How a Bill Becomes a Law: Pharmacy Legislation to Watch

From the American Pharmacists Association to the National Community Pharmacists Association and from state-level pharmacy associations and beyond, advocacy has become a hot topic across the pharmacy profession. Although this trend toward advocacy isn’t new, the COVID-19 pandemic thrust the importance of professional advocacy into a greater spotlight.

Since 2020, numerous bills have been introduced on both the state and federal levels focused on different areas of pharmacy, from pharmacy benefit manager (PBM) transparency to drug importation and opioid abuse prevention. Many of these proposed bills are intended to solidify the continuation of services that pharmacists began to provide during the pandemic—an especially important effort after the Biden administration announced on January 30, 2023, that the COVID-19 national and public health emergencies will end on May 11 of this year.¹

“Although key telehealth and hospital at home [public health emergency]-linked flexibilities have already been extended through 2024 via the Consolidated Appropriations Act of 2023, changes are coming to reimbursement of vaccines and COVID-19 therapeutics,” according to a statement released by the American Society of Health-System Pharmacists.² The organization went on to note that “not all COVID-19–related authorities are tied to the end of the [public health emergency]”; pharmacist authority for vaccination, testing, and treatment granted under the Public Readiness and Emergency Preparedness Act does not expire until the end of 2024.²

Legislative action, however, is a notably arduous process. Bills introduced in 2021, such as HR 2759, the Pharmacy and Medically Underserved Areas Enhancement Act, sponsored by Rep G.K. Butterfield (D, North Carolina),³ are still in the early stages of the legislative process, suggesting that now is the time to begin undertaking the advocacy work necessary to enshrine change years down the line.

In this issue of Total Pharmacy®, we highlight some of the key legislative actions on both the state and federal level that are poised to affect how pharmacists practice every day.

State Legislation

Across the country, 178 pieces of state-level legislation with the power to impact the practice of pharmacy were introduced in 2022.⁴ These bills focused on a range of topics, including pharmacist scope of practice, payment, and provider designation; public health concerns; immunizations; and contraceptive and pre- and postexposure prophylaxis– prescribing authority.

In late December, the National Alliance of State Pharmacy Associations published a year-end legislative update,⁴ showing that 44 bills in 26 states had been signed into law, with 8 additional bills in 6 states awaiting a signature from the respective state’s governor. Similarly, the National Academy for State Health Policy⁵ also tracks various legislative actions, including those taken to lower pharmaceutical costs. By and large, the most prolific category of legislation is related to PBMs and increased transparency around these companies—which should come as no surprise to anyone who has been following the ongoing Federal Trade Commission (FTC) investigations into PBM practices.⁶

Federal Legislation

On the federal level, dozens of bills have been introduced in the House and Senate. Since the 118th Congress began on January 7, 2023, at least 7 pieces of legislation specific to pharmacy have been introduced by representatives and senators on both sides of the aisle; at least 3 of these bills are intended to directly address health care costs. Other bills— including HR 2759—are still pending.

HR 7213, the Equitable Community Access to Pharmacist Services Act (ECAPS),⁷ was first introduced in the House of Representatives on March 24, 2022, by Rep Ron Kind (D, Wisconsin). The goal of this bipartisan legislation is to expand Medicare coverage to permanently include pharmacist-provided services “related to testing, drug regimens, and vaccines for COVID-19, influenza, and certain other illnesses,” according to a summary of the bill. In addition to COVID-19 and influenza, ECAPS provides continued coverage of testing for respiratory syncytial virus and strep throat. This bill was referred to the House Subcommittee on Health on March 25, 2022.

HR 2759, the Pharmacy and Medically Underserved Areas Enhancement Act³ was introduced by Rep G.K. Butterfield (D, North Carolina) on April 4, 2021. The bill would provide Medicare coverage and payment for certain services provided by pharmacists in an area with a health care provider shortage, that would otherwise be covered by a physician. The bill was referred to the House Subcommittee on Health on April 23, 2021.

HR 5376, the Inflation Reduction Act of 2022 was signed into law by President Joe Biden on August 16, 2022.⁸ The bill, introduced on September 27, 2021, by Rep John A. Yarmuth (D, Kentucky), includes multiple provisions⁹ intended to lower prescription drug costs for individuals with Medicare, while reducing drug spending by the federal government. Provisions, including those focused on eliminating cost sharing for adult vaccines, expand eligibility for full benefits through the Medicare Part D Low Income Subsidy program and delay the implementation of the Trump administration’s drug rebate rule to 2027.

References

1. Miller Z, Seitz A. President Biden to end COVID-19 emergencies on May 11. AP News. January 30, 2023. Accessed February 2, 2023. https://apnews.com/article/biden-united-states-government-district-of-columbia-covid-public-health-2a80b547f6d55706a6986debc343b9fe
2. What does the end of the public health emergency mean for pharmacy? News release. American Society of Health-System Pharmacists. January 26, 2023. Accessed February 2, 2023. https://www.ashp.org/News/2023/01/26/what-does-the-end-of-the-public-health-emergency-mean-for-pharmacy
3. HR 2759 - Pharmacy and Medically Underserved Areas Enhancement Act. Congress.gov. Accessed February 2, 2023. https://www.congress.gov/bill/117th-congress/house-bill/2759
4. 2022 provider status end-of-year legislative update. National Alliance of State Pharmacy Associations. December 22, 2022. Accessed February 2, 2023. https://naspa.us/resource/2022-provider-status-legislative-update/
5. 2023 state legislative action to lower pharmaceutical costs. National Academy for State Health Policy. January 1, 2023. Updated January 27, 2023. Accessed February 2, 2023. https://nashp.org/2023-state-legislative-action-to-lower-pharmaceutical-costs/
6. FTC launches inquiry into prescription drug middlemen industry. News release. Federal Trade Commission. June 7, 2022. Accessed February 2, 2023. https://www.ftc.gov/news-events/news/press-releases/2022/06/ftc-launches-inquiry-prescription-drug-middlemen-industry
7. HR 7213 - Equitable Community Access to Pharmacist Services Act. Congress.gov. Accessed February 2, 2023. https://www.congress.gov/bill/117th-congress/house-bill/7213
8. HR 5376 - Inflation Reduction Act of 2022. Congress.gov. Accessed February 2, 2023. https://www.congress.gov/bill/117th-congress/house-bill/5376
9. Cubanski J, Neuman T, Freed M. Explaining the prescription drug provisions in the Inflation Reduction Act. Kaiser Family Foundation. January 24, 2023. Accessed February 2, 2023. https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/