Bulletin Today
On March 22, FDA issued new guidance on required testing for the Risk Evaluation and Mitigation Strategy (REMS) program. Although all REMS requirements remain in effect, the agency said it will not take enforcement action against sponsors or providers for failing to adhere to REMS requirements for certain laboratory testing or imaging studies during this time.
“The completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” stated FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a news release. “Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.”
Providers who prescribe or dispense drugs that are subject to REMS with laboratory testing or imaging requirements should consider whether there are compelling reasons not to complete these tests or studies, FDA said. They should use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of testing or studies and communicate with their patients about these judgments.
The guidance, available at www.fda.gov/media/136317/download, will be in effect for the duration of the COVID-19 public health emergency.
New Mexico, West Virginia make progress on provider status
On March 6, Gov. Michelle Lujan Grisham signed legislation expanding pharmacists’ provider status recognition in New Mexico. The passing of HB 42, also known as Pharmaceutical Service Reimbursement Parity, marks a promising sign of success in states’ efforts to gain provider status.
HB 42, introduced by Rep. Deborah A. Armstrong (D-Albuquerque), mandates that health plans reimburse pharmacist clinicians for clinical and prescriptive services they are already authorized to provide within New Mexico’s scope of pharmacy practice. Pharmacist clinicians would be compensated at the same rate as other providers performing those services.
Prior to the bill’s passing, APhA signed on to a letter in support of the legislation, stating that the bill will expand access to health care services in New Mexico, especially among rural and medically underserved communities.
The move will also reduce overall health care costs and allow the state to be a leader in developing sustainable business models that support pharmacists practicing at the top of their profession.
West Virginia’s state Senate and House of Delegates also recently passed its own provider status bill, SB 787. If signed by Gov. Jim Justice, the bill would require health plans to reimburse pharmacists for services that already fall within their scope of practice and are normally covered when performed by other providers.
APhA sent its own letter and signed onto a joint pharmacy letter supporting the bill. As of press time, Gov. Justice had not acted on the bill.
Pharmacist prescribing of naloxone improves access to life-saving medication
The number of naloxone orders dispensed in Ohio surged by 2,328% after the Ohio General Assembly approved a law in 2015 allowing pharmacists to dispense naloxone without a prescription, according to a recent study in JAMA Network Open. With prior studies estimating a 14% reduction in death by opioid-related overdose in states where access to naloxone is increased, the findings are significant.
“Legal barriers needed to be removed to address this important public health crisis. Pharmacists positively impact the health of patients every day and work tirelessly to address the opioid epidemic. By providing naloxone, pharmacists save lives,” said lead study author Neha Gangal, a PhD candidate in pharmacy practice at the University of Cincinnati’s (UC) James L. Winkle College of Pharmacy, in a UC news release.
Gangal and colleagues compared 18 months of postpolicy to prepolicy data from Ohio’s Medicaid records and the database of Kroger Co.’s Ohio pharmacies, which includes prescriptions for patients with all types of insurance, not just Medicaid. Ohio’s Medicaid population is approximately 2.2 million, or 21% of the state’s population of 11.42 million. Among Medicaid recipients, the number of patients receiving naloxone increased from 183 patients in the prepolicy period to 3,847 patients in the postpolicy period.
The analysis using the Kroger data confirmed an increase in the number of naloxone prescriptions dispensed for all types of insurance, including cash prescriptions. In addition, low-employment counties dispensed 18% more naloxone prescriptions per month than high employment counties. The researchers said the increase in low employment areas is most likely because the local pharmacy is often the sole health care contact for people living in these locations.
The team said it does not know whether the naloxone was for personal use, for a family member, or for a friend because the law was written to specifically allow access. Their study also did not seek to quantify the impact of increased naloxone distribution on the rate of opioid abuse or mortality from overdose.
“Overdoses are not a planned event, so during an emergency is not the time to try and access naloxone,” said study author Pam Heaton, professor of pharmacy practice at UC’s Winkle College. “The intent is for any adult to be able to go to a pharmacy and purchase naloxone for themselves or for anybody who might need it, so they are adequately prepared to administer a lifesaving medication,” Heaton said.
The majority of states now allow pharmacists to dispense naloxone without a prescription under varying guidelines. As of May 2019, approximately 75% of community pharmacies in Ohio were registered to dispense naloxone without a prescription.
APhA, pharmacy groups file amicus brief in PBM Supreme Court case
APhA, along with the National Community Pharmacists Association (NCPA), the Arkansas Pharmacists Association (APA), and the National Alliance of State Pharmacy Associations (NASPA), filed an amicus curiae brief with the U.S. Supreme Court in Rutledge v Pharmaceutical Care Management Association (PCMA). Oral arguments are slated to begin on April 27, 2020, with a ruling typically coming several months later. Access the brief at https://apha.us/AmicusBrief.
Pharmacy associations from almost every state and the District of Columbia have signed on to the brief, which supports states’ right to regulate PBMs. PCMA, the association that represents PBMs, claims that Act 900, an Arkansas statute mandating that PBMs cannot reimburse pharmacies less than the drug cost, is preempted by federal law.
In their brief, the groups argue that “PBMs’ below-cost reimbursements have harmed the pharmacy industry, particularly independent rural pharmacies.
In the last 15 years, 16.1% of independently owned rural pharmacies have closed, and 630 rural communities lost access to pharmacies.
“Amicus curiae” translates to “friend of the court” and refers to legal briefs submitted by entities who are not party to the case at hand. The justices can review amicus briefs to get more insight and expert opinion that could have bearing on the case.
PBMs have argued that they are exempt from state regulation because of vague language in ERISA. The law precludes states from regulating employee benefit plans, the pharmacy groups say, but not third-party vendors hired by the plans.
“When plans enter the market to purchase the goods and services they provide beneficiaries—or anything else they require to function—they are not immune from ordinary market regulation,” the groups say in the brief.