DIR Bill Sponsors Remind CMS they Have Authority
to Act on Pharmacy DIR Fees
Over the past week, House and Senate sponsors of pharmacy DIR fee reform legislation sent letters to CMS Administrator Chiquita Brooks-LaSure to raise concerns about the impact of DIR fees on patients and pharmacies. The sponsors of H.R. 3554 & S. 1909, the Pharmacy DIR Reform to Reduce Senior Drug Costs Act, urged CMS to work with Congress to require pharmacy price concessions, payments, and fees be included at the point-of-sale under Medicare Part D in a manner that lowers out-of-pocket costs and premiums. They also reminded Administrator Brooks-LaSure that Congress has already provided CMS with sufficient authority to make the necessary changes administratively. While reconciliation negotiations are still underway, this letter doubles down on the vital need to finalize DIR fee reform and ensures all options are on the table to accomplish this goal.
Marketing Reminders for Conduct of Plans
in Open Enrollment
NCPA wishes to remind members that plans cannot engage in certain behavior to encourage potential beneficiaries from enrolling in a plan during the Open Enrollment Period. According to the General Marketing Requirements in Medicare Part D and Beneficiary Contact sections – updated earlier this year, CMS prohibits most unsolicited contact with beneficiaries, unless the beneficiary provides consent or initiates contact, including by phone or social media. However, plans may contact current enrollees, or other enrollees within a parent organization, for updates on “plan business.” In conducting such business, plans must give the beneficiary the opportunity to “opt out” of future contact. If any of your patients are being targeted by unsolicited calls or contacted after having opted out of communications, please let NCPA know so we can bring them to the attention of CMS.
CMS Releases 2022 MA and Part D Star Ratings
In preparation for the upcoming open enrollment period of October 15 - December 7, 2021 - CMS has released the 2022 Star Ratings the plan finder. Plans are rated on a 1-to-5-star scale – with one being the lowest and five the highest. These ratings are assessed on an annual basis and reflect the experiences of patients within those plans, based upon 12 measurements so that other patients can make health care decisions which are best for them. No plans were assigned the lowest possible ranking for the 2022 year and ten received the highest possible indicator. Click here for more information on the Part D enrollment period.
State Legal and Legislative Program Focuses
on Legal Wins and PBM Policing in the States
Rob T. Smith, a partner at Katten Muchin Rosenman, LLP and Matt Walker, executive director of the West Virginia Independent Pharmacy Association and a partner at Walker and Stevens, presented at the 2021 NCPA Annual Convention. Their program was titled LEGAL WINS AND LEADING THE CHARGE ON PBM POLICING IN THE STATES and focused on the best approaches to regulating PBMs in the states. Smith gave an overview of the legal landscape involving state regulation of PBMs and spoke to specific provisions that, when passed, would have the most far-reaching impact. Walker discussed first of its kind legislation that recently passed in West Virginia, which prohibits a PBM from requiring a patient to use a mail order pharmacy. Thanks to the Supreme Court decision, this law now applies to most insurers in the state. Smith and Walker will conduct a follow-up webinar on Nov. 16, 2021 at 8:00 ET. The webinar is sponsored by RxSafe in support of the LDF, click here to register.
OSHA Vaccine Mandate Under Review
The US Department of Labor’s Occupational Safety and Health Administration (OSHA) has sent their draft COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS) rule, which would require employers with 100 or more employees to ensure their workforce is fully vaccinated or require unvaccinated workers to produce a weekly negative test, to the White House for final review. It is expected to be an expedited review and approval, at which point OSHA would then publish the ETS and it would take effect immediately. Details of the ETS have not been made available to the public, and many questions remain, including whether employers will be required to collect proof of vaccination, what type of testing will be required, whether remote employees will be covered, or how the 100-employee threshold will be counted. Here’s an overview of what we know so far about President Biden’s “Path out of the Pandemic” plan.
NCPA PAC Hosts Annual Reception at Convention
NCPA PAC hosted its annual fundraising reception at the NCPA Annual Convention and raised over $30,000. NCPA PAC contributors were addressed by PAC Committee Chairman Steve Giroux and newly announced candidate, and NCPA member, Rich Moon who is currently running for a Congressional seat in his home district of New York. We thank all NCPA PAC contributors for their continued support. A strong PAC is essential to our advocacy efforts in Washington and across all 50 states, and it would not be possible without active members contributing. As the leading voice for community pharmacy, it is vital that we have a strong presence on Capitol Hill, and your contributions to NCPA PAC are integral in allowing that to happen. If you would like to learn more about NCPA PAC, including how to contribute to its growing success, please contact Jesse Lirtzman (Jesse.Lirtzman@ncpa.org). For more information on Rich Moon’s candidacy please visit his website.
FDA Withdraws Temporary Guidance
for Alcohol-Based Hand Sanitizers
On October 12, 2021, the FDA announced it will be withdrawing the guidance for alcohol-based hand sanitizers for non-drug manufacturers, including compounding pharmacies. Originally these guidance documents were issued in early 2020 to assist in meeting increased demand during the public health emergency. The agency is halting any production authorized under these guidance policies by December 31, 2021. Any remaining stock produced prior to the 31st must be sold to wholesalers by March 31, 2022. After the cut-off date, any pharmacy, or other entity, who wishes to continue to produce hand sanitizer must comply with the monograph and follow the FDA’s Current Good Manufacturing Practice requirements.
NCPA Signs onto Letter Supporting the Nomination
of Jonathan Kanter as Assistant AG
In a letter to Chairman Durbin and Ranking Member Grassley of the Senate Judiciary Committee, NCPA along with other small business organizations, urged the Senate Judiciary Committee to support the nomination of Jonathan Kanter as Assistant Attorney General for the Antitrust Division at the Department of Justice (DOJ). Independent business organizations from industries including pharmacists, booksellers, office product dealers and many more advocated for Kanter based on his deep legal experience and long-standing record advocating for aggressive action as an antitrust lawyer. NCPA believes that Kanter is exceptionally well-qualified to revive antitrust enforcement and trusts he will use U.S. competition laws to enable independent businesses to compete in the marketplace.
California Governor Vetoes Anti-steering Bill
California Gov. Gavin Newsom (D) vetoed SB 524, which would have prohibited PBMs from steering patients to PBM-owned pharmacies. In his veto message, Gov. Newsom expressed concerns that the bill lacks clarity in its definitions, potentially leading to “misinterpretation or a lack of enforceability.” The Senate is currently considering the governor’s veto.
Biden Administration Likely to Nominate Califf to Head FDA
According to recent reports, President Biden is likely to nominate former Food and Drug Administration Commissioner Robert Califf to return to the agency. At this time, no official nomination has been confirmed and the President may choose another direction as Califf faces some push back from progressive groups due to his connections to the pharmaceutical industry. If Califf is confirmed by the Senate, he will take over an agency which has wide latitude in regulating prescription drugs, including new developments in the treatment of COVID as well as compounding practices. If he is officially nominated, NCPA will review his previous record as Commissioner and look for opportunities to advocate for our membership.
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.