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Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations minimal administration fee to health center patients with low incomes, as determined by the Secretary, who have a high cost sharing requirement for either insulin or injectable epinephrine;
have a high unmet deductible; or have no health insurance.
This final rule also states that the program term established by the Implementation of Executive Order on Access to Affordable Life-Saving Medications rule will not be included on any Notices of Award issued to health centers receiving grant funds under section 330e of the Public Health Service Act. Due to the timing of Health Center Program funding, placement of that program term on health center awards would have first been applied to funds awarded in Fiscal Year 2022. As HHS has issued this final rule prior to the issuance of such awards, this program term has not been placed on Health Center Program awards.
This final rule does not revoke Executive Order 13937, which may only be revoked by executive order. As Executive Order 13937 remains in effect, HHS is exploring non-regulatory options to implement the Executive Order.
V. Rationale for Rescission HHS is rescinding the 2020 Rule because the overall impact of the additional administrative costs and burden that the 2020 Rule would have placed on health centers would have harmed health centers and the patients they serve.
In implementing the requirement of the 2020 Rule, health centers would have had to absorb significant additional costs in financial resources, time, and ongoing support staff to create and maintain new reporting, monitoring, technical and administrative re-engineering, staff training, and workflow re-designs to assess eligibility based on the numerous different categories set forth in the 2020
Rule for patients to receive insulin and injectable epinephrine.
The 2020 Rule would have significantly increased the administrative burden on health centers because it would have required health centers to track and monitor in real time: 1 Whether patients were receiving insulin or injectable epinephrine through a 340B pharmacy, 2 whether patients incomes met the threshold in the 2020 Rule which is different from the standard used for the Health Center Program sliding fee discount schedule and therefore would have had to be calculated separately, and 3 whether patients had a high
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unmet deductible each time they filled their prescriptionswhich may have been further complicated due to medical billing and claims processing delays or whether they had a high deductible or high cost-sharing requirement as part of their insurance plan. These burdens would have also required that health centers work with their contract pharmacies to implement these new requirements, which would have created extra administrative costs. HHS
has determined that, under the 2020
Rule, health centers and pharmacies would have found it challenging to ascertain in real time a patients eligibility for discounted pricing under the 2020 Rule based on whether or not that patient continued to have a high unmet deductible, as defined in the 2020 Rule, particularly due to delays in medical billing and claims processing.
HHS also notes that the 2020 Rule codified a new definition, applicable only to these two classes of drugs, for individuals with low income, to include those individuals with incomes at or below 350 percent of the amount identified in the Federal Poverty Guidelines FPG. This new definition contrasted with the Health Center Programs sliding fee discount schedule requirement for Health Center Program grantees applicable to individuals with incomes at or below 200 percent of the FPG, pursuant to 42 CFR 51c.303f.
Under this subsection, health centers must establish a sliding fee discount schedule for services provided to patients with incomes between 100 and 200 percent of the FPG, with a full discount to individuals and families with annual incomes at or below 100
percent of those set forth in the FPG.
Health centers also may collect nominal fees for services from individuals and families at or below 100 percent of the FPG, and no sliding fee discount may be provided to individuals and families with annual incomes greater than 200
percent of the FPG. Health centers must also demonstrate to HHS that they maintain and apply such sliding fee discount schedules to the provision of health services, which requires them to establish and maintain processes for identifying patient income levels for billing purposes consistent with these requirements.
In its decision to rescind the 2020
Rule, HHS notes the concerns expressed by the vast majority of commenters that the low income definition of 350
percent of the FPG, applicable to patients receiving these two classes of drugs, would have created significant administrative challenges for health centers. HHS is issuing this rule in recognition that the 2020 Rule would
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have resulted in additional administrative burden and costs, resulting in a diversion of resources from needed patient care, especially during the COVID19 pandemic, in order to cover such increased administrative costs.
As commenters have noted, the rule would have forced health centers to construct two different eligibility systems. As the 2020 Rules definition of low income is inconsistent with standards applied in the Health Center Program and in other comparable federal programs with an income eligibility threshold, this would have imposed new administrative burdens on health centers to implement.
Furthermore, the 2020 Rule would require health center staff, who are not clinicians, to ask patients at the time of screening if they use insulin or injectable epinephrine, which may raise concerns related to the sharing of protected health information if not conducted in a confidential setting.
Rescinding the 2020 Rule prevents unnecessary costs to health centers that are on the front lines of fighting COVID
19 and providing care to millions of Americans. The 2020 Rule would have resulted in increased administrative costs and administrative burden and reduced resources available to support critical services to health center patients, including those who use insulin or injectable epinephrine and who receive other services from health centers.
VI. Public Comments and Responses HRSA received a total of 332
comments from the public, including:
Health centers, associations and organizations representing health centers, a health center controlled network, individual health center staff and clinical professionals, individuals and organizations concerned with the high cost of insulin or injectable epinephrine, an association representing pharmacies, an association representing hospitals participating in the 340B
Program, a health insurance issuer, a health innovation and research nonprofit organization, a pharmaceutical manufacturer, and an association representing pharmaceutical manufacturers.
The vast majority of comments 318
favored rescission of the 2020 Rule.
There were 12 comments opposing rescission of the 2020 Rule and supporting its implementation. Two remaining comments did not explicitly support or oppose the rescission of the 2020 Rule.
All comments were considered in developing this final rule. This section
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