NCPA Advocacy Update

Week ending August 20

Author: APCI Staff/Monday, August 23, 2021/Categories: Legislative Affairs

Oral Arguments Set for North Dakota
PBM Regulations Lawsuit

Oral arguments for PCMA v. Wehbi have been scheduled for September 1, 2021. Earlier this year the U.S. Supreme Court vacated a ruling by the U.S. Circuit Court of Appeals for the 8th Circuit in the case formerly known as Wilke v. PCMA. Last August the 8th Circuit struck down North Dakota PBM regulations due to ERISA preemption issues. The Supreme Court determined that the 8th Circuit’s ruling could not stand in light of the recent unanimous ruling in Rutledge v. PCMA, and it was sent back for the circuit court to reevaluate North Dakota’s law under the Rutledge decision. NCPA, along with nine state pharmacy associations, filed a friend of the court (amicus curiae) brief in the 8th Circuit of the U.S. Court of Appeals defending North Dakota’s right to regulate PBMs. PCMA v. Wehbi is the first at the federal appellate level to consider the scope of the U.S. Supreme Court’s unanimous decision last year in Rutledge v. PCMA upholding an Arkansas state law regulating the abusive practices of PBMs. Read more about the case here.


NCPA Urges PREP Act Authorization for Pharmacists
to Order and Administer REGEN-COV

NCPA joined with other pharmacy organizations in a sign on letter to HHS recommending that the agency amend the Public Readiness and Emergency Preparedness (PREP) Act declaration for COVID-19 to allow pharmacists to order and administer REGEN-COV monoclonal antibody (MAB) therapy for post-exposure prophylaxis for COVID-19. The letter also urges HHS to coordinate with payors to ensure adequate reimbursement is available to support access to MAB when provided by pharmacists.


CMS to Require all LTC Staff to be Vaccinated

The Centers for Medicare & Medicaid Services (CMS) has issued a statementannouncing that, in collaboration with the Centers for Disease Control and Prevention (CDC), the agency is developing an emergency regulation that would apply to all nursing homes participating in Medicare and Medicaid to implement a requirement that all staff be vaccinated against COVID-19. It is unclear at this point whether consultant pharmacists or pharmacy delivery personnel will be required to receive the COVID-19 vaccine, nor how CMS expects to audit or enforce this new mandate, which will apply to over 15,000 nursing homes, but the agency expects guidance to be released sometime in September. CMS strongly encourages nursing home staff to get vaccinated ahead of the release of the guidance. NCPA is actively monitoring and will share details as soon as they become available.


CDC Statement on COVID-19 Booster Shots

The Department of Health and Human Services (HHS) issued a statement on Wednesday regarding the administration’s plan to begin offering COVID-19 booster shots beginning the week of September 20 and starting 8 months after an individual’s second dose, subject to the Food and Drug Administration (FDA) conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. HHS also anticipates booster shots will likely be needed for people who received the Johnson & Johnson vaccine. Booster shots are distinct from the third COVID-19 dose FDA authorized last Thursday, August 12 (see FDA news release here). Third doses are authorized for immunocompromised individuals, who can receive the additional dose as soon as four weeks after getting their second shot. Additional information regarding the third dose for immunocompromised individuals can be found here.


New Provider Relief Fund Resource

A new resource on the Provider Relief Fund (PRF) is now available on the NCPA website here. The white paper, prepared for NCPA by law firm Brown & Forunato (B&F) and accounting firm Sykes & Company, P.A., provides details on updated reporting requirements, audit requirements, and upcoming deadlines. NCPA will also be partnering with B&F and Sykes & Co. to put together a webinar series to address timing of the use of PRF funds and reporting due dates, appropriate use of funds, the interplay of PRF with other COVID-19-related funding including Paycheck Protection Program (PPP) loans, and pitfalls and traps to avoid when reporting to avoid potential recoupment of funds, civil monetary penalties, or—in the most extreme cases of deficient reporting—criminal investigations. Stay tuned for additional information related to the PRF and the webinar series.


PBMs File Lawsuit to Stop Drug Pricing
Transparency Requirement

On August 12, 2021, PCMA, the organization representing PBMs, filed a lawsuit against the federal government in an attempt to block a rule requiring them to disclose prices for pharmaceuticals. Specifically, PCMA is challenging a provision which requires the disclosure of historical net prices they negotiate with manufacturers and make such information available to the public. The complaint makes the argument that the Affordable Care Act did not grant the government the authority to make such proprietary information public and the end result of implementing the rule would be an increase in drug prices for patients. The US Chamber of Commerce has also filed a separate lawsuit challenging the rule. NCPA provided comments during the initial proposed rule in 2019 as well as authored a summary of the final rule. While the rule does not impact community pharmacy directly, NPCA will continue to advocate for increased transparency for PBMs.


Merck Pulls Back From 340B Contract Pharmacies

Last week, Merck provided notice to 340B covered entities that unless they submit information related to the 340B claims data to the company, they will restrict contract pharmacy deliveries starting on September 1, 2021. Covered entities without an onsite pharmacy will be permitted to maintain one contract pharmacy. Citing low participation in a voluntary program to submit claims data to check for duplicate discounts in the 340B and the Medicaid programs, Merck joins a number of other manufacturers in placing requirements or enacting restrictions on contract pharmacies – which is the subject of ongoing litigation between the manufacturers and HRSA. NCPA will continue to communicate with stakeholders on the impacts of these restrictions on independent pharmacy and be prepared for any legislation being actively considered by Congress to address the issue.


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. If you have not done so, please take a few moments to send a comment letter to the FTC urging them to investigate unfair terms in PBM contracts and inform them of your own experiences of how these terms harm patient choice and competition. Be sure to add your comment to the more than 1,600 that have been submitted through this link.


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.


North Carolina PBM Licensure Bill Headed
to Conference Committee

A North Carolina PBM licensure bill (SB 257) passed the House and is now headed to conference committee. The House-passed version contains many provisions protecting patients and community pharmacies from PBM conflicts of interest, including preventing PBMs from steering patients to PBM-owned pharmacies and from routinely reimbursing pharmacies below NADAC.


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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