83 FR 25947 - Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 108 (June 5, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 108 (June 5, 2018)
| Page Range | 25947-25949 | |
| FR Document | 2018-11953 |
[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)] [Rules and Regulations] [Pages 25947-25949] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11953] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 414 [CMS-6080-N] Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Update to list. ----------------------------------------------------------------------- SUMMARY: This document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide. DATES: Implementation is effective on September 1, 2018. FOR FURTHER INFORMATION CONTACT: Emily Calvert, (410) 786-4277. Andre Damonze, (410) 786-1795. SUPPLEMENTARY INFORMATION: I. Background Sections 1832, 1834, and 1861 of the Social Security Act (the Act) establish that the provision of durable medical equipment, prosthetic, orthotics, and supplies (DMEPOS) is a covered benefit under Part B of the Medicare program. [[Page 25948]] Section 1834(a)(15) of the Act authorizes the Secretary to develop and periodically update a list of DMEPOS items that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization and to develop a prior authorization process for these items. In the December 30, 2015 final rule (80 FR 81674) titled ``Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies,'' we implemented section 1834(a)(15) of the Act by establishing an initial Master List (called the Master List of Items Frequently Subject to Unnecessary Utilization) of certain DMEPOS that the Secretary determined, on the basis of prior payment experience, are frequently subject to unnecessary utilization and by establishing a prior authorization process for these items. In the same final rule, we also stated that we would inform the public of those DMEPOS items on the Required Prior Authorization List in the Federal Register with 60-day notice before implementation. The Required Prior Authorization List specified in Sec. 414.234(c)(1) is selected from the Master List of Items Frequently Subject to Unnecessary Utilization (as described in Sec. 414.234(b)(1)), and items on the Required Prior Authorization List require prior authorization as a condition of payment. In addition to the prior authorization process for certain DMEPOS items that we established under section 1834(a)(15) of the Act, on September 1, 2012, we implemented the Medicare Prior Authorization for Power Mobility Devices (PMDs) Demonstration that would operate for a period of 3 years (September 1, 2012 through August 31, 2015). This demonstration was established under section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)), which authorizes the Secretary to conduct demonstrations designed to develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services provided under the Medicare program. The demonstration was initially implemented in California, Florida, Illinois, Michigan, New York, North Carolina, and Texas. These states were selected for the demonstration based upon their history of having high levels of improper payments and incidents of fraud related to PMDs. On October 1, 2014, we expanded the demonstration to 12 additional states (Pennsylvania, Ohio, Louisiana, Missouri, Washington, New Jersey, Maryland, Indiana, Kentucky, Georgia, Tennessee, and Arizona) that have high expenditures and improper payments for PMDs based on 2012 billing data. On July 15, 2015, we announced we were extending the demonstration for 3 years, through August 31, 2018. II. Provisions of the Document The purpose of this document is to inform the public that we are updating the Required Prior Authorization List of DMEPOS items that require prior authorization as a condition of payment to include all of the power mobility devices that are part of the PMD demonstration, which are also included on the Master List of Items Frequently Subject to Unnecessary Utilization. To assist stakeholders in preparing for implementation of the prior authorization program, CMS is providing 90 days' notice. The following 31 DMEPOS items are being added to the Required Prior Authorization List: ------------------------------------------------------------------------ HCPCS code Description ----------------------------------------------------------------------- K0813...................... Power wheelchair, group 1 standard, portable, sling/solid seat and back, patient weight capacity up to and including 300 pounds. K0814...................... Power wheelchair, group 1 standard, portable, captains chair, patient weight capacity up to and including 300 pounds. K0815...................... Power wheelchair, group 1 standard, sling/ solid seat and back, patient weight capacity up to and including 300 pounds. K0816...................... Power wheelchair, group 1 standard, captains chair, patient weight capacity up to and including 300 pounds. K0820...................... Power wheelchair, group 2 standard, portable, sling/solid seat/back, patient weight capacity up to and including 300 pounds. K0821...................... Power wheelchair, group 2 standard, portable, captains chair, patient weight capacity up to and including 300 pounds. K0822...................... Power wheelchair, group 2 standard, sling/ solid seat/back, patient weight capacity up to and including 300 pounds. K0823...................... Power wheelchair, group 2 standard, captains chair, patient weight capacity up to and including 300 pounds. K0824...................... Power wheelchair, group 2 heavy duty, sling/solid seat/back, patient weight capacity 301 to 450 pounds. K0825...................... Power wheelchair, group 2 heavy duty, captains chair, patient weight capacity 301 to 450 pounds. K0826...................... Power wheelchair, group 2 very heavy duty, sling/solid seat/back, patient weight capacity 451 to 600 pounds. K0827...................... Power wheelchair, group 2 very heavy duty, captains chair, patient weight capacity 451 to 600 pounds. K0828...................... Power wheelchair, group 2 extra heavy duty, sling/solid seat/back, patient weight capacity 601 pounds or more. K0829...................... Power wheelchair, group 2 extra heavy duty, captains chair, patient weight 601 pounds or more. K0835...................... Power wheelchair, group 2 standard, single power option, sling/solid seat/ back, patient weight capacity up to and including 300 pounds. K0836...................... Power wheelchair, group 2 standard, single power option, captains chair, patient weight capacity up to and including 300 pounds. K0837...................... Power wheelchair, group 2 heavy duty, single power option, sling/solid seat/ back, patient weight capacity 301 to 450 pounds. K0838...................... Power wheelchair, group 2 heavy duty, single power option, captains chair, patient weight capacity 301 to 450 pounds. K0839...................... Power wheelchair, group 2 very heavy duty, single power option, sling/solid seat/back, patient weight capacity 451 to 600 pounds. K0840...................... Power wheelchair, group 2 extra heavy duty, single power option, sling/solid seat/back, patient weight capacity 601 pounds or more. K0841...................... Power wheelchair, group 2 standard, multiple power option, sling/solid seat/ back, patient weight capacity up to and including 300 pounds. K0842...................... Power wheelchair, group 2 standard, multiple power option, captains chair, patient weight capacity up to and including 300 pounds. K0843...................... Power wheelchair, group 2 heavy duty, multiple power option, sling/solid seat/ back, patient weight capacity 301 to 450 pounds. K0848...................... Power wheelchair, group 3 standard, sling/ solid seat/back, patient weight capacity up to and including 300 pounds. K0849...................... Power wheelchair, group 3 standard, captains chair, patient weight capacity up to and including 300 pounds. K0850...................... Power wheelchair, group 3 heavy duty, sling/solid seat/back, patient weight capacity 301 to 450 pounds. K0851...................... Power wheelchair, group 3 heavy duty, captains chair, patient weight capacity 301 to 450 pounds. K0852...................... Power wheelchair, group 3 very heavy duty, sling/solid seat/back, patient weight capacity 451 to 600 pounds. K0853...................... Power wheelchair, group 3 very heavy duty, captains chair, patient weight capacity 451 to 600 pounds. K0854...................... Power wheelchair, group 3 extra heavy duty, sling/solid seat/back, patient weight capacity 601 pounds or more. K0855...................... Power wheelchair, group 3 extra heavy duty, captains chair, patient weight capacity 601 pounds or more. ------------------------------------------------------------------------ These codes will be subject to the requirements of the prior authorization program for certain DMEPOS items as outlined in Sec. 414.234. We believe continued prior authorization of these codes will help further our program integrity goals of reducing fraud, waste, and abuse, while protecting access to care. We will implement a prior authorization program for these codes nationwide, for dates of service beginning September 1, 2018. This approach will allow continuity for those suppliers in the 19 states familiar with prior authorization of PMDs under the demonstration, and allows sufficient time for education and outreach to suppliers in the remaining states. [[Page 25949]] HCPCS codes K0856 and K0861, which we placed on the Required Prior Authorization List in a December 21, 2016 notice (81 FR 93636), will continue to be subject to the requirements of prior authorization as well. Although the PMD demonstration's prior authorization process is similar to the process used for those items on the Required Prior Authorization List, some differences do exist. In particular, items on the Required Prior Authorization List require prior authorization as a condition of payment. As such, lack of a provisionally affirmed prior authorization request will result in a claim denial. Under the PMD demonstration, requesting prior authorization is optional, and claims submitted for payment without an associated prior authorization decision are subject to prepayment review and assessed a 25-percent reduction in Medicare payment if found payable. Additionally, under the PMD demonstration, physicians/treating practitioners may submit prior authorization requests and are eligible to bill HCPCS code G9156 for an incentive payment. This process is not available for items on the Required Prior Authorization List. Prior to furnishing the item to the beneficiary and prior to submitting the claim for processing, a requester must submit a prior authorization request that includes evidence that the item complies with all applicable Medicare coverage, coding, and payment rules. Consistent with Sec. 414.234(d), such evidence must include the order, relevant information from the beneficiary's medical record, and relevant supplier-produced documentation. After receipt of all applicable required Medicare documentation, CMS or one of its review contractors will conduct a medical review and communicate a decision that provisionally affirms or non-affirms the request. We will issue specific prior authorization guidance in subregulatory communications, including final timelines, which are customized for the DMEPOS items subject to prior authorization, for communicating a provisionally affirmed or non-affirmed decision to the requester. In the December 30, 2015 final rule, to allow us to safeguard beneficiary access to care, we stated that this approach to final timelines provides the flexibility to develop a process that involves fewer days, as may be appropriate. If at any time we become aware that the prior authorization process is creating barriers to care, we can suspend the program. The updated Required Prior Authorization list is available in the download section of the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.html. We will post additional educational resources to the website. III. Collection of Information Requirements This notice announces the addition of DMEPOS items on the Required Prior Authorization List and does not impose any new information collection burden under the Paperwork Reduction Act of 1995. However, there is an information collection burden associated with this program that is currently approved under OMB control number 0938-1293 which expires February 28, 2019. Dated: May 14, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2018-11953 Filed 6-1-18; 4:15 pm] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations 25947
not likely to have an economically small entities either by meeting the Paperwork Reduction Act
significant impact. Small Business Administration (SBA) The Paperwork Reduction Act of 1995
Specifically, the RIA for the 2017 Rule size standard for a small business, or by (44 U.S.C. 3507(d)) requires that OMB
stated that, ‘‘[. . .] manufacturers are being a nonprofit organization that is approve all collections of information
required to ensure they do not not dominant in its market. The current by a federal agency from the public
overcharge covered entities, and a civil SBA size standard for health care before they can be implemented. This
monetary penalty could result from providers ranges from annual receipts of final rule is projected to have no impact
overcharging if it met the standards in $7 million to $35.5 million. As of on current reporting and recordkeeping
this final rule. HHS envisions using January 1, 2018, over 12,800 covered burden for manufacturers under the
these penalties in rare situations. Since entities participate in the 340B Program, 340B Program. This final rule would
the Program’s inception, issues related which represent safety-net health care result in no new reporting burdens.
to overcharges have been resolved providers across the country.
between a manufacturer and a covered In addition, the rule would affect drug Dated: May 30, 2018.
entity and any issues have generally manufacturers (North American George Sigounas
been due to technical errors in the Industry Classification System code Administrator, Health Resources and Services
calculation. For the penalties to be used 325412: Pharmaceutical Preparation Administration.
as defined in the statute and in this Manufacturing). The small business size Approved: May 31, 2018.
[2017] rule, the manufacturer standard for drug manufacturers is 750 Alex M. Azar II
overcharge would have to be the result employees. Approximately 600 drug Secretary, Department of Health and Human
of a knowing and intentional act. Based manufacturers participate in the 340B Services.
on anecdotal information received from Program. While it is possible to estimate [FR Doc. 2018–12103 Filed 6–1–18; 11:15 am]
covered entities, HHS anticipates that the impact of the rule on the industry BILLING CODE 4165–15–P
this would occur very rarely if at all.’’ as a whole, the data necessary to project
Since the civil penalties envisioned in changes for specific or groups of
the 2017 Rule were expected to be rare, manufacturers is not available, as HRSA DEPARTMENT OF HEALTH AND
delay of these civil penalties is unlikely does not collect the information HUMAN SERVICES
to have an economically significant necessary to assess the size of an
impact. individual manufacturer that Centers for Medicare & Medicaid
Additionally, the 2017 Rule codified participates in the 340B Program. HHS Services
the practice of manufacturers charging has determined, and the Secretary
$0.01 for drugs with a ceiling price certifies that this final rule will not have 42 CFR Part 414
below $0.01, which the 2017 Rule RIA a significant impact on the operations of
[CMS–6080–N]
described as ‘‘[. . .] a long-standing a substantial number of small
HRSA policy, and HRSA believes the manufacturers; therefore, we are not Medicare Program; Update to the
majority of manufacturers currently preparing an analysis of impact for this Required Prior Authorization List of
follow the practice of charging $0.01.’’ RFA. HHS estimates that the economic Durable Medical Equipment,
Delay of this rule will delay the impact on small entities and small Prosthetics, Orthotics, and Supplies
codification of this practice, but since it manufacturers will be minimal. (DMEPOS) Items That Require Prior
is already a longstanding policy and Authorization as a Condition of
Unfunded Mandates Reform Act
widespread practice, the impact of delay Payment
is not likely to be economically Section 202(a) of the Unfunded
significant. Mandates Reform Act of 1995 requires AGENCY: Centers for Medicare &
Executive Order 13771, titled that agencies prepare a written Medicaid Services (CMS), HHS.
‘‘Reducing Regulation and Controlling statement, which includes an ACTION: Update to list.
Regulatory Costs,’’ was issued on assessment of anticipated costs and
January 30, 2017. This rule is not benefits, before proposing ‘‘any rule that SUMMARY: This document announces the
subject to the requirements of E.O. includes any Federal mandate that may addition of 31 Healthcare Common
13771 because this rule results in no result in the expenditure by State, local, Procedure Coding System (HCPCS)
more than de minimis costs. and Tribal governments, in the codes to the Required Prior
aggregate, or by the private sector, of Authorization List of Durable Medical
The Regulatory Flexibility Act (RFA) $100 million or more (adjusted annually Equipment, Prosthetics, Orthotics, and
The Regulatory Flexibility Act (5 for inflation) in any one year.’’ In 2017, Supplies (DMEPOS) Items that require
U.S.C. 601 et seq.) (RFA) and the Small that threshold is approximately $148 prior authorization as a condition of
Business Regulatory Enforcement and million. HHS does not expect this rule payment. Prior authorization for these
Fairness Act of 1996, which amended to exceed the threshold. codes will be implemented nationwide.
the RFA, require HHS to analyze DATES: Implementation is effective on
options for regulatory relief of small Executive Order 13132—Federalism September 1, 2018.
businesses. If a rule has a significant HHS has reviewed this final rule in FOR FURTHER INFORMATION CONTACT:
economic effect on a substantial number accordance with Executive Order 13132 Emily Calvert, (410) 786–4277.
of small entities, the Secretary must regarding federalism, and has Andre Damonze, (410) 786–1795.
specifically consider the economic determined that it does not have SUPPLEMENTARY INFORMATION:
effect of the rule on small entities and ‘‘federalism implications.’’ This final
analyze regulatory options that could rule would not ‘‘have substantial direct I. Background
amozie on DSK3GDR082PROD with RULES
lessen the impact of the rule. HHS will effects on the States, or on the Sections 1832, 1834, and 1861 of the
use an RFA threshold of at least a 3 relationship between the national Social Security Act (the Act) establish
percent impact on at least 5 percent of government and the States, or on the that the provision of durable medical
small entities. distribution of power and equipment, prosthetic, orthotics, and
For purposes of the RFA, HHS responsibilities among the various supplies (DMEPOS) is a covered benefit
considers all health care providers to be levels of government.’’ under Part B of the Medicare program.
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![Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations 25949
HCPCS codes K0856 and K0861, which The updated Required Prior Audio Division, (202) 418–2700 or
we placed on the Required Prior Authorization list is available in the Albert.Shuldiner@fcc.gov; Thomas
Authorization List in a December 21, download section of the following CMS Nessinger, Senior Counsel, Media
2016 notice (81 FR 93636), will website: https://www.cms.gov/Research- Bureau, Audio Division, (202) 418–2700
continue to be subject to the Statistics-Data-and-Systems/Monitoring- or Thomas.Nessinger@fcc.gov.
requirements of prior authorization as Programs/Medicare-FFS-Compliance- SUPPLEMENTARY INFORMATION: This is a
well. Programs/DMEPOS/Prior- summary of the Commission’s Order on
Although the PMD demonstration’s Authorization-Process-for-Certain- Reconsideration, MB Docket No. 13–
prior authorization process is similar to Durable-Medical-Equipment-Prosthetic- 249, FCC 18–64, adopted on May 21,
the process used for those items on the Orthotics-Supplies-Items.html. We will 2018, and released on May 22, 2018.
Required Prior Authorization List, some post additional educational resources to The full text of this document is
differences do exist. In particular, items the website. available for public inspection and
on the Required Prior Authorization List copying during regular business hours
require prior authorization as a III. Collection of Information
Requirements in the FCC Reference Center, Federal
condition of payment. As such, lack of Communications Commission, 445 12th
a provisionally affirmed prior This notice announces the addition of Street SW, Washington, DC 20554. This
authorization request will result in a DMEPOS items on the Required Prior document will also be available via
claim denial. Under the PMD Authorization List and does not impose ECFS at https://www.fcc.gov/ecfs/.
demonstration, requesting prior any new information collection burden Documents will be available
authorization is optional, and claims under the Paperwork Reduction Act of electronically in ASCII, Microsoft Word,
submitted for payment without an 1995. However, there is an information and/or Adobe Acrobat. Copies of the
associated prior authorization decision collection burden associated with this materials can be obtained from the
are subject to prepayment review and program that is currently approved FCC’s Reference Information Center at
assessed a 25-percent reduction in under OMB control number 0938–1293 (202) 418–0270. Alternative formats are
Medicare payment if found payable. which expires February 28, 2019. available for people with disabilities
Additionally, under the PMD Dated: May 14, 2018. (Braille, large print, electronic files,
demonstration, physicians/treating
Seema Verma, audio format), by sending an email to
practitioners may submit prior
Administrator, Centers for Medicare & fcc504@fcc.gov or calling the
authorization requests and are eligible
to bill HCPCS code G9156 for an Medicaid Services. Commission’s Consumer and
incentive payment. This process is not [FR Doc. 2018–11953 Filed 6–1–18; 4:15 pm] Governmental Affairs Bureau at (202)
available for items on the Required Prior BILLING CODE 4120–01–P 418–0530 (voice), (202) 418–0432
Authorization List. (TTY). This document is not subject to
Prior to furnishing the item to the the Congressional Review Act. The
beneficiary and prior to submitting the FEDERAL COMMUNICATIONS Commission is, therefore, not required
claim for processing, a requester must COMMISSION to submit a copy of this Order on
submit a prior authorization request that Reconsideration to the General
includes evidence that the item 47 CFR Part 73 Accounting Office pursuant to the
complies with all applicable Medicare Congressional Review Act, see 5 U.S.C.
[MB Docket No. 13–249; FCC 18–64]
coverage, coding, and payment rules. 801(a)(1)(A), because the Petition for
Consistent with § 414.234(d), such Revitalization of the AM Radio Service Reconsideration was denied and the
evidence must include the order, Petition for Emergency Stay and Motion
relevant information from the AGENCY: Federal Communications for Extension of Time were dismissed as
beneficiary’s medical record, and Commission. moot.
relevant supplier-produced ACTION: Denial of petition for The Commission rejected
documentation. After receipt of all reconsideration; dismissal of petition for Prometheus’s contentions that the
applicable required Medicare emergency partial stay and processing Commission’s decision not to adopt a
documentation, CMS or one of its freeze pending review of petition for proposed distance limit for siting cross-
review contractors will conduct a reconsideration and motion for service FM translator stations
medical review and communicate a extension of time. (translators re-broadcasting AM station
decision that provisionally affirms or signals) was not a logical outgrowth of
SUMMARY: This document denies the the proposed rule and was arbitrary and
non-affirms the request.
We will issue specific prior Petition for Reconsideration of the capricious. It found that the decision
authorization guidance in subregulatory Second Report and Order in this not to adopt the proposed 40-mile limit
communications, including final proceeding, filed by Prometheus Radio was reasonably foreseeable, especially
timelines, which are customized for the Project (Prometheus) on April 10, 2017. given that commenters had proposed
DMEPOS items subject to prior This document dismisses as moot the omitting the 40-mile limit and that
authorization, for communicating a Petition for Emergency Partial Stay and Prometheus had access to those
provisionally affirmed or non-affirmed Processing Freeze Pending Review of comments. The Commission further
decision to the requester. In the Petition for Reconsideration filed by found that its actions were not arbitrary
December 30, 2015 final rule, to allow Prometheus April 3, 2017, and the and capricious, finding that
us to safeguard beneficiary access to Motion for Extension of Time filed by Prometheus’s contentions do not raise
care, we stated that this approach to Prometheus May 11, 2017. legitimate concerns and are at best
amozie on DSK3GDR082PROD with RULES
final timelines provides the flexibility to DATES: June 5, 2018. speculative. Prometheus did not provide
develop a process that involves fewer ADDRESSES: Federal Communications evidence that omission of a distance
days, as may be appropriate. If at any Commission, 445 12th Street SW, limit encourages translators to ‘‘box in’’
time we become aware that the prior Washington, DC 20554. incumbent low-power FM (LPFM)
authorization process is creating barriers FOR FURTHER INFORMATION CONTACT: stations, restricting their ability to
to care, we can suspend the program. Albert Shuldiner, Chief, Media Bureau, change sites. Additionally, the
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Document Created: 2018-11-02 11:46:36
Document Modified: 2018-11-02 11:46:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Update to list. | |
| Dates | Implementation is effective on September 1, 2018. | |
| Contact | Emily Calvert, (410) 786-4277. | |
| FR Citation | 83 FR 25947 |
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