Supreme Court Unanimously Rules
in Favor of Community Pharmacies

The U.S. Supreme Court on Thursday handed down a historic decision allowing states to regulate PBMs, in an 8-0 decision (Justice Amy Coney Barrett did not participate).

The Court ruled that ERISA cannot be used by PBMs as a shield against state regulation. Justice Sonya Sotomayor wrote for the majority, with Justice Clarence Thomas writing a concurring opinion.

In her opinion, Sotomayor wrote that PBMs “are a little known but important part of the process by which many Americans get their prescription drugs.” This decision has brought PBMs’ questionable practices into the bright light. This is not only a victory for independent pharmacy, but a huge win for our patients.

NCPA will host a webinar on December 15 at 7:00 ET with Attorney General Rutledge and our attorneys Howard Rubin and Rob Smith to provide a recap of the decision and what it means for community pharmacy.

You can also view NCPA’s one page summary of the decision or visit our Battleground: SCOTUS webpage for more information on this case.

Thank you to all those who contributed to the LDF which helped fund this legal battle and contributed greatly to this extremely positive outcome. If you have not done so, please consider contributing to the LDF to support NCPA’s continued efforts on behalf of community pharmacy.

Biden Taps Becerra to Lead HHS

This week, President-elect Joe Biden named California Attorney General Xavier Becerra as his pick to lead the Department of Health and Human Services (HHS), which oversees Medicare and Medicaid. Becerra led 45 states and the District of Columbia in filing an amicus brief in favor of the state of Arkansas in the Rutledge v. PCMA case. Becerra released this statement in response to the Rutledge decision, and NCPA looks forward to working with him on issues important to community pharmacy upon his confirmation .

Survey Confirms Problems with Mail Order Prescriptions

An NCPA survey of independent pharmacists confirms alarming problems with mail order prescriptions, including late deliveries, errant deliveries, and sensitive drugs left out in the elements. The survey showed that 98 percent of community pharmacists say they’ve heard from patients whose mail order drugs arrived late or not at all, and 60 percent say their patients’ drugs were left out in the weather, where the elements can alter the way medicines work. Ninety-two percent of pharmacists who responded to the survey said they’ve had to dispense a short-term supply of medication to patients while they waited for the mail houses to track down their orders, and 78 percent say they’ve called doctors on behalf of patients for new prescriptions. Read more about the survey here. NBC News also ran a story this week about safety concerns surrounding mail order prescriptions.

Congress Still Searching for Elusive COVID Relief Agreement

Congress is finding it difficult to overcome differences between the two parties to reach an agreement on a COVID relief package. Earlier this week, Congress passed a one week continuing resolution to fund the government to give the relief package negotiations more time, but Republicans and Democrats continue to have disagreements over the same issues that have divided them for months: liability protections; state and local aid; and unemployment benefits. NCPA will continue to advocate for relief for pharmacies through its Essential campaign in hopes that a deal does emerge. It is possible that relief negotiations may continue through Christmas as Speaker Nancy Pelosi (D-Calif.) stated that if COVID relief does not move with a government funding package, she would still like to see a relief package passed before unemployment benefits cut off on December 26. As Congress continues its work toward another COVID relief bill, please contact your legislators and voice support for community pharmacy’s essential priorities.

NCPA Issues Member Summary for Anti-Kickback Statute
(AKS) Safe Harbor Revisions Final Rule

NCPA is providing a member summary for the recently released final rule on revisions to the Anti-Kickback Statute (AKS). HHS offered this rule to better align with a focus on value based coordinated care for patients and delivering financial incentives by reducing legal barriers for healthcare providers. The inclusion of pharmacy in the final rule represents a success, as NCPA advocated on behalf of the industry at the HHS OIG office – which excluded pharmacy from participating in the original proposal – and submitted comments in conjunction with CPESN. As a result of those efforts, pharmacies can take advantage of the changes to the safe harbors as a full participant in a value-based arrangement. This rule will take effect on January 19, 2021.

Pharmacy Organizations Provide Recommendations
to President-elect Biden

This week, NCPA joined on a letter with pharmacy organizations to President-elect Biden’s transition team. The letter provided a list of recommendations for addressing critical public health priorities, including rapid vaccine rollout. Collectively, the pharmacy groups represent America’s 309,000 licensed, working pharmacists, as well as pharmacy technicians and student pharmacists, who are essential frontline workers, providing patient care in a variety of settings, including hospitals, clinics, health centers, community pharmacies, long-term care facilities, and physician offices.

Executive Order on Ensuring Access to COVID-19 Vaccines

President Trump signed an Executive Order (EO) on “Ensuring Access to United States Government COVID-19 Vaccines” on December 8, 2020. The purpose of the EO is to ensure that Americans have priority access to COVID-19 vaccines developed in the U.S. or procured by U.S. government. In remarks that accompanied the signing of the EO, President Trump stated that the federal government recommends prioritizing the elderly, those with underlying conditions, health care workers, and first responders, while noting that vaccine distribution decisions rest with state governors. In addition, the President discussed the federal government’s distribution partnerships with Walgreens and CVS to deliver vaccines directly to nursing homes upon state requests, and a partnership with McKesson, Federal Express and UPS to ship vaccines to over 50,000 state-designed sites.

NCPA Submits Comments on HHS Regulatory Initiative

NCPA submitted comments on the HHS Notice of Proposed Rulemaking on the Securing Updated and Necessary Statutory Evaluations Timely proposal. Under this rule, HHS would review and evaluate existing regulations within a ten-year period and enter modifications and revisions as necessary through the Administrative Procedures Act, which governs the executive branch rulemaking process. However, if HHS would not re-evaluate the rule within that time frame, the rule would automatically be sunset. While NCPA supports reviews of easing existing regulatory burdens and updating rules to better reflect the dynamic environment of the healthcare industry, implementing an automatic sunset would be problematic for such a heavily regulated industry. NCPA will continue to work with HHS on their regulatory reform “Patients Over Paperwork” project to reduce compliance burdens on community pharmacy.

HHS Finalizes Rule on Good Guidance Practices

HHS finalized its’ proposed rule on good guidance practices to govern the way the agency releases and maintains guidance documents as part of a broader attempt at regulatory reform. The rule, which takes effect on January 6th, 2021, would apply a cross-agency standard to the information contained within the guidance documents, create a notice and comment period for “significant guidance documents,” and establish an online repository for public viewing of any applicable guidance. An example of guidance would be the issuances from HHS on pharmacist tech and intern authorities granted under the PREP Act. NCPA originally commented on the proposal when HHS would automatically rescind existing guidance if not included in the repository within the timeframe established by the proposal. However, since guidance is issued and revoked at the discretion of HHS, the agency did not feel such additional procedures was warranted. NCPA will continue to monitor potential issues that may arise from these actions and communicate with the agency any negative impact on community pharmacy.

FDA Provides Guidances on Proprietary Naming for Drugs,
Changes to Naming Analysis Program

The Food and Drug Administration (FDA) issued two guidances to drug developers on proprietary naming: Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Final Guidance and Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products, Draft Guidance. These guidances are meant to help ensure that drug names can be properly distinguished and not confused with drugs whose names could sound and appear to be similar, and describe best practices to help minimize proprietary name-related medication errors.

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.