Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations several concerns, including concerns regarding the need for specific guidance to 340B-covered entities for determining the patients deductible at the pharmacy point-of-sale and communicating patient eligibility to contract pharmacies and additional clarity with respect to administration fees. The commenter argued that because these concerns were not addressed in the 2020 Rule, the proper course of action would be for HRSA to rescind the 2020 Rule.
Response: HHS acknowledges that the 2020 Rule would result in significant administrative burden on health centers, which may be passed on to the pharmacies with which they contract to provide access to medications.
Comment: One commenter, a health insurance issuer, stated support for rescinding the 2020 Rule. The commenter also stated that as HHS
considers alternative approaches to implementation of Executive Order 13937, it should prioritize options that can be implemented with minimal administrative burden to the parties involved in the 340B Program, including health centers, their private sector partners, and patients served. The commenter further stated that any alternative approaches should ensure that HRSA maintains a regularly updated directory of health centers, require health centers to adjudicate 340B claims of patients who have health insurance, and require pharmacy providers to adhere to 340B claim stamping using the National Council for Prescription Drugs Programs submission clarification code.
Response: HHS acknowledges the comment and support for minimizing administrative burden. Alternative methods for implementation of Executive Order 13937 are beyond the scope of this rulemaking.
2. Opposition to Proposed Rescission Twelve commenters opposed the proposed rescission of the 2020 Rule.
Commenters cited a number of reasons for their opposition, which are summarized below.
Comment: Six commenters opposed HHSs proposed rescission of the 2020
Rule noting the importance of insulin and the additional costs that could be imposed on the health system if patients were not taking the necessary amounts of insulin to avoid additional complications.
Response: HHS shares commenters concerns about the additional health care costs that can result from a lack of access to timely and appropriate primary health care. The fundamental purpose of the Health Center Program is to ensure access to care for underserved
VerDate Sep<11>2014

16:40 Sep 30, 2021

Jkt 256001

and vulnerable populations; Section 330
of the Public Health Service Act requires health centers to provide comprehensive primary health care to patients without regard to the patients ability to pay. HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to help provide comprehensive primary health care to as many health center patients as possible and that decrease in resources would result in the cost of the 2020 Rule outweighing its benefit.
Comment: Five commenters opposed HHSs proposed rescission of the 2020
Rule noting that the cost of monthly medications poses a financial burden to patients which can be life-threatening, especially for underserved populations who depend on lower medication costs.
These commenters further stated that HHS should consider the cost to patients and not just the financial burden on healthcare systems. A subset of these commenters 3 stated that if medication costs increase, these patients will likely stop taking their medication or be forced to choose between food, rent, or medication. Another subset of these commenters 2 opposed HHSs proposed rescission of the 2020 Rule noting that human life is of greater value than costs to institutions, and that the increased burden on health centers does not justify taking away affordable medications from underserved populations.
Response: HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to the availability of fewer resources to help provide comprehensive primary health care to as many health center patients as possible and that decrease in resources would result in the cost of the 2020 Rule outweighing its benefit. HHS believes the 2020 Rule would improve medication access for only a small percentage of health center patients while not meaningfully impacting medication access for the majority of health center patients.
Comment: Four commenters opposed HHSs proposed rescission of the 2020
Rule noting that they disagree with HHSs reasoning for rescinding the 2020
Rule. The commenters stated that administrative burden and administrative costs do not justify limiting access to lifesaving medications to low income patients who do not have insurance or otherwise cannot afford their medications.
Response: HHS is concerned that the increased costs due to the extra
PO 00000

Frm 00055

Fmt 4700

Sfmt 4700

54393

administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to help provide comprehensive primary health care to as many health center patients as possible and that decreased resources would result in the cost of the 2020 Rule outweighing its benefit.
Executive Order 13937 remains in effect and HHS is exploring alternative approaches to address the high costs of prescription drugs, such as insulin or injectable epinephrine.
Comment: Two commenters opposed HHSs proposed rescission of the 2020
Rule noting that health care institutions including health centers can address increasing costs of providing essential programs, including during the COVID
19 pandemic, without HHS rescinding this rule. Comments included suggested alternative health center cost cutting methods such as allocating resources, improving workflows, and using employee retention strategies.
Response: HHS is rescinding the 2020
Rule to maximize resources health centers have to provide access to high quality, comprehensive primary health care in the most efficient way and to as many health center patients as possible.
HHS believes the 2020 Rule would improve medication access for only a small percentage of health center patients. Examining other cost cutting measures to decrease the burden on health centers is beyond the scope of this proposed rulemaking.
Comment: Two commenters opposed HHSs proposed rescission of the 2020
Rule noting that it would benefit numerous health center patients through greater access to affordable insulin and it should be kept for that reason. One of those commenters further noted that, unlike patients under 200
percent of the FPG who already receive significant discounts from health centers and would be less impacted by the 2020 Rule, patients between 200 and 350 percent of the FPG would greatly benefit from this rule going into effect.
Response: While the 2020 Rule would likely provide benefits to a small number of health center patients with diabetes and severe allergic reactions, HHS is concerned that the increased costs due to the extra administrative burden placed on health centers to comply with the 2020 Rule would lead to fewer resources available to provide comprehensive primary health care to as many health center patients as possible.
As Executive Order 13937 remains in effect, HHS is exploring non-regulatory options to implement the Executive Order.
Comment: One commenter opposed HHSs proposed rescission of the 2020

E:FRFM01OCR1.SGM

01OCR1