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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations
Rule noting that HHS should not place a charge on American families to pay for administrative costs at health centers, nor administrative costs caused by the COVID19 pandemic.
Response: HHS appreciates this comment and is committed to maximizing resources for health centers to provide comprehensive primary health care to health center patients without regard for patients ability to pay.
Comment: One commenter opposed HHSs proposed rescission of the 2020
Rule noting that it would allow health centers to divert resources to other services at the expense of the communitys health needs during the COVID19 pandemic, specifically, access to the lifesaving medications of insulin and injectable epinephrine.
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 fewer resources available to provide comprehensive primary health care to as many health center patients as possible, including those who use insulin or injectable epinephrine, and that decrease in resources would result in the cost of the 2020 Rule outweighing its benefit. In addition, as noted in the 2020 Rule, in many cases, health centers already voluntarily provide medications, including insulin and injectable epinephrine, to their patients at reduced prices.
Comment: One commenter, a pharmaceutical manufacturer, opposed HHSs proposed rescission of the 2020
Rule noting that most of its insulin products are available to covered entities for pennies and rescinding the 2020 Rule would make covered entity patients pay more for the medications.
The commenter also noted that covered entity patients in most cases could receive larger discounts from the companys own discount programs for medications.
Response: Nothing in this rule rescinding the 2020 Rule prohibits health center patients from accessing pharmaceutical company and charity discount programs to find the most affordable medications, including for insulin or injectable epinephrine.
Comment: One commenter, a pharmaceutical manufacturer, opposed HHSs proposed rescission of the 2020
Rule, noting that it provides insulin to several charitable organizations including its own foundation, which provide insulin for free for qualifying patients at or below 400 percent of FPG
and covered entities should be held to the same standard. Additionally, this
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commenter noted that it participates in a number of programs that allow patients, regardless of their income, to purchase insulin at no more than $35 a month.
Response: HHS commends those who are working to ensure underserved patients are able to access discounted medications. As noted above, 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, including those who use insulin or injectable epinephrine.
Comment: One commenter, a pharmaceutical manufacturer, opposed HHSs proposed rescission of the 2020
Rule, noting that grantees that are covered entities under the 340B
Program should not be able to charge large markups on drugs purchased through the 340B Program to uninsured or underinsured individuals to fund their operations.
Response: With regard to the commenters concern regarding the general requirements of the 340B
Program, those requirements, including charges for drugs purchased through the 340B Program by covered entities, are beyond the scope of this rulemaking.
Comment: One commenter, a pharmaceutical manufacturer, opposed HHSs proposed rescission of the 2020
Rule, noting that the commenter is able to verify income and insurance information with minimal burden and that six covered entities have worked with the commenter to provide insulin to their patients for pennies, demonstrating that the 2020 Rule would not be overly burdensome.
Response: HHS has concerns that under the 2020 Rules definition of high unmet deductible, health centers and pharmacies with which they contract may find it challenging to ascertain in real time a patients eligibility for pricing based on whether or not the patient continues to have a high unmet deductible that meets the 2020 Rules definition of the term. The 2020 Rule defined high unmet deductible as the amount a patient owes toward their high deductible at any time during a plan year in which the portion of the patients high deductible for the plan year that has not yet been met exceeds 20 percent of the deductible. Determining whether a patients plan year spending toward their deductible meets this definition has the potential to be particularly challenging due to medical billing and claims processing delays. For these and
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other reasons, HHS believes the administrative burden and costs the 2020 Rule places on health centers outweigh the benefits.
3. General Comments Comment: One commenter, an association of pharmaceutical manufacturers, while not opposing rescission of the 2020 Rule, noted that the 340B Program has grown exponentially in recent years without a commensurate benefit to the underserved patients.
Response: The growth of the 340B
Program is beyond the scope of this rulemaking.
Comment: One commenter stated that the 340B Program is essential to the well-being of all patients that receive care at health centers and asked that the 340B Program be kept in place.
Response: HHS acknowledges the importance of the 340B Program to patients served by health centers. This rulemaking does not change the 340B
Program.
4. Request To Revoke Executive Order 13937
Comment: Approximately 300
commenters urged revocation of the Executive Order on Access to Affordable Lifesaving Medications, on which the 2020 Rule was based. These commenters expressed many concerns with the underlying Executive Order and requested that it be revoked.
Response: Revoking Executive Order 13937, Access to Affordable Lifesaving Medications is beyond the authority of HHS and outside the scope of this final rule.
5. Miscellaneous Other commenters raised a variety of issues that HHS determined did not pertain to the rescission of the 2020
Rule. This rulemaking does not address those issues as they are outside of its scope.
VII. Regulatory Impact Analysis RIA
HHS has examined the effects of this rule as required by Executive Order 12866 on Regulatory Planning and Review September 30, 1993, Executive Order 13563 on Improving Regulation and Regulatory Review January 8, 2011, the Regulatory Flexibility Act Pub. L. 96354, September 19, 1980, the Unfunded Mandates Reform Act of 1995 Pub. L. 1044, and Executive Order 13132 on Federalism August 4, 1999.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
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