Biden administration freezes rule on community health center insulin discounts
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The Biden administration issued a temporary freeze on a final rule that would require community health centers to pass on 340B drug discounts for insulin and injectable epinephrine to low-income patients.
The executive order temporarily delays for 60 days the effective date of the final rule, titled “Implementation of Executive Order on Access to Affordable Life-saving Medications,” until March 22. The order, published Dec. 23, was to go into effect Jan. 22. The rule would apply to all health centers receiving section 330e grant funds that participate in the 340B drug pricing program, and requires such centers to make insulin and injectable epinephrine available to health center patients identified as low-income or below at the same price the health center paid through the 340B program.
“We are deeply grateful the Biden Administration put the brakes on such a harmful rule within hours of taking office,” Tom Van Coverden, president and CEO of National Association of Community Health Centers, said in a statement. “Health centers, bipartisan members of Congress, and leaders within the Department of Health and Human Services (HHS) have indicated that this rule will do more harm than good at a time when too many people are suffering. We hope that this is further acknowledgment that a pandemic is no time to destabilize the safety net.”
The freeze was part of a broader executive action issued Jan. 20 postponing most rules sent to the Office of the Federal Register for 60 days to allow for a review of “any questions of fact, law and policy the rules may raise” and to consider any pending petitions for reconsideration of rules.
“The temporary delay in the effective date of this final rule is necessary to give department officials the opportunity for further review and consideration of new regulations, consistent with the memorandum of January 20, 2021, from the assistant to the president and chief of staff, entitled ‘Regulatory Freeze Pending Review,’” the executive order states.
Community health centers voiced opposition to the rule when the Trump administration first announced the change. In September, the Office of Management and Budget revised the regulation from an interim final rule to a proposed rule, indicating that the public would have an opportunity to submit written comments before it goes into effect. At the time, the NACHC stated that the rule change would place additional administrative burdens on centers that assist vulnerable populations, instead of placing such a burden on pharmaceutical companies.
“We are deeply grateful that there seems to be growing recognition among leaders in the administration that this rule will do more harm than good at a time when too many people are suffering,” Van Coverden said in a press release in September, after the regulation was first revised.
For more information:
NACHC statement. Available at: www.nachc.org/fed-delays-implementation-of-340b-rule-after-health-centers-lawmakers-sound-alarm/. Accessed: Jan. 26, 2021.
The White House. Regulatory freeze pending review. Available at: www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/regulatory-freeze-pending-review/. Accessed: Jan. 26, 2021.
Perspective
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Emily Kosirog, PharmD, BCACP
Community health centers provide excellent primary care to all patients, regardless of their insurance or income status. Most of our patients are from vulnerable communities, which are disproportionately affected by diabetes. Many of our patients cannot afford to see an endocrinologist, or their work hours are limiting. Community health centers typically offer care on evenings and weekends to help meet that need. We also provide whole-person care for diabetes, including mental health support related to the chronic stress of diabetes.
This final rule, first proposed by the Trump administration and currently frozen to allow for a 60-day review process, reflects confusion about how community health centers used the 340B discounts. We are able to purchase drugs at a discounted price through the community 340B program, and then we already pass that savings on to patients. Oftentimes, the pharmacy charges only a small dispensing fee, which is for the pharmacist’s and team’s time. Any additional money that would be generated through this 340B program is funneled directly back into patient care.
The rule change would significantly increase administrative burden on the community health center, and would mean more time, money and effort toward implementing this rule change and money taken away from patient care. For example, many CHCs use any money generated from the 340B program to allow pharmacists the time to manage medications and improve safety, because traditionally the pharmacist cannot bill for that time. I manage diabetes, and most of my day is spent with patients managing and adjusting medications, working through diet plans and troubleshooting problems. No one pays for that time, and the 340B money offsets that. We also use 340B money to improve medication access points, like providing medication dispensaries for areas where there is no pharmacy, or to fund community health workers who help improve patient outcomes.
Community health centers are already stretched to the absolute limit during this pandemic. To better support community health centers, we can allow pharmacists to be considered health care providers to help increase efficiency and improve care. Here in Colorado, we are also providing COVID-19 vaccine access to everyone in the community, so right now, many people are seeing us for the first time.
Many may think they would not qualify for help or that they don’t need a community health center. We want people to know that we are here for everyone. I encourage anyone who is having trouble affording their medications to contact their local community health center. To find a community health center near you, visit, www.findahealthcenter.hrsa.gov.
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