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Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 / Rules and Regulations
implementing the rule. Given the overwhelming support by other commenters for delaying implementation of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule, HHS is finalizing this rule to delay the effective date to July 20, 2021. HHS
will use the delay period to review and consider the questions of fact, law, and policy posed by and the potential impact of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule, including on access to affordable insulin for health center patients, including those with Type 1 diabetes, patients with disabilities, and those with incomes up to 350% of the Federal Poverty Guidelines.
Another commenter, a pharmaceutical manufacturer, opposed any further delay of the effective date, arguing that policymakers are operating under the erroneous assumption that 340B
discounts directly benefit patient access to drugs. Instead, the commenter stated, covered entity middlemen pocket the discounts, rather than pass them on to patients. The commenter provided data suggesting that the markup charged by some covered entities on insulin is as much as 200,000%. However, the commenter noted that none of the covered entities examined were health centers. The commenter encouraged HHS to look at its own data to see if spread pricing on penny priced insulin is an appropriate policy solution for federal grantees. The commenter stated that they have implemented a program for 340B pass-through pricing where patients receive insulin at the 340B price at the point-of-sale, which five covered entities have instituted, as evidence that such a policy is operationally feasible. The commenter stated that the Implementation of Executive Order on Access to Affordable Life-saving Medications rule would dramatically lower the cost of insulin for many of the most vulnerable patients in the country.
Response: HHS appreciates the commenters opposition to delaying the effective date of the rule. However, given the overwhelming support by other commenters for delaying implementation of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule, HHS is finalizing this rule to delay the effective date to July 20, 2021. HHS
will use the delay period to review and consider the questions of fact, law, and policy posed by and the potential impact of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule, whether
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the rule would be likely to significantly lower the cost of insulin for the most vulnerable patients.
As stated in the NPRM for this delay, HHS will further consider and review comments submitted, including those made on the substance of the Implementation of Executive Order on Access to Affordable Life-saving Medications rule.
7. Comments on the Underlying Rule Most commenters raised issues that concerned the underlying rule, in particular, the high cost of these drugs, and the significant administrative costs associated with the rule. The nature of these comments suggests that a further delay of the Implementation of Executive Order on Access to Affordable Life-saving Medications. rule is warranted. This final rule does not address these substantive issues, but rather responds to concerns raised regarding the proposed delayed effective date. However, as stated in the NPRM, HHS will consider and review these comments on the substance of the underlying rule during the delay period.
8. Miscellaneous Other commenters raised a variety of issues that do not pertain directly to either the delay period extended by this final rule or to the underlying Implementation of Executive Order on Access to Affordable Life-saving Medications rule. This final rule does not address those issues as they are outside of its scope.
IV. Regulatory Impact Analysis Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits including potential economic, environmental, public health, safety, distributive, and equity effects.
In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, HHS must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.
The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under section 3f of Executive Order 12866.
HHS has determined that no resources are required to implement the requirements in this rule because compensation will continue to be made consistent with the status quo.
Therefore, in accordance with the
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Regulatory Flexibility Act of 1980
RFA, and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, HHS certifies that this rule will not have a significant impact on a substantial number of small entities.
HHS has also determined that this rule does not meet the criteria for a major rule under the Congressional Review Act or Executive Order 12866
and would have no major effect on the economy or federal expenditures.
Similarly, it will not have effects on state, local, and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995. Nor on the basis of family well-being will the provisions of this rule affect the following family elements: Family safety; family stability; marital commitment; parental rights in the education, nurture and supervision of their children; family functioning;
disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654c of the Treasury and General Government Appropriations Act of 1999.
V. Impact of the New Rule This final rule delays the effective date of the rule entitled Implementation of Executive Order on Access to Affordable Life-saving Medications until July 20, 2021, to allow HHS additional opportunity for review and consideration of the rule.
This delay is reasonable and will not be disruptive because the underlying rule has not yet been implemented or taken effect.
VI. Paperwork Reduction Act of 1995
This rule has no information collection requirements.
Norris Cochran, Acting Secretary, Department of Health and Human Services.
FR Doc. 202105981 Filed 31921; 11:15 am BILLING CODE 416515P

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