Change Requests

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(CMS-R-13) Conditions of Coverage for Organ Procurement Organizations (OPOs) and Supporting Regulations

Key Information

Abstract

OPOs are required to submit accurate data to CMS, through the Organ Procurement and Transplantation Network (OPTN), concerning its organ procurement activities, as well as various OPO business activities, including information on its designated service area; structure; various policies, procedures, and protocols; and its quality assessment and performance improvement (QAPI) program. This information is necessary to assure maximum effectiveness in the procurement and distribution of organs.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

Pub.L. 99 - 509 9318	View Law

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New Source Performance Standards for Stationary Combustion Turbines (40 CFR Part 60, Subpart KKKKa) (Proposed Rule)

Key Information

Abstract

The Environmental Protection Agency (EPA) is proposing amendments to the Standards of Performance for new, modified, and reconstructed stationary combustion turbines and stationary gas turbines based on the preliminary results of a review of available control technologies for limiting emissions of criteria air pollutants. This review of the new source performance standards (NSPS) is required by the Clean Air Act (CAA). In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

42 USC 7401	View Law

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NSPS for Secondary Lead Smelters (40 CFR part 60, subpart L) (Proposed Rule)

Key Information

Abstract

The EPA promulgated the NSPS for the secondary lead smelting source category (40 CFR part 60, subpart L) on March 8, 1974. Subpart L as promulgated in 1974 regulates particulate matter (PM) emissions from blast and reverberatory furnaces and also specifies limits for visible emissions (opacity) for blast, reverberatory, and pot (refining) furnaces. The EPA amended Subpart L on October 10, 1975, to remove a provision providing that the failure to meet the NSPS emissions limits due to the presence of uncombined water in the stack gases was not considered a violation. Currently, there are 11 secondary lead smelting facilities in the United States and each facility operates furnaces that are subject to the PM and opacity limits specified in Subpart L. Section 111 of the Clean Air Act (CAA) requires the EPA to review the NSPS at least every 8 years and to revise the standards of performance that are applicable to new, modified, and reconstructed sources, if appropriate, to reflect the best system of emissions reduction (BSER), accounting for the cost, environmental, and energy impacts associated with achieving the reduction. Based on the CAA Section 111 review of the NSPS for the secondary lead smelting source category, in the recent 2022 action the EPA proposed updates to Subpart L including revisions to the applicability dates and proposed revisions to the definitions of blast furnace, reverberatory furnace, and pot furnace to more closely align with the equipment definitions used in the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for secondary lead smelting (40 CFR part 63, Subpart X). Additionally, the EPA proposed requirements for periodic performance tests for PM and incorporated the monitoring, recordkeeping, and reporting requirements, including electronic reporting of performance tests, specified in NESHAP Subpart X to improve the consistency between the NSPS and NESHAP for secondary lead smelting facilities. This information is being collected to assure compliance with 40 CFR Part 60, Subpart L. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance and are required of all affected facilities subject to NSPS.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

42 USC 7401 et seq.	View Law

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Medicare EDI Enrollment Form and EDI Registration (CMS-10164 A/B)

Key Information

Abstract

Federal law requires that CMS minimize the security risk to federal information systems. CMS is requiring that trading partners who wish to conduct the Electronic Data Interchange (EDI) transactions provide certain assurance as a condition of receiving access to the Medicare system for the purpose of conducting EDI exchanges. Health care providers, clearinghouses, and health plans that wish access to the Medicare system are required to complete this form. The information will be used to assure that those entities that access the Medicare system are aware of applicable provisions and penalties.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 104 - 191 262	View Law

Pub.L. 104 - 191 261	View Law

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Home Mortgage Disclosure (HMDA)

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Abstract

In order to permit the FDIC to detect discrimination in residential mortgage lending, certain insured state nonmember banks are required by FDIC regulation 12 CFR 388 to maintain various data on home loan applicants.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

12 USC § 5301 et seq.	View Law

12 USC § 2801 et seq.	View Law

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Essential Community Provider Data Collection to Support QHP Certification (CMS-10561)

Key Information

Abstract

For plan years beginning on or after January 1, 2017, Health and Human Services (HHS) intends to collect more complete provider data for inclusion on the HHS Essential Community Provider (ECP) list to ensure a more accurate reflection of the universe of qualified available ECPs in a given service area that can be counted toward an issuer's satisfaction of the ECP standard. The HHS will collect data on qualified and available ECPs from providers. Providers will submit an ECP petition to be added to the HHS ECP list or provide required missing data fields to remain on the list. The degree of provider participation in this data collection effort through the ECP provider petition will help inform HHS's future proposals for counting issuers' ECP write-ins toward satisfaction of the ECP standard.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 155 1311(c)(1)(C)	View Law

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Elimination of Cost-Sharing for full benefit dual-eligible Individuals Receiving Home and Community-Based Services (CMS-10344)

Key Information

Abstract

This provision is mandated by the Affordable Care Act, section 3309. To implement this provision, CMS needs data from the States, identifying full benefit dual-eligible individuals who are receiving home and community-based services. The States will provide these data as a new data value on their monthly MMA Phase Down report. These data are not available from any other source. CMS will use these new data to set the affected beneficiaries' Medicare Part D copayment to zero.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 148 3309	View Law

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Guidance on Sound Incentive Compensation Policies

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Abstract

Incentive compensation practices in the financial services industry contributed to the financial crisis that began in 2007. Bank employees too often were rewarded for increasing short-term revenue or profit without adequate regard to the risks taken to achieve those results. These practices exacerbated the risks and losses at a number of banking organizations and resulted in the misalignment of the interests of employees with the long-term safety and soundness of their organizations. The guidance was issued to assist banking organizations in designing and implementing incentive compensation arrangements that do not encourage imprudent risk-taking and that are consistent with the safety and soundness of a banking organization.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

12 USC 161	View Law

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Qualifications for Failed Bank Acquisitions

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Abstract

The FDIC’s policy statement on Qualifications for Failed Bank Acquisitions provides guidance to private capital investors interested in acquiring or investing in failed insured depository institutions regarding the terms and conditions for such investments or acquisitions. The information collected pursuant to the policy statement allows the FDIC to evaluate, among other things, whether such investors (and their related interests) could negatively impact the Deposit Insurance Fund, increase resolution costs, or operate in a manner that conflict with statutory safety and soundness principles and compliance requirements.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

12 USC 1816-1818, 1823	View Law

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DC School Choice Incentive Program

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Abstract

The DC Opportunity Scholarship Program (OSP) is currently authorized under the Scholarships for Opportunity and Results Act (SOAR). Under the SOAR Act, the US Department of Education awards a grant to a non-profit to administer scholarships to students who reside in the District of Columbia and come from households whose incomes do not exceed 185% of the poverty line (300% of the poverty line for returning students). The current administrator of the OSP is Serving Our Children (SOC). Under the law, priority is given to siblings of students in the program, and students who are currently attending low-performing schools, as defined by Title I. To assist in the student selection and assignment process, the information collected is used to determine the eligibility of those students who are interested in the available scholarships.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 108 - 199 3	View Law

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Medicare Advantage and Prescription Drug Program: Final Marketing Provisions CFR 422.111(a)(3) and 423.128(a)(3) (CMS-10260)

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Abstract

This final rule implements provisions of the Social Security Act (the Act) establishing and regulating the Medicare Advantage (MA) program. The MA program was enacted in Title II of The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) on December 8, 2003. The MA program replaces the Medicare+Choice (M+C) program established under Part C of the title XVIII of the Act, while retaining most key features of the M+C program. The MA program attempts to broadly reform and expand the availability of private health plan options to Medicare beneficiaries. Medicare Advantage (MA) organizations and Prescription Drug Plan Sponsors use the information to comply with the eligibility requirements and the MA and Part D contract requirements. CMS will use this information to ensure that correct information is disclosed to Medicare beneficiaries, both potential enrollees and enrollees.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 108 - 117 201	View Law

Pub.L. 110 - 275 103	View Law

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[Medicaid] Limitations on Provider Related Donations and Health Care Related Taxes; Medicaid and Supporting Regulations in 42 CFR 433.68 and 433.74 (CMS-R-148)

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Abstract

This information collection is necessary to ensure compliance with Sections 1903 and 1923 of the Social Security Act for the purpose of preventing payment of FFP on amounts prohibited by statute.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 433	View Law

42 USC 433.	View Law

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Strategic Prevention Framework for Prescription Drugs (SPF Rx)

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Abstract

The SPF-Rx program is designed to address nonmedical use of prescription drugs as well as opioid overdoses by raising awareness about the dangers of sharing medications and by working with pharmaceutical and medical communities. The SPF-Rx program aims to promote collaboration between states/tribes and pharmaceutical and medical communities to understand the risks of overprescribing to youth age 12–17 and adults 18 years of age and older and enhance capacity for and access to Prescription Drug Monitoring Program (PDMP) data for prevention purposes.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 516	View Law

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Public Housing Flat Rent Exception Request Market Analysis

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Abstract

In 2023, the form was updated to reduce the burden on PHAs and to reduce the number of corrections needed after submission. The updated form includes a tab for written justifications that are required by Notice PIH 2022-33 (first established in Notice PIH 2021-27) and allows the justifications to be included directly on the market analysis form. The “cable in rent” amenity was removed, and an amenity category was added for washer and dryer connections (“washer/dryer hook-up”). Additional updates were made to the formulas in the form that allow HUD to automatically calculate the difference in age between the PHA units and market rate units as well as indicate when an amenity is over the threshold allotted in Notice PIH 2022-33. The addition of these formulas reduces the requirement for HUD to manually tabulate the monetary values associated with unit age differences. Typographical errors and formatting inconsistencies were also corrected. The revised form was implemented for the FY23, FY24, and FY25 flat rent exception request cycles. HUD is adjusting the average number of respondents and hourly cost per response to reflect the average level of submissions in FY2023, FY2024, and FY2025. No changes are being made to the form with this renewal. HUD uses the information from the current form (flat rent market analysis) to collect data from PHAs that compares the proposed flat rent for public housing units with the Fair Market Rents (FMRs) in their city or metropolitan area and those in neighboring cities. The information collected is used for data reference purposes by PHAs that are proposing to set their units’ rents lower than 80 percent of the FMR. PHAs are then able to justify the change in rent of public housing units, and the data collected determines if HUD will approve the flat rent exception request. The information collected on the flat rent market analysis form tabulates a comprehensive list of unique unit characteristics applicable to PHAs with similar and varying units based on bedroom size, amenities, services and utilities. This information is contained in one form to streamline the process and reduce the need for redundant data collection across multiple forms and agencies. Since many PHAs lack the ability to obtain such data independently, a central collection method is essential.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 1437z2	View Law

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Examination for Housebound Status or Permanent Need for Regular Aid and Attendance (VA Form 21-2680)

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Abstract

VA Form 21-2680 is used to determine eligibility for the aid and attendance and/or housebound benefits. The purpose of this examination is to record manifestations and findings pertinent to the question of whether the claimant is housebound (confined to the home or immediate premises) or in need of the regular aid and attendance of another person. The report should be in sufficient detail for the VA decision makers to determine the extent that disease or injury produces physical or mental impairment, that loss of coordination or enfeeblement affects the ability: to dress and undress; to feed themselves; to attend to the wants of nature; or keep themselves ordinarily clean and presentable. Findings should be recorded to show whether the claimant is blind or bedridden. Whether the claimant seeks housebound or aid and attendance benefits, the report should reflect how well they ambulate, where they go, and what they are able to do during a typical day. Without this information, entitlement to these benefits cannot be determined.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

38 USC 1521(e)	View Law

38 USC 1114	View Law

38 USC 1115(1)(e)	View Law

38 USC 1311(d)	View Law

38 USC 1541(d)	View Law

38 USC 1541(e)	View Law

38 USC 1521(d)	View Law

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Creditable Coverage Disclosure to CMS OnLine Form and Instructions (CMS-10198)

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Abstract

Information collection requirements will ensure that entities that currently provide prescription drug benefits to any Medicare Part D eligible individual disclose to CMS whether the prescription drug benefit that they offer is creditable coverage. The disclosure is required to be provide annually and upon any change that affects whether the coverage is creditable prescription drug coverage. This collection also provides creditable coverage disclosure instructions for entities complying with these infromation collection request.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

1 Stat. 1860

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JADE Act Questionnaire

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Abstract

The Immigration and Nationality Act (“INA”), 8 U.S.C. § 1101, sets out application and eligibility requirements for aliens seeking to obtain nonimmigrant and immigrant visas. Grounds for the ineligibility of certain individuals to receive a visa or to be admitted to the United States are detailed in INA section 212(a), 8 U.S.C. § 1182(a) and other statutes.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

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Affordable Care Act Internal Claims and Appeals and External Review Procedures for Non-grandfathered Group Health Plans and Issuers and Individual Market Issuers (CMS-10338)

Key Information

Abstract

These interim final regulations set forth rules implementing revisions to the Public Health Service (PHS) Act section 2719 for internal claims and appeals and external review processes to implement Section 110 of the No Surprises Act (NSA), which protects participants, beneficiaries, and enrollees in group health plans and group and individual health insurance coverage from receiving surprise medical bills when they receive emergency services, non-emergency services from non-participating providers at participating facilities, and air ambulance services, under certain circumstances. Specifically Section 110 of the NSA amends section 2719 of the PHS Act to require the external review process to apply to participants, beneficiaries, and enrollees of such plans with respect to any adverse determination by a plan or issuer under section 2799A-1 or 2799A-2 of the PHS Act. These protections also extend to grandfathered plans.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

45 USC 147.136	View Law

Pub.L. 110 - 110 No Surprises Act	View Law

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Annual Information Return/Report of Employee Benefit Plan

Key Information

Abstract

This information collection relates to section 104 of ERISA, which requires administrators of employee benefit pension and welfare plans (collectively referred to as employee benefit plans) to file returns or reports annually with the federal government. The Form 5500 return/reports are the principal source of information and data available to the Department, the Internal Revenue Service, and the Pension Benefit Guaranty Corporation (the Agencies) concerning the operation of employee benefit plans. For this reason, the Form 5500 constitutes an integral part of the Agencies' enforcement, research, and policy formulation programs. The Department has received approval from OMB for this ICR under OMB Control No. 1210-0110.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 116 - 94 O	View Law

29 USC 1023	View Law

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Provider Network Coverage Data Collection (CMS-10594)

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Abstract

Proposed §156.230(e)(1) would require that QHP issuers make a good faith effort to provide written notice of discontinuation of a provider 30 days prior to the effective date of the change or otherwise as soon as practicable, to enrollees who are patients seen on a regular basis by the provider or who receive primary care from the provider whose contract is discontinuing. This is a third-party disclosure requirement. CMS is not proposing to collect this notice from QHP issuers in FFMs, therefore we are not specifying ways in which we will use the data. The purpose of this notice is to provide consumers information on when their providers will no longer be available in-network in their QHP. In proposed 156.230(f)(2), we require QHP issuers to provide a notice to enrollees of the possibility of out-of-network charges from an out-of-network provider in an in-network setting at least 10 calendar days prior to the service being provided to avoid counting the out-of-network costs against to the annual limitation on cost sharing.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 156 1311	View Law

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Transparency in Pricing Information (CMS-10715)

Key Information

Abstract

The information collection requirements contained in the proposed rule titled “Transparency in Coverage,” published November 27, 2019 (84 FR 65464), would require group health plans and health insurance issuers offering coverage in the individual and group markets to disclose to a participant, beneficiary, or enrollee (or an authorized representative on behalf of such individual), the estimated cost-sharing liability for covered items or services from a particular provider or providers, thereby allowing a participant, beneficiary, or enrollee to obtain an accurate estimate and understanding of their potential out-of-pocket expenses and to effectively shop for covered items and services. Group health plans and health insurance issuers would be required to make such information available through a self-service tool on an internet website. The self-service tool must provide the information through real-time responses and allow users to search for cost-sharing information for covered items and services. The self-service tool must also allow users to input information necessary to learn the out-of-network allowed amount for a covered item or service and have the capability to refine and reorder results. Group health plans and health insurance issuers would also be required to make this information available as a disclosure in written form. Both the self-service tool and the paper disclosure would be required to include several disclaimer statements relevant to information provided through the disclosure and could be provided by using a model notice developed by the Departments. Additionally, group health plans and health insurance issuers would be subject requirements to disclose in-network provider negotiated rates and historical payment data for allowed amounts for covered items and services furnished by out-of-network providers through two digital files in a machine-readable format to be specified by the Departments. The Negotiated Rate file and the Allowed Amount file must be posted publicly on an internet website.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

45 USC 156.220	View Law

Pub.L. 111 - 148 1311(e)(3)	View Law

45 USC 155.1040(a)-(c)	View Law

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Law Enforcement Officers (LEOs) Flying Armed

Key Information

Abstract

In order to allow Law Enforcement Officers (LEOs) to fly armed, TSA established a specialized screening process for Federal, State, local, and tribal LEO needing to access the sterile area of the airport when they are going to fly armed. To document such LEO movements, TSA’s specialized screening procedures require the LEO to complete TSA Form 413A, Checkpoint Sign-In Log. This real-time situational awareness is necessary in the event of a contingency on board the aircraft, such as but not limited to, a disruptive passenger, air piracy, or other threat to the safety and security of a commercial aircraft.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

49 USC 114	View Law

49 USC 44901	View Law

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Indian Self-Determination and Education Assistance Act Programs, 25 CFR 900

Key Information

Abstract

The Indian Self-Determination and Education Assistance Act (ISDEAA), as authorized by 25 USC 450 et. seq., authorizes and directs the Bureau of Indian Affairs (BIA) to contract or compact with, and fund Indian Tribes and Tribal organizations that choose to take over the operation of programs, services, functions and activities (PSFAs) that would otherwise be operated by the BIA. These PSFAs include programs such as law enforcement, social services, and tribal priority allocation programs. Congressional appropriations are divided among BIA and Tribes and Tribal organizations to pay for both the BIA’s direct operation of programs and for the operation of programs by Tribes and Tribal organizations through Self-Determination contracts and compacts. The regulations implementing ISDEAA are at 25 CFR 900. An Indian Tribe or Tribal organization is required to submit this information each time that it proposes to contract with BIA under the ISDEAA. The information collected is used by the BIA to determine applicant eligibility, evaluate applicant capabilities, protect the service population, safeguard Federal funds and resources, and permit the BIA to administer and evaluate Tribal ISDEAA contract programs.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

25 USC 450 et seq	View Law

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[NCEZID] National Healthcare Safety Network (NHSN) Respiratory Data

Key Information

Abstract

The goal of this information collection is to 1) capture the daily, aggregate impact of COVID-19 on healthcare facilities, and 2) monitor medical capacity to respond at local, state, and national levels. This information will be used to inform the overall real-time COVID-19 response efforts and possible resource allocation, and enable state and local health departments to gain immediate access to the COVID-19 data for healthcare facilities within their jurisdiction. This Revision is submitted to, make minor changes to wording used on several forms, make adjustments to the burden estimate (increase), and to modify the title of the data collection to: National Healthcare Safety Network (NHSN) Respiratory Data.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 242b, k, m	View Law

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Invoice Submissions by Contractors for NRC Contracts/Orders

Key Information

Abstract

In administering its contracts, the NRC Acquisition Management Division provides billing instructions for its contractors to follow in preparing invoices. These instructions stipulate the level of detail in which supporting data must be submitted for NRC review. The review of this information ensures that all payments made by NRC for valid and reasonable costs are in accordance with the contract terms and conditions.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 83 - 703 1-311	View Law

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