Pfizer Vaccine for Pediatric Use
in Children Ages 5 to 11
This week, the CDC endorsed the Advisory Committee on Immunization Practices (ACIP) recommendation that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine (CDC media statement available here). The vaccine for children 5 through 11 years of age is to be administered as a two-dose primary series at a lower dose than that used for individuals 12 years of age and older (10 micrograms compared to 30 micrograms) three weeks apart. Shipments of the vaccine started last Friday, with some 15 million doses being shipped this week and the federal program for distributing the vaccine fully operational by next Monday, November 8.
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.
Administration Opens the Health Insurance Marketplace
This week, the Administration opened the Health Insurance Marketplace for enrollment from now until December 15, 2021. CMS is providing resources to made it easier for consumers to sign up for coverage and easier for our partners to gain access to valuable Marketplace outreach resources through a new Partner Toolkit.
NCPA Supports New Diabetes Self-Management Bill
Rep. Kim Schrier, (D-Wash.) and members of the Congressional Caucus on Diabetes, introduced H.R. 5804, the Expanding Access to Diabetes Self-Management Training Act that will make it easier for people with diabetes to access training to manage their blood glucose levels and prevent hospitalization. “As someone who has managed my own Type 1 diabetes for 36 years, I understand that it can be complicated. And if you get it wrong, it can be life-threatening,” Schrier said. NCPA is one of more than 20 national organizations supporting this legislation.
Reminder That Controlled Substances Prescriptions
Must be Manually Signed
The Drug Enforcement Administration is sending a letter to all DEA registered pharmacies and prescribers as a reminder that paper prescriptions, including prescriptions created on paper and prescriptions generated by computer or a prescription application that are printed out or faxed by a practitioner, must be manually signed by the prescribing practitioner. Please note that although the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, a corresponding responsibility rests with the pharmacist who fills the prescription. Any questions should be directed to the Policy Section of the DEA Diversion Control Division at (571) 362-3260.
NCPA Helps Launch Main Street Competition Coalition
Last week, NCPA joined with other Main Street business groups to launch the Main Street Competition Coalition today. The group represents business owners across industries who have been harmed by unfair exercises of market power.
In their first act as a coalition, the members sent a letter to the Federal Trade Commission urging action in response to rampant economic discrimination throughout the economy.
Federal Court Issues Ruling in Ongoing 340B Dispute
On October 29, 2021, the U.S. District Court for the Southern District of Indiana ruled that HHS’ advisory opinion, which prohibited manufacturers from restricting drug shipments to contract pharmacies, is invalid because it’s “arbitrary and capricious” as are the letters sent by HRSA in May to drug manufacturers. However, the Court added that drug manufacturers cannot unilaterally impose restrictions on contract pharmacies. In the end, the Court remanded the enforcement letters back to HRSA for the agency to contemplate the next steps for action. The Court also encouraged Congress to clarify the policies for contract pharmacies participating in the 340B program through legislation.
California and New York’s Governors Sign Legislation
to Expand Pharmacists Vaccine Authority
NCPA celebrates the enaction of laws in California and New York that grant authority for pharmacists to administer FDA-approved vaccines to individuals, further codifying authorities provided in the PREP Act. Governor Gavin Newsom (D-Calif.) signed into law legislation authorizing pharmacists to administer all FDA approved vaccinations for California residents 3 years and older. Governor Kathy Hochul (D-N.Y.) signed a law authorizing pharmacists to provide specific vaccinations such as measles, mumps, and the COVID-19 vaccine for individuals over the age of 18. The new law also makes permanent the ability for licensed pharmacists to administer the COVID-19 vaccine.
NCPA Provides Comments to the Virginia Board of Pharmacy
NCPA submitted written comments to the Virginia Board of Pharmacy regarding proposed amendments expanding the definition of unprofessional conduct. The proposed amendments come after documented reports of concerning public and patient safety at retail pharmacies in Virginia. The amendments encourage working conditions that prevent fatigue among pharmacy personnel. John Beckner, Senior Director of Strategic Initiatives at NCPA, provided verbal comments at the meeting applauding the Board’s attention to this issue in highlighting workplace safety and its benefits to pharmacy patients in providing care.
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.