Several key regulatory changes made over the past year affect health-system pharmacists.
Last year proved momentous for health care professionals, including pharmacists. During the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition in 2020, several ASHP officials provided an update on key policy issues poised to effect change in the industry.
Pharmacist Recognition and Scope of Practice
“Pharmacist recognition has been a huge priority for us at ASHP,” Doug Huynh, JD, director of federal legislative affairs, said during the virtual session. However, he added that the scope of pharmacist recognition as providers was narrowed during the coronavirus disease 2019 (COVID-19) pandemic to tailor advocacy efforts toward the COVID-19 response.
The most notable expansion of authority from the federal level occurred in the arena of vaccinations. The recent federal designation allowing licensed pharmacists to order and administer vaccines to any patients 3 years and older, as well as the ability to administer future COVID-19 vaccines, represents a big win.
“In broad strokes, this is really dramatic recognition by the [US Department of Health & Human Services] of the role pharmacists play in COVID-19 response,” Tom Kraus, JD, MHS, JD, vice president of government relations, added. He noted that gaps around reimbursement remain, because the current requirements allow reimbursement only for the vaccine but not necessarily for related services, such as specimen collection or patient counseling.
CMS Reimbursement Changes
Jillanne Schulte Wall, JD, senior director of health and regulatory policy, discussed some of the payment changes made by the Centers for Medicare & Medicaid Services (CMS), particularly in the Physician Fee Schedule.
During the pandemic, CMS clarified that pharmacists providing telehealth or incident-to services, such as medication management services, do not need the same level of supervision required for in-person services. According to CMS, pharmacists can provide these services under virtual supervision until at least 2021.
“One of the things we’ve been pushing them on is the idea of simplifying incident-to billing and making sure that the billing that is being done for pharmacists’ services is actually reflective of the value that is provided,” she said.
Wall noted that ASHP hopes to push CMS to make this change permanent and ensure that pharmacists can be reimbursed at the same level as other providers.
340B Drug Pricing Program
In continuation of the 340B Drug Pricing Program reimbursement cuts, CMS proposes 2 options: the payment of average sales price (ASP) minus 22.5%, the cut initially proposed, or an even steeper cut of ASP minus 34.7% plus an overhead-and-handling payment of 6%, which equals ASP minus 28.7%.
According to Wall, CMS based the new proposals on hospital surveys sent out earlier in 2020. “We asked them not to do this during a pandemic.…This was really the wrong time if they wanted a lot of information from hospitals,” Wall said. “I don’t think they got a very good cross section at all of how hospitals are using this program.” Wall noted that ASHP continues to push for protecting the 340B program.
According to Huynh, the Coronavirus Aid, Relief, and Economic Security Act, passed in March 2020, featured many of ASHP’s key policy priorities related to mitigating drug shortages. These included requirements for manufacturers to provide the FDA with more information about the causes of shortages and expected duration, requirements to establish contingency plans, and incentives to encourage manufacturers to produce drugs in shortage.
In response to COVID-19, the FDA initiated a number of regulatory flexibilities around compounding. Notably, the agency announced that it will not enforce the 1-mile radius requirement from the hospital and health-system draft guidance. The FDA also allowed flexibility around compounding products in short supply and revising beyond-use dates for certain products compounded for patients with COVID-19. However, many of these policies are temporary.
Walls also discussed how the DEA worked with ASHP and other stakeholders to quickly increase allocation of annual production quotes for CIIs used for mechanical ventilation. The agency also allowed hospitals to send CIIs to temporary expansion sites.
“We’re a long way from resolving drug shortages; that’s a perennial issue,” Kraus said. However, he said that ASHP hopes to continue working with these agencies to address impending drug shortages.
Kraus T, Schulte Wall J, Huynh D, Robb K. Key policy issues impacting health-system pharmacy 2020. Presented at: American Society of Health-System Pharmacists Midyear Clinical Meeting and Exhibition; December 6-10, 2020; virtual.