Supreme Court to Hear Arkansas PBM Case:
What It Means for You
The Supreme Court announced last week that it will hear arguments in the Arkansas case on whether ERISA supersedes state law that regulate pharmacy benefit managers (PBMs). The case, Rutledge v. PCMA, is a challenge by the state of Arkansas to a ruling in the Eighth Circuit that invalidated a state PBM law. A summary of the case can be found here.
To help members better understand the case and what it could mean for them, NCPA will be hosting a member only webinar on Tuesday, January 21 at 1:00 EST where NCPA and the Arkansas Pharmacists Association will be presenting along with the law firm representing both associations n the matter. NCPA also created a webpage where you'll find the latest news and analysis on the case as well as a timeline of NCPA’s legal work in this arena.
Bear in mind that litigation is expensive. So, please consider an investment in NCPA's Legislative/Legal Defense Fund. The LDF supports our entire advocacy operation, including attorneys and outside counsel. The better funded the LDF, the more resources and influence we can put toward getting state and federal priority legislation passed and defending your practice in key litigation. If you are not already an investor, please become one today.
Registration Is Open for 2020 Congressional Pharmacy Fly-in
Registration for NCPA’s 2020 Congressional Pharmacy Fly-in opened on January 15. The Fly-in, which will be held April 21-22, is an opportune time to meet with legislators or their key staff about community pharmacy’s legislative priorities. You can register here.
NCPA Urges CMS to Recognize
Pharmacist Services Beyond Dispensing
As a follow up to the President Tump’s Executive Order #13890 Protecting and Improving Medicare for Our Nation’s Seniors, the Centers for Medicare and Medicaid Services (CMS) requested additional input on eliminating specific Medicare regulations that require more stringent supervision than existing state scope of practice laws, or that limit health professionals from practicing at the top of their license. NCPA asserted that when pharmacists collaborate with health care professionals, they improve patient care and outcomes. However, restrictive regulations hinder pharmacists’ ability to continue providing this care at the federal level, especially when state laws are already expanding scope of practice. NCPA urged CMS to enhance coverage of pharmacist-provided care services and reevaluate strict supervision requirements as well as coverage policies for incident-to services. NCPA will continue engaging with CMS to educate the agency about the importance of allowing pharmacists to practice at the top of their professional licenses and education.
House Energy and Commerce Committee Hearing on Cannabis
On Wednesday, the House Energy and Commerce Health Subcommittee held a hearing entitled, “Cannabis Policies for the New Decade.” The hearing focused on examining the implications of reforming marijuana’s classification as a Schedule 1 substance under the Controlled Substances Act, the potential of cannabis research, and federal efforts to review and approve cannabidiol (CBD) products. As a part of the hearing, the subcommittee examined 6 different bills that ranged from expanding research into the medical impacts of cannabis to full descheduling of the drug. Subcommittee Chairwoman Anna Eshoo (D-Calif.) and Committee Chairman Frank Pallone, Jr. (D-N.J.) emphasized the importance of considering the bills, given the evolving cannabis policy landscape in states. Committee Republicans generally supported bills that enhance cannabis research efforts, but cautioned against removing cannabis from Schedule 1 as a step too far given the lack of available data.
Dr. Throckmorton of the FDA discussed the agency’s ongoing efforts to provide answers on the science, safety, and quality of products containing CBD. He stated that rulemaking to regulate CBD is still years away from completion. Mr. Strait of the DEA stated that the agency is working to increase the number of registered marijuana manufacturers and that draft regulations for researchers who want to grow marijuana had been completed and submitted to the Office of Management and Budget. The DEA announced in August that it needed to revisit current regulations because of the large volume of applicants who applied for Schedule I marijuana grow licenses. The committee uniformly expressed their dissatisfaction with the lack of progress that the DEA has made in expanding access to cannabis for researchers and the fact that there is still only one DEA-approved research marijuana growing facility at the University of Mississippi. Chairwoman Eshoo stated that this would continue to be a topic of interest for the committee but did not provide a timeline for action on any of the bills.
New Bill Would Remove Barrier
for CBD Dietary Supplements and Foods
Despite FDA Concerns
House Agriculture Committee Chairman Collin Peterson (D-MN) this week introduced legislation, H.R. 5587, that attempts to overcome certain barriers towards lawfully marketing hemp-derived CBD as an ingredient in dietary supplements. However, there would also be significant implications for food. The bill would amend the Federal Food, Drug and Cosmetic Act to include CBD in the definition of dietary supplements, while also creating an exception to the “exclusionary clause” for CBD for use in foods. While the bill would remove these obstacles toward legal marketing of these products, it would not alter FDA’s authority in any other way. In particular, food companies wishing to use CBD ingredients in their foods would remain subject to the relevant laws and regulations that govern all food products – including those requiring that food additives obtain premarket approval or be determined Generally Recognized as Safe (GRAS) for their intended use. FDA officials also have consistently warned that they have safety concerns about CBD. As we reported in November, the last batch of CBD warning letters FDA sent out said the agency cannot conclude at this point that CBD is GRAS. FMI’s position on CBD has been grounded in public health and safety, and we are therefore seeking member input regarding this legislation.
NCPA supports PBM Registration Bill in Virginia
NCPA sent a letter to the Virginia Senate Commerce and Labor Committee supporting SB 862 and expressing the need for PBM reform in Virginia. The bill would require PBMs to register with the commonwealth, limit PBM adjudication fees, and protect patient choice of pharmacy.
NJ and Washington Proposals Grant Pharmacists
Prescriptive Authority for HIV Prevention Medications
NJ A 687/WA SB 6303, recently introduced in New Jersey and Washington respectively, would allow pharmacist to initiate and furnish at least a 30-day supply, and up to a 60-day supply of HIV preexposure or postexposure prophylaxis (complete course of HIV postexposure prophylaxis – WA) to a patient without an individual prescription pursuant to a standing order, issued upon pharmacist request (NJ), and pending requirements. NJ A 687 and WA SB 6303 also mandates coverage of HIV preexposure and postexposure medications initiated by a pharmacist.
In the past month four states have introduced bills relating to grant pharmacist prescriptive authority for HIV prevention medications. This is all happening while California’s Board of Pharmacy is planning to adopt emergency regulations pursuant to SB 159 HIV: Preexposure and Postexposure Prophylaxis, enacted October 7, 2019. Stay tuned!
Update on Pharmacy Quality Alliance (PQA)
This week the Pharmacy Quality Alliance (PQA) hosted an all-member webinar to discuss endorsement of three new pharmacy measures. NCPA has previously voiced concerns with the measures from both a community and long-term care pharmacy viewpoint because only claims data are being used in the PQA pharmacy level measure analysis and there will be no comparison with pharmacy dispensing data. We also have concerns with the reliability score and that the data source for re-specification is only administrative claims data from Medicare. NCPA suggests PQA get cash data (BIN) from switches. We also have concerns with the large number of Medicare patient claims that are filled for cash and what the magnitude of effect that missing claims may have on PDC measurement error. Lastly, since the measures need 30 patients to be valid a very high % of independent pharmacies will not have this and even when grouping via line of business how would independent pharmacies be grouped for contracting purposes? NCPA members are very appreciative of PQA's diligent work in this space and we want to work collaboratively with PQA to ensure the best pharmacy level measures possible and we fully support and appreciate PQAs focus moving forward. Voting on the measures will be open through Jan 30.
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