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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations
presents a summary of all major issues raised by commenters, grouped by subject, as well as responses to the comments. Commenters used the terms Federally Qualified Health Centers FQHCs and health centers interchangeably. This final rule only applies to health centers funded under Section 330e of the Public Health Service Act, and not to other FQHCs.
For consistency, this final rule uses health center throughout.
1. Support for Rescission Approximately 318 commenters supported rescission of the 2020 Rule.
Commenters cited a number of reasons for their support, which are summarized below.
Comment: Approximately 316
commenters expressed concern that the net impact of implementing the 2020
Rule would be a reduction in access to care for underserved populations. These commenters described the anticipated administrative burden and cost for health centers to implement the rule and noted that these costs would reduce resources available to provide essential primary care services to patients.
A subset of these commenters 61
detailed the specific administrative burdens and costs that would result if the 2020 Rule were implemented, including:
Determining in real time whether a patient has a high remaining deductible.
The remaining deductible amount can be inaccurate as it may change as a result of pending and delayed medical bills;
Adjusting the charge for qualifying patients for every form of insulin and injectable epinephrine every quarter, when the 340B price changes; and Keeping pharmacy partners/
contractors informed and ensuring their compliance with new charges and eligibility rules.
Another subset of commenters 59
also noted that HRSA estimated it would require one full-time equivalent FTE staff member per health center to implement the 2020 Rule, resources the commenters stated would be better spent increasing access in other ways.
For example, commenters stated that one FTE would have greater impact on patient pharmaceutical access by focusing efforts such as helping patients apply to pharmaceutical manufacturers Patient Assistance Programs and for enabling services to connect patients to other services in the community.
Response: HHS agrees with these commenters concerns regarding reduced access to care resulting from the additional burden required of health centers to implement the 2020 Rule.

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Specifically, the 2020 Rule would necessitate some health centers redirecting resources that might have otherwise gone to support patient care to support additional staff to ascertain whether a high unmet deductible has been met in real time.
Comment: Approximately 305
commenters noted that the 2020 Rules definition of low income as persons below 350 percent of the FPG was inconsistent with other federal programs. These commenters further stated that having different definitions across programs increases administrative burden of implementing the 2020 Rule.
A subset of these commenters 58
outlined specific issues that these differing low income definitions would cause for health centers implementing the 2020 Rule:
Health centers would need to establish new policies and procedures for eligibility determinations;
Eligibility workers would need to ask all patients if they use insulin or injectable epinephrine to appropriately screen them, which would require patients to share protected health information with non-clinicians;
The higher income threshold would reduce health center savings on these medications, reducing revenue that could be used to support patient services for all patients; and A higher income threshold would reduce the cost that health centers could charge insurers for insulin and injectable epinephrine, effectively transferring savings from the health centers to insurers. The commenters explained that this is because insurance contracts generally prohibit health centers from billing insurers more than their usual and customary rate for each specific drug, and if the 2020 Rule were not rescinded, it would be very difficult for health centers to argue that the 340B price is not their usual and customary, as very few cash patients would not qualify for the 340B price.
Response: HHS agrees with these commenters concerns that the definition of low income in the 2020
Rule increases the administrative burden of implementing this rule. For example, the 2020 Rules inconsistency with current health center requirements would require health centers to create new policies, procedures, and workflows to ensure that eligible patients would be charged the 340B
price or less for insulin and injectable epinephrine. Additionally, HHS shares commenters concerns regarding the sharing of protected health information with non-clinicians.

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Comment: Approximately 300
commenters expressed concern that implementation of the 2020 Rule would divert health center resources away from the COVID19 pandemic response.
A subset of these commenters 57
further noted that health centers are making meaningful contributions to COVID19 testing, treatment, and vaccination, and that these contributions are very resourceintensive. These commenters stated that reducing burden by rescinding the 2020
Rule would allow this vital work to continue.
Response: HHS appreciates the role health centers continue to play in the response to the COVID19 pandemic.
HHS shares commenters concerns about the potential for implementation of the 2020 Rule to divert resources away from health centers ongoing critical role in the COVID19 pandemic response, stabilization, and recovery.
Comment: Approximately 301
commenters stated that implementing the 2020 Rule would only improve medication access for a small population of patients, and health center services would be drastically reduced for all health center patients given the increase in administrative costs and loss of 340B savings.
A subset of these commenters 59
noted that the 2020 Rule would have no impact on the overall price of the covered medications outside of the 340B
Program; those prices are set by manufacturers and would not be changed by this rule. Further, these commenters stated that 90 percent of diabetic patients in the United States are not health center patients, and therefore the 2020 Rule would not impact what the majority of diabetic patients pay for insulin. Commenters also stated that health center patients with diabetes are already likely to qualify for discounted pricing through health centers.
Response: HHS appreciates the detail provided by commenters in support of their conclusion that the 2020 Rule would not meaningfully impact medication access for health center patients or individuals who are not health center patients. HHS agrees that the 2020 Rule would be unlikely to impact the underlying price of these two medications. HHS also agrees that the 2020 Rule would likely improve medication access for only a small population of health center patients.
Comment: One commenter, an association of chain drug stores, stated that the 2020 Rule would place undue burdens on 340B-covered entities as well as their contract pharmacies. The commenter also stated that the 2020
Rule had not sufficiently resolved
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