An update on COVID-19 advocacy activity and regulations affecting your pharmacy practice.
Pharmacists have made significant authority gains over the past year, as many regulations went into effect that expanded pharmacists’ scope of practice amid the COVID-19 pandemic.
However, because these authorities were enacted under the Public Readiness and Emergency Preparedness (PREP) Act, many of them are temporary and only in effect during the public health emergency.
In a session held during the American Pharmacists Association (APhA) 2021 Annual Meeting and Exposition, which is held virtually March 12-15, policy experts discussed key advocacy efforts and legislative enhancements for pharmacy practice during and beyond the pandemic.
“From the start of the pandemic, it was clear that pharmacists had and will have a significant role in patient care and pandemic response,” Ilisa Bernstein, PharmD, JD, senior vice president of pharmacy practice and government affairs at APhA, said in the presentation.
Bernstein pointed to key advocacy areas that APhA is focusing on right now:
Although pharmacy saw tremendous wins from federal and state officials this past year, a constant struggle for reimbursement for pharmacist-provided patient care services has continued during the pandemic.
“Our concern was, not only pay us, but pay us equitably,” Bernstein said. “We are providing the same services as other health care providers, so we should get paid at the same rates.” For COVID-19 vaccines, pharmacists have been able to get the same administration fee, but there’s been more of a challenge with COVID-19 testing.
“Under Medicare, not only do other health care providers bills for an office visit associated with a test, but because pharmacists are not providers under Part B, they can’t get reimbursed for collecting the specimen, such as the time it takes to take a nasal swab,” she explained.
In April 2020, the US Department of Health and Human Services (HHS) authorized licensed pharmacists to order and administer FDA-authorized COVID-19 tests during the public health emergency under the PREP Act. Subsequently under the PREP Act, pharmacists were also authorized to administer COVID-19 vaccines and childhood vaccines. Other temporary public health emergency authorities included the removal of operational barriers, Part D and Medicare Advantage flexibility, compounding, and telehealth.
According to Bernstein, this has a preemptive effect, which means that the federal law governs and usurps state or local law.
“That said, there are specific guardrails or requirements that the pharmacist must follow in order to benefit from the PREP Act authority,” Bernstein noted. To administer point-of-care testing, for example, pharmacists must obtain the appropriate CLIA Waiver for their pharmacy. Bernstein also advised pharmacists to check with their state requirements for any additional regulations, as there may be some state scope of practice requirements that are not impacted by the PREP Act. Additionally, some employers, particularly chains, have specific policies regarding pharmacist COVID-19 testing.
There are also requirements associated with the newly expanded vaccination authority, Bernstein added. Pharmacists must adhere to certain rules involving training, guidelines, continuing education, outreach to pediatricians or primary care physicians, basic cardiopulmonary resuscitation, and additional requirements.
Bernstein added that the PREP Act provides liability protection to pharmacists, technicians, and interns, but only if the requirements attached to the authorities are followed.
She remarked that, although pharmacy has experienced many wins in expanded scope of practice during the pandemic, these gains are only permissible as long as the public health emergency is in effect. Still, Bernstein pointed to other public health emergencies, such as the opioid epidemic, which have been continuously renewed due to an ongoing impact.
“The public health emergency can last for a very long time,” Bernstein said. “So it’s highly likely that the public health emergency here will continue to be extended for at least another year or so.”
During this time, it will be crucial to continue to press for a permanently expanded scope of practice and demonstrate the value that these services add to patients and the overall health care system.
Making these authorities permanent will take a multi-pronged approach, according to Bernstein. Regulatory collaboration is essential, and consistent pressure and data are required to maintain these authorities. In December 2020, APhA issued a detailed request to HHS advising on which authorities should be made permanent and APhA staff members meet daily with government officials and stakeholders to drive pharmacist-friendly policy change and clarifications. However, Bernstein drove home the importance of continuing advocacy efforts at the state level, as state scope of practice will be key to making these advancements permanent.
“Your state pharmacy association should already be working on a plan to make these new gains permanent in your state,” she said.
Bernstein I, Baxter M, Kerry Mica A, Bolte K. Update: Legislation and Regulations Affecting Your Practice. Presented at: American Pharmacists Association 2021 Annual Meeting and Exposition; virtual; March 12-15, 2021. Accessed March 12, 2021.