TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials
Interim final rule with request for comments.
CFR Part: "32 CFR Part 199"
RIN Number: "RIN 0720-AB83"
Citation: "85 FR 68753"
Document Number: "Docket ID:
Page Number: "68753"
"Rules and Regulations"
Agency: "
SUMMARY: The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this interim final rule (IFR) with request for comments to temporarily modify the TRICARE regulation by adding coverage for
DATES: Effective date: This interim final rule is effective on
Comment date: Comments are invited and must be submitted on or before
ADDRESSES: You may submit comments, identified by docket number and/or Regulation Identification Number (RIN) number and title, by any of the following methods:
* Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
* Mail: The
Instructions: All submissions received must include the agency name and docket number or RIN for this
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:Expiration Date: Unless extended after consideration of submitted comments, this IFR will cease to be in effect upon termination of the President's declared national emergency regarding COVID-19, in accordance with applicable law (50 U.S.C.1622(a)).
If the ASD(HA) determines it would be appropriate to make these changes permanent, the ASD(HA) will follow-up with final rulemaking. The ASD(HA) will publish a document in the
I. Executive Summary
A. Purpose of the Rule
A novel coronavirus (SARS-CoV-2), which causes COVID-19, was first detected in
FOOTNOTE 1 COVID-19 case information updated daily on the
FOOTNOTE 2 https://www.niaid.nih.gov/news-events/covid-19-reminder-challenge-emerging-infectious-diseases. END FOOTNOTE
While stay-at-home orders and recommendations for social distancing have slowed the spread of COVID-19, there is currently no cure for COVID-19, nor are there vaccines capable of preventing transmission of the virus. Many potential COVID-19 treatments and vaccines are being tested in clinical trial settings designed to evaluate their safety and effectiveness. As of
A TRICARE COVID-19-related IFR published on
Pursuant to the President's national emergency declaration regarding COVID-19 and as a result of the worldwide COVID-19 pandemic, the ASD(HA) hereby temporarily modifies the regulation to permit coverage of NIAID-sponsored COVID-19 phase I, II, III, and IV clinical trials. Details as follows:
a. 32 CFR 199.4(e)(26): Title 10, U.S.C. 1079(a)(12) authorizes, pursuant to an agreement with the Secretary of
Based on an agreement with the
This IFR will, pursuant to the agreement with the
b. Dates. This modification will become effective on
If the
B. Interim Final Rule Justification
Agency rulemaking is governed by the Administrative Procedure Act (APA), 5 U.S.C.
As noted in this preamble,
Given the national emergency caused by COVID-19, it would be impracticable and contrary to the public health--and, by extension, the public interest--to delay these implementing regulations until a full public notice-and-comment process is completed.
Therefore, pursuant to 5 U.S.C. 553(b)(B), and for the reasons stated in this preamble, the ASD(HA) concludes that there is good cause to dispense with prior public notice and the opportunity to comment on this rule before finalizing this rule. For the same reasons, the ASD(HA) has determined, consistent with section 5 U.S.C. 553(d), that there is good cause to make this IFR effective immediately upon publication in the
C. Summary of Major Provisions
This provision, 32 CFR 199.4(e)(26), temporarily waives the medical necessity requirements under 10 U.S.C. 1079(a)(12), as authorized by that statute, and establishes a clinical trial benefit for patients participating in NIAID-sponsored clinical trials for the prevention or treatment of COVID-19 during the President's national emergency regarding the COVID-19 outbreak. This provision also removes the reference to the NCI from the 32 CFR 199.4(e)(26) introductory text and authorizes coverage of clinical trials sponsored by any
The current regulatory language only includes waivers for NCI trials related to past or existing demonstrations, and it would be infeasible to create and implement a new COVID-19 demonstration due to the rapid spread of the pandemic, so this provision adds a third category of waiver for public health emergencies and specifically authorizes TRICARE coverage of beneficiary costs related to participation in NIAID-sponsored clinical trials for the treatment or prevention of COVID-19. This third category of waiver for public health emergencies is also a temporary provision; it merely provides an additional waiver type under which the NIAID clinical trials fall and criteria for that waiver type. This provision also establishes regulatory requirements for the coverage of NIAID-sponsored COVID-19 clinical trials to implement the agreement between DHA and
The
Based on the success of the cancer clinical trial benefit and the urgent need for patients to have access to new treatments during the COVID-19 global pandemic, the ASD(HA) is temporarily waiving the medical necessity provision at 10 U.S.C. 1079(a)(12) for NIAID-sponsored clinical trials for the prevention or treatment of COVID-19 under a public health emergency waiver, as established in this regulation change, which implements the provisions of the agreement between DHA and
Covering these trials will encourage participation by TRICARE beneficiaries in eligible clinical trials, contribute to the development of treatments and vaccines for COVID-19, and ensure that covered clinical trials meet similar requirements as those for NCI clinical trials for treatment of cancer. Due to the rapid progression of the COVID-19 pandemic, the severity of the disease in many individuals, and the absence of any existing treatments or vaccines, participation in clinical trials may also be the safest and most successful method of providing TRICARE beneficiaries with early access to care for prevention or treatment of COVID-19. There are already multiple ongoing NIAID-sponsored COVID-19 trials for treatments and vaccines, and we expect many more to be developed. The requirements in this provision, as well as NIAID protocols and institutional review board requirements, will protect participant safety.
Any NIAID-sponsored Phase I, II, III, or IV trial with the purpose of: (1) Preventing infection with COVID-19; (2) diagnosing infection (current or past infection); (3) treating the infection; (4) treating the symptoms of infection (to include associated symptoms such as neurological impairment, cardiovascular illness, or other symptoms as they arise, both acute and long-term); or (5) alleviating pain or other conditions associated with the infection; may be covered under this regulatory provision. Trials that are solely for the purpose of public health research and which do not affect the medical management of the individual patient, such as randomized serological testing to determine prevalence or lasting immunity, may be covered only to the extent that the health plans of other, non-
This temporary provision, including the creation of a public health emergency waiver category, is only effective for the period beginning the date this rule publishes in the
D.
This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program.
II. Regulatory History
Title 32 CFR 199.4 is revised every few years to ensure requirements continue to align with the evolving health care field. It was most recently permanently updated on
III. Regulatory Analysis
A. Regulatory Planning and Review
a. Executive Orders
Executive Order 12866, "Regulatory Planning and Review" and Executive Order 13563, "Improving Regulation and Regulatory Review"
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Accordingly, the rule has been reviewed by the
Executive Order 13771, "Reducing Regulation and Controlling Regulatory Costs"
Executive Order 13771 requires that for every significant regulation promulgated, an agency must identify two for elimination and offset its costs. Executive Order 13771 seeks to control costs associated with the government imposition of private expenditures required to comply with Federal regulations and to reduce regulations that impose such costs. Consistent with the analysis of transfer payments under OMB Circular A-4, this interim final rule does not involve regulatory costs subject to Executive Order 13771.
b. Summary
The modifications to paragraph 199.4(e)(26) in this IFR will temporarily permit TRICARE coverage of cost-sharing for NIAID-sponsored clinical trials for the treatment or prevention of COVID-19 for the duration of the President's national emergency for the COVID-19 outbreak. The modifications will also implement the agreement between
c. Affected Population
This change affects all TRICARE beneficiaries who wish to participate in NIAID-sponsored clinical trials for the treatment or prevention of COVID-19. TRICARE-authorized providers will be affected by being able to treat TRICARE beneficiaries in NIAID clinical trials. The participation of TRICARE beneficiaries in NIAID-sponsored trials positively affects the general public through the development of treatments and vaccines, although it may negatively affect some individuals who desire to participate in such trials but are unable to do so because they were displaced from participation by TRICARE beneficiaries. TRICARE's health care contractors will be affected by being required to implement the provisions of this regulatory change. State, local, and tribal governments will not be affected.
d. Costs
We estimate the total cost for TRICARE participation in NIAID-sponsored COVID-19 clinical trials will be
e. Benefits
This change expands the therapies available to TRICARE beneficiaries in settings that ensure informed consent of the beneficiary, and where the benefits of treatment outweigh the potential risks. Participation in clinical trials may provide beneficiaries with benefits such as reduced hospitalizations and/or use of a mechanical ventilator. Although we cannot estimate the value of this avoidance quantitatively, the potential long-term consequences of serious COVID-19 illness, including permanent cardiac or lung damage, are not insignificant. Beneficiary access to emerging therapies that reduce these long-term consequences or even death can be considered to be high-value for those able to participate.
Providers will be positively affected by being able to provide their patients with a broader range of treatment options. The general public will benefit from an increased pool of available participants for the development of treatments and vaccines for COVID-19, as well as the evidence (favorable or otherwise) that results from this participation.
f. Alternatives
The
The second alternative the
B. Public Law 96-354, "Regulatory Flexibility Act" (5 U.S.C.
The Secretary certifies that this IFR is not subject to the Regulatory Flexibility Act (5 U.S.C.
C. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C.
D. Sec. 202, Public Law 104-4, "Unfunded Mandates Reform Act of 1995"
Section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending by State, local, and tribal governments, in the aggregate, or by the private sector, in any one year of
E. Public Law 96-511, "Paperwork Reduction Act of 1995" (44
32 CFR part 199 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.
F. Executive Order 13132, "Federalism"
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates an IFR (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This IFR will not have a substantial effect on State and local governments.
List of Subjects in 32 CFR Part 199Administrative practice and procedure, Claims, Dental, Fraud, Health care, Health insurance, Individuals with disabilities, Mental health programs, and Military personnel.
Accordingly, 32 CFR part 199 is amended to read as follows:
PART 199--CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED SERVICES (CHAMPUS)
1. The authority citation for part 199 continues to read as follows:
Authority:5 U.S.C. 301; 10 U.S.C. chapter 55.
2. Amend
a. Revising the second sentence in paragraph (e)(26).
b. Adding new paragraph (e)(26)(iii).
The additions read as follows:
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(e) * * *
(26) * * * By law, and pursuant to an agreement between the
(iii) Public Health Emergency Waiver.
(A) General. During public health emergencies (e.g., a national state of emergency declared by the President), TRICARE may cover cost-sharing for TRICARE-eligible patients who participate in Phase I, II, III, or IV trials that are sponsored by the
(B)
(1) TRICARE will cost-share all medical care (including associated health complications) and testing required to determine eligibility for an NIAID-sponsored trial, including the evaluation for eligibility at the institution conducting the NIAID-sponsored study. TRICARE will cost-share all medical care required as a result of participation in NIAID-sponsored studies. This includes purchasing and administering all approved pharmaceutical agents (except for NIAID-funded investigational drugs), all inpatient and outpatient care, including diagnostic, laboratory, rehabilitation, and home health services not otherwise reimbursed under an NIAID grant program if the following conditions are met:
(i) Such treatments are NIAID-sponsored Phase I, Phase II, Phase III, or Phase IV protocols;
(ii) The patient continues to meet entry criteria for said protocol;
(iii) The institutional and individual providers are TRICARE-authorized providers; and
(iv) The requirements for Phase I protocols in paragraph (e)(26)(iii)(B)(2) of this section are met.
(2) Requirements for Phase I protocols are:
(i) Standard treatment has been or would be ineffective, does not exist, or there is no superior non-investigational treatment alternative;
(ii) The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative;
(iii) The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise; and
(iv) The referring physician has concluded that the enrollee's participation in such a trial would be appropriate based upon the satisfaction of paragraphs (e)(26)(iii)(B)(2)(i) through (iii) of this section.
(3) TRICARE will not provide reimbursement for care rendered in the NIH Clinical Center or costs associated with non-treatment research activities associated with the clinical trials.
(4) Cost-shares and deductibles applicable to TRICARE will also apply under the NIAID-sponsored clinical trials.
(5) The Director,
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Dated:
Alternate OSD Federal Register Liaison Officer,
[FR Doc. 2020-24114 Filed 10-28-20;
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