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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 / Rules and Regulations
Estimated Total Annual Burden Cost:
$558,885 DOL$279,496, Treasury $279, 389.
F. Regulatory Flexibility Act The Regulatory Flexibility Act RFA, 5 U.S.C. 601 et seq., requires agencies to analyze options for regulatory relief of small entities to prepare an initial regulatory flexibility analysis to describe the impact of the proposed rule on small entities, unless the head of the agency can certify that the rule will not have a significant economic impact on a substantial number of small entities.
The RFA generally defines a small entity as 1 a proprietary firm meeting the size standards of the Small Business Administration SBA, 2 a not-forprofit organization that is not dominant in its field, or 3 a small government jurisdiction with a population of less than 50,000. States and individuals are not included in the definition of small entity. HHS uses a change in revenues of more than 3 to 5 percent as its measure of significant economic impact on a substantial number of small entities. Individuals and states are not included in the definition of a small entity. These interim final rules are not preceded by a general notice of proposed rulemaking, and thus the requirements of RFA do not apply.

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G. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995 UMRA
requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a proposed rule or any final rule for which a general notice of proposed rulemaking was published that includes any Federal mandate that may result in expenditures in any 1 year by state, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158
million. These interim final rules were not preceded by a general notice of proposed rulemaking, and thus the requirements of UMRA do not apply.
H. Federalism Executive Order 13132 outlines fundamental principles of federalism. It requires adherence to specific criteria by federal agencies in formulating and implementing policies that have substantial direct effects on the states, the relationship between the national government and states, or on the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must
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consult with state and local officials, and describe the extent of their consultation and the nature of the concerns of state and local officials in the preamble to the interim final rules.
These interim final rules protect participants, beneficiaries, or enrollees in group health plans and group and individual health insurance coverage, and covered individuals in FEHB plans, from surprise medical bills for emergency services, air ambulance services furnished by nonparticipating providers, and non-emergency services furnished by nonparticipating providers at participating facilities in certain circumstances. A number of states currently have laws related to surprise medical bills. The Departments are of the view that Congress did not intend to supplant state laws regarding balance billing, but rather to supplement such laws. The provisions in these interim final rules are consistent with the statutes general approach of supplementing state law. In addition, the No Surprises Act and these interim final rules recognize states traditional role as the primary regulators of health insurance issuers, providers, and facilities. The No Surprises Act authorizes states to enforce the new requirements regarding health insurance coverage, including those related to balance billing, with respect to issuers, providers, facilities, and providers of air ambulance services, with HHS enforcing only in cases where the state has notified HHS that the state does not have the authority to enforce or is not otherwise enforcing, or HHS has made a determination that a state has failed to substantially enforce the requirements.
In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have federalism implications or limit the policy making discretion of the states, the Departments have engaged in efforts to consult with and work cooperatively with affected states, including participating in conference calls with and attending conferences of the NAIC, and consulting with state insurance officials on a state-by-state basis. In addition, the Departments consulted with the NAIC, as required by the No Surprises Act, to establish the geographic regions to be used in the methodology for calculating the QPA.
OPM concluded that it would be inappropriate for FEHB plans to adopt varying state standards, and consistent with the FEHBA, it would adopt state laws where appropriate pursuant to bilaterally negotiated FEHB contracts.
While developing these interim final rules, the Departments attempted to balance the states interests in regulating
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health insurance issuers, providers, and facilities with the need to ensure at least the minimum federal consumer protections in every state. By doing so, the Departments complied with the requirements of Executive Order 13132.
I. Congressional Review Act These interim final rules are subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 5 U.S.C. 801 et seq. and will be transmitted to the Congress and to the Comptroller General for review in accordance with such provisions.
Statutory Authority The Office of Personnel Management regulations are adopted pursuant to the authority contained in 5 U.S.C. 8902p and 5 U.S.C. 8913.
The Department of the Treasury regulations are adopted pursuant to the authority contained in sections 7805
and 9833 of the Code.
The Department of Labor regulations are adopted pursuant to the authority contained in 29 U.S.C. 1002, 1135, 1182, 1185d, 1191a, 1191b, and 1191c;
Secretary of Labors Order 12011, 77
FR 1088 Jan. 9, 2012.
The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, 2792, 2794, 2799A1 through 2799B9 of the PHS Act 42 U.S.C. 300gg300gg63, 300gg91, 300gg92, 300gg94, 300gg 300gg139, as amended; sections 1311
and 1321 of the ACA 42 U.S.C. 13031
and 18041.
List of Subjects 5 CFR Part 890
Administrative practice and procedure, Government employees, Health facilities, Health insurance, Health professions, Hostages, Iraq, Kuwait, Lebanon, Military personnel, Reporting and recordkeeping requirements, Retirement.
26 CFR Part 54
Excise taxes, Health care, Health insurance, Pensions, Reporting and recordkeeping requirements.
29 CFR Part 2590
Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements.
45 CFR Part 144
Health care, Health insurance, Reporting and recordkeeping requirements.

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