It is hard to believe, but we at The Grassroots Pharmacist have been putting out content and resources for nearly a year. During the first year of the pandemic, we saw such dramatic health policy changes happening so frequently that it warranted continual blog posts on all that was changing. As we look forward, and less frequent health policy changes occur, we wanted to identify a more sustainable way to inform and empower pharmacists to be involved in grassroots advocacy efforts. That is why we will be publishing a monthly roundup of legislative and regulatory updates relevant to pharmacists moving forward. Many of the topics discussed on these monthly roundups should not only be viewed as us sharing information with our readers, but as calls to action to increase civic engagement and discourse on issues that directly and indirectly relate to pharmacists and the communities we serve. There is so much room for improvement in the healthcare system, and active civic engagement is necessary to ensure advancements in the delivery of quality, equitable, and accessible healthcare.
So with that, let’s get started. There is no time like the present to advocate for the change we hope to see in the world.
There has been a lot of action in the new Congress with the reintroduction of bills that died at the conclusion of the last Congress and discussions on the next COVID package. Here are a few of the top bills we are tracking:
Of course, much of the focus of Congress and the new administration has been on President Biden’s American Rescue Plan. This $1.9 trillion stimulus package is planned to move forward in the coming weeks utilizing the budget reconciliation process in order for Democrats to pass the law without any Republican support. Key provisions of this bill that are relevant to pharmacists include:
- The creation of a national vaccination program that would include the creation of community vaccination sites nationwide. Pharmacists have already been tapped by the administration in expanding COVID vaccine efforts, and would likely be a key piece of this national vaccination program
- Increasing equitable access to the COVID vaccine by ensuring access to those in underserved communities
- Expand access for employers of frontline workers to Occupational Safety and Health Administration (OSHA) grants to ensure workers are protected from unsafe working conditions
- Expand the subsidization of COBRA health benefits through September for those that lost employment and thus health coverage during the pandemic
S. 298: Pharmacy Benefit Manager Accountability Study Act
Introduced by Senator Blackburn (R-TN), this bill would require the Government Accountability Office to study the role of pharmacy benefit managers (PBMs) in the drug supply chain and submit a report to Congress. This bill was introduced in the last Congress (S. 1532/H.R. 3223), though it did not make any progress and gained minimal cosponsors. If the language of S. 298 is consistent with the last version of the bill, the report that would be submitted to Congress would include 1) the state of competition in the PBM industry, 2) the use of rebates/fees by PBMs and who the rebates benefit (patients, payors, or PBMs), 3) if PBMs structure formularies to prioritize high-rebate drugs over lower-rebate drugs, 4) average prior authorization time, 5) analysis of step therapy, and 6) the extent of spread pricing.
The bill has been referred to the Senate Health, Education, Labor, and Pensions (HELP) Committee, which is chaired by Senator Patty Murray (D-WA). Although Senator Murray has supported legislation in the past that looked to reign in PBMs, S. 298 is currently only supported by Republicans, giving it a low likelihood of being prioritized for a committee hearing. If the profession of pharmacy would like such a bill to advance, grassroots efforts should be focused on drumming up bipartisan support for the bill, especially for constituents whose members serve on the Senate HELP Committee.
H.R. 153: Protecting Consumer Access to Generic Drugs Act
Introduced by Representative Bobby Rush (D-IL-1), this bill would prohibit brand name drug manufacturers from paying generic drug manufacturers to delay bringing generic drugs to market. This is one of those bills that leaves you scratching your head and thinking, “Wow…we need a bill for this? This isn’t already illegal?” Well, unfortunately it’s not, and the Federal Trade Commission estimates it’s resulting in $3.5 billion in higher drug costs per year. H.R. 153 would prohibit drug manufacturers from agreeing not to compete with each other in what is referred to as “pay-for-delay.” Banning these anticompetitive deals would benefit patients by ensuring that they have greater access to generic medications.
Versions of this bill have been introduced since 2007. The current bill has been referred to the House Energy and Commerce Committee and the Judiciary Committee. It has gained 15 cosponsors so far, and according to GovTrack and Skopos Labs has a 46% chance of being enacted, which is one of highest rated probabilities of any health-related bill in Congress right now. However, a companion bill has not yet been introduced into the Senate, which means there are still many steps ahead for this bill if it has any hopes of passing into law.
H.R. 280: PDMPs Help Patients Act of 2021
Introduced by Representative David McKinley (R-WV-1), this bill would create a pilot program in five states to integrate a substance use disorder (SUD) and behavioral health treatment locator tool into their prescription drug monitoring programs (PDMP). This tool could then be utilized by health care providers if they suspect misuse or abuse to refer patients for treatment or an assessment. The language of this bill does not specify which health care providers this would apply to. However, with more than half of states requiring pharmacists to register with their PDMP, it would not be surprising if additional expectations may be placed on the pharmacist as a result of H.R. 280. Assuming the implementation of such a policy is done in a way that does not result in significant more burden on the pharmacist, the profession would be in a key and accessible position to provide counseling to patients for SUD assessment and treatment.
This bill does have bipartisan support, but has gained minimal cosponsors and may not make much progress in the current Congress.
Things have slowed down a bit on the regulatory side as the new administration works to get its legs under itself. Below are some of the big updates over this past month:
Chiquita Brooks-LaSure to be nominated CMS Administrator
A past Obama Administration official, Ms. Brooks-LaSure brings with her decades of experiences including roles in the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health & Human Services (HHS). She previously played a large role in the crafting and implementation of the Affordable Care Act (ACA). Ms. Brooks-LaSure has not spoken publicly in the past regarding pharmacy/pharmacist policy, so it is too early to say where she will align herself on some of the policy priorities of pharmacists. Given her past work on the ACA and the resulting increase in access to healthcare for millions across the country, one could make the argument that she could be supportive of further leveraging health care professionals, such as pharmacists, to further increase access to care.
Delays in effective dates of regulations
A normal course of action for new presidential administrations is to place a regulatory freeze on the work that agencies were completing under the direction of the past administration. There are two regulations that have been delayed in being implemented that are relevant to pharmacists. The first is a program that would have required the use of an electronic prior authorization program for Medicare Part-D covered medications. This rule was set to go into effect on February 1, 2021, but has been delayed to March 30, 2021 in order for the new administration to further review the rule.
The second rule is related to pharmaceutical rebates, point-of-sale of medications reductions, and PBM fees. This rule makes three changes under safe harbor regulations within the anti-kickback statute in the Social Security Act. First, protections will be removed that allow PBMs to reduce the price of medications in connection with the sale or purchase of the medication from manufacturers or plan sponsors under Medicare Part D. Second, protections are set in place for certain point-of-sale reductions in prices. And finally, new protections were added for fixed fees that manufacturers pay to PBMs for the services they provide. This rule has been delayed until March 22, 2021, but may be delayed further due to pending litigation from the Pharmaceutical Care Management Association.
Now is the time to take action
Civic engagement should not be limited to voting at the ballot box. Engaging in grassroots advocacy can happen throughout the year and as legislation and regulation advance. As healthcare professionals, our viewpoints and passion for our communities are important perspectives to our elected leaders. Take this moment to reach out to your elected leaders regarding the issues above, or any issue you are passionate about. Our collective voice and vision for a better healthcare system is exactly what needs to be shared during these times of great potential.
The Grassroots Pharmacist 