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Consumer Financial Protection Bureau.
Policy statement; request for comment.
The Consumer Financial Protection Act of 2010 (CFPA) prohibits any “covered person” or “service provider” from “engag[ing] in any unfair, deceptive, or abusive act or practice” and defines abusive conduct. An abusive act or practice: materially interferes with the ability of a consumer to understand a term or condition of a consumer financial product or service, or takes unreasonable advantage of a lack of understanding on the part of the consumer of the material risks, costs, or conditions of the product or service, the inability of the consumer to protect the interests of the consumer in selecting or using a consumer financial product or service, or the reasonable reliance by the consumer on a covered person to act in the interests of the consumer. Since the enactment of the CFPA, government enforcers and supervisory agencies have taken dozens of actions to condemn prohibited abusive conduct. This policy statement summarizes those actions and explains how the Consumer Financial Protection Bureau (CFPB) analyzes the elements of abusiveness through relevant examples, with the goal of providing an analytical framework to fellow government enforcers and supervisory agencies and to the market for how to identify violative acts or practices. While not required under the Administrative Procedure Act, the CFPB is opting to collect comments on the policy statement and may make revisions as appropriate after reviewing feedback received.
This policy statement is applicable as of April 12, 2023. Comments must be received by July 3, 2023.
You may submit comments, identified by Docket No. CFPB-2023-0018, by any of the following methods:
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Bradley Lipton, Senior Counsel, Legal Division, at 202-435-7700. If you require this document in an alternative electronic format, please contact
In 2010, Congress passed the Consumer Financial Protection Act of 2010 (CFPA) and banned abusive conduct.
Since the beginning of the 20th century, Congress has amended these prohibitions in response to evolving norms, economic events, and judicial interpretations, guiding those tasked with enforcing the law. Beginning with the creation of the Federal Trade Commission, and the development of the “unfair methods of competition”
For centuries, lenders and investors generally had an incentive to ensure that a borrower had the ability to repay a debt. But innovations in capital markets and fixed income instruments altered this alignment of incentives.
The 2007-2008 financial crisis tested U.S. consumer protection laws, government watchdogs, and the ability of the existing authorities to address the predatory lending that was a root cause of the collapse.
In response, Congress concluded that the manner in which agencies had enforced the prohibitions on unfair and deceptive acts or practices was too limited to be effective at preventing the financial crisis, and once again amended existing law to better meet new challenges.
Since the enactment of the CFPA, government enforcers and supervisory agencies have taken dozens of actions to condemn prohibited abusive conduct. The CFPB is issuing this Policy Statement to summarize those actions and explain how the CFPB analyzes the elements of abusiveness through relevant examples, with the goal of providing an analytical framework to fellow government enforcers and to the market for how to identify violative acts or practices.
Under the CFPA, there are two abusiveness prohibitions.
• A lack of understanding on the part of the consumer of the material risks, costs, or conditions of the product or service;
• The inability of the consumer to protect the interests of the consumer in selecting or using a consumer financial product or service; or
• The reasonable reliance by the consumer on a covered person to act in the interests of the consumer.
The statutory text of these two prohibitions can be summarized at a high level as: (1) obscuring important features of a product or service, or (2) leveraging certain circumstances to take an unreasonable advantage. The circumstances that Congress set forth, stated generally, concern
Unlike with unfairness but similar to deception, abusiveness requires no showing of substantial injury to establish liability, but is rather focused on conduct that Congress presumed to be harmful or distortionary to the proper functioning of the market. An act or practice need fall into only one of the categories above in order to be abusive, but an act or practice could fall into more than one category.
The first abusiveness prohibition concerns situations where an entity
Material interference may include actions or omissions that obscure, withhold, de-emphasize, render confusing, or hide information relevant to the ability of a consumer to understand terms and conditions. Interference can take numerous forms, such as buried disclosures, physical or digital interference, overshadowing, and various other means of manipulating consumers' understanding.
Buried disclosures include disclosures that limit people's comprehension of a term or condition, including but not limited to, through the use of fine print, complex language, jargon, or the timing of the disclosure.
Physical interference can include any physical conduct that impedes a person's ability to see, hear, or understand the terms and conditions, including but not limited to physically hiding or withholding notices.
Digital interference can include impediments to a person's ability to see, hear, or understand the terms and conditions when they are presented to someone in electronic or virtual format. This form of interference includes but is not limited to user interface and user experience manipulations such as the use of pop-up or drop-down boxes, multiple click-throughs, or other actions or “dark patterns”
Overshadowing includes the prominent placement of certain content that interferes with the comprehension of other content, including terms and conditions.
There are a number of methods to prove material interference with a consumers' ability to understand terms or conditions, including but not limited to those described below. First, while intent is not a required element to show material interference, it is reasonable to infer that an act or omission materially interferes with consumers' ability to understand a term or condition when the entity intends it to interfere.
Certain terms of a transaction are so consequential that when they are not conveyed to people prominently or clearly, it may be reasonable to presume that the entity engaged in acts or omissions that materially interfere with consumers' ability to understand. That information includes, but is not limited to, pricing or costs, limitations on the person's ability to use or benefit from the product or service, and contractually specified consequences of default.
Additionally, an entity's provision of a product or service may interfere with consumers' ability to understand if the product or service is so complicated that material information about it cannot be sufficiently explained or if the entity's business model functions in a manner that is inconsistent with its product's or service's apparent terms.
The second form of “abusiveness” under the CFPA prohibits entities from taking unreasonable advantage of certain circumstances.
(1) A “lack of understanding on the part of the consumer of the material risks, costs, or conditions of the product or service.”
(2) The “inability of the consumer to protect the interests of the consumer in selecting or using a consumer financial product or service.”
(3) The “reasonable reliance by the consumer on a covered person to act in the interests of the consumer.”
Under the CFPA, it is illegal for an entity to take unreasonable advantage of one of these three circumstances, even if the condition was not created by the entity.
The ordinary meaning of the phrase “take advantage of” is generally “to make use of for one's own benefit.”
The CFPA prohibits taking “unreasonable” advantage of the specified statutory circumstances. The term “reasonable” means “[f]air, proper, or moderate under the circumstances,”
In crafting the abusiveness prohibition, Congress identified categories of practices that distort the market and ultimately harm consumers. Therefore, unlike unfairness, government enforcers do not need to independently prove that an act or practice caused substantial injury in order to establish liability under the abusiveness prohibition.
Evaluating unreasonable advantage involves an evaluation of the facts and circumstances that may affect the nature of the advantage and the question of whether the advantage-taking was unreasonable under the circumstances.
First, when Congress formulated the CFPA, one of its main concerns was financial products and services that may be “set up to fail.” Before the 2007-2008 financial crisis, mortgage lenders were willing to make loans on terms that people could not afford in part due to the ability to off-load default risk into the secondary market. This led to significant harm to the household sector, which was ultimately transmitted to the broader financial system.
The CFPA's legislative history explains that, had the CFPB existed, “the CFPB would have been able to see and take action against the proliferation of poorly underwritten mortgages with abusive terms.”
Second, the CFPA's legislative history emphasized that, as a result of CFPB oversight, “a consumer can shop and compare products based on quality, price, and convenience without having to worry about getting trapped by fine print into an abusive deal.”
One may also assess whether entities are obtaining an unreasonable advantage by considering whether they are reaping more benefits as a consequence of the statutorily identified circumstances, or whether the benefit to the entity would have existed if the circumstance did not exist.
The first circumstance, of which entities cannot take “unreasonable advantage,” as defined in the CFPA, concerns “a lack of understanding on the part of the consumer of the material risks, costs, or conditions of the product or service.”
Gaps in understanding as to “risks” encompass a wide range of potential consumer harms. “Risks” include but are not limited to the consequences or likelihood of default
While acts or omissions by an entity can be relevant in determining whether people lack understanding,
The statutory text of the prohibition does not require that the consumer's lack of understanding was reasonable to demonstrate abusive conduct.
A person may lack understanding of risks, costs, or conditions, even if they have an awareness that it is in the realm of possibility that a particular negative consequence may follow or a particular cost may be incurred as a result of using the product or service.
Lastly, one can demonstrate a person's lack of understanding in a number of ways. For example, direct evidence of lack of understanding, including but not limited to complaints and consumer testimony, can suffice. Evidence or analysis showing that reasonable consumers were not likely to understand can likewise be used to establish lack of understanding. One can also demonstrate lack of understanding by considering course of conduct and likely consequences. For example, if a transaction would entail material risks or costs and people would likely derive minimal or no benefit from the transaction, it is generally reasonable to infer that people who nonetheless went ahead with the transaction did not understand those material risks or costs.
The second circumstance, of which entities cannot take “unreasonable advantage,” as defined in the CFPA, concerns “the inability of the consumer to protect the interests of the consumer in selecting or using a consumer financial product or service.”
The consumer “interests” contemplated in section 1031(d)(2)(B) include monetary and non-monetary interests, including but not limited to property, privacy, or reputational interests.
A consumer's “inability” to protect their interests includes situations when it is impractical for them to protect their interests in selecting or using a consumer financial product or service.
The nature of the customer relationship may also render consumers unable to protect their interests in selecting or using a consumer financial product or service. People are often unable to protect their interests when they do not elect to enter into a relationship with an entity and cannot elect to instead enter into a relationship with a competitor. These consumer relationships, including but not limited to those with credit reporting companies, debt collectors, and third-party loan servicers, are generally structured such that people cannot exercise meaningful choice in the
Consumers may also lack power to protect their interests in selecting or using a consumer financial product or service when entities use form contracts, where contractual provisions are not subject to a consumer choice.
Consumers are often unable to protect their interests in selecting or using a consumer financial product or service where companies have outsized market power. When an entity's market share, the concentration in a market more broadly, or the market structure prevents people from protecting their interests by choosing an entity that offers competitive pricing, entities may not use their market power to their “unreasonable advantage.”
In addition, people are often unable to protect their interests in using a product or service if they face high transaction costs to exit the relationship. For example, the time, effort, cost, or risks associated with extricating oneself from a relationship with entities may effectively lock people into the relationship.
The third circumstance, of which entities cannot take “unreasonable advantage,” as defined in the CFPA, concerns “the reasonable reliance by the consumer on a covered person to act in the interests of the consumer.”
First, reasonable reliance may exist where an entity communicates to a person or the public that it will act in its customers' best interest, or otherwise holds itself out as acting in the person's best interest. Where an entity communicates to people that it will act in their best interest, or otherwise holds itself out as doing so, including through statements, advertising, or any other means, it is generally reasonable for people to rely on the entity's explicit or implicit representations to that effect.
Second, reasonable reliance may also exist where an entity assumes the role of acting on behalf of consumers or helping them to select providers in the market. In certain circumstances entities assume the role of acting on behalf of people as their agents or representatives, and people should be able to rely on those entities to act on their behalf. In other circumstances entities often act as intermediaries to help people navigate marketplaces for consumer financial products or services.
This is a general statement of policy under the Administrative Procedure Act (APA).
U.S. Small Business Administration.
Final rule.
The U.S. Small Business Administration (SBA or Agency) is amending its business loan program regulations to lift the moratorium on licensing new Small Business Lending Companies (SBLCs) and add a new type of lending entity called a Community Advantage SBLC. SBA is also removing the requirement for a Loan Authorization in the 7(a) and 504 Loan Programs.
This rule is effective May 12, 2023.
Dianna Seaborn, Director, Office of Financial Assistance, Office of Capital Access, Small Business Administration, at (202) 205-3645 or
The mission of SBA is to “aid, counsel, assist, and protect . . . the interests of small business concerns in order to preserve free competitive enterprise . . . and to maintain and strengthen the overall economy of our nation.” 15 U.S.C. 631(a). SBA accomplishes this mission, in part, through programs that bridge the financing gap in the private market. One such program is the 7(a) Loan Program authorized by section 7(a) of the Small Business Act (15 U.S.C. 636(a)), which supports our nation's economy by providing SBA-guaranteed loans to small businesses that lack adequate access to capital on reasonable terms and conditions.
Section 7(a)(17) of the Small Business Act states that SBA shall authorize lending institutions and other entities, in addition to banks, to make 7(a) loans. To this end, SBA has authorized Small Business Lending Companies (SBLCs) as defined in 13 CFR 120.10 to participate in the 7(a) Loan Program. SBLCs are non-depository lending institutions authorized by SBA only to make loans pursuant to section 7(a) of the Small Business Act and loans to Intermediaries in SBA's Microloan program. Under current regulations, SBLCs may not be affiliated with another SBA Lender, including 7(a) Lenders or Certified Development Companies (CDCs) that participate in SBA's CDC/504 Loan Program. SBLCs are subject to all regulations pertaining to 7(a) loans and Loan Program Requirements (as defined in 13 CFR 120.10) regarding origination, servicing, and liquidation. Unlike the majority of 7(a) Lenders, which are Federally-regulated depository institutions, SBLCs are regulated, supervised, and examined solely by SBA. As SBA-regulated entities, SBLCs are subject to specific regulations and policies regarding formation, capitalization, and enforcement actions.
On August 17, 1981, SBA published a proposed rule (46 FR 41523) to, among other things, impose a moratorium on licensing new SBLCs. Subsequently, on January 4, 1982, SBA published a final rule (47 FR 9) repealing its authority to approve additional SBLCs as participating lenders. Since then, the number of SBLC Licenses has remained unchanged at 14. To become an SBLC under current regulations, an entity must acquire one of the existing 14 SBLC Licenses from an entity that is willing to sell its SBLC License and exit the 7(a) Loan Program.
On February 18, 2011, SBA created the Community Advantage (CA) Pilot
On November 7, 2022, SBA published a notice of proposed rulemaking with a request for comments in the
SBA received 169 comments on the proposed rule. Of these, 11 comments were submitted by trade groups and 85 comments were received from lenders, nonprofit organizations, or individuals. The remaining 73 comments were submitted anonymously. SBA received comments from six trade groups, six lenders or employees of lenders, and two comments from individuals or businesses objecting to the confluence of the proposed changes in the notice of proposed rulemaking in the
SBA received 119 comments on SBA's proposal to remove the moratorium on licensing new SBLCs and create a new type of SBLC called a Mission-Based SBLC. As discussed in the section-by-section analysis below, SBA has determined that the new name for mission-based SBLCs will be Community Advantage SBLCs. Thirteen comments expressed support and 106 comments expressed opposition or suggested modifications to SBA's proposed amendments. The comments covered a range of topics that can be grouped into 9 topics.
Comments stated the proposed rules do not adequately address how current CA Lenders would transition into becoming Community Advantage SBLCs. On May 11, 2023, as determined by the Administration, SBA will grandfather current CA Lenders in accordance with section 120.420(e) that participated in the CA Pilot Program to be licensed as 7(a) Community Advantage SBLCs.
Some comments pointed out that current CA Lenders may operate on a for-profit basis, which is incompatible with SBA's proposal that new Community Advantage SBLCs operate as nonprofit organizations. This and other comments regarding CA Lenders are addressed in the section-by-section analysis below.
Comments stated that licensing additional regular SBLCs and new Community Advantage SBLCs will increase risk to SBA that will in turn increase subsidy costs to SBA and will negatively impact SBA lenders and borrowers, perhaps in the form of higher fees to lenders and borrowers or lower program authority. Some comments speculated that new SBLC licenses may be awarded to financial technology (fintech) lenders and point to reports that in the Paycheck Protection Program (PPP), some fintech lenders were associated with fraud. However, SBLCs are defined as non-depository lending institutions, which is not synonymous with the term fintech. SBA has for many years provided oversite to non-depository entities participating in the SBA business loan programs. This includes SBLCs, non-federally regulated lenders (NFRLs), 504 Certified Development Companies (CDCs), and Microloan Intermediaries. In fact, most all lending institutions incorporate the use of financial technology in their delivery of loans and other financial products. SBA received comments supporting the proposed revisions with these comments stating that PPP lending has different statutory requirements that were enacted in response to an immediate need for capital to prevent a collapse of the small business economy during a worldwide pandemic, and that it is not a fair comparison to equate fraud in PPP with potential fraud in the regular 7(a) loan program, which has well-established and robust operating policies and procedures that have proven successful at protecting the integrity of the program.
Comments expressed concern that SBA will not be able to adequately provide oversight and servicing for SBA lenders. As SBA discussed at length in the proposed rule, SBA conducted in depth assessments to ensure it has capacity to provide oversight and servicing to SBA's entire portfolio of lenders, including any potential additional SBLCs. As a result of these assessments, SBA stated in the proposed rule that it will license, service, and provide oversight to three new regular SBLCs. It should be noted that since January 1982 when SBA imposed the moratorium on licensing new SBLCs, that there have been more than 60 different holders of the 14 authorized SBLC licenses. SBA has successfully overseen transition and operation of various organizational structures of SBLC entities.
Comments allege that the proposed revisions will not increase lending to underserved markets because SBA is not proposing to impose any lending requirements to underserved markets on regular SBLCs, and because SBA has been too vague as to how it will define and identify capital market gaps for new Community Advantage SBLCs. However, SBA received several comments in support of licensing new nonbank lenders, with some of these comments stating that non-bank lenders offer a more flexible and alternative avenue to capital compared to
Comments expressed concern that the proposed revisions will create an uneven playing field between federally regulated lenders and SBLCs/Community Advantage SBLCs. The comments focus on the idea that federally regulated lenders are held to a higher standard by their federal regulators than SBA imposes on SBLCs. However, SBA has and will continue to require that SBA Supervised Lenders and CDCs, including SBLCs and Community Advantage SBLCs, submit their credit policies for review by SBA as part of the application to become an SBA Lender. SBA seeks to ensure that each lender authorized to participate in the program has policies that demonstrate reasonable and prudent credit standards that adequately address SBA's Loan Program Requirements. SBA also reviews lender credit policies during lender oversight and when lenders propose changes to their policies or practices in accordance with Loan Program Requirements as defined in 13 CFR 120.10. Further, SBA Supervised Lenders must use the approved policies and procedures to satisfy underwriting criteria for similarly-sized, non-SBA guaranteed commercial loans, where reference is made in Loan Program Requirements.
Comments expressed concern over the proposed capital requirements for Community Advantage SBLCs. Some comments stated that SBA should set a minimum threshold for capitalization of all Community Advantage SBLCs. However, as SBA indicated in the proposed rule, SBA will examine each lender applicant on an individual basis to determine the capital requirements best suited to minimize risk while not burdening smaller lenders with unnecessarily large capital requirements. However, SBA agrees that further steps should be taken to address risk mitigation for Community Advantage SBLCs. SBA will require Community Advantage SBLCs to maintain a loan loss reserve account as discussed more fully in the section-by-section analysis below for section 120.471.
Additionally, regarding SBA's proposal to set minimum lender capital amounts at the discretion of the Administrator in consultation with SBA's Associate Administrator for SBA's Office of Capital Access (AA/OCA), SBA received comments expressing concern that placing the decision at the level of political appointees may lead to the politicization of the program. SBA disagrees with this concern because political appointees determine the Agency's goals and direction, and across the federal government, political appointees have the authority to make and review final determinations as informed by career employees. In response, the final rule expands the decision-making authority in this case so that the Administrator and the AA/OCA may delegate their decision-making authority to designees.
Comments challenged SBA's assumptions in the proposed rule. A trade group requested that SBA provide information regarding how it determined that allowing decisions regarding the determination of capital requirements for Community Advantage SBLCs to be made on a case-by-case basis is consistent with existing statute. Section 23 of the Small Business Act, Supervisory and Enforcement Authority for Small Business Lending Companies, requires the SBA Administrator to, among other things, “issue regulations outlining the conditions under which the Administrator may determine the level of capital . . .” That language clearly allows the Administrator the discretion to establish the “conditions under which” the required level of capital would be determined for SBLCs. SBA is abiding by this statutory requirement through this rulemaking in revisions to § 120.471.
Some comments challenged the assumptions made in the proposed rule, doubting SBA's estimates that a newly licensed SBLC would make 425 loans over the next 4 years because the commenters believe it likely that some or all of the new regular SBLCs would be fintechs that may have the capacity to approve a significantly higher number of loans than is estimated. SBA stands by its estimate that a new SBLC has the potential to increase 7(a) lending by approximately 425 loans per year over the next four years, because the estimate was derived from actual historical performance of new SBA 7(a) Lenders over a four-year period of fiscal years 2018 through 2022.
Comments stated the proposed rule was too vague or did not provide enough information. For example, commenters stated that SBA should publish the application and evaluation processes for new applicants for SBLC licenses in the regulations. SBA disagrees with this approach because it would be overly restrictive. Instead, the proposed approach allows SBA the flexibility to respond to unique challenges such as pandemics, recessions, issues faced by specific industry sectors, etc.
Comments expressed concern that existing SBLCs will be devalued by the licensing of new SBLCs/Community Advantage SBLCs. However, SBA also received comments in support of expanding the number of SBLCs. These comments pointed out that by imposing a moratorium on licensing new SBLCs and by restricting the total number of SBLCs to 14 for the last 40 years, SBA has created an oligopoly over the $36 billion a year lending market for the existing SBLCs, which unfairly restricts competition. These comments point out that expanding the number of SBLC licenses will increase competition and encourage innovation, which benefits the small business.
SBA received 80 comments on removing the definition of Authorization and removing reference
SBA has determined that certain markets where there are capital market gaps continue to struggle to obtain financing on non-predatory terms. Therefore, SBA is lifting the moratorium on licensing new Small Business Lending Companies (SBLC) and creating a new type of SBLC to help bridge this financing gap.
SBA proposed to add a new definition for Mission-Based SBLC as a specific type of SBLC that is a nonprofit organization that will be licensed to make 7(a) loans. SBA proposed to call this new type of SBLC a Mission-Based SBLC; however as discussed below, SBA will instead call this new type of SBLC a Community Advantage SBLC.
SBA believes Community Advantage SBLCs will increase access to capital in their respective communities. SBA proposed Community Advantage SBLCs to be nonprofit entities because nonprofit lending organizations often serve communities with capital market gaps SBA intends to fill. Adding Community Advantage SBLCs to the possible types of 7(a) Lenders will also allow existing CA Lenders an opportunity to participate in the 7(a) Loan Program on a non-temporary basis as a Community Advantage SBLC while continuing to meet the needs of underserved communities. When SBA authorizes an additional Community Advantage SBLC License to a CA Lender, the CA Lender will transition from making 7(a) loans in a temporary pilot program to instead making loans under the 7(a) loan program without an expiration date associated with their participation. SBA received many comments that SBA should make the CA Pilot Program permanent. However, the nature of a pilot program is that it is a temporary program. SBA will instead provide a process to allow current CA Lenders to transition into Community Advantage SBLCs. Such guidance will be set forth in upcoming Loan Program Requirements. SBA determined that CA Lenders were a potential group of lenders already making loans in underserved markets, that would be able to meet the purpose of mission-based SBLCs, therefore SBA will refer to the new type of SBLCs as Community Advantage SBLCs rather than Mission-Based SBLCs.
To accomplish the goal of expanding capital opportunities and allowing Community Advantage SBLCs and regular SBLCs to increase the availability of 7(a) loans to small businesses, SBA will remove the moratorium on licensing new SBLCs. Current section 120.10 definition of Small Business Lending Company (SBLC) states that SBA has imposed a moratorium on licensing new SBLCs since January 1982, and the number of licenses for SBLCs has remained at 14 ever since. SBA is finalizing the proposed definition to remove the statement that SBA has imposed a moratorium on licensing new SBLCs. Not only will this allow SBA to license Community Advantage SBLCs, but it will allow SBA to increase the number of regular SBLCs as well. SBA plans to issue notices in the
Current section 120.466, paragraph (a)(6), states that in connection with any application to become an SBLC, the applicant must include a letter agreement from the existing SBLC stating that the SBLC is seeking to transfer its lending authority. SBA proposed to revise this section because the lifting of the moratorium on new SBLC Licenses will no longer require that an applicant show that an existing lender is transferring its authority. However, as SBA proposed to accept applications for new SBLCs from time to time in section 120.10, there may be periods when new SBLC Licenses are not being issued and existing Licenses will be acquired and transferred. Therefore, SBA proposed to revise this section to state that an applicant to become an SBLC must show a letter agreement from an existing SBLC if it is acquiring an existing License. For the reasons stated above, SBA is moving forward as proposed.
SBA proposed to revise § 120.470 to reference and include additional requirements for Community Advantage SBLCs. As a type of SBLC, except where otherwise explicitly mentioned in regulations, all requirements imposed on SBLCs and SBA Supervised Lenders will apply to Community Advantage SBLCs as well.
Several comments said that the existing requirement in paragraph (a) that states an SBLC may only make 7(a) loans or loans to Intermediaries is unnecessarily restrictive and is incompatible with the business models of some current CA lenders that are Community Development Financial Institutions (CDFI) or SBA CDCs. They further commented that this would also prevent such entities from applying in the future to become an SBLC or a Community Advantage SBLC because those entities may also conduct other business activities, including loanmaking. SBA agrees with this concern and will revise paragraph (a) by removing the word “only” to make it clear that SBLCs and Community Advantage SBLCs may participate in other lines of business in addition to
SBA proposed to revise paragraph (b) to require Community Advantage SBLCs to be nonprofit organizations without imposing similar requirements on regular SBLCs. As discussed above, some comments expressed concern that current CA Lenders may operate on a for-profit basis. Any Community Advantage Pilot Program lender will be permitted to hold a Community Advantage SBLC license regardless of their profit or nonprofit structure. New Community Advantage SBLC applicants that did not participate as a Community Advantage Pilot Program lender are required to have nonprofit status to qualify.
SBA received multiple comments regarding the costs that lending entities may encounter when they become Community Advantage SBLCs. SBA agrees with these concerns, and in an effort to reduce some ongoing costs for these lenders, SBA will revise the requirement at paragraph (e) for fidelity insurance. The current requirement for fidelity insurance is that an SBLC must maintain a Brokers Blanket Bond, Standard Form 14, or Finance Companies Blanket Bond, Standard Form 15, or such other form of coverage as SBA may approve, in a minimum amount of $2,000,000 executed by a surety holding a certificate of authority from the Secretary of the Treasury pursuant to 31 U.S.C. 9304-9308. SBA has determined this requirement may be overly burdensome for Community Advantage SBLCs to bear; therefore, SBA will provide an exception to this requirement to state that SBA's Administrator, in consultation with SBA's Associate Administrator for the Office of Capital Access (AA/OCA) or their designee(s), at their discretion, will determine the appropriate coverage levels for Community Advantage SBLCs as published in Loan Program Requirements.
SBA also proposed to add a new paragraph (h) to describe the requirements Community Advantage SBLCs must meet. However, SBA has determined that it will not go forward with a new paragraph (h) as proposed and instead, SBA's Administrator, in consultation with SBA's Associate Administrator for the Office of Capital Access (AA/OCA) or their designee(s), at their discretion, will determine the specific market requirements, if any, that apply to Community Advantage SBLCs in Loan Program Requirements.
Current § 120.471, paragraph (a)(1) addresses minimum capital requirements for SBLCs and states that beginning on January 4, 2024, each SBLC that makes or acquires a 7(a) loan must maintain, at a minimum, unencumbered paid-in capital and paid-in surplus of at least $5,000,000, or 10 percent of the aggregate of its share of all outstanding loans, whichever is greater. SBA proposed to revise this paragraph by adding a new paragraph (a)(4) that will state that a Community Advantage SBLC must maintain a minimum amount of capital at the discretion of the Administrator, in consultation with SBA's Associate Administrator for SBA's Office of Capital Access (AA/OCA), or their designee(s) to ensure sufficient risk protection for SBA and lenders while not burdening smaller lenders with large capital requirements. This proposal allows SBA to license Community Advantage SBLCs that are nonprofit lenders when these entities would otherwise not be able to meet SBA's minimum capital requirements.
SBA received comments that SBA should consider requiring a minimum loan loss reserve requirement for Community Advantage SBLCs. Given SBA's determination to create flexibility in minimum capital requirements for lenders participating in the Community Advantage Pilot program, SBA agrees with these comments regarding loan loss reserves and will require Community Advantage SBLCs to maintain a loan loss reserve account as determined at the discretion of the Administrator, in consultation with SBA's Associate Administrator for SBA's Office of Capital Access (AA/OCA), or their designee(s) in Loan Program Requirements
Current section 120.820 limits the entities with which CDCs may be affiliated. SBA proposed to add a new paragraph (g), which states notwithstanding paragraphs (b), (c), and (e), a CDC may be affiliated with a Community Advantage SBLC. This revision will allow CDCs to form the required entity whose purpose is to make 7(a) loans as a Community Advantage SBLC. Additionally, SBA will provide language stating that CDCs that are also CA Lenders as of the effective date of this rule may be licensed as Community Advantage SBLCs without having to form a separate entity to participate in 7(a) loanmaking.
SBA proposed to remove the regulatory definition for Authorization. SBA will continue to rely on the SBA Form 750, which is a written agreement executed by all participating lenders requiring that those same lenders comply with all statutes and regulations. The removal of the regulatory definition for Authorization will not change SBA's ongoing practice of providing specific written instructions regarding documentation of an SBA loan's terms and conditions in SBA's Loan Program Requirements. For loan accounting purposes, SBA Lenders will continue, as they do today, to electronically submit their request for a loan guaranty authorization from the Agency's loan accounting system of record—E-Tran.
SBA proposed to amend the definition of Loan Instruments to remove the word Authorization. The amended definition will state that Loan Instruments are the note, instruments of hypothecation, and all other agreements and documents related to a loan.
SBA proposed to amend the definition of Loan Program Requirements or SBA Loan Program Requirements to remove the word Authorization. The amended definition will state that Loan Program Requirements or SBA Loan Program Requirements are requirements imposed upon Lenders, CDCs, or Intermediaries by statute; SBA and applicable government-wide regulations; any agreement the Lender, CDC, or Intermediary has executed with SBA or to which the Lender or CDC is subject; SBA Standard Operating Procedures (SOPs);
Current § 120.120 states that a small business must use an SBA business loan for sound business purposes, and the uses of proceeds are prescribed in each
Current section 120.192 states that Applicants receive notice of approval or denial by the Lender, CDC, Intermediary, or SBA, as appropriate. Notice of denial will include the reasons. If a loan is approved, an Authorization will be issued. SBA proposed to amend § 120.192 to remove the sentence that states “If a loan is approved, an Authorization will be issued.” SBA's current practice is to review an Authorization and issue an SBA Loan Number when the Authorization is considered satisfactory to SBA. SBA considers the issuance of the loan number to indicate loan approval by SBA. The proposed rule to no longer require an Authorization will only slightly modify the current process. Under the proposed rule, SBA will indicate loan approval by issuing a loan number. For the reasons stated above, SBA is moving forward with the rule as proposed.
Section 120.220 states the requirements for the fees that 7(a) Loan Program Lenders pay SBA. The introductory text of § 120.220 states in part “Acceptance of the guaranty fee by SBA does not waive any right of SBA arising from a Lender's negligence, misconduct or violation of any provision of these regulations, the guaranty agreement, or the loan authorization.” For the reasons stated above, SBA proposed to remove the reference to the loan Authorization so that the sentence states “Acceptance of the guaranty fee by SBA does not waive any right of SBA arising from a Lender's negligence, misconduct or violation of any provision of these regulations, or the guaranty agreement.
Current § 120.220(e) states in part “Acceptance of the guarantee fee by SBA shall not waive any right of SBA arising from the [7(a)] Lender's misconduct or violation of any provision of this part, the guarantee agreement, the Authorization, or other loan documents.” For the reasons stated above, SBA proposed to remove the reference to the loan Authorization so the revised § 120.220(e) will state “Acceptance of the guarantee fee by SBA shall not waive any right of SBA arising from the [7(a)] Lender's misconduct or violation of any provision of this part, the guarantee agreement, or other loan documents. For the reasons stated above, SBA is moving forward with the rule as proposed.
Current § 120.801(a) applies to the 504 Loan Program and states “One or more small businesses may apply for 504 financing through a CDC serving the area where the 504 Project is located. SBA issues an Authorization if it agrees to guarantee part of the funding for a Project.” For the reasons stated above, SBA proposed to remove the sentence that references the Authorization, and SBA is moving forward with the rule as proposed.
Current § 120.842(b)(4) states the requirements for submission of loan documents for 504 Loan Program ALP Express loans and states in part “If approved, SBA will notify the ALP CDC of the loan number assigned to the loan and provide the CDC with a signed copy of the Loan Authorization.” SBA's current practice is to review an Authorization and issue a loan number when the Authorization is considered satisfactory to SBA. Under the proposed rule, SBA will indicate loan approval by issuing a loan number. Therefore, SBA proposed to remove the reference to the Loan Authorization so the sentence will state “If approved, SBA will notify the ALP CDC of the loan number assigned to the loan.”
Current § 120.842(b)(5) states the requirements for loan and debenture closing for 504 Loan Program ALP Express loans and states “After receiving notification of the loan number from SBA, the ALP CDC is responsible for properly undertaking all actions necessary to close the ALP Express Loan and Debenture in accordance with the expedited loan closing procedures applicable to a Priority CDC and with § 120.960.” For the reasons stated above, SBA proposed to remove the reference to the Loan Authorization so that section 120.842(b)(5) will state “After receiving notification of the loan number, the ALP CDC is responsible for properly undertaking all actions necessary to close the ALP Express Loan and Debenture in accordance with the expedited loan closing procedures applicable to a Priority CDC and with § 120.960.” For the reasons stated above, SBA is moving forward with the rule as proposed.
Current § 120.921(a) states the requirements for the loan maturity of the 504 Loan Program Third Party Lender loan. Section 120.921(a) provides that Third Party Loans have loan maturity requirements. A 504 loan for a 10 year loan term must have at least a 7 year Third Party Loan and similarly, a 504 loan for 20 years must have at least 10 years for the Third Party Loan. Additionally, overall loan maturities must be recalculated if there is more than one Third Party Loan. However, a balloon payment must be justified in the Loan Authorization. For the reasons stated above, SBA proposed to remove the last sentence in section 120.921(a) in its entirety so that balloon payments need not be identified in the Loan Authorization. For the reasons stated above, SBA is moving forward with the rule as proposed.
Current § 120.960(c)(1) states that SBA may, within its sole discretion, decline to close a 504 Loan Program Debenture; direct the transfer of the 504 loan to another CDC; or cancel its guarantee of the Debenture, prior to sale, if the CDC has failed to comply materially with any requirement imposed by statute, regulation, SOP, policy and procedural notice, any agreement the CDC has executed with SBA, or the terms of a Debenture or loan authorization. For the reasons stated above, SBA proposed to remove the reference to the loan Authorization, and SBA is moving forward with the rule as proposed.
Section 120.971 states the requirements for the allowable fees that a 504 Loan Program Certified Development Company (CDC) may charge the Borrower in connection with a 504 loan and Debenture. Section 120.971(a)(1) describes the Processing fee and states at what point in the processing of 504 loan a fee is earned and may be collected by the CDC as the time Authorization is issued. For the reasons stated above, SBA proposed to remove the reference to the
The Office of Management and Budget has determined that this rule is a “significant regulatory action” under Executive Order 12866. SBA performed a comprehensive Regulatory Impact Analysis in the proposed rule for the public's information. SBA does not anticipate any of the changes made in this final rule will substantially change any of the assumptions necessary for the analysis. Therefore, the final Regulatory Impact Analysis is unchanged and is synopsized below. Each section begins with a core question.
Is there a need for this regulatory action?
SBA performed a comprehensive cost benefit analysis in the proposed rule. SBA does not anticipate any of the changes made in this final rule will substantially change any of the assumptions necessary for the analysis; therefore, the cost benefit analysis remains unchanged and is synopsized below.
Access to capital is one of the primary factors indicating whether a small business will startup, grow, and survive.
SBA's existing loan programs serve an important role in credit markets for small businesses by providing financing to businesses that do not have credit available elsewhere from conventional sources on reasonable terms. SBA believes that increasing the number of nontraditional lenders will result in the expansion of business opportunities and the creation of more jobs in underserved communities.
SBA's CA Pilot Program, which currently expires September 30, 2024, was specifically created to increase access to capital to small businesses located in underserved markets. SBA has learned that CA Lenders are able to routinely make at least 60 percent of their loans to small businesses located in underserved markets; therefore, SBA is onboarding more lenders to participate in 7(a) lending to increase the number of mission-based lenders that use the program. Licensing new SBLCs and Community Advantage SBLCs will provide a path for successful CA Lenders to become participants in the 7(a) Loan Program long-term. In addition, many non-traditional lenders participated in SBA's Paycheck Protection Program (PPP), which provided billions of dollars to small businesses during the economic upheaval caused by the COVID-19 pandemic. Based on the success of the PPP, removing the moratorium on licensing new SBLCs and Community Advantage SBLCs opens opportunities for more non-traditional lenders to participate in the 7(a) Loan Program, providing additional sources of capital to America's small businesses.
SBA's current policy of requiring a separate Loan Authorization document that contains the loan terms and conditions in addition to the loan terms and conditions that the SBA Lender also submits to SBA with its guaranty application is cumbersome, outdated, and duplicative. SBA is revising its regulations to eliminate the duplication of effort and opportunity for a mismatch of information between multiple sources of the loan terms and conditions. The official source of all terms and conditions (including any modifications) under which SBA has agreed to provide a guaranty will be maintained in SBA's E-Tran system.
SBA anticipates minor additional costs or impact on the subsidy to operate the 7(a) Loan Program in the first 5 years under these proposed regulations resulting from an anticipated modest increase in 7(a) loan activity due to additional SBLCs, as newly established SBLCs take up to five years to reach the current lending activity sustained by established SBLC license holders. SBA has confirmed that there will be no subsidy impact in FY 2024.
The existing 14 licensed SBLCs each approve an average of 125 loans per year. SBA anticipates new SBLCs will require a ramp-up period over the course of their first several years after they are licensed to reach this level of 7(a) lending activity. Over the course of the past four fiscal years, the majority of new 7(a) lenders have made between 1 and 26 7(a) loans in their first year of activity, with the average number of loans from each new 7(a) lender of less than three loans in their first year of 7(a) loan activity. Over the fiscal years 2018 through 2021, there were three new SBLC's that acquired SBLC Licenses, and those new SBLCs approved a total of 40 7(a) loans in their first years of operation, for an average of approximately 13 7(a) loans for each SBLC in their first year. Based on loan volume for other new 7(a) lenders between FY 2018 and FY 2021, SBA anticipates new SBLCs, including Community Advantage SBLCs, to make approximately eight 7(a) loans in their first year after they become fully operational because of the targeted markets of Community Advantage SBLCs. The three new SBLCs have the potential to increase 7(a) lending by the approximately 425 loans per year over the next four years.
SBA will grandfather current CA Lenders in accordance with section 120.420(e) that participated in the CA Pilot Program to be licensed as 7(a) Community Advantage SBLCs. When SBA authorizes a Community Advantage SBLC License to a CA Lender, the CA Lender will transition from making 7(a) loans in a temporary pilot program to instead making 7(a) loans under a non-temporary license in the regular 7(a) program. This means a CA Lender transitioning to a Community Advantage SBLC will pose no additional burden nor increase the total number of entities overseen and supervised by SBA or the cost to SBA.
SBA is authorized
The ongoing oversight fees imposed on the new SBLCs, including Community Advantage SBLCs, will be
In addition to the review/exam fees charged, SBA charges an annual oversight fee that covers the costs of monitoring, Other Lender Oversight Activities, and Delegated Authority Reviews (the latter as applicable). SBA charges 7(a) Lenders a fee annually for monitoring, including the quarterly off-site/monitoring reviews conducted through the Loan and Lender Monitoring System (L/LMS). SBA's annual oversight fee also includes costs related to Other Lender Oversight Activities (
The proposed revisions may have a negative impact to the 14 existing SBLCs by destabilizing the value of their licenses due to increased competition and issuance of new SBLC Licenses. The value of SBLC Licenses may periodically fluctuate based on whether SBA is or is not accepting applications for new SBLCs and entities interested in the program must acquire existing SBLC License.
As previously stated above, the primary function of the Community Advantage Pilot Program was to waive the moratorium on issuing new SBLC licenses to lenders who would not ordinarily qualify to be a 7(a) lender. Therefore, by creating a new type of Community Advantage SBLC, SBA will ensure that all existing Community Advantage Pilot Program participants will become 7(a) lenders without an expiration date associated with their participation. The Community Advantage Pilot Program participants have been important 7(a) lenders, increasing capital to small business by originating loans consistent with 7(a) Loan Program Requirements. As a pilot, the temporary Community Advantage Program will sunset. SBA has concluded that the Community Advantage Pilot Program demonstrated its benefits. By grandfathering in all existing Community Advantage Pilot Program lenders to be Community Advantage SBLCs, the benefits of mission-oriented lenders utilizing the 7(a) loan to extend credit across the country will become a regular feature of SBA lending. Finally, by authorizing the SBA Administrator, Associate Administrator for the Office of Capital Access (AA/OCA), or a designee(s) to determine appropriate capital requirements, loan loss reserve requirements, fidelity insurance levels and create parity in oversight fees, the current Community Advantage Pilot Program participants will not experience material changes in the transition to Community Advantage SBLCs. Accordingly, the SBA pilot program spanning three different Executive Branch Administrations will sunset, with the result being an acknowledgement that these previously ineligible mission-oriented lenders will be able to participate in 7(a) lending, or may apply to become 7(a) lenders, to increase access to capital for America's small businesses.
SBA considered leaving the regulations unchanged and relying upon the CA Pilot Program to address the needs of access to capital in underserved markets; however, the CA Pilot Program will sunset on September 30, 2024, and SBA intends for Community Advantage SBLCs to be a solution that provides greater certainty for lenders.
SBA also considered requiring Community Advantage SBLCs to meet the $5 million capitalization requirements currently in place for all SBLC license holders; however, SBA determined many of these lending entities would be unable to qualify for SBA's program based on such a requirement.
SBA considered leaving the requirements for the Loan Authorization intact. However, SBA Lenders struggle under the burden of the existing lengthy Loan Authorization, and they continue to request relief from this requirement. In the interest of reducing duplicative effort and making better use of existing technology and processes, SBA determined it is in the interest of SBA and SBA Lenders to revise the requirement for a Loan Authorization as proposed.
SBA also considered facilitating electronic entry of the Loan Authorization for the subject SBA loans. However, electronic entry of the Loan Authorization form would not address the duplicative effort resulting from subsequent entry in E-Tran. Therefore, this would also not be a viable alternative.
This action meets applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. The action does not have preemptive effect or retroactive effect.
This rule does not have federalism implications as defined in Executive Order 13132. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Executive Order. As such it does not warrant the preparation of a Federalism Assessment.
A description of the need for this regulatory action and benefits and costs associated with this action, including possible distributional impacts that relate to Executive Order 13563, are included above in the Regulatory Impact Analysis under Executive Order 12866.
The portions of the proposed rule on the SBLC moratorium rescission would require SBA Form 2498, “SBA Supervised Lender Assessment Plan,” to be revised to edit the requirement that an applicant to become an SBLC must include a letter from an existing SBLC evidencing intent to transfer lending authority to conform with revisions to 13 CFR 120.466. The portion of this rule on removing the requirement for a Loan Authorization is not subject to the Paperwork Reduction Act because the Loan Authorization is not an information collection. SBA will submit revisions of this form to OMB and publish notice at a later date.
Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, also known as the Congressional Review Act or CRA, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. SBA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the CRA cannot take effect until 60 days after it is published in the
When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires the agency to “prepare and make available for public comment a final regulatory analysis” which will “describe the impact of the final rule on small entities.” For the reasons stated below, SBA certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities.
Of the 182 new 7(a) Lenders onboarded since FY 2018, only four were new SBLCs that acquired an SBLC License after receiving SBA's approval for the SBLC License transfer. SBA does not require SBLCs to provide SBA with the financial statements of the SBLC parent company, if applicable, or affiliates; therefore, SBA is not able to determine whether the SBLCs are small businesses in accordance with SBA size standards. SBA anticipates approving three SBLCs, in the full first year after this proposed rule becomes effective.
Because some SBLC applicants may be considered small businesses per size standards in 13 CFR 121.201,
Based on SBA's experience with similar data collections, an organization applying to become an SBA Supervised Lender would typically employ the services of a financial manager, an accountant, an attorney, and an administrative assistant when preparing a complete application for submission to SBA. SBA also anticipates a minor increase of additional 7(a) loan approvals each year based on the approximately three new SBLC and Community Advantage SBLC lenders per year.
The cost estimate for an SBLC applicant to complete an SBA SBLC application is based on the estimated time to complete the application multiplied by the median hourly wage by job position wages published by the U.S. Department of Labor's Bureau of Labor Statistics for 2021
SBA believes the one-time estimated cost burden of $15,348 does not represent a significant economic impact to a potential SBLC applicant in comparison to the average annual revenue of existing SBLCs of $81.3 million per SBLC.
Community development, Loan programs—business, Reporting and recordkeeping requirements, Small businesses.
For the reasons stated in the preamble, SBA is amending 13 CFR part 120 as follows:
15 U.S.C. 634(b)(6), (b)(7), (b)(14), (h), and note, 636(a), (h) and (m), and note, 636m, 650, 657t, and note, 657u, and note, 687(f), 696(3), and (7), and note, 697, 697a and e, and note; Pub. L. 116-260, 134 Stat. 1182.
The revisions and addition read as follows:
* * * Acceptance of the guaranty fee by SBA does not waive any right of SBA arising from a Lender's negligence, misconduct or violation of any provision of these regulations or the guaranty agreement or other loan documents.
(e) * * * Acceptance of the guarantee fee by SBA shall not waive any right of SBA arising from the Lender's misconduct or violation of any provision of this part, the guarantee agreement or other loan documents.
(a) * * *
(6) In connection with any application to acquire an existing SBLC License, the applicant must include a letter agreement signed by an authorized official of the SBLC whose License is to be acquired certifying that the SBLC is seeking to transfer its SBA lending authority to the applicant;
In addition to complying with SBA's requirements for SBA Lenders and SBA Supervised Lenders, an SBLC (including a Community Advantage SBLC) must meet the requirements contained in this regulation and the SBLC regulations that follow.
(a)
(b)
(e)
(a) * * *
(4) A Community Advantage SBLC must maintain a minimum amount of capital as determined at the discretion of the Administrator in consultation with SBA's Associate Administrator for the Office of Capital Access (AA/OCA), or their designee(s). The minimum capital amount as published in Loan Program Requirements will ensure sufficient risk protection for SBA and lenders while not burdening smaller lenders with large capital requirements.
(5) Community Advantage SBLCs must maintain a loan loss reserve account as determined at the discretion of the Administrator in consultation with SBA's Associate Administrator for the Office of Capital Access (AA/OCA), or their designee(s) as published in Loan Program Requirements.
(a) * * * SBA issues a loan number if it agrees to guarantee part of the funding for a Project.
(g) Notwithstanding paragraphs (b), (c), and (e) of this section, a CDC may be affiliated with a Community Advantage SBLC. Additionally, CDCs that are also Community Advantage Pilot Program Lenders as of May 11, 2023 may be licensed as Community Advantage SBLCs.
(b) * * *
(4) * * * If approved, SBA will notify the ALP CDC of the loan number assigned to the loan.
(5) * * * After receiving notification of the loan number from SBA, the ALP CDC is responsible for properly undertaking all actions necessary to close the ALP Express Loan and Debenture in accordance with the expedited loan closing procedures applicable to a Priority CDC and with § 120.960, and in compliance with all applicable Loan Program Requirements.
(c) * * *
(1) The CDC has failed to comply materially with any Loan Program Requirement as defined in § 120.10;
(a) * * *
(1)
Federal Aviation Administration (FAA), DOT.
Final rule; correction.
The FAA is correcting an airworthiness directive (AD) that was published in the
This correction is effective April 28, 2023. The effective date of AD 2023-06-06 remains April 28, 2023.
Chirayu A. Gupta, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
AD 2023-06-06, Amendment 39-22392 (88 FR 17682, March 24, 2023) (AD 2023-06-06), requires revising the existing maintenance or inspection program, as applicable, to incorporate two aircraft maintenance manual (AMM) tasks. That AD applies to all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes.
As published, a portion of the initial compliance time specified in paragraph (g)(1)(ii) of AD 2023-06-06 is incorrect. The initial compliance time specified in paragraph (g)(1)(ii) of AD 2023-06-06 is within 90 days after the effective date of this AD or before accumulating 3,000 total flight hours, “whichever occurs later.” That compliance time should be within 90 days after the effective date of this AD or before accumulating 3,000 total flight hours, “whichever occurs first.” This is the compliance time provided in Transport Canada AD CF-2021-38R1, dated May 25, 2022, which the FAA intended to match.
This document corrects an error and correctly adds the AD as an amendment to 14 CFR 39.13. Although no other part of the preamble or regulatory information has been corrected, the FAA is publishing the entire rule in the
The effective date of this AD remains April 28, 2023.
Since this action only corrects a certain compliance time, it has no adverse economic impact and imposes no additional unforeseen burden on any person. Therefore, the FAA has determined that notice and public procedures are unnecessary.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective April 28, 2023.
None.
This AD applies to all MHI RJ Aviation ULC airplanes, certificated in any category, identified in paragraphs (c)(1) through (5) of this AD.
(1) Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes.
(2) Model CL-600-2C11 (Regional Jet Series 550) airplanes.
(3) Model CL-600-2D15 (Regional Jet Series 705) airplanes.
(4) Model CL-600-2D24 (Regional Jet Series 900) airplanes.
(5) Model CL-600-2E25 (Regional Jet Series 1000) airplanes.
Air Transport Association (ATA) of America Code: 21, Air conditioning.
This AD was prompted by a determination that the existing maintenance or inspection program, as applicable, must be revised to incorporate two aircraft maintenance manual (AMM) tasks. The FAA is issuing this AD to address in-service reports of emergency ram air valve part number (P/N) GG670-95019-1 stuck in closed or partially open positions, which, if not corrected could result in a complete loss of outside air supply, leading to an increase in flight deck and cabin temperatures and a possible increased level of contaminated air (carbon monoxide, carbon dioxide, or ozone).
Comply with this AD within the compliance times specified, unless already done.
(1) Within 90 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in figure 1 to the introductory text of paragraph (g)(1) of this AD. The initial compliance time for doing the task is at the applicable time specified in paragraph (g)(1)(i) or (ii) of this AD.
(i) For airplanes that have accumulated less than 1,800 flight hours since the last operational check of the ram air shutoff valve was performed as specified in AMM Task 21-52-04-710-801-A01, and for airplanes that have accumulated less than 1,800 flight hours from the date of issuance of the original airworthiness certificate or original export certificate of airworthiness: Within 90 days after the effective date of this AD, or before accumulating 1,800 total flight hours, whichever occurs later.
(ii) For airplanes that have accumulated 1,800 flight hours or more since the last operational check of the ram air shutoff valve was performed as specified in AMM Task 21-52-04-710-801-A01, and for airplanes that have accumulated 1,800 flight hours or more since the date of issuance of the original airworthiness certificate or original export certificate of airworthiness and for which no operational check of the valve has been performed: Within 90 days after the effective date of this AD or before accumulating 3,000 total flight hours, whichever occurs first.
(2) Within 90 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in figure 2 to the introductory text of paragraph (g)(2) of this AD. The initial compliance time for doing the task is at the applicable time specified in paragraph (g)(2)(i) or (ii) of this AD.
(i) For airplanes that have accumulated less than 17,600 flight hours since the last detailed inspection of the pack discharge and ram air supply ducts was performed as specified in AMM Task 21-51-00-220-801-A01, and for airplanes that have accumulated less than 17,600 flight hours since the date of issuance of the original airworthiness certificate or original export certificate of airworthiness: Within 90 days after the effective date of this AD, or before accumulating 17,600 total flight hours, whichever occurs later.
(ii) For airplanes that have accumulated 17,600 flight hours or more since the last detailed inspection of the pack discharge and ram air supply ducts as specified in AMM Task 21-51-00-220-801-A01, and for airplanes that have accumulated 17,600 flight hours or more since the date of issuance of the original airworthiness certificate or original export certificate of airworthiness, and for which no detailed inspection of the pack discharge and ram air supply ducts has been performed: Within 90 days after the effective date of this AD.
After the existing maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Transport Canada AD CF-2021-38R1, dated May 25, 2022, for related information. This Transport Canada AD may be found in the AD docket at
(2) For more information about this AD, contact Chirayu A. Gupta, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; email
None.
Drug Enforcement Administration, Department of Justice.
Final rule.
The Drug Enforcement Administration (DEA) is finalizing the control of 4-piperidone, its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, and any combination thereof, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act. DEA proposed control of 4-piperidone due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substance fentanyl. This rulemaking finalizes the control of 4-piperidone as a list I chemical.
This rulemaking is effective on May 12, 2023. Persons seeking registration must apply on or before May 12, 2023, to continue their business pending final action by DEA on their application.
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
The Drug Enforcement Administration (DEA) is
This action subjects handlers of 4-piperidone to the chemical regulatory provisions of the Controlled Substances Act (CSA) and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of 4-piperidone. As such, all transactions involving 4-piperidone, regardless of size, shall be regulated and are subject to control under the CSA. In addition, chemical mixtures containing 4-piperidone are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of 4-piperidone shall be regulated pursuant to the CSA.
The CSA gives the Attorney General the authority to specify, by regulation, chemicals as list I chemicals.
The clandestine manufacture of fentanyl remains extremely concerning as the distribution of illicit fentanyl continues to drive drug-related overdose deaths in the United States. Fentanyl is a synthetic opioid and was first synthesized in Belgium in the late 1950s. Fentanyl was introduced into medical practice and is approved for medical practitioners in the United States to prescribe lawfully for anesthesia and analgesia. Yet, due to its pharmacological effects, fentanyl can also be used as a substitute for heroin, oxycodone, and other opioids in opioid dependent individuals. Therefore, despite its accepted medical use in treatment in the United States, the DEA controls fentanyl as a schedule II controlled substance due to its high potential for abuse and dependence.
The unlawful trafficking of fentanyl in the United States continues to pose an imminent hazard to the public safety. Since 2012, fentanyl has shown a dramatic increase in the illicit drug supply as a single substance, in mixtures with other illicit drugs (
DEA has noted a significant increase in overdoses and overdose fatalities from fentanyl in the United States in recent years. According to the Centers for Disease Control and Prevention (CDC), opioids, mainly synthetic opioids (including fentanyl), are predominantly responsible for drug overdose deaths in recent years. According to CDC data, drug-induced overdose deaths involving synthetic opioids (excluding methadone) in the United States increased from 36,359 in 2019 to 56,516 in 2020 to 57,802 in 2021 (provisional).
Fentanyl is not a naturally occurring substance. As such, the manufacture of fentanyl requires it to be produced through synthetic organic chemistry. Synthetic organic chemistry is the process in which a new organic molecule is created through a series of chemical reactions, which involve precursor chemicals. Through chemical reactions, the chemical structures of precursor chemicals are modified in a desired fashion. These chemical reaction sequences, also known as synthetic pathways, are designed to create a desired substance. Several synthetic pathways to fentanyl have been identified in clandestine laboratory settings; these include the original “Janssen method,” the “Siegfried method,” and the “Gupta method.” In response to the illicit manufacture of fentanyl using these methods, DEA controlled
In 2017, the United Nations Commission on Narcotic Drugs placed NPP and ANPP in Table I of the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (1988 Convention) in response to the international reintroduction of fentanyl on the illicit drug market. As such, member states of the United Nations were required to regulate these precursor chemicals at the national level. Importantly, the People's Republic of China regulated NPP and ANPP on February 1, 2018.
To circumvent these regulations, illicit fentanyl manufacturers continue to employ unregulated precursor chemicals in the illicit synthesis of fentanyl. Recent law enforcement information indicates that illicit fentanyl manufacturers may be utilizing precursor chemicals that serve as precursors to those precursor chemicals already controlled, sometimes referred to as “pre-precursors.” 4-Piperidone (also, known as, piperidin-4-one) serves as a precursor chemical for the previously controlled list I chemicals involved in many synthetic routes to fentanyl; it is used to make NPP, benzylfentanyl, and 4-anilinopiperidine, all of which are list I chemicals under the CSA.
In addition to the continuous exploration of viable precursors to manufacture fentanyl, illicit manufacturers also employ protecting group strategies on known fentanyl precursors. These protecting group strategies modify the chemical structure of a known precursor and are specifically designed to disguise the known precursor to evade law enforcement detection or to enhance the manufacturing process of the controlled substance the known precursor is used to make. These modified precursors are sometimes referred to as “masked precursors.” For example, 1-boc-4-anilinopiperidine (
The original published synthetic pathway to fentanyl, known as the Janssen method, does not involve NPP or ANPP as precursor chemicals. This synthetic pathway involves the important precursors, benzylfentanyl and norfentanyl. 4-Piperidone serves as a precursor chemical to benzylfentanyl, a list I chemical under the CSA,
Like in the Janssen method, 4-piperidone also serves as an early-stage precursor chemical in the Siegfried method. 4-Piperidone is a precursor to NPP, a known fentanyl precursor and list I chemical, in the Siegfried method. NPP, a list I chemical under the CSA,
In addition to the Janssen and Siegfried methods, clandestine manufacturers are using other methods to synthesize fentanyl, one of which is known as the Gupta method. 4-Piperidone can be used to synthesize 4-anilinopiperidine, a list I chemical under the CSA
DEA has determined that 4-piperidone is commercially available from both domestic and foreign suppliers. DEA is aware of at least 38 domestic suppliers and 19 foreign suppliers. 4-Piperidone is attractive to illicit manufacturers due to the lack of regulations on this chemical, it is readily available from chemical suppliers, and it can be easily converted to known fentanyl precursors, including NPP, benzylfentanyl, and 4-anilinopiperidine.
4-Piperidone and 1-boc-4-piperidone have been imported and identified in law enforcement encounters in the United States. According to law enforcement information, between March 2016 and October 2021, there have been two seizures of 4-piperidone and one seizure of 1-boc-4-piperidone, amounting to a total of 357 kilograms (kg) at ports of entry in the United States. In addition to these encounters, a query of DEA's Laboratory Information Management System (LIMS) resulted in a total of three domestic reports of 4-piperidone (1) and 1-boc-4-piperidone (2) from analyses conducted on submitted drug evidence by DEA forensic laboratories. 4-Piperidone was also identified at clandestine laboratories located in Arizona and Pennsylvania, which were involved in the illicit manufacture of fentanyl.
As of May 2019, in addition to domestic encounters, the International Narcotics Control Board of the United Nations reported a total of eight international transactions of 4-piperidone (6) and 1-boc-4-piperidone (2) through the Precursors Incident Communication System (PICS).
These recent law enforcement encounters of 4-piperidone coincide with the placement of NPP and ANPP in Table I of the 1988 Convention, the People's Republic of China regulating NPP and ANPP as of February 1, 2018, and the regulation of benzylfentanyl and 4-anilinopiperidine as list I chemicals and the designation of norfentanyl as a
The CSA, specifically 21 U.S.C. 802(34), and its implementing regulations at 21 CFR 1310.02(c), provide the Attorney General with the authority to specify, by regulation, additional precursor or essential chemicals as listed chemicals if they are used in the manufacture of controlled substances in violation of the CSA. Recent law enforcement encounters indicate 4-piperidone is being used in the illicit manufacture of the schedule II controlled substance fentanyl. This rule regulates 4-piperidone, including its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, and any combination thereof, whenever the existence of such is possible, as a list I chemical because DEA finds that 4-piperidone is used in the illicit manufacture of the controlled substance fentanyl, and is important to the manufacture of the controlled substance fentanyl because it cannot be replaced by other chemicals in its respective synthetic pathways which are used in the illicit manufacture of fentanyl. In effort to make clear DEA's intent in the NPRM published on September 22, 2022
As part of the NPRM published on September 22, 2022,
DEA solicited input from all potentially affected parties regarding: (1) The types of legitimate industries using 4-piperidone; (2) the legitimate uses of 4-piperidone, if any; (3) the size of the domestic market for 4-piperidone; (4) the number of manufacturers of 4-piperidone; (5) the number of distributors of 4-piperidone; (6) the level of import and export of 4-piperidone; (7) the potential burden these regulatory controls of 4-piperidone may have on any legitimate commercial activities; (8) the potential number of individuals/firms that may be adversely affected by these regulatory controls (particularly with respect to the impact on small businesses); and (9) any other information on the manner of manufacturing, distribution, consumption, storage, disposal, and uses of 4-piperidone by industry and others. DEA invited all interested parties to provide any information on any legitimate uses of 4-piperidone in industry, commerce, academia, research and development, or other applications. DEA sought both quantitative and qualitative data. DEA did not receive any responses to these specific solicitations.
In response to the NPRM, DEA received three comments. Two commenters were in support of controlling 4-piperidone as a list I chemical. One commenter submitted a response that was outside the scope of the action.
Under this rulemaking, chemical mixtures containing 4-piperidone are
DEA has implemented an application process to exempt mixtures from the requirements of the CSA and its implementing regulations.
This final rule subjects 4-piperidone to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. Upon the effective date of this final rule, persons handling 4-piperidone, including regulated chemical mixtures containing 4-piperidone, will be required to comply with list I chemical regulations, including the following:
1.
DEA notes that under the CSA, “warehousemen” are not required to register and may lawfully possess list I chemicals, if the possession of those chemicals is in the usual course of business or employment.
Upon the effective date of this final rule, any person manufacturing, distributing, importing, or exporting 4-piperidone or a chemical mixture containing 4-piperidone will become subject to the registration requirement under the CSA. DEA recognizes, however, that it is not possible for persons who are subject to the registration requirements to immediately complete and submit an application for registration, and for DEA to immediately issue registrations for those activities. Therefore, to allow any continued legitimate commerce in 4-piperidone or a chemical mixture containing 4-piperidone, DEA is establishing in 21 CFR 1310.09, a temporary exemption from the registration requirement for persons desiring to engage in activities with 4-piperidone or a chemical mixture containing 4-piperidone, provided that DEA receives a properly completed application for registration or application for exemption of a chemical mixture under 21 CFR 1310.13 on or before May 12, 2023. The temporary exemption for such persons will remain in effect until DEA takes final action on their application for registration or application for exemption of a chemical mixture.
The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, would become effective on the effective date of this final rule. This is necessary because a delay in regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.
Additionally, the temporary exemption for registration does not suspend applicable Federal criminal laws relating to 4-piperidone, nor does it supersede State or local laws or regulations. All handlers of 4-piperidone must comply with applicable State and local requirements in addition to the CSA regulatory controls.
2.
Each regulated bulk manufacturer of a listed chemical must submit manufacturing, inventory, and use data on an annual basis. Existing standard industry reports containing the required information are acceptable, provided the information is separate or readily retrievable from the report.
The CSA and its implementing regulations require that each regulated person must report to DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of subchapter I of the CSA. In addition, regulated persons must report any regulated transaction with a person whose description or other identifying characteristics DEA has previously furnished to the regulated person, any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person, and any in-transit loss in which the regulated person is the supplier.
3.
4.
5.
6.
Executive Orders 12866 and 13563, Regulatory Planning and Review, Improving and Regulation and Regulatory Review
This final rulemaking, which adds 4-piperidone as a list 1 chemical, was developed in accordance with the principles of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs 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). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866.
E.O. 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O.
DEA has reviewed this rule under the foregoing principles and has determined that this rule is not a “significant regulatory action” under E.O. 12866. Accordingly, the Office of Information and Regulatory Affairs has not reviewed this rule.
This final rulemaking subjects 4-piperidone to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. 4-Piperidone is a precursor chemical used in, and is important to, the illicit manufacture of the schedule II controlled substance fentanyl. The distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years.
DEA has searched information in the public domain for any legitimate uses of 4-piperidone, and has not documented a use for 4-piperidone other than as an intermediary chemical in the production of fentanyl. Based on the review of import and quota information for NPP, ANPP, and fentanyl, DEA believes the vast majority of, if not all, legitimate pharmaceutical fentanyl is produced via a synthetic route involving NPP and ANPP as intermediaries, not 4-piperidone. The quantities of NPP indicated in import data and quantities of ANPP indicated in import and quota data generally correspond with the quantities of legitimate pharmaceutical fentanyl produced in the United States. Therefore, DEA concludes the vast majority of, if not all, 4-piperidone undergoing chemical transactions is being used for the manufacturing of illicit fentanyl. DEA cannot rule out the possibility that minimal quantities of 4-piperidone is being used for the manufacturing of legitimate pharmaceutical fentanyl. However, if there are any quantities of 4-piperidone used for the manufacturing of legitimate pharmaceutical fentanyl, the quantities are believed to be small and economically insignificant. DEA requested public comment regarding this estimate; however, no public comment was received during the notice and comment period.
DEA evaluated the costs and benefits of this action.
DEA believes the market for 4-piperidone for the legitimate manufacturing of pharmaceutical fentanyl is minimal. As stated above, the only use for 4-piperidone of which DEA is aware is as an intermediary for the manufacturing of fentanyl. Any manufacturer, distributor, importer, or exporter of 4-piperidone for the production of legitimate pharmaceutical fentanyl, if they exist at all, will incur costs. The primary costs associated with this rule would be the annual registration fees for list I chemicals ($3,699 for manufacturers and $1,850 for distributors, importers, and exporters). However, any manufacturer that uses 4-piperidone for legitimate pharmaceutical fentanyl production would already be registered with DEA and have all security and other handling processes in place because of the controls already in place on fentanyl, resulting in minimal cost to those entities. While different forms of handling the scheduled substance versus the list I chemical (distribution of fentanyl vs exporting 4-piperidone) could require a separate registration for the different handling of the substances, if an entity is already registered to handle, manufacture, import, or export a scheduled substance, the entity would not need an additional registration for the list I chemical, provided it is handling the list I chemical in the same manner that it is registered for with the scheduled substance, or as a coincident activity permitted by § 1309.21. Even with the possibility of these additional registrations, DEA believes that the cost will be minimal.
DEA has identified 38 domestic suppliers of 4-piperidone. Only one is registered to handle list I chemicals, the remaining 37 are not registered with DEA to handle list I chemicals. It is difficult to estimate how much 4-piperidone is distributed by these suppliers. It is common for chemical distributors to have items in their catalog while not actually having any material level of sales. Based on the review of import and quota information for NPP, ANPP, and fentanyl, where the quantities of NPP and ANPP imported and manufactured generally correspond with the quantities of fentanyl produced, DEA believes any quantity of sales from these distributors for legitimate pharmaceutical fentanyl manufacturing is minimal. Suppliers for the legitimate use of 4-piperidone are expected to choose the least-cost option, and stop selling the minimal quantities, if any, of 4-piperidone, rather than incur the registration cost. Because DEA believes the quantities of 4-piperidone supplied for the legitimate manufacturing of pharmaceutical fentanyl are minimal, DEA estimates that the cost of foregone sales is minimal; and thus, the cost of this rule is minimal. DEA requested public comment regarding this estimate; however, no public comment was received during the notice and comment period.
This analysis excludes consideration of any economic impact to those businesses that facilitate the manufacturing and distribution of 4-piperidone for the manufacturing of illicit fentanyl. As a law enforcement organization and as a matter of principle, DEA believes considering the economic utility of facilitating the manufacture of illicit fentanyl would be improper.
Controlling 4-piperidone is expected to prevent, curtail, and limit the unlawful manufacture and distribution of the controlled substance, fentanyl. As a list I chemical, handling of 4-piperidone requires registration with DEA and various controls and monitoring as required by the CSA. This rule is also expected to assist preventing the possible theft or diversion of 4-piperidone from any legitimate firms. DEA also believes control is necessary to prevent unscrupulous chemists from synthesizing 4-piperidone and selling it (as an unregulated material) through the internet and other channels, to individuals who may wish to acquire unregulated intermediary chemicals for the purpose of illicitly manufacturing fentanyl.
In summary, DEA conducted a qualitative analysis of costs and benefits. DEA believes this action will minimize the diversion of 4-piperidone. DEA believes the market for 4-piperidone for the legitimate manufacturing of pharmaceutical fentanyl is minimal. Therefore, any potential cost as a result of this regulation is minimal.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 Civil Justice Reform to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national Government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of E.O. 13175. This rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. As discussed above, 4-piperidone or a chemical mixture containing 4-piperidone shall be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. 4-Piperidone is a precursor chemical used in, and is important to, the illicit manufacture of the schedule II controlled substance fentanyl. The distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years. DEA has not identified any legitimate industrial use for 4-piperidone other than its role as an intermediary chemical in the production of fentanyl. However, DEA believes the vast majority, if not all, of legitimate pharmaceutical fentanyl is produced via a synthetic route involving NPP and ANPP as intermediaries, not 4-piperidone. The review of import and quota information for fentanyl, ANPP, and NPP supports this belief. Therefore, DEA believes the vast majority, if not all, of 4-piperidone is used for the illicit manufacturing of fentanyl. The primary costs associated with this rule are the annual registration fees ($3,699 for manufacturers and $1,850 for distributors, importers, and exporters). Additionally, any manufacturer that uses 4-piperidone for legitimate pharmaceutical fentanyl production would already be registered with DEA and have all security and other handling processes in place, resulting in minimal cost. DEA has identified 38 domestic suppliers of 4-piperidone, 37 of which are not registered with DEA to handle list I chemicals. All non-registered domestic suppliers are affected and are estimated to be small entities (based on Small Business Administration size standard for chemical distributors and Statistics of U.S. Business data).
On the basis of information contained in the “Regulatory Flexibility Act” section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501
This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.
This document of the Drug Enforcement Administration was signed on April 3, 2023 by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for
Administrative practice and procedure, Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1310 as follows:
21 U.S.C. 802, 827(h), 830, 871(b), 890.
(a) * * *
The addition reads as follows:
(g) * * *
(1) * * *
(xvi) 4-piperidone (piperidin-4-one), its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, and any combination thereof, whenever the existence of such is possible
(s)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to obtain a registration to manufacture, distribute, import, or export regulated 4-piperidone (piperidin-4-one), its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, and any combination thereof, whenever the existence of such is possible, including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing 4-piperidone pursuant to § 1310.13 on or before May 12, 2023. The exemption would remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.
(2) Any person who manufactures, distributes, imports, or exports a chemical mixture containing 4-piperidone (piperidin-4-one), its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, and any combination thereof, whenever the existence of such is possible whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose application for exemption is denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.
(c) * * *
Department of State.
Final rule and conforming revisions.
The Department of State is amending the International Traffic in Arms Regulations (ITAR) to expand the types of defense articles that may be exported and defense services that may be furnished pursuant to the Treaty between the Government of the United States of America and the Government of Australia Concerning Defense Trade Cooperation, the Treaty between the Government of the United States of America and the Government of the United Kingdom of Great Britain and Northern Ireland Concerning Defense Trade Cooperation, and the Canadian exemptions of the ITAR. The Department of State is also making clarifying amendments and conforming updates.
The rule is effective on May 12, 2023.
Mr. Dilan Wickrema, Office of Defense Trade Controls Policy, Department of State, telephone (202) 634-4981; email
The rules (Public Notice 7828, 77 FR 16591 & Public Notice 8270, 78 FR 21523), published on March 21, 2012 and April 11, 2013, respectively, amended the ITAR to implement the Treaty between the Government of the United States of America and the Government of Australia Concerning Defense Trade Cooperation (referred to herein as “the Australia DTC Treaty”) (Treaty Doc. 110-10) and the Treaty between the Government of the United States of America and the Government of the United Kingdom of Great Britain and Northern Ireland Concerning Defense Trade Cooperation (referred to herein as “the UK DTC Treaty”) (Treaty Doc. 110-7) (together referred to herein as “the Treaty exemptions”), and identified via Supplement No. 1 to part 126 the defense articles that may not be exported, and defense services that may not be furnished, through the use of the Treaty exemptions (ITAR §§ 126.16 and 126.17) and the Canadian exemptions (ITAR § 126.5).
The Department of State is now amending Supplement No. 1 to part 126 to expand the types of defense articles that may be exported, and defense services that may be furnished, pursuant to the Treaty exemptions and Canadian exemptions. The Department of State is implementing this amendment after a series of routine consultations with its interagency and international counterparts. This amendment is intended to ensure the Treaty exemptions and the Canadian exemptions continue to enhance operational capabilities, interoperability, and cooperation between the armed forces of the United States and its allies and partners. While future rulemaking will address other areas of the chart, this final rule implements four specific changes to Supplement No. 1 to part 126.
First, this final rule amends the 25th entry, identified as USML Category IV which previously excluded “[d]efense articles and services specific to torpedoes,” to exclude only “defense articles and services specific to the warhead or the sonar, guidance, and control section of torpedoes.” Second, this final rule amends the 105th entry, identified as USML Category XX(c), which previously excluded “[d]efense articles and services specific to submarine combat control systems,” to remove mounting racks and cabinets from that entry.
Third, this final rule amends the 60th entry, the 66th entry, and explanatory Note 9 to remove specific Underwater Acoustic Decoy Countermeasures (ADC) from Supplement No. 1 and clarify the note. Fourth, this final rule amends the 28th and 29th entries regarding USML Category IV(i) manufacturing know-how and the 67th-70th entries regarding USML Category XII night vision. The USML Category IV(i) technical data entries are amended to reflect the fact that USML Category IV(h) was previously updated (79 FR 34) to describe the specific subassemblies of other USML Category IV defense articles that remain ITAR-controlled. Similarly, the night vision entries are updated to reflect the fact that first generation image intensification tubes are not subject to the ITAR, some items previously controlled in paragraph (c) of Category XII moved to paragraph (e) in a prior rulemaking (81 FR 70340), and to clarify that the technical data and defense services entry only applies to paragraph (f) of Category XII.
The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules implementing this function are exempt from sections 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act (APA), pursuant to 5 U.S.C. 553(a)(1).
This rule is exempt from the notice-and-comment rulemaking provisions of 5 U.S.C. 553 as a foreign affairs function. Therefore, it does not require analysis under the Regulatory Flexibility Act.
This rulemaking does not involve a mandate that will result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions are deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rulemaking will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, is determined that this amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rulemaking.
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
The Department of State reviewed this rulemaking in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
The Department of State determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, Executive Order 13175 does not apply to this rulemaking.
This final rule does not impose or revise any new information collections subject to 44 U.S.C. chapter 35.
Arms and munitions, Exports.
For the reasons set forth above, the Department of State amends 22 CFR part 126 as follows:
22 U.S.C. 287c, 2651a, 2752, 2753, 2776, 2778, 2779, 2779a, 2780, 2791, 2797; Sec. 1225, Pub. L. 108-375, 118 Stat. 2091; Sec. 7045, Pub. L. 112-74, 125 Stat. 1232; Sec. 1250A, Pub. L 116-92, 133 Stat. 1665; Sec. 205, Pub. L. 116-94, 133 Stat. 3052; E.O. 13637, 78 FR 16129, 3 CFR, 2013 Comp., p. 223.
The revisions read as follows:
Treaty exemptions are:
(a) IR countermeasures;
(b) Classified techniques and capabilities;
(c) Exports for precision radio frequency (RF) location that directly or indirectly supports fire control and is used for situation awareness, target identification, target acquisition, and weapons targeting and radio direction finding capabilities. Precision RF location is defined as root mean square (RMS) angle of arrival accuracy of less than five degrees (5° RMS) and RF emitter location of less than ten percent (10%) range error;
(d) Providing the capability to reprogram; and
(e) Acoustics (including underwater), active and passive countermeasures, and counter-countermeasures other than the Underwater Acoustic Decoy Countermeasures (ADC) Mk 2 Mods 1 through 7.
Office of Foreign Assets Control, Treasury.
Publication of Web General Licenses.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing three general licenses (GLs) issued pursuant to the Libyan Sanctions program: GLs 5, 6, and 8A, each of which was previously made available on OFAC's website.
GL 5 was issued on April 26, 2011. See
OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Sanctions Compliance & Evaluation, 202-622-2490.
This document and additional information concerning OFAC are available on OFAC's website:
On April 26, 2011, OFAC issued GL 5 to authorize certain transactions otherwise prohibited by Executive Order (E.O.) 13566 of February 25, 2011, “Blocking Property and Prohibiting Certain Transactions Related to Libya” (76 FR 11315, March 2, 2011). On July 1, 2011, OFAC incorporated the prohibitions of E.O. 13566 into the Libyan Sanctions Regulations, 31 CFR part 570 (LSR). On August 19, 2011, OFAC issued GL 6 to authorize certain transactions otherwise prohibited by the LSR or E.O. 13566. On September 23, 2011, OFAC issued GL 8A to authorize certain transactions otherwise prohibited by the LSR. Each GL was made available on its website (
On December 16, 2011, OFAC issued GL 11 to unblock all property and interests in property of the Government of Libya, with which transactions were authorized pursuant to GL 8A. On August 8, 2012, the interim Transitional National Council of Libya, the internationally recognized Libyan government with which transactions were authorized pursuant to GLs 5 and 6, dissolved and transferred power to the Libyan General National Congress. OFAC is revoking GLs 5, 6, and 8A and
U.S. persons are authorized to engage in transactions with or involving Qatar Petroleum or the Vitol group of companies related to oil, gas, or petroleum products exported from Libya under the auspices of the Transitional National Council of Libya (the “TNC”), provided that neither the Government of Libya nor any other person whose property and interests in property are blocked—with the exception of Arab Gulf Oil Company (“Agoco”), as an entity operating in areas controlled by the TNC and under the auspices of the TNC—receives any benefit from such transactions.
U.S. persons purchasing oil, gas, or petroleum products from Qatar Petroleum or the Vitol group of companies pursuant to this general license are required to submit a report to the Office of Foreign Assets Control detailing such transactions within 30 days of the transactions, including information describing due diligence mechanisms to verify that neither the Government of Libya nor any other person whose property and interests in property are blocked, with the exception of Agoco, is receiving any benefits from such transactions. Reports should be submitted to the attention of the Licensing Division, Office of Foreign Assets Control, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW, Washington, DC 20220.
Dated: April 26, 2011.
On February 25, 2011, the President issued Executive Order 13566 (“E.O. 13566”) in response to the violent actions of Colonel Muammar Qadhafi and his government against the people of Libya, as well as to protect Libyan state assets from misappropriation. E.O. 13566 blocks all property and interests in property of, inter alia, the Government of Libya, its agencies, instrumentalities, and controlled entities, and the Central Bank of Libya, as well as all property in which Colonel Qadhafi, certain members of his family, and certain senior members of his regime have an interest, unless otherwise authorized. On July 15, 2011, the Secretary of State announced that, until an interim authority is in place, the United States recognizes the Transitional National Council of Libya as the legitimate governing authority for Libya. In light of this recognition, E.O. 13566's prohibitions now technically encompass the Transitional National Council of Libya, its agencies, instrumentalities, and controlled entities (the “TNC”), in addition to the Qadhafi regime, including its agencies, instrumentalities, and controlled entities. To address this, the Office of Foreign Assets Control is issuing the following general license to broadly authorize transactions with the TNC, as follows:
(a) Effective July 15, 2011, all transactions involving the TNC are authorized, subject to the following limitations:
(1) The transactions do not involve any other person whose property and interests in property are blocked; and
(2) All property and interests in property blocked pursuant to E.O. 13566 or the Libyan Sanctions Regulations as of August 19,2011, remain blocked.
(b) Except to the extent otherwise provided, all property and interests in property of the Qadhafi regime and persons who are included on OFAC's list of Specially Designated Nationals and Blocked Persons (the “SDN List”) remain blocked, and all transactions involving the Qadhafi regime and persons who are included on the SDN List, including the making of any contribution or provision of funds, goods, or services by them, to them, or for their benefit, continue to be prohibited.
Dated: August 19, 2011.
(a) General License No.8, dated September 19, 2011, is replaced and superseded in its entirety by this General License No. 8A.
(b) Effective September 19, 2011, all transactions involving the Government of Libya, its agencies, instrumentalities, and controlled entities, and the Central Bank of Libya are authorized, subject to the following limitations:
(1) All funds, including cash, securities, bank accounts, and investment accounts, and precious metals blocked pursuant to Executive Order 13566 of February 25, 2011, or the Libyan Sanctions Regulations, 31 CFR part 570, as of September 19, 2011, remain blocked, except as provided in General License No. 7A; and
(2) The transactions do not involve any persons listed on the Annex to this general license.
(c) Effective September 19, 2011, the authorization in paragraph (b) of this general license supersedes General License No. 1B.
Dated: September 23, 2011.
Postal Regulatory Commission.
Direct Final Rule.
The Commission is announcing an update to the Market Dominant and Competitive product lists. This action reflects a publication policy adopted by Commission rules. The referenced policy assumes periodic updates. The updates are identified in the body of this document. The Market Dominant and Competitive product lists, which are re-published in their entirety, include these updates.
This rule is effective May 30, 2023, without further action, unless adverse comment is received by May 12, 2023. If adverse comment is received, the Commission will publish a timely withdrawal of the rule in the
For additional information, this document can be accessed electronically through the Commission's website at
David A. Trissell, General Counsel, at 202-789-6800.
Pursuant to 39 U.S.C. 3642(d)(2) and 39 CFR 3040.103, the Commission provides a Notice of Update to Product Lists by listing all necessary modifications to both the Market Dominant and Competitive product lists between July 1, 2022 and December 31, 2022.
Pursuant to 39 CFR part 3040, the Commission maintains a Mail Classification Schedule (MCS) that includes rates, fees, and product descriptions for each Market Dominant and Competitive product, as well as product lists that categorize Postal Service products as either Market Dominant or Competitive.
Pursuant to 39 CFR 3040.103(d)(1), this Notice of Update to Product Lists identifies any modifications made to the Market Dominant or Competitive product list, including product additions, removals, and transfers.
The following list of products is being added to 39 CFR Appendix B to subpart A of part 3040—Competitive Product List:
The following list of products is being removed from 39 CFR Appendix B to Subpart A of Part 3040—Competitive Product List:
The above-referenced changes to the Competitive product list are incorporated into 39 CFR Appendix B to Subpart A of Part 3040.
1. Part 3040 of title 39, Code of Federal Regulations, is amended as set
2. The Secretary shall arrange for publication of the Notice in the
3. Interested persons may submit adverse comments no later than 30 days from the date of the publication of this Notice in the
4. If adverse comments are received, the Secretary will publish a timely withdrawal of the Notice in the
By the Commission.
Administrative practice and procedure, Postal Service.
For the reasons discussed in the preamble, the Postal Regulatory Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:
39 U.S.C. 503; 3622; 3631; 3642; 3682.
(An asterisk (*) indicates an organizational class or group, not a Postal Service product.)
(An asterisk (*) indicates an organizational class or group, not a Postal Service product.)
Environmental Protection Agency (EPA).
Final rule; notification of administrative change.
The U.S. Environmental Protection Agency (EPA) is updating the materials that are incorporated by reference (IBR) into the Mississippi State Implementation Plan (SIP). The regulations affected by this update have been previously submitted by Mississippi and approved by EPA. In this notice, EPA is also notifying the public of corrections to one of the Code of Federal Regulations (CFR) table that identifies material incorporated by reference into the Mississippi SIP. This update affects the materials that are available for public inspection at the National Archives and Records Administration (NARA) and the EPA Regional Office.
This rule is effective April 12, 2023.
The SIP materials whose incorporation by reference into 40 CFR part 52 is finalized through this action are available for inspection at the following locations: EPA, Region 4, 61 Forsyth Street SW, Atlanta, GA 30303 and
Sarah LaRocca, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. LaRocca can be reached via telephone at (404) 562-8994 or via electronic mail at
Each State has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.
Each State must formally adopt the control measures and strategies in the SIP after the public has had an opportunity to comment on them and then submit the proposed SIP revisions to EPA. Once these control measures and strategies are approved by EPA, and after notice and comment, they are incorporated into the federally approved SIP and are identified in part 52—“Approval and Promulgation of Implementation Plans,” Title 40 of the Code of Federal Regulations (40 CFR part 52). The full text of the State regulation approved by EPA is not reproduced in its entirety in 40 CFR part 52 but is “incorporated by reference.” This means that EPA has approved a given State regulation or specified changes to a given regulation with a specific effective date. The public is referred to the location of the full text version of the regulation(s) should they want to know which measures are contained in a given SIP. The information provided allows EPA and the public to monitor the extent to which a State implements a SIP to attain and maintain the NAAQS and to take enforcement action for violations of the SIP.
The SIP is a living document which the State can revise as necessary to address the unique air pollution problems in the State. Therefore, EPA from time to time must take action on proposed revisions containing new and/or revised regulations. A submission from a State can revise one or more rules in their entirety or portions of rules. The State indicates the changes in the submission (such as by using redline/strikethrough text), and EPA then takes action on the requested changes. EPA establishes a docket for its actions using a unique Docket Identification Number, which is listed in each action. These dockets and the complete submission are available for viewing on
On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference, into the Code of Federal Regulations (CFR), materials approved by EPA into each SIP. These changes revised the format for the identification of the SIP in 40 CFR part 52, streamlined the mechanisms for announcing EPA approval of revisions to a SIP, and streamlined the mechanisms for EPA's updating of the IBR information contained for each SIP in 40 CFR part 52. The revised procedures also called for EPA to maintain “SIP Compilations” that contain the federally approved regulations and source-specific permits submitted by each State agency. EPA generally updates these SIP Compilations on an annual basis. Under the revised procedures, EPA must periodically publish an informational document in the rules section of the
In this action, EPA is providing notice of an update to the materials incorporated by reference into the Mississippi SIP as of December 19, 2022, and identified in 40 CFR 52.1270(c). This update includes SIP materials approved by EPA since the last IBR update.
A. Correcting Table (c)'s title, from “
B. Correcting the header of paragraph (c), from “EPA-Approved Mississippi Regulations” to “EPA-Approved Mississippi Laws and Regulations”.
C. Correcting a typographical error in the CFR under 11 MAC Part 2—Chapter 1, Rule 1.9, changing the title “Stack Height Considerations.” to “Stack Height Considerations”.
D. Correcting a typographical error in the CFR under 11 MAC Part 2, Chapter 2, Rule 2.7, changing the title “Emission Evaluation Report” to “Emissions Evaluation Report”.
E. Correcting a typographical error in the CFR under Mississippi Code, Section 25-4-29, changing the title “Filing dates for statement” to “Filing dates for statements”.
F. Correcting a typographical error in the CFR under Mississippi Code, Section 25-4-105, changing the title “Certain actions, activities and business relationships prohibited or authorized; contacts in violation of section voidable; penalties” to “Certain actions, activities and business relationships prohibited or authorized; contracts in violation of section voidable; penalties”.
EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make an action effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This administrative action simply codifies provisions which are already in effect as a matter of law in Federal and approved State programs, makes typographical/ministerial revisions to a table in the CFR, and makes ministerial changes to the prefatory heading to the table in the CFR. Under section 553(b)(3)(B) of the APA, an agency may find good cause where procedures are “impracticable, unnecessary, or contrary to the public interest.” Public comment for this administrative action is “unnecessary” and “contrary to the public interest” since the codifications (and corrections) only reflect existing law. Immediate notice of this action in the
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on Tribal governments or preempt Tribal law.
The Congressional Review Act, 5 U.S.C. 801
EPA also believes that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. This is because prior EPA rulemaking actions for each individual component of the Mississippi SIP Compilation previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA believes judicial review of this action under section 307(b)(1) is not available.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(b)
(2) EPA Region 4 certifies that the rules/regulations provided by EPA in the SIP compilation at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated State rules/regulations which have been approved as part of the State Implementation Plan as of the dates referenced in paragraph (b)(1) of this section.
(3) Copies of the materials incorporated by reference may be inspected at the Region 4 EPA Office at 61 Forsyth Street SW, Atlanta, GA 30303. To obtain the material, please call (404) 562-9022. You may inspect the material with an EPA approval date prior to December 19, 2022, for Mississippi at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA email
(c)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; possession and trip limit implementation.
This action implements measures for the Northeast multispecies common pool fishery and other measures under Regional Administrator authority for the 2023 fishing year. This action is necessary to ensure that the Northeast multispecies common pool fishery may achieve the optimum yield for the relevant stocks, while controlling catch to help prevent in-season closures or quota overages. These measures include possession and trip limits, the allocation of zero trips into the Closed Area II Yellowtail Flounder/Haddock Special Access Program for common pool vessels to target yellowtail flounder, and the closure of the Regular B Days-at-Sea Program.
Effective at 0001 hours on May 1, 2023, through April 30, 2024.
Spencer Talmage, Fishery Policy Analyst, 978-281-9232.
The Northeast Multispecies Fishery Management Plan (FMP) regulations allow the Regional Administrator to implement possession limits for the common pool fishery, the U.S./Canada Management Area, and Special Management Programs. This action implements a number of these management measures for the 2023 fishing year, effective May 1, 2023.
Regulations at § 648.86(o) allow the Regional Administrator to implement or adjust a per-Day-at-Sea (DAS) possession limit and/or a maximum trip limit in order to prevent exceeding the common pool sub-annual catch limit (sub-ACL) in that fishing year. The possession and trip limits implemented for the start of the 2023 fishing year are included in Tables 1 and 2 below. These possession and trip limits were developed based on the common pool sub-ACLs that will be in effect on May 1, 2023, including those set by Framework Adjustment 63 to the FMP and those that are in place as default specifications consistent with the current regulations at § 648.90(a)(3). NMFS considered preliminary 2023 sector rosters, expected common pool participation, and common pool fishing activity in previous fishing years. NMFS will continue to monitor common pool catch through vessel trip reports, dealer-reported landings, vessel monitoring system catch reports, and other available information and, if necessary, will make further adjustments to common pool management measures based on common pool catch. NMFS may also make necessary changes to the common pool possession and trip limits in consideration of fishing year 2022 catch information in relation to any new catch limits approved in Framework 65.
Under default specification regulations, if the default specifications set at 75 percent of the previous year's amount exceed the Council's recommendations for any stock for the current year, the specifications for that stock shall be reduced to the Council's recommendations. During its December 2022 meeting, the New England Fishery Management Council adopted Framework Adjustment 65 to the Northeast Multispecies FMP, which, if approved, would modify the common pool sub-ACLs for several stocks. NMFS is working to publish a proposed rule to request comment on Framework 65, but the final rule for that action is not expected to be in effect until after the beginning of the fishing year. Consequently, default specifications will be in place until that rule is final, and, when developing the trip limits in this action, NMFS took into account Council-recommended sub-ACLs that may be implemented in Framework 65. The trip limits in this action were designed to not result in the common pool exceeding any sub-ACLs or trimester total allowable catch (TAC) that may be implemented by Framework 65. Based on this information, NMFS projects that these adjustments will facilitate optimized harvest of the common pool quotas, while preventing early trimester closures, and preventing catch from exceeding the 2022 fishing year sub-ACLs.
For Handgear A and Handgear B vessels, possession and trip limits for Georges Bank (GB) and Gulf of Maine (GOM) cod are tied to the possession and trip limits for groundfish DAS vessels. The default cod trip limit is 300 lb (136 kg) for Handgear A vessels and 75 lb (34 kg) for Handgear B vessels. If the GOM or GB cod limit for vessels fishing on a groundfish DAS drops below 300 lb (136 kg), then the respective Handgear A cod trip limit must be reduced to the same limit. Similarly, the Handgear B trip limit must be adjusted proportionally to the DAS limit (rounded up to the nearest 25 lb (11 kg)). In accordance with this process, the Handgear A and Handgear B possession and trip limits for GB and GOM cod are as listed below in Table 2.
Vessels with a Small Vessel category permit can possess up to 300 lb (136 kg) of cod, haddock, and yellowtail flounder, combined, per trip. Additionally, for these vessels, the trip limit for all stocks is equal to the landing limits per DAS applicable to multispecies DAS vessels. This is necessary to ensure that the trip limit applicable to the Small Vessel category permit is consistent with the trip limits for other common pool vessels, as described above.
Weekly quota monitoring reports for the common pool fishery can be found on NMFS' website at:
Table 3 includes the initial common pool trimester TACs for fishing year 2023. These trimester TACs are based on preliminary sector rosters. However, individual permit holders have until the end of the 2022 fishing year (April 30, 2023) to drop out of a sector and fish in the common pool fishery for the 2023 fishing year. Therefore, it is possible that the sector and common pool catch limits, including the trimester TACs, may change due to changes in sector rosters. If changes to sector rosters occur, updated catch limits and/or possession and trip limits will be announced as soon as possible in the 2023 fishing year to reflect the final sector rosters as of May 1, 2023. NMFS is working to publish a proposed rule to request comment on updated 2023 specifications as recommended by the New England Fishery Management Council in Framework Adjustment 65. If approved, Framework Adjustment 65 would make additional changes to common pool sub-ACLs. There could be changes to common pool trimester TACs and possession and trip limits as a result.
The regulations at § 648.85(b)(vii) allow the Regional Administrator to determine the total number of common pool trips that may be declared into the Closed Area II Yellowtail Flounder/Haddock Special Access Program (SAP) to target yellowtail flounder. This action allocates zero trips for common pool vessels to target yellowtail flounder within the Closed Area II Yellowtail Flounder/Haddock SAP for fishing year 2023. As a result, this SAP is only open to target haddock, from August 1, 2023, through January 31, 2024. Northeast multispecies vessels fishing in the SAP must fish with a haddock separator trawl, a Ruhle trawl, or hook gear.
The Regional Administrator determines the allocation of the total number of trips into the Closed Area II Yellowtail Flounder/Haddock SAP based on several criteria, including the GB yellowtail flounder catch limit and the amount of GB yellowtail flounder caught outside of the SAP. Allocating trips to target yellowtail flounder in the Closed Area II Yellowtail Flounder/Haddock SAP is discretionary if the available GB yellowtail flounder catch is insufficient to support at least 150 trips with a 15,000-lb (6,804-kg) trip limit, for a total catch of 2,250,000 lb (1,020,600 kg). This calculation considers projected catch from all vessels from the area outside the SAP. Based on the fishing year 2023 GB yellowtail flounder groundfish sub-ACL implemented by Framework Adjustment 63 of 220,462.3 lb (100,000 kg), there is insufficient GB yellowtail flounder to allocate any trips to the SAP. Further, given the low GB yellowtail flounder catch limit, catch rates outside of this SAP are more than adequate to fully harvest the 2023 GB yellowtail flounder allocation.
If approved, Framework Adjustment 65 would not change the 2023 GB yellowtail flounder sub-ACL. As a result, the final rule implementing Framework 65 is not expected to allocate trips to the SAP to target yellowtail flounder.
The regulations at § 648.85(b)(6)(vi) authorize the Regional Administrator to close the Regular B DAS program by prohibiting the use of Regular B DAS when the continuation of the program would undermine the achievement of the objectives of the Northeast Multispecies FMP or the Regular B DAS Program. One reason for terminating the program is an inability to constrain common pool catches to the Incidental Catch TACs.
Framework Adjustment 63 implemented Common Pool Incidental Catch TACs for the Regular B DAS Program for the 2022 fishing year (Table 4). These TACs are further divided into Quarterly Incidental Catch TACs to be monitored and managed during each calendar quarter.
Given that the Incidental Catch TACs allocated to the Regular B DAS Program for several stocks are very small, in-season management of the Regular B DAS Program is likely to be extremely difficult and impractical. Implementation of an in-season action to close the Regular B DAS Program once a Quarterly Incidental Catch TAC for a stock has been reached would not be possible to complete quickly enough to prevent further catch of that stock.
As a result, it is unlikely that catch can be effectively limited to the Incidental Catch TACs during fishing year 2023, and we project that continuation of the program would undermine the achievement of the objectives of the Northeast Multispecies FMP and the Regular B DAS Program. The Regular B DAS Program will be closed and use of Regular B DAS is prohibited for the 2023 fishing year, through April 30, 2024. This applies to all vessels issued a limited access Northeast multispecies permit.
This action is authorized by 50 CFR part 648 and is exempt from review under Executive Order 12866.
The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be contrary to the public interest and is unnecessary.
Regulations at § 648.86(o) authorize the Regional Administrator to adjust the Northeast multispecies possession and trip limits for common pool vessels in order to prevent the overharvest or under-harvest of the pertinent common pool quotas. This action sets the initial common pool possession and trip limits on May 1, 2023, for the 2023 fishing year. The possession and trip limits implemented through this action help to ensure that the Northeast multispecies common pool fishery may achieve the optimum yield for the relevant stocks, while controlling catch to help prevent in-season closures or quota overages. Delay of this action would leave the common pool fishery with the possession and trip limits found in § 648.86, which are too high to control catch. This would likely lead to early closure of a trimester and quota overages. Any overage of the quota for either of the first two trimesters must be deducted from the Trimester 3 quota, which could substantially disrupt the trimester structure and intent to distribute the fishery across the entire fishing year. An overage reduction in Trimester 3 would further reduce
The regulations at § 648.85(b)(3)(vii) require that the Regional Administrator announce the total number of allowed trips by common pool vessels that may be declared into the Closed Area II Yellowtail Flounder/Haddock SAP on or about June 1. The Regional Administrator's announcement is included in this action to meet this regulatory requirement. Doing so ensures that the fishing industry has sufficient notice in order to plan their activities in the new fishing year. This action occurs annually, and industry participants are accustomed to it and expect its timely implementation. Given the low quota for GB yellowtail flounder in recent years, no trips have been allocated to this SAP from fishing year 2010 to fishing year 2022.
The regulations at § 648.85(b)(6)(vi) authorize the Regional Administrator to close the Regular B DAS program by prohibiting the use of Regular B DAS when the continuation of the program would undermine the achievement of the objectives of the Northeast Multispecies FMP or the Regular B DAS Program. The Regular B DAS program closure implemented through this action will prevent an overage of the Incidental Catch TACs. Delay of this action would provide vessel owners an opportunity to participate in the Regular B DAS Program, but participation and catch in the program may cause the allocation to be exceeded. In addition to the adverse consequences that are against the public interest, delaying implementation of this action for prior notice and opportunity for comment is unnecessary. These processes were established with prior notice and opportunity for comment. They were established to provide for regular and timely implementation of necessary catch limits to avoid adverse economic or ecological consequences that are not in the public interest. Further, adjusting catch limits in accordance with current conditions and limits provides maximum fishing opportunities practicable that avoid excess catch that may result in overfishing. Fishing industry participants and other stakeholders expect these actions to occur annually and in-season. They are regular occurrences to which participants have become accustomed. For the reasons above, delay of this action for additional prior notice and the opportunity for public comment and the 30-day delayed effectiveness period are unnecessary and against the public interest because they would undermine management objectives of the FMP and cause unnecessary negative economic impacts to the common pool fishery.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification of quota transfer.
NMFS announces that the State of Maryland is transferring a portion of its 2023 commercial summer flounder quota to the State of New Jersey. This adjustment to the 2023 fishing year quota is necessary to comply with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan quota transfer provisions. This announcement informs the public of the revised 2023 commercial quotas for Maryland and New Jersey.
Effective April 11, 2023, through December 31, 2023.
Laura Deighan, Fishery Management Specialist, (978) 281-9184.
Regulations governing the summer flounder fishery are found in 50 CFR 648.100 through 648.110. These regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through North Carolina. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.102 and final 2023 allocations were published on January 3, 2023 (88 FR 11).
The final rule implementing Amendment 5 to the Summer Flounder Fishery Management Plan (FMP), as published in the
Maryland is transferring 1,105 lb (501 kg) to New Jersey through mutual agreement of the states. This transfer was requested to repay landings made by an out-of-state permitted vessel under a safe harbor agreement. The revised summer flounder quotas for 2023 are: Maryland, 901,109 lb (408,736 kg) and New Jersey, 2,305,822 lb (1,045,903 kg).
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 648.162(e)(1)(i) through (iii), which was issued pursuant to section 304(b), and is exempted from review under Executive Order 12866.
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule; correction.
This document corrects the preamble to a proposed rule published in the
Comments must be submitted on or before May 1, 2023.
Interested persons are invited to submit comments on the proposed rule of March 31, 2023. Comments may be submitted through the Federal eRulemaking Portal at
Barry Gomoll, USDA AMS; Telephone: (202) 720-8286; Email:
In the proposed rule, FR Doc #2023-06679, beginning on page 19229 in the issue of March 31, 2023, make the following corrections:
On page 19229, in the third column, in the document headings, correct the docket number to read: [Doc. No. AMS-AMS-22-0083].
On page 19229, in the third column, after the
All comments submitted in response to the proposed rule by the May 1, 2023, deadline will be included in the record and made available to the public. Please be advised that the substance of the comments and the identity of the individuals or entities submitting comments will be subject to public disclosure. AMS will make the comments publicly available on the internet via
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive 2021-23-13, which applies to all helicopters equipped with a radio (also known as radar) altimeter. AD 2021-23-13 requires revising the limitations section of the existing rotorcraft flight manual (RFM) for your helicopter to incorporate limitations prohibiting certain operations requiring radio altimeter data when in the presence of 5G C-Band interference in areas as identified by Notices to Air Missions (NOTAMs). Since the FAA issued AD 2021-23-13, the FAA determined that additional limitations are needed due to the continued deployment of new 5G C-Band base stations whose signals are expected to cover most of the contiguous United States at transmission frequencies between 3.7-3.98 GHz. This proposed AD would require revising the limitations section of the existing RFM to incorporate limitations prohibiting certain operations requiring radio altimeter data, due to the presence of 5G C-Band interference. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by May 12, 2023.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
David Swartz, Continued Operational Safety Technical Advisor, COS Program Management Section, Operational Safety Branch, FAA, 222 W. 7th Ave, M/S #14 Anchorage, AK 99513; phone: 817-222-5390; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this proposed AD.
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to David Swartz, Continued Operational Safety Technical Advisor, COS Program Management Section, Operational Safety Branch, FAA, 222 W. 7th Ave, M/S #14 Anchorage, AK 99513; phone: 817-222-5390; email:
The FAA issued Airworthiness Directive (AD) 2021-23-13, Amendment 39-21811 (86 FR 69992, December 9, 2021) (AD 2021-23-13), for all helicopters equipped with a radio altimeter. AD 2021-23-13 was prompted by a determination that radio altimeters cannot be relied upon to perform their intended function if they experience interference from wireless broadband operations in the 3.7-3.98 GHz frequency band (5G C-Band). AD 2021-23-13 requires revising the limitations section of the existing RFM to incorporate limitations prohibiting certain operations requiring radio altimeter data when in the presence of 5G C-Band interference as identified by NOTAMs. The agency issued AD 2021-23-13 because radio altimeter anomalies that are undetected by the automation or pilot, particularly close to the ground, could lead to loss of continued safe flight and landing.
On the same day, the FAA also issued AD 2022-23-12, Amendment 39-21810 (86 FR 69984, December 9, 2021) (AD 2021-23-12), to correct the same unsafe condition on, and require similar operating limitations for, all transport and commuter category airplanes equipped with a radio altimeter.
The FAA received and reviewed many more AMOC proposals from transport category airplane operators for AD 2021-23-12 than from helicopter operators for AD 2021-23-13. Some of the radio altimeters used on rotorcraft are the same model as, or similar to, the radio altimeters installed on transport category airplanes. As a result, the AMOC process for AD 2021-23-12 and AD 2021-23-13 also provided data about the varying levels of interference tolerance for a majority of radio altimeters on the market, allowing the FAA to understand the overall susceptibility to interference of the existing fleet of rotorcraft. In addition, the FAA learned about the aircraft alterations that can be accomplished quickly to improve a radio altimeter's tolerance to transmissions in adjacent or nearby spectrum bands. Now that the FAA better understands the performance of specific radio altimeters and the means to make them more tolerant of transmissions in adjacent or nearby spectrum bands, the FAA is proposing to retain the existing prohibitions in AD 2021-23-13 with an option to upgrade to a radio altimeter tolerant rotorcraft to avoid the prohibitions.
The FAA is concerned that 5G C-Band interference events will occur more frequently as telecommunication companies continue to deploy 5G C-
The FAA determined the proposed interference tolerance requirements by using the fuller understanding of specific radio altimeter capabilities the FAA gained during the AMOC process for AD 2021-23-12 and AD 2021-23-13. This process revealed the radio altimeter modifications that would not require a substantial system redesign, allowing aircraft operators to readily replace radio altimeters or install filters that allowed the aircraft to operate safely in a mitigated 5G environment.
The interference tolerance requirements are represented by a power spectral density (PSD) curve. The PSD curve, as depicted in figure 1 to paragraph (g)(1) of this proposed AD, represents the height over the ground and received power from a 5G C-Band emitter, at or below which the radio altimeter is expected to function reliably, measured in decibel-milliwatts (dBm) per megahertz (MHz). For purposes of this proposed AD, a “radio altimeter tolerant rotorcraft” is one for which the radio altimeter, as installed, demonstrates tolerance to radio altimeter interference at or above PSD curve threshold specified in figure 1 to paragraph (g)(1) of this proposed AD. A radio altimeter tolerant rotorcraft also demonstrates tolerance to an aggregate spurious emission level of -42 dBm/MHz in the 4200-4400 MHz radio altimeter band. For purposes of this proposed AD, a “non-radio altimeter tolerant rotorcraft” is one for which the radio altimeter, as installed, does not demonstrate those tolerances. Operators will have the option to upgrade to a radio altimeter tolerant rotorcraft if they wish to avoid the prohibitions in this proposed AD. Some operators may need to install filters between the radio altimeter and antenna to increase a radio altimeter's tolerance. For others, the addition of a filter will not be sufficient to address interference susceptibility; therefore, the radio altimeter will need to be replaced with an upgraded radio altimeter. The FAA has determined that radio altimeter tolerant rotorcraft are not expected to experience interference during a critical phase of flight in the contiguous U.S. airspace.
Therefore, the FAA has determined that an unsafe condition exists when performing certain operations in the presence of 5G C-Band transmissions affecting the proper function of radio altimeters. For that reason, operators would be required to revise their existing RFM to prohibit these operations unless operating a radio altimeter tolerant rotorcraft. This proposed requirement would take effect on July 1, 2023.
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
For rotorcraft with radio altimeters that meet the proposed interference tolerance requirements, this proposed AD would terminate the operational limitations imposed by AD 2021-23-13 with no further action.
For rotorcraft with radio altimeters that do not meet the proposed interference tolerance requirements, this proposed AD would retain the requirement in AD 2021-23-13 to revise the existing RFM to incorporate limitations prohibiting the following operations in the presence of 5G C-Band wireless broadband interference as identified by NOTAM (NOTAMs will be issued to state the specific airports where the radio altimeter is unreliable due to the presence of 5G C-Band wireless broadband interference) until June 30, 2023. On or before June 30, 2023, this proposed AD would also require, for non-radio altimeter tolerant rotorcraft, revising the existing RFM to incorporate limitations prohibiting these same operations in the contiguous U.S. airspace.
The FAA considers that this AD, if adopted as proposed, would be an interim action. Once the Technical Standard Order (TSO) standard for radio altimeters is established, which will follow the existing international technical consensus on the establishment of the minimum operational performance standards (MOPS), the FAA anticipates that the MOPS will be incorporated into the TSO. The FAA also anticipates that rotorcraft incorporating equipment approved under the new Radio Altimeter TSO will be able to operate in the contiguous U.S. airspace with no 5G C-Band-related RFM limitations. Once a new radio altimeter TSO is developed, approved, and available, the FAA might consider additional rulemaking.
The FAA estimates that this AD, if adopted as proposed, would affect 1,128 helicopters of U.S. registry. The FAA estimates the following costs to comply with this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA has determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by May 12, 2023.
This AD replaces AD 2021-23-13, Amendment 39-21811 (86 FR 69992, December 9, 2021) (AD 2021-23-13).
This AD applies to all helicopters, certificated in any category, equipped with a radio (also known as radar) altimeter. These radio altimeters are installed on various helicopter models including, but not limited to, the helicopters for which the design approval holder is identified in paragraphs (c)(1) through (20) of this AD.
Air Transport Association (ATA) of America Code 3444, Ground Proximity System.
This AD was prompted by determination that radio altimeters cannot be relied upon to perform their intended function if they experience interference from wireless broadband operations in the 3.7-3.98 GHz frequency band (5G C-Band). The FAA is issuing this AD because radio altimeter anomalies that are undetected by the automation or pilot, particularly close to the ground, could lead to loss of continued safe flight and landing.
Comply with this AD within the compliance times specified, unless already done.
(1) For purposes of this AD, a “radio altimeter tolerant rotorcraft” is one for which the radio altimeter, as installed, demonstrates the tolerances specified in paragraphs (g)(1)(i) and (ii) of this AD, using a method approved by the FAA. No actions are required by this AD for radio altimeter tolerant rotorcraft.
(i) Tolerance to radio altimeter interference at or above the power spectral density (PSD) curve threshold specified in figure 1 to paragraph (g)(1) of this AD.
(ii) Tolerance to an aggregate base station conducted spurious emission level of -42 dBm/MHz in the 4200-4400 MHz radio altimeter band.
(2) For purposes of this AD, a “non-radio altimeter tolerant rotorcraft” is one for which the radio altimeter, as installed, does not demonstrate the tolerances specified in paragraphs (g)(1)(i) and (ii) of this AD.
For non-radio altimeter tolerant rotorcraft: On or before January 4, 2022, revise the Limitations Section of the existing RFM for your helicopter by incorporating the limitations specified in figure 2 to paragraph (h) of this AD. This may be done by inserting a copy of this AD into the existing RFM for your helicopter. The action required by this paragraph may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417 or 14 CFR 135.439.
For non-radio altimeter tolerant rotorcraft, do the actions specified in paragraphs (i)(1) and (2) of this AD.
(1) On or before June 30, 2023, revise the Limitations Section of the existing RFM for your helicopter by including the information specified in figure 3 to paragraph (i) of this AD. This may be done by inserting a copy of this AD into the existing RFM for your helicopter. The action required by this paragraph may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417 or 14 CFR 135.439. Incorporating the RFM revision required by this paragraph terminates the RFM revision required by paragraph (h) of this AD.
(2) Before further flight after incorporating the limitations specified in figure 3 to paragraph (i) of this AD, remove the RFM revision required by paragraph (h) of this AD.
(1) The Manager, Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the Operational Safety Branch, send it to the attention of the person identified in paragraph (k) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
(3) AMOCs approved for AD 2021-23-13 are approved as AMOCs for the requirements specified in paragraph (h) of this AD until June 30, 2023.
For more information about this AD, contact David Swartz, Continued Operational Safety Technical Advisor, COS Program Management Section, Operational Safety Branch, FAA, 222 W. 7th Ave, M/S #14 Anchorage, AK 99513; phone: 817-222-5390; email:
None.
Coast Guard, DHS.
Notification of proposed rulemaking.
The Coast Guard proposes to modify the operating schedule that governs the Dearborn Street Bridge, mile 1.13, over the Main Branch of the Chicago River at Chicago, Illinois. During this maintenance period, the bridge need only operate one leaf while the other leaf remains secured to masted navigation. Vessels able to pass under the bridge without an opening may do so at any time. We invite your comments on this proposed rulemaking.
Comments and relate material must reach the Coast Guard on or before May 12, 2023.
You may submit comments identified by docket number USCG-2022-0989 using Federal Decision Making Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this temporary final rule, call or email: Mr. Lee D. Soule, Bridge Management Specialist, Ninth Coast Guard District; telephone 216-902-6085, email
The Dearborn Street Bridge, mile 1.13, spans the Main Branch of the Chicago River at Chicago, Illinois. The Dearborn Street Bridge, mile 1.13, over the Main Branch of the Chicago River provides a horizontal clearance of 200 feet and a vertical clearance of 22 feet above LWD. The bridges of Chicago are historic and all of them are over 100 years old and require frequent maintenance and repairs that occur with little warning. Typically, these repairs must be attended to immediately to protect the health and welfare of pedestrians crossing the bridges each day. The current bridge regulations for the Chicago River are contained in 33 CFR 117.391 and allows the bridges to open on signal if a 12-hour advance notice is provided by commercial vessels and a 20-hour advance notice by recreational vessel during posted times. The Chicago River bridges operate infrequently as almost all vessels can pass through the bridges without an opening. The exceptions are recreational sailing vessels that pass the bridge in City of Chicago sponsored flotillas twice a year; all affected sailing vessels can pass safely with one leaf open. Commercial vessels transits that require both bridge leaves to open are rare, occurring less than once a month on average. All vessels could detour through the Calumet River.
We propose a temporary change to the operation of the Dearborn Street Bridge, mile 1.13, over the Main Branch of the Chicago River at Chicago, Illinois. During the period from midnight on June 1, 2023, through noon on December 1, 2023, the Dearborn Street Bridge, mile 1.13, would only need to operate one leaf for the passage of vessels, while the other leaf is secured to masted navigation for maintenance. The effect of not performing the maintenance would be to deny the bridge to an estimated 10,000 persons commuting to work daily if repairs and required maintenance are not started in a timely manner.
On February 11, 2022, we published in the
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the ability that vessels can still transit the bridge with one leaf open and that most of the vessels can pass safely under the bridge without an opening or can pass through the bridge with only one draw open. Vessels could also detour around the bridge on the Calumet River.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under paragraph L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.
Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We accept anonymous comments. Comments we post to
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No. 0170.1, Revision No, 01.3.
(f) The Dearborn Street Bridge, mile 1.13, need only operate one leaf for the passage of vessels, while the other leaf is secured to masted navigation for maintenance.
Coast Guard, DHS.
Notification of proposed rulemaking.
The Coast Guard proposes to change the operating schedule that governs the US41 Bridge, mile 16.0, over the Keweenaw Waterway between the towns of Houghton and Hancock, Michigan. The Michigan Department of Transportation, who owns and operates the bridge, has requested a change to the drawbridge operation schedule to help facilitate the movement of all modes of transportation at the bridge. We invite your comments on this proposed rulemaking.
Comments and related material must reach the Coast Guard on or before June 12, 2023.
You may submit comments identified by docket number USCG-2022-0237 using Federal Decision-Making Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email Mr. Lee D. Soule, Bridge Management Specialist, Ninth Coast Guard District; telephone 216-902-6085, email
The US41 Bridge, mile 16.0, over the Keweenaw Waterway between the towns of Houghton and Hancock, Michigan, is owned and operated by MDOT and is the only crossing over the waterway. The US41 Bridge, mile 16.0, over the Keweenaw Waterway is a combination highway and railroad double deck lift bridge that provides a horizontal clearance of 7-feet in the down position, 103-feet in the open position, and 35-feet in the intermediate position above LWD.
The Keweenaw Waterway divides the Keweenaw Peninsula and is in the middle of the south shore of Lake Superior, a Great Lake known for hazardous weather conditions.
The federal government improved the Keweenaw Waterway in 1861 to accommodate interstate commerce and create a harbor of safe refuge for vessels caught in bad weather and is located halfway between Duluth, Minnesota and Sault Ste. Marie, Michigan. Commercial vessels, including some over 700-feet in length, and powered and non-powered recreational vessels utilize the waterway. The passenger vessel RANGER III operates from the east side of the US41 Bridge, mile 16.0, over the Keweenaw Waterway to Isle Royal and is operated by the National Park Service with a capacity of 128-passengers. A U.S. Coast Guard Station is located at the far west end of the waterway.
The bridge has special operating conditions listed in 33 CFR 117.635 that requires the bridge to open on signal; except that from April 15 through December 14, between midnight and 4 a.m., the draw shall be placed in the intermediate position and open on signal if at least 2 hours' notice is given. From December 15 through April 14 the draw shall open on signal if at least 12 hours' notice is given.
MDOT has requested a new operating schedule to relieve commuter and commercial vehicle traffic congestion at the bridge on weekdays; the new schedule will not apply to federal holidays. Traffic data impacted by COVID-19 restrictions would not provide the public with an accurate assessment of the traffic conditions at the bridge and have intentionally not been considered.
The MDOT requested three “rush hour restrictions for openings at the bridge to ease the traffic congestion at the crossing. During the test deviation we gathered data and proved there was not three rush hours at the bridge but rather a gradual increase throughout the day in the number of vehicles crossing the bridge. From there we developed a test deviation to gather data throughout the summer and developed the proposed rule.
On November 1, 2022, we published in the
The test deviation and how the public could comment was shared in the local online newspapers, television, and radio stations. The Coast Guard informally reached out to local government and local marine users before the test deviation was started to see what the perceived issues were at the bridge and how scheduled openings could help alleviate the disparities between vehicle crossings and vessel traffic.
The Coast Guard advertised the test deviation in the Local Notice to Mariners and a Broadcast Notice to Mariners that was also released. The Ninth Coast Guard Bridge Office also included the test deviation in its weekly bridge email that is shared with approximately 350 waterway users.
The Michigan Department of Transportation provided vehicle crossing data during the test deviation to discover if there were peak traffic hours often referred to as rush hours at this crossing. The following chart shows the vehicle data collected.
There is a traffic spike on June 15 and June 16 associated with a festival celebrating the bridge. Otherwise the data proves the delays at the bridge are not commensurate with traditional rush hour times and limiting bridge openings to three times a day would not help elevate congestion at the bridge. The bridge experiences a steady flow of traffic from 7 a.m. to 7 p.m.
Local politicians and law enforcement departments insisted that there are three definite rush hours at the bridge and limiting openings during those times would successfully improve the flow of traffic; however, the data provided does not support the theory of three distinct rush hours at the bridge. Based on the data above provided by the MDOT the flow of traffic increases from 6 a.m. to 4 p.m. and then it reduces without any significant spikes typical in a rush hour.
We analyzed the data from the test deviation using the drawtender logs to determine what class of vessel requested the most openings. Recreational vessels request openings 55 times between the hours of 7 a.m. and 7 p.m. and the Passenger vessel Ranger III requested 43 openings during the same times.
During the test deviation between 7 a.m. and 7 p.m., Monday through Friday, less federal holidays, vessels 300 feet and smaller were required to wait for an opening on the hour or half-hour. This limited bridge openings to a 20-minute period every hour allowing vehicles to cross the bridge during the other 40-minutes. The test deviation proved that the reasonable needs of navigation can still be met at the bridge with scheduled openings.
We invited the public to comment on this test deviation and we received three comments. Two commentors provided an analysis based on their personal preference without providing any supportive data. The third comment was from the National Parks Service—Isle Royale National Park.
The National Parks Service stated the test deviation did not provide any opportunity for stakeholder input prior to its implementation. However, in fact, the Coast Guard reached out directly to the park and the Passenger Vessel Ranger III when we reached out to local stake holders prior to developing a test schedule. With the assistance of the MDOT and local Coast Guard Units we received comments from the city of Houghton and Hancock, the Upper Peninsula Health Care Group, the Houghton County Board of Commissioners, the Aspirus Keweenaw Hospital, the Houghton County Sheriff Office, and the Michigan Department of State Police Calumet Post. Additionally, the local news outlets ran stories and interviews that the Coast Guard was considering a schedule that would help balance both land and waterway modes of travel at this crossing. Prior to the test deviation going into effect several news outlets published the test deviation to the public.
National Parks Service—Isle Royale National Park also commented that the temporary deviation negatively impacted their passenger vessel, the Ranger III, by adding expense to their services and claimed a significant inconvenience to passengers without providing any data on how delaying their arrival or departures by 10 or 15 minutes would adversely affect their services.
Almost 50% of the requested openings were from the Ranger III. The Ranger III is not the only issue delaying vehicular traffic, but it is a significant factor to consider if scheduled openings are needed at this location. Awarding the Ranger III clemency to the proposed bridge schedule would fail to balance the transportation needs at the bridge and would eliminate the need for scheduled bridge openings.
Commercial vessels over 300 feet and government vessels normally enter the waterway to service the aids to navigation and stock rock salt for the community. Large commercial vessels holding position in the canal along with recreational vessels is dangerous due to their size and limited maneuverability and will be passed through the draw of the bridge as soon as possible.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the ability that vessels can still transit the bridge twice an hour.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under paragraph L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.
Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal Decision Making Portal at
To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the
We accept anonymous comments. Comments we post to
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No. 0170.1, Revision No. 01.3.
The draw of the U.S. 41 Bridge, mile 16, shall open on signal, except that:
(a) From April 15 through December 14, between the hours of 7 a.m. and 7 p.m. Monday through Friday, less Federal Holidays, the bridge shall open on signal from five minutes before to five minutes after the hour and half hour for vessels. Documented vessels over 300-feet shall not be held at the bridge but will be passed as soon as possible.
(b) From April 15 through December 14 between midnight and 4 a.m. daily, the draw shall be placed in the intermediate position and open on signal if at least 2 hours' notice is given.
(c) From December 15 through April 14 the draw shall open on signal if at least 12 hours' notice is given.
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission) adopted a Notice of Proposed Rulemaking that would facilitate the integration of satellite and terrestrial networks by proposing a new regulatory framework for Supplemental Coverage from Space (SCS). Through this novel approach, satellite operators collaborating with terrestrial service providers would be able to obtain Commission authorization to operate space stations on currently licensed, flexible-use spectrum allocated to terrestrial services. This would enable expanded coverage to a terrestrial licensee's subscribers, especially in remote, unserved, and underserved areas, and would increase the availability of emergency communications.
Interested parties may file comments on or before May 12, 2023; and reply comments on or before June 12, 2023.
You may submit comments, identified by GN Docket No. 23-65 and IB Docket No. 22-271, by any of the following methods:
•
•
Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020).
For additional information on this proceeding, contact Melissa Conway of the Wireless Telecommunications Bureau, Mobility Division, at (202) 418-2887 or
This is a summary of the Commission's Notice of Proposed Rulemaking (
1. In this Notice of Proposed Rulemaking (
2. There is an evolving trend of partnerships between satellite service providers and terrestrial wireless service providers to facilitate this type of enhanced capability. Some collaborations rely on the use of spectrum currently allocated to satellite services to provide expanded service options to subscribers. A growing number of satellite companies are seeking to partner with mobile service providers to provide mobile satellite services through interoperable technologies. Such an approach proposes to rely on satellite operators using spectrum currently allocated for terrestrial mobile service that is exclusively-licensed to terrestrial service providers and subject to an existing terrestrial service regulatory framework, and therefore requires further Commission action to enable satellite use. Some satellite-terrestrial collaborations have requested waivers of various Commission rules in part 25 and the United States Table of Frequency Allocations (U.S. Table) to implement their proposed service. Other companies have received Commission authority to test communications between satellites and mobile devices.
3. Given the complexity of this undertaking, and particularly due to technical considerations, we confine our initial proposal to spectrum and locations where (1) there is only a single terrestrial entity that holds, either directly or indirectly, all co-channel licenses for the relevant frequencies in a given geographically independent area (GIA); and (2) there are no primary, non-flexible-use legacy incumbent operations (whether federal or non-federal) in the band. We seek comment on potentially extending our proposed framework to a range of alternative licensing scenarios.
4. Specifically, the Commission proposes to add a non-federal footnote to the U.S. Table authorizing mobile-satellite service operations on a co-primary basis with existing allocations in a number of terrestrial flexible-use bands. We propose to add the footnote allocation in bands where we are aware of at least one block of the band with an incumbent terrestrial licensee that holds all co-channel licenses throughout a GIA, sufficient to satisfy our proposed entry criteria. Under this proposal, the footnote would be used in each relevant band in lieu of adding a mobile-satellite service listing (
5. The flexible-use terrestrial bands for which we propose at this time to add a non-federal mobile-satellite service footnote allocation are: 600 MHz: 614-652 MHz and 663-698 MHz; 700 MHz: 698-758 MHz, 775 MHz-788 MHz, and 805-806 MHz; 800 MHz: 824-849 MHz and 869-894 MHz; Broadband PCS: 1850-1915 MHz and 1930-1995 MHz; AWS-H Block: 1915-1920 MHz and 1995-2000 MHz; and WCS: 2305-2320 MHz and 2345-2360 MHz. We believe these flexible-use terrestrial bands can benefit from provision of SCS because commercial wireless services have been deployed on these bands and because the bands include at least one spectrum block with an existing licensee that holds rights sufficient to provide the basis for a satellite applicant to satisfy our proposed entry criteria. We seek comment on the inclusion of each band (or block within a band) in our proposed framework. We also seek comment generally on this approach and any alternative methods of selecting bands that may be better suited to achieving the Commission's goals as set forth in this
6. We seek comment on whether we should adopt a footnote allocation that would permit mobile satellite use to communicate with fixed, as well as mobile, devices, and on whether we should expressly include an allocation for the proposed bands authorizing fixed-satellite service (FSS) operations in an SCS context or whether, as
7. To inform our review of the overall record, commenters should indicate the flexible-use bands in which they are currently, or are interested in, testing SCS capabilities. We seek comment on the status of such testing and prospective timelines for each proposed band. We also ask commenters to identify the type of communication contemplated,
8. We propose initially to limit our SCS framework to non-geostationary satellite orbit (NGSO) operators with an existing part 25 license or an existing part 25 grant of market access (for non-U.S. licensed satellite operators) (together, “authorization”), because such satellite operators are likely to rapidly deploy these space stations after receiving any needed modification to their existing authorizations to implement SCS. We believe that proposing this initial step presents the fewest practical and technical complexities and provides the most efficient path for enabling SCS in the near-term.
9.
10.
11. Under our proposed framework, meeting certain entry criteria would allow an entity to apply to modify its existing satellite authorization. We propose that this modification application (using FCC Form 312, Main Form and Schedule S) include a comprehensive proposal for each space station in the applicant's SCS system, together with applicable certifications regarding related pending SCS applications. We further propose that applications that are acceptable for filing be placed on public notice to provide interested parties an opportunity to file pleadings in response to the application. We seek comment on this proposed approach and on whether there is specific technical or other information that should be requested from applicants seeking a modification of a space station authorization to provide SCS.
12. We note that the bands we initially include in the proposed framework do not conform to the International Table. Given this non-conformance, we propose to modify § 25.112(a)(3) of our rules to permit the filing of applications notwithstanding the non-conformance. We seek comment on this approach, including the associated costs and benefits.
13. We seek comment as to whether an SCS framework should permit the filing of applications from licensees holding authorizations for geostationary satellite orbit (GSO) operation. Further, we seek comment on what part 25 rule amendments are necessary to reflect our proposed eligibility limitations placed on applicants seeking authority to provide SCS.
14. We propose to require the satellite operator's use of a terrestrial licensee's exclusive-use spectrum to be subject to a lease arrangement with that terrestrial licensee, coupled with the satellite operator's part 25 authorization. We seek comment on this proposal, including any associated costs and benefits. In the alternative, we seek comment on a similar entry criterion where the satellite operator, in lieu of a leasing arrangement pursuant to part 1 of the Commission's rules, has an operating agreement with a terrestrial licensee holding all necessary geographic area co-channel licenses. We also seek comment on other approaches for satellite operators to seek such authority particularly related to the timing for acquiring such rights.
15. Further, although we limit our initial proposal to modifications of existing NGSO satellite authorizations, we seek comment in the alternative on other approaches that might permit new satellite entrants to participate in this framework. We seek comment on what changes to existing part 25 rules would be necessary to facilitate the receipt and processing of applications for new entrants seeking to provide SCS in collaboration with a terrestrial partner, consistent with our proposed entry criteria that preclude the filing of mutually exclusive applications.
16. In addition to authorizing space station operations, we must also consider the appropriate method for authorizing terrestrial devices communicating with a space station. In this respect, the terrestrial devices would be operating as earth stations in a space radiocommunication service. We propose that a terrestrial licensee seeking to collaborate with a satellite operator to offer SCS must apply for and obtain a blanket earth station license for all of its subscribers' terrestrial devices that will be transmitting to space stations for SCS operations, and we seek comment on this approach and any other approaches that will be consistent with our statutory and international obligations. We also seek comment on how we can streamline earth station licensing processes and forms for SCS blanket earth station applications to eliminate any undue burden. We propose to modify our part 25 rules to
17. We seek comment on whether the terrestrial partner should be required in all cases to hold the part 25 blanket earth station license, or whether we should permit the space station licensee also to hold the earth station license associated with the terrestrial devices, provided other proposed entry criteria are met to give additional flexibility to the parties based on their business needs. We also propose that once the terrestrial licensee receives a part 25 blanket earth station license for its subscribers' terrestrial devices, it may avail itself of the minor modification procedures for blanket earth station licenses under part 25 to add additional terrestrial devices without prior Commission approval, and we seek comment on this approach. We also seek comment whether there is an alternative to the blanket earth station licensing approach that could more efficiently and effectively authorize SCS communications from terrestrial devices consistent with our international obligations and statutory mandates.
18.
19. Under certain leasing arrangements, our current rules allow a lessor to attribute the construction activities of its lessee to the lessor's performance requirements. We seek comment on whether such attribution rules should remain available to terrestrial licensees where SCS is intended to supplement existing terrestrial service to fill coverage gaps. Also, in the proposed framework, the license term of the part 25 licensee is unlikely to consistently align with the license term (and concomitant lease term) of the underlying terrestrial license. Given the integral nature of the lease-based collaboration between satellite operator and terrestrial licensee, we ask how we should account for differences in the length of a part 25 space station authorization to transmit and receive signals and the length of the associated lease, which is tied to the remaining term of the underlying terrestrial license.
20. We seek comment on whether to retain existing interference-related leasing rules in the context of our proposed SCS framework, and on how our proposed SCS framework should address the potential for severability of a lease agreement. We also seek comment on whether subleasing is appropriate in the proposed framework, which relies on the direct collaboration between the lessee and the lessor.
21. In July 2022, the Commission established the Enhanced Competition Incentive Program (ECIP), which among other things, modified the Commission's leasing rules to provide incentives for stakeholders to engage in qualifying transactions that make spectrum available in rural areas for advanced wireless services. Given that our proposed framework is primarily intended to facilitate SCS to existing consumer handsets, and ECIP was adopted with requirements tailored specifically towards provision of service through terrestrial base stations, we seek comment on whether to make SCS participants, necessarily engaged in leasing arrangements, eligible for ECIP benefits.
22. Finally, we seek comment on whether we should modify existing leasing rules related to the provision of 911 service.
23.
24. Second, we seek comment on how best to facilitate access to our nation's emergency response system for consumers using SCS. We seek comment on the technical and operational challenges, costs, and public interest benefits of extending wireless 911 requirements to CMRS providers and satellite providers that offer SCS. We also seek comment on whether it is technically or otherwise feasible for terrestrial service providers to satisfy the requirements in § 9.10 when incorporating their satellite operator collaborator's supplemental service, and if not, which particular requirements are not feasible and why. We also seek comment on whether we should revise our rules to require specific satellite operator compliance with certain 911 requirements.
25. We seek detailed information on the process by which SCS is activated when a consumer attempts to access 911 services during emergencies, including when no cellular or Wi-Fi service is available. We ask commenters to discuss how satellite providers would route 911 services, including voice and text-to-911. In addition, we seek comment on consumer expectations for using SCS to reach 911, and any consumer privacy concerns with SCS. We seek comment on standards development and best practices needed to facilitate 911 services using SCS, including who should develop them and required timelines. We also seek comment on the feasibility, availability, and cost of provisioning consumer devices to support SCS for 911. We seek comment on congestion issues that could be associated with SCS supporting 911 calls and texts.
26. The Commission's rules also require that providers of MSS to end-user customers comply with certain requirements regarding emergency call centers in certain circumstances and annual reporting requirements on call center traffic. We seek comment on how we should apply these current obligations in the context of an SCS offering.
27. We also seek comment on how satellite operators participating in anticipated collaborations with terrestrial licensees intend to support Wireless Emergency Alerts (WEA) and any accompanying public safety benefits. Conversely, we seek comment on whether satellite operators that supplement terrestrial wireless providers' coverage areas could adversely affect WEA's reliability and availability or change the nature of a provider's participation in WEA from in whole to in part if the SCS satellite operators were to not participate in WEA. We seek comment on satellite operators' technical capability to geographically target (geo-target) WEAs
28. Next, we seek comment on applying our existing secondary market policies on spectrum attribution and aggregation to the proposed satellite-terrestrial leasing framework. In other words, to the extent that a satellite operator leases spectrum that is attributed to the lessor for purposes of our existing secondary market aggregation policies, we ask whether that spectrum should be attributed to the satellite operator for the same purposes. We ask whether there are any additional competitive or public interest concerns that we should consider that would weigh in favor of placing limits on collaborations. We ask to what extent would authorizing SCS as proposed impact current commercial agreements (
29. Further, consistent with our proposed framework, a part 25 space station license that is modified to add SCS would retain whatever license term remains under its existing license, and a new part 25 blanket earth station license granted to provide SCS would be granted for a term of 15 years. A modification of an existing part 25 grant of market access to add SCS would not alter the effectiveness of that grant, but to continue operations to provide SCS in the United States, there would need to be a valid blanket U.S. earth station license for purposes of communicating with the non-U.S.-licensed space station with SCS market access. We seek comment on applying this approach in the SCS context, including its costs and benefits. Regarding renewal, we propose to apply current part 25 rules for modified part 25 licenses and for new blanket earth station licenses, and we seek comment on this approach.
30. We note that for terrestrial wireless service providers, § 1.949 of the Commission's rules provides that a licensee seeking renewal must file a renewal application and satisfy a renewal standard. We seek comment on whether we should amend our part 25 rules to require a similar renewal showing for a satellite operator seeking to renew a part 25 license that was modified under our proposed SCS framework. In addition, we seek comment on any relevant changes to the terrestrial licensee renewal rules.
31. Section 25.164 of the Commission's rules describes the milestones applicable to recipients of licenses for an NGSO satellite system. We propose to retain the satellite spectrum milestones applicable to current part 25 NGSO satellite operators to provide SCS. We seek comment on our proposal, including its costs and benefits. We also propose to apply the bond requirements applicable to current part 25 NGSO satellite operators to the satellite operators seeking to provide SCS. We seek comment on the applicability of a performance requirements for the earth stations licensed under the SCS framework.
32. We propose to retain the current part 25 rules regarding automatic termination of station authorizations to satellite licensees seeking to provide SCS jointly with a terrestrial collaborator. We also tentatively conclude that it is unnecessary to revise our parts 22, 24, and 27 rules related to permissible communications to enable the provision of SCS. We seek comment on this tentative conclusion.
33. Finally, we seek comment on whether any other existing service rule obligations applicable to terrestrial providers offering commercial service in the relevant flexible-use bands need to be addressed in our proposed part 25 licensing framework. We propose to apply current part 25 obligations to an applicant seeking authorization modification as part of a collaboration with a terrestrial licensee, such as § 25.114 requirements regarding applications for space station authorizations, including submitting a plan describing the design and operational strategies that will be used to mitigate orbital debris. We seek comment on this proposal. We also seek comment on whether—in jointly authorizing SCS through a satellite authorization modification and a lease of terrestrial exclusive-use licenses—the Commission should consider creating new or additional obligations in the public interest.
34.
35. We note that part 25 does not provide Power Flux Density (PFD) limits in terrestrially allocated bands at issue in this
36. To protect against harmful interference to adjacent band licensees, we propose to apply the existing Out of Band Emission (OOBE) limits for the relevant band of operation for satellite transmitters providing space-to-Earth transmissions. While § 25.202 provides a range of OOBE limits, from relaxed narrowband emissions to stringent emissions for other bands, we propose to implement the current terrestrial service rule OOBE limits deemed necessary to protect adjacent operations in the relevant bands of operation. We seek comment on how satellite downlinks meeting existing terrestrial OOBE limits would affect adjacent channel operations if the satellite downlinks become widespread. We also seek comment on the applicability of other technical limits that currently apply to terrestrial operations in each of the subject bands proposed for SCS.
37. The novel aspects of our proposal introduce new spectrum management challenges that warrant consideration, including the introduction of satellite downlinks and the continuing need to protect radio astronomy and other services that may be susceptible to signals emanating from the sky. We seek comment on whether existing rules addressing the protection of sensitive operations would be adequate in the context of the provision of SCS, and whether we should consider updated approaches to maintaining the unique characteristics of the areas covered by § 1.924 of our rules. We seek comment on all aspects of this issue so that we might facilitate SCS while preventing harmful interference to sensitive passive services, such as radio astronomy and Earth exploration.
38. We propose to maintain the current power limits applicable in each
39. Our terrestrial (parts 22, 24, and 27) and satellite (part 25) service rules require all transmitting devices to meet the relevant technical rules and receive equipment authorization. Accordingly, for new devices certified after the effective date of any rules adopted in this proceeding, we propose to require that the equipment certification applicant specifically seek certification under part 25 as well as the relevant terrestrial rule part(s) for all intended uses of the device. We seek comment on this proposal and any alternatives, including the costs and benefits. Also, we propose to treat as authorized-by-rule under part 25 existing terrestrial devices designed for use in the relevant flexible-use bands that are intended for SCS use, and we propose not to require a separate equipment authorization for such existing devices under part 2. However, if the Commission adopts rules for terrestrial devices that differ from existing rules that permit terrestrial operation (
40. We are aware that the 3GPP standards group is exploring similar applications of satellite service to handsets, which it refers to as NTN for broadband and narrowband Internet of Things (NB-IoT) applications. We seek comment and stakeholder input on the status of any work being done by 3GPP to address interference and other concerns associated with satellite-based operations in flexible-use spectrum currently designated for terrestrial networks, and whether any such work should be incorporated by the Commission through this proceeding. We seek comment on other efforts, both domestically and internationally, to establish standards or conduct related work regarding satellite service to handsets.
41. We propose to apply to SCS operations all existing signal level limits and coordination requirements that apply to the subject terrestrial bands. Any limit we ultimately adopt will be subject to current and future agreements reached with border countries. Further, as many of the terrestrial bands proposed for SCS are not allocated for mobile-satellite service use internationally, any such use would be considered a non-conforming use under the International Telecommunication Union (ITU) Radio Regulations. Further, use of the bands identified in this
42. We also recognize that interference metrics are different between satellites and terrestrial stations and that any interference analysis must be band-specific. Therefore, we seek comment on appropriate procedures for these analyses, as well as the relevant factors to include for specific bands. In implementing our proposal, we also seek comment on the viability of coordination between domestic satellite operators and terrestrial operators in bordering countries.
43. Finally, we note that certain bands under consideration in this
44. We seek comment on the potential for expanding our proposal to permit these innovative new operations in bands and in locations that do not meet the proposed entry criteria. Commenters are encouraged to address technical and legal concerns with each deviation from our proposal, and to offer suggestions on ways we can modify our proposed framework in a given scenario to enable increased provision of SCS.
45.
46.
47. We also seek comment on the unique circumstances regarding the 2.5 GHz band. Although some licenses from Auction 108 have been issued for the 2.5 GHz band, the results indicate that T-Mobile may ultimately hold most licenses for a given co-channel block in some GIAs. We note, however, that the band also hosts a large number of Educational Broadband Service licensees, many of which lease their spectrum rights to T-Mobile. Further, the Commission enabled Tribal Nations to obtain access to the band through a priority window prior to commencement of the 2.5 GHz auction. Accordingly, the auction results may not fully indicate the nature ofT-Mobile's holdings in the band. Given these complexities, we did not include the 2.5 GHz band in our proposal, but we seek comment on whether SCS would be viable in the 2.5 GHz band.
48.
49. Of particular technical concern in these scenarios is the difficulty with which satellite-based transmissions can abide by our field strength limits at license area boundaries. Further, depending on the angle of transmission between the satellite and the ground, the limit on emissions may in fact be exceeded above ground level, even if it not exceeded at ground level. We also note that where the area for which supplemental coverage is sought contains non-partner co-channel licensees, our current rules would require that the signal transmitted by the satellite satisfy the service-specific field strength limit or power flux density at the boundary of the co-channel licensee's adjacent license area. Our rules, however, specifically provide for adjacent market co-channel licensees to reach agreement to establish an alternative limit. We seek comment on whether this is a feasible option to overcome technical challenges presented in the context of newly introduced satellite-based transmissions where non-collaborating licensees are present.
50. Finally, in the event that we were to expand the scope of the SCS framework, we seek comment on how to assign responsibility for mitigating harmful interference between non-partner, co-channel terrestrial licensees and SCS operators in adjacent markets located within a GIA.
51. The framework for SCS proposed in this
52.
53. This
54. The Regulatory Flexibility Act of 1980, as amended (RFA), requires that an agency prepare a regulatory flexibility analysis for notice and comment rulemakings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” Accordingly, the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) concerning potential rule and policy changes contained in the Ninth Further Notice of Proposed Rulemaking. The IRFA is contained in Appendix B of the
55. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the policies and rules proposed in the Notice of Proposed Rulemaking (NPRM). Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments as specified in the
56. In the
57. The Commission's rules require the use of frequencies and frequency bands to be in accordance with the United States Table of Frequency Allocations (U.S. Table). To permit SCS to the subscribers of the relevant terrestrial networks using certain terrestrial bands, the Commission proposes to modify the U.S. Table to authorize mobile-satellite service (space-to-Earth and Earth-to-space) operations in certain terrestrial bands that have no primary, federal or non-federal satellite allocations. The Commission proposes to add a non-federal footnote to the U.S. Table authorizing mobile-satellite service operations on a co-primary basis with existing allocations in a number of terrestrial flexible-use bands. Specifically, given the complexity of the proposed approach (particularly in terms of technical considerations), the Commission limits its initial proposal to spectrum and locations where (1) there is only a single terrestrial entity that holds, either directly or indirectly, all co-channel licenses for the relevant frequencies in a given geographically independent area (GIA); and (2) there are no primary, non-flexible use legacy incumbent operations (whether federal or non-federal) in the band. The flexible-use terrestrial bands for which the Commission proposes at this time to add a non-federal mobile-satellite service footnote allocation are: 600 MHz: 614-652 MHz and 663-698 MHz; 700 MHz: 698-758 MHz, 775 MHz-788 MHz, and 805-806 MHz; 800 MHz: 824-849 MHz and 869-894 MHz; Broadband PCS: 1850-1915 MHz and 1930-1995 MHz; AWS-H Block: 1915-1920 MHz and 1995-2000 MHz; and WCS: 2305-2320 MHz and 2345-2360 MHz.
58. The
59. The Commission strives to realize the public interest benefits of SCS as rapidly as possible, while minimizing the risk of harmful interference. To avoid technical complexities that could arise where SCS is introduced in areas where multiple co-channel licensees are present on a particular spectrum block, the Commission proposes to initially authorize SCS only in cases where a single terrestrial licensee holds all co-channel licenses on the relevant band in one of the following GIAs: (1) the contiguous United States (CONUS); (2) Alaska; (3) Hawaii; (4) American Samoa; (5) Puerto Rico/U.S. Virgin Islands; and (6) Guam/Northern Mariana Islands. In addition, the Commission proposes initially to limit the SCS framework to non-geostationary satellite orbit (NGSO) satellite operators with an existing part 25 license or an existing part 25 grant of market access (for non-U.S. licensed satellite operators) (together, “authorization”), because such operators are best positioned for rapid implementation of supplemental coverage from space. To apply for authorization to provide SCS, a satellite operator with an existing part 25 authorization for NGSO operation must be able to certify that it has: (1) an application on file with the Commission to lease the exclusive-use spectrum, allocated for mobile-satellite service (MSS) provision of SCS, of a terrestrial licensee that holds all co-channel licenses throughout a GIA; (2) a current part 25 space station license or part 25 grant of market access for NGSO satellite operation sufficient to cover the GIA specified in the lease; and (3) proof of an application on file from the satellite operator's terrestrial partner for a part 25 blanket earth station license covering all of its subscribers' terrestrial devices that will be transmitting and receiving from the space station in conjunction with the provision of SCS. In addition to the proposed approach to authorizing space station operations, the
60. In the
61. The proposed action is authorized pursuant to sections 1, 4(i), 157, 301, 303, 307, 308, 309, and 310 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 301, 303, 307, 308, 309, and 310.
62. The RFA directs agencies to provide a description of, and where feasible, an estimate of, the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one that: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
63.
64. Next, the type of small entity described as a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” The Internal Revenue Service (IRS) uses a revenue benchmark of $50,000 or less to delineate its annual electronic filing requirements for small exempt organizations. Nationwide, for tax year 2020, there were approximately 447,689 small exempt organizations in the U.S. reporting revenues of $50,000 or less according to the registration and tax data for exempt organizations available from the IRS.
65. Finally, the small entity described as a “small governmental jurisdiction” is defined generally as “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” U.S. Census Bureau data from the 2017 Census of Governments indicate that there were 90,075 local governmental jurisdictions consisting of general purpose governments and special purpose governments in the United States. Of this number there were 36,931 general purpose governments (county, municipal and town or township) with populations of less than 50,000 and 12,040 special purpose governments—independent school districts with enrollment populations of less than 50,000. Accordingly, based on the 2017 U.S. Census of Governments data, we estimate that at least 48,971 entities fall into the category of “small governmental jurisdictions.”
66.
67.
68.
69. To effectuate SCS in certain flexible-use bands previously allocated solely for terrestrial use, the Commission proposes to authorize satellite-to-terrestrial (uplink and downlink) operations in these bands by allowing an NGSO satellite operator with an existing part 25 authorization to apply to modify such authorization where that entity meets certain prerequisites, or “entry criteria.” The proposed framework and requirements upon which the Commission seeks comment, if adopted, may impose new and/or additional reporting, recordkeeping and other compliance requirements on small entities as well as other licensees to allow those licensees seeking to provide SCS.
70. Specifically, the Commission proposes that a satellite operator authorized for NGSO satellite operation may apply to modify its part 25 authorization only if the satellite operator has: (1) an application on file with the Commission to lease the exclusive-use spectrum, allocated for MSS provision of SCS, of a terrestrial licensee that holds all co-channel licenses, directly or indirectly, throughout a GIA; (2) a current part 25 space station license or part 25 grant of market access for NGSO satellite operation sufficient to cover the leased GIA; and (3) proof of an application on file from the satellite operator's terrestrial partner for a part 25 blanket earth station license covering all of its subscribers' terrestrial devices that will be transmitting and receiving from the space station in conjunction with the provision of SCS.
71. Under the proposed framework, meeting the entry criteria would allow an entity to apply to modify its existing satellite authorization. However, all related applications including those seeking modification, lease applications, and blanket earth station applications—must first be granted to provide supplemental coverage from space. Thus, the requirements proposed in the
72. At this time, the Commission is not in a position to determine whether the proposed rules and associated requirements raised in the
73. The RFA requires an agency to describe any significant, specifically small business, alternatives for small businesses that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
74. The Commission has a longstanding commitment to ensuring that the country's scarce and valuable spectrum resource is put to its highest and best use. Consistent with this commitment, in the
75. Although the Commission limits its initial SCS framework proposal to NGSO operators with an existing part 25 license or an existing part 25 grant of market access (for non-U.S. licensed satellite operators) because these operators are in the best position to rapidly implement supplemental coverage from space, the Commission considered that there may be other alternatives, and in the
76. In the
77. As part of the SCS framework, the Commission proposes that a terrestrial licensee seeking to collaborate with a satellite operator to offer SCS must apply for and obtain a blanket earth station license for all of its subscribers' terrestrial devices that will be transmitting to space stations for SCS operations, and we seek comment on this approach and any other approaches that will be consistent with our statutory and international obligations. The Commission also seeks comment on how we can streamline earth station licensing processes and forms for SCS blanket earth station applications to eliminate any undue burden. For example, the
78. The
79. The ECIP rules were designed to facilitate broader access to wireless spectrum under two prongs: one focused on transactions with small carriers or tribal nations and one focused on transactions resulting in
80. Further, the Commission asks whether there are any additional competitive or public interest concerns that we should consider that would weigh in favor of placing limits on the proposed collaboration. The
81. Allowing smaller entities to collaborate to provide SCS service could facilitate increased small business participation. The Commission considered extending the provision of SCS to geographically independent areas where collaborating terrestrial licensees hold all co-channel licenses and seek to provide SCS and seeks comment on this alternative in the
82. In addition, the Commission considered scenarios where the geographic area subject to potential SCS contains non-partner, co-channel licensees in adjacent markets located within a GIA, which could impact small businesses. For example, a terrestrial wireless licensee that does not hold all co-channel licenses in a given GIA, for example CONUS, may nonetheless seek to partner with a satellite licensee to offer supplemental coverage in a part of CONUS. Such scenarios can present complex legal and technical challenges and the
83. The Commission expects to more fully consider the economic impact and alternatives for small entities following the review of comments and costs and benefits analyses filed in response to the
84. None.
Communications, Satellites, Telecommunications.
Administrative practice and procedure, Satellites. Federal Communications Commission.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 2 and 25 as follows:
47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted.
The revisions and additions read as follows:
(a) * * *
NG33A The bands 614-652 MHz and 663-758 MHz, 775 MHz-788 MHz, and 805-806 MHz, 824-849 MHz and 869-894 MHz, 1850-1920 MHz and 1930-2000 MHz, and 2305-2320 MHz and 2345-2360 MHz are allocated to the mobile-satellite service (MSS) on a co-primary basis. MSS operations in these frequency bands are subject to the Commission's rules for Supplemental Coverage from Space set forth in part 25 of this chapter.
47 U.S.C. 154, 301, 302, 303, 307, 309, 310, 319, 332, 605, and 721, unless otherwise noted.
(f) Space and earth stations providing Supplemental Coverage from Space are subject to technical rules in parts 22, 24, and 27 of this chapter where applicable.
(a) * * *
(3) The application requests authority to operate a space station in a frequency band that is not allocated internationally for such operations under the Radio Regulations of the International Telecommunication Union, unless the application is filed pursuant to §§ 25.122, 25.123, or 25.125.
(q) A blanket license application for an earth station authorization to provide Supplemental Coverage from Space must comply with § 25.125.
(i) An application for modification of a space station authorization to provide Supplemental Coverage from Space must comply with § 25.125.
(a)
(b)
(1) The application shall include a certification to the following:
(i) an application is on file with the Commission to lease spectrum allocated for MSS provision of SCS from a terrestrial mobile service provider that holds, either directly or indirectly, all co-channel licenses throughout a GIA;
(ii) the current part 25 space station license or part 25 grant of market access for NGSO satellite operation is sufficient to cover the leased GIA; and
(iii) a blanket license application is on file, pursuant to paragraph (c) of this section, from the satellite operator's terrestrial licensee partner for earth stations, covering all of its subscribers' terrestrial devices that will be transmitting and receiving from the space station in conjunction with the provision of SCS.
(2) The application shall include a comprehensive proposal for each space station in the proposed SCS system on FCC Form 312, Main Form and Schedule S, as described in § 25.114(a) through (d), together with the certification described in paragraph (b)(1) of this section.
(3) Applications that are acceptable for filing will be placed on public notice pursuant to § 25.151 to provide interested parties an opportunity to file pleadings in response to the application pursuant to § 25.154.
(4) The Commission will review the application and all the pleadings filed in response to the application, and will grant applications that meet the standards of this section, § 25.156(a), and are otherwise in accordance with applicable Commission rules.
(5) Applications to modify a part 25 authorization to provide SCS will not be subject to the processing round procedures in §§ 25.137 and 25.157.
(c)
(1) The terrestrial licensee must file for such earth station authorization using FCC Form 312, Main Form and Schedule B, as described in § 25.115(a), specifying the number of units to be covered by the blanket license.
(2) Applications that are acceptable for filing will be placed on public notice pursuant to § 25.151 to provide interested parties an opportunity to file pleadings in response to the application pursuant to § 25.154.
(3) The Commission will review the application and all the pleadings filed in response to the application, and will grant applications that meet the
(4) Once the terrestrial licensee receives a part 25 blanket license for its subscribers' terrestrial devices, it may avail itself of the minor modification procedures for blanket earth station licenses pursuant to § 25.118 to add additional terrestrial devices without prior Commission approval.
(d)
(e)
(1) Each SCS earth station used for the provision of SCS under this section shall meet the equipment authorization requirements under § 25.129 and all equipment authorization requirements for all intended uses of the device as specified in parts 22, 24, and 27 of this chapter (
(2) Terrestrial devices with existing equipment authorizations under parts 22, 24, or 27 of this chapter as of [[EFFECTIVE DATE OF FINAL RULE]] are authorized by rule for SCS use under this section, consistent with their existing equipment authorizations.
(e) Earth station transceivers used for the provision of SCS shall comply with § 25.125.
(f) A non-U.S.-licensed space station operator that has been granted access to the United States market pursuant to a declaratory ruling may modify its U.S. operations under the procedures set forth in §§ 25.117(d), (h), and (i) and 25.118(e).
(k) Space station downlinks operating as SCS under the provisions of NG33A of the U.S. Table of Allocations and § 25.125 are subject to the following rules.
(1)
(2) Reserved.
(g) Earth stations operating in conjunction with the provision of SCS pursuant to § 25.125 shall comply with the power requirements for the respective band of operation of the terrestrial partner for terrestrial transceivers in parts 22, 24, or 27 of this chapter (
(w) SCS operations in bands authorized by NG33A in the Table of Frequency Allocations and § 25.125 must meet the relevant boundary signal level limits and coordination requirements for the relevant terrestrial band of operation, as specified by treaty and in parts 22, 24, and 27 of this chapter (
U.S. Codex Office, USDA.
Notice of public meeting and request for comments.
The U.S. Codex Office is sponsoring a public meeting on May 16, 2023 from 10 a.m.-12 p.m. EDT. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 42nd Session of the Codex Committee on Methods of Analysis and Sampling (CCMAS) of the Codex Alimentarius Commission (CAC), which will meet in Budapest, Hungary from June 6-13, 2023. The U.S. Manager for Codex Alimentarius and the Under Secretary for Trade and Foreign Agricultural Affairs recognize the importance of providing interested parties the opportunity to obtain background information on the 42nd Session of the CCMAS and to address items on the agenda.
The public meeting is scheduled for May 16, 2023, from 10 a.m.-12 p.m. EDT.
The public meeting will take place via Video Teleconference only. Documents related to the 42nd Session of the CCMAS will be accessible via the internet at the following address:
Dr. Patrick Gray, U.S. Delegate to the 42nd Session of the CCMAS, invites interested U.S. parties to submit their comments electronically to the following email address:
For further information about the 42nd session of CCMAS, contact U.S. Delegate, Dr. Patrick Gray, Research Chemist, Center for Food Safety and Applied Nutrition, Office of Regulatory Science, U.S. Food and Drug Administration, (240) 402-5026,
The Codex Alimentarius Commission was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The Terms of Reference for the Codex Committee on Methods of Analysis and Sampling are:
(a) to define the criteria appropriate to Codex Methods of Analysis and Sampling;
(b) to serve as a coordinating body for Codex with other international groups working in methods of analysis and sampling and quality assurance systems for laboratories;
(c) to specify, on the basis of final recommendations submitted to it by the other bodies referred to in (b) above, Reference Methods of Analysis and Sampling appropriate to Codex Standards which are generally applicable to a number of foods;
(d) to consider, amend, if necessary, and endorse, as appropriate, methods of analysis and sampling proposed by Codex (Commodity) Committees, except that methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives, do not fall within the terms of reference of this Committee;
(e) to elaborate sampling plans and procedures, as may be required;
(f) to consider specific sampling and analysis problems submitted to it by the Commission or any of its Committees; and,
(g) to define procedures, protocols, guidelines or related texts for the assessment of food laboratory proficiency, as well as quality assurance systems for laboratories.
The CCMAS is hosted by Hungary. The United States attends the CCMAS as a member country of Codex.
The following items on the agenda for the 42nd Session of the CCMAS will be discussed during the public meeting:
At the public meeting on May 16, 2023, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Dr. Patrick Gray, U.S. Delegate to the 42nd Session of the CCMAS (see
Public awareness of all segments of rulemaking and policy development is
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved information collection in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) for the reporting and record-keeping burdens associated with the WIC Program regulations.
Written comments must be received on or before June 12, 2023.
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.
The Food and Nutrition Service, USDA, invites interested persons to submit written comment.
•
•
•
All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Allison Post at 703-457-7708.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
The reporting and record-keeping burdens covered by this information collection include requirements that involve the certification of WIC participants; the nutrition education that is provided to participants; the processing of sanctions, complaints, and appeals; the household requirement to pick up food instruments and CVVs outside of scheduled recertification and nutrition education clinic visits; the authorization, training and monitoring of vendors; and the collection of vendor pricing information in order to comply with the Federal regulations regarding WIC cost containment. State Plans are the principal source of information about how each State agency operates its WIC Program. Information collected from participants and local agencies is collected through State-developed forms or Management Information Systems. The information collected is used by the Department of Agriculture to manage, plan, evaluate, make decisions, and report on WIC program operations. This information collection is requesting a revision in the burden hours due to program changes and adjustments that primarily reflect the inclusion of programmatic requirements that are being included in this ICR for the first time and expected changes in the number of WIC participants; WIC authorized vendors; and WIC State and local agencies. The revisions increased the approved reporting burden by
Forest Service, Agriculture (USDA).
Notice of meeting.
The Black Hills National Forest Advisory Board will hold a federal advisory committee meeting according to the details shown below. The committee is authorized under the Forest and Rangeland Renewable Resources Planning Act of 1974, the National Forest Management Act of 1976, the Federal Public Lands Recreation Enhancement Act, and operates in compliance with the Federal Advisory Committee Act (FACA). The advisory board information and meeting details can be found at the following website:
All RAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received upon request.
Bryan Karchut, Designated Federal Officer (DFO), by phone at 605-673-9201 or email at
The purpose of the meeting is to discuss:
1. Black Elk Wilderness Area;
2. Fire Season 2023 Update;
3. Long Eared Bat Reclassification; and
4. Forest Plan Revision.
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Committee. To ensure that the recommendations of the Committee have taken into account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women and persons with disabilities. USDA is an equal opportunity provider, employer, and lender.
Forest Service, Agriculture (USDA).
Notice.
This notice lists the newspapers that will be used by the Ranger Districts, Forests and Regional Office of the Eastern Region to publish legal notices required under Agency regulations. The intended effect of this action is to inform interested members of the public which newspapers the Forest Service will use to publish notices of proposed actions and notices of decisions. This will provide the public with constructive notice of Forest Service proposals and decisions, provide information on the procedures to comment, object, or appeal, and establish the date that the Forest Service will use to determine if comments, appeals, or objections were timely.
Publication of legal notices in the listed newspapers begins on the date of this publication. This list of newspapers will remain in effect until a new list is published in the
Matthew St. Pierre, Administrative Review Specialist, Eastern Region, 626 E. Wisconsin Avenue, Milwaukee, Wisconsin 53202, by email at
The administrative procedures at 36 CFR 218, and 219 require the Forest Service to publish notices in a newspaper of general circulation. The content of the notices is specified in 36 CFR 218 and 219. In general, the notices will identify: The decision or project by title or subject matter, the name and title of the official making the decision, how to obtain additional information, and where and how to file comments or appeals/objection. The date the notice is published will be used to establish the official date for the beginning of the comment, appeal, or objection period.
Regional Forester Notices for Comments and Decisions and Objections affecting National Forest System lands in the Eastern Region, in the states of Illinois, Indiana, Ohio, Michigan, Minnesota, Missouri, New Hampshire, Maine, Pennsylvania, Vermont, New York, West Virginia, and Wisconsin:
Allegheny Forest Supervisor Decisions:
District Ranger Decisions for Bradford District:
District Ranger Decisions for Marienville District:
Chequamegon-Nicolet Forest Supervisor Decisions:
District Ranger Decisions for Eagle River-Florence District and Lakewood-Laona District:
District Ranger Decisions for Great Divide District and Washburn District:
District Ranger Decisions for the Medford-Park Falls District:
Chippewa Forest Supervisor Decisions:
District Ranger Decisions for the Blackduck District:
District Ranger Decisions for the Deer River District:
District Ranger Decisions for the Walker District:
Superior Forest Supervisor Decisions:
District Ranger Decisions for the Gunflint District:
District Ranger Decisions for the Kawishiwi District:
District Ranger Decisions for the LaCroix District and Laurentian District:
District Ranger Decisions for the Tofte District:
Green Mountain Forest Supervisor Decisions:
District Ranger Decisions for the Manchester District, Middlebury District and Rochester. District:
Finger Lakes Forest Supervisor Decisions:
District Ranger Decisions for the Hector District:
Hiawatha Forest Supervisor Decisions:
District Ranger Decisions for the Rapid River District and Manistique District:
District Ranger Decisions for the Munising District:
District Ranger Decisions for the St. Ignace District and Sault Ste. Marie District:
Huron-Manistee Forest Supervisor Decisions:
District Ranger Decisions for the Baldwin-White Cloud Districts:
District Ranger Decisions for the Cadillac-Manistee Districts:
District Ranger Decisions for the Mio District:
District Ranger Decisions for the Huron Shores District:
District Ranger Decisions for the Bergland District, Bessemer District, Kenton District.
Ontonagon District, and Watersmeet Districts:
Hoosier Forest Supervisor Decisions:
District Ranger Decisions for the Brownstone District:
District Ranger Decisions for the Tell City District:
Mark Twain Forest Supervisor Decisions:
District Ranger Decisions for the Ava/Cassville/Willow Springs District:
District Ranger Decisions for the Cedar Creek District:
District Ranger Decisions for the Eleven Point District:
District Ranger Decisions for the Rolla District and Houston District:
District Ranger Decisions for the Poplar Bluff District:
District Ranger Decisions for the Potosi District:
District Ranger Decisions for the Fredericktown District:
District Ranger Decisions for the Salem District:
Midewin Prairie Supervisor Decisions:
Shawnee Forest Supervisor Decisions:
District Ranger Decisions for the Hidden Springs District and Mississippi Bluffs Districts:
Monongahela Forest Supervisor Decisions:
District Ranger Decisions for the Cheat-Potomac District:
District Ranger Decisions for the Gauley District:
District Ranger Decisions for the Greenbrier District and the Marlinton-White Sulphur District:
Wayne Forest Supervisor Decisions:
District Ranger Decisions for the Athens District:
District Ranger Decisions for the Ironton District:
White Mountain Forest Supervisor Decisions affecting National Forest System lands in New Hampshire:
White Mountain Forest Supervisor Decisions affecting only National Forest System lands in Maine:
District Ranger Decisions for the Androscoggin District and Saco District:
District Ranger Decisions for the Androscoggin District and Saco District affecting only National Forest System lands in Maine:
District Ranger Decisions for the Pemigewasset District:
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Nebraska Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a series of buriness meetings via web conference. The purpose of the meetings will be to discuss panel planning as part of their project on the Effects of Covid-19 on Education in the state.
Wednesday, April 26, 2023 at 12:30 p.m. Central Time and Thursday, May 25, 2023, at 4 p.m. Central Time.
The meetings will be held via Zoom.
Registration Link (Audio/Visual):
Join by Phone (Audio Only): 1-833-435-1820 USA Toll Free; Meeting ID: 161 382 8405.
Registration Link (Audio/Visual):
Join by Phone (Audio Only) 1-833-435-1820 USA Toll Free; Meeting ID: 160 402 9919.
Victoria Moreno, DFO, at
Members of the public may listen to the discussions through the above call-in numbers (audio only) or online registration links (audio/visual). An open comment period at each meeting will be provided to allow members of the public to make a statement as time allows. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Individuals who are deaf, deafblind, and/or hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and meeting ID number.
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meetings. Written comments may be emailed to Victoria at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meetings. Records of the meetings will be available via
On December 8, 2022, the CODEZOL, C.D., grantee of FTZ 163, submitted a notification of proposed production activity to the FTZ Board on behalf of Global Manufacturing LLC, within FTZ 163, in Ponce, Puerto Rico.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On December 7, 2022, CNH Industrial America LLC submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 41I, in Sturtevant, Wisconsin.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On December 8, 2022, United Safety Technology Corp submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 74D, in Sparrows Point, Maryland.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that Cellpage Ventures Private Limited (Cellpage) made sales of certain lined paper products from India at prices below normal value, and Navneet Education Ltd. (Navneet) did not, during the period of review (POR) September 1, 2020, through August 31, 2021.
Applicable April 12, 2023.
Samuel Brummitt, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7851.
On October 6, 2022, Commerce published the
The products covered by this
As noted in the
For these final results, we continue to find that Magic International Pvt. Ltd. and Marisa International withheld information requested by Commerce, failed to provide the requested information in a timely manner, and significantly impeded the proceeding, warranting a determination on the basis of the facts available under section 776(a) of the Act. Therefore, we continue to find that Magic International Pvt. Ltd. and Marisa International have not acted to the best of their ability and the application of adverse facts available, pursuant to section 776(b) of the Act, is warranted. No parties submitted comments regarding our preliminary determination to apply adverse facts available to Magic International Pvt. Ltd. and Marisa International.
For the rate for non-selected respondents in an administrative review, generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy investigation. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero or
All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues that parties raised and to which we responded in the Issues and Decision Memorandum is attached at Appendix I to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on a review of the record and comments received from interested parties regarding the
Commerce determines that the following weighted-average dumping margins exist for the period September 1, 2020, through August 31, 2021:
Commerce intends to disclose the calculations performed for these final results to interested parties in this review under administrative protective order within five days after the date of publication of this notice in the
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Pursuant to 19 CFR 351.212(b)(1), for Cellpage and Navneet, we calculated importer-specific antidumping duty assessment rates by aggregating the total amount of dumping calculated for the examined sales of each importer and dividing each of these amounts by the total entered value associated with those sales. Where either the respondent's weighted-average dumping margin is zero or
Commerce's “automatic assessment” will apply to entries of subject merchandise during the POR for which the examined companies did not know that the merchandise they sold to an intermediary (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered entered, or withdrawn from warehouse, for consumption on or after the date of the final results of this administrative review, as provided for by section 751(a)(2)(C) of the Act: (1) the cash deposit rates for the companies identified above in the “Final Results of Review” section will be equal to the company-specific weighted-average dumping margin established in the final results of this administrative review; for merchandise exported by a company not covered in this administrative review but covered in a completed prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review or completed prior segment of this proceeding but the producer is, the cash deposit rate will be the company-specific rate established for the most recently-completed segment of this proceeding for the producer of the subject merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 3.91 percent, the all-others rate established in the investigation of this proceeding.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Commerce's presumption that reimbursement of antidumping and/or countervailing duties has occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a final reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5) and 19 CFR 351.213(h)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Notice; correction.
The U.S. Department of Commerce (Commerce) published a notice in the
Mary Kolberg, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1785.
In the
On March 9, 2023, Commerce published in the
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of determinations by the U.S. Department of Commerce (Commerce) that termination of the Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation (Agreement) and the suspended investigation on uranium from the Russian Federation (Russia) would likely lead to continuation or recurrence of dumping, and by the U.S. International Trade Commission (ITC) that termination of the suspended investigation would likely lead to material injury to an industry in the United States, Commerce is publishing this notice of continuation of the Agreement.
Applicable April 12, 2023.
Sally C. Gannon or Jill Buckles, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0162 or (202) 482-6230, respectively.
On September 1, 2022, Commerce initiated the fifth sunset review of the suspended antidumping duty investigation on uranium from the Russian Federation (Russia), pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).
The product covered by the Agreement is natural uranium in the form of uranium ores and concentrates; natural uranium metal and natural uranium compounds; alloys, dispersions (including cermets), ceramic products, and mixtures containing natural uranium or natural uranium compounds; uranium enriched in U
Uranium ore from Russia that is milled into U
For purposes of this Agreement, uranium enriched in U
HEU is within the scope of the underlying investigation, and HEU is covered by this Agreement. For the purpose of this Agreement, HEU means uranium enriched to 20 percent or greater in the isotope uranium-235.
Imports of uranium ores and concentrates, natural uranium compounds, and all forms of enriched uranium are currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 2612.10.00, 2844.10.20, 2844.20.00, respectively. Imports of natural uranium metal and forms of natural uranium other than compounds are currently classifiable under HTSUS subheadings: 2844.10.10 and 2844.10.50. HTSUS subheadings are provided for convenience and Customs purposes. The written description of the scope of this proceeding is dispositive.
As a result of the respective determinations by Commerce and the ITC that termination of the Agreement and suspended antidumping duty investigation on uranium from Russia would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, consistent with section 751(d)(2) of the Act, Commerce hereby gives notice of the continuation of the Agreement. The effective date of continuation will be the date of publication in the
This notice also serves as the only reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.
We are issuing and publishing these results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) continues to find that Tianjin Magnesium International, Co., Ltd. (TMI) and Tianjin Magnesium Metal, Co., Ltd. (TMM) had no shipments of subject merchandise covered by the antidumping duty order on magnesium metal from the People's Republic of China (China) for the period of review (POR) April 1, 2021, through March 31, 2022.
Applicable April 13, 2023.
John Conniff, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1009.
On December 21, 2022, Commerce published the
The product covered by the
The scope of the
In the
Based on record evidence, we have determined that TMI and TMM had no shipments of subject merchandise during the POR, and, therefore, pursuant to Commerce's assessment practice, any suspended entries entered under their case numbers will be liquidated at the China-wide entity rate.
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) for previously investigated or reviewed Chinese and non-Chinese exporters that received a separate rate in a prior segment of this proceeding, including TMI, the cash deposit rate will continue to be the existing exporter-specific rate; (2) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, including TMM, the cash deposit rate will be the China-wide rate of 141.49 percent;
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return of destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the term of an APO is a sanctionable violation.
This notice is issued and published in accordance with sections 751(a) and 777(i) of the Act, and 19 CFR 351.213(h).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that imports of circular welded carbon quality steel pipe (CWP), completed in the Socialist Republic of Vietnam (Vietnam) using hot-rolled steel (HRS) produced in the People's Republic of China (China), are circumventing the antidumping duty (AD) and countervailing duty (CVD) orders on CWP from China.
Applicable April 12, 2023.
Krisha Hill, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4037.
On July 22, 2008, Commerce published in the
On December 9, 2022, Commerce extended the time limit for issuing the preliminary determination in this circumvention inquiry from January 3 to March 31, 2023.
The products covered by the
This circumvention inquiry covers CWP completed in Vietnam using China-origin HRS and subsequently exported from Vietnam to the United States (inquiry merchandise).
Commerce is conducting this circumvention inquiry in accordance with section 781(b) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.226. For a complete description of the events that followed the initiation of this circumvention inquiry,
On October 7, 2022 and January 9, 2023, Vietnam Haiphong timely filed responses to Commerce's initial and supplemental questionnaires, in which Vietnam Haiphong reported that it did not sell or export the merchandise covered by the circumvention inquiry to the United States during the period of inquiry,
As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that CWP completed in Vietnam using China-origin HRS and subsequently exported from Vietnam to the United States is circumventing the
Based on the preliminary affirmative country-wide determination of circumvention for China, in accordance with 19 CFR 351.226(l)(2), we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation and require a cash deposit of estimated duties on unliquidated entries of CWP completed in Vietnam using China-origin HRS, that were entered, or withdrawn from warehouse, for consumption on or after August 4, 2022, the date of publication of the initiation of this circumvention inquiry in the
CWP produced in Vietnam from HRS that is not of China origin is not subject to this inquiry. Therefore, cash deposits are not required for such merchandise under the
If an importer imports CWP from Vietnam and claims that the CWP was not produced from China-origin HRS, in order to not be subject to the
Where no certification is provided for an entry, and AD/CVD orders from three countries (China, India or Korea) potentially apply to that entry, Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rates applicable to the AD and CVD orders on CWP from China (
Where a certification is provided for the AD/CVD orders on CWP from China (stating that the merchandise was not produced using China-origin HRS), but no other certification is provided, then Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rate applicable to the AD order on pipe and tube from India (
Commerce established the following third country case number in the Automated Commercial Environment (ACE) for entries of CWP produced in Vietnam using China-origin HRS: A-552-009-000 and C-552-010-000 with cash deposit rates of 85.55 percent and 39.01 percent, respectively.
The suspension of liquidation instructions will remain in effect until further notice.
Entries for which the importer and exporter have met the certification requirements described below and in Appendix II to this notice will not be subject to suspension of liquidation, or the cash deposit requirements described above. Failure to comply with the applicable requisite certification requirements may result in the merchandise being subject to duties.
To administer the preliminary affirmative country-wide determination of circumvention for Vietnam, Commerce established importer and exporter certifications, which allow companies to certify that specific entries of CWP from Vietnam are not subject to suspension of liquidation or the collection of cash deposits pursuant to this preliminary affirmative country-wide determination of circumvention because the merchandise is not made with China-origin HRS (
Importers and exporters that claim that the entry of CWP is not subject to suspension of liquidation or the collection of cash deposits because the merchandise is not made with China-origin HRS must complete the applicable certification and meet the certification and documentation requirements described below, as well as the requirements identified in the applicable certification.
Importers are required to complete and maintain the applicable importer certification, and maintain a copy of the applicable exporter certification, and retain all supporting documentation for both certifications. With the exception of the entries described below, the importer certification must be completed, signed, and dated by the time the entry summary is filed for the relevant entry. The importer, or the importer's agent, must submit both the importer's certification and the exporter's certification to CBP as part of the entry process by uploading them into the document imaging system (DIS) in ACE. Where the importer uses a broker to facilitate the entry process, the importer should obtain the entry summary number from the broker. Agents of the importer, such as brokers, however, are not permitted to certify on behalf of the importer.
Exporters are required to complete and maintain the applicable exporter certification and provide the importer with a copy of that certification and all supporting documentation (
Additionally, the claims made in the certifications and any supporting documentation are subject to verification by Commerce or CBP. Importers and exporters are required to maintain the certifications and supporting documentation until the later of: (1) the date that is five years after the latest entry date of the entries covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries.
For all CWP from Vietnam that was entered, or withdrawn from warehouse, for consumption during the period August 4, 2022 (the date of initiation of this circumvention inquiry), through the date of publication of the preliminary determination in the
For unliquidated entries (and entries for which liquidation has not become final) of CWP that were declared as non-AD or non-CVD type entries (
If it is determined that an importer and/or exporter has not met the certification and/or related documentation requirements for certain entries, Commerce intends to instruct CBP to suspend, pursuant to this preliminary affirmative country-wide determination of circumvention and the
Interested parties may comment on these certification requirements, and on the certification language contained in Appendix II to this notice in their case briefs.
As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determination.
Case briefs or other written comments should be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.
All submissions should be filed electronically via ACCESS.
Commerce, consistent with section 781(e) of the Act, will notify the U.S. International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this circumvention inquiry within the
This determination is issued and published in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).
I hereby certify that:
A. My name is {IMPORTING COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY}, located at {ADDRESS OF IMPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of circular welded carbon quality steel pipe (CWP) produced in Vietnam that entered under entry summary number(s), identified below, and are covered by this certification. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, the importer should have direct personal knowledge of the importation of CWP, including the exporter's and/or foreign seller's identity and location;
C. If the importer is acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
The CWP covered by this certification was imported by {IMPORTING COMPANY} on behalf of {U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER};
If the importer is not acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
{NAME OF IMPORTING COMPANY} is not acting on behalf of the first U.S. customer.
D. The CWP covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM THE MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED}.
E. I have personal knowledge of the facts regarding the production of the imported products covered by this certification. “Personal knowledge” includes facts obtained from another party, (
F. This certification applies to the following entries (repeat this block as many times as necessary):
Entry Summary #:
Entry Summary Line Item #:
Foreign Seller:
Foreign Seller's Address:
Foreign Seller's Invoice #:
Foreign Seller's Invoice Line Item #:
Country of Origin of HRS:
Producer:
Producer's Address:
G. The CWP covered by this certification does not contain HRS produced in China;
H. I understand that {IMPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
I. I understand that {IMPORTING COMPANY} is required to maintain a copy of the exporter's certification (attesting to the production and/or exportation of the imported merchandise identified above), and any supporting documentation provided to the importer by the exporter, until the later of: (1) the date that is five years after the date of the latest entry covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries;
J. I understand that {IMPORTING COMPANY} is required to provide U.S.
K. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
L. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the antidumping duty and countervailing duty cash deposits determined by Commerce; and
(iii) the importer no longer being allowed to participate in the certification process.
M. I understand that agents of the importer, such as brokers, are not permitted to make this certification;
This certification was completed and signed on, or prior to, the date of the entry summary if the entry date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
N. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
The party that made the sale to the United States should fill out the exporter certification.
I hereby certify that:
A. My name is {COMPANY OFFICIAL'S NAME} and I am an official of {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES}; located at {ADDRESS OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES};
B. I have direct personal knowledge of the facts regarding the production and exportation of the circular welded carbon quality steel pipe (CWP) for which sales are identified below. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, an exporter should have direct personal knowledge of the producer's identity and location;
C. The CWP covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
D. The CWP covered by this certification does not contain HRS produced in China;
E. This certification applies to the following sales to {NAME OF U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER} (repeat this block as many times as necessary):
Foreign Seller's Invoice # to U.S. Customer:
Foreign Seller's Invoice to U.S. Customer Line item #:
Producer Name:
Producer's Address:
Producer's Invoice # to Foreign Seller: (
Name of Producer of HRS:
Location (Country) of Producer of HRS:
F. The CWP covered by this certification was shipped to {NAME OF U.S. PARTY TO WHOM MERCHANDISE WAS SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
G. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
H. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to provide the U.S. importer with a copy of this certification and is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with this certification, and any supporting documents, upon request of either agency;
I. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
J. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the antidumping duty and countervailing duty cash deposits determined by Commerce; and
(iii) the seller/exporter no longer being allowed to participate in the certification process.
K. I understand that agents of the seller/exporter, such as freight forwarding companies or brokers, are not permitted to make this certification.
L. This certification was completed and signed, and a copy of the certification was provided to the importer, on, or prior to, the date of shipment if the shipment date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
M. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of the determinations by the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC) that revocation of the antidumping duty (AD) orders on stainless steel butt-weld pipe fittings from Italy, Malaysia, and the Philippines would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of these AD orders.
Applicable April 12, 2023.
Emily Bradshaw, AD/CVD Operations,
On February 23, 2001, Commerce published in the
On April 6, 2023, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the
The scope of the
As a result of the determinations by Commerce and the ITC that revocation of the
This notice serves as the only reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Failure to comply with the regulations and terms of the APO is a sanctionable violation.
These five-year (sunset) reviews and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act and published in accordance with section 777(i) of the Act, and 19 CFR 351.218(f)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that imports of light-walled welded rectangular carbon steel tubing (LWR tubing) from Taiwan, completed in the Socialist Republic of Vietnam (Vietnam) using hot-rolled steel (HRS) produced in Taiwan, are circumventing the antidumping duty (AD) order on LWR tubing from Taiwan.
Applicable April 12, 2023.
Bryan Hansen or Christopher Williams, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3683 or (202) 482-5166, respectively.
On March 27, 1989, Commerce published in the
On December 9, 2022, Commerce extended the time limit for issuing the preliminary determination of this circumvention inquiry from January 3 to March 31, 2023.
The product covered by the
This circumvention inquiry covers LWR tubing completed in Vietnam using Taiwan-origin HRS, which is subsequently exported from Vietnam to the United States (inquiry merchandise).
Commerce is conducting this circumvention inquiry in accordance with section 781(b) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.226. For a complete description of the methodology underlying the preliminary determination,
As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that LWR tubing completed in Vietnam, using Taiwan-origin HRS, and subsequently exported from Vietnam to the United States, is circumventing the
Pursuant to section 776(a) of the Act, if the necessary information is not available on the record, or an interested party withholds requested information, fails to provide requested information by the deadline or in the form and manner requested, or significantly impeded a proceeding, Commerce shall use the facts otherwise available in reaching the applicable determination. Moreover, pursuant to section 776(b) of the Act, Commerce may use inferences adverse to the interests of an interested party in selecting from among the facts otherwise available if the party fails to cooperate by not acting to the best of its ability to provide requested information.
Commerce requested information from the two exporters that account for the largest volume of the subject merchandise from Vietnam during the inquiry period that Commerce determined can be reasonably examined for purposes of respondent selection. In these initial questionnaires, Commerce explained that, if the company to which Commerce issued the questionnaire fails to respond timely to the questionnaire, or fails to provide the requested information, Commerce may find that the company failed to cooperate by not acting to the best of its ability to comply with the request for information, and may use an inference that is adverse to the company's interests in selecting from the facts otherwise available. One of the mandatory respondents to which Commerce issued the initial questionnaire in this inquiry,
Therefore, we preliminarily find that Hoa Phat failed to provide requested information by the deadline or in the form and manner requested, and significantly impeded this inquiry. Moreover, we find that this company failed to cooperate to the best of its ability to provide the requested information because it did not provide a timely response to Commerce's initial questionnaire. Consequently, we used adverse inferences with respect to Hoa Phat in selecting from among the facts otherwise available on the record, pursuant to sections 776(a) and (b) of the Act. For details regarding the adverse facts available used in this preliminary determination,
As detailed in the Preliminary Decision Memorandum, based on AFA, we preliminarily determine that Hoa Phat exported inquiry merchandise and that U.S. entries of that merchandise are circumventing the
U.S. entries of inquiry merchandise made on or after August 4, 2022, that are ineligible for certification based on the failure of Hoa Phat to cooperate, or for other reasons, shall remain subject to suspension of liquidation until final assessment instructions on those entries are issued, whether by automatic liquidation instructions, or by instructions pursuant to the final results of an administrative review.
Based on the preliminary affirmative country-wide determination of circumvention for Taiwan, in accordance with 19 CFR 351.226(l)(2), we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation and require a cash deposit of estimated duties on unliquidated entries of LWR tubing completed in Vietnam using Taiwan-origin HRS, that were entered, or withdrawn from warehouse, for consumption on or after August 4, 2022, the date of publication of the initiation of this circumvention inquiry in the
LWR tubing produced in Vietnam from HRS that is not of Taiwan origin is not subject to this inquiry. Therefore, cash deposits are not required for such merchandise under the
If an importer imports LWR tubing from Vietnam and claims that the LWR tubing was not produced from Taiwan-origin HRS, in order to not be subject to the
Where no certification is provided for an entry, and AD/CVD orders from three countries (China, Korea, or Taiwan) potentially apply to that entry, Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rates applicable to the AD and CVD orders on LWRPT from China (
Where a certification is provided for the AD/CVD orders on LWRPT from China (stating that the merchandise was not produced using China-origin HRS), but no other certification is provided, then Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rate applicable to the
Commerce established the following third country case number in the Automated Commercial Environment (ACE) for entries of LWR tubing produced in Vietnam using Taiwan-origin HRS: A-552-863-000. Commerce also established the following company-specific third country case number for Vina One, for which Commerce made an affirmative determination of circumvention, for entries of LWR tubing produced in Vietnam using Taiwan-origin HRS: A-552-863-001. The cash deposit rate will be the Taiwan AD all-others rate (
For Hoa Phat, which will not be permitted to certify that its merchandise was not produced from Taiwan-origin HRS, Commerce will direct CBP to suspend liquidation and require a cash deposit at the AD/CVD rates established for LWRPT from China. Commerce established the following company-specific third country case numbers for Hoa Phat: A-552-914-001 and C-552-915-001.
These suspension of liquidation instructions will remain in effect until further notice.
Entries for which the importer and exporter have met the certification requirements described below and in Appendix II to this notice will not be subject to suspension of liquidation, or the cash deposit requirements described above. Failure to comply with the applicable requisite certification requirements may result in the merchandise being subject to duties.
To administer the preliminary affirmative country-wide determination of circumvention, Commerce established importer and exporter certifications, which allow companies to certify that specific entries of LWR tubing from Vietnam are not subject to suspension of liquidation or the collection of cash deposits pursuant to this preliminary affirmative country-wide determination of circumvention because the merchandise is not made with Taiwan-origin HRS (
Importers and exporters that claim that the entry of LWR tubing is not subject to suspension of liquidation or the collection of cash deposits because the merchandise is not made with Taiwan-origin HRS must complete the applicable certification and meet the certification and documentation requirements described below, as well as the requirements identified in the applicable certification.
Importers are required to complete and maintain the applicable importer certification, and maintain a copy of the applicable exporter certification, and retain all supporting documentation for both certifications. With the exception of the entries described below, the importer certification must be completed, signed, and dated by the time the entry summary is filed for the relevant entry. The importer, or the importer's agent, must submit both the importer's certification and the exporter's certification to CBP as part of the entry process by uploading them into the document imaging system (DIS) in ACE. Where the importer uses a broker to facilitate the entry process, the importer should obtain the entry summary number from the broker. Agents of the importer, such as brokers, however, are not permitted to certify on behalf of the importer.
Exporters are required to complete and maintain the applicable exporter certification and provide the importer with a copy of that certification and all supporting documentation (
Additionally, the claims made in the certifications and any supporting documentation are subject to verification by Commerce and/or CBP. Importers and exporters are required to maintain the certifications and supporting documentation until the later of: (1) the date that is five years after the latest entry date of the entries covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries.
For all LWR tubing from Vietnam that was entered, or withdrawn from warehouse, for consumption during the period August 4, 2022 (the date of initiation of these circumvention inquiries), through the date of publication of the preliminary determination in the
For unliquidated entries (and entries for which liquidation has not become final) of LWR tubing that were declared as non-AD type entries (
If it is determined that an importer and/or exporter has not met the certification and/or related documentation requirements for certain entries, Commerce intends to instruct CBP to suspend, pursuant to this preliminary affirmative country-wide determination of circumvention and the
Interested parties may comment on these certification requirements, and on the certification language contained in Appendix II to this notice in their case briefs.
As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determination.
Case briefs or other written comments should be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.
All submissions should be filed electronically via ACCESS.
Commerce, consistent with section 781(e) of the Act, will notify the U.S. International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this circumvention inquiry within the
This determination is issued and published in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).
I hereby certify that:
A. My name is {IMPORTING COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY}, located at {ADDRESS OF IMPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of the light-walled welded rectangular carbon steel tubing (LWR tubing) produced in Vietnam that entered under entry summary number(s), identified below, and are covered by this certification. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, the importer should have direct personal knowledge of the importation of LWR tubing, including the exporter's and/or foreign seller's identity and location;
C. If the importer is acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
The LWR tubing covered by this certification was imported by {IMPORTING COMPANY} on behalf of {U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER};
If the importer is not acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
{NAME OF IMPORTING COMPANY} is not acting on behalf of the first U.S. customer.
D. The LWR Tubing covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM THE MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED}.
E. I have personal knowledge of the facts regarding the production of the imported products covered by this certification. “Personal knowledge” includes facts obtained from another party, (
F. This certification applies to the following entries (repeat this block as many times as necessary):
Entry Summary #:
Entry Summary Line Item #:
Foreign Seller:
Foreign Seller's Address:
Foreign Seller's Invoice #:
Foreign Seller's Invoice Line Item #:
Country of Origin of HRS:
Producer:
Producer's Address:
G. The LWR tubing covered by this certification does not contain HRS produced in Taiwan;
H. I understand that {IMPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
I. I understand that {IMPORTING COMPANY} is required to maintain a copy of the exporter's certification (attesting to the production and/or exportation of the imported merchandise identified above), and any supporting documentation provided to the importer by the exporter, until the later of: (1) the date that is five years after the date of the latest entry covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries;
J. I understand that {IMPORTING COMPANY}is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with the importer certification, and any supporting documentation, and a copy of the exporter's certification, and any supporting documentation provided to the importer by the exporter, upon request of either agency;
K. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
L. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post cash deposits determined by Commerce; and
(iii) the importer no longer being allowed to participate in the certification process.
M. I understand that agents of the importer, such as brokers, are not permitted to make this certification;
This certification was completed and signed on, or prior to, the date of the entry summary if the entry date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
N. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
The party that made the sale to the United States should fill out the exporter certification.
I hereby certify that:
A. My name is {COMPANY OFFICIAL'S NAME} and I am an official of {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES); located at {ADDRESS OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES);
B. I have direct personal knowledge of the facts regarding the production and exportation of the light-walled welded rectangular carbon steel tubing (LWR tubing) for which sales are identified below. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, an exporter should have direct personal knowledge of the producer's identity and location;
C. The LWR tubing covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
D. The LWR tubing covered by this certification does not contain HRS produced in Taiwan;
E. This certification applies to the following sales to {NAME OF U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER} (repeat this block as many times as necessary):
Foreign Seller's Invoice # to U.S. Customer:
Foreign Seller's Invoice to U.S. Customer Line item #:
Producer Name:
Producer's Address:
Producer's Invoice # to Foreign Seller: (
Name of Producer of HRS:
Location (Country) of Producer of HRS:
F. The LWR tubing covered by this certification was shipped to {NAME OF U.S. PARTY TO WHOM MERCHANDISE WAS SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
G. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
H. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to provide the U.S. importer with a copy of this certification and is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with this certification, and any supporting documents, upon request of either agency;
I. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
J. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the
(i) suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the cash deposits determined by Commerce; and
(iii) the seller/exporter no longer being allowed to participate in the certification process.
K. I understand that agents of the seller/exporter, such as freight forwarding companies or brokers, are not permitted to make this certification.
L. This certification was completed and signed, and a copy of the certification was provided to the importer, on, or prior to, the date of shipment if the shipment date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
M. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that imports of light-walled rectangular pipe and tube (LWRPT), completed in the Socialist Republic of Vietnam (Vietnam) using hot-rolled steel (HRS) produced in the People's Republic of China (China), are circumventing the antidumping duty (AD) and countervailing duty (CVD) orders on LWRPT from China.
Applicable April 12, 2023.
Reginald Anadio, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3166.
On August 5, 2008, Commerce published in the
On December 9, 2022, Commerce extended the time limit for issuing the preliminary determination in this circumvention inquiry from January 3 to March 31, 2023.
The products covered by the
This circumvention inquiry covers LWRPT completed in Vietnam using China-origin HRS and subsequently exported from Vietnam to the United States (inquiry merchandise).
Commerce is conducting this circumvention inquiry in accordance with section 781(b) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.226. For a complete description of the events that followed the initiation of this circumvention inquiry,
As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that LWRPT completed in Vietnam, using China-origin HRS, and subsequently exported from Vietnam to the United States is circumventing the
Pursuant to section 776(a) of the Act, if the necessary information is not available on the record, or an interested party withholds requested information, fails to provide requested information by the deadline or in the form and manner requested, or significantly impeded a proceeding, Commerce shall use the facts otherwise available in reaching the applicable determination. Moreover, pursuant to section 776(b) of the Act, Commerce may use inferences adverse to the interests of an interested party in selecting from among the facts otherwise available if the party fails to cooperate by not acting to the best of its ability to provide requested information.
Commerce requested information from the two producers that account for the largest volume of the LWRPT from the exporting country during the inquiry period that Commerce determined can be reasonably examined for purposes of respondent selection. In these initial questionnaires, Commerce explained that, if the company to which Commerce issued the questionnaire fails to respond to the questionnaire, or fails to provide the requested information, Commerce may find that the company failed to cooperate by not acting to the best of its ability to comply with the request for information, and may use an inference that is adverse to the company's interests in selecting from the facts otherwise available. One of the mandatory respondents to which Commerce issued the initial questionnaire in this inquiry,
Therefore, we preliminarily find that Hoa Phat failed to provide requested information by the deadline or in the form and manner requested and significantly impeded this inquiry. Moreover, we find that this company failed to cooperate by not acting to the best of its ability to provide the requested information because it did not provide a timely response to Commerce's initial questionnaire. Consequently, we used adverse inferences with respect to Hoa Phat in selecting from among the facts otherwise available on the record, pursuant to sections 776(a)(2)(B)-(C) and (b) of the Act. For details regarding the adverse facts available used in this preliminary determination,
As detailed in the Preliminary Decision Memorandum, based on AFA, we preliminarily determine that Hoa Phat exported inquiry merchandise and that U.S. entries of that merchandise are circumventing the
U.S. entries of inquiry merchandise made on or after August 4, 2022, that are ineligible for certification based on the failure of Hoa Phat to cooperate, or for other reasons, shall remain subject to suspension of liquidation until final assessment instructions on those entries are issued, whether by automatic liquidation instructions, or by instructions pursuant to the final results of an administrative review.
Based on the preliminary affirmative country-wide determination of circumvention for China, in accordance with 19 CFR 351.226(l)(2), we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation and require a cash deposit of estimated duties on unliquidated entries of LWRPT, assembled or completed in Vietnam using Chinese-origin HRS, that were entered, or withdrawn from warehouse, for consumption on or after August 4, 2022, the date of publication of the initiation of this circumvention inquiry in the
LWRPT produced in Vietnam from HRS that is not of China origin is not subject to this inquiry. Therefore, cash deposits are not required for such merchandise under the
If an importer imports LWRPT from Vietnam and claims that the LWRPT was not produced from China-origin HRS, in order to not be subject to the
Where no certification is provided for an entry, and AD/CVD orders from three countries (China, Korea, or Taiwan) potentially apply to that entry, Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rates applicable to the AD and CVD orders on LWRPT from China (
Where a certification is provided for the AD/CVD orders on LWRPT from China (stating that the merchandise was not produced using China-origin HRS), but no other certification is provided, then Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rate applicable to the AD order on LWR tubing from Taiwan (
Commerce established the following third-country case numbers in the Automated Commercial Environment (ACE) for entries of LWRPT produced in Vietnam using China-origin HRS: A-552-914-000 and C-552-915-000 with cash deposit rates of 255.07 percent and 15.28 percent, respectively. Commerce also established the following company-specific third-country case numbers for Vina One, for which Commerce made an affirmative determination of circumvention, for entries of LWRPT produced in Vietnam using China-origin HRS: A-552-914-002 and C-552-915-002. With regard to Vina One's company-specific third-country case numbers, the cash deposit rates will be the China-wide entity AD rate (
For Hoa Phat, which will not be permitted to certify that its merchandise was not produced from China-origin HRS, Commerce will direct CBP to suspend liquidation and require a cash deposit at the AD/CVD rates established for LWRPT from China. Commerce established the following company-specific third-country case numbers for Hoa Phat: A-552-914-001 and C-552-915-001.
These suspension of liquidation instructions will remain in effect until further notice.
Entries for which the importer and exporter have met the certification requirements described below and in Appendix II to this notice will not be subject to suspension of liquidation, or the cash deposit requirements described above. Failure to comply with the applicable requisite certification requirements may result in the merchandise being subject to duties.
To administer the preliminary affirmative country-wide determination of circumvention for Vietnam, Commerce established importer and exporter certifications, which allow companies to certify that specific entries of LWRPT from Vietnam are not subject to suspension of liquidation or the collection of cash deposits pursuant to this preliminary affirmative country-wide determination of circumvention because the merchandise is not made with Chinese-origin HRS (
Importers and exporters that claim that the entry of LWRPT is not subject to suspension of liquidation or the collection of cash deposits because the merchandise is not made with China-origin HRS must complete the applicable certification and meet the certification and documentation requirements described below, as well as the requirements identified in the applicable certification.
Importers are required to complete and maintain the applicable importer certification, and maintain a copy of the applicable exporter certification, and retain all supporting documentation for both certifications. With the exception of the entries described below, the importer certification must be completed, signed, and dated by the time the entry summary is filed for the relevant entry. The importer, or the importer's agent, must submit both the importer's certification and the exporter's certification to CBP as part of the entry process by uploading them into the document imaging system (DIS) in ACE. Where the importer uses a broker to facilitate the entry process, the importer should obtain the entry summary number from the broker. Agents of the importer, such as brokers, however, are not permitted to certify on behalf of the importer.
Exporters are required to complete and maintain the applicable exporter certification and provide the importer with a copy of that certification and all supporting documentation (
Additionally, the claims made in the certifications and any supporting documentation are subject to verification by Commerce and/or CBP. Importers and exporters are required to maintain the certifications and supporting documentation until the later of: (1) the date that is five years after the latest entry date of the entries covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries.
For all LWRPT from Vietnam that was entered, or withdrawn from warehouse, for consumption during the period August 4, 2022 (the date of initiation of these circumvention inquiries), through the date of publication of the preliminary determination in the
For unliquidated entries (and entries for which liquidation has not become final) of LWRPT that were declared as non-AD or non-CVD type entries (
If it is determined that an importer and/or exporter has not met the certification and/or related documentation requirements for certain entries, Commerce intends to instruct CBP to suspend, pursuant to this preliminary affirmative country-wide determination of circumvention and the
Interested parties may comment on these certification requirements, and on the certification language contained in Appendix II to this notice in their case briefs.
As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determination.
Case briefs or other written comments should be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline for case briefs.
All submissions should be filed electronically via ACCESS.
Commerce, consistent with section 781(e) of the Act, will notify the U.S. International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this circumvention inquiry within the
This determination is issued and published in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).
I hereby certify that:
A. My name is {IMPORTING COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY}, located at {ADDRESS OF IMPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of the light-walled rectangular pipe and tube (LWRPT) produced in Vietnam that entered under entry summary number(s), identified below, and are covered by this certification. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, the importer should have direct personal knowledge of the importation of LWRPT, including the exporter's and/or foreign seller's identity and location;
C. If the importer is acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
The LWRPT covered by this certification was imported by {IMPORTING COMPANY} on behalf of {U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER};
If the importer is not acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
{NAME OF IMPORTING COMPANY} is not acting on behalf of the first U.S. customer.
D. The LWRPT covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM THE MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED}.
E. I have personal knowledge of the facts regarding the production of the imported products covered by this certification. “Personal knowledge” includes facts obtained from another party, (
F. This certification applies to the following entries (repeat this block as many times as necessary):
Entry Summary #:
Entry Summary Line Item #:
Foreign Seller:
Foreign Seller's Address:
Foreign Seller's Invoice #:
Foreign Seller's Invoice Line Item #:
Country of Origin of HRS:
Producer:
Producer's Address:
G. The LWRPT covered by this certification does not contain HRS produced in China;
H. I understand that {IMPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
I. I understand that {IMPORTING COMPANY} is required to maintain a copy of the exporter's certification (attesting to the production and/or exportation of the imported merchandise identified above), and any supporting documentation provided to the importer by the exporter, until the later of: (1) the date that is five years after the date of the latest entry covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries;
J. I understand that {IMPORTING COMPANY} is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with the importer certification, and any supporting documentation, and a copy of the exporter's certification, and any supporting documentation provided to the importer by the exporter, upon request of either agency;
K. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
L. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the antidumping duty and countervailing duty cash deposits determined by Commerce; and
(iii) the importer no longer being allowed to participate in the certification process.
M. I understand that agents of the importer, such as brokers, are not permitted to make this certification;
This certification was completed and signed on, or prior to, the date of the entry summary if the entry date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
N. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
The party that made the sale to the United States should fill out the exporter certification.
I hereby certify that:
A. My name is {COMPANY OFFICIAL'S NAME} and I am an official of {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES); located at {ADDRESS OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES};
B. I have direct personal knowledge of the facts regarding the production and exportation of the LWRPT for which sales are identified below. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, an exporter should have direct personal knowledge of the producer's identity and location;
C. The LWRPT covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
D. The LWRPT covered by this certification does not contain HRS produced in China;
E. This certification applies to the following sales to {NAME OF U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER} (repeat this block as many times as necessary):
Foreign Seller's Invoice # to U.S. Customer:
Foreign Seller's Invoice to U.S. Customer Line item #:
Producer Name:
Producer's Address:
Producer's Invoice # to Foreign Seller: (
Name of Producer of HRS:
Location (Country) of Producer of HRS:
F. The LWRPT covered by this certification was shipped to {NAME OF U.S. PARTY TO WHOM MERCHANDISE WAS SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
G. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
H. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to provide the U.S. importer with a copy of this certification and is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with this certification, and any supporting documents, upon request of either agency;
I. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
J. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the antidumping duty and countervailing duty cash deposits determined by Commerce; and
(iii) the seller/exporter no longer being allowed to participate in the certification process.
K. I understand that agents of the seller/exporter, such as freight forwarding companies or brokers, are not permitted to make this certification.
L. This certification was completed and signed, and a copy of the certification was provided to the importer, on, or prior to, the date of shipment if the shipment date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
M. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that imports of certain circular welded non-alloy steel pipe (CWP), completed in the Socialist Republic of Vietnam (Vietnam) using hot-rolled steel (HRS) produced in the Republic of Korea (Korea), are circumventing the antidumping duty (AD) order on CWP from Korea.
Applicable April 12, 2023.
Andre Gziryan, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2201.
On November 2, 1992, Commerce published in the
On December 9, 2022, Commerce extended the time limit for issuing the preliminary determination in this circumvention inquiry from January 3 to March 31, 2023.
The products covered by the
This circumvention inquiry covers CWP completed in Vietnam using Korea-origin HRS and subsequently exported from Vietnam to the United States (inquiry merchandise).
Commerce is conducting this circumvention inquiry in accordance with section 781(b) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.226. For a complete description of the events that followed the initiation of this circumvention inquiry,
On October 7, 2022 and January 9, 2023, Vietnam Haiphong timely filed responses to Commerce's initial and supplemental questionnaires, in which Vietnam Haiphong reported that it did not sell or export the merchandise covered by the circumvention inquiry to the United States during the period of inquiry, January 1, 2017, through December 31, 2021.
As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that CWP completed in Vietnam using Korea-origin HRS and subsequently exported from Vietnam to the United States is circumventing the
Based on the preliminary affirmative country-wide determination of circumvention for Korea, in accordance with 19 CFR 351.226(l)(2), we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation and require a cash deposit of estimated duties on unliquidated entries of CWP completed in Vietnam using Korea-origin HRS, that were entered, or withdrawn from warehouse, for consumption on or after August 4, 2022, the date of publication of the initiation of this circumvention inquiry in the
CWP produced in Vietnam from HRS that is not of Korean origin is not subject to this inquiry. Therefore, cash deposits are not required for such merchandise under the
If an importer imports CWP from Vietnam and claims that the CWP was not produced from Korea-origin HRS, in order to not be subject to the
Where no certification is provided for an entry, and AD/CVD orders from three countries (China, India or Korea) potentially apply to that entry, Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rates applicable to the AD and CVD orders on CWP from China (
Where a certification is provided for the AD/CVD orders on CWP from China (stating that the merchandise was not produced using China-origin HRS), but no other certification is provided, then Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rate applicable to the AD order on pipe and tube from India (
To enter inquiry merchandise (CWP produced in Vietnam using Korea-origin HRS) parties must provide certifications for the AD/CVD orders on CWP from China (stating that the merchandise was not produced using China-origin HRS) and for the AD order on pipe and tube from India (stating that the merchandise was not produced using India-origin HRS). Commerce established the following third country case number in the Automated Commercial Environment (ACE) for entries of CWP produced in Vietnam using Korea-origin HRS: A-552-011-000. Commerce also established the following company-specific third-country case number for SeAH Vina, for which Commerce made an affirmative determination of circumvention, for entries of CWP produced in Vietnam using Korea-origin HRS: A-552-011-001. The cash deposit rate will be the Korea AD all-others rate (
These suspension of liquidation instructions will remain in effect until further notice.
Entries for which the importer and exporter have met the certification requirements described below and in Appendix II to this notice will not be subject to suspension of liquidation, or the cash deposit requirements described above. Failure to comply with the applicable requisite certification requirements may result in the merchandise being subject to duties.
To administer the preliminary country-wide affirmative determination of circumvention for Vietnam, Commerce established importer and exporter certifications, which allow companies to certify that specific entries of CWP from Vietnam are not subject to suspension of liquidation or the collection of cash deposits pursuant to this preliminary country-wide affirmative determination of circumvention because the merchandise is not made with Korea-origin HRS (
Importers and exporters that claim that the entry of CWP is not subject to suspension of liquidation, or the collection of cash deposits based on the merchandise not being made with Korea-origin HRS, must complete the applicable certification and meet the certification and documentation requirements described below, as well as the requirements identified in the applicable certification.
Importers are required to complete and maintain the applicable importer certification, and maintain a copy of the applicable exporter certification, and retain all supporting documentation for both certifications. With the exception of the entries described below, the importer certification must be completed, signed, and dated by the time the entry summary is filed for the relevant entry. The importer, or the importer's agent, must submit both the importer's certification and the exporter's certification to CBP as part of the entry process by uploading them into the document imaging system (DIS) in ACE. Where the importer uses a broker to facilitate the entry process, the importer should obtain the entry summary number from the broker. Agents of the importer, such as brokers, however, are not permitted to certify on behalf of the importer.
Exporters are required to complete and maintain the applicable exporter certification and provide the importer with a copy of that certification and all supporting documentation (
Additionally, the claims made in the certifications and any supporting documentation are subject to verification by Commerce and/or CBP. Importers and exporters are required to maintain the certifications and supporting documentation until the later of: (1) the date that is five years after the latest entry date of the entries covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries.
For all CWP from Vietnam that was entered, or withdrawn from warehouse, for consumption during the period August 4, 2022 (the date of initiation of this circumvention inquiry), through the date of publication of the preliminary determination in the
For unliquidated entries (and entries for which liquidation has not become final) of CWP that were declared as non-AD type entries (
If it is determined that an importer and/or exporter has not met the certification and/or related documentation requirements for certain entries, Commerce intends to instruct CBP to suspend, pursuant to this preliminary country-wide affirmative determination of circumvention and the
Interested parties may comment on these certification requirements, and on the certification language contained in Appendix II to this notice in their case briefs.
As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determination.
Case briefs or other written comments should be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.
All submissions should be filed electronically via ACCESS.
Commerce, consistent with section 781(e) of the Act, will notify the U.S. International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this circumvention inquiry within the
This determination is issued and published in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).
I hereby certify that:
A. My name is {IMPORTING COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY}, located at {ADDRESS OF IMPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of certain circular welded non-alloy steel pipe (CWP) produced in Vietnam that entered under entry summary number(s), identified below, and are covered by this certification. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, the importer should have direct personal knowledge of the importation of CWP, including the exporter's and/or foreign seller's identity and location;
C. If the importer is acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
The CWP covered by this certification was imported by {IMPORTING COMPANY} on behalf of {U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER};
If the importer is not acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
{NAME OF IMPORTING COMPANY} is not acting on behalf of the first U.S. customer.
D. The CWP covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM THE MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED}.
E. I have personal knowledge of the facts regarding the production of the imported products covered by this certification. “Personal knowledge” includes facts obtained from another party, (
F. This certification applies to the following entries (repeat this block as many times as necessary):
Entry Summary #:
Entry Summary Line Item #:
Foreign Seller:
Foreign Seller's Address:
Foreign Seller's Invoice #:
Foreign Seller's Invoice Line Item #:
Country of Origin of HRS:
Producer:
Producer's Address:
G. The CWP covered by this certification does not contain HRS produced in Korea;
H. I understand that {IMPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
I. I understand that {IMPORTING COMPANY} is required to maintain a copy of the exporter's certification (attesting to the production and/or exportation of the imported merchandise identified above), and any supporting documentation provided to the importer by the exporter, until the later of: (1) the date that is five years after the date of the latest entry covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries;
J. I understand that {IMPORTING COMPANY} is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with the importer certification, and any supporting documentation, and a copy of the exporter's certification, and any supporting documentation provided to the importer by the exporter, upon request of either agency;
K. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
L. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the cash deposits determined by Commerce; and
(iii) the importer no longer being allowed to participate in the certification process.
M. I understand that agents of the importer, such as brokers, are not permitted to make this certification;
This certification was completed and signed on, or prior to, the date of the entry summary if the entry date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
N. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
EXPORTER CERTIFICATION
The party that made the sale to the United States should fill out the exporter certification.
I hereby certify that:
A. My name is {COMPANY OFFICIAL'S NAME} and I am an official of {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES); located at {ADDRESS OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES);
B. I have direct personal knowledge of the facts regarding the production and exportation of the certain circular welded non-alloy steel pipe (CWP) for which sales are identified below. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, an exporter should have direct personal knowledge of the producer's identity and location;
C. The CWP covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
D. The CWP covered by this certification does not contain HRS produced in Korea;
E. This certification applies to the following sales to {NAME OF U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER} (repeat this block as many times as necessary):
Foreign Seller's Invoice # to U.S. Customer:
Foreign Seller's Invoice to U.S. Customer Line item #:
Producer Name:
Producer's Address:
Producer's Invoice # to Foreign Seller: (
Name of Producer of HRS:
Location (Country) of Producer of HRS:
F. The CWP covered by this certification was shipped to {NAME OF U.S. PARTY TO WHOM MERCHANDISE WAS SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
G. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
H. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to provide the U.S. importer with a copy of this certification and is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with this certification, and any supporting documents, upon request of either agency;
I. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
J. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the cash deposits determined by Commerce; and
(iii) the seller/exporter no longer being allowed to participate in the certification process.
K. I understand that agents of the seller/exporter, such as freight forwarding companies or brokers, are not permitted to make this certification.
L. This certification was completed and signed, and a copy of the certification was provided to the importer, on, or prior to, the date of shipment if the shipment date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
M. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that imports of certain welded carbon steel standard pipes and tubes (pipe and tube), completed in the Socialist Republic of Vietnam (Vietnam) using hot-rolled steel (HRS) produced in India, are circumventing the antidumping duty (AD) order on pipe and tube from India.
Applicable April 12, 2023.
Dmitry Vladimirov, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0665.
On May 12, 1986, Commerce published in the
On December 9, 2022, Commerce extended the time limit for issuing the preliminary determination in this circumvention inquiry from January 3 to March 31, 2023.
The products covered by the
This circumvention inquiry covers pipe and tube completed in Vietnam using India-origin HRS and subsequently exported from Vietnam to the United States (inquiry merchandise).
Commerce is conducting this circumvention inquiry in accordance with section 781(b) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.226. For a complete description of the methodology underlying the preliminary determination,
On October 7, 2022 and January 9, 2023, Vietnam Haiphong timely filed responses to Commerce's initial and supplemental questionnaires, in which Vietnam Haiphong reported that it did not sell or export the merchandise covered by the circumvention inquiry to the United States during the period of inquiry, January 1, 2017, through December 31, 2021.
As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that pipe and tube completed in Vietnam using India-origin HRS and subsequently exported from Vietnam to the United States is circumventing the
Based on the preliminary affirmative country-wide determination of circumvention for India, in accordance with 19 CFR 351.226(l)(2), we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation and require a cash deposit of estimated duties on unliquidated entries of pipe and tube completed in Vietnam using India-origin HRS, that were entered, or withdrawn from warehouse, for consumption on or after August 4, 2022, the date of publication of the initiation
Pipe and tube produced in Vietnam from HRS that is not of Indian origin is not subject to this inquiry. Therefore, cash deposits are not required for such merchandise under the
If an importer imports pipe and tube from Vietnam and claims that the pipe and tube was not produced from India-origin HRS, in order to not be subject to the
Where no certification is provided for an entry, and AD/CVD orders from three countries (China, India or Korea) potentially apply to that entry, Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rate applicable to the AD and CVD orders on CWP from China (
Where a certification is provided for the AD/CVD orders on CWP from China (stating that the merchandise was not produced using China-origin HRS), but no other certification is provided, then Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rate applicable to the
Commerce established the following third country case number in the Automated Commercial Environment (ACE) for entries of pipe and tube produced in Vietnam using India-origin HRS: A-552-012-000. Commerce also established the following company-specific third country case number for SeAH VINA, for which Commerce made an affirmative determination of circumvention, for entries of pipe and tube produced in Vietnam using India-origin HRS: A-552-012-001. The cash deposit rate will be the India AD all-others rate (
These suspension of liquidation instructions will remain in effect until further notice.
Entries for which the importer and exporter have met the certification requirements described below and in Appendix II to this notice will not be subject to suspension of liquidation, or the cash deposit requirements described above. Failure to comply with the applicable requisite certification requirements may result in the merchandise being subject to duties.
To administer the preliminary country-wide affirmative determination of circumvention for Vietnam, Commerce established importer and exporter certifications which allow companies to certify that specific entries of pipe and tube from Vietnam are not subject to suspension of liquidation or the collection of cash deposits pursuant to this preliminary country-wide affirmative determination of circumvention because the merchandise is not made with India-origin HRS (
Importers and exporters that claim that the entry of pipe and tube is not subject to suspension of liquidation or the collection of cash deposits because the merchandise is not made with India-origin HRS must complete the applicable certification and meet the certification and documentation requirements described below, as well as the requirements identified in the applicable certification.
Importers are required to complete and maintain the applicable importer certification, and maintain a copy of the applicable exporter certification, and retain all supporting documentation for both certifications. With the exception of the entries described below, the importer certification must be completed, signed, and dated by the time the entry summary is filed for the relevant entry. The importer, or the importer's agent, must submit both the importer's certification and the exporter's certification to CBP as part of the entry process by uploading them into the document imaging system (DIS) in ACE. Where the importer uses a broker to facilitate the entry process, the importer should obtain the entry summary number from the broker. Agents of the importer, such as brokers, however, are not permitted to certify on behalf of the importer.
Exporters are required to complete and maintain the applicable exporter certification and provide the importer with a copy of that certification and all supporting documentation (
Additionally, the claims made in the certifications and any supporting documentation are subject to verification by Commerce and/or CBP. Importers and exporters are required to maintain the certifications and supporting documentation until the later of: (1) the date that is five years after the latest entry date of the entries covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries.
For all pipe and tube from Vietnam that was entered, or withdrawn from warehouse, for consumption during the period August 4, 2022 (the date of initiation of this circumvention inquiry), through the date of publication of the preliminary determination in the
For unliquidated entries (and entries for which liquidation has not become final) of pipe and tube that were declared as non-AD type entries (
If it is determined that an importer and/or exporter has not met the certification and/or related documentation requirements for certain entries, Commerce intends to instruct CBP to suspend, pursuant to this preliminary country-wide affirmative determination of circumvention and the
Interested parties may comment on these certification requirements, and on the certification language contained in Appendix II to this notice in their case briefs.
As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determination.
Case briefs or other written comments should be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.
All submissions should be filed electronically via ACCESS.
Commerce, consistent with section 781(e) of the Act, will notify the U.S. International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this circumvention inquiry within the
This determination is issued and published in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).
I hereby certify that:
A. My name is {IMPORTING COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY}, located at {ADDRESS OF IMPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of certain welded carbon steel standard pipes and tubes (pipe and tube) produced in Vietnam that entered under entry summary number(s), identified below, and are covered by this certification. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, the importer should have direct personal knowledge of the importation of pipe and tube, including the exporter's and/or foreign seller's identity and location;
C. If the importer is acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
The pipe and tube covered by this certification was imported by {IMPORTING COMPANY} on behalf of {U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER};
If the importer is not acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
{NAME OF IMPORTING COMPANY} is not acting on behalf of the first U.S. customer.
D. The pipe and tube covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM THE MERCHANDISE WAS FIRST
E. I have personal knowledge of the facts regarding the production of the imported products covered by this certification. “Personal knowledge” includes facts obtained from another party, (
F. This certification applies to the following entries (repeat this block as many times as necessary):
Entry Summary #:
Entry Summary Line Item #:
Foreign Seller:
Foreign Seller's Address:
Foreign Seller's Invoice #:
Foreign Seller's Invoice Line Item #:
Country of Origin of HRS:
Producer:
Producer's Address:
G. The pipe and tube covered by this certification does not contain HRS produced in India;
H. I understand that {IMPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
I. I understand that {IMPORTING COMPANY} is required to maintain a copy of the exporter's certification (attesting to the production and/or exportation of the imported merchandise identified above), and any supporting documentation provided to the importer by the exporter, until the later of: (1) the date that is five years after the date of the latest entry covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries;
J. I understand that {IMPORTING COMPANY} is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with the importer certification, and any supporting documentation, and a copy of the exporter's certification, and any supporting documentation provided to the importer by the exporter, upon request of either agency;
K. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
L. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the cash deposits determined by Commerce; and
(iii) the importer no longer being allowed to participate in the certification process.
M. I understand that agents of the importer, such as brokers, are not permitted to make this certification;
This certification was completed and signed on, or prior to, the date of the entry summary if the entry date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
N. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
The party that made the sale to the United States should fill out the exporter certification.
I hereby certify that:
A. My name is {COMPANY OFFICIAL'S NAME} and I am an official of {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES); located at {ADDRESS OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES);
B. I have direct personal knowledge of the facts regarding the production and exportation of the certain welded carbon steel standard pipes and tubes (pipe and tube) for which sales are identified below. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, an exporter should have direct personal knowledge of the producer's identity and location;
C. The pipe and tube covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
D. The pipe and tube covered by this certification does not contain HRS produced in India;
E. This certification applies to the following sales to {NAME OF U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER} (repeat this block as many times as necessary):
Foreign Seller's Invoice # to U.S. Customer:
Foreign Seller's Invoice to U.S. Customer Line item #:
Producer Name:
Producer's Address:
Producer's Invoice # to Foreign Seller: (
Name of Producer of HRS:
Location (Country) of Producer of HRS:
F. The pipe and tube covered by this certification was shipped to {NAME OF U.S. PARTY TO WHOM MERCHANDISE WAS SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
G. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
H. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to provide the U.S. importer with a copy of this certification and is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with this certification, and any supporting documents, upon request of either agency;
I. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
J. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the cash deposits determined by Commerce; and
(iii) the seller/exporter no longer being allowed to participate in the certification process.
K. I understand that agents of the seller/exporter, such as freight forwarding companies or brokers, are not permitted to make this certification.
L. This certification was completed and signed, and a copy of the certification was provided to the importer, on, or prior to, the date of shipment if the shipment date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
M. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
{NAME OF COMPANY OFFICIAL}
{TITLE OF COMPANY OFFICIAL}
{DATE}
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that imports of aluminum sheet produced from aluminum alloy 4017 (4017 aluminum sheet) from the People's Republic of China (China) are circumventing the antidumping (AD) and countervailing duty (CVD) orders on Common Alloy Aluminum Sheet (CAAS) from China.
Applicable April 12, 2023.
Frank Schmitt, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4880.
On February 6 and 8, 2019, respectively, Commerce published the CVD and AD orders on imports of CAAS from China.
On August 26, 2022, Commerce published in the
The merchandise covered by the
This circumvention inquiry covers aluminum sheet produced from aluminum alloy 4017 produced in China and exported to the United States. A complete description of the merchandise subject to the circumvention inquiry is contained in the Preliminary Decision Memorandum.
Commerce is conducting this circumvention inquiry pursuant to section 781(c) of the Act and 19 CFR 351.226(j). For a complete description of the methodology underlying the preliminary determination,
As detailed in the Preliminary Decision Memorandum, we preliminarily determine that 4017 aluminum sheet produced in China and exported to the United States constitutes merchandise altered in form or appearance in such minor respects that it should be included within the scope of the
Pursuant to section 776(a) of the Act, if the necessary information is not available on the record, or an interested party withholds requested information, fails to provide requested information by the deadline or in the form and manner requested, or significantly impedes a proceeding, Commerce shall use the facts otherwise available in reaching the applicable determination. Moreover, pursuant to section 776(b) of the Act, Commerce may use inferences adverse to the interests of an interested party in selecting from among the facts otherwise available if the party fails to cooperate by not acting to the best of its ability to provide requested information.
Commerce requested quantity and value (Q&V) information from eleven companies including Chalco Ruimin Co Ltd (Chalco Ruimin); Chalc-Swa Cold Rolling Co. Ltd (Chalc-Swa Cold Rolling); Jiangsu Alcha Aluminum Co Ltd (Jiangsu Alcha); Nanjie Resources Co Limited (Nanjie Resources); and Yantai Jintai International Trade Co.,
Therefore, we preliminarily find that necessary information is not available on the record and that Chalco Ruimin, Chalc-Swa Cold Rolling, Jiangsu Alcha, Nanjie Resources, Yantai Jintai, and Mingtai failed to provide requested information by the deadline or in the form and manner requested, and significantly impeded this inquiry pursuant to sections 776(a)(1) and (2)(A)-(C) of the Act. Moreover, we find that these companies failed to cooperate by not acting to the best of their ability to provide the requested information because they did not provide a timely response to Commerce's questionnaires. Consequently, for this preliminary determination we are relying on adverse inferences with respect to Chalco Ruimin, Chalc-Swa Cold Rolling, Jiangsu Alcha, Nanjie Resources, Yantai Jintai, and Mingtai in selecting from among the facts otherwise available on the record, pursuant to section 776(b) of the Act.
For details regarding the adverse facts available used in this preliminary determination,
In accordance with 19 CFR 351.226(l)(2), we will direct U.S. Customs and Border Protection (CBP) to continue the suspension of liquidation of previously suspended entries and to suspend liquidation of all entries of 4017 aluminum sheet produced in and exported from China that are entered, or withdrawn from warehouse, for consumption on or after August 26, 2022 (
Pursuant to 19 CFR 351.226(f)(4), interested parties may submit case briefs or other written comments within 14 days of the date of publication of this notice; seven days thereafter, interested parties may submit rebuttal comments. In accordance with 19 CFR 351.226(f)(4), no new factual information will be accepted in the comments or rebuttal comments.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; (3) whether any participant is a foreign national; and (4) a list of the issues to be discussed. If a request for a hearing is made, parties will be notified of the date and time for the hearing at a later date. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date of the hearing.
All submissions must be filed electronically and received successfully in their entirety via ACCESS by 5:00 p.m. Eastern Time on the date that they are due. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice.
This determination is published in accordance with section 781(c) of the Act and 19 CFR 351.226(g)(1).
Notice of issuance of an amended Export Trade Certificate of Review to Aerospace Industries Association of America, Inc., Application No. 92-16A001.
The Secretary of Commerce, through the Office of Trade and Economic Analysis (“OTEA”), issued an amended Export Trade Certificate of Review (“Certificate”) to Aerospace Industries Association of America, Inc., on March 27, 2023.
Joseph Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4011-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the
Aerospace Industries Association of America, Inc.'s Certificate has been amended as follows:
1. Added the following companies as new Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):
2. Removed the following companies as Members of AIA's Certificate:
3. Changed names or addresses for the following Members:
The effective date of the Certificate is December 28, 2022, the date on which the application to amend was deemed submitted.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that imports of light-walled rectangular pipe and tube (LWRPT), completed in the Socialist Republic of Vietnam (Vietnam) using hot-rolled steel (HRS) produced in the Republic of Korea (Korea), are circumventing the antidumping duty (AD) order on LWRPT from Korea.
Applicable April 12, 2023.
George McMahon or Carolyn Adie, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1167 or (202) 482-6250, respectively.
On August 5, 2008, Commerce published in the
On December 9, 2022, Commerce extended the time limit for issuing the preliminary determination in this circumvention inquiry from January 3 to March 31, 2023.
The products covered by the
This circumvention inquiry covers LWRPT completed in Vietnam using Korea-origin HRS, which is subsequently exported from Vietnam to the United States (inquiry merchandise).
Commerce is conducting this circumvention inquiry in accordance with section 781(b) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.226. For a complete description of the methodology underlying the preliminary determination,
As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that LWRPT completed in Vietnam, using Korea-origin HRS, and subsequently exported from Vietnam to the United States, is circumventing the
Pursuant to section 776(a) of the Act, if the necessary information is not available on the record, or an interested party withholds requested information, fails to provide requested information by the deadline or in the form and manner requested, or significantly impeded a proceeding, Commerce shall use the facts otherwise available in reaching the applicable determination. Moreover, pursuant to section 776(b) of the Act, Commerce may use inferences adverse to the interests of an interested party in selecting from among the facts otherwise available if the party fails to cooperate by not acting to the best of its ability to provide requested information.
Commerce requested information from the two producers that account for the largest volume of the LWRPT from the exporting country during the inquiry period that Commerce determined can be reasonably examined for purposes of respondent selection. In these initial questionnaires, Commerce explained that, if the company to which Commerce issued the questionnaire fails to respond to the questionnaire, or fails to provide the requested information, Commerce may find that the company failed to cooperate by not acting to the best of its ability to comply with the request for information, and may use an inference that is adverse to the company's interests in selecting from the facts otherwise available. One of the mandatory respondents to which Commerce issued the initial questionnaire in this inquiry,
Therefore, we preliminarily find that Hoa Phat failed to provide requested information by the deadline or in the form and manner requested, and significantly impeded this inquiry. Moreover, we find that this company failed to cooperate by not acting to the best of its ability to provide the requested information because it did not provide a timely response to Commerce's initial questionnaire. Consequently, we used adverse inferences with respect to Hoa Phat in selecting from among the facts otherwise available on the record, pursuant to sections 776(a)(2)(B)-(C) and (b) of the Act. For details regarding the adverse facts available used in this preliminary determination,
As detailed in the Preliminary Decision Memorandum, based on AFA, we preliminarily determine that Hoa Phat exported inquiry merchandise and that U.S. entries of that merchandise are circumventing the
U.S. entries of inquiry merchandise made on or after August 4, 2022, that are ineligible for certification based on the failure of Hoa Phat to cooperate, or for other reasons, shall remain subject to suspension of liquidation until final assessment instructions on those entries are issued, whether by automatic liquidation instructions, or by instructions pursuant to the final results of an administrative review.
Vina One timely responded to Commerce's circumvention questionnaire, in which it reported that it did not sell or export the merchandise covered by the circumvention inquiry to the United States during the period of inquiry.
Based on the preliminary affirmative country-wide determination of circumvention for Korea, in accordance with 19 CFR 351.226(l)(2), we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation and require a cash deposit of estimated duties on unliquidated entries of LWRPT completed in Vietnam using Korea-origin HRS, that were entered, or withdrawn from warehouse, for consumption on or after August 4, 2022, the date of publication of the initiation of this circumvention inquiry in the
LWRPT produced in Vietnam from HRS that is not of Korean origin is not subject to this inquiry. Therefore, cash deposits are not required for such merchandise under the
If an importer imports LWRPT from Vietnam and claims that the LWRPT was not produced from Korea-origin HRS, in order to not be subject to the
Where no certification is provided for an entry, and AD/CVD orders from three countries (China, Korea, or Taiwan) potentially apply to that entry, Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rates applicable to the AD and CVD orders on LWRPT from China (
Where a certification is provided for the AD/CVD orders on LWRPT from China (stating that the merchandise was not produced from China-origin HRS), but no other certification is provided, then Commerce intends to instruct CBP to suspend the entry and collect cash deposits at the rate applicable to the AD order on LWR tubing from Taiwan (
To enter inquiry merchandise (LWRPT produced in Vietnam using Korea-origin HRS) parties must provide certifications for the AD/CVD orders on LWRPT from China (stating that the merchandise was not produced using China-origin HRS) and for the AD order on LWR tubing from Taiwan (stating that the merchandise was not produced using Taiwan-origin HRS). Commerce established the following third-country case number in the Automated Commercial Environment (ACE) for entries of LWRPT produced in Vietnam using Korea-origin HRS: A-552-859-000. The cash deposit rate will be the Korea AD all-others rate (
For Hoa Phat, which will not be permitted to certify that its merchandise was not produced from Korea-origin HRS, Commerce will direct CBP to suspend liquidation and require a cash deposit at the AD/CVD rates established for LWRPT from China. Commerce established the following company-specific third country case numbers for Hoa Phat: A-552-914-001 and C-552-915-001.
These suspension of liquidation instructions will remain in effect until further notice.
Entries for which the importer and exporter have met the certification requirements described below and in Appendix II to this notice will not be subject to suspension of liquidation, or the cash deposit requirements described above. Failure to comply with the applicable requisite certification requirements may result in the merchandise being subject to duties.
To administer this preliminary country-wide affirmative determination of circumvention, Commerce established importer and exporter certifications, which allow companies to certify that specific entries of LWRPT from Vietnam are not subject to suspension of liquidation or the collection of cash deposits pursuant to this preliminary affirmative country-wide determination of circumvention because the merchandise is not made with Korea-origin HRS (
Importers and exporters that claim that the entry of LWRPT is not subject to suspension of liquidation or the collection of cash deposits because the merchandise is not made with Korea-origin HRS must complete the applicable certification and meet the certification and documentation requirements described below, as well as the requirements identified in the applicable certification.
Importers are required to complete and maintain the applicable importer certification, and maintain a copy of the applicable exporter certification, and retain all supporting documentation for both certifications. With the exception of the entries described below, the importer certification must be completed, signed, and dated by the time the entry summary is filed for the relevant entry. The importer, or the importer's agent, must submit both the importer's certification and the exporter's certification to CBP as part of the entry process by uploading them into the document imaging system (DIS) in ACE. Where the importer uses a broker to facilitate the entry process, the importer should obtain the entry summary number from the broker. Agents of the importer, such as brokers, however, are not permitted to certify on behalf of the importer.
Exporters are required to complete and maintain the applicable exporter certification and provide the importer with a copy of that certification and all supporting documentation (
Additionally, the claims made in the certifications and any supporting documentation are subject to verification by Commerce and/or CBP. Importers and exporters are required to maintain the certifications and supporting documentation until the later of: (1) the date that is five years after the latest entry date of the entries covered by the certification; or (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries.
For all LWRPT from Vietnam that was entered, or withdrawn from warehouse, for consumption during the period August 4, 2022 (the date of initiation of these circumvention inquiries), through the date of publication of the preliminary determination in the
For unliquidated entries (and entries for which liquidation has not become
If it is determined that an importer and/or exporter has not met the certification and/or related documentation requirements for certain entries, Commerce intends to instruct CBP to suspend, pursuant to this preliminary affirmative country-wide determination of circumvention and the
Interested parties may comment on these certification requirements, and on the certification language contained in Appendix II to this notice in their case briefs.
As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determination.
Case briefs or other written comments should be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.
All submissions should be filed electronically via ACCESS.
Commerce, consistent with section 781(e) of the Act, will notify the U.S. International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this circumvention inquiry within the
This determination is issued and published in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).
I hereby certify that:
A. My name is {IMPORTING COMPANY OFFICIAL'S NAME} and I am an official of {IMPORTING COMPANY}, located at {ADDRESS OF IMPORTING COMPANY};
B. I have direct personal knowledge of the facts regarding the importation into the Customs territory of the United States of the light-walled welded rectangular carbon steel pipe and tube (LWRPT) produced in Vietnam that entered under entry summary number(s), identified below, and are covered by this certification. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, the importer should have direct personal knowledge of the importation of LWRPT, including the exporter's and/or foreign seller's identity and location;
C. If the importer is acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
The LWRPT covered by this certification was imported by {IMPORTING COMPANY} on behalf of {U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER};
If the importer is not acting on behalf of the first U.S. customer, include the following sentence as paragraph C of this certification:
{NAME OF IMPORTING COMPANY} is not acting on behalf of the first U.S. customer.
D. The LWRPT covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM THE MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED}.
E. I have personal knowledge of the facts regarding the production of the imported products covered by this certification. “Personal knowledge” includes facts obtained from another party, (
F. This certification applies to the following entries (repeat this block as many times as necessary):
Entry Summary #:
Entry Summary Line Item #:
Foreign Seller:
Foreign Seller's Address:
Foreign Seller's Invoice #:
Foreign Seller's Invoice Line Item #:
Country of Origin of HRS:
Producer:
Producer's Address:
G. The LWRPT covered by this certification does not contain HRS produced in Korea;
H. I understand that {IMPORTING COMPANY} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
I. I understand that {IMPORTING COMPANY} is required to maintain a copy of the exporter's certification (attesting to the production and/or exportation of the imported merchandise identified above), and any supporting documentation provided to the importer by the exporter, until the later of: (1) the date that is five years after the date of the latest entry covered by the certification or; (2) the date that is three years after the conclusion of any litigation in United States courts regarding such entries;
J. I understand that {IMPORTING COMPANY} is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with the importer certification, and any supporting documentation, and a copy of the exporter's certification, and any supporting documentation provided to the importer by the exporter, upon request of either agency;
K. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
L. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of liquidation of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the cash deposits determined by Commerce; and
(iii) the importer no longer being allowed to participate in the certification process.
M. I understand that agents of the importer, such as brokers, are not permitted to make this certification;
This certification was completed and signed on, or prior to, the date of the entry summary if the entry date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
N. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
The party that made the sale to the United States should fill out the exporter certification.
I hereby certify that:
A. My name is {COMPANY OFFICIAL'S NAME} and I am an official of {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES}; located at {ADDRESS OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES};
B. I have direct personal knowledge of the facts regarding the production and exportation of the light-walled rectangular pipe and tube (LWRPT) for which sales are identified below. “Direct personal knowledge” refers to facts the certifying party is expected to have in its own records. For example, an exporter should have direct personal knowledge of the producer's identity and location;
C. The LWRPT covered by this certification was shipped to {NAME OF PARTY IN THE UNITED STATES TO WHOM MERCHANDISE WAS FIRST SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
D. The LWRPT covered by this certification does not contain HRS produced in Korea;
E. This certification applies to the following sales to {NAME OF U.S. CUSTOMER}, located at {ADDRESS OF U.S. CUSTOMER} (repeat this block as many times as necessary):
Foreign Seller's Invoice # to U.S. Customer:
Foreign Seller's Invoice to U.S. Customer Line item #:
Producer Name:
Producer's Address:
Producer's Invoice # to Foreign Seller: (
Name of Producer of HRS:
Location (Country) of Producer of HRS:
F. The LWRPT covered by this certification was shipped to {NAME OF U.S. PARTY TO WHOM MERCHANDISE WAS SHIPPED}, located at {U.S. ADDRESS TO WHICH MERCHANDISE WAS SHIPPED};
G. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to maintain a copy of this certification and sufficient documentation supporting this certification (
H. I understand that {NAME OF FOREIGN COMPANY THAT MADE THE SALE TO THE UNITED STATES} is required to provide the U.S. importer with a copy of this certification and is required to provide U.S. Customs and Border Protection (CBP) and/or the U.S. Department of Commerce (Commerce) with this certification, and any supporting documents, upon request of either agency;
I. I understand that the claims made herein, and the substantiating documentation, are subject to verification by CBP and/or Commerce;
J. I understand that failure to maintain the required certification and supporting documentation, or failure to substantiate the claims made herein, or not allowing CBP and/or Commerce to verify the claims made herein, may result in a
(i) suspension of all unliquidated entries (and entries for which liquidation has not become final) for which these requirements were not met;
(ii) the importer being required to post the cash deposits determined by Commerce; and
(iii) the seller/exporter no longer being allowed to participate in the certification process.
K. I understand that agents of the seller/exporter, such as freight forwarding companies or brokers, are not permitted to make this certification.
L. This certification was completed and signed, and a copy of the certification was provided to the importer, on, or prior to, the date of shipment if the shipment date is more than 14 days after the date of publication of the notice of Commerce's preliminary determination of circumvention in the
M. I am aware that U.S. law (including, but not limited to, 18 U.S.C. 1001) imposes criminal sanctions on individuals who knowingly and willfully make material false statements to the U.S. government.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that certain circular welded carbon steel pipes and tubes (pipe and tube) and circular welded non-alloy steel pipe (CWP) imported into the United States during the period of inquiry, January 1, 2017, through December 31, 2021, were not completed in the Socialist Republic of Vietnam (Vietnam) using hot-rolled steel (HRS) manufactured in Taiwan, and, therefore, no such imports are circumventing the antidumping duty (AD) orders on pipe and tube and CWP from Taiwan. We invite interested parties to comment on these preliminary determinations.
Applicable April 12, 2023.
Nicolas Mayora (Pipe and Tube) or Preston Cox and Scarlet Jaldin (CWP), AD/CVD Operations, Offices V and VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3053, (202) 482-5041, and (202) 482-4275, respectively.
On May 7, 1984 and November 2, 1992, Commerce published the orders on pipe and tube and CWP from Taiwan, respectively.
The products covered by these
These circumvention inquiries cover pipe and tube and CWP completed in Vietnam using Taiwan-origin HRS and subsequently exported from Vietnam to the United States.
Commerce is conducting these circumvention inquiries in accordance with section 781(b) of the Act and 19 CFR 351.226. For a full description of the methodology underlying Commerce's preliminary determinations,
As detailed in the Preliminary Decision Memoranda, Commerce preliminarily determines that SeAH VINA and Vietnam Haiphong did not complete pipe and tube and CWP using Taiwanese HRS in Vietnam, nor did they export pipe and tube or CWP incorporating Taiwan HRS to the United States during the period of inquiry. Accordingly, Commerce is making negative preliminary findings of circumvention of the
As provided in 19 CFR 351.307, Commerce may verify information relied upon in making its final determinations.
Because Commerce intends to conduct verification, a timeline for the submission of case briefs and written comments will be provided to interested parties at a later date.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined.
All submissions should be filed electronically via ACCESS.
This determination is issued and published in accordance with section 781(b) of the Act and 19 CFR 351.226(g)(1).
National Institute of Standards and Technology (NIST), Commerce.
Notice of Information Collection; request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before June 12, 2023.
Interested persons are invited to submit written comments by email to Nina Argent, Management Analyst, National Institute of Standards and Technology, at
Requests for additional information or specific questions related to collection activities should be directed to Cierra Bean, Business Operations Analyst, CHIPS Program Office,
The CHIPS Incentives Program is authorized by Title XCIX—Creating Helpful Incentives to Produce Semiconductors for America of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283, referred to as the CHIPS Act or Act), as amended by the CHIPS Act of 2022 (Division A of Pub. L. 117-167). The CHIPS Incentives Program is administered by the CHIPS Program Office (CPO) within the National Institute of Standards and Technology (NIST) of the United States Department of Commerce (Department). The Ask CHIPS web form will be available as a streamlined method for customers to submit requests to meet with the CHIPS team or request a speaker engagement. The information will be used by the CHIPS Program Office to schedule and coordinate engagements with CHIPS stakeholders.
Information to be collected includes:
Basic customer contact information, details on who they would like to meet with and when/where, as well as CHIPS-related topics they would like to discuss. The data requested is limited to the information necessary to efficiently schedule these engagements and provide the customer with the desired information during these engagements.
CHIPS engagement meeting requests may be submitted via the web portal at
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Institute of Standards and Technology (NIST), Commerce.
Notice of information collection; request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before June 12, 2023.
Interested persons are invited to submit written comments by email to Maureen O'Reilly, Management Analyst, National Institute of Standards and Technology, at
Requests for additional information or specific questions related to collection activities should be directed to Cierra Bean, Business Operations Analyst, CHIPS Program Office,
The CHIPS Incentives Program is authorized by Title XCIX—Creating Helpful Incentives to Produce Semiconductors for America of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283, referred to as the CHIPS Act or Act), as amended by the CHIPS Act of 2022 (Division A of Pub. L. 117-167). The CHIPS Incentives Program is administered by the CHIPS Program Office (CPO) within the National Institute of Standards and Technology (NIST) of the United States Department of Commerce (Department). Businesses and other entities applying for CHIPS Act funding under the CHIPS Incentive Program must submit a full application via a form available at
Applications must be submitted electronically at
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Institute of Standards and Technology (NIST), Commerce.
Notice of information collection; request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before June 12, 2023.
Interested persons are invited to submit written comments by
Requests for additional information or specific questions related to collection activities should be directed to Cierra Bean, Business Operations Analyst, CHIPS Program Office,
The CHIPS Incentives Program is authorized by Title XCIX—Creating Helpful Incentives to Produce Semiconductors for America of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283, referred to as the CHIPS Act or Act), as amended by the CHIPS Act of 2022 (Division A of Pub. L. 117-167). The CHIPS Incentives Program is administered by the CHIPS Program Office (CPO) within the National Institute of Standards and Technology (NIST) of the United States Department of Commerce (Department). Businesses and other entities applying for CHIPS Act funding may submit an optional pre-application and must submit a full-application via a form available at
Information to be collected includes information pertaining to an applicant's:
The Environmental Questionnaire must be submitted electronically as part of the Pre-application or Full-application at
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Institute of Standards and Technology (NIST), Commerce.
Notice of Information Collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection
To ensure consideration, comments regarding this proposed information collection must be received on or before June 12, 2023.
Interested persons are invited to submit written comments by email to Nina Argent, Management Analyst, National Institute of Standards and Technology, at
Requests for additional information or specific questions related to collection activities should be directed to Cierra Bean, Business Operations Analyst, CHIPS Program Office,
The CHIPS Incentives Program is authorized by Title XCIX—Creating Helpful Incentives to Produce Semiconductors for America of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283, referred to as the CHIPS Act or Act), as amended by the CHIPS Act of 2022 (Division A of Pub. L. 117-167). The CHIPS Incentives Program is administered by the CHIPS Program Office (CPO) within the National Institute of Standards and Technology (NIST) of the United States Department of Commerce (Department). Businesses and other entities applying for CHIPS Act funding under the CHIPS Incentive Program may, but are not required to, submit a pre-application via a form available at
Information to be collected includes:
• A Cover Page with general contact and project information;
• A Project Plan that describes each project expected to be included in the future full application. The project plan should explain how each project satisfies the program description and the evaluation criteria in the CHIPS Incentive Program—Commercial Fabrication Facilities Notice of Funding Opportunity;
• Financial Information summarizing financial information for the applicant and the project(s), as well as a detailed sources and uses of funds, including overview of CHIPS incentive request;
• Workforce Development Information describing the applicant's approach to recruit, train, and retain a diverse and skilled set of workers to fill the good jobs that will be created to operate its semiconductor facilities.
Applications must be submitted electronically at
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Institute of Standards and Technology (NIST), Commerce.
Notice of Information Collection; request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before June 12, 2023.
Interested persons are invited to submit written comments by email to Maureen O'Reilly, Management Analyst, National Institute of Standards and Technology, at
Requests for additional information or specific questions related to collection activities should be directed to Cierra Bean, Business Operations Analyst, CHIPS Program Office,
The CHIPS Incentives Program is authorized by Title XCIX—Creating Helpful Incentives to Produce Semiconductors for America of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283, referred to as the CHIPS Act or Act), as amended by the CHIPS Act of 2022 (Division A of Pub. L. 117-167). The CHIPS Incentives Program is administered by the CHIPS Program Office (CPO) within the National Institute of Standards and Technology (NIST) of the United States Department of Commerce (Department). Applicants must submit a statement of interest (SOI) via a form available at
Information to be collected includes:
Applications must be submitted electronically at
The SOI will consist of a series of questions presented to registered users via a web form. Question types will include basic contact information, picklists, cost estimates, and brief project narratives. This method was chosen to reduce applicant burden by eliminating redundant entries to the greatest extent possible and consolidating entries into one online form.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
United States Patent and Trademark Office, U.S. Department of Commerce.
Notice of public listening sessions; request for comments.
The United States Patent and Trademark Office (USPTO) seeks public comments on areas related to the study of the patent pro bono programs identified in the Unleashing American Innovators Act of 2022. This study builds upon the work the USPTO has conducted for over a decade and has scaled during the Biden Administration, to bring more people in America into the innovation ecosystem to create more jobs, foster economic prosperity, and solve world problems. The USPTO is announcing two public listening sessions on June 5 and 7, 2023, titled “Inventor Listening Session for Patent Pro Bono Programs” and “Patent Practitioner Listening Session for Patent Pro Bono Program,” respectively, to provide further opportunity for the public to provide input on these subject areas.
Visit the Federal eRulemaking Portal for additional instructions on providing comments via the portal. If electronic submission of comments is not feasible due to a lack of access to a computer and/or the internet, please contact the USPTO using the contact information below for special instructions regarding how to submit comments by mail or by hand delivery.
Will Covey, Deputy General Counsel for Enrollment and Discipline and Director of the Office of Enrolment and Discipline, at 571-272-4097.
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, Public Law 117-328. The Act provided appropriations to federal agencies and established or modified various programs. It included the Unleashing American Innovators Act of 2022 (UAIA or the Act) which, among other things, required that the Director of the USPTO complete a study of the patent pro bono programs,
According to the USPTO Chief Economist's report titled “Intellectual Property and the U.S. Economy: Third Edition,” the average weekly earnings in 2019 for those employed in industries that intensively use intellectual property (IP) (
Our IP-intensive industries directly employ 47.2 million Americans, and indirectly, they employ another 15.5 million. They account for 44% of all the jobs in the United States. In 2019, MIT's Sloan School of Management observed from a sample that firms with patent and trademark protection were 278 times more likely to experience financial growth than firms that did not.
At the USPTO, we are guided by the vision that expanding participation of under-represented groups to achieve equitable representation in patenting can substantially grow our economy, adding an estimated $1 trillion to GDP.
Increased participation in our patent system is essential for job creation, economic prosperity, and for solving world problems. Preparing a patent application and conducting proceedings before the USPTO to obtain a patent require significant knowledge of patent laws, regulations, and USPTO procedures. As a result, most inventors hire registered patent attorneys or agents to assist them. Under-resourced inventors may not be able to afford such representation. To help address this issue, Congress directed the USPTO to support a nationwide network of independently operated pro bono programs, collectively referred to as the Patent Pro Bono Program. The Patent Pro Bono Program helps under-resourced inventors obtain free legal help to prepare, file, and prosecute patent applications and is available nationwide via 21 regional independent not-for-profit programs, many of which serve multiple states.
When the USPTO meets people where they are with pro bono legal counsel, we see vast improvements in representation. Under the Biden Administration, the USPTO has worked with the 21 regional independent not-for-profit programs and the Pro Bono Advisory Council to expand the USPTO's support for the Patent Pro Bono Program and to expand the program's offerings. Although women make up about 13% of U.S. inventors, our data for participation in 2022 shows that 43% of those who participate in our Patent Pro Bono Program and chose to identify their gender, identify as women. 35% identify as African American or Black, 5.7% identify as Asian American or Native Pacific Islander and 1.5% identify as Native American. Nearly 14% of those who chose to identify their ethnicity, identified as Hispanic American. Approximately 8% of patent pro bono participants identified as veterans.
The USPTO encourages and supports pro bono offerings for patent prosecution through the USPTO Law School Clinic Certification Program (LSCCP). During the Biden Administration, participation in the LSCCP reached an all-time high and now includes 62 law schools across the U.S. that provide pro bono patent and/or trademark legal services to qualified under-resourced inventors, entrepreneurs, and small businesses.
The USPTO offers a Patent Trial and Appeal Board (PTAB) Pro Bono Program. The PTAB Pro Bono Program helps under-resourced inventors obtain free legal assistance to prepare and file appeals before the PTAB and similarly is available nationwide. The PTAB Bar Association operates as a clearinghouse for the PTAB Pro Bono Program. The USPTO and PTAB Bar Association have plans to extend the PTAB Pro Bono
The USPTO currently collects data from participating law school clinics on a semi-annual basis.
For the Patent Pro Bono Program, the regional pro bono programs match volunteer patent attorneys and agents with financially under-resourced inventors and small businesses for the purpose of securing patent protection. Each regional program sets different requirements for participation. The participation requirements address income level, knowledge of the U.S. patent system, and that the inventor possess an invention. Most regional programs require that an applicant's gross household income be less than three times the federal poverty level guidelines. Applicants should demonstrate knowledge of the patent system through filing of a provisional patent application or completing a training course. The applicant must be able to describe the features of the invention and how it works. For a list of the participation requirements for the Patent Pro Bono Program, see
The PTAB Pro Bono Program operates through a national clearinghouse, administered by the PTAB Bar Association, which matches volunteer patent attorneys and agents with financially under-resourced inventors for the purpose of preparing appeals. Participation requires an applicant to have a gross household income less than three times the federal poverty level guidelines, knowledge of the appeal process through completion of two training videos, and a distinct issue for appeal. The national clearinghouse sets a one-month timing requirement for applicants to apply to the program to ensure enough time to file the appeal and to avoid USPTO extension of time fees. For a list of the participation requirements for the PTAB Pro Bono Program, see
Following the congressional mandate set forth in the UAIA, the USPTO is currently performing a study to assess the functioning of the Patent Pro Bono Program. The agency desires feedback from stakeholders so that it may, as appropriate, evaluate the programs and make recommendations to Congress regarding possible administrative and legislative action. We are seeking feedback from a broad group of stakeholders, including, but not limited to, inventors, small businesses, entrepreneurs, patent attorneys, patent agents, law firms, non-profit organizations, academic institutions, public interest groups, and the general public.
The USPTO is holding two listening sessions on June 5 and 7, 2023, and requesting public comments on several questions posed in this section. The USPTO will use a portion of the listening sessions to provide an overview of the programs. An agenda will be available a month before each listening session on the USPTO website. The agenda for the inventor listening session is available at:
The USPTO poses the following questions for public comment. These questions are not meant to be exhaustive. We encourage interested stakeholders to address these and/or other related issues and to submit research and data that inform their comments on these topics. Commenters are welcome to respond to any of the questions and are encouraged to indicate which questions their comments address. Reference to the “patent pro bono programs” in these questions covers the 21 regional programs participating in the Patent Pro Bono Program. Commenters may also provide general feedback regarding the PTAB Pro Bono Program for the same questions set forth below. Commenters providing feedback regarding the PTAB Pro Bono Program should specify that their response pertains to the PTAB Pro Bono Program.
1. What is your experience with the patent pro bono programs,
2. Are the patent pro bono programs sufficiently serving
3. If the patent pro bono programs are not sufficiently serving
4. Are there additional services that existing participants would like to see the patent pro bono programs provide?
5. Are the patent pro bono programs sufficiently serving
6. If the patent pro bono programs are not sufficient to serve
7. Are the patent pro bono programs sufficiently funded to serve prospective and existing participants? If not, how much additional funding would be appropriate to serve prospective and existing participants and how would that funding be utilized?
8. Are any of the current participation requirements for the patent pro bono programs a deterrent for prospective participants? How can or should the participation requirements be changed to better serve these participants?
9. Are prospective participants aware of the patent pro bono programs? What more can be done to improve awareness of the pro bono programs for these participants?
10. Would the removal of any of the current participation requirements for the patent pro bono programs be a deterrent for attorneys or agents to volunteer to participate in the programs?
11. Are there any participation requirements that attorneys would like to see changed or added to facilitate their representation of participants?
12. What factors deter attorneys from volunteering to participate in patent pro bono programs?
13. What barriers exist to greater participation of attorneys in the patent pro bono programs?
14. What factors encourage attorneys to volunteer to participate in patent pro bono programs?
15. What services, beyond patent application drafting and prosecution, do pro bono program attorneys provide to patent pro bono program participants?
16. Would the patent pro bono programs be improved by expanding them to include non-attorneys, including patent agents and patent paralegals?
17. Have the patent pro bono programs made existing and prospective participants more informed about the U.S. patent system, and if so, how?
18. One of the goals of the program is to provide support to innovators, particularly underrepresented
19. For patent pro bono program administrators, what steps do you recommend that the USPTO take to dramatically increase patent pro bono representation within your region?
Department of Defense (DoD).
Establishment of Federal advisory committee.
The DoD gives notice that it is establishing the Armed Forces Retirement Home Advisory Council (AFRHAC) as a non-discretionary Federal advisory committee.
Jim Freeman, DoD Advisory Committee Management Officer, 703-697-1411.
The DoD gives notice that it is establishing the AFRHAC as a non-discretionary Federal advisory committee in accordance with chapter 10 of title 5 United States Code (U.S.C.) (formerly the Federal Advisory Committee Act (FACA) (5 U.S.C., App.)). The AFRHAC, required by 24 U.S.C. 416, provides guidance and recommendations on the administration of the Armed Forces Retirement Home (AFRH) and the quality of care provided to residents of the AFRH. Pursuant to 24 U.S.C. 411(b), the purpose of the AFRH is to provide, through the AFRH-Washington [Washington, DC] and AFRH-Gulfport [Gulfport, Mississippi], residences and related services for certain retired and former members of the Armed Forces.
In carrying out its objectives and activities, the AFRHAC provides to the Secretary of Defense, the AFRH Chief Operating Officer, and the Administrator of each facility such guidance and recommendations on the administration of the facility and the quality of care provided to residents as the AFRHAC considers appropriate. In carrying outs its functions, the AFRHAC provides for participation in its activities by a representative of the Resident Advisory Committee of each facility of the AFRH; and may make recommendations to the DoD Inspector General regarding issues that the Inspector General should investigate. Not less often than annually, the AFRHAC shall submit to the Secretary of Defense a report summarizing its activities during the preceding year and providing such observations and recommendations with respect to the AFRH as the AFRHAC considers appropriate.
In reviewing the mission/scope of the AFRHAC, the Secretary of Defense directed that the AFRHAC membership should include appropriate individuals from both the private and public sectors to promote diversity of background, experience, and thought in support of the AFRHAC mission. Based upon the Secretary's decision, the AFRHAC will be established in accordance with chapter 10 of title 5 U.S.C. and 41 Code of Federal Regulations (CFR) 102-3.50(a). The charter and contact information for the AFRHAC's Designated Federal Officer (DFO) can be found at
Pursuant to 24 U.S.C. 416(c), the AFRHAC shall be composed of at least 15 members. Members of the AFRHAC shall be appointed by the Secretary of Defense or the Deputy Secretary of Defense (“the DoD Appointing Authority”), or in the case of employees of other Federal departments or agencies, appointed in consultation with the DoD Appointing Authority by their respective departments and agencies. Membership shall consist of (1) one member who is an expert in nursing home or retirement home administration and financing; (2) one member who is an expert in gerontology; (3) one member who is an expert in financial management; (4) two representatives of the Department of Veterans Affairs, one to be designated from each of the regional offices nearest in proximity to the facilities of the AFRH; (5) the chairpersons of the AFRH Resident Advisory Committees; (6) one enlisted representative of the Services' Retiree Advisory Council; (7) the senior noncommissioned officer of one of the Armed Forces; (8) two senior representatives of military medical treatment facilities, one to be designated from each of the military hospitals nearest in proximity to the facilities of the AFRH; (9) one senior judge advocate from one the Armed Forces; (10) one senior representative of one of the chief personnel officers of the Armed Forces; (11) such other members as the Secretary of Defense may designate; and (12) the Administrator of each facility of the AFRH, who shall be a nonvoting member of the AFRHAC.
In accordance with 24 U.S.C. 416(d)(1) and DoD policy, members shall serve a two-year term of service, with annual renewal, and the DoD Appointing Authority may designate a member to serve one additional term of service. Pursuant to 24 U.S.C. 416(e), a vacancy in the AFRHAC shall be filled in the manner in which the original designation was made. An AFRHAC member designated to fill a vacancy occurring before the end of the term of the predecessor shall be designated for the remainder of the term of the predecessor.
Pursuant to 24 U.S.C. 416(d)(2) through (4), a member of the AFRHAC member, unless earlier terminated by the DoD Appointing Authority, may continue to serve as a member of the AFRHAC after the expiration of the member's term until a successor is designated; the DoD Appointing Authority may terminate the term of service of a member of the AFRHAC before the expiration of the member's term; and a member of the AFRHAC serves as a member of the AFRHAC only for as long as the member is assigned to or serving in a position for which the duties include the duty to serve as a member of the AFRHAC.
The DoD Appointing Authority shall appoint the AFRHAC's Chair from among the membership previously approved, in accordance with DoD policy and procedures, for a term of service of one-to-two years, with annual renewal, which shall not exceed the member's approved AFRHAC appointment. Pursuant to 24 U.S.C. 416(c)(5), the AFRHAC's Chair shall conduct the meetings of the AFRHAC.
AFRHAC members who are not full-time or permanent part-time Federal civilian officers or employees, or active-duty members of the Uniformed Services, are appointed as experts or consultants, pursuant to 5 U.S.C. 3109, to serve as special government employee members. AFRHAC members who are full-time or permanent part-time Federal civilian officers or employees, or active-duty members of the Uniformed Services, are designated pursuant to 41 CFR 102-3.130(a) to serve as regular government employee members.
All AFRHAC members are appointed to exercise their own best judgment without representing any particular point of view and in a manner that is
The public or interested organizations may submit written statements about the AFRHAC's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the AFRHAC. All written statements shall be submitted to the DFO for the AFRHAC, who will ensure that the written statements are provided to the membership for their consideration.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before May 12, 2023.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Karen Holliday, (202) 245-7318.
The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Section 302 (b)(2)(C) of the Act requires tracking of scholars' employment status and location of former scholars supported under the grants in order to ensure that students are meeting the payback requirement. Scholars must provide requested information necessary to meet the exit certification requirements.
In addition to meeting the requirement that all scholars be tracked, the information collected will provide performance data relevant to the rehabilitation fields and degrees pursued by RSA scholars, as well as the funds owed and the rehabilitation work completed by them.
In summary, RSA is requesting a revision of the currently approved collection by adding a section titled State Vocational Rehabilitation (VR) Agency: RSA Job Board Posting, where RSA envisions State VR agencies may initiate posting of an open position on the RSA Job Board on a rolling basis as positions become available. This addition to the current collection will be a helpful resource to students who receive RSA support, graduate, and seek qualifying employment to fulfill their required service obligation. This collection package adds the participation of State VR agencies to the existing approved ICR. Job leads will be submitted electronically through the online RSA Payback Information Management System (PIMS). There is minimal estimated burden required to report job information using the PIMS system.
Office of Postsecondary Education, Department of Education.
Notice.
The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal
For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the
Don Crews, U.S. Department of Education, 400 Maryland Avenue SW, Room 2B110, Washington, DC 20202-4260. Telephone: (202) 280-8775. Email:
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
Concerns for college students' mental health have increased because there is a growing discovery that student exposure to trauma, disruptions in learning and disengagement from school and peers negatively impact students' mental health and well-being.
Through this grant program, the Department encourages Native American-Serving Nontribal Institutions to develop, create, or enhance programs that foster students' sense of belonging and to implement services that will help students complete their degree programs. Through the competitive preference priorities for this grant competition, the Department invites applicants to submit proposals to provide high-quality learning, improve student engagement, and meet the needs of Native American students.
These priorities are:
Projects that are designed to improve students' social, emotional, academic, and career development, with a focus on underserved students (as defined in this notice), by creating a positive, inclusive, and identity-safe climate at IHEs through one or more of the following activities:
(a) Fostering a sense of belonging and inclusion for underserved students.
(b) Implementing evidence-based practices for advancing student success for underserved students.
Projects that are designed to increase postsecondary access, affordability, completion, and success for underserved students by addressing one or more of the following priority areas:
(a) Supporting the development and implementation of student success programs that integrate multiple comprehensive and evidence-based services or initiatives, such as academic advising, structured/guided pathways, career services, credit-bearing academic undergraduate courses focused on career, and programs to meet basic needs, such as housing, childcare and transportation, student financial aid, and access to technological devices.
(b) Supporting the development and implementation of high-quality and accessible learning opportunities, including learning opportunities that are accelerated or hybrid online; credit-bearing; work-based; and flexible for working students.
(c) Providing secondary school students with access to career exploration and advising opportunities to help students make informed decisions about their postsecondary enrollment decisions and to place them on a career path.
This priority is:
Projects that support activities to strengthen and institutionalize Native language preservation and revitalization.
Other sources include:
(a) A student who is living in poverty.
(b) A student who is a member of a federally recognized Indian Tribe.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in subsequent years from the list of unfunded applications from this competition.
1.
To qualify as an eligible institution under the NASNTI Program, an institution must—
(i) Be accredited or preaccredited by a nationally recognized accrediting agency or association that the Secretary has determined to be a reliable authority as to the quality of education or training offered;
(ii) Be legally authorized by the State in which it is located to be a junior or community college or to provide an educational program for which it awards a bachelor's degree; and
(iii) Be designated as an “eligible institution,” by demonstrating that it: (A) has an enrollment of needy students as described in 34 CFR 607.3; and (B) has low average education and general expenditures per full-time equivalent (FTE) undergraduate student as described in 34 CFR 607.4.
An eligible IHE that submits applications for an Individual Development Grant and a Cooperative Arrangement Development Grant in this competition may be awarded both in the same fiscal year. A grantee with an Individual Development Grant or a Cooperative Arrangement Development Grant may be a partner in one or more Cooperative Arrangement Development Grants. The lead institution in a Cooperative Arrangement Development Grant must be an eligible institution. Partners are not required to be eligible institutions. Tribally Controlled Colleges and Universities, as authorized by title III of the HEA, may participate in more than one Cooperative Arrangement Development Grant as a partner.
A grantee under the DHSI program, which is authorized under title V of the HEA, may not receive a grant under any HEA, title III, part A program. The title III, part A programs are: Strengthening Institutions Program; the Tribally Controlled Colleges and Universities Program; the Alaska Native and Native Hawaiian-Serving Institutions Program; the Asian American and Native American Pacific Islander-Serving Institutions Program; and the NASNTI Program. Furthermore, a current DHSI program grantee may not give up its HSI grant to receive a grant under any title III, part A program as described in 34 CFR 607.2(g)(1).
An eligible HSI that is not a current grantee under the DHSI program may apply for a FY 2023 grant under all title III, part A programs for which it is eligible, as well as receive consideration for a grant under the DHSI program. However, a successful applicant may receive only one grant as described in 34 CFR 607.2(g)(1).
2. a.
b.
c.
d.
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• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double-space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger, and no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.
The recommended page limit does not apply to the cover sheet; the budget
1.
(a)
The Secretary considers the need for the proposed project. In determining the need for the proposed project, the Secretary considers:
(1) The magnitude of the need for the services to be provided or the activities to be carried out by the proposed project. (5 points)
(2) The extent to which the proposed project will focus on serving or otherwise addressing the needs of disadvantaged individuals. (5 points)
(3) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses. (5 points)
(b)
The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers:
(1) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable. (10 points)
(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs. (10 points)
(3) The extent to which the proposed project demonstrates a rationale (as defined in this notice). (5 points)
(c)
The Secretary considers the quality of the services to be provided by the proposed project.
(1) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (4 points)
(2) In addition, the Secretary considers:
(i) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services. (4 points)
(ii) The extent to which the services to be provided by the proposed project reflect up-to-date knowledge from research and effective practice. (2 points)
(d)
The Secretary considers the quality of the personnel who will carry out the proposed project.
(1) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (9 points)
(2) In addition, the Secretary considers:
(i) The qualifications, including relevant training and experience, of the project director or principal investigator. (3 points)
(ii) The qualifications, including relevant training and experience, of key project personnel. (8 points)
(e)
The Secretary considers the adequacy of resources for the proposed project. In determining the adequacy of resources for the proposed project, the Secretary considers:
(1) The extent to which the budget is adequate to support the proposed project. (2 points)
(2) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project. (3 points)
(f)
The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers:
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks. (8 points)
(2) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project. (2 points)
(3) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project. (5 points)
(g)
The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers:
(1) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project. (5 points)
(2) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible. (5 points)
2.
In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
A panel of three non-Federal reviewers will review and score each application in accordance with the selection criteria. A rank order funding slate will be made from this review. Awards will be made in rank order according to the average score received from the peer review and from the competitive preference priority, if addressed by the applicant.
In tie-breaking situations for development grants, under 34 CFR 607.23(b), we award one additional point to an application from an IHE that has an endowment fund of which the
(1) Faculty development.
(2) Funds and administrative management.
(3) Development and improvement of academic programs.
(4) Acquisition of equipment for use in strengthening management and academic programs.
(5) Joint use of facilities.
(6) Student services.
For the purpose of these funding considerations, we use 2020-2021 data.
If a tie remains after applying the tie-breaker mechanism above, priority will be given to applicants that have the lowest endowment values per FTE enrolled student.
3.
4.
Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.
5.
(a) Selecting recipients most likely to be successful in delivering results based on the program objectives through an objective process of evaluating Federal award applications (2 CFR 200.205);
(b) Prohibiting the purchase of certain telecommunication and video surveillance services or equipment in alignment with section 889 of the National Defense Authorization Act of 2019 (Pub. L. 115-232) (2 CFR 200.216);
(c) Providing a preference, to the extent permitted by law, to maximize use of goods, products, and materials produced in the United States (2 CFR 200.322); and
(d) Terminating agreements in whole or in part to the greatest extent authorized by law if an award no longer effectuates the program goals or agency priorities (2 CFR 200.340).
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
Additionally, a grantee or subgrantee that is awarded competitive grant funds must have a plan to disseminate these public grant deliverables. This dissemination plan can be developed and submitted after your application has been reviewed and selected for funding. For additional information on the open licensing requirements please refer to 2 CFR 3474.20.
4.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
5.
(a) The percentage of first-time, full-time, degree-seeking undergraduate students at 4-year NASNTIs who were in their first year of postsecondary enrollment in the previous year and are enrolled in the current year at the same NASNTI;
(b) The percentage of first-time, full-time, degree-seeking undergraduate students at 2-year NASNTIs who were in their first year of postsecondary
(c) The percentage of first-time, full-time, degree-seeking undergraduate students enrolled at 4-year NASNTIs who graduate within 6 years of enrollment; and
(d) The percentage of first-time, full-time, degree-seeking undergraduate students enrolled at 2-year NASNTIs who graduate within 3 years of enrollment.
6.
In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
You may also access documents of the Department published in the
Take notice that the Commission received the following Complaints and Compliance filings in EL Dockets:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Federal Energy Regulatory Commission, Department of Energy.
Notice of a modified system of records.
The Federal Energy Regulatory Commission (FERC) is publishing a notice of modifications to an existing FERC system of records, FERC-35 titled Commission Security Investigation Records. In accordance with the Privacy Act of 1974, and to comply with the Office of Management and Budget (OMB) Memorandum M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, January 3, 2017, this notice will create 9 new routine uses, and will incorporate two new routine uses that permit FERC to disclose information as necessary in response to an actual or suspected breach that pertains to a breach of its own records or to assist another agency in its efforts to respond to a breach that were previously published separately in the
In accordance with 5 U.S.C. 552a(e)(4) and (11), this system of records notice is effective upon publication, with the exception of the routine uses, which will go into effect 30 days after publication of this notice, unless comments have been received from interested members of the public requiring modification and republication of the notice.
Any person interested in commenting on the establishment of this modified system of records may do so by submitting comments in writing to:
For United States Postal Service-delivered mail: Director, Office of the Secretary (OSEC) Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. For hand-delivered or courier-delivered mail: Director, Office of External Affairs, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
Mittal Desai, Chief Information Officer & Senior Agency Official for Privacy, Office of the Executive Director, Office of the Executive Director, 888 First Street NE, Washington, DC 20426, (202) 502-6432.
The FERC Commission Security Investigations Records notice has 9 new routines and includes two prescribed routine uses that permit FERC to disclose information as necessary in response to an actual or suspected breach that pertains to a breach of its own records or to assist another agency in its efforts to respond to a breach that were previously published in the
Commission—FERC-35.
Unclassified.
Federal Energy Regulatory Commission, Chief Security Officer Directorate, 888 First Street NE, Room 3A-09, Washington, DC 20426.
Chief Security Officer Directorate, Federal Energy Regulatory Commission, 888 First Street NE, Room ED-43, Washington, DC 20426.
5 U.S.C. 301, 2302(b)(2)(B), 2302(b)(10), 7311, 7313; Executive Order 13764; 5 CFR 731.103, 18 CFR 3b.
The records in this system are used to provide investigative and related administrative, adjudicative, and other information necessary to determine whether an individual is suitable or fit for Government employment; eligible for physical access to FERC controlled facilities and information systems; eligible to hold sensitive positions (including but not limited to eligibility for access to classified information); fit to perform work for or on behalf of the U.S. Government as a contractor; qualified to perform contractor services for the U.S. Government; or loyal to the United States; while maintaining compliance with applicable legal, regulatory and policy authorities.
Current and former FERC employees, contractors, interns, volunteers, as well as other individuals (including contractor personnel of other Government entities and foreign nationals) requiring a FERC determination for suitability or fitness for duty, HSPD-12 access, access to classified national security information, Sensitive Compartmented Information, and/or assignment to a position with sensitive duties; and officials or employees of State, local, tribal and private sector entities sponsored for access to classified and other sensitive information by a Federal agency.
This system maintains information collected as part of the investigative vetting process. This information may include the individual's personally identifiable information; residential, educational, employment, and mental health history; financial details, and criminal and disciplinary histories; to include:
Current, former, alternate name, social security number, home and work address and phone number, reference's home and work address and phone number. Additional information collected may include date of birth; place of birth; height; weight; hair and eye color; gender; sex; mother's maiden name; residential history, phone numbers, and email addresses; employment history; military records and discharge information; selective service registration record; educational data, including conduct records and degrees earned; names of relatives, associates and references with their contact information; country/countries of citizenship; travel, immigration, and passport information; mental health history; records related to drug and/or alcohol use; financial record information; information pertaining to income tax returns; bureau of vital statistics records (
In addition, this system may contain records documenting the outcomes of investigations and adjudications conducted by other Federal investigative organizations (
Records are obtained from individual employees, applicants, consultants, experts and contractors (including the results of in-person interviews) whose files are on record as authorized by those concerned; investigative reports from Federal investigative agencies; criminal or civil investigations; continuous evaluation records; police and credit record checks; personnel records; educational records and instructors; current and former employers; coworkers, neighbors, family members, acquaintances; and authorized security representatives.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, information maintained in this system may be disclosed to authorized entities outside FERC for purposes determined to be relevant and necessary as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To appropriate agencies, entities, and persons when (1) FERC suspects or has confirmed that there has been a breach of the system of records; (2) FERC has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Commission (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Commission's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
To another Federal agency or Federal entity, when FERC determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of that individual.
To the Equal Employment Opportunity Commission (EEOC) when requested in connection with investigations of alleged or possible discriminatory practices, examination of Federal affirmative employment programs, or other functions of the Commission as authorized by law or regulation.
To the Federal Labor Relations Authority or its General Counsel when requested in connection with investigations of allegations of unfair labor practices or matters before the Federal Service Impasses Panel.
To disclose information to another Federal agency, to a court, or a party in litigation before a court or in an administrative proceeding being conducted by a Federal agency, when the Government is a party to the judicial or administrative proceeding. In those cases where the Government is not a party to the proceeding, records may be disclosed if a subpoena has been signed by a judge.
To the Department of Justice (DOJ) for its use in providing legal advice to FERC or in representing FERC in a proceeding before a court, adjudicative body, or other administrative body, where the use of such information by the DOJ is deemed by FERC to be relevant and necessary to the advice or proceeding, and such proceeding names as a party in interest: (a) FERC; (b) any employee of FERC in his or her official capacity; (c) any employee of FERC in his or her individual capacity where DOJ has agreed to represent the employee; or (d) the United States, where FERC determines that litigation is likely to affect FERC or any of its components.
To non-Federal Personnel, such as contractors, agents, or other authorized individuals performing work on a contract, service, cooperative agreement, job, or other activity on behalf of FERC or Federal Government and who have a need to access the information in the performance of their duties or activities.
To the National Archives and Records Administration in records management inspections and its role as Archivist.
To the Merit Systems Protection Board or the Board's Office of the Special Counsel, when relevant information is requested in connection with appeals, special studies of the civil service and other merit systems, review of OPM rules and regulations, and investigations of alleged or possible prohibited personnel practices.
To appropriate Federal, State, or local agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information may be relevant to a potential violation of civil or criminal law, rule, regulation, order.
To the Department of Defense's Defense Counter Intelligence and Security Agency (DOD/DCSA), and other Departments and agencies that shares PII with FERC, in connection with the vetting of individuals (employees or applicants) for Federal employment, military service, consulting, volunteer personnel and/or contractor personnel, for national security purposes, including but not limited to, personnel background investigations, continuous vetting, suitability investigations and for satisfying the credentialing requirements of HSPD-12.
Records are maintained in electronic and paper format. Electronic records are stored by individuals first and last names. In addition, all FERC employees and contractors with authorized access have undergone a thorough background security investigation. Data access is restricted to agency personnel or contractors whose responsibilities require access. Access to electronic records is controlled by user ID and password combination and/or other network access or security controls (
Records may be retrieved by name, social security number, date of birth, place of birth, Defense Counterintelligence and Security Agency [Investigative Service Provider] investigation number, adjudicative case identification number or some combination thereof.
Records are retained under the National Archives and Records Administration's General Records Schedule 5.6: Security Management Records; Disposition Authority: DAA-GRS-2021-0001-0007). Destroy 1 year after consideration of the candidate ends, but longer retention is authorized if required for business use.
All FERC employees and contractors with authorized access have undergone a thorough background security investigation. Data access is restricted to agency personnel or contractors whose responsibilities require access. Access to electronic records is controlled by “User ID” and password combination and/or other network access or security controls (
Submit a Privacy Act Request.
The Privacy Act permits access to records about yourself that are maintained by FERC in a Privacy Act system of records. In addition, you may request that incorrect or incomplete information be changed or amended. Privacy requests follow FERC's Freedom of Information Act (FOIA) request process. You may access the FOIA website at
For questions: Contact the FOIA Service Center at 202-502-6088 or by email at
The Privacy Act permits access to records about yourself that are maintained by FERC in a Privacy Act system of records. In addition, you may request that incorrect or incomplete information be changed or amended. Privacy requests follow FERC's FOIA request process. You may access the FOIA website at
The Privacy Act permits access to records about yourself that are maintained by FERC in a Privacy Act system of records. In addition, you may request that incorrect or incomplete information be changed or amended. Privacy requests follow FERC's FOIA request process. You may access the FOIA website at
None.
65 FR 21752.
Take notice that the Commission has received the following Natural Gas & Oil Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on March 28, 2023, WBI Energy Transmission, Inc. (WBI Energy), 1250 West Century Avenue, Bismarck, North Dakota 58503, filed a prior notice request in accordance with 18 CFR 157.205 and 157.216 of the Federal Energy Regulatory Commission's (Commission) regulations under the Natural Gas Act and WBI Energy's blanket certificate issued in Docket No. CP82-487-000. WBI Energy requests authorization to abandon: (1) six natural gas storage wells, (2) approximately 1.26 miles of associated pipeline, and (3) one aboveground measurement facility, all located at WBI Energy's Baker Storage Field in Fallon County, Montana. WBI Energy states the wells are not necessary to satisfy its firm storage requirements and their abandonment will not change the overall firm withdrawal capabilities of the Baker Storage Field.
In addition to publishing the full text of this document in the
Any questions concerning this application should be directed to Lori Myerchin, Director, Regulatory Affairs and Transportation Services, WBI Energy Transmission, Inc., 1250 West Century Avenue, Bismarck, North Dakota 58503, by phone at (701) 530-1563 or by email to
Pursuant to section 157.9 of the Commission's Rules of Practice and Procedure,
There are three ways to become involved in the Commission's review of this project: you can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on June 5, 2023. How to file protests, motions to intervene, and comments is explained below.
Pursuant to section 157.205 of the Commission's regulations under the NGA,
Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before June 5, 2023. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.
There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP23-123-000 in your submission.
(1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP23-123-000.
The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail or email (with a link to the document) at: Lori Myerchin, Director, Regulatory Affairs and Transportation Services, WBI Energy Transmission, Inc., 1250 West Century Avenue, Bismarck, North Dakota 58503, or by email to
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
Federal Accounting Standards Advisory Board.
Notice.
Notice is hereby given that the Federal Accounting Standards Advisory Board (FASAB) has issued Statement of Federal Financial Accounting Standards (SFFAS) 61 titled
SFFAS 61 is available on the FASAB website at
Ms. Monica R. Valentine, Executive Director, 441 G Street NW, Suite 1155, Washington, DC 20548, or call (202) 512-7350.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's
Written PRA comments should be submitted on or before June 12, 2023. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The Commission has updated the International Bureau Filing System (IBFS) to allow for filing of electronic forms directly into the system through an integrated web-based program with fillable fields. The integrated web-based program requires the use of an FCC Registration Number (FRN) and includes support for Form 309-IBFS, 310-IBFS, and 311-IBFS. The new system also includes a standardized form to file frequency requests, Form 426, which were previously done through email correspondence and approved as part of this collection. Applicants will be required to submit these forms through the integrated web-based program. Filing through the web-based program will reduce the burden hours on the on applicants. Therefore, this information collection is being revised to reflect the new form format for Forms 309-IBFS, 310-IBFS and 311-IBFS, the new Form 426, and changes in costs associated with the automated functions of the forms.
On July 13, 2021, the Commission released an Order titled, “In the Matter of Mandatory Electronic Filing of Section 325(c) Applications, International Broadcast Applications, and Dominant Carrier Section 63.10(c) Quarterly Reports” (FCC 21-87). Over the past decades, the Commission has made significant progress to upgrade and modernize its filing systems and procedures. The purpose of this Order is to require that any remaining applications and reports administered by the International Bureau and filed on paper or through an alternative filing process be filed only electronically through the Commission's International Bureau Filing System (IBFS).
The information collected pursuant to the rules set forth in 47 CFR part 73 Subpart F is used by the Commission to assign frequencies for use by international broadcast stations, to grant authority to operate such stations, and to determine if interference or adverse propagation conditions exists that may impact the operation of such stations. If the Commission did not collect this information, it would not be in a position to effectively coordinate spectrum for international broadcasters or to act for entities in times of frequency interference or adverse propagation conditions. The orderly nature of the provision of international broadcast service would be in jeopardy without the Commission's involvement.
The full title and purpose of each application are summarized below:
1. Application for Authority to Construct or Make Changes in an International, Experimental Television, Experimental Facsimile, or a Developmental Broadcast Station (FCC Form 309-IBFS)—The FCC Form 309-IBFS is filed on occasion when the applicant is requesting authority to construct or make modifications to the international broadcast station.
2. Application for an International, Experimental Television, Experimental Facsimile, or a Developmental Broadcast Station License (FCC Form 310-IBFS)—The FCC Form 310-IBFS is filed on occasion when the applicant is submitting an application for a new international broadcast station.
3. Application for Renewal of an International or Experimental Broadcast Station License (FCC Form 311-IBFS)—The FCC Form 311-IBFS is filed by applicants who are requesting renewal of their international broadcast station licenses.
4. Application for International High Frequency Broadcasting—Frequency Coordination Request (Form 426)—The FCC Form 426 is filed by applicants who are requesting frequencies for an upcoming broadcast season.
As part of and in addition to the FCC Forms 309-IBFS, 310-IBFS and 311-IBFS, this information collection includes the following collections of information:
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(a) Upon completion of construction of an international broadcasting station in accordance with the terms of the construction permit, the technical provisions of the application therefor, and the rules and regulations and the applicable engineering standards, and when an application for station license has been filed showing the station to be in satisfactory operating condition, the permittee may request authority to conduct program tests. Such request shall be electronically filed with the FCC in the International Filing System (IBFS) at least 10 days prior to the date on which it is desired to begin such operation. All data necessary to show compliance with the terms and conditions of the construction permit must be filed with the license application.
(b) Program tests shall not commence until specific Commission authority is received. The Commission reserves the right to change the date of the beginning of such tests or to suspend or revoke the authority for program tests as and when such action may appear to be in the public interest, convenience, and necessity.
(c) Unless sooner suspended or revoked, program test authority continues valid during Commission consideration of the application for license and during this period further extension of the construction permit is not required. Program test authority shall be automatically terminated by final determination upon the application for station license.
(d) All operation under program test authority shall be in strict compliance with the rules governing international broadcasting stations and in strict accordance with representations made in the application for license pursuant to which the tests were authorized.
(e) The granting of program test authority shall not be construed as approval by the Commission of the application for station license.
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(a) A license for an international broadcasting station will be issued only after a satisfactory showing has been made in regard to the following, among others:
(1) That there is a need for the international broadcasting service proposed to be rendered.
(2) That the necessary program sources are available to the applicant to render the international service proposed.
(3) That the production of the program service and the technical operation of the proposed station will be conducted by qualified persons.
(4) That the applicant is legally, technically and financially qualified and possesses adequate technical facilities to carry forward the service proposed.
(5) That the public interest, convenience and necessity will be served through the operation of the proposed station.
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(a) Application for construction permit, or modification of a construction permit, for a new facility or change in an existing facility is to be made on the following forms:
(1) FCC Form 301, “Application for Authority to Construct or Make Changes in an Existing Commercial Broadcast Station.”
(2) FCC Form 309, “Application for Authority to Construct or Make Changes in an Existing International or Experimental Broadcast Stations.” For International Broadcast Stations, applications shall be filed electronically in the International Bureau Filing System (IBFS).
(3) [Reserved]
(4) FCC Form 340, “Application for Authority to Construct or Make Changes in a Noncommercial Educational Broadcast Station.”
(5) FCC Form 346, “Application for Authority to Construct or Make Changes in a Low Power TV, TV Translator or TV Booster Station.”
(6) FCC Form 349, “Application for Authority to Construct or Make Changes in an FM Translator or FM Booster Station.”
(7) FCC Form 318, “Application for Construction Permit for a Low Power FM Broadcast Station.”
(b) The filing of an application for modification of construction permit does not extend the expiration date of the construction permit. Extension of the expiration date must be applied for on FCC Form 307, in accordance with the provisions of § 73.3533.
(c) In each application referred to in paragraph (a) of this section, the applicant will provide the Antenna Structure Registration Number (FCC Form 854R) of the antenna structure upon which it will locate its proposed antenna. In the event the antenna structure does not already have a Registration Number, either the antenna structure owner shall file FCC Form 854 (“Application for Antenna Structure Registration”) in accordance with part 17 of this chapter or the applicant shall provide a detailed explanation why registration and clearance of the antenna structure is not necessary.
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(a) The application for station license shall be filed by the permittee pursuant to the requirements of § 73.1620 Program tests.
(b) The following application forms shall be used:
(1)
i. Form 302-AM for AM stations, “Application for New AM Station Broadcast License.”
ii. Form 302-FM for FM stations, “Application for FM Station License.”
iii. Form 302-TV for television stations, “Application for TV Station Broadcast License.”
(2) FCC Form 310, “Application for an International or Experimental Broadcast Station License.”
(3) [Reserved]
(4) FCC Form 347, “Application for a Low Power TV, TV Translator or TV Booster Station License.”
(5) FCC Form 350, “Application for an FM Translator or FM Booster Station License.”
(6) FCC Form 319, “Application for a Low Power FM Broadcast Station License.”
(c) Eligible low power television stations which have been granted a certificate of eligibility may file FCC Form 302-CA, “Application for Class A Television Broadcast Station Construction Permit Or License.”
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(a) Unless otherwise directed by the FCC, an application for renewal of license shall be filed not later than the first day of the fourth full calendar month prior to the expiration date of the license sought to be renewed, except that applications for renewal of license of an experimental broadcast station shall be filed not later than the first day of the second full calendar month prior to the expiration date of the license sought to be renewed. If any deadline prescribed in this paragraph falls on a nonbusiness day, the cutoff shall be the close of business of the first full business day thereafter. For International Broadcast Stations, applications shall be filed electronically in the International Bureau Filing System (IBFS).
(b) No application for renewal of license of any broadcast station will be considered unless there is on file with the FCC the information currently required by §§ 73.3612 through 73.3615, inclusive, for the particular class of station.
(c) Whenever the FCC regards an application for a renewal of license as essential to the proper conduct of a hearing or investigation, and specifically directs that it be filed by a date certain, such application shall be filed within the time thus specified. If the licensee fails to file such application within the prescribed time, the hearing or investigation shall proceed as if such renewal application had been received.
(d) Renewal application forms titles and numbers are listed in § 73.3500, Application and Report Forms.
The Commission has updated the International Bureau Filing System (IBFS) to allow for filing of electronic forms directly into the system through an integrated web-based program with
On July 13, 2021, the Commission released an Order titled, “In the Matter of Mandatory Electronic Filing of Section 325(c) Applications, International Broadcast Applications, and Dominant Carrier Section 63.10(c) Quarterly Reports.” The purpose of this Order is to require that any remaining applications and reports administered by the International Bureau and filed on paper or through an alternative filing process be filed only electronically through the Commission's International Bureau Filing System (IBFS).
In July 2021, OMB approved this information collection under OMB Control No 3060-1290 to implement mandatory electronic filing of International Broadcast station applications in the International Bureau Filing System (IBFS). The versions of FCC Forms 314, 315, and 316 to be used by International Bureau licensees were renamed as FCC Form 314-IBFS, FCC Form 315-IBFS and FCC Form 316-IBFS. These forms will only be used by the International Broadcast stations in IBFS.
Under 47 CFR 73.3540, the filings of the FCC Forms 314-IBFS, 315-IBFS, and 316-IBFS are required when applying for consent for assignment of a broadcast station construction permit or license. In addition, the applicant must notify the Commission when an approved assignment or transfer of control of a broadcast station construction permit or license has been consummated.
The FCC Forms 314, 315, and 316 were previously shared between the Media Bureau and the International Bureau. The forms were used by the International Bureau for International Broadcast stations and by the Media Bureau for other broadcast licenses. These FCC Forms were previously approved by Office of Management and Budget (OMB) for use by Media Bureau licensees under OMB 3060-0031 and OMB 3060-0009.
Accordingly, the early forms included references to all broadcast services. The new version of the forms removes references to all services except for International Broadcast stations, since they are only used for these stations. The changes also remove references to rules that do not apply to International Broadcast stations and updates the instructions to comport with the new sections.
Specifically, the Commission modified its rules to mandate the electronic filing of, among other things, applications for International Broadcast Stations, including applications for voluntary assignments and transfers of control. These mandatory electronic filing requirements will reduce costs and administrative burdens, result in greater efficiencies, facilitate faster and more efficient communications, and improve transparency to the public. The changes to section 73.3540 (c) and (d) state that “[f]or International Broadcast Stations, the application shall be filed electronically in the International Bureau Filing System (IBFS).” There are currently fewer than 20 International Broadcast stations subject to obligations in section 73.3540, and the International Bureau receives an average of one application involving voluntary transactions per year pursuant to section 73.3540.
(a) Prior consent of the FCC must be obtained for a voluntary assignment or transfer of control.
(b) Application should be filed with the FCC at least 45 days prior to the contemplated effective date of assignment or transfer of control.
(c) Application for consent to the assignment of construction permit or license must be filed on FCC Form 314 “Assignment of license” or FCC Form 316 “Short form” (See paragraph (f) of this section). For International Broadcast Stations, the application shall be filed electronically in the International Bureau Filing System (IBFS).
(d) Application for consent to the transfer of control of a corporation holding a construction permit or license must be filed on FCC Form 315 “Transfer of Control” or FCC Form 316 “Short form” (see paragraph (f) of this section). For International Broadcast Stations, the application shall be filed electronically in the IBFS.
(e) Application for consent to the assignment of construction permit or license or to the transfer of control of a corporate licensee or permittee for an FM or TV translator station, a low power TV station and any associated auxiliary station, such as translator microwave relay stations and UHF translator booster stations, only must be filed on FCC Form 345 “Application for Transfer of Control of Corporate Licensee or Permittee, or Assignment of License or Permit for an FM or TV translator Station, or a Low Power TV Station.”
(f) The following assignment or transfer applications may be filed on FCC “Short form” 316:
(1) Assignment from an individual or individuals (including partnerships) to a corporation owned and controlled by such individuals or partnerships without any substantial change in their relative interests;
(2) Assignment from a corporation to its individual stockholders without effecting any substantial change in the disposition of their interests;
(3) Assignment or transfer by which certain stockholders retire and the interest transferred is not a controlling one;
(4) Corporate reorganization which involves no substantial change in the beneficial ownership of the corporation;
(5) Assignment or transfer from a corporation to a wholly owned subsidiary thereof or vice versa, or where there is an assignment from a corporation to a corporation owned or controlled by the assignor stockholders without substantial change in their interests; or
(6) Assignment of less than a controlling interest in a partnership.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's
Written PRA comments should be submitted on or before June 12, 2023. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
47 CFR 15.123(c)(5)(iii) states subsequent to the successful testing of its initial M-UDCP, a manufacturer or importer is not required to have other M-UDCP models tested at a qualified test facility for compliance with M-Host UNI-DIR-PICS-IO1-061101 (incorporated by reference, see § 15.38) unless the first model tested was not a television, in which event the first television shall be tested as provided in § 15.123(c)(5)(i). The manufacturer or importer shall ensure that all subsequent models of M-UDCPs comply with M-Host UNI-DIR-PICS-IO1-061101 (incorporated by reference, see § 15.38) and all other applicable rules and standards. The manufacturer or importer shall maintain records indicating such compliance in accordance with the verification procedure requirements in part 2, subpart J of this chapter. For each M-UDCP model, the manufacturer or importer shall further submit documentation verifying compliance with M-Host UNI-DIR-PICS-IO1-061101 to the testing laboratory representing cable television system operators serving a majority of the cable television subscribers in the United States.
47 CFR 76.1203 provides that a multichannel video programming distributor may restrict the attachment or use of navigation devices with its system in those circumstances where electronic or physical harm would be caused by the attachment or operation of such devices or such devices that assist or are intended or designed to assist in the unauthorized receipt of service. Such restrictions may be accomplished by publishing and providing to subscribers standards and descriptions of devices that may not be used with or attached to its system. Such standards shall foreclose the attachment or use only of such devices as raise reasonable and legitimate concerns of electronic or physical harm or theft of service.
47 CFR 76.1205 states that technical information concerning interface parameters which are needed to permit navigation devices to operate with multichannel video programming systems shall be provided by the system operator upon request.
47 CFR 76.1207 states that the Commission may waive a regulation related to Subpart P (“Competitive Availability of Navigation Devices”) for a limited time, upon an appropriate showing by a provider of multichannel video programming and other services offered over multichannel video programming systems, or an equipment provider that such a waiver is necessary to assist the development or introduction of a new or improved multichannel video programming or other service offered over multichannel video programming systems, technology, or products. Such waiver requests are to be made pursuant to 47 CFR 76.7.
47 CFR 76.1208 states that any interested party may file a petition to the Commission for a determination to provide for a sunset of the navigation devices regulations on the basis that (1) the market for multichannel video distributors is fully competitive; (2) the market for converter boxes, and interactive communications equipment, used in conjunction with that service is fully competitive; and (3) elimination of the regulations would promote competition and the public interest.
47 CFR 15.118(a) and 47 CFR 15.19(d) state that consumer electronics equipment that is labeled as “cable ready” or “cable compatible” must meet certain technical standards.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.” The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments and recommendations for the proposed information collection should be submitted on or before May 12, 2023.
Comments should be sent to
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) go to the web page
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it can further reduce the information collection burden for small business concerns with fewer than 25 employees.
Written comments and recommendations for the proposed information collection should be submitted on or before May 12, 2023.
Comments should be sent to
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) go to the web page
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
The Commission has referred to the North American Numbering Council the development of a technical requirements document for the reassigned numbers database for review by the Commission. The technical requirements document will contain a single, unified set of functional and interface requirements for: technical interoperability and operational standards; the user interface specifications and data format for service providers to report to the Administrator; the user interfaces and other means by which callers may submit queries, including providing callers the abilities for high-volume and batch processing or to submit individual queries; appropriate safeguards to protect the privacy and security of subscribers, protect the database from
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.” The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments and recommendations for the proposed information collection should be submitted on or before May 12, 2023.
Comments should be sent to
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) go to the web page
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
The Commission submits this information collection, which seeks to have collected information described in the Report and Order, to support its adoption of the MDRI. The collected information will be used by the Commission, consumers and consumer groups, service providers to realize significant public safety benefits. For example, consumers and consumer groups will use the information to increase consumer education and improve consumer preparedness for disasters and other emergencies.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before June 12, 2023. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before June 12, 2023. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington DC 20551-0001, not later than May 12, 2023.
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Board of Governors of the Federal Reserve System.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers.” This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled “Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers,” issued on March 15, 2019.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5431, Silver Spring, MD 20993-0002; or the Office of Clinical Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Mona Shing, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3355, Silver Spring, MD 20993-0002, 301-796-0910,
FDA is announcing the availability of a guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers.” Sponsors of clinical investigations involving human drugs, biological products, medical devices, and combination products are required to provide oversight of the conduct of their clinical investigations. Such oversight helps to ensure adequate protection of the rights, welfare, and safety of human subjects and the integrity of the data submitted to FDA. Therefore, FDA recommends that sponsors implement a system to manage risks to human subjects and data integrity throughout all stages of the clinical investigation process.
This system to manage the quality of the investigation should help ensure data integrity while safeguarding the rights, safety, and welfare of trial participants by, for example, focusing on the design of efficient clinical trial protocols, tools for identifying and tracking potential risks, and procedures for data collection and processing. This system should include a risk-based approach to monitoring tailored to the potential risks for the specific clinical investigation. Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned, so that, among other things, deficiencies can be identified and corrected. The types and intensity of monitoring activities should be proportionate to the risks to participants' rights, safety, and welfare and to data integrity inherent in the investigation. Effective implementation of risk-based monitoring of clinical investigations, including the prioritization of monitoring and other oversight activities directed at processes and procedures critical for human subject protection and maintaining data integrity, should help maximize the quality of a clinical investigation.
This guidance finalizes the draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers,” issued on March 15, 2019 (84 FR 9531). FDA considered comments received on the draft guidance as the guidance was being finalized and revised the guidance as appropriate in response to the comments. Additionally, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 50 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 11 have been approved under OMB control number 0910-0303; and the collections of information in FDA's guidance for industry entitled “Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” have been approved under OMB control number 0910-0733.
Persons with access to the internet may obtain the guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Radiation Sterilization Master File Pilot Program (“Radiation Pilot Program”). The Radiation Pilot Program is voluntary and intends to allow companies that terminally sterilize single-use medical devices (“sterilization providers”) using gamma radiation or ethylene oxide (EO) to submit Master File(s) when making certain changes to sterilization sites, methods, or processes under the specific conditions outlined in this notice. Under this voluntary pilot program, manufacturers of class III devices subject to premarket approval (“PMA holders”) who have been granted a right of reference by a sterilization provider may, upon notification from FDA that a manufacturer may do so, include references to Master File(s) accepted into the Radiation Pilot Program in postapproval reports describing the particular changes noted above affecting the sterilization sites, methods, or processes of their class III devices, in lieu of submitting premarket approval application (PMA) supplements for such changes. By helping industry advance alternatives for gamma radiation and EO sterilization of medical devices, the Radiation Pilot Program seeks to help ensure patient access to safe medical devices and, through evaluation of data from pilot participants, provide insights into future regulatory approaches that may help address potential device shortages related to sterilization site, method, or process shifts and facilitate supply chain resiliency.
FDA is seeking participation in the voluntary Radiation Pilot Program beginning April 12, 2023. See the “Participation” section for eligibility criteria for participation in the Radiation Pilot Program and the “Procedures” section for instructions on how to submit a Master File for consideration for inclusion into the Radiation Pilot Program. Up to nine eligible participants may be selected for the Radiation Pilot Program.
Clarence W. Murray, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4536, Silver Spring MD 20993, 301-796-0270,
Radiation-based sterilization is widely used to sterilize medical devices and thereby keep them safe for patient use. Established sources of radiation that may be used to generate radiation for medical device sterilization in accordance with FDA-recognized international consensus standards include gamma radiation, x-rays, and electron beams. Of these three types of radiation-based sterilization, gamma radiation is the most frequently used radiation source for medical device sterilization and, more broadly, is the second most frequently used sterilization method by sterilization providers,
Before sterile medical devices subject to PMA requirements are approved for marketing, FDA reviews the submitted PMA to determine if the sterility information is adequate (
However, FDA recognizes the need to facilitate more timely changes to alternative sterilization methods, processes, or sites among sterilization providers who use gamma radiation or EO to support sterilization supply chain resiliency.
For these reasons, FDA is announcing and soliciting voluntary participation in the Radiation Pilot Program. Under this pilot program, sterilization providers that sterilize single-use medical devices using gamma radiation may submit a Master File when making certain changes between sterilization sites, certain changes to sterilization methods to utilize non-gamma radiation sources (
For the purposes of this document, the term “sterilization provider” includes a device manufacturer's own in-house sterilization facility or a device manufacturer's contract sterilization provider and encompasses any subcontractor facilities utilizing the same quality system as the contract sterilization provider, as applicable.
Up to nine sterilization providers may be included for participation in this voluntary Radiation Pilot Program. The pilot program is limited to selected sterilization providers that follow the procedures set forth in section I.B and that also meet the following eligibility criteria:
1. Be a sterilization provider of a single-use device that is provided sterile;
2. Be in good compliance standing with the Agency;
3. Have an approved gamma radiation or fixed chamber EO sterilization process for the device in an existing PMA; and
4. Be proposing one of the following changes:
a. A change from a gamma radiation sterilization process at an existing PMA-approved sterilization site to the same gamma radiation sterilization process at a different site for the same sterilization provider;
b. A change from a gamma radiation sterilization process at an existing PMA-approved sterilization site to an x-ray or electron beam radiation sterilization process at the same site or at a different site for the same sterilization provider;
c. A change from a gamma radiation sterilization process at an existing PMA-approved sterilization site to a gamma radiation sterilization process with a lower radiation dose than the original process at the same site or at a different site for the same sterilization provider; or
d. A change from a fixed chamber EO sterilization method at an existing PMA-approved sterilization site to an x-ray or electron beam radiation sterilization method at the same site or at a different site for the same sterilization provider.
Sterilization processes that include changes to the sterilization dose, radiation source (
The following are outside the scope of the Radiation Pilot Program and are inappropriate for inclusion in this pilot:
1. Reusable devices, reprocessed single-use devices, or devices that are provided non-sterile.
2. Combination products.
3. Devices regulated by CBER.
4. Sterilization providers that do not have an approved gamma radiation or fixed chamber EO sterilization process for the device in an existing PMA.
5. Changes in contract sterilization providers or addition of a new sterilization provider not approved in an existing PMA.
6. Changes to device design, specifications, or materials.
7. Sterilization processes used only for intermediate processing prior to final device assembly.
8. Devices with alternate sterility assurance levels other than 10
While the sterilization provider serves as the primary participant of the Radiation Pilot Program, FDA anticipates that close collaboration between sterilization providers and PMA holders will be necessary to ensure the success of the pilot program. Accordingly, the procedures for sterilization providers and PMA holders are set forth below.
To be considered for the voluntary Radiation Pilot Program, a sterilization provider should submit the following information in a Master File for the Agency's review with a cover sheet clearly indicating “Radiation Sterilization Master File Pilot Program” in the subject heading:
a. Name, address, and FDA Establishment Identification (FEI) number of the proposed sterilization facility.
b. List of device(s) to be sterilized (identified by manufacturer, trade name, model number, and PMA number) if known at the time of submission, and a letter of authorization from each PMA holder for each identified device.
c. Clear identification of all responsibilities of the sterilization facility and device manufacturers with respect to sterilization validation.
d. For sterilization providers proposing to implement changes according to section (I)(A)(4)(a through c) above: a complete description of all qualification testing used to support validation of the device(s) under the proposed radiation sterilization process including:
(1) A complete description of the proposed sterilization cycle(s) including radiation type, target dose, dose range, sterilization load geometry relative to the radiation source, etc.
(2) A risk analysis with identified risk mitigation measures to address any risks that may impact the PMA approved device's product parameters or safety and effectiveness profile. This should also include an analysis of material compatibility considerations and how risks related to material compatibility are mitigated.
(3) Installation Qualification, Operational Qualification, and Performance Qualification methodology.
(4) Clear, detailed product definition, along with a documented procedure for determining whether a device meets the product definition, or confirmation that the product definition has not differed from the approved PMA.
(5) All reports, protocols, and process summaries presented in an easily understandable template that supports incorporation of the PMA product to be sterilized in its defined package and load configuration.
(6) Process capability for the radiation sterilization process.
(7) Identification and explanation of common potential protocol deviations, along with proposed mitigation of potential deviations. The Master File should also include a strategy to address any deviations that could significantly affect the safety or effectiveness of a device and any deviations not addressed in the Master File.
(8) Identification and explanation of management structure and involvement for process and facility review.
(9) Acceptable installation and operational requalification schedule to support continuous process effectiveness.
(10) A structured program and schedule for independent audits and monitors.
(11) The sterilization facility's inspectional history and history of compliance with applicable regulations (including, but not limited to, requirements under parts 814 and 820 (21 CFR parts 814 and 820)).
e. For sterilization providers proposing to implement changes according to section (I)(A)(4)(d) above: in addition to the description of all qualification testing used to support validation of the device(s) under the proposed radiation sterilization process requested in section (I)(B)(1)(d) above:
(1) A description of how the change from EO sterilization to radiation sterilization is validated to not negatively impact device performance or specifications.
(2) A description of how biocompatibility is assessed for devices that are switched from EO sterilization to radiation sterilization and the methods used to ensure that biocompatibility is not significantly affected.
(3) A description of how material compatibility is assessed to support the change from EO sterilization to radiation sterilization.
For more information on Master Files, see FDA's website:
Upon receipt of a Master File containing the above information, FDA will determine a sterilization provider's eligibility in the pilot program by evaluating whether the criteria outlined in sections (I)(A) and (I)(B)(1) above have been met and provide written feedback that FDA either accepts the Master File into the Radiation Pilot Program, or rejects the Master File as not eligible for the pilot program. FDA intends to work interactively with the Master File holder to address any deficiencies with the information provided in the Master File. If a Master File is rejected from the pilot program, the written feedback will identify the reason(s) the Master File was rejected.
If accepted into the pilot program, the Master File holder should submit amendments every 6 months with information on any process changes, new devices, or PMA submissions brought into the pilot program, and any other changes to the information contained in the Master File, to maintain participation in the pilot program. If there are no updates or changes, the Master File holder should notify FDA of the absence of any updates or changes in the amendment. If a sterilization provider is accepted into the pilot program and does not maintain participation (
FDA will consider permitting PMA holders affected by a sterilization provider's participation in the Radiation Pilot Program to reference the sterilization provider's existing Master File in a postapproval report to the Agency, as an alternative to the submission of a PMA supplement under § 814.39(a) and (e). The postapproval report should be submitted with a cover sheet clearly indicating “Periodic Report for Radiation Sterilization Master File Pilot Program” in the subject heading, in accordance with § 814.84,
a. Name, address, and FEI number of the sterilization facility.
b. Master File number in which the referenced sterilization procedures are described, with signed right of reference from the Master File holder.
c. List of device(s) sterilized (identified by manufacturer, trade name, model number, and PMA number).
Upon receipt of a postapproval report containing the above information, FDA will notify the PMA holder of whether the postapproval report is permitted as an alternate submission under § 814.39(a) and (e). Additionally, FDA will notify the PMA holder of whether the PMA identified device(s) and referenced Master File are eligible for the sterilization provider's participation in the pilot. If the PMA is not eligible for the sterilization provider's participation in the pilot program, FDA will notify the PMA holder of the reasons for rejection.
This Pilot Program does not otherwise remove or replace any requirements, such as, but not limited to, recordkeeping and reporting requirements under part 814 or part 820. It is the manufacturer's responsibility to ensure compliance with applicable laws and regulations administered by FDA.
During this voluntary Radiation Pilot Program, CDRH staff intends to be available to answer questions or concerns that may arise. The Radiation Pilot Program participants may comment on and discuss their experiences with the Center.
This notice refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231. The collections of information in part 820, regarding the Quality System Regulation, have been approved under OMB control number 0910-0073.
The following references are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
1. FDA, “FDA Executive Summary Prepared for the November 6-7, 2019 meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee,” available at:
2. FDA, Sterilization for Medical Devices, available at:
3. FDA, PMA Supplements and Amendments, available at:
4. National Academies of Sciences, Engineering, and Medicine. 2021. Radioactive Sources: Applications and Alternative Technologies. Washington, DC: The National Academies Press.
5. FDA, “Statement on Concerns With Medical Device Availability Due to Certain Sterilization Facility Closures,” available at:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Olga L. Torres from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Torres was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Ms. Torres was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of January 20, 2023 (30 days after receipt of the notice), Ms. Torres had not responded. Ms. Torres' failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.
This order is applicable April 12, 2023.
Any application by Olga L. Torres for special termination of debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 335a(d)(4)) may be submitted as follows:
If you want to submit an application with confidential information that you do not wish to be made available to the public, submit the application as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
For a written/paper application submitted to the Dockets Management Staff, FDA will post your application, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in “Instructions.”
Jaime Espinosa, Division of Compliance and Enforcement, Office of Policy, Compliance, and Enforcement, Office of Regulatory Affairs, Food and Drug Administration, at 240-402-8743, or
Section 306(a)(2)(A) of the FD&C Act requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. On September 30, 2022, Ms. Olga L. Torres was convicted as defined in section 306(l)(1) of the FD&C Act in the U.S. District Court for the Southern District of Florida, Miami Division, when the court accepted her plea of guilty and entered judgment against her for one count of obstruction of agency proceeding in violation of 18 U.S.C. 1505.
The factual basis for this conviction is as follows: as contained in the information, entered into the docket on October 28, 2021, and the Factual Proffer in support of her guilty plea, entered into the docket on January 13, 2022, Ms. Torres co-owned a business called Unlimited Medical Research, LLC (Unlimited Medical Research) that conducted clinical trials on behalf of pharmaceutical company sponsors. On or around October 25, 2013, on behalf of Unlimited Medical Research, Ms. Torres signed a contract with a contract research organization retained by a drug manufacturer (Sponsor) to conduct a clinical trial (Study) initiated by the Sponsor. The clinical trial was designed to study the safety and efficacy of an investigational asthma medication in children between the ages of 4 and 11 with persistent asthma. Dr. Yvelice Villaman-Bencosme was a licensed medical doctor who had been retained by Unlimited Medical Research to serve as the clinical investigator for the Study.
On or about February 6, 2017, Ms. Torres learned that FDA investigators intended to conduct a regulatory inspection of Dr. Villaman-Bencosme in her capacity as the clinical investigator for the Study at Unlimited Medical Research. Ms. Torres also learned that, as part of the inspection, FDA investigators would review records prepared and maintained by Unlimited Medical Research concerning the study. The FDA regulatory inspection began on or about February 6, 2017, and continued until on or about April 28, 2017. In or around February 2017, as part of the inspection, Ms. Torres was interviewed by FDA investigators. On or about February 24, 2017, while the regulatory inspection remained ongoing, Ms. Torres reviewed and signed an affidavit which summarized her interview. In that affidavit, Ms. Torres made a number of false statements for purposes of falsely portraying to FDA investigators that the Study had been conducted legitimately and honestly, when in fact it had not. For example, Ms. Torres falsely represented in her signed affidavit that subjects were seen at Unlimited Medical Research and that medical records prepared and maintained by Unlimited Medical Research, which had been provided to the FDA investigators during the course of the inspection, and which purported to document the participation of subjects in the Study, were accurate and complete. In fact, Unlimited Medical Research employees falsified case histories to portray persons as legitimate study subjects who attended scheduled study visits at Unlimited Medical Research, when in fact such persons were not subjects participating in the Study. Ms. Torres knew these statements were dishonest and were made with the specific intent to conceal the truth about the Study from the FDA investigators and thereby prevent FDA from recommending further regulatory enforcement action against Unlimited Medical Research or its staff.
Based on this conviction, FDA sent Ms. Torres by certified mail on December 9, 2022, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) of the FD&C Act, that Ms. Torres was convicted, as set forth in section 306(l)(1) of the FD&C Act, of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. The proposal also offered Ms. Torres an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted an election not to use the opportunity for a hearing and a waiver of any contentions concerning this action. Ms. Torres received the proposal on December 21, 2022. She did not request a hearing within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and any contentions concerning her debarment (21 CFR part 12).
Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(a)(2)(A) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Ms. Torres has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product under the FD&C Act.
As a result of the foregoing finding, Ms. Torres is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, applicable as of the date of this order (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by June 12, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection supports statutory and regulatory requirements that govern food labeling, and information collection recommendations discussed in associated Agency guidance. Sections 4, 5, and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e), establish provisions under which a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. Implementing regulations are codified in parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105). While regulations in part 101 sets forth general food labeling provisions, requirements pertaining to the common or usual name for nonstandardized foods; guidelines for nutritional quality to prescribe the minimum level or range of nutrient composition appropriate for a given class of food; and requirements for foods for special dietary use are found in parts 102, 104, and 105, respectively. The requirements are intended to ensure the safety of food products produced or sold in the United States and enable consumers to be knowledgeable about the foods they purchase and include corresponding information disclosure requirements, along with the reporting and recordkeeping provisions, subject to enforcement by FDA.
We provide information resources regarding Food Labeling under the FD&C Act and its amendments on our website at
The information collection includes Form FDA 3570 entitled, “Small Business Nutrition Labeling Exemption Notice,” for use as applicable and available for download from our website at
• “Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body” (June 1998). The guidance document is available from our website at
• “Questions and Answers: Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act” (September 2009). The guidance document is available from our website at
• “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act” (January 2009). The guidance document is available from our website at
For operational efficiency, we are revising the information collection to account for burden that may result from activities associated with the labeling of certain beers, currently approved in OMB control number 0910-0728. The Tobacco Tax and Trade Bureau is
We are also revising the information collection to include new requirements applicable to the gluten-free labeling of fermented or hydrolyzed foods established through rulemaking (RIN 0910-AH00) and approved in OMB control number 0910-0817.
We estimate the burden of this collection of information as follows:
Our estimate reflects the cumulative average burden we attribute to the reporting and recordkeeping requirements found in the applicable regulations; individual collection activities may not be evenly distributed among respondents and/or the corresponding requirements.
These estimates reflect our continued experience with the information collection. We have made nominal adjustments to reflect the addition of burden associated with gluten and certain bottled or otherwise packaged beer; petition submissions received since our last evaluation of the information collection; and informal communications with industry regarding food product labeling.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Joanne Demchok, Program Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, Md. 20892 or call non-toll-free number 240-276-5959 or Email your request, including your address to:
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public, and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize
The discovery and validation of cancer prevention markers require researchers' access to quality clinical biospecimens. In response to this need, NCI's Cancer Diagnosis Program developed, and is expanding, a searchable database: Specimen Resource Locator (SRL)
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 105.
National Institutes of Health, HHS.
Notice.
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for attending in person and required for viewing the webcast and presenting oral statements. Information about the meeting and registration are available at
Meeting: May 18 and 19, 2023, 9 a.m. to approximately 3 p.m. EDT both days.
Registration to attend in person is requested; registration to view the webcast and present oral public statements is required.
Meeting Location: William H. Natcher Conference Center, National Institutes of Health (NIH), Bethesda, MD 20892. Meeting web page: Registration and other meeting materials are at
Dr. Nicole Kleinstreuer, Director, National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), email:
ICCVAM's goals include promotion of national and international partnerships between governmental and nongovernmental groups, including academia, industry, advocacy groups, and other key stakeholders. To foster these partnerships ICCVAM initiated annual public forums in 2014 to share information and facilitate direct communication of ideas and suggestions from stakeholders (79 FR 25136).
This year's meeting will be held on May 18 and 19, 2023. NICEATM and ICCVAM members will give presentations on current activities related to the development and validation of alternative test methods and approaches.
There will be opportunities for participants to ask clarifying or follow-up questions of the ICCVAM members about their presentations. Instructions for submitting these questions will be provided to webcast viewers prior to the event. The agenda will also include time for public oral statements relevant to the ICCVAM mission and current activities from participants who have registered to do so in advance.
NIH visitor and security information is available at
In addition, the Safer Federal Workforce website has FAQs for visitors at
Written statements on topics relevant to ICCVAM's mission may be submitted to support an oral public statement or as standalone documents. These should be emailed to
Responses to this notice are voluntary. No proprietary, classified, confidential, or sensitive information should be included in statements submitted in response to this notice or presented during the meeting. This request for input is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to the request. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285
NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies for validation studies and technical evaluations. Additional information about NICEATM can be found at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The cooperative agreement applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the cooperative agreement applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP).
The date of September 7, 2023 has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Comments are to be submitted on or before July 11, 2023.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-2328, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP).
The date of August 15, 2023 has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Comments are to be submitted on or before July 11, 2023.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-2327, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Office of Policy Development and Research, Chief Data Officer, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Colette Pollard, Reports Management Officer, REE, Department of Housing and Urban Development, 7th Street SW, Room 8210, Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
(5) ways to minimize the burden of the collection of information on those who are respond, including the use of automated collection techniques or other forms of information technology.
HUD encourages interested parties to submit comments in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
This notice establishes Renewal Funding Inflation Factors (RFIFs) to adjust Fiscal Year (FY) 2023 renewal funding for the Housing Choice Voucher (HCV) Program of each public housing agency (PHA), as required by the Consolidated Appropriations Act, 2023. The notice apportions the expected percent change in national Per Unit Cost (PUC) for the HCV program, 9.60 percent, to each PHA based on the change in Fair Market Rents (FMRs) for their operating area to produce the FY 2023 RFIFs. HUD's FY 2023 methodology is the same as that which was used in FY 2022.
Miguel A. Fontanez, Director, Housing Voucher Financial Division, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, telephone number 202-402-4212; or Adam Bibler, Program Parameters and
Division L, Title II of the Consolidated Appropriations Act, 2023 requires that the HUD Secretary, for the calendar year 2023 funding cycle, provide renewal funding for each public housing agency (PHA) based on validated voucher management system (VMS) leasing and cost data for the prior calendar year and by applying an inflation factor as established by the Secretary, by notice published in the
RFIFs are used to adjust the allocation of Housing Choice Voucher (HCV) program funds to PHAs for local changes in rents, utility costs, and tenant incomes. To calculate the RFIFs, HUD first forecasts a national inflation factor, which is the annual change in the national average Per Unit Cost (PUC). HUD then calculates individual area inflation factors, which are based on the annual changes in the two-bedroom Fair Market Rent (FMR) for each area. Finally, HUD adjusts the individual area inflation factors to be consistent with the national inflation factor.
HUD's forecast of the national average PUC is based on forecasts of gross rent and tenant income. Each forecast is produced using historical and forecasted macroeconomic data as independent variables, where the forecasts are consistent with the Economic Assumptions of the Administration's FY 2023 Budget. The forecast of gross rent is itself based on forecasts of the Consumer Price Index (CPI) Rent of Primary Residence Index and the CPI Fuels and Utilities Index. Forecasted values of these series are applied to the FY 2023 national average two-bedroom FMR to produce a CY 2023 value. A “notional” PUC is calculated as the difference between gross rent value and 30 percent of tenant income (the standard for tenant rent contribution in the voucher program). The change between the forecasted CY 2023 notional PUC and the CY 2022 notional PUC is the expected national change in PUC, or 9.60 percent. HUD uses a notional PUC as opposed to the actual PUC to project costs that are consistent with PHAs leasing the same number and quality of units. For more information on HUD's forecast methodology, see 82 FR 26710.
The inflation factor for an individual geographic area is based on the annualized change in the area's FMR between FY 2022 and FY 2023. These changes in FMRs are then scaled such that the voucher-weighted average of all individual area inflation factors is equal to the national inflation factor,
HUD subsequently applies the calculated individual area inflation factors to eligible renewal funding for each PHA based on VMS leasing and cost data for the prior calendar year.
As explained above, inflation factors based on area FMR changes are produced for all FMR areas and applied to eligible renewal funding for each PHA. The tables showing the RFIFs, available electronically from the HUD data information page, list the inflation factors for each FMR area on a state-by-state basis. The inflation factors use the same OMB metropolitan area definitions, as revised by HUD, that are used in the FY 2023 FMRs. PHAs should refer to the Area Definitions Table on the following web page to make certain that they are referencing the correct inflation factors:
This notice involves a statutorily required establishment of a rate or cost determination which does not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Office of Policy Development and Research, Chief Data Officer, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Written comments and
Colette Pollard, Reports Management Officer, REE, Department of Housing and Urban Development, 7th Street SW, Room 8210, Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
The Department seeks to identify families who no longer participate in a HUD rental assistance program due to adverse termination of tenancy and/or assistance, and owe a debt to a Public Housing Agency (PHA). In accordance with 24 CFR 982.552 and 960.203, the PHA may deny admission to a program if the family is not suitable for tenancy for reasons such as, but not limited to: unacceptable past performance in meeting financial obligations, history of criminal activity, eviction from Federally assisted housing in the last five years, family has committed fraud, bribery, or any other corrupt or criminal act in connection with a Federal housing program, or if a family currently owes rent or other amounts to the PHA or to another PHA in connection with a Federally assisted housing program under the U.S. Housing Act of 1937.
Within the scope of this collection of information, HUD seeks to collect from all PHAs, the following information:
1. Amount of debt owed by a former tenant to a PHA;
2. If applicable, indication of executed repayment agreement;
3. If applicable, indication of bankruptcy filing;
4. If applicable, the reason for any adverse termination of the family from a Federally assisted housing program.
This information is collected electronically from PHAs via HUD's EIV system. This information is used by HUD to create a national repository of families that owe a debt to a PHA and/or have been terminated from a federally assisted housing program. This national repository is available within the EIV system for all PHAs to access during the time of application for rental assistance. PHAs are able to access this information to determine a family's suitability for rental assistance, and avoid providing limited Federal housing assistance to families who have previously been unable to comply with HUD program requirements. If this information is not collected, the Department is at risk of paying limited Federal dollars on behalf of families who may not be eligible to receive rental housing assistance. Furthermore, if this information is not collected, the public will perceive that there are no consequences for a family's failure to comply with HUD program requirements.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
(5) ways to minimize the burden of the collection of information on those who are respond, including the use of automated collection techniques or other forms of information technology.
HUD encourages interested parties to submit comments in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.
Office of Policy Development and Research, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection can be sent within 60 days of publication of this notice to
Anna Guido, Reports Management Officer, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email Anna Guido at
Copies of available documents submitted to OMB may be obtained from Ms. Guido.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in section A.
The evaluation of the Eviction Protection Grant Program is a mixed-methods and multiphase study designed to understand how the grantees implemented this new program and to assess the effectiveness of the grant program in supporting low-income families at risk or facing eviction through the provision of legal assistance at no-cost to eligible households. The evaluation is comprised of an implementation analysis utilizing qualitative and quantitative data to understand how the Eviction Protection Grant Program reduces or prevents eviction among program participants. The evaluation will comprehensively document the implementation of the Eviction Protection Grant Program, including a review and collection of data to understand successes and challenges to program implementation, the characteristics of grantees and other stakeholders, the types of client services provided, how grantees work with other social service providers, and program outcomes.
Over the course of the evaluation, HUD plans to conduct two rounds of data collection. The first round of primary data collection will take place early in the grant period and be focused on assessing program rollout, program take-up, and program implementation. The second round of primary data collection will take place later in the grant period and will focus on the overall experience of grantees, subrecipients, and program participants with the Eviction Protection Grant Program. Each round of data collection will include semi-structured interviews with staff from each of the 21 grantees and their 21 subrecipients, as well as data collection from program participants to understand their perspective on the program. HUD intends to conduct focus groups with program participants, but if that is not feasible, HUD will conduct 1:1 online interviews with a sample of program participants.
In the first round of data collection, HUD plans to conduct 42 semi-structured interviews, which will include 126 grantee and subrecipient staff (an average of three staff per interview). In the second round of data collection, HUD again plans to conduct 42 semi-structured interviews, which will include 126 grantee and subrecipient staff (an average of three staff per interview). Across both rounds of data collection, HUD will facilitate 21 focus groups with 105 program participants (5 program participants per focus group), and 1:1 online interviews with 42 program participants.
All outreach may be made available in language-appropriate materials suggested by grantees as relevant for their beneficiary population. Recruitment materials will also specify the process of requesting accommodations for people with limited English proficiency and reasonable accommodations for persons with disabilities.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comments in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507.
Office of the Secretary, U.S. Department of Housing and Urban Development (HUD).
Notice.
In accordance with the Build America, Buy America Act (BABA), this notice advises that HUD is proposing an extension to the previously issued public interest, general applicability waiver for an additional period of one year to the Buy America Domestic Content Procurement Preference (“Buy America Preference,” or “BAP”) as applied to Federal Financial Assistance (“FFA”) provided to Tribes, Tribally Designated Housing Entities (“TDHE”s), and other Tribal Entities (hereinafter collectively “Tribal Recipients”).
HUD published this proposed waiver on its website on April 7, 2023. Comments on the proposed waiver set out in this document are due on or before April 24, 2023 in consideration of Saturday being the fifteen-day expiration of the comment period. HUD will consider comments received and announce any subsequent changes to this waiver through a subsequent Notice.
Interested persons are invited to submit comments on the general applicability waiver. Copies of all comments submitted are available for inspection and downloading at
Faith Rogers, Department of Housing and Urban Development, 451 Seventh Street SW, Room 10126, Washington, DC 20410-5000, at (202) 402-7082 (this is not a toll-free number). HUD welcomes and is prepared to receive calls from individuals who are deaf or hard of hearing, as well as individuals with speech and communication disabilities. To learn more about how to make an accessible telephone call, please visit
The Build America, Buy America Act (“BABA” or “the Act”) was enacted on November 15, 2021, as part of the Infrastructure Investment and Jobs Act (“IIJA”) (Pub. L. 117-58). The Act establishes a domestic content procurement preference, the BAP, for Federal infrastructure programs. Section 70914(a) of the Act establishes that no later than 180 days after the date of enactment, HUD must ensure that none of the funds made available for infrastructure projects may be obligated by the Department unless it has taken steps to ensure that the iron, steel, manufactured products, and construction materials used in a project are produced in the United States. In section 70912, the Act further defines a project to include “the construction, alteration, maintenance, or repair of infrastructure in the United States” and includes within the definition of infrastructure those items traditionally included along with buildings and real property. Thus, starting May 14, 2022, new awards of HUD FFA, and any of those funds newly obligated by HUD then obligated by the grantee for infrastructure projects, are covered under BABA provisions of the Act, 41 U.S.C. 8301 note, unless covered by a waiver.
Since the enactment of the Act, HUD has worked diligently to develop a plan to fully implement the BAP across its FFA programs awarding funds to non-Tribal Recipients. HUD understands that advancing Made in America objectives is a continuous effort and believes setting forth a transparent schedule of future implementation in those programs provides industry partners and non-Tribal Recipients with the time and notice necessary to efficiently and effectively implement the BAP. HUD recently announced plans to move forward with the implementation of the new BAP requirements in connection with its award of FFA to non-Tribal Recipients in a manner designed to maximize coordination and collaboration to support long-term investments in domestic production. HUD continues its efforts to implement the Act in those programs consistent with the guidance and requirements of the Made in America Office of the Office of Management and Budget, including guidance concerning appropriate compliance with the BAP.
In order to ensure orderly implementation of the BAP across HUD's FFA programs awarding funds to non-Tribal Recipients, HUD has provided public interest, general applicability waivers in order to implement the BAP in phases in connection with the application of the BAP in such programs and announced a corresponding implementation plan for all non-Tribal Recipients. As part of those efforts, HUD has published two general applicability, public interest waivers covering Exigent Circumstances and De Minimis and Small Grants, which can be found at
Additionally, as noted above, HUD previously published a one-year general applicability, public interest waiver of the BAP in connection with FFA provided to Tribal Recipients
HUD is now moving forward with consultation on specific plans for implementation of the BAP in HUD's FFA provided to Tribal Recipients, in light of the comments received from the Tribal leaders and the progress the agency has made implementing the BAP in other FFA programs. In order to appropriately engage in consultation as described in HUD's Tribal Government-to-Government Consultation Policy,
Under Section 70914(b), HUD and other Federal agencies have authority to waive the application of a domestic content procurement preference when (1) application of the preference would be contrary to the public interest, (2) the materials and products subject to the preference are not produced in the United States at a sufficient and reasonably available quantity or satisfactory quality, or (3) inclusion of domestically produced materials and products would increase the cost of the overall project by more than 25 percent. Section 70914(c) provides that a waiver under section 70914(b) must be published by the agency with a detailed written explanation for the proposed determination and provide a public comment period of not less than 15 days. Pursuant to section 70914(d)(2), when seeking to extend a waiver of general applicability, HUD is required to provide for a public comment period of not less than 30 days on the continued need such waiver.
On May 14, 2022, HUD published a General Applicability Waiver of Build America, Buy America Provisions as Applied to Tribal Recipients of HUD Federal Financial Assistance for a period of one year. This current waiver expires on May 14, 2023. During this time period, HUD participated in an interagency Tribal Consultation on the implementation of BABA and participated in an interagency workgroup to address issues raised during the joint consultation.
Many Tribal communities still lack basic infrastructure such as roads, running water, and indoor plumbing. The need for safe, decent, and sanitary housing is immense. In its 2017 Housing Needs Study, HUD concluded that 68,000 new units were needed in Indian Country to replace inadequate units and eliminate severe overcrowding. That same study found that the lack of infrastructure was the number one barrier to housing development in many Tribal communities. Not only is infrastructure in many Tribal communities in dire need of repair and modernization, but Tribes also often find it difficult to locate available supplies, suppliers, and construction labor necessary to develop that infrastructure.
The COVID-19 pandemic compounded the infrastructure challenges faced by many Native American communities. Recent feedback from Tribal Recipients has disclosed the numerous challenges they experienced while implementing the various HUD COVID-19 relief programs. A lack of supplies and a lack of available contractors working in Tribal communities were identified as the primary challenges faced by Tribal Recipients. Tribal Recipients indicated to HUD that procuring supplies and materials can be very difficult at times, and this made HUD-funded infrastructure projects challenging to implement to completion and at budgeted cost. Even when supplies were available for purchase, increased costs for steel, lumber, and transportation combined with lack of developers to bid on projects led to a backlog of construction projects and severely impacted Tribes' ability to complete important infrastructure projects and construct new housing.
Unfortunately, many Tribes are more disconnected from American supply chains than the average HUD grantee due to their remoteness. For example, some Alaska Native villages are not on the road system, must develop infrastructure and housing during an extremely short construction season, and must grapple with unique transportation limitations, including having to ship basic construction materials only twice per year by barge at extremely elevated costs. These Tribes often report to HUD that it can be a major challenge to secure space on a barge for construction materials. At times, even when space is secured, any unexpected setbacks faced, such as loss of cargo, materials damaged through shipping, or miscalculation of the appropriate amount or quality of materials needed, can result in infrastructure and housing projects being delayed an entire construction season. These Tribes end up waiting for the next barge in six months and face cost overruns.
Annually, HUD provides over $1 billion in FFA to almost 600 sovereign Tribal Nations. Programs like the Indian Housing Block Grant (“IHBG”) and the Indian Community Development Block Grant (“ICDBG”) program are critical programs that allow the Federal Government to carry out its trust responsibilities and support affordable housing and infrastructure development in Tribal communities. Under these programs, HUD provides block grant funding to Tribal Recipients to help address these housing and infrastructure needs—particularly for the benefit of low- and moderate-income families. HUD anticipates that the BAP will apply to some projects funded under these programs. Accordingly, HUD must ensure that Tribal Recipients are able to effectively implement the BAP in a manner that ensures that the purposes of BABA are carried out, while at the same time preventing additional undue barriers to the development of Tribal infrastructure, which has suffered from decades of underinvestment.
HUD has determined that the prior one-year waiver period was insufficient to fully consult and assess the impacts that BAP will have on HUD's Tribal Recipients. While the interagency consultation webinar provided HUD with some additional insight into how the BAP will impact Tribal communities generally, HUD is particularly interested in seeking more tailored Tribal feedback on the impact of the BAP on infrastructure projects that are funded under HUD's various Tribal programs. Additionally, since the interagency webinar was held in 2022, HUD has determined to implement the BAP in a phased manner across its non-Tribal programs. With the benefit of this recent determination, HUD needs additional time to seek Tribal feedback on whether and when HUD should take a similar phased approach with respect to the implementation of the BAP under its Tribal programs. HUD will also assess the unique and diverse conditions of Tribal communities across Indian Country and determine how the BAP should be applied after taking those conditions into account. Additional time is needed to consult with Tribal Leaders.
In this notice, HUD is seeking comment on a limited, one-year extension of HUD's existing public interest, general applicability waiver of the BAP in connection with HUD's FFA to Tribal Recipients to provide the Department with sufficient time to complete consultation consistent with HUD's Tribal Government-to-Government Consultation Policy. HUD's `Tribal Government-to-Government Consultation Policy' was adopted in compliance with Executive Order 13175, “Consultation with Indian Tribal Governments,” and outlines the internal procedures and principles HUD must follow when communicating and coordinating on HUD programs and activities that affect Native American Tribes. HUD's Tribal Consultation policy recognizes the right of Tribes to self-government and facilitates Tribal participation and input in HUD's implementation of programs and FFA directed to Tribal communities.
In fiscal year 2023, Tribal Entities received over $1 billion through the Department's programs. Infrastructure is an eligible activity under some of these programs and could be subject to the BAP. HUD believes that full compliance with the BAP will create ongoing demand for domestically produced products and deepen domestic supply chains. Because the potential application of BAP mandated by the Act would be new to all HUD Tribal FFA recipients, HUD has not had the benefit of engaging in fulsome consultation consistent with its Tribal Consultation policy concerning the application of the BAP to Tribal Recipients—particularly with respect to how the BAP should apply to HUD's various Tribal programs, how the BAP should be phased in to allow for successful implementation, and how compliance will be verified. While HUD participated in a general consultation session as part of a governmentwide interagency process regarding the general application of the BAP to Tribal Recipients, because of the significance and potentially wide scope of new requirements necessary to demonstrate compliance with BAP or to seek waivers of BAP for specific products or projects, it is imperative that HUD further engage in Tribal consultation on the specific intended application of the BAP to FFA awarded to HUD's Tribal Recipients.
HUD now has the benefit of having fully considered an appropriate method of phased implementation across its other FFA programs and has begun the methodical implementation of the BAP in those other FFA programs. With the benefit of this experience and the benefit of the governmentwide consultation efforts, HUD will conduct a more tailored consultation process with the Tribal Recipients of HUD FFA specifically focused on the BAP application to HUD's various Tribal housing and community development programs. HUD believes that the Tribal consultation process is necessary for the successful implementation of the BAP across its covered FFA programs funding infrastructure projects, that a full and meaningful Tribal consultation process will allow HUD to determine the potential impact of the Act's Buy America Preference on Tribal governments and communities and will inform a tailored implementation for Tribal Recipients that recognizes the sovereignty and unique status of Tribal governments. Accordingly, HUD has determined that it would be contrary to the public's interest to apply the BAP to FFA awards to Tribal Recipients prior to completion of further Tribal consultation.
Similar to other HUD programs, HUD will seek Tribal feedback consistent with HUD's Tribal Government-to-Government Consultation Policy and Executive Order 13175 on when and how to phase in the BAP for FFA provided to Tribal Recipients. HUD will also solicit Tribal feedback on other related issues, including how to effectively implement the BAP for extremely remote communities, such as remote Native Alaskan Villages, that are more disconnected from traditional supply chains, have an extremely short construction seasons, are located off the road system, and are reliant on barges to ship construction materials. HUD acknowledges that rural Tribal communities and Alaska Native Villages have expressed major concerns about availability of American-made products and continue to struggle with challenges because of their proximity away from main supply sources. Tribes are already facing major challenges with accessing construction materials, and major cost overruns due to a lack of available materials—particularly in remote Tribal communities.
During the one-year waiver period, HUD has identified various scheduled national and regional convenings and conferences where HUD intends to host in-person Tribal consultation sessions with Tribal leaders to discuss the BAP. Additionally, HUD will seek to engage with Tribes and Tribal housing practitioners at the various quarterly and semi-annual regional housing association meetings that are planned during the one-year waiver period. These association meetings are routinely attended by HUD Tribal Recipients who will be charged with complying with the BAP once it goes into effect. Consistent with past practice, HUD also intends to conduct some Tribal consultation virtually. HUD will do so by soliciting written feedback from Tribal leaders specifically addressing the impact of the BAP on HUD's Tribal programs.
After receiving Tribal feedback, HUD will seek to implement the BAP in a manner that advances the Made in America objectives while also ensuring that the BAP implementation does not serve as a major barrier to Tribal communities' efforts to develop critical infrastructure. Many Tribal communities lack running water, sewer, roads, and basic infrastructure. HUD will implement the BAP in a thoughtful manner that ensures that Tribal Recipients can effectively implement the BAP without substantial negative impacts on planned and ongoing critical infrastructure projects. HUD will also seek to provide additional technical assistance resources to ensure that Tribal Recipients can build capacity and be in a better position to comply with the BAP. Based on prior practice, HUD is proposing a one-year extension of its general applicability, public interest waiver of the application of the BAP in connection with FFA awards to Tribal Recipients that are obligated by HUD during the pendency of the waiver.
Under OMB Memorandum M-22-11, “Memorandum for Heads of Executive Departments and Agencies,” published on April 18, 2022, agencies are expected to assess “whether a significant portion of any cost advantage of a foreign-sourced product is the result of the use of dumped steel, iron, or manufactured products or the use of injuriously subsidized steel, iron, or manufactured products” as appropriate before granting a public interest waiver. HUD's analysis has concluded that this assessment is not applicable to this waiver, as this waiver is not based in the cost of foreign-sourced products.
HUD remains committed to the successful implementation of the important BAP across its programs providing covered FFA for infrastructure projects, while recognizing the unique government-to-government relationship it has with Tribal Recipients receiving HUD FFA for infrastructure projects. HUD is committed to engaging in a timely consultation process as noted above to further this goal.
As required under section 70914 of the Act, HUD is soliciting comment from the public on the waiver announced in this Notice for a period of 30 days. If issued, this waiver would be applicable to HUD FFA that HUD obligates on or after the effective date of the final waiver and throughout the applicable waiver periods.
National Park Service, Interior.
Notice.
The National Park Service is soliciting electronic comments on the significance of properties nominated before April 1, 2023, for listing or related actions in the National Register of Historic Places.
Comments should be submitted electronically by April 27, 2023.
Comments are encouraged to be submitted electronically to
Sherry A. Frear, Chief, National Register of Historic Places/National Historic Landmarks Program, 1849 C Street NW, MS 7228, Washington, DC 20240,
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before April 1, 2023. Pursuant to § 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Nominations submitted by State or Tribal Historic Preservation Officers.
Additional documentation has been received for the following resources:
A request to move has been requested for the following resource:
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of West Pharmaceutical Services, Inc. and West Pharma. Services IL, Ltd., on April 6, 2023. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain liquid transfer devices with an integral vial adapter. The complaint names as respondents: Advcare Medical, Inc. of Taiwan; Dragon Heart Medical Devices Co., Ltd. of China; Dragon Heart Medical, Inc. of Addison, IL; and Summit International Medical Technologies, Inc. of Franklin, MA. The complainant requests that the Commission issue limited exclusion order, cease and desist orders, and impose a bond upon respondent alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3674) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of expedited reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the countervailing duty orders on carbon and certain alloy steel wire rod (“wire rod”) from Italy and Turkey and the antidumping duty orders on wire rod from Belarus, Italy, Russia, South Africa, South Korea, Spain, Turkey, Ukraine, the United Arab Emirates, and the United Kingdom would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
March 6, 2023.
Peter Stebbins (202-205-2039), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
In accordance with §§ 201.16(c) and 207.3 of the rules, each document filed by a party to these reviews must be served on all other parties to these reviews (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.62 of the Commission's rules.
On April 6, 2023, the Department of Justice lodged a proposed First Amendment to Consent Decree with the United States District Court for the Northern District of Indiana in the lawsuit entitled
The Complaint in the United States' lawsuit sought civil penalties and injunctive relief for alleged violations of the Clean Air Act (“CAA”) relating to a closed landfill owned and operated by the City of Gary, Indiana (“Gary” or “City”). The Complaint alleged that Gary: (1) violated its permit and the CAA by failing to install a compliant gas collection and control system; (2) failed to properly operate its current system; (3) violated the landfill's surface methane standard; (4) failed to monitor proper operation of its flares; and (5) failed to demonstrate compliance with its gas collection wellhead standards.
A Consent Decree resolving the claims in the Complaint was entered by the Court on January 5, 2021. Under the Consent Decree, Gary is required to take a number of measures to come into compliance with the CAA. Gary must undertake a suite of improvements to Gary's gas collection and control system, including replacement of the existing flare and system upgrades to actively collect, rather than passively vent, landfill gas. Gary is also required to carry out enhanced monitoring and maintenance requirements and follow certain standard operating procedures, attached to the Consent Decree as appendices.
In August 2022, Gary formally made a request to amend the Consent Decree and extend the GCCS deadline, citing unforeseen design changes, delays in receiving permit approvals, supply chain issues, and unavoidable delays in the bid process for the project. The proposed First Amendment to Consent Decree extends the deadline for Gary to complete its GCCS improvements from October 27, 2022, to October 27, 2023. In the interim, the Amendment requires Gary to more frequently monitor surface methane and implement corrective action if methane concentrations reach a trigger level; improve record-keeping for cover integrity repairs; and investigate and propose an additional corrective action for a portion of the landfill experiencing high methane readings.
The publication of this notice opens a period for public comment on the First Amendment to Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the First Amendment to Consent Decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $2.50 (25 cents per page reproduction cost) payable to the United States Treasury.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Veterans' Employment and Training Service (VETS)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before May 12, 2023.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Mara Blumenthal by telephone at 202-693-8538, or by email at
The Department of Labor's Veterans' Employment and Training Service (VETS) administers funds for the Jobs for Veterans State Grant (JVSG) to each state, the District of Columbia, Puerto Rico, Guam, and the U.S. Virgin Islands on an annual fiscal year basis. These non-competitive, formula-driven grants are codified under 38 U.S.C. 4102A(b)(5). This ICR collects the required information for the submission of JVSG State Plans and Modifications. The information covered includes the state's plan for furnishing employment, training, and placement services, including their performance goals for Disabled Veterans Outreach Program staff services to eligible veterans and other eligible persons. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Solicitation for nominations to serve on the Advisory Board on Toxic Substances and Worker Health for the Energy Employees Occupational Illness Compensation Program Act (EEOICPA).
Due to one recent vacancy, the Secretary of Labor (Secretary) invites interested parties to submit nominations for individuals to serve on the Advisory Board on Toxic Substances and Worker Health for Part E of the Energy Employees Occupational Illness Compensation Program Act (EEOICPA). The nominee shall serve as a member from the claimant community, under the Board's statute and Charter.
Nominations for individuals to serve on the Board must be submitted (postmarked, if sending by mail; submitted electronically; or received, if hand delivered) within 30 days of the date of this notice.
Nominations may be submitted, including attachments, by any of the following methods:
•
•
Follow-up communications with nominees may occur as necessary through the process.
You may contact Ryan Jansen, Designated Federal Officer, at
The Advisory Board on Toxic Substances and Worker Health (the Board) is mandated by section 3687 of EEOICPA. The Secretary of Labor established the Board under this authority and Executive Order 13699 (June 26, 2015) and in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. app. 2. The purpose of the Board is to advise the Secretary with respect to: (1) the Site Exposure Matrices (SEM) of the Department of Labor; (2) medical guidance for claims examiners for claims with the EEOICPA program, with respect to the weighing of the medical
The Board shall consist of 12-15 members, to be appointed by the Secretary. A Chair of the Board will be appointed by the Secretary from among the Board members. Pursuant to section 3687(a)(2), the Advisory Board will reflect a reasonable balance of scientific, medical, and claimant members, to address the tasks assigned to the Advisory Board. The members serve two-year terms. At the discretion of the Secretary, members may be appointed to successive terms or removed at any time. The Board will meet no less than twice per year. On July 18, 2022, twelve members were appointed to the Board by the Secretary to two-year terms. One member from the medical community has recently resigned from the Board, creating a vacancy.
Pursuant to section 3687(d), no Board member, employee, or contractor can have any financial interest, employment, or contractual relationship (other than a routine consumer transaction) with any person who has provided or sought to provide, within two years of their appointment or during their appointment, goods or services for medical benefits under EEOICPA. A certification that this is true will be required with each nomination.
The Department of Labor is committed to equal opportunity in the workplace and seeks broad-based and diverse Advisory Board membership. Any interested person or organization may nominate one or more individuals for membership. Interested persons are also invited and encouraged to submit statements in support of nominees.
• The nominee's contact information (name, title, business address, business phone, fax number, and/or business email address) and current employment or position;
• A copy of the nominee's resume or curriculum vitae;
• Category of membership that the nominee is qualified to represent (claimant);
• A summary of the background, experience, and qualifications that addresses the nominee's suitability for the nominated membership category identified above;
• Articles or other documents the nominee has authored that indicate the nominee's knowledge, experience, and expertise in fields related to the EEOICPA program, particularly as pertains to industrial hygiene, toxicology, epidemiology, occupational medicine, lung conditions, or the nuclear facilities covered by the EEOICPA program;
• Documents or other supportive materials that demonstrate the nominee's familiarity, experience, or history of participation with the EEOICPA program or with the administration of a technically complex compensation program such as EEOICPA;
• A signed statement that the nominee does not have any financial interest, employment, or contractual relationship (other than a routine consumer transaction) with any person who has provided or sought to provide, within two years of their appointment or during their appointment, goods or services for medical benefits under EEOICPA; and
• A signed statement that the nominee is aware of the nomination; is willing to regularly attend and participate in Advisory Board meetings; during the last 10 years, has not been convicted of a felony, has not been imprisoned, been on probation, or been on parole for a felony, and is not currently under charges for a felony; and has no conflicts of interest that would preclude membership on the Board.
Nominees will be appointed based on their demonstrated qualifications, professional experience, and knowledge of issues the Advisory Board may be asked to consider. Nominees will also be selected in accordance with statutory obligations under FACA and section 3687 of EEOICPA regarding a balanced membership.
The activities of the Advisory Board may necessitate its members obtaining security clearance. Pursuant to section 3687(f), the Secretary of Energy will ensure that the members and staff of the Board, and any contractors performing work in support of the Board, are afforded the opportunity to apply for a security clearance for any matter for which such a clearance is appropriate, and should provide a determination on eligibility for clearance within 180 days of receiving a completed application.
The new member shall be appointed to fill a vacancy occurring prior to the expiration of a resigning Board member's term, and shall be appointed for the remainder of such term:
Members are Special Government Employees (SGEs). Members will serve without compensation. However, members may each receive reimbursement for travel expenses for attending Board meetings, including per diem in lieu of subsistence, as authorized by the federal travel regulations.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the National Space-Based Positioning, Navigation and Timing (PNT) Advisory Board. This will be the 28th meeting of the PNT Advisory Board.
Wednesday, May 3, 2023, from 9 a.m.-6 p.m., Eastern Time; and Thursday, May 4, 2023, from 9 a.m.-12 p.m., Eastern Time.
Arundel Ballroom, Crowne Plaza Annapolis, 173 Jennifer Rd. Annapolis, MD 21401.
Mr. James Joseph Miller, Designated Federal Officer, PNT Advisory Board, Space Operations Mission Directorate, NASA
This meeting will be open to the public up to the capacity of the meeting room. In-person attendees will be requested to sign a register prior to entrance to the proceedings. Webcast details to observe the meeting livestream remotely will be available on the PNT Advisory Board website at:
The agenda for the meeting will include the following:
For further information in advance, visit the PNT Advisory Board website at:
It is imperative that the meeting be held on this date to meet the scheduling availability of key participants.
Institute of Museum and Library Services. National Foundation on the Arts and the Humanities.
Submission for OMB review, request for comments, collection of information.
The Institute of Museum and Library Services announces that the following information collection has been submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. This Notice proposes the clearance of a Notice of Funding Opportunity for the American Latino Museum Internship and Fellowship Initiative. A copy of the proposed information collection request can be obtained by contacting the individual listed below in the
Written comments must be submitted to the office listed in the
Written comments and recommendations for proposed information collection requests should be sent within 30 days of publication of this Notice to
OMB is particularly interested in comments that help the agency to:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Gibran Villalobos, Project Manager, Institute of Museum and Library Services, 955 L'Enfant Plaza North SW, Suite 4000, Washington, DC 20024-2135. Gibran Villalobos can be reached by telephone at 202-653-4649, or by email at
The Institute of Museum and Library Services is the primary source of Federal support for the nation's libraries and museums. We advance, support, and empower America's museums, libraries, and related organizations through grant making, research, and policy development. To learn more, visit
The 60-day Notice was published in the
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
1.
This Notice will be published in the
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 18(a)(2), 18(c) and 18(i) of the Act and for an order pursuant to section 17(d) of the Act and rule 17d-1 under the Act.
The Commission:
Trace W. Rakestraw, Senior Special Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' second amended and restated application, dated March 23, 2023, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
The MSRB filed with the Commission a proposed rule change to amend MSRB Rules G-12, on uniform practice, and G-15, on confirmation, clearance, settlement and other uniform practice requirements with respect to transactions with customers, to define regular-way settlement for municipal securities transactions as occurring one business day after the trade date and a proposed amendment to Rule G-12 to update an outdated cross reference (the “proposed rule change”).
The MSRB requests that the proposed rule change be approved with an implementation date of May 28, 2024, to align with the implementation date for Exchange Act Rule 15c6-1, as amended.
The text of the proposed rule change is available on the MSRB's website at
In its filing with the Commission, the MSRB included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The MSRB has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Consistent with the MSRB's strategic goal to modernize the MSRB Rule Book, the proposed rule change would amend MSRB Rule G-12(b)(ii)(B)-(D) and MSRB Rule G-15(b)(ii)(B)-(C) to define regular-way settlement for municipal securities transactions as occurring on one business day after the trade date (“T+1”). This proposed rule change would align with regular-way settlement on T+1 for equities and corporate bonds under Exchange Act Rule 15c6-1, as amended.
The SEC initially adopted Exchange Act Rule 15c6-1
Amended SEC Rule 15c6-1(a)
Shortening the settlement process can serve to reduce operational risks that can be present between trade date and settlement date, which can promote investor protection, help reduce the risk of counterparty default and the capital required to mitigate this risk.
As a result, with regular-way settlement occurring on T+1, settlement for “when, as and if issued” transactions under MSRB Rule G-12(b)(ii)(C) would be required to be a date agreed upon by both parties that is not earlier than one business day after notification of the initial settlement date for the issue.
Lastly, the proposed rule change would correct an outdated cross-reference within MSRB Rule G-12. Specifically, MSRB Rule G-12(b)(ii)(C) regarding the settlement date for “when, as and if issued” transactions currently cross-references MSRB Rule G-34 subsection paragraph (a)(ii)(D)(2) in referring to the obligation that a managing underwriter has to provide notification of initial settlement date of an issue to the registered clearing agency. This obligation remains in MSRB Rule G-34 but was moved to subparagraph (a)(ii)(E)(2) due to previous amendments to Rule G-34. Correcting the cross-reference will not alter the obligation of dealers under MSRB Rule G-34 or MSRB Rule G-12.
The compliance date of the proposed rule change will be announced by the MSRB in a notice published on the MSRB website, which date would correspond with the industry's transition to a T+1 regular-way settlement consistent with the implementation of Amended SEC Rule 15c6-1,
The MSRB believes that the proposed rule change is consistent with Section 15B(b)(2) of the Exchange Act,
Section 15B(b)(2)(C) of the Exchange Act
The MSRB believes the proposed rule change is consistent with Section 15B(b)(2)(C) of the Act.
The MSRB believes the proposed amendment to correct an outdated cross-reference in MSRB Rule G-12(b)(ii)(C) is consistent with Section 15B(b)(2)(C) of the Act.
Section 15B(b)(2)(C) of the Exchange Act
Therefore, the MSRB believes the proposed rule change would not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Exchange Act. In determining whether these standards have been met the MSRB was guided by the Board's Policy on the Use of Economic Analysis in MSRB Rulemaking.
In accordance with this policy, the MSRB has evaluated the potential impacts on competition of the proposed rule change.
With the adoption of the Amended SEC Rule 15c6-1, the regular-way settlement cycle for all securities (other than an exempted security, a government security, commercial paper, commercial bills, bankers' acceptances and municipal securities) is being shortened from T+2 to T+1 starting on May 28, 2024. Without the MSRB's proposed amendments, market participants would encounter different settlement cycles between municipal securities and other securities such as equity and corporate bonds, which would result in market inefficiencies and cause confusion in the clearing and settlement process, especially for investors who trade both municipal securities and other securities. The proposed amendments are necessary to ensure a consistent settlement cycle for municipal securities transactions and other securities transactions.
The MSRB considered the economic impact associated with the proposed rule change relative to the baseline, which is the current T+2 settlement cycle, and assessed incremental changes in benefits and costs in a proposed future state with a T+1 settlement cycle.
The proposed rule change would yield long-term benefits for a range of market participants including, but not limited to, operational cost savings, reduced counterparty risk due to a shorter settlement cycle, reduced market risk for unsettled trades, decreasing clearing capital requirements, reduced pro-cyclical margin and therefore reduced liquidity demands and risk. The MSRB believes the proposed rule change would promote regulatory consistency
The MSRB does not have the data necessary to form its own firm-level estimates of the costs of updates to systems and processes and utilized the Commission's estimates for its analysis.
In summary, the MSRB believes that the industry is equipped with readily available technology for the transition to a T+1 settlement cycle, and the changes are necessary or appropriate in furtherance of the purposes of the Exchange Act. The MSRB believes the proposed rule change would promote regulatory consistency and market efficiency by having regular-way settlement for municipal securities transactions consistent with the standard settlement for other security classes and harmonized with Amended SEC Rule 15c6-1.
Written comments were neither solicited nor received on the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.
For the Commission, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold an Open Meeting on Friday, April 14, 2023 at 10 a.m.
The meeting will be webcast on the Commission's website at
This meeting will begin at 10:00 a.m. (ET) and will be open to the public via webcast on the Commission's website at
1. The Commission will consider whether to reopen the comment period for proposed amendments to Rule 3b-16 under the Securities Exchange Act of 1934 regarding the definition of “exchange” as set forth in Securities Exchange Act Release No. 94062.
For further information, and to ascertain what, if any, matters have been added, deleted or postponed, please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Social Security Administration (SSA).
Notice of a New Matching Program.
In accordance with the provisions of the Privacy Act, as amended, this notice announces a new matching program with the United States Department of the Treasury, Internal Revenue Service (IRS). Under this matching program, the IRS will disclose IRS return information to SSA to administer benefits to qualified aged, blind and disabled individuals.
The deadline to submit comments on the proposed matching program is May 12, 2023. The matching program will be applicable on July 1, 2023, or once a minimum of 30 days after publication of this notice has elapsed, whichever is later. The matching program will be in effect for a period of 18 months.
You may submit comments by any one of three methods—internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA-2022-0049 so that we may associate your comments with the correct notice.
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Interested parties may submit general questions about the matching program to Cynthia Scott, Division Director, Office of Privacy and Disclosure, Office of the General Counsel, Social Security Administration, G-401 WHR, 6401 Security Boulevard, Baltimore, MD 21235-6401 or send an email to
None.
Public Law (Pub. L.) 98-369, Deficit Reduction Act of 1984, requires agencies administering certain federally-assisted benefit programs to use certain information to ensure proper distribution of benefit payments (98 Stat. 494).
Section 6103(l)(7) of the Internal Revenue Code (IRC) (26 U.S.C. 6103(l)(7)) authorizes IRS to disclose return information with respect to unearned income to Federal, State and local agencies administering certain federally-assisted benefit programs under the Act.
Section 1631(e)(1)(B) of the Social Security Act (Act) (42 U.S.C. 1383(e)(1)(B)) requires verification of Supplemental Security Income (SSI) eligibility and benefit amounts with independent or collateral sources. This section of the Act provides that the “Commissioner of Social Security shall, as may be necessary, request and utilize information available pursuant to section 6103(l)(7) of the Internal Revenue Code of 1986” for purposes of federally-administered supplementary payments of the type described in section 1616(a) of the Act (including payments pursuant to an agreement entered into under section 212(a) of Pub. L. 93-66).
The legal authority for the disclosure of SSA data under this agreement is section 1106 of the Act (42 U.S.C. 1306), section (b)(3) of the Privacy Act (5 U.S.C. 552a(b)(3)), and the regulations and guidance promulgated under these provisions.
IRS will disclose to SSA the following:
IRS will match SSA's information with its Information Return Master File (IRMF) and disclose to SSA return information with respect to unearned income from the IRMF [Treasury/IRS 22.061], as published at 80 FR 54081-082 (September 8, 2015), through the
Notice of request for public comment.
The Department of State (Department) is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to June 12, 2023.
You may submit comments by any of the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Family Reunification Project Manager, Office of the Coordinator for Afghan Relocation Efforts, Department of State, Washington, DC 20522-0603, who may be reached on 703-875-3087 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The U.S. Government agreed that Afghans paroled under Operation Allies Welcome (OAW) or those paroled then subsequently granted Temporary Protected Status (TPS), could request U.S. Government-supported family reunification support for their spouses and unmarried children under 21 who remain physically present in Afghanistan. The Office of the Coordinator for Afghan Relocation Efforts (CARE) is using the DS-4317 to collect this information under emergency authorization from OMB. This authorization expires on 7/31/2023.
State requires a publicly advertised system that is sustainable and efficient and that enables data validation with U.S. Government databases. The Department requests continuance of the existing authority to use the DS-4317 to acquire the most current and accurate data possible to inform its relocation assistance efforts. It will enable the Department to build a current picture of how many Afghans may be eligible for relocation and to progress with assisting them to depart Afghanistan. The online form helps avoid unstructured requests for assistance, such as those that arrive via email messages, which may not include important information, such as family size and their biodata, and which often require entry into other systems to facilitate responses. This form is integrated with other elements of the Department's evolving information technology platform, enhancing the efficient handling of individual cases.
The information on this form is requested pursuant to 5 U.S.C. 301 (Secretary of State's authorities with respect to Management of the Department of State), 22 U.S.C. 2651a (Organization of the Department of State), and 8 U.S.C. 1101-1537 (Immigration and Nationality Act of 1952, as amended).
Information from applicants is collected through an electronic version of the DS-4317. Data from the application is stored in IRM's ServiceNow platform.
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary display in the exhibitions “Charles Darwin: A Life in Letters” and “Charles Darwin: Then and Now” at the New York Public Library, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “The Golden Path: Maimonides Across Eight Centuries” at the Yeshiva University Museum, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Elliot Chiu, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Surface Transportation Board.
Notice of Rail Energy Transportation Advisory Committee meeting.
Notice is hereby given of a meeting of the Rail Energy Transportation Advisory Committee (RETAC), pursuant to the Federal Advisory Committee Act.
The meeting will be held on Wednesday, April 26, 2023, at 9 a.m. E.D.T.
The meeting will be held at the Surface Transportation Board headquarters at 395 E Street SW, Washington, DC 20423.
Kristen Nunnally at (202) 245-0312 or
RETAC was formed in 2007 to provide advice and guidance to the Board, and to serve as a forum for discussion of emerging issues related to the transportation of energy resources by rail.
The meeting, which is open to the public, will be conducted in accordance with the Federal Advisory Committee Act, 5 U.S.C. app. 2; Federal Advisory Committee Management regulations, 41 CFR 102-3; RETAC's charter; and Board procedures. Further communications about this meeting may be announced through the Board's website at
By the Board, Mai T. Dinh, Director, Office of Proceedings.
Susquehanna River Basin Commission.
Notice.
This notice lists the minor modifications approved for a previously approved project by the Susquehanna River Basin Commission during the period set forth in
March 1-31, 2023.
Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel and Secretary to the Commission, telephone: (717) 238-0423, ext. 1312; fax (717) 238-2436; email:
This notice lists previously approved projects, receiving approval of minor modifications, described below, pursuant to 18 CFR 806.18 or to Commission Resolution Nos. 2013-11
1. East Cocalico Township Authority (Wells 3A, 5, 6, and 7), Docket No. 20230318, East Cocalico Township, Lancaster County, Pa.; modification to remove Well 4 from approved sources; Approval Date: March 17, 2023
Susquehanna River Basin Commission.
Notice.
This notice lists Approvals by Rule for projects by the Susquehanna River Basin Commission during the period set forth in
March 1-31, 2023.
Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel and Secretary to the Commission, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436; email:
This notice lists the projects, described below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(e) and (f) for the time period specified above. Water Source Approval—Issued Under 18 CFR 806.22(f):
1. Repsol Oil & Gas U.S.A., L.L.C.; Pad ID: DCNR 587 (02 015); ABR-201012012.R2; Ward Township, Tioga County, Pa.; Consumptive Use of Up to 6.0000 mgd; Approval Date: March 14, 2023.
2. Seneca Resources Company, L.L.C.; Pad ID: Crittenden 593; ABR-201012016.R2; Richmond Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 14, 2023.
3. Seneca Resources Company, L.L.C.; Pad ID: Hitesman 580; ABR-201012052.R2; Covington Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 14, 2023.
4. S.W.N. Production Company, L.L.C.; Pad ID: BOMAN PAD; ABR-201212011.R2; Jackson Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: March 14, 2023.
5. S.W.N. Production Company, L.L.C.; Pad ID: CONKLIN EAST; ABR-201212009.R2; New Milford Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: March 14, 2023.
6. S.W.N. Production Company, L.L.C.; Pad ID: SWEENEY PAD; ABR-201212005.R2; New Milford Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: March 14, 2023.
7. S.W.N. Production Company, L.L.C.; Pad ID: Swisher (Pad R); ABR-201212012.R2; Stevens Township, Bradford County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: March 14, 2023.
8. S.W.N. Production Company, L.L.C.; Pad ID: TINGLEY PAD; ABR-201212010.R2; New Milford Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: March 14, 2023.
9. Coterra Energy Inc.; Pad ID: ZickW P1; ABR-201212008.R2; Lenox Township, Susquehanna County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 21, 2023.
10. Pennsylvania General Energy Company, L.L.C.; Pad ID: C.O.P. Tract 322 Pad A; ABR-201301004.R2; Cummings and McHenry Townships, Lycoming County, Pa.; Consumptive Use of Up to 3.5000 mgd; Approval Date: March 21, 2023.
11. Pennsylvania General Energy Company, L.L.C.; Pad ID: C.O.P. Tract 322 Pad B; ABR-201301005.R2; McHenry Township, Lycoming County, Pa.; Consumptive Use of Up to 3.5000 mgd; Approval Date: March 21, 2023.
12. Range Resources—Appalachia, L.L.C.; Pad ID: Ogontz Fishing Club #18H-#23H Drilling Pad; ABR-201011073.R2; Cummings Township, Lycoming County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 21, 2023.
13. Range Resources—Appalachia, L.L.C.; Pad ID: Ogontz Fishing Club #24H-#29H Drilling Pad; ABR-201011077.R2; Cummings Township, Lycoming County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 21, 2023.
14. Range Resources—Appalachia, L.L.C.; Pad ID: Ogontz Fishing Club #30H-#35H; ABR-201012043.R2; Cummings Township, Lycoming County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 21, 2023.
15. Range Resources—Appalachia, L.L.C.; Pad ID: Paulhamus, Frederick Unit #5H & #6H Drilling Pad; ABR-201011074.R2; Mifflin Township, Lycoming County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 21, 2023.
16. Seneca Resources Company, L.L.C.; Pad ID: Buckwalter 429; ABR-201012049.R2; Delmar Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 23, 2023.
17. Seneca Resources Company, L.L.C.; Pad ID: Stratton 885; ABR-201101008.R2; Farmington Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 23, 2023.
18. Chesapeake Appalachia, L.L.C.; Pad ID: Weisbrod; ABR-201011010.R2; Sheshequin Township, Bradford County, Pa.; Consumptive Use of Up to 7.5000 mgd; Approval Date: March 27, 2023.
19. Coterra Energy Inc.; Pad ID: MacDowallR P1; ABR-201201002.R2; Harford Township, Susquehanna County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 27, 2023.
20. S.T.L. Resources, L.L.C.; Pad ID: Hillside Pad; ABR-20091233.R2; Gaines Township, Tioga County, Pa.; Consumptive Use of Up to 4.9900 mgd; Approval Date: March 27, 2023. Seneca Resources Company, L.L.C.; Pad ID: Bielski 628; ABR-201101009.R2; Richmond Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 27, 2023.
21. Seneca Resources Company, L.L.C.; Pad ID: Violet Bieser Revoc Liv Tr 833; ABR-201101010.R2; Chatham Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 27, 2023.
22. S.W.N. Production Company, L.L.C.; Pad ID: WALKER WEST PAD 14; ABR-201301010.R2; Jackson Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: March 27, 2023.
23. Chesapeake Appalachia, L.L.C.; Pad ID: Castle A Drilling Pad #1; ABR-201202012.R2; Canton Township, Bradford County, Pa.; Consumptive Use of Up to 7.5000 mgd; Approval Date: March 28, 2023.
24. Chesapeake Appalachia, L.L.C.; Pad ID: SGL 12 M NORTH DRILLING PAD; ABR-201802002.R1; Leroy Township, Bradford County, Pa.; Consumptive Use of Up to 7.5000 mgd; Approval Date: March 28, 2023.
25. Coterra Energy Inc.; Pad ID: KropaT P1; ABR-201301017.R2; Springville Township, Susquehanna County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 28, 2023.
26. EXCO Resources (P.A.), L.L.C.; Pad ID: Dale Bower East Unit Pad; ABR-201202009.R2; Penn Township, Lycoming County, Pa.; Consumptive Use of Up to 8.0000 mgd; Approval Date: March 28, 2023.
27. JKLM Energy, L.L.C.; Pad ID: Headwaters 146; ABR-201803006.R1; Ulysses Township, Potter County, Pa.; Consumptive Use of Up to 3.2000 mgd; Approval Date: March 28, 2023.
28. JKLM Energy, L.L.C.; Pad ID: Judson Hollow 302; ABR-201802003.R1; Pike Township, Potter County, Pa.; Consumptive Use of Up to 3.2000 mgd; Approval Date: March 28, 2023.
29. S.T.L. Resources, L.L.C.; Pad ID: Sturgis Pad; ABR-201802001.R1; Gallagher Township, Clinton County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 28, 2023.
30. Seneca Resources Company, L.L.C.; Pad ID: DCNR 100 Pad T; ABR-201301013.R2; Lewis Township, Lycoming County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 28, 2023.
31. Chesapeake Appalachia, L.L.C.; Pad ID: SGL 12 K UNIT PAD; ABR-201702004.R1; Leroy Township, Bradford County, Pa.; Consumptive Use of Up to 7.5000 mgd; Approval Date: March 31, 2023.
32. Chesapeake Appalachia, L.L.C.; Pad ID: Taylor Drilling Pad B; ABR-201703003.R1; Lenox Township, Susquehanna County, Pa.;
33. Coterra Energy Inc.; Pad ID: LoffredoJ P1; ABR-201211017.R2; Nicholson Township, Wyoming County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 31, 2023.
34. Inflection Energy (P.A.) L.L.C.; Pad ID: Brass Well Site; ABR-201802004.R1; Upper Fairfield Township, Lycoming County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 31, 2023.
35. Range Resources—Appalachia, L.L.C.; Pad ID: Bobst A Unit 25H-27H; ABR-201202018.R2; Cogan House Township, Lycoming County, Pa.; Consumptive Use of Up to 5.0000 mgd; Approval Date: March 31, 2023.
36. Range Resources—Appalachia, L.L.C.; Pad ID: Goodwill Hunting Club Unit #4H-#9H Drilling Pad; ABR-201011054.R2; Lewis Township, Lycoming County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 31, 2023.
37. Seneca Resources Company, L.L.C.; Pad ID: Covington Pad M; ABR-201102031.R2; Covington Township, Tioga County, Pa.; Consumptive Use of Up to 4.0000 mgd; Approval Date: March 31, 2023.
38. S.W.N. Production Company, L.L.C.; Pad ID: FLICKS RUN EAST PAD; ABR-201302003.R2; Cogan House Township, Lycoming County, Pa.; Consumptive Use of Up to 4.9990 mgd; Approval Date: March 31, 2023.
Susquehanna River Basin Commission.
Notice.
This notice lists Grandfathering Registration for projects by the Susquehanna River Basin Commission during the period set forth in
January 1-31, 2023.
Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel and Secretary to the Commission, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436; email:
This notice lists GF Registration for projects described below, pursuant to 18 CFR part 806, subpart E, for the time period specified above:
1. Penn-View, Inc.—Wyncote Golf Club, GF Certificate No. GF-202303243, Lower Oxford Township, Chester County, Pa.; On-site Well; Issue Date: March 6, 2023.
2. Red Hill Farms, Inc., GF Certificate No. GF-202303244, Various Municipalities and Counties, Pa.; see Addendum; Issue Date: March 6, 2023.
3. Ski Roundtop Operating Corp—Roundtop Mountain Resort, GF Certificate No. GF-202303245, Warrington Township, York County, Pa.; Well 1; Issue Date: March 6, 2023.
4. Village of South Corning—Public Water Supply System, GF Certificate No. GF-202303246, Village of South Corning, Steuben County, N.Y.; Well 1; Issue Date: March 6, 2023.
5. Strasburg Lancaster County Borough Authority—Public Water Supply System, GF Certificate No. GF-202303247, Paradise and Strasburg Townships, Lancaster County, Pa.; combined withdrawal from the King Well and Rohrer Well; Issue Date: March 14, 2023.
6. Knouse Foods Cooperative, Inc.—Peach Glen Plant, GF Certificate No. GF-202303248, Tyrone and Huntingdon Townships, Adams County, and Dickinson Township, Cumberland County, Pa.; combined withdrawal from Wells 2, 4, 5, 7, 8, 9, 10, and 13 and Well 13; Issue Date: March 16, 2023.
Public Law 91-575, 84 Stat. 1509
Susquehanna River Basin Commission.
Notice.
The Susquehanna River Basin Commission will hold a public hearing on May 4, 2023. The Commission will hold this hearing in person and telephonically. At this public hearing, the Commission will hear testimony on the projects listed in the
The public hearing will convene on May 4, 2023, at 6:30 p.m. The public hearing will end at 9 p.m. or at the conclusion of public testimony, whichever is earlier. The deadline for submitting written comments is Monday, May 15, 2023.
This public hearing will be conducted in person and virtually. You may attend in person at Susquehanna River Basin Commission, 4423 N Front St., Harrisburg, Pennsylvania, or join by telephone at Toll-Free Number 1-877-304-9269 and then enter the guest passcode 2619070 followed by #.
Jason Oyler, General Counsel and Secretary to the Commission, telephone: (717) 238-0423 or
Information concerning the project applications is available at the Commission's Water Application and Approval Viewer at
The public hearing will cover the following projects:
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Interested parties may call into the hearing to offer comments to the Commission on any business listed above required to be the subject of a public hearing. Given the nature of the meeting, the Commission strongly encourages those members of the public wishing to provide oral comments to pre-register with the Commission by emailing Jason Oyler at
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 13
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before May 12, 2023.
You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2014-0379, Docket No. FMCSA-2016-0011, Docket No. FMCSA-2016-0313, Docket No. FMCSA-2018-0057, Docket No. FMCSA-2020-0045, Docket No. FMCSA-2020-0047, or Docket No. FMCSA-2020-0053 using any of the following methods:
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To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001,
If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2014-0379, Docket No. FMCSA-2016-0011, Docket No. FMCSA-2016-0313, Docket No. FMCSA-2018-0057, Docket No. FMCSA-2020-0045, Docket No. FMCSA-2020-0047 or Docket No. FMCSA-2020-0053), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
The 13 individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in § 391.41(b)(8), in accordance with
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 13 applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The 13 drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous 2-year exemption period. In addition, for commercial driver's license (CDL) holders, the Commercial Driver's License Information System and the Motor Carrier Management Information System are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency. These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of 2 years is likely to achieve a level of safety equal to that existing without the exemption.
In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of drivers received renewed exemptions in the month of April and are discussed below.
As of April 2, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following seven individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket number FMCSA-2020-0045, FMCSA-2020-0047, or FMCSA-2020-0053. Their exemptions are applicable as of April 2, 2023 and will expire on April 2, 2025.
As of April 30, 2023, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following six individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:
The drivers were included in docket number FMCSA-2014-0379, FMCSA-2016-0011, FMCSA-2016-0313, or FMCSA-2018-0057. Their exemptions are applicable as of April 30, 2023 and will expire on April 30, 2025.
The exemptions are extended subject to the following conditions: (1) each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based on its evaluation of the 13 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of final disposition.
FMCSA announces its decision to exempt six individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.
The exemptions are applicable on March 31, 2023. The exemptions expire on March 31, 2025.
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001,
To view comments go to
In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to
On February 13, 2023, FMCSA published a notice announcing receipt of applications from six individuals requesting an exemption from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and requested comments from the public (88 FR 9316). The public comment period ended on March 15, 2023, and two comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8).
The physical qualification standard for drivers regarding epilepsy found in § 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
FMCSA received two comments in this proceeding. One commenter supported granting exemptions if the decision was determined by a physician on a case-by-case basis. The remainder of the comment was outside the scope of this notice. The second commenter had concerns about granting exemptions to CMV operators that have had seizures indicating that medication is not always effective to prevent a seizure from occurring.
The Agency has evaluated each driver's application and determined that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety. Therefore, exempting these applicants from the epilepsy and seizure disorder prohibition in § 391.41(b)(8) is likely to achieve a level of safety equal to that existing without the exemption.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
The Agency's decision regarding these exemption applications is based on the 2007 recommendations of the Agency's Medical Expert Panel. The Agency conducted an individualized assessment of each applicant's medical information, including the root cause of the respective seizure(s) and medical information about the applicant's seizure history, the length of time that has elapsed since the individual's last seizure, the stability of each individual's treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician's medical opinion related to the ability of the driver to safely operate a CMV with a history of seizure and each applicant's driving record found in the commercial driver's license Information System for commercial driver's license (CDL) holders, and interstate and intrastate inspections recorded in the Motor Carrier Management Information System. For non-CDL holders, the Agency reviewed the driving records from the State Driver's Licensing Agency. A summary of each applicant's seizure history was discussed in the February 13, 2023,
These six applicants have been seizure-free over a range of 31 years while taking anti-seizure medication and maintained a stable medication treatment regimen for the last 2 years. In each case, the applicant's treating physician verified his or her seizure history and supports the ability to drive commercially.
The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers granted this exemption have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety.
Consequently, FMCSA finds that in each case exempting these applicants from the epilepsy and seizure disorder prohibition in § 391.41(b)(8) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).
The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: (1) each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5T; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the six exemption applications, FMCSA exempts the following drivers from the epilepsy and seizure disorder prohibition in § 391.41(b)(8), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of information collection; request for comment.
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, this notice announces that FRA is forwarding the Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On January 20, 2023, FRA published a notice providing a 60-day period for public comment on the ICR.
Interested persons are invited to submit comments on or before May 12, 2023.
Written comments and recommendations for the proposed ICR should be sent within 30 days of publication of this notice to
Ms. Arlette Mussington, Information Collection Clearance Officer, at email:
The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages.
Before OMB decides whether to approve this proposed collection of information, it must provide 30-days' notice for public comment. Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d);
Comments are invited on the following ICR regarding: (1) Whether the information collection activities are necessary for FRA to properly execute its functions, including whether the information will have practical utility; (2) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (3) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (4) ways to minimize the burden of information collection activities on the public, including the use of automated collection techniques or other forms of information technology.
The summary below describes the ICR that FRA will submit for OMB clearance as the PRA requires:
FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information that does not display a currently valid OMB control number.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of information collection; request for comment.
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, this notice announces that FRA is forwarding the Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On January 20, 2023, FRA published a notice providing a 60-day period for public comment on the ICR.
Interested persons are invited to submit comments on or before May 12, 2023.
Written comments and recommendations for the proposed ICR should be sent within 30 days of publication of this notice to
Ms. Arlette Mussington, Information Collection Clearance Officer, at email:
The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages.
Before OMB decides whether to approve the proposed collection of information, it must provide 30 days for public comment. Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(a);
Comments are invited on the following ICR regarding: (1) whether the information collection activities are necessary for FRA to properly execute its functions, including whether the information will have practical utility; (2) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (3) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (4) ways to minimize the burden of information collection activities on the public, including the use of automated collection techniques or other forms of information technology.
The summary below describes the ICR that FRA will submit for OMB clearance as the PRA requires:
FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information that does not display a currently valid OMB control number.
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).
Notice of public meeting.
PHMSA's Office of Hazardous Materials Safety (OHMS) will hold a public meeting to solicit input on the development of the 2024 edition of the Emergency Response Guidebook (ERG2024). The meeting will take place virtually on Microsoft Teams on May 16, 2023.
The meeting will be held virtually on Microsoft Teams on May 16, 2023, from 1:00 p.m. to 4:00 p.m. EDT.
DOT requests that attendees pre-register for this meeting. The meeting will be hosted on Microsoft Teams and a conference call line will be provided upon registration by completing the form at
Ryan Vierling or Peter Heitzmann, Office of Hazardous Materials Safety, Pipeline and Hazardous Materials Safety
PHMSA developed the United States version of the Emergency Response Guidebook (ERG) for use by emergency services personnel to provide guidance for initial response to hazardous materials transportation incidents. Since 1980, it has been PHMSA's goal that all public emergency response personnel (
The meeting will include a discussion of the methodology used to determine the appropriate response protective distances for poisonous vapors resulting from spills involving dangerous goods considered toxic by inhalation in the 2020 Edition of the Emergency Response Guidebook “Green Pages” as requested by stakeholders. To pursue our objective of continually improving the ERG, PHMSA will solicit comments related to new methodologies and considerations for future editions of the ERG. Additionally, the meeting will include discussions on the outcomes of field experiments, ongoing research efforts to better understand environmental effects on airborne toxic gas concentrations, and updates to be published in the ERG2024.
DOT is committed to providing equal access for all Americans and ensuring that information is available in appropriate alternative formats to meet the requirements of persons who have a disability. If you require an alternative version of files provided or alternative accommodations, please contact
Office of the Secretary of Transportation, U.S. Department of Transportation (DOT or the Department).
Notice of funding opportunity (NOFO), assistance listing # 20.939.
The purpose of this notice is to solicit applications for Safe Streets and Roads for All (SS4A) grants. Funds for the fiscal year (FY) 2023 SS4A grant program are to be awarded on a competitive basis to support planning, infrastructure, behavioral, and operational initiatives to prevent death and serious injury on roads and streets involving all roadway users, including pedestrians; bicyclists; public transportation, personal conveyance, and micromobility users; motorists; and commercial vehicle operators.
Applications must be submitted by 5:00 p.m. EDT on Monday, July 10, 2023. Late applications will not be accepted.
Applications must be submitted via Valid Eval, an online submission proposal system used by USDOT, at
Please contact the SS4A grant program staff via email at
Each section of this notice contains information and instructions relevant to the application process for SS4A grants, and all applicants should read this notice in its entirety so that they have the information they need to submit eligible and competitive applications.
Section A (Program Description) describes the Department's goals and purpose in making awards, and Section E (Application Review Information) describes how the Department will select from eligible applications. To support applicants through the process, the Department will provide technical assistance and resources at
Section 24112 of the Infrastructure Investment and Jobs Act (Pub. L. 117-58, November 15, 2021; also referred to as the “Bipartisan Infrastructure Law” or “BIL”) authorized and appropriated $1 billion to be awarded by the Department of Transportation for FY 2023 for the SS4A grant program. This NOFO solicits applications for activities to be funded under the SS4A grant program. The FY 2023 funding will be implemented, as appropriate and consistent with law, in alignment with the priorities in Executive Order 14052, Implementation of the Infrastructure Investment and Jobs Act (86 FR 64355).
The purpose of SS4A grants is to improve roadway safety by significantly reducing or eliminating roadway fatalities and serious injuries through safety action plan development and refinement and implementation focused on all users, including pedestrians, bicyclists, public transportation users, motorists, personal conveyance and
The FY 2023 NOFO incorporates lessons learned from the FY 2022 NOFO, and substantively differs in a few ways:
• Applications are submitted through Valid Eval instead of
• Updated the definition of an underserved community, with different tools to determine whether a U.S. Census tract is an underserved community.
• Planning and Demonstration Grants replaced Action Plan Grants from FY 2022, with a number of substantive changes throughout the NOFO:
○ Section A further clarifies eligible planning and demonstration activities;
○ Section B.3 changed the expected minimum and maximum award range to $100,000 to $10 million;
○ Section B.4 has a longer expected period of performance under certain circumstances;
○ Section C.3 has changed eligibility requirements and allows applicants currently developing a comprehensive safety action plan to request additional funding for planning and demonstration; and
○ Section E has a revised selection criteria requirement for the “Additional Safety Context” narrative, which is now expected to be between 1 and 2 pages.
• Implementation Grants had the following substantive changes:
○ Section B.3 changed the expected minimum and maximum award range to $2.5 million to $25 million;
○ Section E selection criteria were refined, and a fifth selection criterion specifically for applicants who bundle planning and supplemental planning was added; and
○ Section E award selection considerations were expanded to include rural areas, whether the applicant is identified as a priority community within the Federal Thriving Communities Network, requests less than $10 million, and selections that support diversity amongst the award recipients, in addition to project readiness and percent of funds to underserved communities.
The SS4A program provides funding for two main types of grants: Planning and Demonstration Grants for comprehensive safety action plans, including supplemental safety planning, and/or safety demonstration activities; and Implementation Grants. Planning and Demonstration Grants are used to develop, complete, or supplement a comprehensive safety action plan, as well as carry out demonstration activities that inform an Action Plan. Implementation Grants are used to implement strategies or projects that are consistent with an existing Action Plan and may also bundle funding requests for supplemental planning and demonstration activities that inform an Action Plan. To apply for an Implementation Grant, an eligible applicant must have a qualifying Action Plan; see Section C for what constitutes a qualifying Action Plan. Applicants for Implementation Grants can self-certify that they have one or more plans in place by June 2023 that together are substantially similar to and meet the eligibility requirements for an Action Plan.
Planning and Demonstration Grants have three different types of activities:
(a) Develop an Action Plan;
(b) Conduct supplemental safety planning to enhance an Action Plan; and
(c) Carry out demonstration activities to inform the development of, or an update to, an Action Plan.
The three different types of activities under Planning and Demonstration Grants can either be bundled together into one application, or an applicant may choose to request funding for only one of the activities. Applicants may only apply for a single grant type, but both grant types have the option to include Planning and Demonstration projects under them. The development of, or updates to, an Action Plan must be the intended end result of each supplemental planning and demonstration activity. Further information on which activities can be bundled together are described in Section C.3.i.
An Action Plan is the foundation of the SS4A grant program. Grants for Action Plans provide Federal funds to eligible applicants to develop, complete, or enhance an Action Plan.
The primary deliverable is a publicly available Action Plan. For the purposes of the SS4A grant program, an Action Plan includes the components in Table 1. DOT considers the process of developing an Action Plan to be critical for success, and the components reflect a process-oriented set of activities.
Applicants requesting funds to develop an Action Plan may also request funding for supplemental planning and demonstration activities subsequently described in Section A.2.i.b and A.2.i.c below. The goal of an Action Plan is to develop a holistic, well-defined strategy to prevent roadway fatalities and serious injuries in a locality, Tribe, or region. Further information on eligibility requirements is in Section C.
Supplemental action plan activities support or enhance an existing Action Plan. To only fund supplemental Action Plan activities through the SS4A program, an applicant must have an existing Action Plan; have a plan that is substantially similar and meets the eligibility requirements for having an existing plan; or be in the process of completing an Action Plan described in Table 1. Examples of supplemental planning include:
• Topical safety sub-plans focused on topics such as speed management, vulnerable road users, accessibility for individuals with disabilities, Americans with Disabilities Act of 1990 (ADA) transition plans, health equity, safety-focused Intelligent Transportation System implementation, lighting, or other relevant safety topics.
• Road safety audits.
• Additional safety analysis and expanded data collection and evaluation using integrated data.
• Targeted equity assessments.
• Required supplemental planning as a condition to receiving an
○ Updating Action Plans finalized and last updated in 2020 or earlier.
○ Broadening the road user focus to include all road users.
○ Updating plan components laid out in Table 1 and missing in an eligible plan.
• Follow-up stakeholder engagement and collaboration.
• Reporting on the progress from Action Plan implementation for transparency.
• Other roadway safety planning activities that enhance an Action Plan.
The final deliverable for supplemental planning is a written product that connects to, and enhances, an Action Plan. Final products shall be made publicly available. Additional information on supplemental planning is located at
Demonstration activities inform an Action Plan by testing proposed project and strategy approaches to determine their potential benefits and future scope; demonstration activities are temporary. Demonstration activities must measure potential benefits through data collection and evaluation and inform an Action Plan's list of selected projects and strategies and their future implementation. To receive funds only for demonstration activities through the SS4A program, an applicant must have an existing Action Plan, have a plan that is substantially similar and meets the eligibility requirements for having an existing plan, or be in the process of completing an Action Plan described in Table 1. Demonstration activities could include:
• Feasibility studies using quick-build strategies that inform permanent projects in the future (
• Various MUTCD Engineering Studies that further safety applications of the MUTCD (
• Pilot programs for behavioral or operational activities that include at least one element of the Safe System Approach (
• Pilot programs that demonstrate safety benefits of technologies not yet adopted in the community (
Demonstration activities and pilot programs must inform Action Plans through small-scale tests with finite trial periods intended to gauge potential project and strategy effectiveness that will lead to project and strategy selection at a systemic level. The final deliverable is an assessment of the demonstration activities and an updated Action Plan that incorporates the information gathered from the demonstration activities into the Action Plan's list of projects or strategies and/or informs another part of the Action Plan. DOT intends to prioritize demonstration activities that are set up within 18 months (
Implementation Grants fund projects and strategies identified in an Action Plan that address roadway safety problems. Implementation Grants may also fund supplemental planning and demonstration activities as described in Section A.2.i, as well as planning, design, and development activities for projects and strategies identified in an Action Plan. DOT encourages Implementation Grant applicants to include supplemental planning and demonstration activities in their application. Applicants must have an existing Action Plan to apply for Implementation Grants or have an existing plan that is substantially similar and meets the eligibility requirements of an Action Plan. If applicants do not have an existing Action Plan, they should apply for Planning and Demonstration Grants and
The Action Plan components may be contained within several plans. DOT requires applicants who have an Action Plan that is missing components required in Table 1 but still have a substantially similar plan based on the Self-Certification Eligibility Worksheet outlined in Section C to update an Action Plan to contain all components in a Comprehensive Safety Action Plan as outlined in Table 1. Updating an existing Plan to address missing components is a condition to receive Implementation Grant funding, and applicants applying for Implementation Grants can request to use SS4A supplemental planning funds to update an existing Action Plan to conform with all the components in Table 1. Additional information on eligibility requirements and eligible activities is in Section C below.
This section discusses priorities specific to SS4A and those related to the Department's overall mission, which are reflected in the selection criteria and NOFO requirements. Successful grant applications will:
• Promote safety to prevent death and serious injuries on public roadways;
• Employ low-cost, high-impact strategies that can improve safety over a wide geographic area;
• Ensure equitable investment in the safety needs of underserved communities, which includes both underserved urban and rural communities;
• Incorporate evidence-based projects and strategies and adopt innovative technologies and strategies;
• Demonstrate engagement with a variety of public and private stakeholders; and
• Align with the Department's mission and Strategic Goals such as safety; climate change and sustainability; equity and Justice40; and workforce development, job quality, and wealth creation.
The Department seeks to award Planning and Demonstration Grants based on safety impact, equity, and other safety considerations. For Implementation Grants, DOT seeks to make awards to projects and strategies that save lives and reduce roadway fatalities and serious injuries; incorporate equity, engagement, and collaboration into how projects and strategies are executed; use effective practices and strategies; consider climate change, sustainability, and economic competitiveness in project and strategy implementation; and will be able to complete the full scope of funded projects and strategies within five years after the establishment of a grant agreement. Additional award consideration will be made for Implementation Grant applicants that have a high percentage of funds that
The SS4A grant program aligns with both Departmental and Biden-Harris Administration activities and priorities. The National Roadway Safety Strategy (NRSS, issued January 27, 2022) commits the Department to respond to the current crisis in roadway fatalities by “taking substantial, comprehensive action to significantly reduce serious and fatal injuries on the Nation's roadways,” in pursuit of the goal of achieving zero roadway deaths through a Safe System Approach.
This NOFO aligns with and considers Departmental policy priorities that have a nexus to roadway safety and grant funding. Consistent with the Department's implementation of Executive Order 14008, Tackling the Climate Crisis at Home and Abroad (86 FR 7619), the Department seeks to fund applications that address equity and environmental justice, particularly for communities that have experienced decades of underinvestment and are most impacted by climate change, pollution, and environmental hazards.
Consistent with Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (86 FR 7009), the Department seeks to award funds under the SS4A grant program that will create proportional impacts to all populations in a project area, remove transportation related disparities to all populations in a project area, and increase equitable access to project benefits. An important area for DOT's focus is the disproportionate, adverse safety impacts that affect certain groups on our roadways, particularly people walking, biking, and rolling in underserved communities. In accordance with the Americans with Disabilities Act of 1990 (ADA), awards focused on infrastructure and demonstration activities must ensure that newly constructed facilities in the public right-of-way are accessible to, and usable by, individuals with disabilities to the extent that it is not structurally impracticable to do so. The ADA also requires that, when an existing facility is altered, the altered facility be made accessible to and usable by individuals with disabilities to the maximum extent feasible (28 CFR 35.151[a] and 35.151[b]). See Section E of this NOFO for climate and equity-related selection criteria and Section F for related award administration requirements.
The Department intends to use the SS4A program to support the creation of good-paying jobs with the free and fair choice to join a union and the incorporation of strong labor standards and training and placement programs, especially registered apprenticeships, in project planning stages, consistent with Executive Order 14025, Worker Organizing and Empowerment (86 FR 22829), and Executive Order 14052, Implementation of the Infrastructure Investment and Jobs Act (86 FR 64335). The Department also intends to use the SS4A program to support wealth creation, consistent with the Department's Equity Action Plan through the inclusion of local inclusive economic development and entrepreneurship such as the utilization of Disadvantaged Business Enterprises, Minority-owned Businesses, Women-owned Businesses, or 8(a) firms.
The BIL established the SS4A program with $5,000,000,000 in advanced appropriations in Division J, including $1,000,000,000 for FY 2023. Additionally, DOT has $177,213,000 in FY 2022 carryover funds set aside for Planning and Demonstration Grants as well as certain eligible safety planning and demonstrative activities that may be included under an Implementation Grant request. Therefore, this Notice makes available up to $1,177,213,000 for FY 2023 grants under the SS4A program. Refer to Section D for greater detail on additional funding considerations and Section D.5 for funding restrictions.
Grant funding obligation occurs when a selected applicant and DOT enter into a written grant agreement after the applicant has satisfied applicable administrative requirements. Unless authorized by DOT in writing after DOT's announcement of FY 2023 SS4A grant awards, any costs incurred prior to DOT's obligation of funds for activities (“pre-award costs”) are ineligible for reimbursement and may not be used as matching funds. All SS4A funds must be expended within five years after the grant agreement is executed and DOT obligates the funds.
In FY 2023, DOT expects to award hundreds of Planning and Demonstration Grants and up to one hundred Implementation Grants. The Department reserves the right to make more, or fewer, awards. DOT reserves the discretion to alter minimum and maximum award sizes upon receiving the full pool of applications and assessing the needs of the program in relation to the SS4A grant priorities in Section A.3. Federal funding requests must be made in whole dollar amounts (no cents).
For Planning and Demonstration Grants, award amounts will be based on estimated costs, with an expected
An application that engages multiple jurisdictions in the same region is encouraged in order to ensure collaboration across multiple jurisdictions and leverage the expertise of agencies with established financial relationships with DOT and knowledge of Federal grant administration requirements. For applicants developing a new Action Plan, the application may propose the development of a single Action Plan covering all jurisdictions, several plans for individual jurisdictions, or a system to administer sub-awards to entities within its jurisdiction.
Of the total amount available, DOT anticipates that it will award at least $250 million for demonstration activities that will inform the development of an Action Plan, as described in Section A.
For Implementation Grants, DOT expects the minimum award will be $2,500,000 and the maximum award will be $25,000,000. DOT reserves the right to make Implementation Grant awards less than the total amount requested by the applicant.
DOT expects to obligate SS4A award funding via a signed grant agreement between the Department and the recipient, as flexibly and expeditiously as possible, within 12 months after awards have been announced. Applicants who have never received Federal funding from DOT before are encouraged to partner with eligible applicants within the same region, such as an MPO, that have established financial relationships with DOT and knowledge of Federal grant administration requirements. While States are not eligible applicants and cannot be a co-applicant (which includes State Departments of Transportation and similar State-level entities), eligible applicants are encouraged to separately coordinate with States and other entities experienced with administering Federal grants, outside of the SS4A grant award process, to ensure effective administration of a grant award. The expected period of performance for Planning and Demonstration Grant agreements is between 12 months and 5 years, depending on the scope and extent of the grant activities. The period of performance for Planning and Demonstration Grant and Implementation Grant agreements may not exceed five years.
Under BIL, the Department shall post on a publicly available website best practices and lessons learned for preventing roadway fatalities and serious injuries pursuant to strategies or interventions implemented under SS4A. Additionally, DOT shall evaluate and incorporate, as appropriate, the effectiveness of strategies and interventions implemented under the SS4A grant program.
Eligible applicants for SS4A grants are:
(1) a metropolitan planning organization (MPO);
(2) a political subdivision of a State or territory;
(3) a federally recognized Tribal government; and
(4) a multijurisdictional group of entities described in any of the aforementioned three types of entities.
A multijurisdictional group of entities described in (4) should identify a lead applicant as the primary point of contact. For the purposes of this NOFO, a political subdivision of a State under (2), above, is defined as a unit of government under the authority of State law. This includes cities, towns, counties, special districts, and similar units of local government. A transit district, authority, or public benefit corporation is eligible if it was created under State law, including transit authorities operated by political subdivisions of a State. States are not eligible applicants, but DOT encourages applicants to coordinate with State entities, as appropriate. Eligible MPOs, transit agencies, and multijurisdictional groups of entities with a regional scope are encouraged to support subdivisions of a State such as cities, towns, and counties with smaller populations within their region. The Department strongly encourages applications that involve multijurisdictional partnerships for Planning and Demonstration Grants and for applicants who have never received Federal funding and can apply with entities experienced in executing DOT grants.
An eligible applicant for an Implementation Grant must also meet at least one of these conditions:
(1) have ownership and/or maintenance responsibilities over a roadway network;
(2) have safety responsibilities that affect roadways; or
(3) have agreement from the agency that has ownership and/or maintenance responsibilities for the roadway within the applicant's jurisdiction.
For the purposes of this NOFO, an applicant's jurisdiction is defined as the U.S. Census tracts where the applicant operates or performs their safety responsibilities.
The Federal share of a SS4A grant may not exceed 80 percent of total eligible activity costs. Recipients are required to contribute a local matching share of no less than 20 percent of eligible activity costs. Unless otherwise authorized by statute, all matching funds must be from non-Federal sources. Matching funds may include funding from the applicant, or other eligible non-Federal sources. In accordance with 2 CFR 200.306, grant recipients may use in-kind or cash contributions toward local match requirements so long as those contributions meet the requirements under 2 CFR 200.306(b). Any in-kind contributions used to fulfill the cost-share requirement for both Planning and Demonstration Grants and Implementation Grants must:
• Be in accordance with the cost principles in 2 CFR 200 subpart E;
• Include documented evidence of completion within the period of performance; and
• Support the execution of the eligible activities in Section C.4.
SS4A funds will reimburse recipients only after a grant agreement has been executed, allowable expenses are incurred, and valid requests for reimbursement are submitted. Grant agreements are expected to be administered on a reimbursement basis, and at the Department's discretion alternative funding arrangements may be established on a case-by-case basis.
If an applicant is eligible for both a Planning and Demonstration Grant and an Implementation Grant, the applicant may only apply for a Planning and Demonstration Grant
Eligibility requirements are contingent on whether an applicant is requesting funds to develop a new Action Plan, conduct supplemental planning to update an existing Action Plan, and/or carry out demonstration activities to inform the development of or update to an Action Plan. Any applicant that meets the eligibility requirements may apply for a Planning and Demonstration Grant to develop an Action Plan. Applicants applying to develop an Action Plan may also bundle supplemental planning and demonstration activities into their funding request. Applicants with an existing Action Plan may also apply to update their Action Plan. The development of an Action Plan must include all relevant road users and be at a broad, systemic geographic level (
If a higher-level jurisdiction (
To apply for an Implementation Grant, the applicant must certify that they have an existing plan that is substantially similar to an Action Plan. The plan or plans must be uploaded as an attachment to the application or provided as web links to publicly available sites. Applicants should use the Self-Certification Eligibility Worksheet to determine eligibility.
Further, Implementation Grant applicants who meet any of the following conditions must update their Action Plan during the execution of a grant agreement to align with all the Comprehensive Safety Action Plan components in Table 1 as a condition to receiving SS4A funds:
• Self-Certification Eligibility Worksheet areas that include a “no” response;
• Safety focus in the qualifying Action Plan does not include all road users, including pedestrians, bicyclists, and motor vehicle safety; or
• Action Plans last updated more than three years ago (to apply in the first place, applicants must have a plan that was finalized and/or last updated between 2018 and June 2023).
Implementation Grant applicants are encouraged to request supplemental planning funding in their application to complete missing components of an existing plan but may choose to complete such activities without Federal funding.
Broadly, eligible activity costs must comply with the cost principles set forth in 2 CFR, Subpart E (
A. Developing a comprehensive safety action plan or Action Plan (
B. Conducting planning, design, and development activities for projects and strategies identified in an Action Plan; and
C. Carrying out projects and strategies identified in an Action Plan.
For Implementation Grants, activities
• Projects and strategies whose primary purpose is not roadway safety.
• Projects and strategies exclusively focused on non-roadway modes of transportation, including air, rail, marine, and pipeline. Roadway intersections with other modes of transportation (
• Capital projects to construct new roadways used for motor vehicles. New roadway facilities exclusively for non-motorists (
• Infrastructure projects primarily intended to expand capacity to improve Levels of Service for motorists on an existing roadway, such as the creation of additional lanes.
• Maintenance activities for an existing roadway primarily to maintain a state of good repair. However, roadway modifications on an existing roadway in support of specific safety-related projects identified in an Action Plan are eligible activities.
• Development or implementation of a public transportation agency safety plan (PTASP) required by 49 U.S.C. 5329. However, a PTASP that identifies and addresses risks to pedestrians, bicyclists, personal conveyance and micromobility users, transit riders, and others may inform Action Plan development.
Projects, strategies, and demonstration activities must have equity—the consistent, fair, just, and impartial treatment of all people—at their foundation. This includes traffic enforcement strategies. As part of the Safe System Approach adopted in the USDOT's National Roadway Safety Strategy, any activities related to compliance or enforcement efforts to make our roads safer should affirmatively improve equity outcomes as part of a comprehensive approach to achieve zero roadway fatalities and serious injuries. The SS4A program can be used to support safety projects and strategies that address serious safety violations of drivers (
For Implementation Grants, applications must identify the problems to be addressed, the relevant geographic locations (
All grant application materials can be accessed at grants.gov under opportunity number DOT-SS4A-FY23-01. Applicants must submit their applications via Valid Eval at
The Planning and Demonstration Grant, and the Implementation Grant, respectively, have different application submission and supporting document requirements.
The application must include the following: Standard Forms (SF); Key Information Questions; Project Narrative and Summary Budget Narrative. This information must be submitted via Valid Eval at
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For applicants requesting funding for demonstration activities to inform an Action Plan: you must provide a brief schedule showing when the activities will be in place (
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The application must include the following: Standard Forms (SF); Key Information Questions; Project Narrative and Summary Budget Narrative. This information must be submitted via Valid Eval at
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The Department recommends that the narrative follows the outline below to address the program requirements and assist evaluators in locating relevant information. The narrative may not exceed 12 pages in length, excluding cover pages and the table of contents. The Self-Certification Eligibility Worksheet and Budget sections do not count towards the 12-page limit. Appendices may include documents supporting assertions or conclusions made in the 12-page narrative and also do not count towards the 12-page limit. If possible, website links to supporting documentation should be provided rather than copies of these supporting materials. If supporting documents are submitted, applicants should clearly identify within the narrative the relevance of each supporting document. Letters of support will only be considered if they are submitted with the application as one consolidated set of support letters in one supporting attachment.
This section should provide an introduction, describe the safety context, jurisdiction, and any high-level background information that would be useful to understand the rest of the application.
This section of the application should describe the jurisdiction's location, the jurisdiction's High-Injury Network or equivalent geospatial identification (geographic or locational data using maps) of higher risk locations, and potential locations and corridors of the projects and strategies. Note that the applicant is not required to provide exact locations for each project or strategy; rather, the application should identify which geographic locations are under consideration for projects and strategies to be implemented and what analysis will be used in a final determination.
This section should respond to the criteria for evaluation and selection in Section E.1.ii of this Notice and include a compelling narrative to highlight how the application aligns with criteria #1 Safety Impact; #2 Equity, Engagement, and Collaboration; #3 Effective Practices and Strategies; #4 Other DOT Strategic Goals; #5 Additional Safety Context (only if applying for supplemental planning and/or demonstration activities).
Note, criterion #1 Safety Impact assesses “implementation cost” information, which will be described in SF-424C, Budget of the narrative, and the Key Information Table. The Federal funding requested per person(s) killed or seriously injured from 2017-2021 in the Key Information Table should be itemized by separating different locations and/or different sets of proposed projects and strategies that address a similar safety problem and match the itemization in the Budget.
The applicant must respond to each of the four criteria 1-4 and respond to criterion #5 if applying for supplemental planning and/or demonstration activities. Applicants are not required to follow a specific narrative format, but the structure should clearly identify the narrative associated with each selection criterion. To the extent practical, DOT encourages applicants to incorporate existing content from their Action Plan/established plan(s).
The applicant must provide information to demonstrate the applicant's ability to substantially execute and complete the full scope of work in the application proposal within five years of when the grant is executed, with a particular focus on design and construction, as well as environmental, permitting, and approval processes. Applicants should indicate if they will be seeking permission to use roadway design standards that are different from those generally applied by the State in which the project is located. As part of this portion of the narrative, the applicant must include a detailed activity schedule that identifies all major project and strategy milestones. Examples of such milestones include State and local planning approvals; start and completion of National Environmental Policy Act (NEPA) and other Federal environmental reviews and approvals including permitting; design completion; right of way acquisition; approval of plans, specifications, and estimates; procurement; State and local approvals; public involvement; partnership and implementation agreements; and construction. Environmental review documentation should describe in detail known project impacts, and possible mitigation for those impacts. When a project results in impacts, an award recipient must take steps to engage the public. At a minimum, the project readiness narrative and detailed project activity schedule must include the applicability and disposition of: NEPA and Federal environment reviews and approvals; utility relocation; and right-of-way acquisition. For additional guidance and resources, visit
Attach a completed Self-Certification Eligibility Worksheet.
This section of the application should describe the budget for the SS4A proposal. Applicants are required to provide a brief budget summary and provide a high-level overview of estimated activity costs, as organized by all major cost elements. The budget shall provide itemized estimates of the costs by separating different locations and/or different sets of proposed projects and strategies that address a similar safety problem, and then providing additional details about those from the itemized list at the component level. This information should include capital costs for infrastructure safety improvements and costs associated with behavioral and operational safety projects and strategies. The section should also distinguish between the three eligible activity areas: (A) supplemental planning and demonstration activities in support of an existing Action Plan; (B) conducting planning, design, and development activities for projects and strategies identified in an Action Plan; and (C) carrying out projects and strategies identified in an Action Plan.
Funding sources should be grouped into two categories: SS4A funding Federal share, and non-Federal share funds. Estimated costs or value of in-kind matches should also be provided. The budget should show how each source of funds will be spent. This budget should not include any previously incurred expenses, or costs to be incurred before the time of award and obligation because these expenses are not eligible for reimbursement or cost-sharing. DOT requires applicants use form SF-424C, and the applicant must also provide the information in Table 4 below.
Each applicant is required to: (i) be registered in SAM (
Applications must be submitted by 5:00 p.m. EDT on Monday, July 10, 2023. Late applications will not be accepted.
Per BIL requirements, not more than 15 percent of the $1 billion in FY 2023 funds made available to carry out the SS4A program may be awarded to eligible applicants in a single State.
The format of the Section D.2 application submission should be in PDF format, with font size no less than 12-point Times New Roman, margins a minimum of 1 inch on all sides, and include page numbers. The necessary file formats for each application component will be displayed on the Valid Eval intake site.
The complete application must be submitted via Valid Eval, an online submission proposal system used by USDOT at
This section specifies the criteria DOT will use to evaluate and select applications for SS4A grant awards. The Department will review merit criteria for all complete applications from eligible applicants. Planning and Demonstration Grants, and Implementation Grants, respectively, each have their own set of application review and selection criteria.
For Planning and Demonstration Grants, the Department will use three evaluation criteria. The Department will evaluate quantitative data in two selection criteria areas: #1 Safety Impact; and #2 Equity. The Department will also assess the narrative for #3 Additional Safety Context. Costs will also be considered.
The activities are in jurisdictions that will likely support a significant
• The count of roadway fatalities from the most recent set of 5-year data
• The fatality rate, which is calculated using 5-year annual average from the total count of fatalities (based on FARS data or an alternative traffic crash dataset) divided by the 2020 population of the applicant's jurisdiction based on 2020 ACS population data from the U.S. Census. The rate should be normalized per 100,000 persons.
The activities will ensure equitable investment in the safety needs of underserved communities in preventing roadway fatalities and injuries, including rural communities. The Department will assess the equity criterion using one quantitative rating:
• The percentage of the population in the applicant's jurisdiction that resides in an Underserved Community Census tract.
The applicant must address these considerations in narrative form. The Department will assess whether the applicant has: described the scope of work to be performed; the roadway safety issues that necessitate further Action Plan development, supplemental planning, and/or demonstration activities, as applicable; and how the funded activities will inform an Action Plan and support the identification of projects and strategies that will:
• Lead to a significant reduction or elimination of roadway fatalities and serious injuries involving various road users;
• Employ low-cost, high-impact strategies that can improve safety over a wider geographical area;
• Involve engaging with a variety of public and private stakeholders;
• Adopt innovative technologies to promote safety and equity; and
• Be evidence-based or build evidence around what works.
Applicants applying to carry out demonstration activities to inform the development of an Action Plan will also be assessed as to whether their approach to measuring the potential benefits of the demonstration activities through data collection and evaluation are described, and the extent to which the activities will be set up (
The Department will assess the extent to which the budget and costs to perform the activities required to execute the Planning and Demonstration Grant are reasonable, necessary, and allocable based on 2 CFR 200.404 and 405, and the extent to which the application delineates the breakdown of Federal funds requested between developing an Action Plan, conducting supplemental planning to update an existing plan, and/or carrying out demonstration activities to inform the development or update of an Action Plan.
Implementation Grants have five merit criteria: #1 Safety Impact; #2 Equity, Engagement, and Collaboration; #3 Effective Practices and Strategies; #4 Other DOT Strategic Goals; and #5 Supplemental Planning and Demonstration Activities. DOT will only evaluate selection criterion #5 Supplemental Planning and Demonstration Activities for Implementation Grant applicants requesting funds to conduct supplemental planning and/or carry out demonstration activities. Two considerations will also be used in the selection process: Project Readiness, and Additional Considerations. The response to each criterion, to the extent practicable, should be aligned with the applicant's Action Plan. Below describes the specific content the applicant should respond to for each of these criteria.
DOT will assess whether the proposal is likely to: significantly reduce or eliminate roadway fatalities and serious injuries; employ low-cost, high-impact strategies over a wide geographic area; and include evidence-based projects and strategies. Safety impact is the most important criterion and will be weighed more heavily in the review and selection process. The Department will assess the applicant's description of the safety problem, safety impact assessment, and costs as part of the Safety Impact criterion:
• Description of the safety problem. DOT will assess the extent to which:
○ The safety problem to be addressed is described, including historical trends, fatal and serious injury crash locations, contributing factors, and crash types by category of road user.
○ Crashes and/or crash risk are displayed in a High-Injury Network, hot spot analysis, or similar geospatial risk visualization.
○ Project and strategy locations are described in relation to the High-Injury Network and geospatial information.
○ Safety risk is summarized from risk models, hazard analysis, the identification of high-risk roadway features, road safety audits/assessments, near miss data, and/or other proactive safety analyses.
• Safety impact assessment. DOT will assess the extent to which projects and strategies:
○ Align with and comprehensively address the identified safety problems.
○ Are primarily on a High-Injury Network or address high-risk roadway features correlated with severe crash types.
○ Significantly reduce or eliminate roadway fatalities and serious injuries involving various road users.
○ Use low-cost, high-impact strategies and projects over a wide geographical area.
○ Use evidence-based, Proven Safety Countermeasures or other effective safety countermeasures to significantly improve existing roadways.
○ Use evidence-based Countermeasures that Work with four or five stars to address persistent behavioral safety issues and consider equity in their implementation.
○ Measure safety impact through models, studies, reports, proven noteworthy practices, Crash Modification Factors (CMF), and other information on project and strategy effectiveness.
○ Will have safety benefits that persist over time.
• Implementation Costs. DOT will assess the extent to which the projects and strategies:
○ Are itemized and summarized in a logical manner, including capital costs for infrastructure, behavioral, and operational safety improvements.
○ Fund locations with past traffic fatalities and serious injuries and is expected to prevent fatalities and serious injuries per funds requested. Injuries will be weighted and combined with fatalities to assess this figure in relation to the Federal funding request.
This criterion supports the legislative requirements to assess the extent to which the application ensures the equitable investment in the safety needs of underserved communities and demonstrates engagement with a variety of public and private stakeholders. The response to this criterion should focus on equity, engagement, and collaboration in relation to the implementation of the projects and strategies. DOT will assess the extent to which projects and strategies:
• Ensure equitable investment in underserved communities in preventing roadway fatalities and serious injuries, including rural communities.
• Are designed to decrease existing disparities identified through equity analysis.
• Consider key population groups (
• Include equity analysis, both quantitative and qualitative, and stakeholder engagement in underserved communities as part of the development and implementation process.
• Include meaningful engagement with the public, including public involvement for underserved communities, community benefit agreements, and relevant stakeholders such as private sector and community groups, as part of implementation.
• Leverage partnerships within their jurisdiction, with other government entities, non-governmental organizations, the private sector, academic institutions, and/or other relevant stakeholders to achieve safety benefits while preventing unintended consequences for persons living in the jurisdiction.
• Inform representatives from areas impacted on implementation progress and meaningfully engage over time to evaluate the impact of projects and strategies on persons living in the jurisdiction.
• Align with the equity analysis performed as part of the development of an existing Action Plan.
DOT will assess the extent to which the applicant demonstrates how it applies policies, guidelines, standards, and practices to promote systemic safety improvements. DOT will assess the extent to which the projects and strategies reflect effective safety practices that:
• Demonstrate how updated policies, guidelines, and standards improve safety decision making.
• Are supported by an existing Complete Streets Policy that prioritizes safety in standard agency procedures and guidance, or other roadway safety policies that have eliminated barriers to prioritizing the safety of all users.
• Incorporate practices that promote efficiency within the planning and road management lifecycle (
• Consider the impacts of land use and the built environment to promote transportation efficient design.
• Leverage a Safe System Approach that uses multiple activities and interventions to address safety problems.
• Encompass at least three of the five Safe System Approach elements in the National Roadway Safety Strategy (Safer People, Safer Roads, Safer Speeds, Safer Vehicles, and Post-Crash Care) to address the identified safety problem.
• Include a mix of infrastructure, behavioral, operational, and/or post-crash safety activities.
• Involve widely implemented improvements based on high-risk roadway features correlated with particularly severe crash types, including design features that reinforce appropriate motor vehicle speeds.
• Incorporate technologies that promote safety and/or equity.
• Improve safety for all road users along a roadway by providing accessible facilities (
• Improve multimodal networks for people outside of a motor vehicle, including people who are walking, biking, rolling, public transit users, and have disabilities.
This program's focus on equity and safety is also advanced by considerations of how applications address climate and sustainability considerations, as well as whether applications support economic competitiveness. DOT will assess the extent to which the projects and strategies use safety strategies to support the Departmental strategic goals of climate change, sustainability, workforce, and economic competitiveness, and the extent to which the proposal is expected to:
• Reduce motor vehicle-related pollution such as air pollution and greenhouse gas emissions.
• Increase safety of lower-carbon travel modes such as public transit, micromobility and active transportation (
• Improve multimodal transportation systems that incorporate affordable transportation options such as public transit, micromobility, and active transportation such as walking and biking to transit stops and stations.
• Reduce the lifecycle greenhouse gas emissions from the project materials such as the use of lower-carbon pavement and construction materials.
• Support fiscally responsible land use and transportation efficient design that reduces greenhouse gas emissions through land use and zoning reform, rural main street revitalization, growth management, and equitable transit-oriented development.
• Includes evidence-based climate resilience measures or features such as enhanced storm water management practices, upgrading infrastructure using the Federal Flood Risk Management Standard, and nature-based solutions that improve the built and/or natural environment.
• Lead to increased economic or business activity due to enhanced safety features for all road users.
• Increase mobility and expand connectivity for all road users to critical community services such as education and healthcare, jobs, and business opportunities, especially for people in underserved communities.
• Address the unique challenges rural and Tribal communities face related to mobility and economic development, including isolation and transportation cost burden.
• For skilled construction labor needed on the project, incorporate strong labor standards (
• For non-construction work on the project, commit to supporting training opportunities as part of the project, including pre-apprenticeship or apprenticeship readiness programs and youth service, with a description of how training and job opportunities on the project will lead into registered apprenticeship or good-paying jobs.
• Track and publish aggregate workforce data, including information on demonstrating that employment opportunities are available to historically underserved workers in the community.
• Include Local inclusive economic development and entrepreneurship such as utilization of Disadvantaged Business Enterprises, Minority-owned Businesses, Women-owned businesses, or 8(a) firms.
Implementation Grant applicants should only respond to this selection criterion if supplemental planning and/or demonstration activities are included in the application. DOT will assess whether the applicant has described the scope of supplemental planning or demonstration work to be performed; the roadway safety issues that necessitate further Action Plan development, including supplemental planning, and/or demonstration activities, as applicable; and how the funded activities will inform an Action Plan and support the identification of projects and strategies that will:
• Lead to a significant reduction or elimination of roadway fatalities and serious injuries involving various road users;
• Employ low-cost, high-impact strategies that can improve safety over a wider geographical area;
• Involve engaging with a variety of public and private stakeholders;
• Adopt innovative technologies to promote safety and equity; and
• Be evidence-based or build evidence around what works.
Applicants applying to carry out demonstration activities will also be assessed as to whether their approach to measuring the potential benefits of the demonstration activities through data collection and evaluation are described, and the extent to which the activities will be set up (
Applications will be reviewed for Project Readiness, which will be a consideration for application selection. Project Readiness focuses on the extent to which the applicant will be able to substantially execute and complete the full scope of work in the Implementation Grant application within five (5) years of when the grant is executed. This includes information related to required design and construction standards, as well as environmental, permitting, and approval processes. DOT will evaluate the extent to which the application:
• Documents all applicable local, State, and Federal requirements.
• Includes information on activity schedule, required permits and approvals, the National Environmental Policy Act (NEPA) class of action and status, State Transportation Improvement Program (STIP) and Transportation Improvement Program (TIP) status (if applicable), public involvement, right-of-way acquisition plans, procurement schedules, multi-party agreements, utility relocation plans and risk and mitigation strategies, as appropriate.
• Is reasonably expected to begin any construction-related projects in a timely manner consistent with all applicable local, State, and Federal requirements.
The Department may consider the following when SS4A Implementation Grant awards:
• The percentage of Implementation Grant funds that will be spent in, and provide safety benefits to, locations in Census tracts designated as underserved communities as defined by this NOFO.
• Whether the applicant is in a rural area.
• Whether the applicant is identified as a priority community within the federal Thriving Communities Network.
• Whether the applicant would enhance the geographic diversity of Implementation Grant award recipients.
• Federal funding requests under $10 million.
This section addresses the BIL requirement to describe the methodology for evaluation in the NOFO, including how applications will be rated according to selection criteria and considerations, and how those criteria and considerations will be used to assign an overall rating. The SS4A grant program review and selection process consists of eligibility reviews, merit criteria review, and Senior Review. The Secretary makes the final selections.
Among well-rated applicants, the Secretary may prioritize applicants and jurisdictions that did not receive an SS4A grant in FY 2022 over applicants that did receive an FY 2022 award. The Secretary may also prioritize applications that will use demonstration activities or supplemental planning as part of the development of, or update to, an Action Plan.
The process for the application review is described below:
Teams of Department and contractor support staff will review all applications to determine eligibility based on the eligibility information in Section C.
• Eligible Action Plan applications received by the deadline will be reviewed for their merit based on the selection criteria in Section E.1.i.
• If multiple applications are received from the same applicant, the last one submitted will be reviewed.
• Applications are rated numerically based on Merit Criteria #1 Safety Impact and #2 Equity Criteria.
• The #3 Additional Safety Context criterion narrative will be reviewed and assessed, and then receive a rating of
• The Teams will note which of the three Planning and Demonstration Grant activities—develop a new Action Plan, conduct supplemental planning to update an existing plan, and carry out demonstration activities to inform the development or update of an Action Plan—are requested in an application.
• In order to ensure that final selections will meet the statutory requirement that no more than 15 percent of program funds may be awarded to eligible applicants in one State, applications will have their State location denoted. Awards to Federally recognized Tribal governments are not counted towards this 15 percent maximum.
• The Teams will examine the locations of the applicants to identify if an applicant is requesting funds in a geographic area that received an Action Plan Grant in FY 2022, as well as any potential overlap in geographic boundaries in funding requests for FY 2023. DOT will assess the extent to which the application is duplicative of existing or proposed activities and reserves the right to request applicants with duplicative funding requests to consolidate their efforts as one multijurisdictional group prior to receiving an award. DOT may decline to fund duplicative applications irrespective of their individual merits.
For the #3 Additional Safety Context, the Department will assess the narrative's alignment to the selection criterion, and will determine a rating of “high,” “medium,” “low,” or “non-responsive.”
Teams of Department and contractor support staff review all applications to determine whether they are eligible applicants based on the eligibility information in Section C. If multiple applications are received from the same applicant, the last one submitted will be reviewed. All eligible Implementation Grant applications received by the deadline will be reviewed and receive ratings for each of these criteria: #1 Safety Impact; #2 Equity, Engagement, and Collaboration; #3 Effective Practices and Strategies; #4 Other DOT Strategic Goals. Based on the criteria ratings, the Department will assign an overall application rating of “Highly Recommended,” “Recommended,” “Acceptable,” or “Not Recommended” as a result of evaluation team consensus discussion. The selection criteria are considered in numeric order of most to least important (
Implementation Grant applications that include supplemental planning or demonstration activities will also be reviewed for criterion #5 Additional Safety Context and quantitative Key Information Table information on fatality counts, fatality rate per 100,000 persons, and percentage of population in underserved communities, but it will not affect the overall Implementation Grant rating. Instead, DOT will use the information to determine whether the supplemental planning and/or demonstration activities should be funded as part of the overall project. DOT is more likely to fund, as part of an overall implementation project, supplemental planning and demonstration activities that rate well on criterion #5. Alternatively, DOT may award an Implementation Grant but exclude proposed supplemental planning or demonstration activities from the scope of the award if those activities were not rated well under criterion #5.
For the #1 Safety Impact criterion, the Department will assess three subcomponents, and for each determine a rating of “high,” “medium,” and “low,” or “non-responsive.” The three subcomponents are: the description of the safety problem; the safety impact assessment; and the implementation costs.
The sub-ratings will use the guidelines below:
For the merit criteria #2 Equity, Engagement, and Collaboration, #3 Effective Practices and Strategies, and #4 Other DOT Strategic Goals, the Department will consider whether the application narrative is clear, direct, responsive to the selection criterion focus areas, logical, and includes specific details and examples, which will result in a rating of “high, “medium,” “low,” or “non-responsive.”
All applications will receive a Project Readiness evaluation, as described below. The reviewers will use the application materials outlined in Section D to assess the applicant's Project Readiness and will provide a rating of either “Likely” or “Unlikely.”
Implementation Grant applications that include supplemental planning and/or demonstration activities will be assessed on the extent to which the narrative aligns with the selection criterion #5 Additional Safety Context and will be evaluated to determine a rating of “high,” “medium,” “low,” or “non-responsive.”
For the Planning and Demonstration Grants, the Secretary will review the three quantitative criteria ratings as well as the rating from the Additional Safety Context and select projects that are most advantageous to the U.S. Government's interest. The Secretary will consult with a Senior Review Team (SRT) to make the determinations.
Once every Implementation Grant application has been assigned an overall rating based on the methodology above, all “Highly Recommended” applications will be included in a list of Applications for Consideration. The SRT will also review all “Highly Recommended” applications that received an “Unlikely” project readiness rating, and either remove those applicants from the Applications for Consideration or recommend a reduced scope to remove components that reduced the project's readiness, so that if awarded the applicant would be likely to complete the scope of work within five years of the grant agreement execution. The Secretary will consider the applications with a reduced scope due to the Unlikely project readiness in the same way as applications with a “Likely” rating.
Additionally, to ensure the funding awards align to the extent practicable to the program goal of equitable investment in the safety needs of underserved communities, the SRT may review “Recommended” applications and set a threshold based on the percentage of funds that will be spent in, and provide safety benefits to, locations within underserved communities. Any “Recommended” applications at or above that threshold will be included in the proposed list of Applications for Consideration.
For applications that would not otherwise be included on the list of Applications for Consideration, the SRT may include applications with supplemental planning and demonstration activity funding that received a “High” rating for selection criterion #5 Additional Safety Context. The SRT may recommend the Secretary to fund a reduced scope of only the supplemental planning and demonstration activities for these applications.
For each grant type, the SRT will present the list of Applications for Consideration to the Secretary, either collectively or through a representative of the SRT. The SRT may advise the Secretary on any application on the list of Applications for Consideration, including options for reduced awards; the Secretary makes final selections. If an Implementation Grant application includes supplemental planning and demonstration activities, DOT may award just those activities as a standalone Planning and Demonstration Grant based on the rating received in selection criterion #5 Additional Safety Context. The Secretary's final selections identify the applications that best address program requirements and are most worthy of funding.
Prior to entering into a grant agreement, each selected applicant will be subject to a risk assessment as required by 2 CFR 200.206. The Department must review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently the Federal Awardee Performance and Integrity Information System [FAPIIS]). An applicant may review information in FAPIIS and comment on any information about itself that a Federal awarding agency previously entered. The Department will consider comments by the
Because award recipients under this program may be first-time recipients of Federal funding, DOT is committed to implementing the program as flexibly as permitted by statute and to provide assistance to help award recipients through the process of securing a grant agreement and delivering both Planning and Demonstration Grant activities and Implementation Grant projects and strategies. Award recipients are encouraged to identify any needs for assistance in delivering the Implementation Grant projects and strategies so that DOT can provide directly, or through a third party, sufficient support and technical assistance to mitigate potential execution risks.
The Department anticipates making two rounds of awards for this NOFO: one earlier round of awards only focused on applications requesting Planning and Demonstration Grants, and a later round of awards that will encompass Implementation Grants as well as Planning and Demonstration Grant applicants who did not receive funding in the earlier round. The earlier round is anticipated to be in October 2023, and the later round is anticipated to be in December 2023.
Following the evaluation outlined in Section E, the Secretary will announce awarded applications by posting a list of selected recipients. The posting of the list of selected award recipients will not constitute an authorization to begin performance. Following the announcement, the Department will contact the point of contact listed in the SF-424 to initiate negotiation of a grant agreement unless the applicant notifies DOT of a changed contact via
Each applicant selected for SS4A grant funding must demonstrate effort to consider climate change and environmental justice impacts as described in Section A. Projects that have not sufficiently considered climate change and environmental justice in their planning, as determined by the Department, will be required to do so before receiving funds, consistent with Executive Order 14008, Tackling the Climate Crisis at Home and Abroad (86 FR 7619).
Each applicant selected for SS4A grant funding must demonstrate effort to improve equity and reduce barriers to opportunity as described in Section A. Projects that have not sufficiently considered equity and barriers to opportunity in their planning, as determined by the Department, will be required to do so before receiving funds, consistent with Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (86 FR 7009).
As a condition of a grant award, grant recipients should demonstrate that the recipient has a plan for compliance with civil rights obligations and nondiscrimination laws, including Title VI of the Civil Rights Act of 1964 and implementing regulations (49 CFR 21), the Americans with Disabilities Act of 1990 (ADA), and Section 504 of the Rehabilitation Act, all other civil rights requirements, and accompanying regulations. This should include a current Title VI plan, completed Community Participation Plan, and a plan to address any legacy infrastructure or facilities that are not compliant with ADA standards. DOT's and the applicable Operating Administrations' Office of Civil Rights may work with awarded grant recipients to ensure full compliance with Federal civil rights requirements.
Funding recipients must comply with NEPA under 42 U.S.C. 4321
As expressed in Executive Order 14005, Ensuring the Future Is Made in All of America by All of America's Workers (86 FR 7475), it is the policy of the executive branch to maximize, consistent with law, the use of goods, products, and materials produced in, and services offered in, the United States. Infrastructure projects and demonstration activities are subject to the Build America, Buy America Act (Pub. L. 117-58, div. G sections 70901-70927) as clarified in OMB Memorandum M-22-11.
Each applicant selected for SS4A grant funding must demonstrate, to the full extent possible consistent with the law, an effort to create good-paying jobs with the free and fair choice to join a union and incorporation of high labor standards. To the extent that applicants have not sufficiently considered job quality and labor rights in their planning, as determined by the Department of Labor, the applicants will be required to do so before receiving funds, consistent with Executive Order 14025, Worker Organizing and Empowerment (86 FR 22829), and Executive Order 14052, Implementation of the Infrastructure Investment and Jobs Act (86 FR 64335).
As a condition of grant award and consistent with E.O. 11246, Equal Employment Opportunity (30 FR 12319, and as amended), all Federally assisted contractors are required to make good faith efforts to meet the goals of 6.9 percent of construction project hours being performed by women, in addition to goals that vary based on geography for construction work hours and for work being performed by people of color. Under Section 503 of the Rehabilitation Act and its implementing regulations, affirmative action obligations for certain contractors include an aspirational employment goal of 7 percent workers with disabilities.
The U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) is charged with enforcing Executive Order 11246, Section 503 of the Rehabilitation Act of 1973, and the Vietnam Era Veterans' Readjustment Assistance Act of 1974. OFCCP has a Mega Construction Project Program through which it engages with project sponsors as early as the design phase to help promote compliance with non-discrimination and affirmative action obligations. OFCCP will identify projects that receive an award under this notice and are required to
It is the policy of the United States to strengthen the security and resilience of its critical infrastructure against both physical and cyber threats. Each applicant selected for SS4A grant funding must demonstrate, prior to the signing of the grant agreement, effort to consider and address physical and cyber security risks relevant to the transportation mode and type and scale of the activities. Award recipients that have not appropriately considered and addressed physical and cyber security and resilience in their planning, design, and oversight, as determined by the Department and the Department of Homeland Security, will be required to do so before receiving Implementation Grant funds for construction, consistent with Presidential Policy Directive 21, Critical Infrastructure Security and Resilience and the National Security Presidential Memorandum on Improving Cybersecurity for Critical Infrastructure Control Systems. Additionally, funding recipients must be in compliance with 2 CFR 200.216 and the prohibition on certain telecommunications and video surveillance services or equipment.
All awards will be administered pursuant to the Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards found in 2 CFR 200 as adopted by the Department at 2 CFR 1201. Additionally, as permitted under the requirements described above, applicable Federal laws, rules, and regulations of the relevant operating administration (
In connection with any program or activity conducted with or benefiting from funds awarded under this notice, recipients of funds must comply with all applicable requirements of Federal law, including, without limitation, the Constitution of the United States; the conditions of performance, nondiscrimination requirements, and other assurances made applicable to the award of funds in accordance with regulations of the Department of Transportation; and applicable Federal financial assistance and contracting principles promulgated by the Office of Management and Budget. In complying with these requirements, recipients, in particular, must ensure that no concession agreements are denied, or other contracting decisions made on the basis of speech or other activities protected by the First Amendment. If the Department determines that a recipient has failed to comply with applicable Federal requirements, the Department may terminate the award of funds and disallow previously incurred costs, requiring the recipient to reimburse any expended award funds.
Reporting responsibilities include quarterly program performance reports using the Performance Progress Report (SF-PPR) and quarterly financial status using the SF-425 (also known as the Federal Financial Report or SF-FFR).
Budget and recipient performance information will be gathered on a quarterly basis in a Performance Progress Report (SF-PPR). To fulfill the data collection requirements and in accordance with the USDOT Public Access Plan, award recipients must consider, budget for, and implement appropriate data management, for data and information outputs acquired or generated during the course of the grant.
All award recipients shall submit a report by the end of the period of performance that describes:
• The costs of each eligible project and strategy carried out using the grant;
• The roadway safety outcomes and any additional benefits (
○ Identified in the grant application; and
○ Measured by data, to the maximum extent practicable;
• The percent of funds spent in, and providing benefits to, underserved communities; and
• The lessons learned and any recommendations relating to future projects or strategies to prevent death and serious injury on roads and streets.
Implementation Grant recipients must also provide: geo-coordinate information identifying specific project location(s); crash data on serious injury and fatalities in the locations where projects and strategies are implemented on an annual basis and at the end of the period of performance, which are expected to include crash characteristics and contributing factor information associated with the safety problems being addressed; and quantitative and qualitative project benefits documented in a final report.
Award recipients carrying out demonstration activities must also measure potential benefits through data collection and evaluative activities and report to the Department how the demonstration activities informed an Action Plan's list of projects and strategies and future implementation.
If the total value of a selected applicant's currently active grants, cooperative agreements, and procurement contracts from all Federal awarding agencies exceeds $10,000,000 for any period of time during the period of performance of this Federal award, then the applicant during that period of time must maintain the currency of information reported in SAM that is made available in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)) about civil, criminal, or administrative proceedings described in paragraph 2 of this award term and condition. This is a statutory requirement under section 872 of Public
As a condition of grant award, SS4A grant recipients may be required to participate in an evaluation undertaken by DOT, or another agency or partner. The evaluation may take different forms such as an implementation assessment across grant recipients, an impact and/or outcomes analysis of all or selected sites within or across grant recipients, or a benefit/cost analysis or assessment of return on investment. The Department may require applicants to collect data elements to aid the evaluation and/or use information available through other reporting. As a part of the evaluation, as a condition of award, grant recipients must agree to: (1) make records available to the evaluation contractor; (2) provide access to program records, and any other relevant documents to calculate costs and benefits; (3) in the case of an impact analysis, facilitate the access to relevant information as requested; and (4) follow evaluation procedures as specified by the evaluation contractor or DOT staff.
Recipients and sub-recipients are also encouraged to incorporate program evaluation including associated data collection activities from the outset of their program design and implementation to meaningfully document and measure the effectiveness of their projects and strategies. Title I of the Foundations for Evidence-Based Policymaking Act of 2018 (Evidence Act), Public Law 115-435 (2019) urges Federal awarding agencies and Federal assistance recipients and sub-recipients to use program evaluation as a critical tool to learn, to improve equitable delivery, and to elevate program service and delivery across the program lifecycle. Evaluation means “an assessment using systematic data collection and analysis of one or more programs, policies, and organizations intended to assess their effectiveness and efficiency” (codified at 5 U.S.C. 311). For grant recipients, evaluation expenses are allowable costs (either as direct or indirect), unless prohibited by statute or regulation, and such expenses may include the personnel and equipment needed for data infrastructure and expertise in data analysis, performance, and evaluation (2 CFR 200).
For further information concerning this notice, please contact the Office of the Secretary via email at
Following the completion of the selection process and announcement of awards, the Department intends to publish a list of all applications received along with the names of the applicant organizations and a few relevant data fields from the application. This includes unsuccessful applicants. The Department may share application information within the Department or with other Federal agencies if the Department determines that sharing is relevant to the respective program's objectives.
The Department will not review applications in advance, but Department staff are available for technical questions and assistance. DOT expects to hold “virtual-office hours” to further describe how to submit a complete application; for more information visit
The Department will provide resources to help interested applicants understand the different DOT discretionary grant programs through webinars, frequently asked questions, and other materials provided such as the SS4A program website
Internal Revenue Service (IRS), Treasury.
Notice.
This document provides notice of the availability of the application packages for the 2024 Tax Counseling for the Elderly (TCE) Program.
Application instructions are available electronically from the IRS on May 1, 2023, by visiting:
Internal Revenue Service, Grant Program Office, 5000 Ellin Road, NCFB C4-110, SE:W:CAR:SPEC:FO:GPO, Lanham, Maryland 20706.
Lorraine Thompson, Senior Tax Analyst, Grant Program Office on (470) 639-2935 or via email address at
Authority for the Tax Counseling for the Elderly (TCE) Program is contained in Section
Veterans Health Administration (VHA), Department of Veterans Affairs (VA).
Notice of a modified system of records.
Pursuant to the Privacy Act of 1974, notice is hereby given that the VA is modifying the system of records entitled, “National Patient Databases-VA” (121VA10A7). VA provides health care services to many of America's Veterans through the VHA. However, the care of America's Veterans extends beyond VHA and into community providers. During the course of providing health care, VHA collects medical and health information about Veterans under their care. Similarly, outside of VHA, community providers also collect medical and health information about Veterans under their care. This SORN requires modification to ensure the appropriate sharing of Veterans' medical or health information for disease management and population-based activities for improving health outcomes.
Comments on this modified system of records must be received no later than 30 days after date of publication in the
Comments may be submitted through
Stephania Griffin, VHA Chief Privacy Officer, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420; telephone (704) 245-2492 (Note: This is not a toll-free number).
VA is modifying the system of records by revising the System Number; System Location; System Manager; Purpose of the System; Categories of Individuals Covered by this System; Categories of Records in the System; Records Source Categories; Routine Uses of Records Maintained in the System; Policies and Practices for Storage of Records; Policies and Practices for Retention and Disposal of Records; Administrative, Technical and Physical Safeguards; and Appendix 4.
The System Number will be changed from 121VA10A7 to 121VA10 to reflect the current VHA organizational routing symbol.
The System Location will be updated to include: information from these records or copies of these records may be maintained at VA Enterprise Cloud Data Centers/Amazon Web Services, 1915 Terry Avenue, Seattle, WA 98101.
The System Manager is being updated to replace “Assistant Deputy Under Secretary for Informatics and Information Governance (10P2)”, with, “Chief Officer for Health Informatics (105).”
The Purpose of the System is being modified to include: “to monitor the performance outside the VA as relevant; and to study, monitor and report epidemiological trends and disease incidence.” It is also being modified to include: “The Public Health National Program Office System data will be available to VA personnel, Federal agencies and State/Local Health Departments for the monitoring of infections, emerging pathogens, and environmental issues of interest that might reasonably affect the health of the public.” This section will remove: “National Center for Patient Safety Public Health System data will be available to VHA clinicians to use for the monitoring of health care-associated infections and for the transmittal of data to state/local health departments for bio surveillance purposes.”
Categories of Individuals Covered by this System is being updated, number (2) is being updated to reflect the following: “Providing health care to individuals for VHA.” Section (3) is also being added and will state: “Whose data is provided to VA clinical registries, including but not limited to the VA Central Cancer Registry.”
The Categories of Records in the System is being updated to replace 24VA10P2 with 24VA10A7.
The Records Source Categories is being updated to replace “VA Austin Automation Center” with “Austin Information Technology Center”; 33VA113 with 33VA10; and “Healthcare Eligibility Records-VA” (89VA10NB) with “Income Verification Records-VA” (89VA10)”. “Veterans and Beneficiaries Identification and Records Location Subsystem-VA” (38VA23) is being removed from this section since this SORN was rescinded and is now encompassed in “Compensation, Pension, Education, and Vocational Rehabilitation and Employment Records-VA” (58VA21/22/28). This section will also include the National Cancer Institute (NCI) and/or their designee, and a state cancer or tumor registry.
The language in Routine Use #28 is being updated. It previously reflected the following language, “VA may disclose relevant health care information to the CDC and/or their designee in response to its request or at the initiation of VA, in connection with disease-tracking, patient outcomes, bio-surveillance, or other health information required for program accountability.”
Routine Use #28 will now read as follows, “To the Centers for Disease Control and Prevention (CDC) and/or their designee, or other Federal and state public health authorities in response to its request or at the initiation of VA, in connection with disease-tracking, patient outcomes, bio-surveillance or other health information required for program accountability.”
Routine Use #31 is being added to state, “To the NCI and/or their designee, and/or a state cancer or tumor registry in response to its request or at the initiation of VA for the purpose of population-based activities to improve health and disease management. VA needs the ability to determine trends in the rates of the incidence of cancer in Veterans.”
Policies and Practices for Storage of Records is being updated to include “VA Enterprise Cloud.”
Policies and Practices for Retention and Disposal of Records is being updated to remove General Records Schedule 20, item 4. Item 4 provides for deletion of data files when the agency determines that the files are no longer needed for administrative, legal, audit or other operational purposes. This section will now reflect the following, Records in this system are retained and disposed of in accordance with the
Administrative, Technical and Physical Safeguards is being updated to include #6, “VA Enterprise Cloud data storage conforms to security protocols as stipulated in VA Directives 6500 and 6517. Access control standards are stipulated in specific agreements with cloud vendors to restrict and monitor access.”
Appendix 4 is being updated to replace “Master Veteran Index” with “Master Person Index-VHA.” The address for the VA Clinical Assessment Reporting and Tracking Program is being updated to replace “Denver VA Medical Center, 1055 Clermont Street, Denver, CO 80220” with “Digital Realty 350 E Cermak Road, Main Building 7th Transport RM, Chicago, IL 60616, and Evoque Data Centers, 11830 Webb Chapel Road, Suite 200, Dallas, TX 75234”.
The Senior Agency Official for Privacy, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Kurt D. DelBene, Assistant Secretary for Information and Technology and Chief Information Officer, approved this document on March 6, 2023 for publication.
“National Patient Databases-VA” (121VA10).
Unclassified.
Records are maintained at the Department of Veterans Affairs (VA) medical centers, VA data processing centers, Veterans Integrated Service Networks (VISN) and Office of Information Technology Field Offices. The address for each VA national patient database is listed in VA Appendix 4 at the end of this document. In addition, information from these records or copies of these records may be maintained at VA Enterprise Cloud Data Centers/Amazon Web Services, 1915 Terry Avenue, Seattle, WA 98101.
Officials responsible for policies and procedures: Chief Officer for Health Informatics, Department of Veterans Affairs, 810 Vermont Avenue NW, (105), Washington, DC 20420. Officials maintaining this system of records: Director, National Data Systems, Austin Information Technology Center, 1615 Woodward Street, Austin, Texas 78772. Telephone number 512-326-6780 (this is not a toll-free number).
38 U.S.C 501.
The records and information may be used for statistical analysis to produce various management, workload tracking and follow-up reports; to track and evaluate the ordering and delivery of equipment, services and patient care; for the planning, distribution and utilization of resources; to monitor the performance of VISNs and/or outside the VA as relevant; to allocate clinical and administrative support to patient medical care; and to study, monitor and report epidemiological trends and disease incidence; for VA's extensive research programs in accordance with VA policy; to assist in workload allocation for patient treatment services including provider panel management, nursing care, clinic appointments, surgery, prescription processing, diagnostic and therapeutic procedures; to plan and schedule training activities for employees; for audits, reviews and investigations conducted by the network directors office and VA Central Office; for quality assurance audits, reviews and investigations; for law enforcement investigations; and for personnel management, evaluation and employee ratings, and performance evaluations. Pursuant to Executive Order 12862 and VHA Customer Service Standards Directive, survey data in this system will used to measure and monitor national, VISN and facility-level performance on the Veterans Health Administration (VHA) Veteran Health Care Service Standards (VHSS). The VHSS are designed to measure levels of patient satisfaction in areas that patients have defined as important in receiving quality, patient-centered health care. Results of the survey data analysis are shared throughout the VHA system. External Peer Review Program (EPRP) data in this system will be used to provide medical centers and outpatient clinics with diagnosis and procedure-specific quality of care information. EPRP is a contracted review of care, specifically designated to collect data to be used to improve the quality of care. The Veteran Homeless records and information will be used for case management in addition to statistical analysis to produce various management, workload tracking and follow-up reports; to track and evaluate the goal of ending Veteran homelessness. The Public Health National Program Office System data will be available to VA personnel, Federal agencies and State/Local Health Departments for the monitoring of infections, emerging pathogens, and environmental issues of interest that might reasonably affect the health of the public.
These records include information for all individuals that are; (1) Receiving health care from VHA; (2) Providing health care to individuals for VHA; or (3) Whose data is provided to VA clinical registries, including but not limited to the VA Central Cancer Registry. Individuals encompass veterans and their immediate family members; members of the Armed Services; current and former employees, trainees, contractors, subcontractors, consultants, volunteers; and other individuals working collaboratively with VA.
These records include information and health information related to; (1) Patient medical record abstract information including, but not limited to, information from “Patient Medical Record-VA” (24VA10A7); (2) Identifying information (
Information in this system of records may be provided by veterans; VA employees; VA computer systems; Veterans Health Information Systems and Technology Architecture; VA medical centers; VA Health Eligibility Center; VA program offices; VISNs; Austin Information Technology Center; the Food and Drug Administration (FDA); Department of Defense; Department of Housing and Urban Development (HUD); Survey of Healthcare Experiences of Patients; EPRP; National Cancer Institute (NCI) and/or their designee; a state cancer or tumor registry; “Patient Medical Records-VA” (24VA10A7); “National Prosthetics Patient Database-VA” (33VA10); “Income Verification Records-VA” (89VA10); VA Veterans Benefits Administration automated record systems (including the “Compensation, Pension, Education, and Vocational Rehabilitation and Employment Records-VA” (58VA21/22/28)); and subsequent iterations of those systems of records.
To the extent that records contained in the system include information protected by 45 CFR parts 160 and 164,
1. To a Federal, state, local, territorial, tribal or foreign law enforcement authority or other appropriate entity charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing such law, provided that the disclosure is limited to information that, either alone or in conjunction with other information, indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature. The disclosure of the names and addresses of Veterans and their dependents from VA records under this routine use must also comply with the provisions of 38 U.S.C. 5701.
2. To any source from which additional information is requested (to the extent necessary to identify the individual, inform the source of the purpose(s) of the request and identify the type of information requested), when necessary to obtain or provide information relevant to an individual's eligibility, care history or other benefits across different Federal, state or local, public health, health care or program benefit agencies that improves the quality and safety of health care for our Veterans.
3. To a Federal agency in the executive, legislative or judicial branch, state and local Government or the District of Columbia Government in response to its request or at the initiation of VA, in connection with disease tracking, patient outcomes or other health information required for program accountability.
4. To the National Archives and Records Administration (NARA) in records management inspections conducted under 44 U.S.C. 2904 and 2906, or other functions authorized by laws and policies governing NARA operations and VA records management responsibilities.
5. To the Department of Justice (DoJ), or in a proceeding before a court, adjudicative body or other administrative body before which VA is authorized to appear, when:
(a) VA or any component thereof;
(b) Any VA employee in their official capacity;
(c) Any VA employee in their individual capacity where DoJ has agreed to represent the employee; or
(d) The United States, where VA determines that litigation is likely to affect the agency or any of its components,
is a party to such proceedings or has an interest in such proceedings, and VA determines that the use of such records is relevant and necessary to the proceedings.
6. To a Federal agency, a state or local government licensing board, the Federation of State Medical Boards or a similar non-governmental entity that maintains records concerning individuals' employment histories or concerning the issuance, retention or revocation of licenses, certifications or registration necessary to practice an occupation, profession or specialty. This information can be used to inform such non-governmental entities about the health care practices of a terminated, resigned or retired health care employee whose professional health care activity so significantly failed to conform to generally accepted standards of professional medical practice as to raise reasonable concern for the health and safety of patients in the private sector or from another Federal Agency. These records may also be disclosed as part of an ongoing computer matching program to accomplish these purposes.
7. To a former VA employee or contractor, as well as the authorized representative of a current or former employee or contractor of VA, in connection with or in consideration of reporting that the individual's professional health care activity so significantly failed to conform to generally accepted standards of professional medical practice as to raise reasonable concern for the health and safety of patients, to a Federal agency, a state or local government licensing board, or the Federation of State Medical Boards or a similar nongovernmental entity that maintains records concerning individuals' employment histories or concerning the issuance, retention or revocation of licenses, certifications, or registration necessary to practice an occupation, profession or specialty.
8. To survey teams of The Joint Commission (TJC, College of American Pathologists, American Association of Blood Banks, and similar national accreditation agencies or boards with which VA has a contract or agreement to conduct such reviews, as relevant and necessary for the purpose of program review or the seeking of accreditation or certification.
9. To a national certifying body that has the authority to make decisions concerning the issuance, retention or revocation of licenses, certifications or registrations required to practice a health care profession, when requested in writing by an investigator or supervisory official of the national certifying body for the purpose of making a decision concerning the issuance, retention or revocation of the license, certification or registration of a named health care professional.
10. To officials of labor organizations recognized under 5 U.S.C. Chapter 71 provided that the disclosure is limited to information identified in 5 U.S.C. 7114(b)(4) that is relevant and necessary to their duties of exclusive representation concerning personnel policies, practices and matters affecting working conditions.
11. To the representative of an employee of all notices, determinations, decisions or other written communications issued to the employee in connection with an examination
12. To the Merit Systems Protection Board (MSPB) in connection with appeals, special studies of the civil service and other merit systems, review of rules and regulations, investigation of alleged or possible prohibited personnel practices, and such other functions promulgated in 5 U.S.C. 1205 and 1206, or as authorized by law.
13. To the Equal Employment Opportunity Commission (EEOC) in connection with investigations of alleged or possible discriminatory practices, examination of Federal affirmative employment programs or other functions of the Commission as authorized by law.
14. To the Federal Labor Relations Authority (FLRA) in connection with the investigation and resolution of allegations of unfair labor practices, the resolution of exceptions to arbitration awards when a question of material fact is raised, matters before the Federal Service Impasses Panel, and the investigation of representation petitions and the conduct or supervision of representation elections.
15. To non-Federal research facilities for research purposes determined to be necessary and proper when approved in accordance with VA policy; disclosure of medical record data, excluding name and address, unless name and address are furnished by the requester.
16. To: (a) A Federal department or agency, at the written request of the head or designee of that agency or (b) directly to a contractor or subcontractor of a Federal department or agency, for the purpose of conducting Federal research necessary to accomplish a statutory purpose of an agency, provided that the disclosure is limited to the names and addresses of present or former members of the armed services or their beneficiaries, the records will not be used for any purpose other than that stated in the request, and the organization is aware of the penalty provision of 38 U.S.C. 5701(f). When disclosure of this information is made directly to a contractor, VA may impose applicable conditions on the department, agency and/or contractor to insure the appropriateness of the disclosure to the contractor.
17. To contractors, grantees, experts, consultants, students and others performing or working on a contract, service, grant, cooperative agreement or other assignment for VA, when reasonably necessary to accomplish an agency function related to the records.
18. To a Member of Congress or staff acting upon the Member's behalf when the Member or staff requests the information on behalf of, and at the request of, the individual who is the subject of the record.
19. To a Federal agency for research and data analysis to perform a statutory purpose of that Federal agency upon the prior written request of that agency, provided that there is legal authority under all applicable confidentiality statutes and regulations to provide the data and the VHA Office of Informatics has determined prior to the disclosure that VHA data handling requirements are satisfied.
20. To another Federal agency for the purpose of matching and acquiring information held by that agency for VHA for the purposes stated for this system of records, provided that disclosure is of limited individual identification information.
21. To appropriate agencies, entities and persons when (1) VA suspects or has confirmed that there has been a breach of the system of records; (2) VA has determined that as a result of the suspected or confirmed breach there is a risk to individuals, VA (including its information systems, programs and operations), the Federal Government or national security; and (3) the disclosure made to such agencies, entities or persons reasonably necessary to assist in connection with VA efforts to respond to the suspected or confirmed breach or to prevent, minimize or remedy such harm.
22. To the general public, on its own initiative, via an internet website, Primary Care Management Module information, including the names of its providers, provider panel sizes and reports on provider performance measures of quality when approved in accordance with VA policy.
23. To other Federal agencies to assist such agencies in preventing and detecting possible fraud or abuse by individuals in their operations and programs.
24. To a nonprofit organization if the release is directly connected with the conduct of programs and the utilization of benefits under title 38, provided that the disclosure is limited to the names and addresses of present or former members of the armed services or their beneficiaries, the records will not be used for any purpose other than that stated in the request, and the organization is aware of the penalty provision of 38 U.S.C. 5701(f).
25. To HUD, including demographic information, for the purpose of reducing homelessness among Veterans by implementing the Federal strategic plan to prevent and end homelessness and by evaluating and monitoring the HUD-Veterans Affairs Supported Housing program.
26. To the FDA, Department of Health and Human Services concerning an adverse drug reaction of a patient, for the purpose of quality of care management, including detection, treatment, monitoring, reporting, analysis and follow-up actions relating to adverse drug reactions.
27. To an organization with whom VA has a documented partnership, arrangement or agreement (
28. To Center for Disease Control and Prevention (CDC) and/or their designee or other Federal or state public health authorities in response to its request or at the initiation of VA, in connection with disease-tracking, patient outcomes, bio-surveillance or other health information required for program accountability.
29. To another Federal agency or Federal entity, when VA determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs and operations), the Federal Government or national security, resulting from a suspected or confirmed breach.
30. To health and welfare agencies, housing resources and community providers, consistent with good medical-ethical practices, for Veterans assessed by or engaged in VA homeless programs for purposes of coordinating care, expediting access to housing, providing medical and related services, participating in coordinated entry processes, reducing Veteran homelessness, identifying homeless individuals in need of immediate assistance and ensuring program accountability by assigning and tracking responsibility for urgently required care.
31. To the NCI and/or their designee and/or a state cancer or tumor registry in response to its request or at the initiation of VA for the purpose of population-based activities to improve health and disease management.
Records are maintained on electronic storage media including magnetic tape, disk, laser optical media and the VA Enterprise Cloud.
Records are retrieved by name, Social Security Number or other assigned identifiers of the individuals on whom they are maintained.
Records in this system are retained and disposed of in accordance with the schedule approved by the Archivist of the United States, General Records Schedule, 5.2, item 020.
1. Access to and use of national patient databases are limited to those persons whose official duties require such access, and VA has established security procedures to ensure that access is appropriately limited. Information security officers and system data stewards review and authorize data access requests. VA regulates data access with security software that authenticates users and requires individually unique codes and passwords. VA provides information security training to all staff and instructs staff on the responsibility each person has for safeguarding data confidentiality.
2. VA maintains Business Associate Agreements and Non-Disclosure Agreements with contracted resources in order to maintain the confidentiality of the information.
3. Physical access to computer rooms housing national patient databases are restricted to authorized staff and protected by a variety of security devices. Unauthorized employees, contractors and other staff are not allowed in computer rooms. The Federal Protective Service or other security personnel provide physical security for the buildings housing computer rooms and data centers.
4. Data transmissions between operational systems and national patient databases maintained by this system of record are protected by state-of-the-art telecommunication software and hardware. This may include firewalls, encryption and other security measures necessary to safeguard data as it travels across the VA Wide Area Network. Data may be transmitted via a password protected spreadsheet and placed on the secured SharePoint Web portal by the user that has been provided access to their secure file. Data can only be accessed by authorized personnel from each facility within the Polytrauma System of Care and the Physical Medicine and Rehabilitation Program Office.
5. In most cases, copies of backup computer files are maintained at off-site locations.
6. VA Enterprise Cloud data storage conforms to security protocols as stipulated in VA Directives 6500 and 6517. Access control standards are stipulated in specific agreements with cloud vendors to restrict and monitor access.
Individuals seeking information on the existence and content of records in this system pertaining to them should contact the system manager in writing as indicated above or write or visit the VA facility location where they normally receive their care. A request for access to records must contain the requester's full name, address and telephone number, be signed by the requester and describe the records sought in sufficient detail to enable VA personnel to locate them with a reasonable amount of effort.
Individuals seeking to contest or amend records in this system pertaining to them should contact the system manager in writing as indicated above. A request to contest or amend records must state clearly and concisely what record is being contested, the reasons for contesting it, and the proposed amendment to the record.
Generalized notice is provided by the publication of this notice. For specific notice, see Record Access Procedure, above.
None.
69 FR 18436 (April 7, 2004); 73 FR 16103 (March 26, 2008); 75 FR 72873 (November 26, 2010); 77 FR 27863 (May 11, 2012); 79 FR 8245 (February 11, 2014); 83 FR 6094 (February 12, 2018).
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Final rule.
This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, and other programmatic areas. This final rule will also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes provisions that will codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs.
Lucia Patrone, (410) 786-8621—General Questions.
Carly Medosch, (410) 786-8633—Part C and Cost Plan Issues.
Catherine Gardiner, (410) 786-7638—Part D Issues.
Sonia Eaddy, (410) 786-5459—Part D Issues.
Kristy Nishimoto, (206) 615-2367—Beneficiary Enrollment and Appeals Issues.
Kelley Ordonio, (410) 786-3453—Parts C and D Payment Issues.
Hunter Coohill, (720) 853-2804—Enforcement Issues.
Lauren Brandow, (410) 786-9765—PACE Issues.
Sara Klotz, 410-786-0507—D-SNP Issues.
CMS intends to address all of the remaining proposals from the December 2022 proposed rule in subsequent rulemaking. Therefore, CMS plans to make provisions adopted in the subsequent, second final rule applicable to coverage beginning no earlier than January 1, 2025. Notwithstanding the foregoing, for proposals from the December 2022 proposed rule that would codify statutory requirements that are already in effect, CMS reminds organizations, plan sponsors, and other readers that the statutory provisions apply and will continue to be enforced. CMS intends to implement the statutory requirements in section 118 of Division CC of the Consolidated Appropriations Act, 2021 (CAA) and section 11404 of the Inflation Reduction Act (IRA) consistent with their effective provisions.
We received nearly one thousand timely pieces of correspondence containing multiple comments on the CY 2024 proposed rule. We note that some of the public comments were outside of the scope of the proposed rule. These out-of-scope public comments are not addressed in this final rule. Summaries of the public comments that are within the scope of the proposed rule and our responses to those public comments are set forth in the various sections of this final rule under the appropriate heading. However, we note that in this final rule, we are not addressing comments received on the provisions of the proposed rule that we are not addressing or finalizing at this time. Rather, we will address them at a later time, in a subsequent rulemaking document, as appropriate.
The primary purpose of this final rule is to amend the regulations for the Medicare Advantage (Part C), Medicare Cost Plan, and Medicare Prescription Drug Benefit (Part D) programs, and Programs of All-Inclusive Care for the Elderly (PACE). This final rule includes a number of new policies that would improve these programs as well as codify existing Part C and Part D sub-regulatory guidance.
Additionally, this rule implements certain sections of the following Federal laws related to the Parts C and D programs:
• The Inflation Reduction Act (IRA) of 2022.
• The Consolidated Appropriations Act (CAA), 2021.
We are finalizing a health equity index (HEI) reward for the 2027 Star Ratings to further incentivize Parts C and D plans to focus on improving care for enrollees with social risk factors (SRFs); as part of this change, we also are finalizing the removal of the current reward factor (a reward for consistently high performance). This policy supports CMS efforts to ensure attainment of the highest level of health for all people. We are finalizing the reduction in the weight of patient experience/complaints and access measures to further align efforts with other CMS quality programs and the current CMS Quality Strategy, as well as to better balance the contribution of the different types of measures in the Star Ratings program. We also are finalizing the removal of the Part C Diabetes Care—Kidney Disease Monitoring measure; addition of the Part C Kidney Health Evaluation for Patients with Diabetes measure; and substantive updates to the Part D Medication Adherence for Diabetes Medications, Medication Adherence for
The remaining Star Ratings provisions of the proposed rule are not being finalized in this rule and instead will be addressed in a later final rule. Those provisions include removing the stand-alone Medication Reconciliation Post-Discharge measure; adding the updated Colorectal Cancer Screening and Care for Older Adults—Functional Status Assessment measures; adding the Part D Concurrent Use of Opioids and Benzodiazepines, Polypharmacy Use of Multiple Anticholinergic Medications in Older Adults, and Polypharmacy Use of Multiple Central Nervous System Active Medications in Older Adults measures; removing guardrails (that is, bi-directional caps that restrict upward and downward movement of a measure's cut points for the current year's measure-level Star Ratings compared to the prior year's measure-threshold specific cut points) when determining measure-specific-thresholds for non-Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures; modifying the Improvement Measure hold harmless policy; and adding technical clarifications related to Quality Bonus Payment (QBP) appeals and weighting of measures after a substantive specification change.
CMS is working to achieve policy goals that advance health equity across its programs and pursue a comprehensive approach to advancing health equity for all, including those who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality.
First, current regulations require MA organizations to ensure that services are provided in a culturally competent manner. The regulation provides examples of populations that may require consideration specific to their needs. In this final rule, we further clarify the broad application of our policy. Specifically, we are amending the list of populations to include people: (1) with limited English proficiency or reading skills; (2) of ethnic, cultural, racial, or religious minorities; (3) with disabilities; (4) who identify as lesbian, gay, bisexual, or other diverse sexual orientations; (5) who identify as transgender, nonbinary, and other diverse gender identities, or people who were born intersex; (6) who live in rural areas and other areas with high levels of deprivation; and (7) otherwise adversely affected by persistent poverty or inequality.
Next, CMS currently provides best practices for organizations to use in developing their provider directories, including incorporating non-English languages spoken by each provider and provider/location accessibility for people with physical disabilities. In this rule, we are codifying these best practices by requiring organizations to include providers' cultural and linguistic capabilities (including American Sign Language, ASL) in their provider directories. This change will improve the quality and usability of provider directories, particularly for non-English speakers, limited English proficient individuals, and enrollees who use ASL.
In addition, as the use of telehealth becomes more prevalent, there is evidence of disparities in telehealth access due in part to low digital health literacy, especially among populations who already experience health disparities. Low digital health literacy is one of the most significant obstacles in achieving telehealth equity, and many older adults with low digital health literacy experience gaps in access to the health care they need. This is concerning for the MA program because its enrollee population includes older adults who are age 65 or older, which is why we are finalizing policies to address the issue by requiring MA organizations to develop and maintain procedures to identify and offer digital health education to enrollees with low digital health literacy to assist with accessing any medically necessary covered telehealth benefits. We solicited comments from stakeholders on various aspects of our proposal, which informed the types of MA plans we are subjecting to the finalized regulatory requirements, and how we will collect information related to compliance with these requirements.
Finally, MA organizations' existing quality improvement (QI) programs are an optimal vehicle to develop and implement strategies and policies designed to reduce disparities in health and health care, and advance equity in the health and health care of MA enrollee populations, especially those that are underserved. To support these efforts, we will require MA organizations to incorporate one or more activities into their overall QI program that reduce disparities in health and health care among their enrollees. MA organizations may implement activities such as improving communication, developing and using linguistically and culturally appropriate materials (to distribute to enrollees or use in communicating with enrollees), hiring bilingual staff, community outreach, or similar activities. We believe adopting this proposed requirement for MA organizations as part of their required QI programs will align with health equity efforts across CMS policies and programs.
In recent years, CMS has received numerous inquiries regarding MA organizations' use of prior authorization and its effect on beneficiary access to care. We are finalizing several regulatory changes to address these concerns regarding prior authorization. First, we are finalizing that prior authorization policies for coordinated care plans may only be used to confirm
Finally, to ensure prior authorization and other utilization managed policies are consistent with the rules we are adopting on coverage criteria and coverage policies and relevant current clinical guidelines, we are finalizing that all MA plans establish a Utilization Management Committee to review all utilization management, including prior authorization, policies annually and ensure they are consistent with the coverage requirements, including current, traditional Medicare's national and local coverage decisions and guidelines. These changes will help ensure MA enrollees have consistent access to medically necessary care, without unreasonable barriers or interruptions.
In accordance with our statutory authority to review marketing materials and application forms and to develop marketing standards under sections 1851(h), 1851(j), 1860D-1(b)(1)(vi), and 1860D-4(l) of the Act, as well as the statutory requirements in sections 1852(c) and 1860D-4(a) of the Act requiring MA organizations and Part D sponsors disclose specific types of information to enrollees, we proposed several changes to 42 CFR parts 422 and 423, subpart V, to strengthen beneficiary protections and improve MA and Part D marketing. We are finalizing the following changes: notifying enrollees annually, in writing, of the ability to opt out of phone calls regarding MA and Part D plan business; requiring agents to explain the effect of an enrollee's enrollment choice on their current coverage whenever the enrollee makes an enrollment decision; simplifying plan comparisons by requiring medical benefits be in a specific order and listed at the top of a plan's Summary of Benefits; limiting the time that a sales agent can call a potential enrollee to no more than 12 months following the date that the enrollee first asked for information; limiting the requirement to record calls between third-party marketing organizations (TPMOs) and beneficiaries to marketing (sales) and enrollment calls; prohibiting a marketing event from occurring within 12 hours of an educational event at the same location; clarifying that the prohibition on door-to-door contact without a prior appointment still applies after collection of a business reply card (BRC) or scope of appointment (SOA); prohibiting marketing of benefits in a service area where those benefits are not available, unless unavoidable because of use of local or regional media that covers the service area(s); prohibiting the marketing of information about savings available that are based on a comparison of typical expenses borne by uninsured individuals, unpaid costs of dually eligible beneficiaries, or other unrealized costs of a Medicare beneficiary; requiring TPMOs to list or mention all of the MA organization or Part D sponsors that they represent on marketing materials; requiring MA organizations and Part D sponsors to have an oversight plan that monitors agent/broker activities and reports agent/broker non-compliance to CMS; modifying the TPMO disclaimer to add SHIPs as an option for beneficiaries to obtain additional help; modifying the TPMO disclaimer to state the number of organizations represented by the TPMO as well as the number of plans; prohibiting the collection of Scope of Appointment cards at educational events; placing discrete limits around the use of the Medicare name, logo, and Medicare card; prohibiting the use of superlatives (for example, words like “best” or “most”) in marketing unless the material provides documentation to support the statement, and the documentation is based on data from the current or prior year; clarifying the requirement to record calls between TPMOs and beneficiaries, such that it is clear that the requirement includes virtual connections such as video conferencing and other virtual telepresence methods; and requiring 48 hours between a Scope of Appointment and an agent meeting with a beneficiary, with exceptions for beneficiary-initiated walk-ins and the end of a valid enrollment period. We are not addressing our proposal to prohibit TPMOs from distributing beneficiary contact information in this final rule and may address it in a future final rule.
We are finalizing and implementing the changes, as previously discussed, to Subpart V in this rule for CY 2024. As such, they will become effective on September 30, 2023 for all activity related to CY 2024.
Sections 422.2267(a)(2) and 423.2267(a)(2) require MA organizations, cost plans, and Part D sponsors to translate required materials into any non-English language that is the primary language of at least 5 percent of individuals in a plan benefit package service area. In addition, 45 CFR part 92 requires plans to provide appropriate auxiliary aids and services, including interpreters and information in alternate formats, to individuals with impaired sensory, manual, or speaking skills, where necessary to afford such persons an equal opportunity to benefit from the service in question. However, CMS has learned from oversight activities, enrollee complaints, and stakeholder feedback that enrollees often must make a separate request each time they would like a material in a non-English language or accessible format.
In addition, an increasing number of dually eligible individuals are enrolled in managed care plans where the same plan covers both Medicare and Medicaid services. In some cases, Medicaid standards for Medicaid managed care plans require translation of plan materials into a non-English language not captured by the Medicare Advantage requirements.
We are finalizing a requirement that MA organizations, cost plans, and Part D sponsors must provide materials to enrollees on a
In this rule, we are finalizing and implementing the changes as proposed for materials produced for CY 2024.
As part of the January 2022 proposed rule, we solicited comments from stakeholders regarding challenges in building MA behavioral health networks and opportunities for improving access to services. Stakeholders commented on the importance of ensuring adequate access to behavioral health services for enrollees and suggested expanding network adequacy requirements to include additional behavioral health specialty types.
To strengthen our network adequacy requirements and reaffirm MA organizations' responsibilities to provide behavioral health services, we are finalizing to: (1) add Clinical Psychology and Licensed Clinical Social Work as specialty types that will be evaluated as part of the network adequacy reviews under § 422.116, and make these new specialty types eligible for the 10-percentage point telehealth credit as allowed under § 422.116(d)(5); (2) amend our general access to services standards in § 422.112 to include explicitly behavioral health services; (3) codify, from existing guidance on reasonable wait times for primary care visits, standards for wait times that apply to both primary care and behavioral health services; (4) clarify that some behavioral health services may qualify as emergency services and, therefore, must not be subject to prior authorization; and (5) extend current requirements for MA organizations to establish programs to coordinate covered services with community and social services to behavioral health services programs to close equity gaps in treatment between physical health and behavioral health.
CMS requires notification to MA enrollees when a provider network participation contract terminates. Continuity of care is essential, especially for primary care and behavioral health, and consequently, adequate communication to enrollees is vital when network changes occur so that patients of any terminating primary care or behavioral health providers can decide how to proceed with their course of treatment. CMS is finalizing amendments to § 422.111(e) that establish specific enrollee notification requirements for no-cause and for-cause provider contract terminations and add specific and more stringent enrollee notification requirements when primary care and behavioral health provider contract terminations occur. CMS is also amending § 422.2267(e)(12) to specify the content and additional procedural requirements for the notification to enrollees about a provider contract termination. These requirements will generally increase enrollee protections when MA network changes occur and will raise the standards for the stability of enrollees' primary care and behavioral health treatment.
CMS has operated the LI NET demonstration since 2010. The LI NET demonstration provides transitional, point-of-sale coverage for low-income beneficiaries who demonstrate an immediate need for prescriptions, but who have not yet enrolled in a Part D plan, or whose enrollment is not yet effective. LI NET also provides retroactive and/or temporary prospective coverage for beneficiaries determined to be eligible for the Part D low-income subsidy (LIS) by the Social Security Administration (SSA) or a State. In this final rule, we are making the LI NET program a permanent part of Medicare Part D, as required by the Consolidated Appropriations Act, 2021 (CAA). We are finalizing the regulation largely as proposed, with a few minor clarifying modifications.
Section 11404 of the IRA amended section 1860D-14 of the Act to expand eligibility for the full LIS to individuals with incomes up to 150 percent of the Federal poverty level (FPL) beginning on or after January 1, 2024. In addition, the IRA allows for individuals to qualify for the full subsidy based on the higher resource requirements currently applicable to the partial LIS group. This change will provide the full LIS subsidy for those who currently qualify for the partial subsidy. In this rule, we are finalizing implementing regulations at §§ 423.773 and 423.780 as proposed.
In the final rule titled “Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program” which appeared in the
We established these contract limitations to address the proliferation and growth of D-SNP look-alikes, which raised concerns related to effective implementation of requirements for D-SNPs established by section 1859 of the Act (including amendments made by the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275) and the Bipartisan Budget Act of 2018 (Pub. L. 115-123)). We adopted the regulation to ensure full implementation of requirements for D-SNPs, such as contracts with State Medicaid agencies; a minimum integration of Medicare and Medicaid benefits; care coordination through health risk assessments (HRAs); and evidence-based models of care. In addition, we noted how limiting these D-SNP look-alikes would address beneficiary confusion stemming from misleading marketing practices by brokers and agents that misrepresent to dually eligible individuals the characteristics of D-SNP look-alikes. For a more detailed discussion of D-SNP look-alikes and their impact on the implementation of D-SNP Medicare and Medicaid integration, we direct readers to the June 2020 final rule (85 FR 33805
As written at § 422.514(d) and (e), the contracting limitations for D-SNP look-alikes are based on analysis at the MA
In the proposed rule (87 FR 79465), we described examples of non-SNP MA plan segments that would be identified as D-SNP look-alikes if we were to apply the § 422.514(d)(2) criteria at the MA plan segment level. The segments in those three plans collectively have approximately 3,000 enrollees. While the number of non-SNP MA plans at the segment level is currently small, this number could grow in the future and provide an opportunity for MA organizations to circumvent the D-SNP look-alike contracting limitations at § 422.514(d).
We proposed adding a new paragraph at 42 CFR 422.514(g) to provide that § 422.514(d) through (f) apply to segments of the MA plan in the same way that those provisions apply to MA plans. Under the proposal, CMS would not contract with or renew a contract with a plan segment where the MA plan or segment is not a D-SNP and the enrollment thresholds in paragraph (d)(1) or (d)(2) are met. This proposal, to treat a segment of an MA plan as an MA plan, is consistent with CMS' annual review of MA plan bids and Medicare cost-sharing, in which each MA plan segment submits a separate bid pricing tool and plan benefit package (PBP) like an unsegmented MA plan and CMS separately evaluates these submissions for compliance with MA requirements.
As discussed in the June 2020 final rule, CMS implements the contracting prohibition in § 422.514 at the plan level. Where an MA plan is one of several offered under a single MA contract and the MA organization does not voluntarily non-renew the D-SNP look-alike, CMS will sever the D-SNP look-alike from the overall contract using its authority under § 422.503(e) to sever a specific MA plan from a contract and terminate the deemed contract for the look-alike plan (85 FR 33812). However, CMS does not currently have clear regulatory authority to sever a
We identified a second loophole during our analysis of contract year 2023 MA plan bids to identify any new MA plans that meet the contract limitation at § 422.514(d)(1). An existing (that is, renewing) MA plan that did not meet the criteria in § 422.514(d)(2) (using January 2022 MMR data as provided in paragraph (e)(3)) projected in its contract year 2023 bid that the MA plan would have 80 percent or higher enrollment of dually eligible individuals in 2023. Because this MA plan is not a new MA plan for contract year 2023, the contract prohibition in § 422.514(d)(1) did not apply. To prevent similar situations in the future, we proposed to amend § 422.514(d)(1) to apply it to both new and existing (that is, renewing) MA plans that are not D-SNPs and submit bids with projected enrollment of 80 percent or more enrollees of the plan's total enrollment that are dually eligible for Medicare and Medicaid. We proposed to revise paragraph (d)(1) to provide that CMS does not enter into or renew an MA contract for plan year 2024 and subsequent years when the criteria in paragraphs (d)(1)(i) and (ii) are met. We proposed to begin this prohibition with 2024 because we expect that 2024 will be the first plan year after the final rule adopting this proposal. Pending finalization of this proposal, § 422.514(d)(1) will continue to prohibit contracts with new MA plans that meet the criteria. We noted in the proposed rule at 87 FR 79466 that the earliest our proposed revision to expand the scope of § 422.514(d)(1) could apply is 2024.
Finally, we proposed an amendment to § 422.510(a)(4), which outlined the bases for termination of an MA contract. Specifically, we proposed to add language at § 422.510(a)(4) to add a new paragraph (a)(4)(xvi) that permits CMS to terminate an MA contract when the MA organization meets the criteria in § 422.514(d)(1) or (d)(2). This proposed amendment is consistent with how § 422.514(d) provides that CMS will not enter into or renew an MA contract in certain circumstances. In our view, § 422.514(d) is sufficient authority for the non-renewal, that is termination, of MA contracts when § 422.514(d) applies. However, we believe that adopting a specific provision in § 422.510(a)(4) will avoid any inadvertent ambiguity on this topic and make it clear that the procedures outlined in § 422.510, including notices, timeframes, and appeal rights, apply when CMS does not renew an MA contract based on application of § 422.514(d).
We received the following comments, and our responses follow.
Some of these commenters emphasized their overall support for CMS' proposals and general approach to limiting D-SNP look-alikes, noting that D-SNP look-alikes detract from plans that integrate Medicare and Medicaid benefits. MACPAC stated that it views D-SNP look-alikes as acting at cross purposes to State and Federal efforts to integrate care by drawing dually eligible individuals away from integrated products and avoiding the additional requirements for D-SNPs. MedPAC indicated that D-SNP look-alikes undermine efforts to develop integrated plans for dually eligible individuals by encouraging them to enroll instead in plans that provide many of the same extra benefits as D-SNPs but do nothing to integrate Medicaid coverage. A commenter stated that dually eligible individuals are better served in integrated plans, and thus, in areas with highly integrated dual eligible special needs plans (HIDE SNPs) or fully integrated dual eligible special needs plans (FIDE SNPs), they should have a choice among these available integrated modalities rather than D-SNP look-alikes. A commenter supported CMS' proposals as an important step to advance Medicare-Medicaid integration. A few commenters supported the proposals noting that D-SNP look-alikes create unnecessary competition for integrated products without meeting any requirements to work with States to integrate or coordinate Medicaid services, have specific models of care approved by the National Committee on Quality Assurance, or incorporate additional SNP quality measures designed for complex needs populations.
Several commenters supported CMS efforts to close unforeseen loopholes that have allowed D-SNP look-alikes to persist. A commenter appreciated CMS' efforts, citing the integrity of D-SNPs is critical since their membership consists of people with disabilities of all ages.
A commenter expressed concern that CMS' current policy for calculating the 80 percent threshold may fail to maximize advances in health equity, as partial-benefit dually eligible individuals who are harmed are more likely than the overall Medicare population to be Black or Hispanic/Latino, under age 65, experience isolation and food insecurity, have a mental illness, and have a multiple chronic condition diagnosis. This commenter further stated that MA plans have the ability to offer unique, targeted benefits that are tailored to low-income populations (for example, groceries, health meals, transportation, and over-the-counter benefits) that directly address social determinants of health and drive higher quality and believed that, where plans are forced to offer less targeted benefits to avoid triggering the 80 percent threshold, partial-benefit dually eligible individuals are harmed. This commenter noted that at least eight States currently prohibit partial-benefit dually eligible individuals from enrolling in D-SNPs. Without a solution, according to the commenter, plans in these States will need to take benefits and resources away from this complex low-income population to instead use them to reduce Part D cost-sharing to attract enough non-dually eligible enrollees to avoid the 80 percent threshold.
A few commenters emphasized the value of allowing partial-benefit dually eligible individuals to enroll into D-SNPs. These commenters stated that D-SNPs provide supplemental benefits and care coordination provided through individualized care plans. A commenter noted that although partial-benefit dually eligible individuals are ineligible for most Medicaid services, these individuals have similar clinical, functional, and social needs as full-benefit dually eligible individuals and can benefit from access to stronger care management models available in D-SNPs. Recognizing that States decide whether or not to allow D-SNPs to enroll partial-benefit dually eligible individuals, a commenter recommended that CMS exclude these individuals from the calculation of the 80 percent threshold.
A commenter suggested that CMS consider alternative approaches, such as working with Congress to require States that limit D-SNP enrollment to full-benefit dually eligible individuals to, in turn, require their D-SNPs to have a separate PBP for partial-benefit dually eligible individuals, as Pennsylvania and Virginia have already done.
A commenter stated that excluding partial-benefit dually eligible individuals from the 80 percent threshold calculation would allow CMS to enforce D-SNP look-alike contracting restrictions in States where dually eligible individuals have D-SNPs they can move to, while not penalizing States that have not yet adopted the D-SNP model for all partial- and full-benefit dually eligible individuals.
We believe the commenter noting that limitations on D-SNPs enrolling only full-benefit dually eligible individuals would apply to all States with FIDE SNPs in 2025 is referencing an amendment we made to the FIDE SNP definition in the Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, which appeared in the
The recommendation to extend the contracting limitations at 422.514(d) to C-SNPs and I-SNPs is outside of the scope of our proposed amendments. We stated in the February 2020 proposed rule (85 FR 9021) and June 2020 final rule (85 FR 33813) that we proposed applying the requirement at § 422.514(d) only to non-SNP plans to allow for the predominant dually eligible enrollment that characterizes D-SNPs, I-SNPs, and some C-SNPs by virtue of the populations that the statute expressly permits each type of SNP to exclusively enroll. At this time, we are not aware of any non-SNP MA plans with features similar to C-SNPs and I-SNPs that do not meet the C-SNP or I-SNP requirements. Nonetheless, we will monitor evolution in enrollment patterns.
Where an MA plan is one of several offered under a single MA contract and the MA organization does not voluntarily non-renew the D-SNP look-alike, CMS will sever the D-SNP look-alike from the overall contract using its authority under § 422.503(e) to sever a specific MA plan from a contract, and then terminate the deemed contract for the D-SNP look-alike. The other, non-D-SNP look-alike plans offered under the original contract would not be terminated. This action, in effect, allows CMS to renew only the portion of the contract that does not include the D-SNP look-alike. In this final rule, we are finalizing an amendment to § 422.503(e) to allow for CMS to sever a segment from an MA plan and allow the remaining non-D-SNP look-alike segments of that MA plan to continue along with any other non-D-SNP look-alike plans offered under the same contract.
Further, MA plans and MA plan segments that meet the criteria at § 422.514(d)(2) will have the opportunity to transition enrollees from a D-SNP look-alike per § 422.514(e). The transition authority at § 422.514(e) only permits transitioning the enrollment from the D-SNP look-alike plan or segment, that is, MA plans or segments that meet contracting limitation requirements at § 422.514(d)(2). The transition authority at § 422.514(e) does not apply to non-SNP MA plans with less than 80 percent dually eligible enrollees; a permissible crosswalk may be available depending on the circumstances. The comments about permitting transition of enrollees from plans at risk of reaching the 80 percent threshold and allowing a correction action period before termination of the MA plan meeting § 422.514(d) are out of scope for this rulemaking; we believe that policymaking on this issue would benefit from further study and engagement with interested parties. We will consider these comments for future rulemaking.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing revisions to §§ 422.503(e), 422.504(a)(19), 422.510(a)(4), and 422.514(g) as proposed.
Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) established a Part D—Voluntary Prescription Drug Benefit program for Medicare-eligible individuals. The MMA added section 1860D-1(b)(3)(C) of the Act, which authorized the Secretary to establish Part D special enrollment periods (SEP) for Medicare-eligible individuals to enroll in a Part D plan based on exceptional conditions—that is, an individual may elect a plan or change his or her current plan election when the individual meets an exceptional condition as determined by the Secretary.
In 2020, we codified a number of exceptional condition SEPs, including the SEP for Individuals Who Enroll in Part B During the Part B General Enrollment Period (GEP) (85 FR 33909). This SEP, as codified at § 423.38(c)(16), allowed individuals who are not entitled to premium-free Part A and who enroll in Part B during the GEP for Part B (January-March) to enroll in a Part D plan. This SEP begins April 1st and ends June 30th, with a Part D plan enrollment effective date of July 1st. This SEP effective date aligns with the
Prior to January 1, 2023, when an individual enrolled in Part B during the GEP, their Part B enrollment entitlement date was July 1st, regardless of when during the GEP they enrolled. Division CC, title I, subtitle B, section 120 of the Consolidated Appropriations Act, 2021 (CAA) Public Law 116-260 modified section 1838(a)(2) of the Act, to address the beginning of the entitlement for individuals enrolling during their GEP pursuant to section 1837(e) of the Act. As added by the CAA, section 1838(a)(2)(D)(ii) of the Act requires that, for an individual who enrolls in Part B during the GEP on or after January 1, 2023, entitlement begins the first day of the month following the month in which the individual enrolled. For example, if an individual enrolls in Part B in February 2023 (during the GEP), their Part B coverage will begin on March 1st.
Based on Medicare enrollment statutory changes made by the CAA described previously, we proposed to modify § 423.38(c)(16) to provide that on or after January 1, 2023, an individual who is not entitled to premium-free Part A and who enrolls in Part B during the GEP is eligible to use the SEP for Individuals Who Enroll in Part B During the Part B GEP to request enrollment in a Part D plan, and that this SEP will begin when the individual submits the application for Part B, and will continue for the first 2 months of enrollment in Part B. Further, we proposed to modify § 438.38(c)(16) to provide that where an individual uses this Part D SEP to request enrollment in a Part D plan, the Part D plan enrollment would be effective the first of the month following the month the Part D plan sponsor receives the enrollment request.
These proposed revisions are needed to align the timeframe for use of this Part D SEP based on new Part B GEP enrollment effective date parameters.
Because an individual may elect a Part D plan only during an election period, Medicare Part D sponsors already have procedures in place to determine the election period(s) for which an applicant is eligible. Finalizing this SEP will not add to existing enrollment processes, so we believe any burden associated with this aspect of enrollment processing would remain unchanged from the current practice and will not impose any new requirements or burden.
All information impacts of this provision have already been accounted for under OMB control number 0938-1378 (CMS-10718). We do not believe finalizing this SEP will adversely affect individuals requesting enrollment in Medicare plans, the plans themselves, or their current enrollees. Similarly, we do not believe finalizing this SEP will have any impact to the Medicare Trust Funds.
We received a number of comments on this proposal—those comments and our responses follow.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the SEP for Individuals Who Enroll in Part B During the Part B GEP to request enrollment in a Part D plan at § 423.38(c)(16) without modification.
Section 1851(e)(4)(D) of the Act authorizes the Secretary to create special enrollment periods (SEPs) for an individual to disenroll from an MA plan or elect another MA plan if the individual meets an exceptional condition provided by the Secretary. This authority was originally codified at § 422.62(b)(4) in the June 1998 interim final rule as a general SEP for CMS to apply on an ad hoc basis. (63 FR 35073)
As noted previously, section 1860D-1(b)(3)(C) of the Act authorizes the Secretary to establish Part D SEPs for Medicare-eligible individuals to enroll in a Part D plan if they meet certain exceptional conditions. This authority was originally codified at § 423.38(c)(8)(ii) (70 FR 4529). The MMA also added section 1860D-1(b)(1)(B) of the Act which provides that in adopting the Part D enrollment process, the Secretary “shall use rules similar to (and coordinated with) the rules for enrollment, disenrollment, termination, and change of enrollment with an MA-PD plan under the following provisions of section 1851.”
As required by section 1851(a)(3) of the Act (for the MA program) and section 1860D-1(a)(3)(A) of the Act (for the Part D program) and described in §§ 422.50(a)(1) and 423.30(a)(1)(i), eligibility for MA or Part D plan enrollment requires that an individual first have Medicare Parts A and B for MA eligibility and either Part A or B for
Based on Medicare enrollment changes made by the CAA described previously, we proposed to add corresponding exceptional condition SEPs for MA and Part D enrollment, as authorized under sections 1851(e)(4)(D) and 1860D-1(b)(3)(C) of the Act, to align with the new Medicare premium—Part A and B exceptional condition SEPs that CMS has finalized in 42 CFR 406.27 and 407.23.
We proposed at § 422.62(b) to redesignate current paragraphs (26) as (27) and add a new paragraph (26) to provide an SEP for individuals to enroll in a MA plan or MA plan that includes Part D benefits (MA-PD plan), when they use a Medicare exceptional condition SEP to enroll in premium Part A and/or Part B. We also proposed at § 423.38(c) to redesignate current paragraph (34) as (35) and add new paragraph (34) to provide an SEP for individuals to enroll in a stand-alone Part D prescription drug plan (PDP) when they use a Medicare exceptional condition SEP to enroll in premium Part A or Part B.
The proposed new MA SEP would begin when the individual submits the application for premium Part A and Part B, or only Part B, and would continue for the first 2 months of enrollment in Part A (premium or premium-free) and Part B. Similarly, the proposed new Part D SEP would begin when the individual submits their premium-Part A or Part B application and would continue for the first 2 months of enrollment in premium Part A or Part B. The MA or Part D plan enrollment would be effective the first of the month following the month the MA or Part D plan receives the enrollment request.
Because an individual may elect an MA or Part D plan only during an election period and when eligible, MA organizations and Part D sponsors already have procedures in place to determine the election period(s) for which an applicant is eligible. Finalizing these coordinating SEPs will not add to existing enrollment processes, so we believe any burden associated with this aspect of enrollment processing will remain unchanged from the current practice, and will not impose any new requirements or burden.
Consequently, finalizing these SEPs will not have added impact. All burden impacts of these provisions have already been accounted for under OMB control number 0938-1378 (CMS-10718). We do not believe finalizing these SEPs will adversely impact individuals requesting enrollment in Medicare plans, the plans themselves, or their current enrollees. Similarly, we do not believe the finalized SEPs will have any impact to the Medicare Trust Funds.
We received a number of comments on this proposal—those comments and our responses follow.
• For MA enrollment, the SEP begins when the individual, using an exceptional condition SEP, submits their application for—
++ Premium—Part A and Part B; or
++ Part B only, if the individual is already entitled to Part A, (or enrolls in premium-free Part A within the timeframe for use of this SEP).
• For Part D enrollment, the SEP begins when the individual, using an exceptional condition SEP, submits their premium—Part A or Part B application.
We note that the timeframe for use of both of these SEPs extends two months beyond the premium—Part A and/or Part B entitlement date, which will be visible to plans.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing, the MA SEP at §§ 422.62(b)(26) with a minor edit to the regulation text to clarify that this SEP applies to an individual submitting an application for Part B only if they are already entitled to Part A, or are enrolling in premium-free Part A within the timeframe of this SEP. We are finalizing the Part D enrollment SEP at 423.38(c)(34) as proposed without modification.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) established the Medicare Part D prescription drug benefit, which became effective on January 1, 2006. Prior to 2006, beneficiaries who were eligible for both Medicaid and Medicare (dually eligible) received prescription drug benefits through Medicaid. When the MMA went into effect, dually eligible beneficiaries began receiving their prescription drug benefits through Medicare Part D.
From the beginning of Part D, CMS recognized the need to provide both immediate and retroactive coverage for full-benefit dually eligible (FBDE) beneficiaries who were newly identified by either CMS or a State. Prior to 2010, CMS automatically enrolled newly identified beneficiaries eligible for the Part D low-income subsidy (LIS) into a Part D plan with a premium at or below the low-income benchmark (“benchmark” plans), which have no or reduced premiums for LIS-eligible beneficiaries. Each benchmark plan receiving these beneficiaries was required to grant retroactive coverage to the beginning of a beneficiary's LIS-eligible status or their last uncovered month, whichever date was later. At the time, there were around 300 Part D benchmark plans, and each needed to develop the capacity to provide transitional and retroactive coverage for these beneficiaries. Conducting retroactive claims adjudication and providing point-of-sale coverage was not efficient for Part D sponsors and accordingly, in 2010, CMS established the Medicare Part D Demonstration for Retroactive and Point of Sale Coverage for Certain Low-Income Beneficiaries, also known as Medicare's Limited Income Newly Eligible Transition (LI NET) demonstration. The LI NET demonstration consolidates administration of transitional and retroactive Part D coverage for eligible beneficiaries to a single Part D sponsor.
Part D coverage under the LI NET demonstration differs from coverage under traditional Part D plans in that the LI NET demonstration provides point-of-sale coverage for beneficiaries who demonstrate an immediate need for prescriptions, and also provides retroactive and/or temporary coverage for beneficiaries determined to be eligible, or likely to be eligible, for the Part D LIS by the Social Security Administration (SSA) or a State. The LI NET demonstration provides temporary, transitional Part D prescription drug coverage for LIS-eligible beneficiaries, including beneficiaries who are eligible for the Part D LIS but who are not yet enrolled in a Part D drug plan, or are enrolled in a plan but for whom coverage has not yet taken effect.
The purposes of the demonstration are to provide the following:
• More efficient prescription drug coverage and claims reimbursement for newly eligible low-income beneficiaries, including periods of retroactive eligibility;
• More efficient prescription drug coverage and claims reimbursement for individuals who are not enrolled in a PDP and whose LIS status is not yet established in CMS' systems, but who arrive at a pharmacy with an immediate need for their prescription. This may occur, for instance, when a State has determined that a beneficiary is eligible for Medicaid but that information does not yet appear in CMS' systems;
• A seamless transition for LIS-eligible beneficiaries from LI NET into a qualifying PDP with basic prescription drug coverage absent a beneficiary's choice otherwise; and
• More efficient prescription drug coverage and claims reimbursement for LIS-eligible beneficiaries who are losing existing coverage in a PDP. For example, a beneficiary could be terminated for moving out of the service area of their current PDP. The beneficiary would be automatically enrolled into LI NET for that month and the following month, with enrollment into a qualifying PDP with basic prescription drug coverage that would become effective at the end of the LI NET enrollment absent the beneficiary's choice otherwise.
Division CC, title I, subtitle B, section 118 of the Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260) modified section 1860D-14 of the Act by redesignating subsection (e) of section 1860D-14 as subsection (f) and by establishing a new subsection (e) Limited Income Newly Eligible Transition Program. New subsection (e)(1) requires the Secretary to “carry out a program to provide transitional coverage for covered Part D drugs for LI NET eligible individuals . . .” no later than January 1, 2024. This directive in section 118 of the CAA makes LI NET a permanent program within Part D, beginning in 2024.
The proposed rulemaking to establish the LI NET program is consistent with President Biden's Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (January 20, 2021) and Executive Order 14085 on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government (December 13, 2021). LI NET ensures that low-income beneficiaries transitioning from Medicaid to Medicare do not experience a gap in coverage for their prescription medications. Executive Order 14085 calls for the Federal Government to design and deliver services with “a focus on the actual experience of the people whom it is meant to serve” and “deliver services more equitably and effectively, especially for those who have been historically underserved.” We have designed the LI NET program with beneficiary needs foremost in mind, ensuring continuous drug coverage and access for eligible low-income individuals.
LI NET policies, infrastructure, and operations have evolved over the past 13 years to balance providing needed coverage with responsible stewardship of taxpayer dollars and efficiency in administering the program. The LI NET demonstration has proven successful in providing low-income individuals transitional Part D coverage. Approximately 8 million low-income individuals received the benefits of the LI NET program under the demonstration, with over 100,000 beneficiaries enrolled in LI NET in any given month. It has become a program that beneficiary advocacy groups rely on when supporting low-income individuals and connecting them with services. LI NET works directly with over a dozen advocacy groups and 51 State Health Insurance Assistance Programs (SHIPs), which collectively work with LIS beneficiaries to remove access barriers and provide health insurance counseling.
We believe the LI NET demonstration is a reliable, stable program that has been successful in providing transitional and retroactive Part D coverage to millions of beneficiaries. In developing our proposals for implementing the permanent LI NET program, we took into consideration our experience under the LI NET demonstration. Where appropriate, we discuss the policies and practices under the LI NET demonstration that informed our proposals for how to implement aspects of the LI NET program that are not directly specified by the statute.
We rely on the premise that Part D regulations apply to the LI NET program and to the LI NET sponsor as part of the Part D program and as a type of Part D sponsor, except for when the statute requires us to deviate or when existing regulations would not apply. For example, as discussed further in this final rule, because the LI NET sponsor is required to have an open formulary, existing Part D requirements on formulary development would not be applicable.
Our proposals to make LI NET a permanent program started with § 423.2500. In § 423.2500(a), we proposed the LI NET program would be based on section 1860D-14 of the Act. We proposed in § 423.2500(b) the scope of the LI NET program, which would begin no later than January 1, 2024. Under this program, eligible individuals would be provided transitional coverage for Part D drugs. Section § 423.2504 sets forth the LI NET eligibility and enrollment proposals and § 423.2508 proposed LI NET benefits and beneficiary protections. Next, we proposed in § 423.2512 the requirements to be an LI NET sponsor and § 423.2516 proposed how the Part D sponsor administering LI NET in partnership with CMS would be selected and the requirements set forth in the LI NET contract to provide services and coverage. In § 423.2518, we included a proposal for intermediate sanctions in the event of contract violations. In § 423.2520, we proposed how an LI NET contract would be non-renewed or terminated. In § 423.2524, we included our proposals for bidding and determining the LI NET payment rate. Finally, § 423.2536 enumerated the Part D requirements we proposed waiving for LI NET.
We proposed to align sunsetting the demonstration seamlessly with the start of the LI NET program under this section. Specifically, the LI NET demonstration will continue to operate until December 31, 2023, and the LI NET program would start to operate on January 1, 2024 according to the regulations that we finalize.
Section 1860D-14(e)(2) of the Act provides that an individual is eligible for LI NET coverage if they: (A) meet the requirements of section 1860D-14(a)(3)(A)(ii) and (iii) of the Act; and (B) have not yet enrolled in a prescription drug plan or an MA-PD plan, or, who have so enrolled, but with respect to whom coverage under such plan has not yet taken effect. This means that to be eligible, the individual would need to be a full-benefit dual-eligible individual or low-income subsidy (LIS) eligible individual as defined at § 423.773 and—
• Not yet be enrolled in a prescription drug plan or an MA-PD plan; or
• Be enrolled but their coverage has not yet taken effect.
Under these requirements, LI NET would be available to all categories of individuals who are LIS-eligible, including—
• Full Subsidy-Full Benefit Dually Eligible (FBDE) individuals, including institutionalized beneficiaries and beneficiaries receiving home and community-based services;
• Full Subsidy-Non-FBDE Individuals, including those who have applied or are eligible for QMB/SLMB/QI or SSI, with income and resource thresholds at or below the amounts set by CMS each year; and
• Partial Subsidy Individuals, including those who have applied and have income and resource amounts below the thresholds set by CMS each year.
We proposed to codify at Subpart Y the LI NET eligibility requirements set forth in section 1860D-14(e)(2) of the Act. We proposed to establish in paragraph (a) of new § 423.2504 two categories of individuals eligible to enroll in LI NET that encompass the previously noted categories of low-income individuals recognized by Part D. The first category, which we term “LIS-eligible” in proposed paragraph (a)(1), would be composed of individuals whose low-income status has been confirmed either through CMS's data in our system of record or because the individual can demonstrate their current or future low-income status. The second category, which we term “immediate need” in proposed paragraph (a)(2), would consist of individuals whose low-income status has not been confirmed, because CMS's data do not yet reflect the individual's low-income status, but the individual has indicated that they are eligible for the LIS.
We refer to the individuals in the category established in proposed paragraph (a)(2) as “immediate need” because they present at a pharmacy or to the LI NET sponsor in immediate need of a prescription and have no Part D coverage. Ideally, these beneficiaries would be able to show documentation of their pending LIS status, such as a letter received from the State showing the beneficiary's LIS status. However, we do not believe an absence of documentation in hand at the point-of-sale should be a barrier to entry to LI NET for immediate need individuals. This is because our experience in the demonstration is that 80 percent of immediate need individuals do have their eligibility confirmed,
We proposed in § 423.2504(a)(2) to grant immediate access to covered Part D drugs at the point-of-sale for individuals whose eligibility as defined at § 423.773 cannot be confirmed at the point-of-sale. We proposed to permit
• A copy of the beneficiary's Medicaid card that includes their name and eligibility date;
• A copy of a letter from the State or SSA showing LIS status;
• The date that a verification call was made to the State Medicaid agency, the name and telephone number of the State staff person who verified the Medicaid period, and the Medicaid eligibility dates confirmed on the call;
• A copy of a State document that confirms active Medicaid status;
• A screen-print from the State's Medicaid systems showing Medicaid status; or
• Evidence at point-of-sale of recent Medicaid billing and payment in the pharmacy's patient profile.
Under our proposal, if an immediate need individual's LIS status cannot be confirmed within a period of 2 months, that individual would not be automatically enrolled into a Part D plan. This is the same as current practice under the LI NET demonstration. We solicited comment on the proposal to align the 2 months of enrollment with the ability to fill prescriptions for these immediate need beneficiaries.
We proposed to permit immediate need beneficiaries whose eligibility cannot be confirmed to continue to fill prescriptions throughout their 2-month enrollment in LI NET. We believe this ensures access to LI NET benefits and is an administratively simple approach as compared with alternative ideas, such as the approach under the demonstration of keeping immediate need beneficiaries with uncertain eligibility enrolled in LI NET but unable to fill prescriptions. We proposed that if, by the end of an immediate need individual's enrollment in LI NET, neither CMS's systems nor the beneficiary's provision of documentation confirms low-income status, then that individual would not be auto-enrolled into a qualifying standalone Part D plan following their LI NET coverage.
Section 1860D-14(e) of the Act does not specify a process for enrollment into the LI NET program. Therefore, in forming our proposed enrollment process, we looked to the process used in the demonstration. Under the LI NET demonstration, there are four ways for eligible individuals to be enrolled into the demonstration. They are as follows:
• Automatic enrollment. Individuals who are LIS-eligible but do not yet have Part D coverage, and those individuals who have selected a Part D plan but whose enrollment has not taken effect, are enrolled by CMS into the LI NET demonstration unless the beneficiary has affirmatively declined enrollment in Part D.
• Point of sale enrollment. Immediate need individuals whose claims are submitted by the pharmacy at the point-of-sale and billed to LI NET are enrolled into the LI NET demonstration by the LI NET sponsor.
• Direct reimbursement request. Individuals who are LIS-eligible and who submit receipts for reimbursement for claims paid out of pocket are retroactively enrolled into the LI NET demonstration by the LI NET sponsor, with 36-month retroactive coverage for full dually eligible individuals and those who receive supplemental security income (SSI) benefits.
• LI NET application form. Beneficiaries who are not enrolled into LI NET through auto-enrollment, point-of-sale enrollment or via an approved direct reimbursement request may submit an application form to the LI NET sponsor with supporting documentation demonstrating their LIS status. The LI NET sponsor will periodically check for eligibility and enroll applicants once eligibility is confirmed.
The majority of LI NET beneficiaries are enrolled into the LI NET demonstration automatically by CMS; about 90 to 95 percent of LI NET beneficiaries are those we identify in our systems and enroll into the demonstration. To do this, CMS “sweeps” our data monthly to identify all beneficiaries who are—
• Eligible for LIS;
• Eligible for Part D;
• Not enrolled in a Part D plan or receiving the Retiree Drug Subsidy (RDS) or coverage through Veterans Affairs;
• Have not opted-out of Part D enrollment for any reason (for example, because they declined it);
• Not incarcerated, are lawfully present in the US, and do not live in another country; and
• Are not enrolled in a Part C plan that disallows concurrent enrollment in a Part D plan.
Beneficiaries identified in the monthly sweep are automatically enrolled into the LI NET demonstration for that month and the following month. CMS then prospectively enrolls the beneficiary into a traditional Part D plan, with coverage under that plan taking effect immediately after the LI NET coverage ends. This population of beneficiaries includes those who may be gaining Part D eligibility or LIS status but have not made an election into a Part D plan.
A smaller number of beneficiaries, about five to ten percent of LI NET beneficiaries, enroll in the LI NET demonstration outside of the sweeps process. Some enroll at the point-of-sale, as described previously. An even smaller number of beneficiaries contact the LI NET sponsor directly to enroll in the LI NET demonstration. Individuals can submit a request for reimbursement to the LI NET sponsor. If the person is LIS-eligible, the LI NET sponsor enrolls them into the LI NET demonstration and reimburses them for eligible out-of-pocket costs for the duration of their retroactive enrollment. As with an individual who is enrolled at the point-of-sale, the start date of LI NET enrollment would be the first of the month the request is received. There may be individuals who do not have an immediate need for medication and believe they are eligible for LI NET. These individuals can either bring documentation of LIS status to a pharmacy or fill out an application form, which allows the LI NET sponsor to periodically check their eligibility and enroll them into LI NET if they become eligible.
Consistent with the enrollment processes under the demonstration, we proposed in § 423.2504(b) to codify the ways in which individuals can be enrolled into LI NET: auto-enrollment, point-of-sale for immediate need individuals, direct reimbursement, and LI NET enrollment form.
In § 423.2504(b)(1), we proposed that individuals who are LIS-eligible and whose auto-enrollment into a Part D plan (as outlined in § 423.34(d)(1)) has not taken effect will be automatically enrolled by CMS into the LI NET program unless they have affirmatively declined enrollment in Part D per § 423.34(e). LIS-eligible beneficiaries who have made the decision to opt out of enrollment in Part D must take a proactive step to contact CMS for us to record that decision in our systems by placing a flag on the beneficiary's record. Beneficiaries may opt out of Part D enrollment if they have other insurance or do not want to participate as a matter of principle. We assume that a beneficiary who opts out of Part D enrollment would also want to opt out of transitional coverage under the LI NET program. Therefore, proposed § 423.2504(b)(1) provided that when a beneficiary affirmatively declines enrollment in Part D per § 423.34(e),
In defining “transitional coverage” for LI NET, the statute sets forth requirements for the duration of LI NET coverage under section 1860D-14(e)(3) of the Act. Section 1860D-14(e)(3)(A) establishes that “immediate access to covered part D drugs at the point of sale during the period that begins on the first day of the month such individual is determined to meet the requirements of clauses (ii) and (iii) of subsection (a)(3)(A) and ends on the date that coverage under a prescription drug plan or MA-PD plan takes effect with respect to such individual.” The starting point of enrollment into LI NET for these types of LIS-eligible beneficiaries, whether they are automatically enrolled or immediate need individuals, is required by statute but the duration of time they prospectively remain enrolled in LI NET is not specified. Under the demonstration, we typically cap non-retroactive coverage in LI NET to 2 months. Consistent with the statute and with our operations under the demonstration, in § 423.2504(c), we proposed that LI NET enrollment begins on the first day of the month an individual is identified as eligible under § 423.2504 and ends after 2 months.
Section 1860D-14(e)(3)(B) of the Act sets a limit on how far back retroactive LI NET coverage can extend. Full-benefit dually eligible individuals (as defined in section 1935(c)(6)) and recipients of supplemental security income (SSI) benefits under title XVI are eligible for up to 36 months of retroactive coverage. In proposed § 423.2504(c)(2), retroactive LI NET coverage would begin on the date an individual is identified as full-benefit dual or an SSI benefit recipient, or 36 months prior to the date such individual enrolls in (or opts out of) Part D coverage, whichever is later. This duration of time is similar to retroactive coverage under the demonstration, which provides for a maximum retroactive period of 36 months for Full Subsidy LIS eligible individuals.
We proposed in § 423.2504(d) that enrollment in LI NET would end on the date that coverage under Part D takes effect, consistent with section 1860D-14(e)(3) of the Act. In the case of immediate need beneficiaries for whom LIS-eligibility is not confirmed and who are not enrolled into a PDP, enrollment would end 2 months after the immediate need enrollment begins. No matter the method of enrollment, we proposed that the minimum duration of LI NET enrollment is 2 months unless the beneficiary elects to disenroll from LI NET or to enroll in a Part D plan. For example, an individual whom we auto-assign into LI NET starting April 1, 2024 would remain in LI NET for April and May 2024 before being enrolled into an appropriate Part D plan starting June 1, 2024.
We provided the following two examples to further explain how LI NET enrollment and disenrollment would work under our proposals:
As noted previously, our goal in the proposals is to match current eligibility and enrollment policy in effect in the demonstration and the Part D program, to the extent the statute permits. We requested comment on whether revised or additional regulations were needed to achieve accurate, streamlined, and beneficiary-friendly eligibility determinations and enrollment in the LI NET program.
Section 1860D-14(e)(4)(B)(i) of the Act requires the LI NET program to provide eligible beneficiaries with access to all Part D drugs under an open formulary. The statute, at clauses (ii) and (iii) of section 1860D-14(e)(4)(B) of the Act, also requires the LI NET program to permit all pharmacies that are determined by the Secretary to be in good standing to process claims under the program, and to be consistent with such requirements as the Secretary considers necessary to improve patient safety and ensure appropriate dispensing of medication. These requirements are consistent with how the LI NET demonstration has operated, and we proposed to codify the requirement that the LI NET program provide access to all Part D drugs under an open formulary in § 423.2508(a). We proposed in § 423.2508(b) to require the LI NET sponsor to permit all pharmacies that CMS determines to be in good standing to process claims under the program, whether or not the pharmacy is a network or out-of-network (OON) pharmacy for the LI NET sponsor. Under the demonstration, we consider a pharmacy, including retail, mail-order, and institutional pharmacies, to be “in good standing” when it is licensed and does not have a fraud, waste, or abuse determination against it. For the permanent LI NET program, we proposed that a pharmacy would be in good standing if it is licensed, has not been revoked from Medicare under § 424.535, does not appear on the Office of Inspector General's list of entities excluded from Federally funded health care programs pursuant to section 1128 of the Act and from Medicare under section 1156 of the Act (unless the OIG waives the exclusion, which the OIG has authority to do in certain specified circumstances), and does not appear on the preclusion list as defined in § 423.100. A pharmacy will appear on the preclusion list if it:
• Is currently revoked from Medicare, is under an active reenrollment bar, and CMS has determined that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program, including LI NET;
• Has engaged in behavior for which CMS could have revoked the entity to
• Has been convicted of a felony under Federal or State law within the previous 10 years that CMS deems detrimental to the best interests of the Medicare program, including LI NET.
In § 423.2508(c), we proposed requirements we consider necessary to improve patient safety and ensure appropriate dispensing of medication consistent with subpart D of the Part D regulations. Existing Part D requirements related to appropriate dispensing, patient safety, electronic dispensing, quality improvement organization (QIO) activities, compliance, and accreditation would improve patient safety and appropriate dispensing. Specifically, we proposed to apply the following provisions to the LI NET program and LI NET sponsor, as appropriate:
• § 423.153(b) and (c) for dispensing and point-of-sale safety edits.
• § 423.154 for appropriate dispensing of prescription drugs in long-term care facilities.
• § 423.159, requiring an electronic prescription drug program.
• § 423.160, excepting the requirements pertaining to formulary standards in § 423.160(b)(5), setting forth standards for electronic prescribing.
• § 423.162, for quality improvement organization (QIO) activities.
• § 423.165, regarding compliance deemed on the basis of accreditation.
We solicited comment on whether any of these provisions would not be compatible with the LI NET program as proposed.
Section 1860D-14(e)(4)(B)(iv) of the Act provides the Secretary the authority to establish requirements for the LI NET coverage provided to LI NET eligible individuals. As noted in the proposed rule, we drew upon our experience under the demonstration to develop our proposed cost sharing and appeals policies for LI NET, which we proposed to codify in § 423.2508(d) and (e), respectively.
We proposed in § 423.2508(d)(1) that LI NET beneficiaries under § 423.2504(a)(1) (that is, beneficiaries whose LIS-eligibility is established and who have not yet enrolled in a prescription drug plan or MA-PD plan, or who have enrolled in a prescription drug or MA-PD plan but coverage under such plan has not yet taken effect) would pay the applicable cost sharing for their low-income category as established in the yearly Announcement of Calendar Year Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Rate Announcement publication specified in § 422.312). Under the demonstration, LI NET beneficiaries pay the reduced cost-sharing aligned with the LIS categories defined in the Part D program. Because there is already the existing statutory requirement for CMS to update the parameters for the LIS benefit each year using statutory indexing methods, and because CMS and pharmacy systems are already set up to reflect the appropriate cost-sharing based on the LIS category of the individual, we believe it is reasonable to calculate and charge cost-sharing in alignment with the Part D LIS categories. For immediate need beneficiaries, we proposed in § 423.2508(d)(2) these individuals would by default pay the cost-sharing associated with the category of non-institutionalized FBDE individuals with incomes above 100 percent of the Federal poverty level and full-subsidy-non-FBDE individuals (that is, Category Code 1).
We proposed in § 423.2508(e) that LI NET enrollees have rights with respect to Part D grievances, coverage determinations, and appeals processes set out in subpart M of the Part D regulations. The established processes would adequately adjudicate LI NET beneficiary concerns. This approach of using existing processes avoids needing to devote resources to establishing separate processes for grievances, coverage determinations, and appeals processes. Furthermore, consistency with other Part D contracts with respect to grievances, coverage determinations, and appeals would be simplest for the LI NET sponsor.
Section 1860D-14(e)(4)(A) of the Act specifies that, as determined appropriate by the Secretary, the LI NET program is to be administered through a contract with a single administrator. Since the beginning of the demonstration, CMS has had one Part D sponsor serve as the sole contractor for administering LI NET. We have found that this approach supports our goal of administrative simplicity by making it unnecessary for each individual plan sponsor to check eligibility and conduct a retroactive enrollment/reimbursement process. In our experience, the benefits of having a single Part D sponsor administer LI NET include the following:
• Providing a single point of contact for beneficiaries and pharmacies attempting to have their claims paid.
• Providing a single point of contact for State Medicaid agencies submitting Medicaid eligibility and attempting to reconcile and coordinate claims.
• Simplifying the filing of retroactive beneficiary claims.
There may be circumstances in which CMS may want to consider contracting with more than one Part D sponsor to administer LI NET. Though we have had stability in LI NET in terms of only having a single LI NET sponsor for the duration of the demonstration, we recognize the need for some protections should it become necessary for another entity to take over as LI NET sponsor and assume responsibility for providing LI NET coverage. The downside of consolidating LI NET functions into a single sponsor is the potential for beneficiary impact should there be a reason that the single LI NET sponsor no longer continues its functions. We believe that this potential for beneficiary impact is mitigated by our proposals to non-renew or terminate the LI NET contract per proposed § 423.2520. Accordingly, while we proposed at new § 423.2512 that the program will be operated by “one or more” Part D sponsors, we intend to initially continue with the current practice of operating the program through a single sponsor because we determined the benefits outweigh potential beneficiary impacts, which have not come to bear since the start of the demonstration in 2010.
We proposed to establish at § 423.2512 the requirements the LI NET sponsor must meet when administering the LI NET program:
• Because LI NET may enroll beneficiaries from across the nation, we proposed to specify at § 423.2512(a)(1) that the LI NET sponsor would be selected from among the Part D sponsors
• We find that some experience as a Part D sponsor should be a pre-requisite for being the LI NET sponsor, and proposed at § 423.2512(b) that any candidates to be the LI NET sponsor have a minimum of 2 consecutive years contracting with CMS as a Part D sponsor.
• We proposed at § 423.2512(c) some technical and operational requirements of the LI NET sponsor. In § 423.2512(c)(1) and (c)(2) we proposed that the LI NET sponsor have the technical capability and the infrastructure to provide immediate, current, and retroactive coverage for LI NET enrollees and the technical capability to develop the infrastructure necessary for verifying Medicaid dual eligibility status for presumed eligible LI NET enrollees. In § 423.2512(c)(3), we proposed requiring the LI NET sponsor to identify, develop, and implement outreach plans in consultation with CMS targeting key stakeholders to inform them about the LI NET program. Under the demonstration, CMS enrolls over 90 percent of LI NET beneficiaries into the LI NET plan and we expect CMS would continue to be responsible for most enrollments in a permanent LI NET program. For the beneficiaries who are not auto-enrolled, outreach is important so that stakeholders like the states, SHIPs, and pharmacies have awareness and knowledge about the LI NET program. Under the demonstration, the LI NET sponsor routinely conducts outreach in consultation with CMS to inform stakeholders about the program. We proposed to adopt this approach for the permanent LI NET program.
As discussed further in this section of this rule, we proposed to waive requirements under §§ 423.128(d)(2)(ii), 423.128(d)(2)(iii), and 423.128(d)(4). We also proposed in § 423.2512(c)(4) that the LI NET sponsor be required to establish and manage a toll-free customer service telephone line and fax line that can be accessed by pharmacy providers and beneficiaries, or others acting on their behalf, for purposes that include but are not limited to: handling inquiries about services under the LI NET program, providing the status of eligibility or claims, and having the ability to accept documentation for evidence of eligibility.
Reimbursement to beneficiaries with retroactive coverage is provided for in section 1860D-14(e)(3)(B) of the Act, as the “amounts that would have been paid under this Part had such individual been enrolled in a prescription drug plan or MA-PD plan.” Implementing this statutory provision entails establishing a process for beneficiaries to request and receive such reimbursement. In the demonstration, we provide a means for beneficiaries who receive retroactive coverage to submit a direct member out-of-pocket reimbursement request for Part D covered drugs for any past month(s) in which they were entitled to retroactive coverage under LI NET. The LI NET sponsor provides reimbursement to eligible beneficiaries based on the submitted cost minus any applicable copayments. Once the LI NET sponsor receives a written reimbursement request, they follow timeframes that are consistent with the timeframes that apply when a Part D sponsor authorizes payment for a benefit due to a reversal in its coverage determination (see § 423.636(a)(2)). That is, under the demonstration, the LI NET sponsor has 14 calendar days to reply with whether the claim is eligible for reimbursement, including the reason for denying the request if applicable. If the request for reimbursement is granted, the LI NET sponsor issues the reimbursement no later than 30 days after it determines the claim is eligible for reimbursement. As these timeframes have proved workable under the demonstration, we proposed in § 423.2512(c)(5) that the LI NET sponsor meet these deadlines related to direct reimbursement in the permanent LI NET program.
In § 423.2512(c)(6), we proposed requiring the LI NET sponsor to adjudicate claims from OON pharmacies according to the LI NET sponsor's standard reimbursement for its network pharmacies. As the LI NET sponsor must provide access to all Part D drugs under an open formulary, we believe there is the need for some protection against unreasonably high drug costs for OON claims in LI NET. Other Part D sponsors have the option to deny such claims, or to pay OON claims according to their standard reimbursement for their network pharmacies (with beneficiaries paying any difference between the cost of the OON claim and the negotiated price). Because this restraint on unreasonable drug costs borne by the Medicare Trust Funds would not otherwise be present for LI NET, we believe a limit on how much the LI NET sponsor can be reimbursed for OON claims is needed.
Section 1860D-14(e)(6) of the Act authorizes us to implement LI NET without regard to laws relating to the making, performance, amendment, or modification of contracts of the United States as we may determine to be inconsistent with the furtherance of the purpose of Title XVIII. Thus, CMS is not required to follow the Federal Acquisition Regulation (FAR) or the contracting authority used under the Part D program. Neither is CMS required to contract with every qualified plan sponsor to provide LI NET Part D coverage, as we are required to do for qualified plan sponsors providing non-LI NET Part D coverage. If we followed the same approach for LI NET, we could have many points of contact for beneficiaries and pharmacies attempting to have their retroactive claims paid and multiple points of contact for State Medicaid agencies submitting Medicaid eligibility and attempting to reconcile and coordinate claims. This approach would not serve the purpose of providing smooth, transitional coverage for Part D drugs for LI NET eligible individuals through the LI NET program, which is a Part D program under Medicare in Title XVIII.
Using the authority in section 1860D-14(e)(6) of the Act, we proposed to follow the contracting approach set forth in proposed § 423.2516 to select the LI NET sponsor for the 2024 plan year and onwards.
In § 423.2516(a), we proposed that CMS would appoint a Part D sponsor that meets the requirements at § 423.2512 to serve as the LI NET sponsor. To determine this appointment, we proposed that CMS may choose to conduct discussions with potentially eligible entities to establish mutual interest and ability to administer the program. This circumstance could arise if, for example, CMS needs additional information in any particular year to learn more about a Part D sponsor's ability to administer the LI NET program. Under the demonstration, there is a multi-year contract approved by the Office of Management and Budget, and each year CMS and the LI NET sponsor have executed an addendum to the contract that included such information as the payment rates and risk corridors as determined in the final bid. As we consider options for establishing regulations to implement the permanent LI NET program, we find it is appropriate that we bring the LI
• Experience covering low-income beneficiaries, including but not limited to enrolling and providing coverage to low-income subsidy individuals as defined in § 423.34;
• Pharmacy access as outlined in § 423.120;
• Past performance consistent with § 423.503(b), including Star Ratings (as detailed in § 423.186), and previous intermediate sanctions (as detailed in § 423.750); and
• Ability to meet the requirements listed in § 423.505 that are not waived under § 423.2536.
As noted in the proposed rule and consistent with our general approach of applying Part D requirements to the LI NET program unless waived, we stated our intention for § 423.505 to apply to LI NET with the exception of § 423.505(k)(6), which we proposed to waive in § 423.2536(g). For example, the contract between the LI NET sponsor and CMS would be required to contain provisions in which the LI NET sponsor agrees to accept new enrollments, make enrollments effective, process voluntary disenrollments, and limit involuntary disenrollments (see § 423.505(a) and (b)(2)). As another example, consistent with § 423.505(b)(22), the LI NET contract would be required to include a provision in which the LI NET sponsor agrees to use the CMS complaint tracking system to address and resolve complaints received by CMS against the sponsor. Per § 423.505(k), the LI NET contract would also require the LI NET sponsor to submit certifications of data that determine payment as applicable, such as for enrollment and payment information, claims data, bid submission information, DIR data, and overpayments. The only certification the LI NET sponsor would not submit is the one pertaining to data for price comparison under § 423.505(k)(6); we believe this certification is unnecessary given that the LI NET plan is not one for which beneficiaries shop and thus would not be comparing against other plan options based on price considerations. We intend to exclude LI NET from Medicare Plan Finder, consistent with past practice under the demonstration. Therefore, it would not make sense to require certification to data for price comparison purposes, and we proposed to waive this requirement in § 423.2536(g).
In § 423.2516(c), we proposed that the term of the LI NET sponsor's appointment would be ongoing provided mutual agreement between CMS and the selected party, subject to an annual contracting and bid process (per proposed § 423.2524(c)) to determine payment rates for the upcoming year. As explained in the proposed rule, this approach has worked well during the demonstration, and we saw no reason to adopt a different approach for the permanent program.
We proposed to establish in § 423.2518 that, if the LI NET sponsor violates its contract, CMS would have the authority to impose intermediate sanctions as outlined in subpart O of the Part D regulations, just as we would for any other Part D sponsor.
In § 423.2520(a) we proposed that if the LI NET sponsor decides for any reason to non-renew its existing LI NET contract, it must notify CMS by January 1 of the year before the next contract year. Except as provided in paragraph (c) of this section, if CMS decides for any reason to non-renew the existing contract with the incumbent LI NET sponsor, CMS would notify the LI NET sponsor by January 1 of the year before the next contract year. We proposed that CMS could non-renew for any reason, without cause, and the LI NET sponsor would not have a right to appeal the non-renewal. To provide CMS the authority to non-renew the LI NET contract with that particular sponsor for any reason with no appeal, we proposed in § 423.2536(e) waiving the appeals requirements in Subpart N except for those relevant to a contract termination. As there has only been a single LI NET sponsor for the duration of the demonstration, and we are anticipating a single LI NET sponsor for the permanent LI NET program, we do not want to assume the risk of the appeals process not providing finality by the time an LI NET sponsor would need to begin preparing the LI NET bid. Even if we required the appeals process to be complete by the April timeframe and while the appeal was pending moved forward with selection process, we would be cutting into or needing to forgo entirely the transition time of 3 months we proposed in § 423.2520(b) to ensure seamless transition of the LI NET program. Proposing to assume these risks would not further the purpose of the LI NET program being ready and available to provide immediate, current, and retroactive coverage for LI NET enrollees. We note that non-renewal, whether at the election of CMS or the LI NET sponsor, would not have an impact on the sponsor's eligibility to be selected as the LI NET sponsor in future years. We intend to initially contract with a single Part D sponsor to administer the LI NET program. Unlike beneficiaries in traditional Part D plans, beneficiaries enrolled in LI NET would not have the option of simply choosing to enroll in LI NET under a different sponsor. For these reasons, ample notice is needed if the LI NET sponsor does not intend to continue as the LI NET sponsor in the following year. We anticipate that CMS would be able to provide the same amount of notice to the LI NET sponsor if we were contemplating changing the LI NET sponsor for the following year. A decision to non-renew the LI NET contract with a particular Part D sponsor would not bar or prohibit that sponsor from being considered to be the LI NET sponsor in a future year. Any CMS decisions regarding LI NET sponsor selection would have no bearing on a Part D sponsor proceeding with the application process for other, non-LI NET, Medicare prescription drug plans.
In § 423.2520(b), we proposed that after a notice of non-renewal, CMS would select a successor LI NET sponsor from among the other eligible entities (as detailed in proposed § 423.2516). Similar to how our multi-year contracts with our contractors require an outgoing contractor to coordinate with any successor contractor during a transition period, proposed § 423.2520(b) would require the outgoing LI NET sponsor to coordinate with the successor LI NET sponsor appointed by CMS for a period of no less than 3 months to ensure seamless transition for LI NET enrollees, including timely transfer of any data or files. All data, files, written materials, and LI NET work products would be considered CMS's property. During the transition period, the outgoing and incoming LI NET sponsors would work together to develop a transition plan, including setting up a training schedule and a schedule of events for a smooth changeover.
There may be exigent circumstances of risk to beneficiaries in which a more immediate termination is warranted. Referencing portions of CMS's immediate termination authority in § 423.509, we proposed to establish in
• CMS determinates that a delay in termination, resulting from non-compliance with the procedures provided in this Part prior to termination, would pose an imminent and serious risk to the health of the individuals enrolled with the LI NET sponsor, per § 423.509(b)(2)(i)(A);
• The LI NET sponsor has experienced financial difficulties so severe that its ability to make necessary health services available is impaired to the point of posing an imminent and serious risk to beneficiary health, or otherwise fails to make services available to the extent that such a risk to health exists per § 423.509(b)(2)(i)(B); or
• The LI NET sponsor has had one or more of the issues enumerated in paragraphs (a)(4)(i) and (xii) of § 423.509.
Proposed § 423.2520(d) would provide that if CMS intends to terminate the contract under proposed § 423.2520(c), CMS provides written notice to the LI NET sponsor informing it of its termination appeal rights in accordance with subpart N of this Part.
We expect to identify the LI NET contract as X0001 and to advance the plan benefit package number by one each year so that we can update the payment rates in our systems for the new payment year. If the LI NET contract with a particular LI NET sponsor is terminated, we would not discontinue use of the contract number X0001. Instead, we would terminate the relationship with that specific LI NET sponsor to provide LI NET coverage and continue to allow enrollment under contract X0001.
Section 1860D-14(e) of the Act does not specify how CMS is to determine the amounts that it pays to the LI NET sponsor under the contract or how payments are to be made. We proposed to establish the methodology and formulas that we would use to determine the amounts we pay to the LI NET sponsor under the contract. As noted in the proposed rule, we use our payment policies under the demonstration, including the bidding requirements, as the basis for the proposed payment policies for the LI NET program.
We proposed in § 423.2524(a) that CMS payments for the LI NET program would be made from the Medicare Prescription Drug Account, as payments are made to other Part D sponsors.
In § 423.2524(b) we proposed requirements related to the LI NET bid. Because most of the provisions in Subpart F would not be applicable to LI NET, we proposed to waive Subpart F except for those provisions we proposed to apply to LI NET.
Section 423.2524(b)(1) proposed that the submission of LI NET bids and related information will follow the requirements and limitations in Part 423, Subpart F, § 423.265(b), (c), (d)(1), (d)(2)(i), (d)(2)(ii), (d)(2)(iv), (d)(2)(v), (d)(4), (d)(6), and (e). This proposal would require the LI NET sponsor to submit a bid and supplemental information in a format specified by CMS, with the same deadline as other Part D bids of no later than the first Monday of June each year. It also gives CMS the ability to request additional information from the LI NET sponsor to support bid amounts, and the ability to require revisions to the submitted LI NET bid before it is accepted. As with other Part D bids, a qualified actuary, whether internal or external to the plan sponsor, would certify the LI NET sponsor's actuarial valuation (which may be prepared by others under the qualified actuary's direction or review). The qualified actuary would need to be a member of the American Academy of Actuaries.
We proposed in § 423.2524(b)(2) that the following provisions would apply in the review, negotiation, and approval of the LI NET bid: § 423.272(a), (b)(1), and (b)(4). This would allow CMS to review the LI NET bid, conduct negotiations regarding the terms and conditions of the proposed bid, and approve it only if the bidding LI NET sponsor and the LI NET plan comply with all applicable CMS Part D requirements. As in typical Part D bid reviews, CMS would be able to decline the LI NET bid if it proposed significant increases in cost sharing (§ 423.272(b)(4)). This approach follows the bid process under the demonstration, in which the LI NET sponsor submits a bid that estimates their costs and includes assumptions for enrollment and utilization based on prior experience. Starting with plan year 2021, the LI NET sponsor began using an LI NET Bid Pricing Tool (BPT) and accompanying instructions that were adapted from the traditional Part D BPT and instructions. Once the LI NET bid is accepted, we update this information in our systems for the new payment year for the LI NET demonstration. Each year, we advance by one the number designating the current plan benefit package. For example, the contract-PBP was X0001-011 for plan year 2021 and X0001-012 for plan year 2022.
Proposed § 423.2524(b)(3) specifies the basic rule and major components of the LI NET bid, which are the LI NET sponsor's estimate of its revenue needs for Payment Rates A and B, which are discussed in greater detail in proposed § 423.2524(d).
In § 423.2524(c) we proposed that CMS would provide advance monthly LI NET payments, on a per-member, per-month (PMPM) basis, equal to the sum of Payment Rates A and B as established in the LI NET sponsor's approved bid submitted annually under paragraph (b) of this proposed section. Paying on a PMPM basis would align with other Part D payments and with our operations under the LI NET demonstration in which we provide a capitated PMPM amount established by the bid for each beneficiary enrolled in the demonstration. Unlike typical Part D monthly payments, the monthly LI NET payment under the demonstration is a PMPM amount that represents the sum of Payment Rates A and B, as determined by the LI NET bid. The bid represents the LI NET sponsor's total expected cost, minus any beneficiary co-pays, and with a reasonable margin that represents the LI NET sponsor's profit. Also, unlike other Part D payments, payments under the LI NET demonstration would not be risk adjusted. Because payments under the LI NET demonstration are cost reconciled (with the exception of risk corridors) and there is no concern about the LI NET sponsor cherry-picking beneficiaries, we use a simpler payment methodology that does not include risk adjustment.
We proposed in § 423.2524(c)(1) that Payment Rate A would be a monthly payment for projected administrative costs, constrained by an annual percentage cap set as part of the bid review and negotiation under § 423.272(a). Payment Rate A would include two elements, as it does under the demonstration. The first would be the LI NET sponsor's estimated administrative costs, which would represent the administrative costs to run the LI NET program inclusive of an amount for the margin, which represents the LI NET sponsor's profit. The second element in Payment Rate A would be the LI NET sponsor's estimated costs to pay pharmacy claims for prescriptions filled by immediate need individuals, for which the LI NET sponsor may not be able to submit a prescription drug event (PDE) record to CMS due to the individual's unconfirmed LIS status. We expect that these are generally the “immediate need” beneficiaries who are not confirmed to be LIS-eligible. We
In § 423.2524(c)(2), we proposed that Payment Rate B would reflect the projected net costs of the Part D drugs dispensed to individuals who receive the LI NET benefit. Payment Rate B would be the estimated actual drug costs minus direct and indirect remuneration (DIR). In the demonstration, we apply risk corridors to Payment Rate B so that excess gains and losses are shared between CMS and the LI NET sponsor. These risk corridors are symmetrical in sharing upside and downside risk, but are narrower than the risk corridors provided for under section 1860D-15(e) of the Act and applicable to other Part D plans. Because the risk corridors in the demonstration are so narrow, the LI NET sponsor has not assumed as much risk for LI NET as traditional Part D plans assume. CMS has not shared risk on Payment Rate A, in keeping with typical Part D plans for which CMS does not share risk on margin or administrative costs. In 2012, CMS revised the risk corridors under the LI NET demonstration to limit payment adjustments on Payment Rate B. For the portion of a plan's cost for drugs that is between the target amount and the threshold upper limit (101 percent of the target amount), the LI NET sponsor pays 100 percent of this amount. For the portion of the plan's cost for drugs that exceeds the threshold upper limit, the government pays 99.9 percent and the plan pays 0.1 percent. Similarly, if a plan's cost for drugs is between the target amount and the threshold lower limit (99 percent of the target amount), the LI NET sponsor keeps 100 percent of the difference between the drug cost and the target amount. If a plan's cost for drugs is lower than the threshold lower limit, the government keeps 99.9 percent and the plan keeps 0.1 percent of the difference between the plan's drug cost and the threshold lower limit.
Both under the demonstration and for other Part D plans, after a payment year is over and the deadline for submitting payment data for that payment year has passed, we reconcile the payments for the year. This allows us to narrow the gap between what predicted and actual costs were in a given year, as well as share risk with plan sponsor in gains and losses. To provide for payment reconciliation and risk sharing in the LI NET program, we proposed in § 423.2524(d) to establish the payment policies for reconciliation and risk corridors, including adopting targeted provisions of existing risk sharing requirements. Proposed § 423.2524(d)(1) provides that CMS would conduct LI NET payment reconciliation each year for Payment Rates A and B after the annual PDE data submission deadline has passed and make the resulting payment adjustment consistent with § 423.343(a).
In § 423.2524(d)(2), we proposed to establish the same risk corridors for Payment Rate B that apply under the demonstration: no risk sharing within 1 percent of the target amount and symmetrical 0.1 percent risk sharing beyond the 1 percent corridor. To carry out risk sharing as part of reconciliation, we proposed to have § 423.336(c) apply to LI NET, which requires a plan sponsor to provide necessary cost data information to CMS and authorizes CMS to make either lump-sum payments or adjustments based on the risk corridor calculations.
Proposed § 423.2524(e) would establish that the LI NET contract is subject to the existing provision at § 423.346 pertaining to payment reopenings. Per § 423.346, CMS may reopen and revise an initial or reconsidered final payment determination for up to 5 payment years. Under the demonstration, each LI NET reconciliation has been in alignment with § 423.346 and included the prior 5 years of PDEs. The most recently completed payment year gets reconciled for the first time along with reopening the prior 4 years. For example, in 2019, PBP 008 for payment year 2018 was reconciled for the first time while PBPs 004-007 (for payment years 2014 through 2017) were reopened. Sequestration is not used or accounted for in reconciliation, consistent with how we apply sequestration for other Part D plans. Under the demonstration, we maintain consistency between LI NET's PDE and DIR reporting deadlines and the reporting deadlines that apply to Part D plans (for example, the yearly deadline for data used for payment year reconciliation is June 30th). Enrollment, risk adjustment, and PDE certifications (attestations) are collected under the LI NET demonstration just like other contracts, and we proposed to adopt the requirements in § 423.505(k)(1) through (5), except for certifying to reinsurance data because LI NET does not receive a reinsurance subsidy. This proposal would require the LI NET sponsor to certify to the accuracy, completeness, and truthfulness of all data related to payment.
As noted earlier in this section of this final rule, as a general matter, all payment rights and responsibilities under Part D that otherwise apply and are not explicitly waived in proposed § 423.2536 would apply to the LI NET program, as appropriate. Proposed § 423.2524(f) would provide that the LI NET sponsor could appeal the payment calculation under § 423.350. Proposed § 423.2524(g) would establish that the LI NET contractor is subject to the “report and return” overpayment requirements under § 423.360.
Because the LI NET sponsor is a Part D sponsor and the LI NET contract is a PDP contract, many existing provisions in Part 423 apply to LI NET. The exceptions are those provisions waived by the statute, those provisions that are inapplicable to LI NET, and the requirements we proposed to waive through this rulemaking.
Section 1860D-14(e)(5)(A) of the Act provides that paragraphs (1) and (3)(B) of section 1860D-4(a) of the Act, subparagraphs (A) and (B) of section 1860D-4(b)(3) of the Act, and paragraphs (1)(C) and (2) of section 1860D-4(c) of the Act do not apply to the LI NET program; thus, requirements relating to dissemination of general information and the provision of formulary information, formulary requirements, and medication therapy management (MTM) program requirements do not apply to LI NET. For this reason, we proposed to waive formulary requirements in §§ 423.120(b), 423.128(e)(5), and 423.128(e)(6) and MTM program requirements in § 423.153.
Section 1860D-14(e)(5)(B) of the Act contains broad waiver authority to “waive such other requirements of title XI and this title as may be necessary to carry out the purposes of the program established under this subsection”. We also proposed to waive for LI NET some of the cost control and quality improvement requirements in Part 423
We solicited comment on whether we should waive any additional regulatory provisions related to paragraphs (1) and (3)(B) of section 1860D-4(a) of the Act and subparagraphs (A) and (B) of section 1860D-4(b)(3) of the Act.
We proposed that the LI NET sponsor submit most of the certifications listed in § 423.505(k), with the exception that we are waiving the certification of accuracy of data for price comparison in paragraph (k)(6), given that the LI NET plan is not one for which beneficiaries shop.
Part D beneficiaries receiving a low-income subsidy are not eligible for the coverage gap discount program, and under the demonstration LI NET is not subject to coverage gap discount requirements under subpart W of Part 423. Thus, we proposed in § 423.2536(i) to waive subpart W in full for LI NET.
We proposed in § 423.2536(j) to waive the MLR requirements in subpart X of Part 423. Section 1857 of the Act as incorporated into section 1860D-14(e) does not speak to MLR requirements for LI NET. Under the LI NET demonstration, CMS does not require the LI NET sponsor to meet the minimum medical loss ratio (MLR) requirement or to report the MLR for the LI NET contract as it does for other Part D contracts. This is due to the unique payment structure for the contract. Under Part D, a sponsor submits a single bid including estimated administrative costs, returns on investment, and drug costs, which are risk-adjusted. After a payment year concludes, Part D sponsors are required under subpart X of Part 423 to report the MLR for each contract, and if the MLR for a contract is below 85 percent, the sponsor is required to remit payment to CMS. Enrollment sanctions are applied to contracts that fail to meet the minimum MLR requirement for 3 consecutive years, and contracts that fail to meet the requirement for 5 consecutive years are subject to termination. The minimum MLR requirement is intended to create incentives for Part D sponsors to reduce administrative costs such as marketing costs, profits, and other such uses of plan revenues, and to help ensure that taxpayers and enrolled beneficiaries receive value from Medicare health plans. Because of the limits we proposed to place on how much administrative costs in LI NET under Payment Rate A can increase year over year and because of the differing payment structure, we do not believe MLR reporting should be applicable to LI NET.
The Affordable Care Act amended section 1893(h) of the Act to expand the use of Recovery Audit Contractors (RACs) to include the MA and Part D programs. Section 1893(h)(9) of the Act specifies that, under contracts with the Secretary, Part D RACs are required to ensure that each PDP has an anti-fraud plan in effect and to review the effectiveness of each such anti-fraud plan, to examine claims for reinsurance payments to determine whether PDPs submitting such claims incurred costs in excess of the costs allowed, and to review estimates submitted by PDPs with respect to the enrollment of high-cost beneficiaries and compare such estimates with the numbers of such beneficiaries actually enrolled by such plans. Because the LI NET sponsor must enroll every eligible LI NET beneficiary, and because LI NET does not receive reinsurance, a Part D RAC's review or examination of LI NET claims would likely be extremely limited in scope. As other audit, oversight, and compliance requirements would continue to apply to the LI NET program, the other program integrity safeguards we have proposed for the LI NET program would be adequate, and we therefore proposed to waive application of the RAC requirements in subpart Z of Part 423.
In surveying the items under Part 423 for the Voluntary Medicare Prescription Drug Benefit, we attempted to categorize existing requirements as applicable, inapplicable, or a candidate for waiver. We solicited comment on whether there are additional provisions in part 423 that we did not mention in the proposed rule and that we should address for LI NET.
In the course of this rulemaking, we noticed the need for a technical correction in § 423.505(b)(22), which requires Part D sponsors to address and resolve complaints received by CMS against the Part D sponsor. The regulation text currently refers to MA organization when it should refer to Part D sponsor, and thus we proposed to make the correction.
We also proposed to make a technical correction in the header of subpart Z of Part 423. The header in regulation text currently is “Recovery Audit Contractor Part C Appeals Process” when it should be referring to Part D. Thus, we proposed to make the technical correction so the header correctly reads, “Recovery Audit Contractor Part D Appeals Process.”
We received a number of comments on the LI NET proposals. Summaries of the comments and our responses follow.
We also take this opportunity to clarify that the list of documentation of LIS eligibility in proposed § 423.2504(a)(2)(i)(A) through (F) is a non-exhaustive list of types of “best available evidence” as defined in § 423.772. “Best available evidence” in § 423.772 means “evidence recognized by CMS as documentation or other information that is directly tied to State or Social Security Administration systems that confirm an individual's low-income subsidy eligibility status, and that must be accepted and used by the Part D sponsor to change low-income subsidy status.” As applied to LI NET, when a beneficiary chooses to provide documentation at the POS, with their direct reimbursement request form, or with their LI NET application form, the documentation is reviewed by CMS and upon approval the LI NET sponsor would change the beneficiary's LIS status appropriately.
In § 423.2504(b)(3), the proposed rule refers to individuals submitting receipts for reimbursement for claims paid out of pocket when making a direct reimbursement request. We finalize § 423.2504(b)(3) with a modification to clarify that that we are referring to “eligible claims”. This change makes explicit that eligible claims, namely those for Part D drugs from dates when the person was retroactively LIS eligible, are needed for enrollment to successfully occur using a direct reimbursement request.
In § 423.2504(b)(4), for consistency in referring to the documentation that may be optionally submitted along with the LI NET application form, we revise the proposed language of “supporting documentation demonstrating their LIS status” to “optional documentation of LIS eligibility listed in [new] paragraph (a)(3)” and clarify that if no documentation is submitted and accepted, the LI NET sponsor will periodically check for eligibility and enroll applicants once LIS eligibility is confirmed.
In making these clarifications, we note that LI NET individuals will be enrolled via one of the four enrollment options. Though they can, for example, submit an LI NET application form and a direct reimbursement request form at the same time, the first in time to effectuate the enrollment will be the way in which the beneficiary is enrolled.
In sum, to clarify the role of documentation in LI NET, we are finalizing § 423.2504 with the following revisions:
• Renumber proposed § 423.2504(a)(2)(i) to § 423.2504(a)(3) and add a heading that reads “Documentation of LIS Eligibility”;
• Renumber the succeeding subsections under proposed § 423.2504(a)(2)(i) accordingly;
• Insert § 423.2504(a)(4) to say “CMS uses documentation submitted under paragraph (a)(3) of this section to confirm LIS eligibility”;
• Renumber proposed § 423.2504(a)(2)(ii) to § 423.2504(a)(5) and revise to specify that “If CMS cannot confirm an immediate need individual's eligibility during the period of LI NET coverage, the individual will not be auto-enrolled into a standalone Part D plan in accordance with § 423.34(d) following their LI NET coverage”;
• Finalize § 423.2504(b)(2) as follows: “(2)
• Finalize § 423.2504(b)(3) as follows: “(3) Direct reimbursement request. An individual described in paragraph (a)(1) of this section who is not automatically enrolled in accordance with paragraph (b)(1) or at the point-of-sale as provided in paragraph (b)(2) and who submits a direct reimbursement request form, receipts for reimbursement for eligible claims paid out of pocket (with optional documentation of LIS eligibility listed in paragraph (a)(3)), will be retroactively enrolled into the LI NET program by the LI NET sponsor. The LI NET sponsor has 14 calendar days to reply with a coverage decision”; and
• Finalize § 423.2504(b)(4) as follows: “(4)
Recognizing that the SSA letter uses the terminology “Extra Help” instead of “LIS”, we also add for clarity the term “Extra Help” to § 423.2504(a)(3)(ii).
We also note the need for a technical correction in § 423.2504(b)(2), to specify that the claim submitted at the point-of-sale must be accepted by the LI NET sponsor—it must pass the edits for the LI NET sponsor to accept the claim into its system. For instance, a claim that is billed but is rejected due to a misspelling of the beneficiary's name would not be sufficient to complete an LI NET enrollment.
We finalize § 423.2504(b)(2) to say, “An individual who is not automatically enrolled in accordance with paragraph (b)(1) of this section and whose claim is submitted at the point-of-sale and accepted by the LI NET sponsor will be enrolled into the LI NET program by the LI NET sponsor.”
It makes sense to similarly require the LI NET sponsor to make its own determination of what is credible instead of adopting a standard that
Additionally, we noted an omission in § 423.2508(b) of the description of OIG's exclusion authority. OIG has the authority to exclude individuals and entities from Medicare
Thus, we finalize section 423.2508(b) to read, “(b) Network. The LI NET sponsor must allow its network and out-of-network pharmacies that are in good standing to process claims under the program. Licensed pharmacies are considered to be in good standing for the LI NET program so long as they: are not revoked from Medicare under § 424.535; do not appear on the Office of Inspector General's list of entities excluded from Federally funded health care programs pursuant to section 1128 of the Act or from Medicare and State health care programs under section 1156 of the Act (unless waived by the OIG); do not appear on the preclusion list as defined at § 423.100; and do not have a determination by the LI NET sponsor of a credible allegation of fraud as defined at § 423.4.”
We note that § 423.504(b)(4)(vi)(G) is not waived for LI NET and requires the LI NET sponsor to establish and implement “procedures and a system for promptly responding to compliance issues as they are raised, investigating potential compliance problems as identified in the course of self-evaluations and audits, correcting such problems promptly and thoroughly to reduce the potential for recurrence, and ensure ongoing compliance with CMS requirements.” Further, § 423.504(b)(4)(vi)(G)(2) says that the Part D sponsor must conduct appropriate corrective actions (for example, repayment of overpayments and disciplinary actions against responsible individuals) in response to the potential violation, as previously referenced.
We believe the commenter is requesting that the LI NET regulations
Thus, we finalize these concepts as proposed in § 423.2512(c)(6), and add the cross-reference to the good reference standard in § 423.2508(b) to say that the LI NET sponsor must “[a]djudicate claims from out-of-network pharmacies that are in good standing (as defined in § 423.2508(b)) according to the LI NET sponsor's standard reimbursement for their network pharmacies.”
Section 423.128(d) also sets forth requirements for interactive voice response systems, timeframes for return calls, average wait times, disconnect rates, provision of interpreters (including how quickly the interpreters are made available), and provision of effective real-time communication with individuals using auxiliary aids and services like TTY.
We note that the requirement to maintain a fax line is not separately discussed in § 423.128(d), but we believe as a practical matter that it will be necessary for the LI NET sponsor to maintain a fax line in order to conduct point-of-sale enrollments in accordance with § 423.2504(b)(2).
“CMS waives the following Part D program requirements for the LI NET program:
(a) General information. Paragraphs (1) and (3)(B) of section 1860D-4(a) of the Act (relating to dissemination of general information; availability of information on changes in formulary through the internet).
(b) Formularies. Subparagraphs (A) and (B) of section 1860D-4(b)(3) of the Act (relating to requirements on development and application of formularies; formulary development) and formulary requirements in §§ 423.120(b) and 423.128(e)(5) and (6).
(c) Cost control and quality improvement requirements. Provisions under subpart D of this part, including requirements about medication therapy management, are waived except for the provisions in § 423.2508(d)(1) through (5).
(1) Section 423.153(b) and (c) for dispensing and point-of-sale safety edits;
(2) Section 423.154 for appropriate dispensing of prescription drugs in long-term care facilities;
(3) Sections 423.159 and 423.160 for electronic prescribing, excepting the requirements pertaining to formulary standards in § 423.160(b)(5);
(4) Section 423.162 for QIO activities; and
(5) Section 423.165 for compliance deemed on the basis of accreditation.
(d) Out-of-network access. Section 423.124 Special rules for out-of-network access to Part D drugs at out-of-network pharmacies, except for § 423.124(a)(2), which applies to LI NET.
(e) Medicare contract determinations and appeals. Subpart N, except for the provisions that apply to LI NET in § 423.2520(d).
(f) Risk-sharing arrangements. Section 423.336(a), (b), and (d).
(g) Certification of accuracy of data for price comparison. Section 423.505(k)(6).
(h) Part D communication requirements. Portions of subpart V of this part related to Part D communication requirements that are inapplicable to LI NET, including:
(1) Section 423.2265(b)(4), (5), (11), and (13);
(2) Section 423.2265(c);
(3) Section 423.2266(a);
(4) Section 423.2267(e)(3) through (5), (9) through (12), (14) through (17), (25), (29), and (33); and
(5) Section 423.2274.
(i) Medicare Coverage Gap Discount Program. Subpart W of this part.
(j) Requirements for a minimum medical loss ratio. Subpart X of this part.
(k) Recovery audit contractor Part C appeals process. Subpart Z of this part.”
We appreciate the feedback we received from the commenters. After consideration of all public comments, we are finalizing the LI NET largely as proposed, with modifications to §§ 423.2504, 423.2508, and 423.2512, as previously discussed in our responses to comments. The revisions include:
• § 423.2504: renumber proposed § 423.2504(a)(2)(i) to § 423.2504(a)(3) and add a heading that reads “Documentation of LIS Eligibility”; renumber the succeeding subsections under proposed § 423.2504(a)(2)(i) accordingly; insert § 423.2504(a)(4) to say “CMS uses documentation submitted under paragraph (a)(3) of this section to confirm LIS eligibility”; and renumber proposed § 423.2504(a)(2)(ii) to § 423.2504(a)(5) and revise to specify that “If CMS cannot confirm an immediate need individual's eligibility during the period of LI NET coverage, the individual will not be auto-enrolled into a standalone Part D plan in accordance with § 423.34(d) following their LI NET coverage”; striking “with an immediate need” from the description of point-of-sale enrollment in § 423.2504(b)(2); revise § 423.2504(b)(2) to say, “(2) Point-of-sale enrollment. An individual who is not automatically enrolled in accordance with paragraph (b)(1) of this section and whose claim is submitted at the point-of-sale and accepted by the LI NET sponsor will be enrolled into the LI NET program by the LI NET sponsor”; finalize § 423.2504(b)(3) as follows: “(3) Direct reimbursement request. An individual described in paragraph (a)(1) of this section who is not automatically enrolled in accordance with paragraph (b)(1) or at the point-of-sale as provided in paragraph (b)(2) and who submits a direct reimbursement request form, receipts for reimbursement for eligible claims paid out of pocket (with and optional documentation of LIS eligibility listed in paragraph (a)(3)), will be retroactively enrolled into the LI NET program by the LI NET sponsor. The LI NET sponsor has 14 calendar days to reply with a coverage decision”; and finalize § 423.2504(b)(4) as follows: “(4) LI NET application form. An individual who is not enrolled through one of the methods in paragraphs (b)(1) though (3) of this section may submit an LI NET application form to the LI NET sponsor (with optional documentation of LIS eligibility listed in paragraph
• § 423.2508: removing CMS' role in determining pharmacies' “good standing” for LI NET and adding a reference to OIG's authority to exclude State health care programs; and
• § 423.2512(c)(6): adding a cross reference to the good standing standard we are adopting in § 423.2508(b).
The Part D low income subsidy (LIS) helps people with Medicare who meet certain statutory income and resource criteria pay for prescription drugs and lowers the costs of prescription drug coverage.
Individuals who qualify for the full LIS receive assistance to pay their full premiums and deductibles (in certain Part D plans) and have reduced cost sharing. Individuals who qualify for the partial LIS pay reduced premiums (on a sliding scale based on their income) and also have reduced deductibles and cost sharing.
Section 11404 of the IRA (Pub. L. 117-169), enacted on August 16, 2022, amended section 1860D-14 of the Act to expand eligibility for the full LIS to individuals who are determined to have incomes below 150 percent of the FPL and who meet either the resource standard in paragraph (3)(D) or paragraph (3)(E) of section 1860D-14(a) of the Act, with respect to plan years beginning on or after January 1, 2024. This change will provide the full LIS for individuals who currently qualify for the partial subsidy.
To implement the changes to the LIS income requirements, we proposed to amend § 423.773(b)(1) to add that to be eligible for the full subsidy for plan years beginning on or after January 1, 2024, an individual must have an income below 150 percent of the FPL. To coordinate with this change, we also proposed to amend § 423.773(d) to specify that the requirement that an individual have an income below 150 percent of the FPL to be eligible for the partial subsidy applies only to plan years beginning before January 1, 2024. This latter change is consistent with the IRA effectively sunsetting the partial LIS after 2023.
To implement the changes to the resource limits, we proposed to amend § 423.773 to state that the current resource limits applicable for the full subsidy at paragraph (b)(2)(ii) apply to years 2007 through 2023. We also proposed to add a new § 423.773(b)(2)(iii) to state that for years beginning on or after January 1, 2024, the resource limits at paragraph (d)(2) of § 423.773—the resource standards currently applicable for the partial subsidy—would apply to full subsidy eligible individuals. This result of this change is that individuals are able to have a higher value of resources and still be eligible for the full subsidy.
Lastly, we proposed to amend § 423.780(d) to specify that the sliding scale premium amounts currently applicable for individuals with the partial subsidy apply with respect to plan years beginning before January 1, 2024. These individuals who have incomes between 135 and 150 percent of the FPL and who meet the resource requirements will now qualify for the full subsidy beginning in 2024, and will be entitled to a premium subsidy of 100 percent of the premium subsidy amount, as outlined in § 423.780(a).
We received the following comments, and our responses follow.
We are contemplating sending notices in the Fall of 2023 to individuals who will be transitioning from the partial LIS subsidy to the full subsidy to inform them of the increased assistance they will be receiving beginning January 1, 2024. We did not propose any changes to the LIS notice requirements, therefore, plans will continue to be responsible for sending their members required information (for example, the LIS rider).
Lastly, we are always exploring avenues for improving and simplifying our communication materials to beneficiaries, including enrollment forms. We will continue to work to refine materials, but note that there can be limitations in how much we are able to simplify forms given the information we are conveying to beneficiaries and the required information we need from them to process their request. We note that beneficiaries who require materials in a language other than English and Spanish can contact 1-800-MEDICARE to request translated materials.
We would note that while a few commenters stated that individuals with incomes between 135 percent and 150 percent of the FPL are not automatically enrolled into LIS-eligible plans, this is not entirely accurate. Since the beginning of the Part D program, CMS has had a mechanism in place—referred to as facilitated enrollment—that enrolled partial benefit individuals into benchmark plans. This is essentially the same as the auto-enrollment that CMS conducts for full-benefit dually eligible beneficiaries and results in LIS-eligible individuals without prescription drug coverage being enrolled into Part D plans.
We appreciate the feedback we received from the commenters. After consideration of all public comments, we are finalizing our proposal with one minor change. We are revising the regulatory text of proposed § 423.773(b)(2)(iii) by adding the word “plan” before “years”, so that the provision as finalized in this rule refers to “plan years beginning on or after January 1, 2024”. This change is consistent with the references to “plan years” in paragraphs (b)(1) and (d) of § 423.773, as revised by this final rule.
On January 20, 2021, President Biden issued Executive Order (E.O.) 13985: “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” (hereinafter referred to as E.O. 13985).
CMS continues to work diligently to identify regulatory actions that can help support CMS's goal to advance health equity or that already address health equity topics but should be expanded in order to meet the increasingly diverse needs of enrollees served by MA organizations. In order to support the Administration's goal of advancing equity for all, it is imperative that we ensure our regulations address topics that enable disadvantaged populations to fully access the care that the regulations already allow them to receive. Consequently, in the proposed rule, we proposed several regulatory updates in the MA program related to health equity. These proposals included requirements intended to ensure equitable access to MA services, ensure MA provider directories reflect providers' cultural and linguistic capabilities and notate MOUD-waivered providers, ensure MA enrollees with low digital health literacy are identified and offered digital health education to assist them in accessing any medically necessary covered telehealth benefits, and ensure MA organizations incorporate one or more activities into their overall quality improvement program that reduce disparities in health and health care among their enrollees. We are finalizing these proposals, some with modification. CMS believes that the changes included in this final rule will address health disparities in the MA program and could be essential to more broadly supporting other equity-focused efforts across CMS policies and programs.
Currently, § 422.112(a)(8) requires MA organizations that offer coordinated care plans to ensure that services are provided in a culturally competent manner to all enrollees, including those with limited English proficiency or reading skills, and diverse cultural and ethnic backgrounds. We emphasized in our proposal and reiterate here that “all enrollees” indicates that all enrollees are included in this protection even if they do not identify as belonging to one of the groups specifically listed in the regulation. Additionally, all of the changes we proposed are designed to strengthen the regulation's current application or requirements.
Our proposal was two-part. First, we proposed to change the current paragraph heading from “Cultural considerations” to “Ensuring Equitable Access to Medicare Advantage (MA) Services”; the term “equitable access” is a broader and more suitable description for the paragraph, as it does not emphasize protecting access to care for one population over another. As we stated in our proposal, this change would more clearly reflect the inclusive nature of the protections MA organizations must guarantee for all enrollees under this provision.
The second part of our proposal was to add more populations to the existing list of groups that appear in the regulation. Specifically, at § 422.112(a)(8), CMS proposed to replace the phrase “those with limited English proficiency or reading skills, and diverse cultural and ethnic backgrounds” after the word “including” and to add in its place additional paragraphs listing more examples of populations that an MA organization must ensure services are provided to in a culturally competent manner and promote equitable access to services for in order to satisfy the existing requirement: “(i) people with limited English proficiency or reading skills; (ii) people of ethnic, cultural, racial, or religious minorities; (iii) people with disabilities; (iv) people who identify as lesbian, gay, bisexual, or other diverse sexual orientations; (v) people who identify as transgender, nonbinary, and other diverse gender identities, or people who were born intersex; (vi) people who live in rural areas and other areas with high levels of deprivation; and (vii) people otherwise adversely affected by persistent poverty or inequality.” As we noted in our proposal, MA organizations must provide all enrollees, without exception, accommodations to equitably access services according to applicable statutory, regulatory, and other guidance. In other words, the presence of this list should not be construed to mean that accommodations or steps necessary to ensure cultural competency in delivering benefits are required only for enrollees who belong to the groups listed herein. Instead, the proposed changes, with respect to a revised list of populations, are clarifying in nature, non-exhaustive, and are intended to provide additional examples of populations MA organizations should be mindful of in their plan designs. We again emphasize that the regulation already explicitly applies to all enrollees without exception; therefore, the protections of this provision, which were already in effect prior to our proposal, must continue to be part of an MA organization's work to ensure that all Medicare-covered items and services are available and accessible to all enrollees.
For example, one commenter recommended a slight change to the language “rural areas and other areas with high levels of deprivation” to include “under-resourced areas.” Another commenter suggested that CMS change the language “persistent poverty and inequality” to include “and/or lack of access to health care services.” Some commenters suggested that we address intersectional conditions affecting some enrollees.
Finally, all public comments received on this proposal were generally supportive, including those that requested that modifications be made to the final rule. After consideration of the comments and for the reasons outlined in the proposed rule and our responses to comments, including that the requested modifications would not produce substantive changes to either the application or requirements of the provisions (which were in effect prior to the proposal), we are finalizing the revision to § 422.112(a)(8) as proposed.
Section 1852(c)(1) of the Act requires an MA organization to disclose, among other things, the number, mix, and distribution of plan providers in a clear, accurate, and standardized form to each enrollee in an MA plan offered by the MA organization at the time of enrollment and at least annually thereafter. CMS implemented this requirement in a regulation at § 422.111(a) and (b)(3)(i), requiring that an MA organization must disclose the number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services, in the manner specified by CMS, to each enrollee electing an MA plan it offers; in a clear, accurate, and standardized form; and at the time of enrollment and at least annually thereafter, by the first day of the annual coordinated election period. In addition, under § 417.427, the MA disclosure requirements at § 422.111 also apply to section 1876 cost plans.
CMS has historically interpreted the disclosure requirement at § 422.111(b)(3)(i)—“the number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services”—as
The current provider directory model contains an array of specific required information based on § 422.111(b)(3)(i); we refer to this information collectively as required provider directory data elements. For example, organizations must list only the office or practice location(s) where the provider regularly practices, must clearly identify the capacity in which the provider is serving (that is, specialty type), and must clearly identify whether or not a provider is accepting new patients or provide a notice directing beneficiaries to contact a provider to determine if he or she is accepting new patients. Several of these data elements are tied to how § 422.111(b)(3)(i) requires the organization to disclose information about providers from whom enrollees may reasonably be expected to obtain services; issues of access, including whether the provider is accepting new patients and the location, are integral to whether an enrollee may reasonably be expected to obtain covered services from that provider. In addition, some of these provider directory data elements, such as notations on restrictions in access, or indicators regarding whether a provider is accepting new patients, contain important information that organizations should consider when verifying that their networks are truly adequate. This consideration enables organizations to ensure that all covered services are available and accessible under the plan, as required by section 1852 of the Act and § 422.112(a).
In addition to the required provider directory data elements, the current provider directory model also addresses best practices for provider directories, including encouraging organizations to identify non-English languages spoken by each provider as well as include a specific notation on any restrictions on the accessibility of the provider and the provider's location for people with physical disabilities.
We note that the phrase “cultural and linguistic capabilities” as proposed for § 422.111(b)(3)(i) refers to the capabilities of a provider or skilled medical interpreter at the provider's office to deliver culturally and linguistically appropriate services (CLAS), which are defined by the HHS Office of Minority Health (OMH) as “services that are respectful of and responsive to individual cultural health beliefs and practices, preferred languages, health literacy levels, and communication needs.”
This proposed change does not implement, take the place of, or supersede an organization's or provider's obligations to take reasonable steps to ensure meaningful access to such programs or activities by limited English proficient individuals and appropriate steps to ensure that communications with individuals with disabilities are as effective as communications with others in such programs or activities, including the provision of oral language assistance services and/or auxiliary aids and services when required by applicable law (section 1557 of the Patient Protection and Affordable Care Act (PPACA) and 45 CFR part 92). We proposed this new requirement for MA provider directories as a standard for implementing and ensuring compliance with section 1852(c)(1)(C) of the Act and as a necessary and appropriate standard to ensure that MA enrollees have the information they need in order to access covered services from an MA plan.
This proposal is also consistent with the health equity objectives of CMS's first strategic pillar “Advance Equity” under the 2022 CMS Strategic Plan.
To further enhance our requirements for MA provider directories in the area of behavioral health, we also proposed to amend § 422.111(b)(3)(i) to add a new required provider directory data element for certain providers who offer medications for opioid use disorder (MOUD). Access to MOUD can be life-saving, but too often, patients do not know how to access this type of care. MA enrollees may have little insight as to which providers can provide MOUD. This problem is especially urgent, as overdose deaths from opioids
As we stated in the proposed rule, we believe that this additional MA provider directory data element is important and necessary for ensuring access to behavioral health services for MA enrollees. We further stated that it supports both national and CMS efforts related to behavioral health priorities and strategies, as described in section III.B.1. of this final rule. We also explained our goal that the proposed change would help MA enrollees struggling with opioid use disorder to find providers who could treat them by prescribing MOUD, moving these enrollees further along the path towards long-term recovery.
In summary, CMS proposed to add two new requirements to § 422.111(b)(3)(i) that organizations must include providers' cultural and linguistic capabilities and identify certain providers waived to treat patients with MOUD in their provider directories. We solicited comment on these proposed improvements to the content of MA provider directories. We also refer readers to section III.B.2. of this final rule to review our summary of comments and outcome for our proposal to add prescribers of MOUD as a new specialty type to be subject to MA network adequacy evaluation. We thank commenters for their input on CMS's proposed new MA provider directory requirements. We received the following comments on this proposal, and our response follows:
We received a range of comments pertaining to this proposal, the majority of which reflected support for the regulation. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the proposed change to § 422.111(b)(3)(i) to require organizations to include in their provider directories each provider's cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider's office.
We are not finalizing our proposal to require organizations to include in their provider directories notations for MOUD-waivered providers.
Telehealth has become an increasingly popular and important tool in providing access to health care, especially during the COVID-19 Public Health Emergency (PHE). For the purposes of this section of this final rule, we are using the term “telehealth benefits” very broadly to encompass covered services that are furnished to the enrollee (that is, the patient) in a different location than where the provider is located. There are multiple categories of covered benefits where this circumstance is present, with additional criteria or requirements applying to different categories of covered benefits when the enrollee and provider are not in the same place at the time the service is furnished.
Under the MA program, there are various requirements and options for coverage of telehealth benefits. When original Medicare covers telehealth benefits, such as services described in section 1834(m) of the Act and § 411.78, MA organizations must cover those telehealth benefits as basic benefits, as defined in § 422.100(c). If an MA organization wishes to offer telehealth benefits that go beyond the scope of the original Medicare telehealth benefits that must be covered by every MA plan, MA organizations have the option to offer “Additional Telehealth Benefits” (ATBs) and/or supplemental telehealth benefits. Section 1852(m) of the Act and § 422.135 outline the requirements for ATBs, which are generally services for which benefits are available under Medicare Part B but which are not payable under section 1834(m) of the Act, and the services are furnished when the patient and the physician or practitioner are not in the same location. ATBs may be included in the bid and treated as basic benefits when the requirements of § 422.135 are met.
If an MA organization wishes to offer telehealth benefits that are not covered by original Medicare and are not within the scope of § 422.135, then the MA organization may choose to offer them as supplemental benefits. The requirements for MA supplemental benefits are set forth at section 1852(a)(3) of the Act and §§ 422.100(c) and 422.102. An MA organization's bid must accurately reflect the covered telehealth service, whether it is covered as an ATB or a supplemental benefit. In addition, during the COVID-19 PHE, MA organizations have been required to account for the various waivers, amendments to regulations, and other guidance published by CMS, with regard to telehealth benefits. In using the term “telehealth benefits” here, we mean to include all of these various categories of covered benefits. In the regulation text we are finalizing in this rule, we use the phrase “covered benefits that are furnished when the enrollee and the provider are not in the same location using electronic exchange, as defined in § 422.135” as a means to encompass all of the potential covered benefits included in our broad use of the term “telehealth benefits.” As defined in § 422.135, electronic exchange means electronic information and telecommunications technology, which we believe is broad enough to include telecommunications and technologies permitted for covered Part B services under section 1834(m) of the Act and implementing regulations as well as MA ATBs and other supplemental benefits.
In recent years, CMS has seen a significant increase in the offering of telehealth benefits in the MA program. Almost 99 percent of MA plans offered some form of telehealth benefits in contract year 2022, either in the form of ATBs or supplemental telehealth benefits. This is a 16 percent increase since contract year 2018 and a 9 percent increase since contract year 2020, which was the first year MA organizations were permitted to offer ATBs. ATB offerings alone have increased by approximately 39 percent since their inception 2 years ago. The total number of MA enrollees who have access to MA telehealth benefits of any kind has risen from approximately 89 percent in contract year 2018 to nearly 100 percent in contract year 2022.
While the supply and demand of telehealth has clearly grown in recent years, there is evidence that barriers to accessing telehealth leave room to improve health equity in telehealth. The regulatory changes we are finalizing here, taken together, are an attempt to improve health equity in telehealth and are consistent with both E.O. 13985 and CMS's first strategic pillar “Advance
As we described in the proposed rule, health equity in telehealth is difficult to attain due to barriers to telehealth access, which may include: lack of video sharing technology (for example, a smartphone, tablet, or computer), spotty or no internet access, lack of housing or private space to participate in virtual visits, few local providers who offer telehealth practices, language barriers (including oral, written, and signed language), the inability to incorporate third party auxiliary aids and services such as live captioners, telehealth software, apps, and websites that are accessible and usable by people with disabilities, and lack of adaptive equipment for people with disabilities along with incompatibility with external assistive technologies used by people with disabilities.
The existence of communities with low digital health literacy who in turn cannot access telehealth represents a significant obstacle in achieving health equity in telehealth. The World Health Organization defines digital health literacy as “the ability to seek, find, understand, and appraise health information from electronic sources and apply the knowledge gained to addressing or solving a health problem. Examples of digital health literacy include accessing your electronic health record, communicating electronically with your health care team, ability to discern reliable online health information, and using health and wellness apps.”
Many older adults with low digital health literacy experience gaps in access to the health care they need, and this is concerning for the MA program, whose enrollee population includes individuals age 65 and older (as well as individuals under age 65 with disabilities). For example, the American Association of Retired Persons (AARP) annual technology survey found that more than half of older adults (age 50 and older) in 2021 indicated they need more digital education, while more than one in three indicated they lacked confidence when using technology.
As outlined in this final rule, research indicates that older adults, people with disabilities, people from some racial and ethnic groups, rural communities, underserved populations, and those adversely affected by persistent poverty and inequality are all disadvantaged by limited access to modern information and communications technology (sometimes referred to as a digital divide).
As we described in the proposed rule, CMS does not currently have requirements for MA organizations in the area of digital health literacy. Given the need to increase digital health literacy in many communities with MA enrollees and the goal to achieve health equity in telehealth, we believe it is necessary to implement regulations addressing digital health literacy in the MA program. CMS expects that these
In the proposed rule, we proposed to add requirements for certain MA organizations to develop and maintain procedures to identify and offer digital health education to enrollees with low digital health literacy to assist them with accessing any medically necessary covered telehealth benefits. Specifically, we proposed to amend current continuity of care requirements for MA organizations offering coordinated care plans to “ensure continuity of care and integration of services through arrangements with contracted providers” at § 422.112(b), by adding a new paragraph (9). We indicated that the new proposed paragraph would require MA organizations to develop and maintain procedures to identify and offer digital health education to enrollees with low digital health literacy to assist with accessing any medically necessary covered benefits that are furnished when the enrollee and the provider are not in the same location using electronic exchange; we used the term “electronic exchange” as it is broadly defined in § 422.135.
We noted that this proposed new continuity of care requirement would apply to all MA organizations offering coordinated care plans (that is, HMOs, PPOs, HMO-POSs, and SNPs) and would be relevant for all types of covered telehealth benefits, including basic telehealth benefits, ATBs, and supplemental telehealth benefits offered by MA coordinated care plans. We solicited comment on whether to amend § 422.100 instead of § 422.112(b) in order to apply this new requirement to all MA plans and not just coordinated care plans. As we indicated in the proposed rule, this additional standard was proposed to ensure that MA enrollees would be able to access covered benefits and that MA organizations met their obligations under section 1852(d) of the Act to make covered benefits available and accessible to enrollees in the plan. Section 1856(b) of the Act authorizes the adoption of standards that are consistent with and to carry out the Part C statute. As telehealth benefits become more prevalent in the MA program, taking steps to provide enrollees with digital health education will ensure that these telehealth benefits are truly accessible and available to enrollees.
After considering the comments received, and for reasons described in this section of the rule, we are finalizing this policy, but we are amending § 422.100 rather than § 422.112(b) as we originally proposed to apply this new requirement to all MA plans and not just coordinated care plans.
This policy will be a first step for MA organizations to assess the landscape of health equity in telehealth in their plans and help enrollees navigate telehealth. We noted in the proposed rule that, under this policy CMS would provide a degree of discretion for MA organizations in the procedures developed and used to identify enrollees with low digital health literacy and the digital health education services the MA organization provides for those enrollees. We also explained that compliance with the proposal, if finalized, would require that MA organizations introduce a digital health literacy screening program or other similar procedure to identify current enrollees with low digital health literacy; however, MA organizations would have flexibility to design their own screening program or procedure. We noted in the proposed rule that some experts recommend such an assessment should examine patient-level barriers such as telehealth readiness, broadband access, and inaccessible or unusable information and communication technologies by individuals with disabilities that limit patient use of telehealth.
Once the MA organization determines which enrollees experience low digital health literacy, the MA organization will then have to implement a digital health education program to offer to these enrollees. CMS did not propose to identify explicit parameters for this digital health education requirement, and we are not finalizing any such parameters. Rather, we have chosen to keep it flexible and allow for innovation in this area by MA organizations. Depending on the specific enrollment in an MA plan, the procedures to identify enrollees and the mechanisms and content of the digital health education could vary. However, some examples of digital health education designs include: distributing educational materials about how to access certain telehealth technologies in multiple languages, including sign language, and in alternative formats; holding digital health literacy workshops; integrating digital health coaching; offering enrollees in-person digital health navigators; and partnering with local libraries and/or community centers that offer digital health education services and supports.
As we discussed in the proposed rule, as a best practice, CMS encourages MA organizations to ensure that there are no system requirements (for example, online portal enrollment) that could act as barriers to accessing covered telehealth benefits or digital health education for enrollees with low digital health literacy, so as to promote ease of access in the simplest way possible. However, we note that MA organizations must be mindful to remain compliant with all applicable health data privacy and security laws in establishing systems for enrollees with low digital health literacy. In addition, if an MA organization offers enrollees assistance with any necessary telehealth technology—for instance, if the MA organization provides limited use smartphones/tablets or cellular data plans as supplemental benefits in order to aid in the use of telehealth services—then the MA organization must comply with applicable laws about those benefits and make enrollees aware of these available benefits per section 1852(c)(1)(F) of the Act and § 422.111(b)(6). This disclosure is especially important for enrollees identified as having low digital health literacy.
Smartphones and tablets (or other similar equipment) must only be used for primarily health related purposes (and cellular data plans can only be provided if use of these plans is locked and limited to health-related activities), such as when the device is locked except for remote monitoring or to enable engagement with health care providers, in order for these items and services to be permissible supplemental
For more information on SSBCI, please see the June 2020 final rule and the Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly final rule which appeared in the
To further emphasize the importance of health equity and health equity in telehealth specifically, CMS reminds MA organizations that § 422.112(a)(8) as it currently reads requires MA organizations offering coordinated care plans to ensure that services are provided in a culturally competent manner to all enrollees, including limited English proficient individuals or those with limited reading skills, and those with diverse cultural and ethnic backgrounds. CMS is finalizing changes in this rule to amend § 422.112(a)(8) to better reflect the broad scope of potentially underserved populations and to emphasize how MA plans must ensure equitable access to services. As adopted and with the revisions we are finalizing in this rule, § 422.112(a)(8) requires MA organizations offering coordinated care plans to ensure that services are provided in an equitable manner to all enrollees. MA organizations offering coordinated care plans must consider these additional obligations, as applicable, when developing and maintaining the digital health education programs they are required to implement under this final rule.
Furthermore, the HHS Office for Civil Rights and the U.S. Department of Justice (DOJ) Civil Rights Division recently published new guidance providing clarity on how Federal nondiscrimination laws require accessibility for people with disabilities and limited English proficient individuals in health care provided via telehealth.
We also proposed to require MA organizations to make information about their required digital health literacy screening and digital health education programs available to CMS upon request at proposed § 422.112(b)(9)(i) (finalized at § 422.100(n)(1)). We indicated that this would allow CMS to monitor the impact of the new requirement for these programs on MA organizations, providers, enrollees, and the MA program as a whole. In addition, we proposed that this requested information may include, but is not limited to, statistics on the number of enrollees identified with low digital health literacy and receiving digital health education, manner(s) or method of digital health literacy screening and digital health education, financial impact of the programs on the MA organization, evaluations of effectiveness of digital health literacy interventions, and demonstration of compliance with the requirements of proposed § 422.112(b)(9) (finalized at § 422.100(n)).
We indicated that the purposes of requiring MA organizations to make such information available to CMS upon request would be to identify best practices for improving digital health literacy amongst MA enrollees and to determine whether CMS should make improvements to the regulation and/or guidance regarding this requirement. We noted that the regulation text, now at § 422.100(n)(1), would include the language “upon request,” which would serve to communicate that while CMS does not intend to establish uniform data collection from all MA organizations at this time, CMS reserves the right to ask for this information from individual MA organizations. However, we noted that this provision would not limit CMS's audit access when program audits review the performance of MA organizations. We solicited comment on this aspect of our proposal and whether we should require regular reporting of data of this type from all MA organizations alongside other Part C reporting requirements.
We are also finalizing the proposed requirement that the MA organization must make information about its digital health literacy screening and digital health education programs available to CMS upon request. We are further finalizing language providing a non-exhaustive list of the information CMS may request from MA organizations under this policy. Finally, we are not finalizing regular reporting of the data alongside other Part C reporting requirements.
In the proposed rule, we provided that our proposal to amend § 422.112(b) (finalized at § 422.100(n)) would impact MA organizations in terms of the burden required to both identify enrollees with low digital health literacy and to develop digital health education programs for these enrollees. We also described how our estimated analysis of these impacts was qualitative in nature as we were proposing to provide MA organizations flexibility in determining how they wish to implement these proposed CMS requirements. We indicated that CMS does not currently collect data regarding digital health literacy among MA enrollees. Consequently, we would have no way of knowing or estimating the extent of low digital health literacy specifically among MA organizations' enrollees; how MA organizations would approach digital health literacy screening and digital health education; how much spending they would engage in related to these efforts; how much savings they would encounter (due to improved enrollee health outcomes because of improved digital health literacy), for example, how much time they would spend on these efforts; or how the MA program would grow as we see the effects of the proposed regulation. We estimated the direct non-quantified burden consists of MA organization staff hours spent, resources purchased, and any digital health education for enrollees performed. We further noted that MA organizations may differ in how their spending for the proposed requirements evolves over time as they test strategies and redevelop their approaches to complying with the regulation. Thus, we concluded that the proposed provision would impose an unknown amount of information collection requirements (that is,
We solicited comment from MA organizations on how much burden they expect this proposed provision might add. Regarding the impact of the proposed requirement for the MA organization to make information about its digital health literacy screening and digital health education programs available to CMS upon request, we noted that we did not anticipate requesting this information from more than nine MA organizations in a given year. We noted, however, that we believed it important to reserve the right to ask for this information if necessary, and that we structured the proposed regulation text accordingly. We also provided that since we estimate fewer than ten respondents, the information collection requirement was exempt (5 CFR 1320.3(c)) from the requirements of the PRA of 1995 (44 U.S.C. 3501
In terms of economic impact on the Medicare Trust Fund, we indicated that we did expect that improved digital health literacy would increase telehealth visits, which in turn would increase prevention of MA enrollee illness, both of which affect Medicare Trust Fund spending. Yet, as we discussed in the proposed rule, we have no way of knowing or estimating how much of an increase in telehealth visits there would be, for what specific services they would increase, or the effects of prevented future illnesses among MA enrollees. Thus, we concluded that this provision is expected to have an unknown economic impact on the Medicare Trust Fund.
In summary, CMS proposed to add a new requirement at § 422.112(b) that all MA organizations offering coordinated care plans have procedures to identify enrollees with low digital health literacy and offer them digital health education to assist with accessing any medically necessary covered benefits that are furnished when the enrollee and the provider are not in the same location using electronic exchange, as defined in § 422.135. We solicited comments on this proposal, including whether this requirement should be expanded to all MA organizations rather than only those offering coordinated care plans. In addition, CMS proposed to include a requirement that MA organizations make information about these programs available to CMS upon request, and questioned whether we should require regular reporting of data related to these from MA organizations alongside other Part C reporting requirements. We solicited comment on these proposals. We received the following comments on these proposals, and our responses follow:
Moreover, at this time we believe that establishing such standardized resources and metrics would be counter to the principles of flexibility upon which this provision was established. We are concerned that any reporting metrics would limit the flexibility we intend to provide MA organizations in initially establishing and implementing digital health education programs tailored to their respective covered populations. However, we believe that reporting metrics may be appropriate to add in the future after MA organizations and enrollees have gained experience with these programs, and we may consider adding reporting metrics in the future.
In addition, we note that both the proposed and final rules reference several sources of information on digital health literacy, the kinds of challenges that lack of digital health literacy pose to enrollees, especially those in vulnerable populations, and a range of additional information on this topic. While these references are not meant to serve as guidance, they may prove useful as a starting point for MA organizations beginning to build a digital health education program which is compliant with the new final rule. We further note that MA organizations are afforded the flexibility in this final rule to determine the most appropriate tools and methods for the populations they serve. As such, we encourage plans to engage with enrollees, providers, and other MA organization affiliated entities to determine the best methods for implementing this provision. Therefore, CMS is not finalizing any standard set of resources or reporting metrics at this time.
Also, CMS will not be providing standard definitions or language for describing telehealth at this time due to concerns of limiting MA organization discretion. We encourage MA organizations to use resources referenced throughout the preamble to this final rule as well as other sources as deemed appropriate.
We thank commenters for their suggestion to improve language used to describe telehealth services in EOCs and will consider adding language updates regarding telehealth to the EOC in the future.
We note that the proposed rule reiterates the authority of CMS to collect information upon request, including but not limited to statistics on the number of enrollees identified with low digital health literacy and receiving digital health education, manner(s) or method of digital health literacy screening and digital health education, financial impact of the programs on the MA organization, evaluations of effectiveness of digital health literacy interventions, and demonstration of compliance with the requirements of § 422.100(n). However, MA organizations may record and keep this and any other information related to their digital health education programs in the manner they deem most appropriate, and CMS is not pursuing any uniform data collection effort (such as Part C reporting requirements) at this time.
We acknowledge the commenter's concerns that these programs may increase MA organization burden or costs, and we agree that these requirements will impose some level of burden and cost on MA organizations. However, commenters did not provide specific feedback or data regarding the anticipated increased costs and/or burdens imposed on MA organizations, and as a result, CMS is unable to make broadly applicable estimates regarding either. Additionally, for reasons set forth in this final rule, CMS is not able to provide quantitative estimates regarding probable MA organization burden for implementing this provision.
CMS does not agree that digital health literacy and education should be exclusively dependent on, nor under the exclusive purview of, individual providers. MA organizations are often better positioned than individual providers to coordinate the care of their enrollees, and this digital health education programming is part of such care coordination. Further, we note that providing support for digital health education programs falls outside the scope of daily work assignments for most MA network providers and medical staff. Placing such a burden on providers to educate all patients who are MA enrollees in the context of hospital, clinic, or other health-related visits would therefore be counter to the principles of this provision. While providers may be well suited to give occasional guidance and support to enrollees regarding digital health literacy, CMS notes that many individuals with lower digital health literacy may attend fewer provider appointments. The potential lack of or limited access for these vulnerable enrollees means that providers may not be providing support to those who have the greatest need. In addition, we note that hospital, clinical, and other health-related visits are often brief and focused on specific medical issues, and that digital health education would not fit well into enrollees' medical visits.
We believe MA organizations are better positioned than providers and suppliers to evaluate their enrollee population's digital health literacy and provide meaningful digital health education to enrollees. MA organizations are well situated to leverage data they have that providers
We note the commenter's concerns about providing in-home training and agree that, in some cases, such a digital health education program would be beneficial to enrollees. However, we also note that this is a broad generalization, and that MA organizations are best suited to make this determination based on the mobility, health status, and other factors unique to each enrollee. Additionally, as noted previously, CMS agrees that there may be some cost involved in implementing a digital health literacy screening and a digital health education program. However, we are unable at this time to provide specific cost estimates.
We also note commenter's concerns about their ability to limit use of digital equipment to health services. However, we disagree. Current digital capability allows for a variety of controls, firewalls, and other programs that are designed to limit or otherwise curate the functions available to individuals utilizing digital equipment. Moreover, CMS has established standards in regulation relating to allowable supplemental benefits, and we believe that these regulations effectively clarify when MA organizations may offer specific supplement benefits and to whom MA organizations may offer them. We encourage MA organizations that provide digital equipment to their enrollees to take advantage of controls, firewalls, and other capabilities that would safeguard against enrollees using such equipment in an unintended or otherwise noncompliant manner.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing, with modification, the requirement that MA organizations must establish procedures to identify and offer digital health education to enrollees with low digital health literary to assist with accessing any medically necessary covered benefits that are furnished when the enrollee and the provider are not in the same location using electronic exchange, as defined in § 422.135. We are finalizing the proposal with modifications to apply the new requirement to all MA organizations, rather than only to MA organizations offering coordinated care plans by finalizing the revision at § 422.100(n) instead of § 422.112(b)(9). In addition, we are finalizing without modification the proposed policy that the MA organization must make information about its digital health literacy screening and digital health education programs available to CMS upon request. We are further finalizing our proposed language providing a non-exhaustive list of the information CMS may request from MA organizations under this policy.
In accordance with section 1852(e) of the Act, all MA organizations must have an ongoing Quality Improvement (QI) Program for the purpose of improving the quality of care provided to enrollees. Per § 422.152(a), MA organizations must develop a QI plan that sufficiently outlines the QI program elements; have a chronic care improvement program (CCIP) that meets the requirements at § 422.152(c) and addresses populations identified by CMS based on a review of current quality performance; and, encourage its providers to participate in CMS and HHS quality improvement initiatives.
Section 422.152(c) provides that CCIPs must include methods for identifying MA enrollees with multiple or sufficiently severe chronic conditions that would benefit from participating in a CCIP; mechanisms for monitoring MA enrollees that are participating in the CCIP and evaluating participant outcomes, such as changes in health status; performance assessments that use quality indicators that are objective, clearly and unambiguously defined, and based on current clinical knowledge or research, and systematic and ongoing follow-up on the effect of the CCIP. Organizations must report the status and results of each program to CMS as requested. The intent of the CCIPs is to promote effective chronic disease management and improve care and health outcomes for enrollees with chronic conditions. Furthermore, CCIPs should support the CMS Quality Strategy; include interventions that surpass MA organizations' inherent care coordination role and overall management of enrollees; engage enrollees as partners in their care; promote utilization of preventive services; facilitate development of targeted goals, specific interventions,
In accordance with 1852(e) of the Act, MA organizations are required to report quality performance data to CMS. MA organizations generally report such data through the Healthcare Effectiveness Data and Information Set (HEDIS), Health Outcomes Survey (HOS), Consumer Assessment of Healthcare Providers and Systems (CAHPS), and other related data collection tools. As codified at § 422.152(b)(3) and (5), MA coordinated care plans are required to report on quality performance data which CMS can use to help beneficiaries compare plans; MA local and regional PPO plans must similarly report under § 422.152(e)(2)(i). The areas of measurement include outcomes, patient experience, access, and process measures. In addition, CMS uses this information to develop and publicly post a 5-star rating system for MA plans based on its authority to disseminate comparative information, including about quality, to beneficiaries under sections 1851(d) and 1860D-1(c) of the Act.
To meet the needs of their enrolled special needs populations, MA special needs plans (SNPs) have additional QI program requirements, including the implementation of an approved model of care (MOC), which serves as the framework for meeting the individual needs of SNP enrollees, and the infrastructure to promote care management and care coordination (see § 422.152(g)). As part of the initial MA SNP application and renewal requirements and through MOC submissions, SNPs provide to CMS a detailed profile of the medical, social, cognitive, and environmental aspects, the living conditions, and the co-morbidities associated with the SNP population, including information about health conditions impacting SNP enrollees along with other characteristics that affect health, such as population demographics (for example, average age, sex, gender, ethnicity), and potential health disparities associated with specific groups (for example, language barriers, deficits in health literacy, poor socioeconomic status, cultural beliefs/barriers, caregiver considerations, or other). SNPs must also capture limitations and barriers that pose potential challenges for accessing care and/or maintaining and improving SNP enrollee health status.
Additionally, through health risk assessments (HRAs), SNPs identify the medical, functional, cognitive, psychosocial, and mental health needs of their enrollees, who are all special needs individuals, and address those needs in an individualized care plan for each enrollee. In the final rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” which appeared in the
Persistent inequities in health care outcomes exist in the United States, including among populations enrolled in MA organizations.
In the final rule titled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2023,” which appeared in the
MA organizations have long focused on addressing health disparities through QI program requirements. By assessing cultural, language, health literacy,
To improve the quality of care and health outcomes for MA enrollees and support the first pillar in the 2022 CMS strategic plan for advancing health equity, CMS proposed to amend the MA QI program regulations at § 422.152(a). Specifically, we proposed to amend § 422.152 by adding a new paragraph (a)(5), to require MA organizations to incorporate one or more activities into their overall QI program that reduce disparities in health and health care among their enrollees. We believe that many MA organizations are already addressing disparities and gaps in care for underserved populations through a variety of quality initiatives. Rather than limit these activities to specific QI program requirements such as the CCIPs, we proposed that MA organizations would be required to incorporate one or more activities that reduce disparities in health and health care across the broad spectrum of QI program requirements. MA organizations may implement activities such as improving communication, developing and using culturally appropriate materials (to distribute to enrollees or use in communicating with enrollees, community outreach, or similar activities. MA organizations should design activities so that they meet the needs of their particular enrollees, and therefore CMS is not prescriptive in the types of activities MA organizations must implement to meet this proposed new requirement. However, MA organizations must ensure that all their designed activities are broadly accessible irrespective of race, ethnicity, national origin, religion, sex, disability, or gender. These activities may be based upon health status and health needs, geography, or factors not listed in the previous sentence only as appropriate to address the relevant disparity in health or health care. Furthermore, adopting this requirement for MA organizations as part of their required QI programs aligns with health equity efforts across CMS policies and programs.
We summarize the comments received on the proposal at § 422.152(a)(5) and provide our responses to those comments in this section of this rule.
Lastly, we note that various aspects of the QI program require that MA organizations have processes in place to evaluate participant outcomes, the effectiveness of QI programs, report the status of CCIP results to CMS as requested, report quality performance data, etc. CMS' current oversight efforts include these requirements, and therefore, we do not believe it is necessary to impose additional means of oversight.
After consideration of the comments and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing our proposed change to 422.152(a)(5) without modification.
On March 1, 2022, President Biden announced a national strategy regarding behavioral health to strengthen system capacity and connect more individuals to care by ensuring that the nation's health and social services infrastructure addresses mental health holistically and equitably.
According to the Health Resources and Services Administration (HRSA), more than one-third of Americans live in designated Mental Health Professional Shortage Areas,
CMS continues to evaluate and seek ways to enhance our behavioral health policies to address the health care needs of those we serve. In order to support these goals, we are finalizing regulatory changes that focus on ensuring access to behavioral health services for MA enrollees.
We solicited comment on our proposals.
Section 1852(d)(1) of the Act permits an MA organization to select the providers from which an enrollee may receive covered benefits, provided that the MA organization, in addition to meeting other requirements, makes such benefits available and accessible in the service area with promptness and in a manner that assures continuity in the provision of benefits. To implement and adopt related standards for this, CMS codified, with some modifications, network adequacy criteria and access standards that were previously outlined in sub-regulatory guidance in the “Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program” final rule, which appeared in the
Currently, MA organizations are required to demonstrate that they meet network adequacy for two behavioral health specialty types, psychiatry and inpatient psychiatric facility services, under § 422.116(b). Further, the regulation at § 422.112 includes a number of requirements to ensure that MA enrollees have adequate access to covered services. Of note, § 422.112(a)(1) requires MA organizations to maintain and monitor a network of appropriate providers that provides access to typically used services including, primary care providers, specialists, hospitals, skilled nursing facilities, home health agencies, ambulatory clinics and other providers.
In response to the RFI in the January 2022 proposed rule, we received comments emphasizing the importance of network adequacy and ensuring adequate access to behavioral health providers in MA plans. Stakeholders responses to the RFI suggested that CMS expand the network adequacy time and distance standards for MA plans beyond those that we currently review through our network adequacy evaluations. Commenters suggested that we expand the standards to include other outpatient behavioral health physicians and health professionals, including those that treat substance use disorders (SUDs), as part of our evaluation of MA plan networks in order to better meet MA enrollees needs in accessing behavioral health care.
Even though over one million Medicare beneficiaries had a diagnosis of Opioid Use Disorder (OUD) and more than fifty thousand experienced an overdose in 2021, fewer than 1 in 5 of these Medicare beneficiaries with a diagnosis of OUD receive treatment for their OUD.
CMS is committed to ensuring that MA enrollees have access to provider networks sufficient to provide covered services, including access to behavioral health service providers. Medicare fee-for-service claims data for 2020 shows that for certain outpatient behavioral health services, the top provider specialty types to provide services to beneficiaries included psychiatrists, clinical social workers, nurse practitioners, and clinical psychologists. OTPs had the largest number of claims for SUD in this same time period. Therefore, we proposed to strengthen our network adequacy requirements for MA plans as it relates to behavioral health in three ways.
First, we proposed to add three new provider specialty types to the list at § 422.116(b)(1) to make them subject to the time, distance and minimum number requirements in our network adequacy evaluation: (1) clinical psychology, (2) clinical social work, and (3) one category called Prescribers of Medication for Opioid Use Disorder that includes two specialty types: providers with a waiver under section 303(g)(2) of the Controlled Substances Act (CSA) and OTPs. Most of these new specialty types are defined the same way as they are used for the original Medicare program in section 1861(hh) of the Act (defining “clinical social worker”), § 410.71(d) (defining “clinical psychologist”), and section 1861(jjj)(2) of the Act (defining “Opioid Treatment Program”). Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)(G)(ii)) establishes which providers have a waiver and we do not believe a definition in the MA regulations at 42 CFR part 422 is necessary.
Our current regulations, at § 422.116(a)(2), specify that an MA plan must meet maximum time and distance standards and contract with a specified minimum number of each provider and facility-specialty type. Therefore, as part of the proposed changes to our list of provider specialty types under § 422.116(b)(1), we proposed base time and distance standards and minimum number of in-person providers in each county type for each new specialty type as follows:
Maximum Time and Distance
Minimum Ratios:
In the proposed rule titled “Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” proposed rule which appeared in the
Further, we explained in the February 2020 proposed rule how CMS determines the minimum number requirement for all provider specialty types. By multiplying the “minimum ratio” by the “number of beneficiaries required to cover,” dividing the resulting product by 1,000, and rounding up to the next whole number. This is reflected in § 422.116(e)(2)(i) and (e)(3); the current regulation text addresses how the number of beneficiaries required to cover is calculated and will apply to the proposed new provider specialty types. The minimum ratio is the number of providers required per 1,000 beneficiaries. We developed the minimum ratios that currently appear in § 422.116 using various data sources, including, Medicare fee for-service claims data, American Medical Association (AMA) and American Osteopathic Association (AOA) physician workforce data, US Census population data, National Ambulatory Medical Care Survey data, and AMA data on physician productivity. In developing the proposal here to add new specialty types subject to network adequacy evaluation, we conducted additional research to inform appropriate minimum ratio requirements. We reviewed utilization data among FFS Medicare beneficiaries for the proposed specialty types for 2019 through 2021. We reviewed literature on the prevalence of behavioral health disorders among Medicare beneficiaries and existing models for projecting the needed behavioral health workforce such as the Health Resources and Services Administration's (HRSA) Health Workforce Simulation Model,
Second, in order to reinforce regulatory requirements for MA plans on their responsibility to provide access to critical behavioral health care services, we proposed to amend the list of health care providers in the existing access to services standards at § 422.112(a)(1)(i) to include that the network must also include providers that specialize in behavioral health services.
Finally, to encourage increased access to telehealth providers in contracted MA networks, § 422.116(d)(5) provides that for certain specialties, MA plans may receive a 10-percentage point credit towards the percentage of beneficiaries that reside within published time and distance standards when the plan includes one or more telehealth providers of that specialty type that provide additional telehealth benefits, as defined in § 422.135, in its contracted network. Medicare FFS claims data shows that telehealth was the second most common place of service for claims with a primary behavioral health diagnosis in 2020. As noted previously, the top provider specialty types to provide certain outpatient behavioral services to beneficiaries in that year included psychiatrists, clinical social workers, nurse practitioners, and clinical psychologists. Additionally, previous input from stakeholders discussed the importance of access to telehealth services specific to behavioral health in expanding access to care. Based on these considerations, we also proposed to add all the new behavioral health specialty types to the list at § 422.116(d)(5) of the specialty types that that will receive the credit if the MA organization's contracted network of providers includes one or more telehealth providers of that specialty type that provide additional telehealth benefits, as defined in § 422.135, for covered services.
We solicited comment on this proposal.
In addition, we are not adding OTPs to the facility-specialty type list in § 422.116(b)(2). We proposed a combined specialty type called Prescribers of Medication for Opioid Use Disorder, which included OTPs and MOUD Waivered Providers, that allowed us to create meaningful access standards. At this time there is not enough supply of OTPs to create meaningful access standards. As OTPs continue to expand, we will monitor the appropriateness of setting network adequacy standards in future rulemaking. We remind MA organizations that they are required to arrange for and cover the Part B OTP benefit, which may only be furnished by certified OTPs. Therefore, as a practical matter, MA organizations must include certified OTPs in their networks or arrange out-of-network care (at in-network cost sharing) for their enrollees who need OTP benefits.
Finally, we thank commenters for their suggestions on alternative standards for this important category of providers, and we will consider all comments in future rulemaking.
We are extending the telehealth credit for the new specialty types consistent with other established credits afforded to MA organizations in meeting network standards. We will continue to monitor the credit and consider whether changes are appropriate in future rulemaking.
Based on our review and consideration of the comments received, and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing these provisions with two modifications as follows:
• We are not finalizing the addition of Prescribers of Medication for Opioid Use Disorder as a specialty type for which we set network adequacy standards. We are finalizing the addition of clinical psychology and clinical social work to the list of provider specialty types at § 422.116(b)(1), requiring these new specialty types to be subject to network adequacy standards.
• Adding time and distance standards and minimum ratios for the two new specialty types to § 422.116 to Table 1 to Paragraph (d)(2) and Table 2 to Paragraph (e)(3)(i)(C), respectively, to indicate the standards for the two new specialty types, clinical psychology and clinical social work.
• Amending § 422.112(a)(1)(i) to include that the network must also include providers that specialize in behavioral health services.
• Adding clinical psychology and clinical social work to the list at § 422.116(d)(5) that that will receive the 10 percentage point credit if the MA organization's contracted network of providers includes one or more telehealth providers of that specialty type that provide additional telehealth benefits, as defined in § 422.135, for covered services.
Section 1852(d)(1)(A) of the Act requires MA organizations that use a network of providers to make benefits under the plan available and accessible to each individual electing the plan within the plan service area. CMS proposed to further ensure that enrollees have access to behavioral health services by adding behavioral health services to the types of services for which MA organizations that offer MA coordinated care plans must have programs in place to ensure continuity of care and integration of services at § 422.112(b)(3). Under 422.112(b)(3), MA organizations must coordinate plan services with community and social services available through contracting or noncontracting providers in the area served by the MA plan, which must be made available for enrollees as part of overall delivery and coordination of services. CMS proposed to revise § 422.112(b)(3) to include behavioral health services by adding the phrase “, and behavioral health services” after the words “community-based services” at the end of § 422.112(b)(3). CMS believes the inclusion of behavioral health care services among the services for which MA organizations must have a care coordination program in place will better ensure enrollee access to such services.
An “emergency medical condition” under § 422.113(b)(1)(i) is defined as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, with an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in serious jeopardy to the health of the individual or their unborn child, serious impairment to bodily function, or serious dysfunction of any bodily organ or part; this regulatory definition generally mirrors the statutory definition in section 1852(d)(3)(B) of the Act. However, the definition does not explicitly address that its criteria extends to conditions both physical and mental, that is, behavioral, health. CMS interprets the scope of the definition to pertain to both physical and behavioral health conditions when those conditions meet the prudent layperson standard discussed in § 422.113(b)(1)(i), consistent with the statute.
Accordingly, CMS proposed to amend the regulation by inserting “, mental or physical,” after the word “condition” and before the word “manifesting.” We explained that we intended the proposed revision to ensure that emergency medical conditions are easily interpreted as including both physical and mental health conditions, thereby prohibiting the use of prior authorization as required by the statute and guaranteeing that coverage is provided by the MA organization, consistent with the statute. This ensures that enrollees have access to emergency behavioral health services in parity with access to other medical emergency services.
Under § 422.113(b)(3), the physician treating the enrollee must decide when the enrollee may be considered stabilized for transfer or discharge, and that decision is binding on the MA organization. The MA organization is financially responsible (consistent with § 422.100(b) and 422.214 regarding payment) for post-stabilization services as specified in § 422.113(c)(2) and (c)(3).
All public comments received on these proposals were generally supportive, including those that requested modifications be made to the final rule. For reasons presented in the proposed rule and our discussion of the public comments, we are finalizing changes to § 422.113 as proposed.
CMS solicited public comment through RFI that appeared in the January 2022 proposed rule regarding the challenges that exist with accessing behavioral health providers for MA enrollees and how to resolve issues with building adequate behavioral health networks within MA plans. The responses to this RFI included requests that CMS consider strengthening network adequacy standards and improving access to care and services for enrollees by establishing requirements for appointment wait times for behavioral health services. We also heard that beneficiaries experience barriers to treatment for behavioral health conditions, including opioid use disorder.
Section 1852(d) of the Act requires MA plans that limit coverage using provider networks to make covered benefits available and accessible to enrollees in the plan service area with reasonable promptness and in a manner that assures continuity in the provision of benefits, and that medically necessary care must be available and accessible 24 hours a day and 7 days a week. The MA regulation at § 422.112 includes requirements and standards to ensure that MA organizations that offer coordinated care plans, which generally use networks of providers, meet the statutory requirements. Under these rules, MA organizations must ensure that all covered services are made available and accessible to enrollees by the plan's designated provider network. Furthermore, MA organizations are required under § 422.112(a)(6)(i) to maintain written standards that require timely access to care for enrollees which meet or exceed those established by CMS. Timely access to care and member services within a plan's provider network must be continuously monitored to ensure compliance with these standards, and the MA organization must take corrective action as necessary. CMS has provided guidelines for MA organizations in the Medicare Managed Care Manual, Chapter 4, “Benefits and Beneficiary Protections,” section 110.1.1,
The 2022 CMS Behavioral Health Strategy
We proposed that the wait time standards for behavioral health services would apply to both mental health services and substance use disorder services. We remind MA organizations that substance use disorder services include medications for opioid use disorder (MOUD), which is particularly important as opioid-related overdose deaths have spiked during the pandemic,
In addition, the proposal to codify wait time standards for primary care is consistent with the goal to increase
We also sought comment on alternative specific appointment wait times standards to apply to MA organizations. For example, we considered, as suggested by a commenter on our RFI, establishing appointment wait time standards that align with those established for qualified health plans, (QHPs) as outlined by CMS in the “2023 Final Letter to Issuers in the Federally-facilitated Exchanges.”
The proposal for mandatory standards for minimum wait times for MA enrollees is intended to ensure that MA enrollees are able to access covered services and that MA organizations meet their obligations under section 1852(d) of the Act to make covered benefits available and accessible to enrollees in the plan. Section 1856(b) of the Act authorizes the adoption of standards that are consistent with and to carry out the Part C statute.
We are also considering requiring new and expanding service area applicants to attest to their ability to provide timely access to care consistent with the CMS standards for appointment wait time we would add to § 422.112(a)(6)(i). We would implement a new application requirement by adding a new attestation to our “Part C—Medicare Advantage and 1876 Cost Plan Expansion Application” that specifically addresses requirements at § 422.112(a)(6)(i). Such an attestation would not be reflected in a specific regulation, however, because we believe the requirement at § 422.501(c)(2), that an applicant thoroughly describe how the entity and MA plan meet, or will meet, all the requirements described in this part, permits CMS to use an attestation to support the ability of an MA organization to comply with performance requirements. Adequate access to services for MA enrollees is a key consideration.
We solicited comment on our proposal, including whether one or more of the previously described sets of standards for wait time would more effectively address our goals of ensuring that MA organizations are meeting timely access standards for primary care and behavioral health services for enrollees, supporting parity between behavioral health and physical health services, and strengthening our requirements for MA organizations to ensure beneficiary protections in access to care. In addition, we solicited comment on whether a specific standard limit for appointment wait times for emergency or urgently needed services is duplicative of the mandatory coverage and access requirements in § 422.113.
After consideration of the comments and for the reasons outlined in the proposed rule and our response to comments, we are finalizing the proposed revisions to § 422.112(a)(6)(i) substantially as proposed but with a modification to clarify that the standards are based on business days.
Section 1852(d)(1)(A) of the Act establishes that an MA organization offering an MA plan may select the providers from whom the benefits under the plan are provided so long as the organization makes such benefits available and accessible to each individual electing the plan within the plan service area with reasonable promptness and in a manner that assures continuity in the provision of benefits. This is generally implemented at § 422.112(a), which provides that an MA organization that offers an MA coordinated care plan may specify the networks of providers from whom enrollees may obtain services if the MA organization ensures that all covered services are available and accessible under the plan. The regulation also includes specific additional requirements for MA organizations offering coordinated care plans related to the availability and accessibility of coverage. In addition, the statute and regulation apply these requirements to all benefits covered by the plan, including both basic and supplemental benefits.
More specifically, section 1852(d)(1)(D) of the Act requires an MA organization to provide access to appropriate providers, including credentialed specialists, for medically necessary treatment and services, as a condition of the MA organization limiting coverage to a specified network of providers. CMS implemented this statutory requirement at § 422.112(a)(1)(i), which provides that the MA organization offering a coordinated care plan must maintain and monitor a network of appropriate providers that is supported by written agreements and is sufficient to provide adequate access to covered services to meet the needs of the population served. In addition, § 422.112(a)(3) requires that the MA organization provide or arrange for necessary specialty care and arrange for specialty care outside of the plan's provider network when network providers are unavailable or inadequate to meet an enrollee's medical needs.
Historically, CMS has interpreted these statutory and regulatory requirements to mean that in the event an in-network provider or service is unavailable or inadequate to meet an enrollee's medical needs, the MA organization must arrange for any medically necessary covered benefit outside of the plan provider network at in-network cost sharing for the enrollee. For example, if an enrollee needs OTP services but there is no in-network OTP available, then the MA organization must arrange for the enrollee to go to an out-of-network OTP at in-network cost sharing. In our view, furnishing access out of network with higher cost sharing when the MA plan's network is inadequate or otherwise does not address the medically necessary benefit required by an enrollee is not consistent with section 1852(d)(1) of the Act. Enrollees should not bear a financial burden because of the inadequacy of the MA plan's network. This interpretation is reflected in CMS guidance in section 110.1.1 of Chapter 4 of the MMCM,
Currently, the regulation text at § 422.112(a)(3) does not fully account for the scope of an MA organization's obligations when medically necessary benefits are only accessible out of network in two key ways. First, the regulation text refers to specialty care only, not all medically necessary covered benefits. This oversight does not align with the statutory requirement at section 1852(d)(1)(D) of the Act, which states broadly that the organization must provide access to “appropriate providers, including credentialed specialists,” and does not limit the requirement to specialists only. Second, the aspect of maintaining in-network cost sharing when the MA organization arranges for the benefit outside of the network is not clearly stated in § 422.112(a)(3). Therefore, CMS proposed to amend § 422.112 to be consistent with current, longstanding sub-regulatory policy and our implementation of section 1852(d) of the Act.
CMS proposed to codify this policy by revising § 422.112(a)(3) and adding new regulatory text to § 422.112(a)(1) to reflect the longstanding policy. Specifically, we proposed to move the sentence requiring the MA organization to arrange for out-of-network care currently in paragraph (a)(3) to a new paragraph (a)(1)(iii) and revise and supplement it with additional text to better state the full scope of the current policy. We proposed that new paragraph (a)(1)(iii) would require MA organizations offering coordinated care plans to arrange for any medically necessary covered benefit outside of the plan provider network, but at in-network cost sharing, when an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs.
CMS currently monitors MA organization compliance with this existing policy through account management activities, complaint tracking and reporting, and auditing activities. These oversight operations alert CMS to any issues with access to care, and CMS may require MA organizations to address these matters if they arise. We stated in the proposed rule that, if finalized, CMS intends to continue these oversight operations to ensure MA organizations' compliance with the proposed regulation.
This proposal to amend § 422.112 codifies the agency's existing interpretation of applicable law and longstanding guidance. CMS has not been made aware of any issues of MA organization non-compliance with this policy and, as such, believes that MA organizations have been complying with this longstanding guidance. Therefore, we stated in the proposed rule that the proposed amendment to § 422.112(a)(1) and (a)(3) would not impose new information collection requirements (that is, reporting, recordkeeping, or third-party disclosure requirements), and we did not provide burden estimates in the Collection of Information section of the proposed rule. In addition, this provision is not expected to have any economic impact on the Medicare Trust Fund.
We solicited comment on this proposal, including on the accuracy of our assumptions regarding information collection requirements and regulatory impact. We did not receive comment on our information collection requirements nor regulatory impact. We thank commenters for their input on CMS's proposed amendment to § 422.112. We received the following comments on this proposal, and our response follows:
The term “arranges for” means that the MA organization may need to enter into case-by-case agreements with non-contracted, out-of-network providers to ensure enrollees' access to services. In the example previously discussed, if an enrollee needs to see a particular out-of-network specialist or subspecialist, the MA organization may need to enter into a limited contract with the closest available qualified specialist to ensure its enrollee has access to the medically necessary specialist services. (We note that except for emergency services, non-contracted providers are generally not legally required to treat MA enrollees.) Or the MA organization may authorize and cover services furnished by a non-contracted provider selected by the enrollee without the MA organization engaging in a short-term agreement with the provider. Regarding what constitutes “necessary specialty care,” the MA organization must make medical
We understand commenters' concerns around timeliness of access to care. Per current CMS regulations at § 422.112(a)(6)(i), MA organizations must establish written access standards for timeliness of access to care that meet or exceed standards established by CMS, timely access to care within a plan's provider network must be continuously monitored to ensure compliance with these standards, and the MA organization must take corrective action as necessary. CMS does not (and will not under the revisions to § 422.112(a)(6)(i) adopted elsewhere in this final rule) apply the same wait time standards for out-of-network care because MA organizations do not have contracts with out-of-network providers to require timely access to care; we appreciate that MA organizations have no contractual mechanism to hold out-of-network providers accountable and ensure out-of-network care is provided timely to their enrollees. While these requirements for timeliness of access to care apply to in-network care only, per § 422.568, MA organizations must notify the enrollee of its determination to in or out-of-network care as expeditiously as the enrollee's health condition requires, but no later than 14 calendar days after the MA organization receives the request for a standard request, and no later than 72 hours for an expedited request, with the exception that the MA organization may extend the timeframe by up to 14 calendar days if the extension is justified and in the enrollee's interest. If an MA organization chose to enter into a case-by-case agreement or limited contract with a non-contracted provider, as described in the preceding paragraph, then they may be able to include a clause about timely access to care in their agreement or contract with an expedited review time no greater than the requirement established in § 422.568(b)(1)(i)(B), but CMS does not require this.
In general, while MA organizations may not have the same level of control when it comes to care provided outside of their plan provider network, we still expect MA organizations to make their best effort to ensure that the out-of-network care they arrange for is provided timely, including for cancer diagnoses. The manner in which they do so is at the MA organization's discretion, however, enrollees' best interests should always be prioritized.
We note that the inability to offer in-network care may be evidence that an MA organization is failing to meet CMS's required network adequacy standards. Arranging for care outside of the network, while a responsibility of MA organizations, should not be the norm. Any out-of-network alternative arrangements should only be made in the rare circumstance that an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs. We also note that MA organizations are required to arrange for medically necessary covered out-of-network care at in-network cost sharing if in-network care is unavailable or inadequate to meet the enrollee's medical needs, despite the type of care (cancer or otherwise).
We are finalizing § 422.112(a)(1)(iii) as proposed and not adding any definitions to the regulatory text, however, we hope our response provides some helpful clarification and guidance to commenters on how we interpret and will implement these changes.
Alternatively, if the MA organization has another means or mechanism to address the enrollee's need for care without contracting with an out-of-network provider to furnish that care, then the applicable regulations do not necessarily prohibit alternate solutions. For example, the MA organization may waive referral or “gatekeeper” requirements for an enrollee who cannot access in-network primary care providers (PCPs) in a timely manner to get a referral or gatekeeper approval for a specialist visit. In addition, if an MA organization requires its enrollees to obtain a referral in most situations before receiving services from a specialist, specialty care is medically necessary, and the enrollee has not selected a PCP, then the MA organization could assign a PCP for purposes of making the needed referral. To account for situations like these—where the enrollee finds the provider and the issue is not about the MA organization not contracting with that provider, but rather authorizing the ability to obtain medically necessary services out-of-network—we are modifying the regulatory text at § 422.112(a)(1)(iii) to read “arrange for and cover” instead of just “arrange for.”
Regarding comments about reimbursement rates for non-contracted providers, it is true that MA organizations are required to pay non-contracted providers at least what they would have received had they furnished the services in an original Medicare setting, but providers are not obligated to participate in Medicare. This is required by section 1852(k)(1) of the Act and § 422.100(b)(2). We note that § 422.220(a) prohibits MA organization from paying, directly or indirectly, on any basis, for basic benefits furnished to a Medicare enrollee by a physician (as defined in paragraphs (1), (2), (3), and (4) of section 1861(r) of the Act) or other practitioner (as defined in section 1842(b)(18)(C) of the Act) who has filed with the Medicare contractor an affidavit promising to furnish Medicare-covered services to Medicare beneficiaries only through private contracts under section 1802(b) of the Act with the beneficiaries. In addition, § 422.224(a) prohibits MA organizations from paying, directly or indirectly, on any basis, for items or services furnished to a Medicare enrollee by any individual or entity that is excluded by the Office of the Inspector General (OIG) or is included on the preclusion list, defined in § 422.2. We reiterate that MA organizations must prioritize meeting CMS's required network adequacy standards, and arranging for care outside of the network, while a responsibility of MA organizations, should not be the norm. Any out-of-network alternative arrangements should only be made in the rare circumstance that an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs.
Finally, we recognize the commenter's concern that many MA organizations' existing processes for providing access to out-of-network care are problematic. It is our hope that this regulation will strengthen our requirement that MA organizations ensure adequate access to medically necessary covered benefits and compel MA organizations to reexamine their existing processes and make improvements to fully comply with CMS's requirements.
We received a range of comments pertaining to this proposal, the majority of which reflected support for the regulation. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the proposed changes to § 422.112(a)(1)(iii) and (3) with slight modification. We are modifying the regulation text as follows. In proposed regulation text § 422.112(a)(1)(iii), we are adding the phrase “and cover.” Thus, we are revising § 422.112(a)(1)(iii) to read as follows: “Arrange for and cover any medically necessary covered benefit outside of the plan provider network, but at in-network cost sharing, when an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs.”
As provided in section 1852(d) of the Act and discussed in section 110.1.2.1 of Chapter 4 of the MMCM, MA organizations have considerable discretion to select the providers with whom to contract in order to build high-performing, cost effective provider networks.
First, we proposed to clarify the regulatory text at § 422.111(e) regarding whether the provider contract termination was for cause or without cause. The regulation currently requires that the MA organization must make a good faith effort to notify enrollees at least 30 calendar days before the termination effective date, irrespective of whether the termination was for cause or without cause. This last clause does not consider § 422.202(d)(4), which outlines the timeframe requirement for suspension or termination of an MA organization's contract with a provider. An MA organization and a contracted provider are required by § 422.202(d)(4) to provide at least 60 days written notice to each other before terminating the contract without cause. We stated in the proposed rule that consequently, because MA organizations are provided at least a 60-day notice of any no-cause provider contract termination, MA organizations should be able to timely meet a CMS established enrollee notification requirement that provides the MA organization a period of time that is less than 60 days to notify enrollees of the no-cause provider contract termination. Provider contract terminations that are for-cause, however, do not have an equivalent notification requirement as exists at § 422.202(d)(4) for MA organizations and contracted providers, which means that for-cause provider contract terminations could potentially occur with little notice or without any notice at all. In this case, it may not always be possible for the MA organization to notify enrollees in a reasonable amount of time before the provider contract termination effective date. Thus, we proposed to preserve the phrase “good faith effort” for enrollee notifications for for-cause provider contract terminations regarding the proposed timeframes. We proposed that the “good faith effort” standard would apply to the timing component for for-cause provider contract terminations. However, we proposed to remove “good faith effort” for no-cause provider contract terminations. We stated in the proposed rule that we believe when an MA organization's contracted provider network changes, these enrollee notifications are essential for updating enrollees who are patients of the terminating providers. If an enrollee's provider is terminated from their network during the contract year, the enrollee must be notified so that they can decide how to proceed with the care they are receiving from that provider. By limiting the “good faith effort” standard to the timing of for-cause provider contract terminations, we stated that our proposal would make it clear that issuing the notification to enrollees is a requirement that all MA organizations must follow without exception, but in the case of for-cause provider contract terminations, MA organizations must make a good faith effort to notify enrollees of the termination within the proposed timeframes.
Next, we proposed to add new provisions to § 422.111(e) to address provider contract terminations that involve behavioral health providers. For purposes of this proposal, CMS considered various specialty types (both providers and facilities) as fitting the
According to a recent study, because of the ongoing nature of patient/provider relationships, when a provider leaves a plan's network, there is a potential disruption to the patient's treatment plan; this disruption could be especially problematic in the case of behavioral health treatment because this treatment may be longer in duration than that of physical health, and providers and patients are likely to need more time to develop mutual trust.
A similar case is made for terminating primary care providers both due to the fact that behavioral health services are often offered by primary care providers and the foundational role primary care providers play in an individual's overall health. According to the American Academy of Family Physicians, up to 75 percent of primary care visits include aspects of behavioral health.
To address the previously detailed concerns surrounding unexpected changes in MA primary care and behavioral health provider networks, we proposed to add specific enrollee notification requirements for these types of provider contract terminations. Our proposal had three key aspects. We first proposed to add behavioral health providers to the current requirement at § 422.111(e) that all enrollees who are patients of a terminating primary care provider must be notified (not just those enrollees who are patients seen on a regular basis by the terminating provider, which is the case for all other specialty types), and expand the scope of this requirement to refer to all enrollees who have ever been patients of these terminating primary care or behavioral health providers (not just current patients). We proposed that this addition would be reflected at proposed new paragraph (e)(1)(iii). Next, at proposed new paragraph (e)(1)(ii), we proposed to require MA organizations to provide notice to enrollees at least 45 calendar days before the termination effective date for contract terminations that involve a primary care or behavioral health provider, which is longer than the 30-day standard for all other specialty types. Finally, we proposed to require both written and telephonic notice for contract terminations that involve a primary care or behavioral health provider at new proposed paragraph (e)(1)(i), while only written notice would be required for all other specialty types. We proposed that both types of notice would need to be provided at least 45 calendar days before the termination effective date. For the telephonic notice, we proposed that the first telephone call be made to the enrollee at least 45 calendar days in advance. We proposed that the MA organization would be required to continue attempting to reach the enrollee by telephone to provide notice of the termination of the provider from the network. We did not propose a specific number of attempts required by the MA organization when they reach out to the enrollee by telephone and the call goes unanswered, but we solicited comment from MA organizations on how many telephonic attempts they believe are reasonable in this circumstance (for example, 1-5, 6-10, 11-15). To help inform our proposal, we requested qualitative feedback based on any MA organization's actual experience providing enrollees telephonic notice of primary care and behavioral health provider contract terminations.
In the proposed rule, we stated that these proposed requirements for MA organizations providing enrollees notice of primary care and behavioral health provider contract terminations are intended to raise the standards for the stability of enrollees' primary care and
We proposed that MA organizations would continue to be required to provide written notice at least 30 days before the termination effective date of a termination of a contracted provider that is not a primary care or behavioral health provider to all enrollees who are patients seen on a regular basis by the terminating provider. We also proposed to codify at § 422.111(e)(2)(iii) a definition of the phrase “enrollees who are patients seen on a regular basis by the provider whose contract is terminating.” CMS currently has sub-regulatory guidance in section 110.1.2.3 of Chapter 4 of the MMCM that defines this term as enrollees who are assigned to, currently receiving care from, or have received care within the past three months from a provider or facility being terminated, also called “affected enrollees.”
We proposed that the requirements for contract terminations that involve specialty types other than primary care or behavioral health (written notice only, at least 30 calendar days before the termination effective date, and to all enrollees who are patients seen on a regular basis by the provider whose contract is terminating) would be set forth at new proposed § 422.111(e)(2). This would provide a clear distinction for MA organizations between CMS's enrollee notification requirements for contract terminations that involve a primary care or behavioral health provider (at new proposed paragraph (e)(1)) and all other provider contract terminations. We reiterate that the beginning proposed revised regulatory text at § 422.111(e) also distinguished between no-cause and for-cause provider contract terminations, with the former scenario prompting a requirement for MA organizations to provide the enrollee notifications and the latter requiring MA organizations to make a good faith effort to notify enrollees within the required timeframes. Regardless, whenever an MA organization notifies enrollees about a provider contract termination (whether it is with or without cause), CMS proposed that MA organizations must follow these new requirements outlined at proposed paragraphs (e)(1) and (2).
Finally, regarding the content of the provider termination notice, CMS's regulation at § 422.2267(e)(12) currently provides that the Provider Termination Notice is a required model communications material through which MA organizations must provide the information required under § 422.111(e). CMS has provided additional guidance regarding the content of the provider termination notice in section 110.1.2.3 of Chapter 4 of the MMCM.
First, at proposed § 422.2267(e)(12)(ii)(A), we proposed that the provider termination notice must inform the enrollee that the provider will no longer be in the network and the date the provider will leave the network. We modeled this proposed regulatory text after the established precedent for the equivalent notice requirement for the Non-renewal Notice model communications material as provided at § 422.2267(e)(10)(ii)(A) (we refer readers to section III.I. of this final rule for our amendment to paragraph (e)(10) to make the Non-renewal Notice a standardized communications material). Next, we proposed to codify a requirement to include the information currently described in the best practices guidance in Chapter 4 of the MMCM at proposed § 422.2267(e)(12)(ii)(B), (C), and (E), specifically: names and phone numbers of in-network providers that the enrollee may access for continued care (this information may be supplemented with information for accessing a current provider directory, including both online and direct mail options) (at proposed paragraph (e)(12)(ii)(B)); how the enrollee may request a continuation of ongoing medical treatment or therapies with their current provider (at proposed paragraph (e)(12)(ii)(C)); and the MA organization's call center telephone number, TTY number, and hours and days of operation (at proposed paragraph (e)(12)(ii)(E)). For proposed paragraph (e)(12)(ii)(B) and (C), we proposed to use the same description for the relevant content that is currently found in CMS's guidance in Chapter 4 of the MMCM. However, for proposed paragraph (e)(12)(ii)(E), instead of using the existing Chapter 4 language (“customer service number(s) where answers to questions about the network changes will be available”), we proposed to model the proposed
In addition, at proposed § 422.2267(e)(12)(ii)(D), we proposed that the provider termination notice must provide information about the Annual Coordinated Election Period (AEP) and the MA Open Enrollment Period (MA-OEP) and must explain that an enrollee who is impacted by the provider termination may contact 1-800-MEDICARE to request assistance in identifying and switching to other coverage, or to request consideration for a special election period (SEP), as specified in § 422.62(b)(26), based on the individual's unique circumstances and consistent with existing parameters for this SEP. We solicited comment on our proposal to consider an enrollee who is impacted by a provider contract termination to be someone who is experiencing an exceptional condition, as specified in § 422.62(b)(26), and therefore eligible for this SEP. We also solicited comment on alternative approaches; specifically, the adoption of a new SEP for this type of provider contract termination, with explicit standards for when termination of a provider from the network should serve as a basis for SEP eligibility.
The last proposal we made regarding the provider termination notice requirements at § 422.2267(e)(12) concerned CMS's requirements for the telephonic notice that we proposed MA organizations must provide to enrollees at least 45 days in advance of a primary care or behavioral health provider contract termination. Specifically, at proposed § 422.2267(e)(12)(iii), we proposed that the telephonic notice of provider termination specified in proposed § 422.111(e)(1)(i) must relay the same information as the written provider termination notice as described in paragraph (e)(12)(ii) of § 422.2267. We stated in the proposed rule that we believed that requiring the MA organization to communicate the same information on the primary care or behavioral health provider contract termination through two different channels—a written letter and a telephone call—would ensure that affected enrollees receive the information they need to decide how to proceed with their current course of treatment. We stated that the telephonic communication would reiterate the change occurring in the plan's network and the options the enrollee has moving forward in the absence of their current provider.
The provider termination notice is a model communications material which, per § 422.2267(c), is created by CMS as an example of how to convey enrollee information. When drafting this required communications material, MA organizations must: (1) accurately convey the vital information in the required material to the enrollee, although the MA organization is not required to use the CMS model material verbatim; and (2) follow CMS's order of content, when specified (see § 422.2267(c)(1) and (2)). While the regulation currently identifies the provider termination notice as a model communications material, CMS has not yet developed the model document for MA organizations to use. Rather, MA organizations have been expected to follow the current guidance in section 110.1.2.3 of Chapter 4 of the MMCM.
Regarding compliance monitoring for the regulatory amendments we proposed, CMS currently monitors MA organization compliance with the existing policies at §§ 422.111(e) and 422.2267(e)(12) through account management activities, complaint tracking and reporting, and auditing activities. These oversight operations alert CMS to any issues with enrollees that did not receive adequate notice of a provider contract termination, and CMS may require MA organizations to address these matters if they arise. We stated in the proposed rule that if finalized, CMS intends to continue these oversight operations to ensure MA organizations' compliance with the proposed regulation. We stated that in accordance with § 422.2261(c)(2), CMS may require submission or submission and approval of communications materials prior to use if additional oversight is warranted as determined by CMS based on feedback such as complaints or data gathered through reviews. This is to ensure the information being received by enrollees is accurate. Furthermore, § 422.2261(d)(1) and (3) establish that CMS reviews materials to ensure compliance with all applicable requirements under §§ 422.2260 through 422.2267 and that CMS may determine, upon review of such materials (either prospective or retrospective), that the materials must be modified, or may no longer be used. Therefore, we stated in the proposed rule that CMS reserves the right to review any MA organization's provider termination notice if we receive complaints or other information signifying that the notice warrants additional oversight to ensure compliance with CMS regulations for provider termination notices at §§ 422.111(e) and 422.2267(e)(12). We also stated that if CMS does exercise its authority under § 422.2261(c) to review an MA organization's provider termination notice, per § 422.2261(d)(1) and (3), CMS will review the notice to ensure compliance with the applicable regulations and, as a result, may require the MA organization to modify the notice or no longer use it.
In summary, CMS proposed to revise: (1) § 422.111(e) by establishing specific enrollee notification requirements for no-cause and for-cause provider contract terminations and adding specific and more stringent enrollee notification requirements when primary care and behavioral health provider contract terminations occur; and (2) § 422.2267(e)(12) to specify the requirements for the content of the notification to enrollees about a provider contract termination. We solicited comment on these proposals. We thank commenters for their input on CMS's proposed new enrollee notification requirements for MA provider contract terminations. We received the following comments on this proposal, and our response follows:
Two commenters requested that information on the SEP for exceptional conditions be featured more prominently in CMS publications.
We also solicited comment on alternative approaches; specifically, the adoption of a new SEP for this type of provider contract termination, with explicit standards for when termination of a provider from the network should
Another commenter requested that CMS take the position that that any enrollee who has ever received care from a particular provider or facility is eligible for an SEP upon termination of that provider or facility, including an enrollee who attests to having confirmed a provider's or facility's in-network status when making a decision to join the MA plan.
One commenter who expressed opposition to offering an SEP to an enrollee who is impacted by a provider contract termination stated that an enrollee should not be eligible for an SEP if other providers are available in the network. Another stated that notifying enrollees of a potential SEP may create confusion when a provider retires and there are other providers available in the network.
We received a range of comments pertaining to this proposal, the majority of which reflected support for the regulations. After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the proposed changes to § 422.111(e) with the following modifications:
• In proposed regulation text § 422.111(e)(1)(i), we are removing the phrase “both written and telephonic notice” and adding the phrase “written notice and make one attempt at telephonic notice to those enrollees identified in paragraph (e)(1)(iii) of this section who have not opted out of calls regarding plan business as described in § 422.2264(b).” Thus, we are revising (e)(1)(i) to read as follows: “Provide written notice and make one attempt at telephonic notice to those enrollees identified in paragraph (e)(1)(iii) of this section who have not opted out of calls regarding plan business as described in § 422.2264(b),”
• In proposed regulation text § 422.111(e)(1)(iii), we are adding the phrase “are currently assigned to that primary care provider and to enrollees who” and removing the word “ever” and adding the phrase “within the past three years.” Thus, we are revising (e)(1)(iii) to read as follows: “To all enrollees who are currently assigned to that primary care provider and to enrollees who have been patients of that primary care or behavioral health provider within the past three years.”
We are finalizing changes to § 422.2267(e)(12) as proposed.
A majority of MA plans are coordinated care plans, which is defined at § 422.4(a) as a plan that includes a network of providers that are under contract or arrangement with an MA organization to deliver the benefit package approved by CMS. CMS regulations at § 422.202(b) require that each MA organization consult with network providers on the organization's medical policy, quality improvement programs, medical management procedures, and ensure that certain standards are met. For example, coordinated care plans must ensure that practice guidelines and utilization management guidelines are based on reasonable medical evidence or a consensus of health care professionals in the particular field; consider the needs of the enrolled population; are developed in consultation with contracting physicians; and are reviewed and updated periodically. Further, these guidelines must be communicated to providers and, as appropriate, to enrollees.
Coordinated care plans are designed to manage cost, service utilization, and quality by ensuring that only medically necessary care is provided. This is done in part through the use of utilization management tools, including prior authorization, expressly referenced at section 1852(c)(1)(G) and (c)(2)(B) of the Act. These tools are designed to help MA plans determine the medical necessity of services and minimize the furnishing of unnecessary services, thereby helping to contain costs and protect beneficiaries from receiving unnecessary care. Additionally, section 1852(g)(1)(A) of the Act states that MA plans shall have a procedure for making determinations regarding whether an enrollee is entitled to receive a health care service and that such determinations must be made on a timely basis; that provision applies to both prior authorization determinations and to post-service decisions about coverage and payment.
In addition, CMS regulations at § 422.101(a) and (b) require that MA plans provide coverage of all basic benefits (that is, services covered under Medicare Parts A and B, except hospice care and the cost of kidney acquisitions for transplant) and that MA plans must comply with Traditional Medicare national coverage determinations (NCDs) and local coverage determinations (LCDs) applicable in the MA plan's service area.
In addition, in April 2022, the Office of the Inspector General (OIG) released a report
CMS understands that utilization management tools are an important means to coordinate care, reduce inappropriate utilization, and promote cost-efficient care. In light of the feedback we have received from stakeholders and the findings in the OIG report, however, we have concluded that certain guardrails are needed to ensure that utilization management tools are used, and associated coverage decisions are made, in ways that ensure timely and appropriate access to medically necessary care for beneficiaries enrolled in MA plans. We proposed to clarify requirements for the coverage criteria that MA plans use when making medical necessity determinations. We also proposed additional beneficiary protection requirements in order to improve continuity of care and integration of health care services and to increase plan compliance with regards to utilization management policies. Our proposals interpreted and implemented the requirements in section 1852 of the Act regarding the provision and coverage of services by MA plans and were, therefore, proposed under our authority in section 1856 of the Act to adopt standards to carry out the Part C statute and MA program.
As originally stated in the June 2000 final rule (65 FR 40207), MA organizations must cover all Part A and B benefits, excluding hospice services and the cost of kidney acquisitions for transplant, on the same conditions that items and services are furnished in Traditional Medicare. This means that MA organizations may not limit coverage through the adoption of policies and procedures—whether those policies and procedures are called utilization management and prior authorization or the standards and criteria that the MA organization uses to assess and evaluate medical necessity—when those policies and procedures result in denials of coverage or payment where the Traditional Medicare program would cover and pay for the item or service furnished to the beneficiary. In addition, this means that limits or conditions on payment and coverage in the Traditional Medicare program—such as who may deliver a service and in what setting a service may be provided, the criteria adopted in relevant NCDs and LCDs, and other substantive conditions—apply to set the scope of basic benefits as defined in § 422.100(c).
MA organizations have flexibility to furnish and cover services without meeting all substantive conditions of coverage in Traditional Medicare, but that flexibility is limited to and in the form of supplemental benefits. As stated in the June 2000 final rule, MA organizations' flexibility to deliver care using cost-effective approaches should not be construed to mean that Medicare coverage policies do not apply to the MA program. If Traditional Medicare covers a service only when certain conditions are met, these conditions must be met in order for the service to be considered part of the Traditional Medicare benefits (that is, basic benefits) component of an MA plan. MA organizations may cover the same service when the conditions are not met, but these benefits would then be defined as supplemental benefits within the scope of §§ 422.100(c)(2) and 422.102 and must be included in the supplemental benefits portion of the MA plan's bid. For example, when services are furnished by a type of provider other than the type of provider who may furnish the service in Traditional Medicare, those services are supplemental benefits. We proposed policies that provide less flexibility for MA organizations to deny or limit coverage of basic benefits than provided in the 2000 final rule. However, as provided by section 1852(a)(3) of the Act and reflected in §§ 422.100(c)(2) and 422.102, MA plans may cover benefits beyond what is covered (and when it is covered) under Traditional Medicare by offering supplemental benefits. Our proposal was primarily directed at ensuring that minimum coverage requirements are met and that MA plans do not deny or limit coverage of basic benefits; we were not proposing to limit the scope of permissible supplemental benefits, but our proposal applies certain requirements for the use of utilization management for all covered benefits as discussed in section III.E. of this proposed rule.
In this rule, we clarify acceptable cost-effective utilization management approaches for MA organizations to use in the context of the new proposed requirements. These clarifications aim to ensure access to medically necessary care, while maintaining MA organizations' ability to apply utilization management that ensures clinically appropriate care. Additionally, we are codifying substantive rules regarding clinical coverage criteria for basic benefits and how they interact with utilization management policies, including revisions to existing regulations and adopting new regulations to ensure that MA enrollees receive the basic benefits coverage to which they are entitled and to ensure appropriate treatment of a benefit as a basic benefit or supplemental benefit for purposes of the bid under § 422.254. We solicited comment on whether our proposed regulatory provisions sufficiently address the requirements and limits that we described in the preamble.
The final rules adopted here related to utilization management requirements and limitations, coverage criteria and medical necessity determinations, use of prior authorization and continuity of care requirements for MA plans are additional standards to implement the statutory requirements at section 1852(a) of the Act that MA plans provide to their enrollees (by furnishing directly or through contracted providers, arranging for, or paying for) basic benefits (that is, all Part A and Part B benefits with limited exceptions) and such supplemental benefits the MA plan elects to offer. CMS has authority to adopt standards to carry out the applicable MA provisions in Title XVIII of the Act and to add new contract terms that we find necessary, appropriate, and not inconsistent with the statute in sections 1856(b) and 1857(e) of the Act. In addition, section 1854(a)(5) and (6) of the Act provide that CMS is not obligated to accept every bid submitted and may negotiate with MA organizations regarding the
In interpreting requirements involving coverage criteria, whether used for prior authorization or post-service payment, CMS has a longstanding policy, discussed in sub-regulatory guidance (section 10.16 of Chapter 4 of MMCM), that MA plans must make medical necessity determinations based on internal policies that include coverage criteria that are no more restrictive than Traditional Medicare's national and local coverage policies and approved by a plan's medical director. In light of the previously discussed feedback and the OIG recommendation that we issue new guidance on the appropriate use of MA organization clinical criteria in medical necessity reviews, we proposed to codify standards for coverage criteria to ensure that basic benefits coverage for MA enrollees is no more restrictive than Traditional Medicare. Section 1862 of the Act requires original Medicare benefits to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Thus, in order to meet the statutory requirements at section 1852(a)(1) of the Act, which requires MA plans to cover A and B services, MA plan coverage criteria must do the same. We also proposed to amend § 422.101(b) and (c) to clarify the obligations and responsibilities for MA plans in covering basic benefits.
Section 1852(a)(1) of the Act and CMS regulations at § 422.101(a) and (b) require all MA organizations to provide coverage of, by furnishing, arranging for, or making payment for, all items and services that are covered by Part A and Part B of Medicare and that are available to beneficiaries residing in the plan's service area. Section 422.101 requires MA organizations to comply with all NCDs; LCDs written by Medicare Administrative Contractors (MACs) with jurisdiction for Medicare claims in the MA organization's or plan's service area; and coverage instructions and guidance in Medicare manuals, instructions and other guidance documents unless those materials are superseded by regulations in part 422.
We proposed to amend § 422.101(b)(2) by removing the reference to “original Medicare manuals and instructions” and clarify that MA organizations must comply with general coverage and benefit conditions included in Traditional Medicare laws, unless superseded by laws applicable to MA plans, when making coverage decisions. Our proposal was designed to prohibit MA organizations from limiting or denying coverage when the item or service would be covered under Traditional Medicare and to continue the existing policies that permit MA organizations to cover items and services more broadly than original Medicare by using supplemental benefits. In proposing this change to § 422.101(b)(2), we reiterated that limits or conditions on payment and coverage in the Traditional Medicare program—such as who may deliver a service and in what setting a service may be provided, the criteria adopted in relevant NCDs and LCDs, and other substantive conditions—apply to define the scope of basic benefits. By removing the reference to “original Medicare manuals and instructions,” we were not diminishing the content and value that these manuals and instructions provide in interpreting and defining the scope of Part A and Part B benefits. These manuals contain significant explanations and interpretations of Traditional Medicare laws governing Part A and Part B benefits, most of it longstanding, to provide instructions and procedures for day to day operations for those responsible for administering the Medicare program. Our goal to ensure that MA enrollees receive the same items and services as beneficiaries in the FFS program is accomplished when the same coverage policies and approaches are used. We expect that MA plans will consult the Medicare Benefit Policy Manual, Medicare Program Integrity Manual, and similar CMS guidance materials. We note that MA organizations must agree to comply with all applicable requirements, conditions, and general instructions under the terms of their contract with CMS under § 422.504(a). The proposed revision to § 422.101(b)(2) clarifies that statutes and regulations that set the scope of coverage in the Traditional Medicare program are applicable to MA organizations in setting the scope of basic benefits that must be covered by MA plans. We also proposed to refer in § 422.101(b)(2) to specific Medicare regulations that include coverage criteria for Part A inpatient admissions, Skilled Nursing Facility (SNF) care, Home Health Services and Inpatient Rehabilitation Facilities (IRF) as examples of general coverage and benefit conditions in Traditional Medicare that apply to basic benefits in the MA program. The list of Medicare regulations referred to is not exhaustive and provides examples of substantive coverage and benefit conditions that apply to MA. In addition, we also proposed to revise the current provision that states that Traditional Medicare coverage rules apply unless superseded by regulations in this part. We proposed to revise that aspect of § 422.101(b)(2) to refer to laws applicable to MA plans in order to avoid implying that a Part 422 regulation could supersede an applicable statute.
For example, the existing rule at § 422.101(c), which states that MA organizations may elect to furnish, as part of their Medicare covered benefits, coverage of post-hospital SNF care in the absence of the prior qualifying hospital stay is a special rule in MA that deviates from coverage criteria articulated in Traditional Medicare. The regulation is based on section 1812(f) of the Act, which authorizes CMS to permit coverage of SNF care without the 3-day qualifying hospital stay in limited circumstances. (68 FR 50847-50848). This rule provides MA organizations the flexibility to cover, as a basic benefit, SNF stays for MA enrollees that would not be otherwise coverable in Traditional Medicare, if the beneficiary had not met the prior qualifying hospital stay of 3 days prior to admission in the SNF. This special rule continues to apply in the MA program; however, we proposed to redesignate this rule to paragraph (c)(2) of § 422.101 as part of our proposal to add a heading to § 422.101(c) and to expand the scope of the paragraph. We proposed to add the heading “Medical Necessity Determinations and Special Coverage Provisions” to § 422.101(c). As such, we proposed to reassign the special rule for coverage of posthospital SNF in the absence of the prior qualifying hospital
We proposed to codify at § 422.101(c)(1)(A) that MA organizations must make medical necessity determinations based on coverage and benefit criteria as specified at § 422.101(b) and (c) and may not deny coverage for basic benefits based on coverage criteria that are not specified in § 422.101(b) or (c). This means that when an MA organization is making a coverage determination on a Medicare covered item or service with fully established coverage criteria, the MA organization cannot deny coverage of the item or service on the basis of internal, proprietary, or external clinical criteria that are not found in Traditional Medicare coverage policies. Under this proposal, certain utilization management processes, such as clinical treatment guidelines that require another item or service be furnished prior to receiving the requested item or service, would violate the proposed requirements at § 422.101(b) and (c), and thus, their use by an MA organization would be prohibited unless specified within the applicable NCD or LCD or Medicare statute or regulation. We note that we did not propose to revise § 422.136, which authorizes MA plans to use step therapy policies for Part B drugs under certain circumstances; in the next paragraph, we discuss the basis for authorizing MA plan-specific step therapy for Part B drugs in § 422.136 in more detail. Otherwise, clinical criteria that restrict access to a Medicare covered item or service unless another item or service is furnished first, when not specifically required in NCD or LCD, would be considered additional internal coverage criteria that are prohibited. When MA plans are allowed to create internal coverage criteria as specified at proposed § 422.101(b)(6), the current evidence in widely used treatment guidelines or clinical literature relied upon to make the coverage determination may recommend clinical treatment guidelines that require another item or service first. When use of MA plan internal coverage criteria is permitted under this rule, as long as the supporting, widely used treatment guidelines or clinical literature recommend another item or service first, this approach would be acceptable under our proposed policy. We discuss adding § 422.101(b)(6) later in this section of the rule.
In an HPMS memo released August 7, 2018, CMS announced that under certain conditions beginning in contract year 2019, MA plans may use utilization management tools such as step therapy for Part B drugs. In a May 2019 final rule (84 FR 23832), we codified MA organizations' ability to use step therapy for Part B drugs under certain conditions that protect beneficiaries and acknowledged that utilization management tools, such as step therapy, can provide a means for MA plans to better manage and negotiate the costs of providing Part B drugs.
We clarified that, with respect to clinical concerns and interference with provider care, step therapy or other utilization management policies may not be used as unreasonable means to deny coverage of medically necessary services or to eliminate access to medically necessary Part B covered drugs (84 FR 23856). The requirements in the 2019 rule, in combination with current MA program regulations, ensure access to Part B drugs and limit the potential for step therapy policies to interfere with medically necessary care. Organizations have been and remain subject to the MA regulations and must comply with national and applicable local coverage determinations. Step therapy protocols cannot be stricter than an NCD or LCD with specified step therapy requirements. Thus, this proposal was consistent with the 2019 rule in that MA plans must still comply with NCDs and LCDs when developing step therapy programs for Part B drugs.
Finally, in the May 2019 final rule, we did not authorize step therapy practices for Part A or Part B (non-drug) items or services and our proposal here was to limit the ability of MA organizations to use such UM policies in connection with non-drug covered items or services that are basic benefits. There are a number of differences with step therapy for Part B drugs and step therapy for non-drug items and services that we cited in the proposed rule to support how our proposals on coverage criteria and utilization management would treat items and services that are not Part B drugs differently. From a clinical standpoint, there tends to be more than one drug that has demonstrated success in treating a certain disease or condition, and also there are generic alternatives, which is somewhat different than other Part A and B services. Often, there are not head-to-head comparisons between drugs in a certain class of medications, because a non-inferiority study
In addition, the manner in which Part B drugs are purchased and furnished is somewhat different from coverage of non-drug health care items and services. Generally, MA organizations pay the provider for both the service of administering a Part B drug and the cost of the drug, but do not directly pay drug manufacturers or suppliers for the cost of the drug. MA organizations may negotiate pricing discounts or rebates with the manufacturer, who is not the entity that directly furnishes the Part B drug to enrollees and who is not ordinarily paid directly by the MA organization for what is furnished to enrollees. As we explained in the May 2019 final rule (84 FR 23858, 23863, and 23869), we believe that § 422.136 can put MA organizations in a stronger position to negotiate lower pharmaceutical prices with drug manufacturers, reducing the cost sharing for the beneficiary. Furthermore, as previously discussed, studies have demonstrated that increased cost sharing for medications can reduce patient adherence to those medications. Therefore, we did not propose to revise our current regulations regarding Part B step therapy.
Similar to MACs in Traditional Medicare, we expect MA organizations to make medical necessity decisions based on NCDs, LCDs, and other applicable coverage criteria in Medicare statutes and regulations to determine if an item or service is reasonable, necessary and coverable under Medicare Part A or Part B. In some circumstances, NCDs or LCDs expressly include flexibility that allows coverage in circumstances beyond the specific coverage or non-coverage indications that are listed in the NCD or LCD. For example, an NCD or LCD may state that the item or service can be covered when reasonable and necessary for the individual patient. When deciding whether an item or service is reasonable and necessary for an individual patient, we expect the MA plan to make this medical necessity decision in a manner that most favorably provides access to
We recognize that there are some Part A or Part B benefits that do not have applicable Medicare NCDs, LCDs, or specific traditional Medicare coverage criteria in regulation for MA plans to follow when making medical necessity determinations. Therefore, we proposed at § 422.101(b)(6) that when coverage criteria are not fully established in applicable Medicare statute, regulation, NCD or LCD, an MA plan may create internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available. In creating these internal policies, we proposed that MA organizations must follow similar rules that CMS and MACs must follow when creating NCDs or LCDs. Specifically, MA organizations must provide publicly available information that discusses the factors the MA organization considered in making coverage criteria for medical necessity determinations.
Section 1862(l) of the Act requires the Secretary to issue publicly a discussion and explanation of the factors considered in making NCDs, after following a process that affords the public an opportunity to comment prior to implementation. We proposed at § 422.101(b)(6) that MA organizations must follow a somewhat similar process when creating internal plan coverage criteria by providing a publicly accessible summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations, a list of the sources of such evidence, and include an explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination. We did not propose that MA organizations must provide a pre-determination explanation and opportunity for the public to comment on the MA organization's coverage criteria; however, providing a publicly accessible summary of the evidence, a list of the sources of evidence, and an explanation of the rationale for the internal coverage criteria will protect beneficiaries by ensuring that coverage criteria are rational and supportable by current, widely used treatment guidelines and clinical literature. This requirement provides further transparency into MA organizations' medical necessity decision making and is consistent with CMS's expectation that MA organizations develop and use coverage criteria in a way that aligns with Traditional Medicare.
We also proposed at § 422.101(b)(6) a requirement that an MA organization's internal clinical criteria must be based on current evidence in widely used treatment guidelines or clinical literature. Current, widely-used treatment guidelines are those developed by organizations representing clinical medical specialties, and refers to guidelines for the treatment of specific diseases or conditions (such as referring to the Infectious Diseases Society of America for the Treatment of
https://www.jabfm.org/content/17/1/59#F1).
Per CMS regulations at § 422.112(a)(6)(ii), MA plans must have policies and procedures that allow for individual medical necessity determinations. As a result, an MA organization's coverage rules, practice guidelines, payment policies, and utilization management policies should be applied to make individual medical necessity determinations based on the individual circumstances for the enrollee and item or benefit to be covered. CMS has longstanding guidance interpreting the obligations of MA organizations when making medical necessity determinations. Chapter 4 of the MMCM, section 10.16, provides that MA organizations make coverage
Authority for MA organizations to use utilization management policies with regard to basic benefits is subject to the mandate in section 1852(a)(1) of the Act that MA plans cover Medicare Part A and Part B benefits (subject to specific, limited statutory exclusions) and, thus, to CMS's authority under section 1856(b) of the Act to adopt standards to carry out the MA provisions. We believe these proposals will further implement the requirements set forth in section 1852 of the Act and §§ 422.100 and 422.101, which require MA organizations to furnish all reasonable and necessary Part A and B benefits. These requirements for how MA organizations make coverage decisions will ensure that MA organizations provide equal access to Part A and Part B benefits as provided in the Traditional Medicare program; overall these mean that MA organizations will not be able to deny coverage for basic benefits using coverage criteria that is not consistent with coverage criteria in Medicare statutes, regulations, NCDs and LCDs or that is not consistent with the limitations proposed in § 422.101(b)(6).
In explaining the proposals in the proposed rule, we affirmed that coordinated care plans may continue to include mechanisms to control utilization, such as prior authorization, referrals from a gatekeeper for an enrollee to receive services within the plan, and, subject to the rules on physician incentive plans at §§ 422.208 and 422.210, financial arrangements that offer incentives to providers to furnish high quality and cost-effective care in addition to the coverage criteria that comply with § 422.101(b). We also affirmed that MA organizations may furnish a given service using a defined network of providers, some of whom may not see patients in Traditional Medicare, under these proposals. Further, we affirmed that MA organizations may encourage patients to see more cost-effective provider types than would be the typical pattern in Traditional Medicare (as long as those providers are working within the scope of practice for which they are licensed to provide care and comply with the provider antidiscrimination rules set forth under § 422.205). For instance, MA organizations may offer more favorable cost sharing for certain provider types within their network. We remind MA organizations that any incentives offered to providers and to patients must comply with applicable fraud and abuse laws.
In the proposed rule, we acknowledged in the June 2000 final rule that when a health care service can be Medicare-covered and delivered in more than one way, or by more than one type of practitioner, that an MA plan could choose how the covered services will be provided. We proposed a narrower policy that permits MA organizations to continue to choose who provides Part A and Part B benefits through the creation of their contracted networks, but limits MA organizations' ability to limit when and how covered benefits are furnished when Traditional Medicare will cover different provider types or settings. We explained that under our proposal at § 422.101(c)(1)(i), when care can be delivered in more than one way or in more than one type of setting, and a contracted provider has ordered or requested Medicare covered items or services for an MA enrollee, the MA organization may only deny coverage of the services or setting on the basis of the ordered services failing to meet the criteria outlined in § 422.101(c)(1)(i). (We proposed to reserve paragraph (c)(1)(ii) to provide flexibility in modifying the limits on MA medical necessity policies in the future.) For example, if an MA patient is being discharged from an acute care hospital and the attending physician orders post-acute care at a SNF because the patient requires skilled nursing care on a daily basis in an institutional setting, the MA organization cannot deny coverage for the SNF care and redirect the patient to home health care services unless the patient does not meet the coverage criteria required for SNF care in §§ 409.30-409.36 and proposed § 422.101(b) and (c).
We explained that we were unable to quantify the impact of these proposed changes on MA organizations because many MA organizations may already be interpreting our current rules in a way that aligns with what we proposed. MA organizations may have interpreted our longstanding policy that they cannot apply coverage criteria that are more restrictive than Traditional Medicare national and local coverage policies to mean exactly what we proposed here: that they may only deny Medicare items or services based on criteria consistent with Traditional Medicare coverage rules. Other MA organizations may have interpreted our current rules to mean that they can use internal policies, like utilization management guidelines, to deny approval for a particular item or service while directing the MA enrollee to a different, but clinically appropriate, Medicare-covered item or service. The OIG stated in their report that “CMS guidance is not sufficiently detailed to determine whether MA organizations may deny authorization based on internal MA organization clinical criteria that go beyond Medicare coverage rules.” As a result, we proposed to be clear that MA organizations may not deny authorization based on internal MA
We thank commenters for helping inform CMS's policy on coverage criteria for basic benefits in MA. We summarized comments in this section of this rule and our responses follow.
MA organizations are required by Section 1852(a) to provide Part A or Part B items and services (with limited exceptions) through providers that have a contract with the MA organization or by payment to a provider that does not have a contract with the MA organization. CMS has interpreted those obligations in § 422.101(a) to require MA organizations to “provide coverage of, by furnishing, arranging for, or making payment for” these Part A or Part B items and services. Therefore, the distinctions between regulations that contain coverage criteria and regulations that contain criteria for Medicare payment in Traditional Medicare are not similarly applicable in the MA program because MA organizations provide coverage by furnishing, arranging for, or making payment for Part A and Part B items and services. As a result, when determining whether Traditional Medicare criteria apply in MA, it is irrelevant whether Traditional Medicare considers the criteria part of a coverage rule or a payment rule, as both address the scope items and services for which benefits are available to Medicare beneficiaries under Parts A and B. MA organizations have discretion about how much and under what conditions they pay their contracted providers that furnish services, but § 422.101(a) and (b) are about ensuring that MA enrollees receive the same items and services they would receive if they were enrolled in Traditional Medicare. We explain here what the new rule means and how it works using examples of Traditional Medicare criteria listed at § 422.101(b)(2) of this final rule.
In regards to inpatient admissions at 412.3, we confirm that the criteria listed at 412.3(a)-(d) apply to MA. We acknowledge that 412.3 is a payment rule for Medicare FFS, however, providing payment for an item or service is one way that MA organizations provide coverage for benefits. Therefore, under § 422.101(b)(2), an MA plan must provide coverage, by furnishing, arranging for, or paying for an inpatient admission when, based on consideration of complex medical factors documented in the medical record, the admitting physician expects the patient to require hospital care that crosses two-midnights (§ 412.3(d)(1), the “two midnight benchmark”); when admitting physician does not expect the patient to require care that crosses two-midnights, but determines, based on complex medical factors documented in the medical record that inpatient care is nonetheless necessary (§ 412.3(d)(3), the “case-by-case exception”); and when inpatient admission is for a surgical procedure specified by Medicare as inpatient only (§ 412.3(d)(2)). However, it is important to clarify that the “two-midnight presumption” (the presumption that all inpatient claims that cross two midnights following the inpatient admission order are “presumed” appropriate for payment and are not the focus of medical review absent other evidence) does not apply to MA plans. The two-midnight presumption is a medical review instruction given to Medicare contractors (for example, MACs, RACs, QIOs) to help them in the selection of claims for medical necessity review. CMS guidance
However, this final rule does not dictate how MA organizations will decide which claims to subject to review. Section 1852(g)(1)(A) of the Act states that an MA organization shall have a procedure for making determinations regarding whether an individual enrolled with the plan is entitled to receive a health service and that such determinations regarding whether or not an individual may receive a health service must be made on a timely basis. CMS has adopted regulations governing certain minimum procedures that MA plans must use, including the timing of organization determinations, the content of denial notices, and who must review a decision that the plan expects to be a full or partial denial on the basis of
Further, we do not believe that § 422.101(b), as finalized with our clarification about how 42 CFR 412.3 applies in the context of MA, violates the non-interference rule at section 1854(a)(6)(iii). We affirm MA organizations' rights to contract with providers of their choosing and to set the price structures, including how and how much contracted providers are paid. In addition, under the rules finalized here, MA organizations may adopt procedures, and in those situations specified in § 422.101(b)(6), internal coverage policies for making medical necessity determinations regarding whether an individual is entitled to receive a health care service under Part A or Part B, so long as the requirements and conditions set forth in the regulations are met. Our focus of this policy is not on how or how much MA organizations pay their contracted providers, but on ensuring that MA enrollees receive items and services for which benefits are available under Part A and Part B (excluding hospice care and organ acquisitions for kidney transplants) that they would receive under Traditional Medicare.
We clarify here and amend the regulation text at § 422.101(b)(2) to state the applicability of the Inpatient Only list in MA, which, under § 419.22(n) are those services and procedures that the Secretary designates as requiring inpatient care and for which payment is not made when furnished in a hospital outpatient department under the Medicare Hospital Outpatient Prospective Payment System. We confirm that the Inpatient Only list applies to MA consistent with our read of the statute that when Traditional Medicare pays for a service only when certain conditions are met, meaning that those certain conditions must be met for the service to be considered a Traditional Medicare basic benefit, these same conditions, including setting, must be met in order for the service to be considered part of the basic benefit of an MA plan. As previously stated in this rule and in the proposed rule, if Traditional Medicare covers a service only when certain conditions are met, these conditions must be met in order for the service to be considered part of the Traditional Medicare benefits that must be included as basic benefits covered by an MA plan. Also, we remind MA plans that they may cover the same service when the conditions are not met—such as in a different setting or from a different type of provider—as a supplemental benefit. The regulation at § 412.3(d)(2) provides that an inpatient admission for a surgical procedure specified by Medicare as inpatient only under § 419.22(n) is generally appropriate for payment under Medicare Part A regardless of the expected duration of care. Therefore, coverage of the inpatient admission for a procedure on the inpatient only list is fully established under the applicable Medicare regulations and the MA plan must cover this type of inpatient admission without application of additional internal criteria under new § 422.101(b)(6).
We agree with commenters that medical conditions and a patient's medical history can be complex and that Medicare coverage guidelines are not specific enough to address every possible scenario when benefits are available under Medicare Parts A or B for every item or service. We also acknowledge, as commenters stated, that MACs are permitted to consider evidence-based guidelines when making individual medical necessity determinations. Based on these comments, and in order to clarify when Traditional Medicare coverage criteria are not fully established, this final rule will permit MA organizations to adopt publicly accessible internal coverage criteria based on current evidence in widely used treatment guidelines when additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently. First, we proposed and address in more detail in the following pages how, in addition to basing internal coverage criteria on current evidence in widely established treatment guidelines, MA organizations must follow certain procedures. Second, as specified at § 422.101(b)(6)(i)(A), the MA organization must demonstrate that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. We will use this interpretation in monitoring and evaluating compliance with this regulation. We also require in this rule that MA organizations make this explanation publicly accessible, along with the internal coverage criteria in use, and identify the general provisions that the internal coverage criteria supplement so that general provisions can be applied in specific factual circumstances.
We explained in the proposed rule, that in some circumstances, NCDs or LCDs expressly include flexibility that allows coverage in circumstances beyond the specific coverage or non-coverage indications that are listed in the NCD or LCD. We also acknowledged in the proposed rule that there are some Part A or Part B benefits that do not have applicable Medicare NCDs, LCDs, or specific traditional Medicare coverage criteria in regulation for MA plans to follow when making medical necessity determinations. Commenters agreed with these statements, and therefore, we are finalizing in the regulation text at § 422.101(b)(6)(i)(B) and (C) that coverage criteria are not fully established when NCDs or LCDs include flexibility that explicitly allows for coverage in circumstances beyond the specific indications that are listed in an NCD or LCD or when there is an absence of any applicable Medicare statutes, regulations, NCDs or LCDs setting forth coverage criteria. When identifying whether there is an absence of applicable Medicare statutes, regulations, NCDs, or LCDs, the MA organization needs to look beyond the labels of “payment rule” or “coverage rule”, as both serve to establish coverage criteria in MA. Therefore, this rule prohibits MA organizations from applying internal coverage criteria in addition to the applicable Traditional Medicare statutes, regulations, NCDs, or LCDs, unless § 422,101(b)(6)(i)(A) or (B) apply.
As part of applying and complying with § 422.101(b)(6), we expect that MA plans will consult the Medicare Benefit Policy Manual, Medicare Program Integrity Manual, and similar CMS guidance materials. These manuals contain significant explanations and interpretations of Traditional Medicare laws governing Part A and Part B benefits, most of it longstanding, to provide instructions and procedures for day to day operations for those responsible for administering the Medicare program and for making coverage decisions. Using these resources will ensure that MA plans are covering items and services for which benefits are available under Part A and Part B for their enrollees and minimize the number of potential situations where Traditional Medicare coverage policies have insufficient detail such that an MA plan must develop its own internal coverage criteria.
When MA plans are permitted to adopt such internal criteria, however, it must be based on current evidence in widely used treatment guidelines or clinical literature and made publicly available. We believe that permitting the use of publicly accessible internal coverage criteria in these limited circumstances and contexts is necessary to promote transparent, and evidence-based clinical decisions by MA plans that are consistent with Traditional Medicare. We do not view the use of internal coverage criteria in these instances as being more restrictive than, or applying additional criteria beyond, Traditional Medicare because that is precisely what is contemplated, for example, by the NCDs or LCDs that provide for this type of flexibility and interpretation in Traditional Medicare. Use of internal policies based on current evidence in widely used treatment guidelines or clinical literature is appropriate to fill in gaps where coverage criteria cannot specify all possible circumstances where coverage of a Part A or Part B item or service may be available for a beneficiary. These policies provide MA organizations with limited discretion to interpret Traditional Medicare coverage rules and must not create barriers to access to care in a way that is not aligned with access in Traditional Medicare.
In order to demonstrate how this rule applies, we discuss an example of an actual coverage policy to further elucidate the limited circumstances under which MA plans may apply internal coverage criteria to supplement the existing coverage guidelines. First, in NCD 220.1 for Computed Tomography (CT)
In another example, NCD 220.2 for Magnetic Resonance Imaging (MRI),
We proposed at 422.101(c)(1) that MA organizations must make medical necessity determinations based on a number of factors, including the criteria in § 422.101(b), the enrollee's medical history, and other factors. Thus, to the extent that an MA organization has developed internal coverage criteria as permitted by § 422.101(b)(6) (including compliance with the procedures set forth in paragraphs (b)(6)(i) through (ii)), the current evidence in widely used treatment guidelines or clinical literature that are the basis for the internal coverage policy should also be used in making individual medical necessity determinations. Therefore, MA organizations may use these internal criteria to deny coverage of an item or service. However, as required by § 422.568 and 422.631 (for applicable integrated plans), MA organizations must give enrollees written notice of a denial and the notice must state the specific reasons for the denial. We clarify here that if an MA organization denies care based on internal criteria, that criteria must be clearly stated in the denial notice, just as other applicable Medicare coverage criteria must be stated under § 422.568(e)(2), when used as the basis for a denial of coverage. Communicating all necessary information needed for the enrollee or provider to effectively appeal the decision, including the evidence used to support the internal coverage policy when applicable, is one of the purposes of the denial notice. The standardized Integrated Denial Notice is properly completed when it includes a specific and detailed explanation of why the medical services, items or Part B drugs were denied, including a description of the applicable coverage rule or applicable plan policy (for example, Evidence of Coverage provision) upon which the action was based, and a specific explanation about what information is needed to approve coverage must be included, if applicable.
In light of the issues raised by commenters, we are finalizing 422.101(b) with modifications to clarify when Traditional Medicare coverage criteria are not fully established and what information about internal coverage criteria must be made publicly accessible. We will continue to conduct audit and monitoring activities to ensure that appropriate coverage criteria are applied during medical necessity reviews, and if CMS identifies abuses of this policy, we will consider future rulemaking on this topic.
We understand that utilization management tools such as InterQual or MCG, among others, are coverage criteria products created to assist the plans, providers and others, in clinical review processes and to help guide medical necessity determinations. We understand from commenters that these products were created with the intention of serving as a single source that consolidates clinical data, medical literature, and CMS guidance and coverage policies to assist MA plans in making medical necessity determinations. We understand from commenters that these tools are often used in conducting inpatient, post-acute and home care medical necessity reviews, in particular.
As finalized, §§ 422.101(b), (c) and 422.566(d) address different aspects of how these products appear to be used so consideration of all three regulations is necessary. As proposed and finalized in § 422.101(b)(2), MA plans must comply with general coverage and benefit conditions included in Traditional Medicare laws, unless superseded by laws applicable to MA plans. This includes criteria for determining whether an item or service is a benefit available under Traditional Medicare, such as payment criteria for inpatient admissions at 42 CFR 412.3, services and procedures that the Secretary designates as requiring inpatient care under 42 CFR 419.22(n), and requirements for payment of Skilled Nursing Facility (SNF) Care, Home Health Services under 42 CFR part 409, and Inpatient Rehabilitation Facilities (IRF) at 42 CFR 412.622(a)(3)). Thus, MA plans may not use InterQual or MCG criteria, or similar products, to change coverage or payment criteria already established under Traditional Medicare laws.
We recognize that there are some Part A or Part B benefits that do not have applicable Medicare NCDs, LCDs, or specific traditional Medicare coverage criteria in regulation for MA plans to follow when making medical necessity determinations. Therefore, we proposed at § 422.101(b)(6) that when coverage criteria are not fully established in applicable Medicare statute, regulation, NCD or LCD, an MA plan may create internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available. In creating these internal policies, we proposed that MA organizations must follow rules similar to those CMS and MACs follow when creating NCDs or LCDs. Specifically, MA organizations must provide publicly available information that discusses the factors the MA organization considered in making coverage criteria for medical necessity determinations.
Under this final rule, when coverage criteria are not fully established in applicable Medicare statute, regulation, NCD or LCD, MA plans may create internal coverage criteria under specific circumstances described at § 422,101(b)(6)(i). In these circumstances, an MA plan is permitted to choose to use a product, such as InterQual or MCG or something similar, to assist in creating internal coverage criteria only so long as the requirements in § 422.101(b), (c), and § 422.566(d) are met. Specifically, MA plans must comply with § 422.101(b) and (c) as to: (i) what coverage criteria are applied; (ii) how, if those criteria are not only from Medicare laws, NCDs or LCDs, the coverage criteria were developed and what they are based on, and (iii) how individualized determinations of medical necessity take into account the information and considerations specified in § 422.101(c)(1). In addition, if the organization determination made using the product is expected to be a full or partial denial, the MA plan must ensure that the additional review requirements in § 422.566(d) are met. (See section III.G of this final rule.) The MA plan must therefore ensure that the coverage criteria used in these products are based on current evidence in widely used treatment guidelines and clinical literature consistent with the definitions and standards in § 422.101(b)(6) before using the product as the MA plan's internal coverage policy. Further, MA organizations must comply with specific procedures, which we discuss in more depth later in this preamble, before an internal coverage policy—including a product such as those described by the commenters—may be used; the MA plan must provide, in a publicly accessible way, the internal coverage criteria in use; a summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations; a list of the sources of such evidence; and an explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination. This includes, when applicable, how the additional criteria interpret or supplement general provisions in Traditional Medicare and provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. MA organizations must ensure that they are making medical necessity determinations based on the circumstances of the specific individual, as outlined at § 422.101(c), as opposed to using an algorithm or software that doesn't account for an individual's circumstances. Finally, MA organizations must comply with amended § 422.566(d), as in section III.G of this final rule, which requires that a denial based on a medical necessity determination must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.
We understand from commenters that many of these products and their software are proprietary in nature and may be proprietary to the particular organization that uses these products. However, use of such tools and their proprietary nature does not absolve MA plans from their responsibilities under this final rule. For an MA plan to use the coverage criteria in these tools, the MA plan will need to understand the external clinical evidence relied upon in these products and how that evidence supports the coverage criteria applied by these tools. The MA plan must make the evidence that supports the internal criteria used by (or used in developing) these tools publicly available, along with the internal coverage policies themselves. Furthermore, under § 422.504, MA organizations must provide information and access to CMS (and HHS and the OIG) as it conducts its oversight of MA plans and their compliance with MA program requirements. CMS may, therefore, review all aspects of the plan's decision-making including whatever evidence might be contained within a decision tool, or support the determinations made from the use of decision tool, including such tools provided by third-parties as discussed here. We expect MA plans already using these tools, or those that may plan to use these tools in the future, to work with third parties that provide these tools to revise any utilization management products and ensure that these products meet the requirements at § 422.101(b), (c), and § 422.566(d).
With regards to requiring MA plans to have a review and comment process for their internal coverage criteria, we remind commenters that per CMS regulations at § 422.202(b), MA organizations that use a network of providers (for example, coordinated care plans) have obligations with regard to developing and using practice guidelines and utilization management guidelines, including establishing a formal mechanism to consult with the physicians who have agreed to provide services under the MA plan offered by the organization, regarding the organization's medical policy, quality improvement programs and medical management procedures. We believe that the regulations at § 422.202(b) provide a formal and sufficient mechanism for MA organizations to receive comment from contracted providers on internal coverage criteria, instead of having a review and comment period open to the general public. Therefore, we proposed and are finalizing a revision to § 422.202(b)(1)(i) to require practice guidelines and utilization management guidelines used by an MA organization that uses a network of providers to base those guidelines on current evidence in widely used treatment guidelines or clinical literature. Additionally, existing requirements under § 422.202(b) require that MA plans' practice guidelines and utilization management guidelines must consider the needs of the enrolled population; be developed in consultation with contracting physicians; be reviewed and updated periodically; and be communicated to providers and, as appropriate, to enrollees. Further, decisions with respect to utilization management, enrollee education, coverage of services and other areas in which the guidelines apply must be consistent with the guidelines. We believe that an additional requirement that plans go through a comment period is redundant of these existing requirements regarding provider participation and that no additional requirements along such lines are necessary.
At 87 FR 79501, we proposed that an MA organization provide a publicly accessible summary of the evidence considered in developing the internal coverage criteria, a list of the sources of evidence, and an explanation of the rationale for the internal coverage criteria in order to protect beneficiaries by ensuring that coverage criteria are rational and supportable by current, widely used treatment guidelines and clinical literature and to provide transparency. However, the regulation text at proposed § 422.101(b)(6)(i) through (iii) inadvertently limited the phrase “publicly accessible” to only the summary of evidence. We are finalizing the proposal with modifications to the regulation text to be consistent with the scope of the proposal described in the preamble. Additionally, we are renumbering these criteria to as (A) through (C) in newly established subparagraph (ii).
Along with the new standards being adopted at § 422.101(b)(6)(i)(A) to allow MA organizations to create internal coverage criteria when additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently, we also are enhancing transparency requirements at § 422.101(b)(6)(ii)(C). When an MA organization uses internal coverage criteria in accordance with § 422.101(b)(6)(i)(A), they must also include in their publicly accessible explanation of the rationale that supports the adoption of the coverage criteria, an identification of the general provisions that are being supplemented or interpreted, and explain how the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services. For example, the evidence supporting use of an internal policy may demonstrate that patients benefit from increased efficacy of treatment or increased patient safety and highly outweighs the potential for the criteria to be used as a barrier to care that delays or denies access to items or services. While we acknowledge that this new requirement in § 422.101(b)(6)(ii) will increase burden on MA organizations, we believe that the benefits of transparency in the development of internal coverage criteria balances out that burden. We note that MA organizations may cite to policies or publicly available evidence that is behind a paywall without having to provide access to the policy directly. The standard at § 422.101(b)(6) allows MA organizations to create publicly accessible internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature; it does not require that the MA organization to provide direct access to the source, but they must make
We solicited comment on the burden associated with our proposals. As discussed, we stated that we were unable to quantify or predict how many MA organizations are currently operating in a manner that would conform with our proposed changes to § 422.101(b) and (c). We solicited comment from stakeholders on the full scope of this burden. As previously discussed, some commenters stated that the utilization management provisions and coverage criteria requirements in this rule would require significant administrative effort. For example, some commenters stated that providing a publicly accessible summary of evidence would require significant administrative effort. Some commenters asserted that the rules presented here would require changes to contracts, staff, resource infrastructure, and other plan related systems and processes. One commenter stated that CMS did not adequately account for the effort associated with meeting these requirements. However, we did not receive comments on our cost and burden analyses. The stakeholder comments of increased administrative burden are consistent with our statement in the proposed rule that due to its complexity and many unknowns, we cannot quantify the burden.
After careful consideration of all comments received, and for the reasons set forth in the final rule and in our responses to the related comments in sections III.E.2 of this final rule, we are finalizing the substance of our proposals for § 422.101(b) and (c) with modifications as follows:
• We are finalizing amendments to § 422.101(b)(2), largely as proposed but with modifications to clarify the scope of the requirement and to correct the citation to 42 CFR 412.622(a)(3) and to explicitly state the applicability of the inpatient only list.
• We are finalizing the regulatory language at § 422.101(b)(6) largely as proposed, but with modifications to state when coverage criteria are not fully established, to clarify that the obligation to make information publicly accessible applies to the internal criteria in use, to enhance transparency requirements related to use of internal coverage criteria. Based on the scope of these modifications and clarifications, we have slightly reorganized paragraph (b)(6) to add a new paragraph (b)(6)(i) to address when Medicare coverage criteria are not fully established and a new paragraph (b)(6)(ii) to address the procedural and transparency requirements that apply when an MA
• We are finalizing the modifications at 422.101(c) as proposed; and
• We are finalizing the re-designation of
Except for emergency, urgently needed, and stabilization services (§ 422.113(a)), and out-of-network services covered by MA PPO plans, all services covered by MA coordinated care plans (including MSA network plans, which are coordinated care plans under 422.4(a)(iii)(D)), may be subject to prior authorization. In addition, MA PFFS and MA MSA plans are not permitted to use prior authorization policies or “prior notification” policies that reduce cost sharing for enrollees based on whether the enrollee or provider notifies the PFFS or MSA plan in advance that services will be furnished. See § 422.4(a)(2)(i)(B) and (a)(3)(iv). Appropriate prior authorization should only be used to confirm the presence of diagnoses or other medical criteria and to ensure that the furnishing of a service or benefit is medically necessary or, for supplemental benefits, clinically appropriate and should not function to delay or discourage care. Therefore, we proposed to codify this at new § 422.138(a). Specifically, we proposed a new § 422.138(a) to provide that a coordinated care plan may use prior authorization processes for basic benefits and supplemental benefits only when the prior authorization processes are consistent with new § 422.138. We explained that, for purposes of this proposal, we used the term “processes” to include prior authorization policies and procedures that address any and all aspects of how prior authorization is used by an MA organization in a coordinated care plan.
We also proposed a new § 422.138(b)(1) through (3) to limit the use of prior authorization processes only to confirm the presence of diagnoses or other medical criteria that are the basis for coverage determinations for the specific item or service, to ensure basic benefits are medically necessary based on standards specified in § 422.101(c)(1), or to ensure that the furnishing of supplemental benefits is clinically appropriate.
The standard “clinically appropriate” used for supplemental benefits is consistent with longstanding guidance in Chapter 4, section 30.2, of the MMCM (and also stated in the CY 2021 Final Rule [86 FR 5864]) that supplemental benefits must be medically necessary. Special Supplemental Benefits for the Chronically Ill (SSBCI) may be non-primarily health related so a standard based on medical necessity may not always be appropriate. Regular supplemental benefits must be medically necessary, but SSBCI need to have a reasonable expectation of improving or maintaining the health or overall function of the enrollee as required at § 422.102(f)(1)(ii) and discussed in CY 2020 Final Rule (85 FR 33796).
To illustrate how these proposed prior authorization policies would work, we discussed an example regarding coverage of acupuncture. Traditional Medicare currently has an NCD for Acupuncture for Chronic Lower Back Pain (cLBP).
Finally, we also reminded MA plans that section 1852(b) of the Act states that an MA plan may not deny, limit, or condition the coverage or provision of benefits under this part, for individuals permitted to be enrolled with the organization under this part, based on any health status-related factor described in section 2702(a)(1) of the Public Health Service Act. Additionally, per CMS regulations at § 422.100(f)(2), plan benefit designs may not discriminate against beneficiaries, promote discrimination, discourage enrollment or encourage disenrollment, steer subsets of Medicare beneficiaries to particular MA plans, or inhibit access to services. We consider prior authorization processes to be part of the plan benefit design, and therefore such processes cannot be used to discriminate or direct enrollees away from certain types of services.
We explained that a complete estimation of impact from proposed § 422.138(a) and (b) cannot be given because we would need detailed knowledge of proprietary plan information on the frequency and specific services for which prior authorization is done in each plan. (As noted in a prior paragraph, proposed § 422.138(c) would only codify existing guidance to MA organizations.) We solicited comment from stakeholders on the impact and any additional information that would assist CMS in making an estimation. Some commenters stated that publicly posting a summary of evidence considered during the development of the criteria would require significant administrative effort. However, we did not receive specific comments on our estimates. The stakeholder comments of increased administrative burden are consistent with our statements in the proposed
We proposed, and are finalizing, at § 422.138(b)(1) through (3) that coordinated care plans may use prior authorization processes only to confirm the presence of diagnoses or other medical criteria that are the basis for coverage determinations for the specific item or service, to ensure basic benefits are medically necessary based on standards specified in § 422.101(c)(1), or to ensure that the furnishing of supplemental benefits is clinically appropriate. With regards to supplemental benefits at § 422.138(b)(3), we state that MA organizations may use prior authorization to ensure that the furnishing of supplemental benefits is clinically appropriate. The regulation text uses the term “clinically appropriate” as opposed to “medically necessary” because while supplemental benefits must be medically necessary based on long standing guidance, certain supplemental benefits (that is, SSBCI) may be non-primarily health related. Thus, a standard based on medical necessity may not always be appropriate and using the term “clinically appropriate” is more inclusive of SSBCI that may or may not be primarily health related. As discussed in section III.E.2 of this rule, MA plans are still permitted to use additional coverage criteria when Traditional Medicare coverage criteria are not fully established to determine medical necessity as specified at § 422.101(b)(6). This codifies CMS's existing expectations about the appropriate use of prior authorization and will provide important beneficiary protections that prior authorization processes are not used as a barrier to accessing medically necessary services.
As to suggestions that CMS do more to prohibit the use of prior authorization, we do not believe that we have authority for a sweeping prohibition on
In response to the suggestion that CMS require MA plans to exempt providers participating in value-based
As to the comment requesting that CMS require MA plans to make prior authorization criteria publicly available, we do not believe adopting that requirement in this rule is necessary. Currently, § 422.111(b)(7) requires MA plans to disclose to enrollees any prior authorization rules and other review requirements that must be met in order to ensure payment for the services. In addition, § 422.202(b)(2) requires MA plans that use a network of providers to communicate practice guidelines and utilization management guidelines to providers and, as appropriate, to enrollees. Finally, the proposed rule “Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program” (“Interoperability proposed rule”), which appeared in the
In addition to these existing requirements that apply to organization determinations that involve PA, CMS recently released the Interoperability proposed rule,, which includes proposals to expand access to health information and streamline certain procedures used for prior authorization. The Interoperability proposed rule includes proposals requiring implementation of a HL7® Fast Healthcare Interoperability Resources® (FHIR®) standard Application Programming Interface (API) for electronic access to certain information about pending and approved prior authorization requests, including the reason for a denial of a prior authorization request. In addition, there are proposals to require MA organizations to send decisions within 72 hours for expedited (that is, urgent) requests and seven calendar days for standard (that is, non-urgent) requests, and publicly report certain prior authorization metrics. We believe the proposals in the Interoperability proposed rule, if finalized, may address these commenters' recommendations. As we continue to monitor the needs of the program, we will consider these comments for future rulemaking. Finally, in response to whether prior authorization policies or procedures that dictate specific definitions of medical diagnoses is considered more restrictive than Traditional Medicare, we consider coverage policies that dictate specific definitions of medical diagnoses to be additional coverage criteria that are only authorized in accordance with § 422.101(b)(6) as finalized in this rule. We do not
We believe that the commenter's suggested revision with respect to an MA organization having evidence of good cause or fraud or similar fault is redundant of what is already stated in the proposed regulation text and therefore, there is no need to revise the proposed regulation text exactly as suggested. However, for added clarity, we are finalizing the regulation text with modifications to make clear that the types of decisions contemplated in § 422.138(c) cannot be reopened except for good cause (as provided in § 405.986) or if there is reliable evidence of fraud or similar fault per the reopening provisions at § 422.616. We further clarify in § 422.138(c) that the definitions of the terms “reliable evidence” and “similar fault” in § 405.902 of this chapter apply to this provision.
We believe there are a number of differences between step therapy for Part B drugs and guidelines for non-drug items and services that require another item or service be furnished prior to receiving the requested item or service. From a clinical standpoint, there tends to be more than one drug that has demonstrated success in treating a certain disease or condition, and also there are generic alternatives, which is somewhat different than other Part A and B services. Additionally, as discussed in the proposed rule, we believe that § 422.136 can put MA organizations in a stronger position to negotiate lower pharmaceutical prices with drug manufacturers, reducing the cost sharing and potentially other out of pocket costs like premiums or costs for other benefits for MA enrollees. Reducing drug costs for beneficiaries remains a top concern of CMS. Additionally, as stated in the 2019 rule (84 FR 23856), MA plans have been and remain subject to the MA regulations and must comply with national and applicable local coverage determinations. Step therapy protocols for part B drugs cannot be stricter than an NCD or LCD with specified step therapy requirements. We believe that this interpretation of § 422.136 is consistent with this rule.
We acknowledge the concerns about the potential for step therapy programs for Part B drugs to deviate from existing clinical guidelines and peer-reviewed supporting evidence, but believe that § 422.136 adequately addresses this. Per § 422.136(b)(5), the P&T committee used by an MA plan to review and approve its Part B step therapy programs must base clinical decisions on the strength of scientific evidence and standards of practice, including assessing peer-reviewed medical literature, pharmacoeconomic studies, outcomes research data, and other such information as the P&T committee determines appropriate. Similarly, we believe existing MA regulations adequately address disclosure of Part B step therapy policies to beneficiaries before enrollment. Per § 422.136(a)(2), MA organizations must have policies and procedures to educate and inform providers and enrollees of any Part B step therapy program used by the MA plan. Per § 422.111(b)(2), MA plans are required to disclose accurate information about benefits coverage, including applicable conditions and limitations on benefits coverage. MA plans that apply step therapy to Part B drugs must disclose that Part B drugs may be subject to step therapy requirements in the plan's Annual Notice of Change (ANOC) (when initially adopted or subsequently changed) and Evidence of Coverage (EOC) documents as part of their obligations under § 422.111 (84 FR 23854). As to the recommendation that CMS prohibit MA plans from requiring an off-label Part B drug when an on-label is available, we did not propose this additional limitation to the existing rule at § 422.136(c). Step therapy for Part B drugs regulations at § 422.136(c), state that an MA plan may include a drug supported only by an off-label indication in step therapy protocols only if the off-label indication is supported by widely used treatment guidelines or clinical literature that CMS considers to represent best practices. This type of substantive change in the regulation would require additional rulemaking; we may consider this issue as part of future policy development but currently believe that the reasons for adopting § 422.136(c) are sufficient (See 84 FR 23855 and 23863). Finally, in response to this recommendation that we adopt certain Part D oversight methods and apply them to Part B drug step therapy programs, we did not propose any changes to § 422.136, thus we cannot finalize any of these recommendations in this rule. However, we will continue to monitor step therapy for Part B drug programs in MA and will consider these recommendations in any future rulemaking on this subject.
In response to the assertion that the OIG report found that denials were based on human error, we note that the OIG report stated that among the payment requests that MAOs denied, 18 percent met Traditional Medicare coverage rules but that many of the payment denials in their sample were caused by human error during manual claims-processing reviews as well as system processing errors. This statement was made in regards to payment denials, not prior authorization requests. Prior authorization requests and payment requests are not the same as described by OIG in the report.
After careful consideration of all comments received, and for the reasons set forth in the final rule and in our responses to the related comments in sections III.E.3 of this final rule, we are adopting the new regulation at § 422.138 substantially as proposed with minor modifications to clarify the text. Specifically, we are including that prior authorization processes include all policies and procedures used in prior authorization unless otherwise noted.
In addition to the requirements of section 1852(d) of the Act, § 422.112(b) requires MA organizations that offer coordinated care plans to ensure continuity of care and integration of services through arrangements with contracted providers. Requirements in § 422.112(b)(1) through (b)(7) detail specific arrangements with contracted providers by which MA coordinated care plans are to ensure effective continuity and integration of health care services for their enrollees. This includes requiring MA coordinated care plans to have policies and procedures that provide enrollees with an ongoing source of primary care, programs for coordination of plan services with community and social services, and procedures to ensure that the MA coordinated care plan and its provider network have the information required for effective and continuous patient care and quality review.
Stakeholders have communicated to CMS that MA coordinated care plans' prior authorization processes sometimes require enrollees to interrupt ongoing treatment. We also have received feedback that MA plans require repetitive prior approvals for needed services for enrollees that have a previously-approved plan of care or are receiving ongoing treatments for a chronic condition. When MA plans require repetitive prior approvals, enrollees may face delays in receiving medically necessary care or experience gaps in care delivery that threaten an enrollee's health.
We believe the inclusion of additional continuity of care requirements at § 422.112 will help ensure coordinated care plans comply with and implement the statutory requirement (in section 1852 of the Act) that MA plans provide access to all medically necessary Traditional Medicare (that is, Part A and Part B) benefits that MA plans must cover. We proposed to add a new paragraph (b)(8)(i) and (ii) at § 422.112 to establish two new requirements for the use of prior authorization by MA coordinated care plans for covered Part A and B services (that is, basic benefits as defined in § 422.100(c)). Section 422.112(b) requires MA organizations offering coordinated care plans to ensure continuity of care and integration of services through arrangements with contracted providers that include the types of policies, procedures and systems that are specified in current paragraphs (b)(1) through (b)(7). First, we proposed at § 422.112(8)(i) that MA coordinated care plans must have, as part of their arrangements with contracted providers, policies that when enrollees are undergoing an active course of treatment, approved prior authorizations must be valid for the duration of the entire approved course of treatment or service. Under our proposal, if an MA coordinated care plan has approved a prescribed or ordered course of treatment or service for which the duration is 90 days, then the MA coordinated care plan's prior authorization approval must apply to
Additionally, we proposed at § 422.112(b)(8)(i)(B) that MA organizations offering coordinated care plans must have, as part of their arrangements with contracted providers, policies for using prior authorization that provide for a minimum 90-day transition period for any ongoing course(s) of treatment when an enrollee has enrolled in an MA coordinated care plan after starting a course of treatment, even if the course of treatment was for a service that commenced with an out-of-network provider. We explained that this includes enrollees who are new to an MA coordinated care plan having either been enrolled in a different MA plan with the same or different parent organization, or an enrollee in Traditional Medicare and joining an MA coordinated care plan, and beneficiaries new to Medicare and enrolling in an MA coordinated care plan.
We explained that under our proposal, during the initial 90 days of an enrollee's enrollment with an MA coordinated care plan, the MA coordinated care plan would not be permitted to subject any active course of treatment (as defined at the proposed § 422.112(b)(8)(ii)(B)) to additional prior authorization requirements, even if the service is furnished by an out-of-network provider. We explained how we expect any active course of treatment to be documented in the enrollee's medical records so that the enrollee, provider, and an MA plan can track an active course of treatment to avoid disputes over the scope of this proposed new requirement. We also explained that we intended that an active course of treatment covered by the proposal could include scheduled procedures regardless of whether there are specific visits or activities leading up to the procedure. We explained that under the proposal, if an enrollee has a procedure or surgery planned for January 31st at the time of enrollment in a new MA coordinated care plan effective January 1st, the new MA coordinated care plan would be required to cover the procedure without subjecting the procedure to prior authorization because it is within the 90-day timeframe. In this example, the planned surgery is a part of an active course of treatment and thus would not be subjected to prior authorization by the MA coordinated care plan in which the beneficiary has newly enrolled under the proposed new § 422.112(b)(8)(B). In proposing to limit the way MA coordinated care plans use prior authorization for enrollees undergoing an active course of treatment, CMS seeks to ensure the availability and accessibility of basic benefits, which is consistent with section 1852 of the Act. CMS proposed to use a 90-day transition policy here because it mirrors Part D transition requirements and using the same period will ensure consistency across the MA and Part D programs. In addition, use of one consistent transition period will likely make it easier for new enrollees to understand their transition coverage. We solicited public comment on alternative timeframes for transition periods of ongoing treatment, including the clinical and economic justification for alternative proposals.
We outlined in the proposed rule CMS's authority to adopt the proposed new requirements for MA coordinated care plans. In addition, we noted and briefly explained how CMS implemented a similar policy regarding coverage during a transition period using CMS's authority to negotiate bids and with a similar explanation in the 2005 final rule (70 FR 4193); CMS has similar negotiation authority in the MA program. As explained in the December 2022 proposed rule, we believe it is appropriate to incorporate a similar beneficiary protection and coverage requirement in the MA program to address the transition for new enrollees.
Coordinated care plans are already required to ensure continuity of care and integration of services through arrangements with contracted providers at 422.112(b). Therefore, some MA organizations may already be exercising discretion to eliminate or waive prior authorization for enrollees undergoing an active course of treatment. However, prior to our proposed rule, CMS received anecdotal feedback from stakeholders that care transitions can be difficult for enrollees due to MA plan processes that require new coverage decisions when an enrollee transitions from one MA plan to another. We are not aware of the extent to which current MA plans are already ensuring continuity of care in the way our proposals would require, nor do we have a strong basis upon which to quantify how often this type of transition occurs. Therefore, we solicited stakeholder input on both of these assumptions: that some MA plans are providing continuity of care, as defined in the proposed § 422.112(b)(8) today and the lack of available data by which to quantify it.
In summary, CMS proposed to add new continuity of care requirements to § 422.112(b)(8), to require that approval of a prior authorization be valid for the entire duration of the approved course of treatment, and that plans provide a minimum 90-day transition period when an enrollee who is currently undergoing an active course of treatment switches to a new MA plan. We thank commenters for their input on CMS's proposed new MA continuity of care requirements.
We received the following comments on this proposal, and our response follows:
One commenter suggested that CMS modify the proposal to allow limits on the duration of the prior authorization that are consistent with guideline-suggested reassessment of disease, in cases where treatments may be indefinite (for example, in cases of chronic illnesses). Another commenter suggested that the definition of “active course of treatment” should be aligned with industry standards, specifically: (1) a course of treatment for a serious and complex condition, which includes a condition that is serious enough to require specialized medical treatment to avoid the reasonable possibility of death or permanent harm, or a condition that is life threatening, potentially disabling, degenerative, or congenital, and requires specialized medical care over a prolonged period of time; (2) course of institutional or inpatient care; (3) scheduled nonelective surgery, including related postoperative care; (4) a course of treatment for a pregnancy; and (5) treatment for a terminal illness. Several commenters requested clarification as to whether there are a minimum number of days that constitute a “course of treatment.” Another commenter requested that CMS explicitly define “course of treatment” in reference to Traditional Medicare coverage and benefits benchmarks (for example, the mean Length of Stay for a given Medicare Severity Diagnosis Related Group). Finally, one commenter requested additional examples of what is and is not permissible to ensure treatments that are not medically necessary under Traditional Medicare guidelines are not required to be covered under this policy.
We agree that clarification of the policy being finalized will help ensure the new regulation is implemented appropriately. Therefore, we are finalizing the revisions at § 422.112(8)(i)(A) with modifications from the proposed rule, to require that an approval of a prior authorization request for a course of treatment must be valid for as long as medically necessary to avoid disruptions in care, in accordance with applicable coverage criteria, the patient's medical history (for example, diagnoses, conditions, functional status), and the treating provider's recommendation. The determination of medical necessity to establish the duration of the approved course of treatment must be made consistent with § 422.101(c); any adverse determination on medical necessity, such as approval of a duration that this less than the requested duration for the course of treatment, must be reviewed in accordance with § 422.566(d) (and § 422.629(k) for an applicable integrated plan) before an MA plan may issue the determination. Further, the coverage policies governing these determinations must also comply with § 422.101(b). This will ensure that services delivered during the approved and previously authorized course of treatment remain consistent with Medicare coverage guidelines, are reasonable and necessary for the individual enrollee, and do not overly burden the provider with unnecessary and repeated prior authorization requests.
CMS is not requiring a minimum or maximum number of days for a course of treatment, since the necessary scope and duration of a course of treatment can vary widely from enrollee to enrollee and should be based upon the individual's needs and medical necessity. We believe flexibility is necessary to accommodate the varying complexities of a multitude of conditions for which an enrollee may be receiving care, and recognize that many treatment courses last for varying periods of time and may require varying amounts of interventions that are unique to the individual being treated.
In response to comments expressing concern over the potential for treatment continuing indefinitely or recommending that treatments should be revisited at certain intervals, we believe that in many cases additional evaluation of the patient to ensure ongoing medical necessity and efficacy of treatment at certain intervals will be required or recommended and supported by the relevant coverage criteria, or by the patient's medical needs and the treating provider's recommendation. Under this final rule, all decisions for prior authorization, including those involving the authorization of treatment that lasts over a period of time, must be made in accordance with § 422.138. This means that prior authorization may only be used to confirm the presence of a diagnosis or other medical criteria that are the basis for coverage or to ensure an item or service is medically necessary based on standards specified in § 422.101(c)(1). In order for an approval of a prior authorization request for a course of treatment to last indefinitely, it would have to be medically necessary and supported by the applicable coverage criteria, and the patient's medical condition and provider's recommendation. Therefore, we believe it would be uncommon that a MA organization would be required to approve a request for a treatment indefinitely. Additionally, where prior authorization is used by fee-for-service Medicare, the use of prior authorization by the MA organization on the same services must apply the fee-for-service Medicare standards based on § 422.101(b)(2). Further, pursuant to § 422.138(c), if the MA organization approved the furnishing of a covered item or service through a prior authorization or pre-service determination of coverage or payment, it may not deny coverage later on the basis of lack of medical necessity unless the MA organization has the authority to reopen the decision for good cause or fraud or similar fault per the reopening provisions at § 422.616.
An MA plan may approve and authorize treatment for a different period of time than the treating provider's ordered course of treatment if the plan has determined that what was ordered or prescribed by the treating provider was not medically necessary or appropriate based on the enrollee's condition or diagnosis. The following example illustrates how this modification will work in practice:
The patient is a type 1 diabetic. The treating provider orders a course of treatment that consists of continuous subcutaneous insulin infusions for a period of 3 months. The treatment is subject to prior authorization. In order to apply prior authorization, the MA plan must follow the requirements of § 422.101(b), and apply any applicable coverage criteria for the service. The applicable NCD
However, MA plans should not shorten authorization periods that are outlined in Traditional Medicare coverage criteria. The only instances where an MA plan may use a shorter (or different) periodicity or frequency of evaluation or other such review would be if the change were consistent with the relevant coverage criteria, and supported by the evidence in the patient's medical record, and by treatment guidelines or clinical literature that is widely available. This must be clearly documented and referenced by the MA plan in the prior authorization decision. Moreover, in all instances, we expect the MA plan and its contracted provider to coordinate care to ensure that the prior authorization is approved for a period that ensures that care is delivered for as long as is medically necessary and that minimizes disruptions in care for the enrollee. In other words, the MA plan may not establish blanket rules for the duration of an authorization associated with course of treatment decisions for purposes of convenience or simplicity; the duration of a prior authorization must be valid for as long as medically necessary to avoid disruptions in care and not in conflict with applicable coverage criteria.
In response to the comments, we clarify that the transition period required by § 422.112(b)(8)(i)(B), as proposed and finalized, applies, beginning with coverage January 1, 2024, to all new enrollees who are undergoing an active course of treatment—including where the active course of treatment is taking a physician-administered drug covered under Part B. An MA organization must not disrupt or require reauthorization for an active course of treatment for new plan enrollees for a period of at least 90 days.
For example, if an enrollee is undergoing an active course of treatment that is 60 days in duration, and the enrollee transfers to a new MA plan 30 days into that course of treatment, then the MA plan may not subject that course of treatment to a prior authorization requirement for the next 30 days. After that time, the course of treatment is complete and any future treatments may be subject to prior authorization as appropriate. This does not mean that an MA plan may not apply prior authorization to
In response to the comments that the proposal is redundant due to many MA plans already utilizing internal practices for continuing prior authorization approvals, or allowing for a continuation of services, CMS continues to believe that codification and standardization are necessary. While some plans may have internal processes in place to allow for a continuation of services, we are not aware that these practices have been universally adopted and consistently applied by all plans. If plans are already allowing for these types of transitions, then existing practices may already comply with what is proposed.
Finally, since the provision only applies to active courses of treatment, CMS does not foresee the possibility that medically necessary services could or would be delayed solely for the purpose of requiring another plan to pay for that service. If treatment is medically necessary at the time it is ordered, it would be highly inappropriate for that treatment to be delayed solely for the purposes of shifting payment responsibility. While, as stated in the preamble, we have interpreted active
At this time, CMS is not adding a requirement for notification to enrollees because pursuant to § 422.111(b)(7), MA organizations are required to disclose information to enrollees regarding prior authorization and review rules. This includes the continuity of care provisions outlined in this proposal. CMS urges plans and their contracted providers to work with these transitioning enrollees and their previous treating providers, even if those previous treating providers are not contracted with the receiving plan, during the transition period to ensure that care is continued in the least disruptive manner possible. CMS also notes that the 90-day transition period is a minimum requirement. Therefore, if an active course of treatment is approved by the previous treating provider or plan to last longer than the 90-day minimum, an MA plan that is newly covering the enrollee may elect to permit the enrollee to finish the course of treatment, which lasts beyond 90 days, before imposing additional prior authorization(s). CMS will consider adding an additional notice requirement during future policymaking.
Regarding the comments that different plans may offer differing courses of treatment, we do not find this a compelling reason to alter the transition time frame. Since this requirement only affects active courses of treatment, altering the course of treatment when the enrollee enrolls in a new MA plans is precisely the type of disruption this requirement aims to eliminate.
After careful consideration of all comments received, and for the reasons set forth in the proposed rule and in our responses to the related comments, we are finalizing § 422.112(b)(8) largely as proposed but with modifications. We are finalizing § 422.112(b)(8)(i)(A) with revisions to require approval of a prior authorization request for a course of treatment be valid for as long as medically necessary to avoid disruptions in care, in accordance with the applicable coverage criteria, the individual patient's medical history, and the treating provider's recommendation.
We proposed procedural improvements to ensure that utilization management policies are reviewed on a timely basis and have the benefit of provider input. Any authority for MA organizations to use utilization management policies with regard to basic benefits is subject to the mandate in section 1852(a)(1) of the Act that MA plans cover Medicare Part A and Part B benefits (subject to specific, limited statutory exclusions) and, thus, to CMS's authority under section 1856(b) of the Act to adopt standards to carry out the MA provisions. In light of the feedback we received and our concern that enrollees may be facing unreasonable barriers to needed care, we proposed to require MA organizations to establish a Utilization Management (UM) committee to operate similar to a Pharmacy and Therapeutics, or P&T, committee. We proposed to add requirements pertaining to this UM committee in a new regulation at § 422.137.
At § 422.137(a), we proposed that an MA organization that uses UM policies, such as prior authorization, must establish an UM committee that is led by an MA plan's medical director (described in § 422.562(a)(4)). Section 422.562(a)(4) requires every MA organization to employ a medical director who is responsible for ensuring the clinical accuracy of all organization determinations and reconsiderations involving medical necessity and establishes that the medical director must be a physician with a current and unrestricted license to practice medicine in a State, Territory, Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia. We also proposed, at § 422.137(b), that an MA plan may not use any UM policies for basic or supplemental benefits on or after January 1, 2024, unless those policies and procedures have been reviewed and approved by the UM committee. This proposal would ensure that plan policies and procedures meet the standards set forth in this final rule beginning with the contract year after the finalization of this proposed rule. We explained that we anticipate that there will be sufficient time between our issuance of a final rule and January 1,
We proposed the committee responsibilities at § 422.137(d). The responsibilities would include that the UM committee, at least annually, review the policies and procedures for all utilization management, including prior authorization, used by the MA plan. We proposed at § 422.137(d)(1)(i) through (iii) that such review must consider—
• The services to which the utilization management applies;
• Coverage decisions and guidelines for original Medicare, including NCDs, LCDs, and laws; and
• Relevant current clinical guidelines.
We proposed at § 422.137(d)(2)(i) though (iv) the committee approve only utilization management policies and procedures that:
• Use or impose coverage criteria that comply with the requirements and standards at § 422.101(b);
• Comply with requirements and standards at § 422.138(a)-(c);
• Comply with requirements and standards at § 422.202(b)(1); and
• Apply and rely on medical necessity criteria that comply with § 422.101(c)(1).
Currently, § 422.202(b) requires MA organizations to establish a formal mechanism to consult with the physicians who have agreed to provide services under the MA plan offered by the organization, regarding the organization's medical policy, quality improvement programs and medical management procedures; that formal mechanism for consultation must ensure that certain standards are met. Specifically, § 422.202(b)(1)(i) through (iv) require that MA plan practice guidelines and UM guidelines must: (i) be based on reasonable medical evidence or a consensus of health care professionals in the particular field; (ii) consider the needs of the enrolled population; (iii) be developed in consultation with contracting physicians; and (iv) be reviewed and updated periodically. We proposed to modify § 422.202(b)(1)(i) to align it with our standard for creating internal coverage criteria. We therefore proposed to replace the requirement that practice and UM guidelines be based on reasonable medical evidence or a consensus of health care professionals in the particular field with a requirement that UM guidelines be based on current widely used treatment guidelines or clinical literature. This is consistent with the proposed coverage criteria requirements at § 422.101(b)(6), which are discussed in detail in section III.E.2. of this final rule.
We solicited comment on whether we should also require the UM committee to ensure that the UM policies and procedures are developed in consultation with contracted providers; whether the UM committee should ensure that the MA organization, as required by § 422.202(b)(2), communicates information about practice guidelines and UM policies to providers and, when appropriate, to enrollees; and whether the UM committee should have an ongoing or active oversight role in ensuring that decisions made by an MA plan throughout the year are consistent with the final, approved practice guidelines and UM policies. We also proposed at § 422.137(d)(3) that the committee must revise UM policies and procedures as necessary, and at least annually, to comply with the standards in the regulation, including removing requirements for UM for services and items that no longer warrant UM so that UM policies and procedures remain in compliance with current clinical guidelines. We explained that mandating annual review of utilization management policies using these standards will help ensure that medically necessary services are accessible to all enrollees. Because prior authorization and referral or gatekeeper policies are included in UM policies and procedures, these proposed requirements would apply as well to those polices and CMS expects MA organizations to update their UM policies after the UM committee approves or revises them.
As this final rule as a whole makes clear, ensuring that enrollees have access to and are furnished covered benefits is a priority. We solicited comment on whether to require the UM Committee to review all internal coverage criteria used by the MA plan. We also solicited comment on the extent to which the proposed regulation text sufficiently and clearly establishes the standards and requirements discussed here.
At § 422.137(c)(1) through (4), we proposed that the UM committee must include a majority of members who are practicing physicians; include at least one practicing physician who is independent and free of conflict relative to the MA organization and MA plan; include at least one practicing physician who is an expert regarding care of elderly or disabled individuals; and include members representing various clinical specialties (for example, primary care, behavioral health) to ensure that a wide range of conditions are adequately considered in the development of the MA plan's utilization management policies. These composition requirements are in addition to the proposal that the medical director, required for each MA plan under § 422.562(a)(4), lead the UM committee.
We solicited comment on recommendations for other types of providers, practitioners, or other health care professionals that should also be included on the UM committee and whether additional standards for composition of the UM committee are necessary with regard to expertise, freedom from conflicts of interest, or representation by an enrollee representative. We also solicited comment on whether we should include a requirement, that when the proposed UM committee reviews UM policies applicable to an item or service, that the review must be conducted with the participation of at least one UM committee member who has expertise in the use of, or medical need for that specific item or service.
We proposed at § 422.137(d)(4) that the UM committee must clearly articulate and document processes to determine that the requirements under paragraphs (c)(1) through (4) of this section have been met, including the determination by an objective party of whether disclosed financial interests are conflicts of interest and the management of any recusals due to such conflicts. Finally, we proposed at § 422.137(d)(5) that the UM committee must document in writing the reason for its decisions regarding the development of UM policies and make this documentation available to CMS upon request. We explained that the documentation should provide CMS with an understanding of the UM committee's rationale for their decision, and may include, but is not limited to, information such as meeting minutes outlining issues discussed and any relevant supporting documentation.
As discussed in our proposal, we believe it is appropriate that the establishment of an MA plan UM committee, with certain exceptions, largely mirror the requirements in § 422.136 that MA organizations have a
To meet the existing requirements at § 422.136(b), MA-PDs are permitted to utilize an existing P&T committee established for purposes of administration of the Part D benefit under part 423 of this chapter. In the proposed rule, we stated that we anticipate that some of the requirements proposed for the UM committee may overlap or duplicate existing P&T committee requirements in connection with coverage of and utilization management policies for Part B drugs. We solicited comment on whether an MA plan should be permitted to utilize the proposed UM committee at § 422.137 to also meet the existing P&T committee requirements of § 422.136(b), provided that elements and requirements of all applicable regulations governing the committees and their functions (that is, §§ 422.136, proposed 422.137, and 423.120) are met. To the extent that LCD policies and localized or regional professional standards of practice are used by the proposed UM committee in performing its duties, it may not be advisable to permit use of one UM committee to serve multiple functions for diverse service areas. We also solicited comment on whether to explicitly permit an MA organization, or the parent organization of one or more MA organizations, to use one UM committee to serve multiple MA plans, including whether that should be limited to MA plans that are offered under the same contract.
In summary, CMS proposed to require at § 422.137 that all MA organizations that use utilization management policies, such as prior authorization, must establish an UM committee that is led by an MA plan's medical director. Further, we proposed than an MA plan may not use any UM policies for basic or supplemental benefits on or after January 1, 2024, unless those policies and procedures have been reviewed and approved by the UM committee. We thank all commenters for their input on CMS's proposed new requirements. We received the following comments on this proposal, and our response follows:
As proposed, § 422.137(a) requires the UM committee to be led by a plan's medical director. In light of our decision to interpret and implement § 422.137 by permitting one UM committee to serve multiple MA plans offered by the same MA organization, one plan's medical director may fulfill this role for the MA organization.
We are not finalizing an additional requirement for participation or involvement by a specific specialty provider or health care provider with expertise related to each individual UM policy. We believe that is unnecessary because, as previously noted, all utilization management policies must comply with § 422.101(b), which requires any permissible internal coverage criteria must be based on current evidence in widely used treatment guidelines or clinical literature. Current widely-used treatment guidelines are those developed by organizations representing clinical medical specialties, and refers to guidelines for the treatment of specific diseases or conditions. Therefore, we do not believe it is necessary for additional involvement of specialists when reviewing utilization management policies and procedures. CMS encourages plans to include relevant experts when feasible during the review process.
We thank all commenters for their comments. After careful consideration of all comments received, and for the reasons set forth in the proposed rule and in our responses to the related comments, as previously summarized, we are finalizing the new regulation § 422.137 and the modification to § 422.202(b)(1)(i) as proposed.
CMS solicited comment on three areas: (1) termination of services in post-acute care, (2) gold carding, and (3) addressing vulnerabilities that can lead to manual review errors and system errors. Since no regulations were proposed, we are not finalizing anything in these areas at this time. We thank commenters for their input, and will consider all comments during future rulemaking.
Section 3713 of The Coronavirus Aid, Relief, and Economic Security (CARES) Act (2020) (Pub. L. 116-136) requires coverage of the COVID-19 vaccine and its administration at zero cost-sharing for enrollees of Traditional Medicare and Medicare Advantage. The CARES Act revised section 1861(s)(10)(A) of the Act to include among services provided at zero cost-sharing in the Medicare FFS program, the COVID-19 vaccine and its administration. As amended by section 3713 of the CARES Act, section 1852(a)(1)(B)(iv)(VI) of the Act prohibits MA plans from using cost-sharing that exceeds the cost-sharing imposed under Traditional Medicare for a COVID-19 vaccine and its administration when the MA plan covers this Traditional Medicare benefit.
Cost plans are coordinated care plans and share many of the same features as Medicare Advantage plans, but have a separate statutory authority (section 1876 of the Act) and are paid on a reasonable cost basis. In addition, unlike with MA plans, enrollees in cost plans may receive services from original Medicare in addition to services from the cost plan's network; when they receive benefits from health care providers that are not contracted with the cost plan, cost plan enrollees are covered by Traditional Medicare, with the same cost sharing and coverage as the Traditional Medicare program. The CARES Act did not include the zero cost-sharing provision for section 1876 cost contract plans (cost plans), so using its authority under section 1876(i)(3)(D) of the Act, which authorizes CMS to impose “other terms and conditions not inconsistent with [section 1876]” that are deemed “necessary and appropriate,” CMS established a requirement for cost plans to use cost sharing that does not exceed the cost sharing in Traditional Medicare for a COVID-19 vaccine and its administration in an interim final rule, titled Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, which appeared in the
CMS believes that it is necessary and appropriate to ensure that cost plan enrollees, like other Medicare beneficiaries, are provided access to the COVID-19 vaccine and its administration without cost-sharing in-network. Requiring cost plans to comply with the same cost-sharing protections available to Medicare beneficiaries in Traditional Medicare and those enrolled in MA plans would ensure equitable access to care and that cost is not a barrier for beneficiaries to receive the COVID-19 vaccine. CMS has extended to cost plans other statutory requirements related to cost-sharing via regulation for those services that the Secretary determines require a level of predictability and transparency for beneficiaries. For example, in a final rule which appeared in the
We received several supportive comments on this proposal and are finalizing the provision as proposed.
We proposed to revise §§ 422.566(d) and 422.629(k)(3) to state if the MA organization or applicable integrated plan expects to issue a partially or fully adverse medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) decision based on the initial review of the request, the organization determination must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the services at issue, including knowledge of Medicare coverage criteria, before the MA organization issues the organization determination decision. This is the same standard of review with respect to expertise that applies to physician review of reconsiderations at § 422.590(h)(2). The rule at § 422.590(h)(2) interprets and implements the requirement in section 1852(g)(2)(B) of the Act that any reconsideration that relates to a determination to deny coverage based on a lack of medical necessity be made only by “a physician with appropriate expertise in the field of medicine which necessitates treatment” to mean a physician with an expertise in the field of medicine that is appropriate for the covered services at issue. As stated in the proposed rule, we believe it is
We received the following comments on the proposal related to the review of medical necessity decisions by a physician or other health care professional with expertise in the field of medicine appropriate to the requested service.
Several commenters were also concerned about the cost associated with implementing this requirement. A commenter suggested that this proposal could result in plans being required to scale back available benefits due to the cost of specialist reviews. Commenters also expressed concern that the requirement to find a specialist with appropriate expertise could delay access to necessary care as plans work to find the appropriate reviewer and recommended that, if finalized, we provide as much flexibility for plans as possible in determining what constitutes appropriate expertise on a case-by-case basis. Another commenter, indicated that the costs could be excessive and further add to administrative expense, thereby increasing beneficiary premiums, especially when not scalable to smaller regional not-for-profit health plans that may not see the volume of subspecialty review over a given period. Another commenter provided the example of MA plans offering dental, vision and hearing benefits as a supplemental benefit, and questioned if CMS expects each MA plan to have these provider types on call 24/7 for medical necessity review. This commenter indicated that most plans do not have dentists, for example, on staff, so to require these physician types be on call, this requirement will be costly and CMS should evaluate the aggregate costs of this proposal across the program and determine whether the benefit outweighs the cost.
We understand the commenter's concern regarding the difficulties a plan may encounter in employing a specialist in every field of medicine, which is why our proposal did not include a requirement that the plan reviewer be of the same specialty as the treating physician. To the extent a plan uses a “generalist” as suggested by the commenter, to satisfy this standard, that reviewer would need to have relevant training or experience in the field of medicine related to the requested service in order to determine the medical necessity of the requested item or service.
With respect to the IRF example cited by several commenters, the plan reviewer reviewing a request for IRF care would need to have the background and knowledge to determine that the enrollee's medical condition requires intensive rehabilitation, continued medical supervision, and coordinated care. Accurately assessing the enrollee's diagnoses, conditions and functional status requires clinical expertise that is appropriate to the requested item or service and could be made, for example, by a physical medicine and rehabilitation doctor, a neurosurgeon, a physical therapist or a rehabilitation nurse.
Finally, given the related provisions in this rule with respect to determinations of medical necessity and utilization management tools, including prior authorization, we do not believe that this review standard requiring appropriate expertise needs to be unduly prescriptive to make an overall positive impact in the thoroughness of medical necessity reviews. For example, the codification of existing policy at § 422.101(c)(1)(i)(C) that MA organizations consider the enrollee's medical history (for example, diagnoses, conditions, functional status), physician recommendations, and clinical notes dovetails with the proposed requirement that plans utilize reviewers with appropriate expertise in the requested service. In addition, there are several other related provisions in this rule regarding utilization management and prior authorization at §§ 422.112, 422.137 and 422.138 that we believe will strengthen medical necessity reviews, such as the proposal that prior authorization policies for coordinated care plans may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary based on standards specified in this rule. Again, decisions to deny coverage on the basis of medical necessity require the exercise of clinical judgment based on the considerations specified in § 422.101(c) as finalized in this rule. Exercising that type of judgment necessarily requires that the reviewer have knowledge and experience relevant to the requested services to reasonably determine when a requested service is reasonable, necessary and covered under the clinical coverage criteria that plans must use under § 422.101(b) as finalized in section III.E of this rule. We believe the totality of the provisions addressed in this rule will enhance the overall decision-making process and the quality of the
Since we did not specifically propose that the reviewer be of the same specialty or sub-specialty as the physician requesting the service on the enrollee's behalf, we decline to finalize this proposal with such a requirement. As stated in the proposed rule, CMS's goal is to balance strengthening clinical review in the organization determination process when the plan expects to issue a partially or fully adverse medical necessity determination, with plan flexibility and operational efficiency in selecting appropriate reviewers. We plan to monitor implementation of this standard to assess whether future rulemaking may be necessary related to additional specificity on what constitutes expertise appropriate to the requested service.
Several commenters expressed concern related to the plan's discretion to determine the appropriate expertise on a case-by-case basis. These commenters recommended that CMS require MA organizations to develop a list to be shared with its contracted providers each year of services which require prior authorization and delineate the specific provider types and specialties, noting requisite training and rationale, who will be conducting medical necessity reviews, prior authorization reviews and peer-to-peer consults for those services. Another commenter suggested that the Utilization Management Committee, as proposed in this rule, should play a prominent role in developing this list of provider types and specialties in order to ensure compliance. A commenter requested that CMS ensure that this proposal also extends to inpatient care decisions and to the reporting of medical diagnoses that support inpatient care.
With respect to the comment on inpatient care decisions, any organization determination where the plan expects to make an adverse decision based on medical necessity will be subject to this provision. If an organization determination is requested for authorization of an inpatient admission and the plan has a prior authorization requirement that a particular diagnosis or diagnoses be present and the plan intends to issue an adverse decision based on its initial review of the request, the request must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the services at issue, including knowledge of Medicare coverage criteria, before the MA organization issues the organization determination decision.
Further, the enrollee (or the treating physician acting on behalf of the enrollee) always has recourse through the appeals process if the enrollee is dissatisfied with the plan's decision. This proposal in no way affects the enrollee's right to appeal a denied organization determination or to file a grievance expressing dissatisfaction with any aspect of an MA organization's or a provider's operations or activities. As stated in the proposed rule, the goal of this proposed policy change is to enhance medical necessity reviews at the initial coverage decision level which should ultimately reduce the number of cases that get into the appeals process. We expect this policy to result in a decrease in the number of denied organization determinations because we believe requiring reviewers with
Based on the feedback we received from commenters, we are finalizing this requirement as proposed by revising §§ 422.566(d) and 422.629(k)(3) to state if the MA organization or applicable integrated plan expects to issue a partially or fully adverse medical necessity (or any substantively equivalent term used to describe the concept of medical necessity) decision based on the initial review of the request, the organization determination must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the services at issue, including knowledge of Medicare coverage criteria, before the MA organization issues the organization determination decision.
We also proposed a technical correction at § 422.590(b)(1) to include the correct cross reference regarding favorable decisions on payment requests at § 422.618(a)(2). We did not receive comments on this technical correction and we are finalizing this correction.
In accordance with our authority to interpret and implement the requirements and limitations in sections 1851(h), 1851(j), 1852(c), 1860D-1(b)(1)(B)(vi), 1860D-4(a), and 1860D-4(l) of the Act, §§ 422.2267(a)(2) and 423.2267(a)(2) of the regulations require MA organizations and Part D sponsors to translate materials into any non-English language that is the primary language of at least 5 percent of the individuals in a plan benefit package service area. In addition, per § 417.428, cost plans with contracts under section 1876 of the Act must follow the same
In addition, MA organizations and Part D sponsors must comply with section 504 of the Rehabilitation Act of 1973 and section 1557 of the Affordable Care Act, and the Department of Health and Human Services implementing regulations at 45 CFR parts 84 and 92. As recipients of Federal financial assistance, MA organizations and Part D sponsors must provide appropriate auxiliary aids and services, including interpreters and information in alternate formats, to individuals with impaired sensory, manual, or speaking skills, where necessary to afford such persons an equal opportunity to benefit from the service in question. Auxiliary aids and services can include braille, large print, data/audio files, relay services, and TTY communications. We further explained the obligation of plans to provide accessible communications for individuals with disabilities in an August 30, 2017, Health Plan Management System memorandum titled, “Frequently Asked Questions Regarding Accessible Communications for Individuals with Disabilities, Pursuant to Section 504 of the Rehabilitation Act of 1973 (Section 504) and Section 1557 of the Affordable Care Act (Section 1557).”
These requirements notwithstanding, CMS has learned from oversight activities, enrollee complaints, and stakeholder feedback that enrollees often must make a separate request each time they need material in an alternate language or in an alternate format. In addition, during CMS program audits and oversight activities, we have found that special needs plans (SNPs) do not always translate individualized care plans (ICPs) into enrollees' primary languages, even when the enrollee has expressed a need for translation as part of completing the health risk assessment. To address these issues, we proposed, based on our authority under the Medicare statute, to adopt regulations to impose additional Medicare marketing and communications standards on plans to ensure access to important information and materials for individuals who have limited English proficiency and individuals with disabilities.
The materials required under §§ 422.2267(e) and 423.2267(e) and ICPs are vital to how individuals access services and make decisions about their health care. These materials furnish important information about coverage and benefits under Medicare health and drug plans. We noted our belief that our proposal would make it easier for beneficiaries to understand the full scope of available Medicare benefits (as well as Medicaid benefits available through the D-SNPs, where applicable), increasing their ability to make informed health care decisions, and promote a more equitable health care system by increasing the likelihood that MA enrollees have access to information and necessary health care.
At 87 FR 79521 through 79522 of the proposed rule, we described the need for providing materials in non-English languages and in any accessible formats. We explained that communication and language barriers are associated with decreased quality of care and poorer health outcomes. In addition, individuals with limited English proficiency are less likely to have routine health visits, more likely to defer needed health care, and more likely to leave the hospital against medical advice.
We believe that it is a substantial burden for enrollees to have to request each material in a non-English language or accessible format and that requiring enrollees to do so could impede access to care. It is also possible that enrollees may require materials in both an alternate format and a non-English language (for example Spanish braille). In addition, to ensure the ICPs are developed in consultation with the enrollee as required at § 422.101(f)(1)(ii), it is important that ICP materials be provided in the enrollee's primary language and, where appropriate, in an accessible format. As described at 87 FR 79522 of the proposed rule, research has found patients with limited English proficiency experience negative health outcomes due to the barriers they encounter, including when interacting with their doctors and care team members. We have become attuned to this issue through our work with Medicare-Medicaid Plans (MMPs), as explained at 87 FR 79522 of the proposed rule.
We believe that there are many ways for MA organizations and Part D sponsors to learn of an enrollee's need for an accessible format and language needs and maintain this information. We outlined examples at 87 FR 79522 of the proposed rule.
We would like to minimize barriers for enrollees (and potential enrollees) with limited English proficiency and/or with disabilities who need materials in non-English languages and accessible formats and remove any ambiguity associated with MA and Part D plan responsibilities. Therefore, we proposed to re-designate the paragraphs at §§ 422.2267(a)(3) and 423.2267(a)(3) as §§ 422.2267(a)(5) and 423.2267(a)(5) and add new paragraphs at §§ 422.2267(a)(3) and 423.2267(a)(3). In these new paragraphs, we proposed to require that MA organizations and Part D sponsors provide materials to enrollees on a
As we noted in the proposed rule at 87 FR 79523, there are no information collections related to creating a standing request for translated materials or materials in alternate formats. We believe the burden associated with these proposed requirements is exempt from the requirements of PRA as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement would be incurred by persons in the normal course of their activities. We believe most cost plans, MA organizations, and Part D sponsors have translators on staff or access them via contractors because of existing translation and auxiliary aid requirements.
We received the following comments, and our responses follow.
We also understand that some commenters are concerned about the cost of translating materials into several languages on a standing basis. Each fall, we release an HPMS memorandum announcing that plans can access in the HPMS marketing review module a list of all languages that meet the 5 percent threshold for plan service areas, which is the threshold for translation.
For auxiliary aids and services, section 504 of the Rehabilitation Act of 1973, section 1557 of the ACA, and the regulations at 45 CFR 92.102(b) already require plans to provide appropriate auxiliary aids and services in alternate formats to individuals with impaired sensory, manual, or speaking skills, where necessary to afford such persons an equal opportunity to benefit from the service in question. The requirement we are finalizing at §§ 422.2267(a)(3) and 423.2267(a)(3) only clarifies that plans must provide the materials based on the enrollee's preference on a standing basis.
While we understand that plans may need to make some adjustments to vendor contracts and make system updates, plans should already have resources in place to provide these materials translated into the languages required currently under §§ 422.2267(a)(2) and 423.2267(a)(2) and accessible formats. In addition, plans should have systems in place that can be adjusted to track standing requests since they are already required to track a request for hard copy materials as described in §§ 422.2267(d)(2)(i)(E) and 423.2267(d)(2)(i)(E). We believe the benefit of ensuring access to materials that can be easily understood by enrollees so that they can receive timely access to care outweighs any additional effort that plans may need to undertake. As stated earlier in this section and in the proposed rule at 87 FR 79522, we believe it is a substantial burden for enrollees to have to request each material in a non-English language or request accessible formats for each material and that requiring enrollees to do so could cause a critical delay to timely access to care. Thus, we are finalizing the provisions at §§ 422.2267(a)(3) and 423.2267(a)(3) as proposed, without a delay in implementation.
A commenter noted that the proposed rule is in addition to existing obligations under 45 CFR part 92 and that plans are expected to comply with both, even if one imposes a higher or different standard, unless it is impossible to do so. This commenter stated that the lack of clarity in the proposal on whether the standards under 45 CFR part 92 for determining reasonableness apply to the draft regulation could cause confusion for plans in implementing the guidance and, in turn, result in differential application across payers. The commenter explained that such ambiguity could result in beneficiary confusion and unnecessary cost for plans. The commenter included an example where a visually impaired enrollee could request an alternate format of braille, which the commenter noted under 45 CFR part 92 plans are permitted to determine the reasonableness by applying the applicable standards. The commenter suggested that CMS revise the current proposal to include explicit language that the same standards under 45 CFR part 92 apply to the proposed CMS requirement for providing all CMS required materials in both the preferred format and/or language.
A few commenters raised concerns regarding their ability to meet the September 30 deadline for providing a translated or accessible format Annual Notice of Change (ANOC) to current enrollees. Several commenters recommended that CMS establish a stakeholder workgroup that includes translation contractors to discuss how turnaround times can be improved and which communications can be translated fast enough to meet the need of the beneficiaries.
As outlined in the HPMS memorandum titled, “Frequently Asked Questions Regarding Accessible Communications for Individuals with Disabilities, Pursuant to Section 504 of the Rehabilitation Act of 1973 (Section 504) and Section 1557 of the Affordable Care Act (Section 1557)” dated August 30, 2017,
Section 504 and section 1557 require reasonable modification. For example, the August 30, 2017 memorandum describes one scenario which could occur if an individual with a disability used an out-of-network provider and now requests instructions in an alternate format. This scenario describes how an individual could request that the MA plan reimburse them for the out-of-pocket claim. If the MA plan requires the claim to be filed within a certain amount of time, the August 30, 2017 memo states that the MA plan must take into account any added time needed to provide the instructions in the alternate format if the request is reasonable as required under section 504 and section 1557. If it took the MA plan an extra three days to put the instructions into the alternate format, three days should be added to the length of time in which the MA plan will accept the individual's claim.
The MA plan should document how it ensured that the individual had an equal opportunity to participate in the program or activity. If an MA plan denies a request, the MA plan should document its decision and be able to share it with CMS or the HHS Office for Civil Rights (OCR) upon request. If CMS or HHS OCR reviews an MA plan's decision, it will give weight to the individual's request based on the communications standards in 45 CFR 84.52(d), and 92.102.
We note that CMS provides translated models for the ANOC and EOC each summer in Spanish and Chinese so that plans then can focus on including the plan-specific information prior to the September 30 annual deadline. For CY 2023, CMS also provided Spanish and Chinese versions of the ANOC and EOC for the D-SNP specific models. We plan to provide these translated models for CY 2024 as well. Finally, we will consider establishing a stakeholder workgroup to discuss how turnaround times can be improved. We believe the benefit of ensuring access to materials that can be easily understood by enrollees so that they can receive timely access to care outweighs any additional effort that plans may need to undertake. For these reasons and those noted previously, we are finalizing and implementing these requirements for CY 2024. As such, these requirements will be applicable for all required materials related to CY 2024.
We are finalizing the requirements at §§ 422.2267(a)(3) and 423.2267(a)(3) as applicable for all required materials related to CY 2024. We expect the tracking and use of standing requests can begin with requests received from enrollees in connection with materials for coverage in CY 2024. Unless an MA plan already has an existing process to track and use standing enrollee requests, we do not expect MA plans to go back to past enrollee requests to apply them as standing requests for 2024 materials. Consistent with Question 14 in the August 30, 2017 HPMS memo, an MA plan must make a best effort to ensure that an enrollee needs to only make the request of an MA plan once during the time the beneficiary is enrolled with the MA plan. If the enrollee leaves the MA plan and returns, the individual may need to make the request to the MA plan again.
This means that plans can send the notice in the enrollee's primary non-English language or accessible format stating how the enrollee can access the materials electronically in lieu of sending a hard copy in the primary non-English language or accessible format. However, if an enrollee confirms that they want a hard copy of the material on a standing basis in their primary non-English language or alternate format, then the plan must provide that material in the primary non-English language or alternate format on a standing basis unless the enrollee noted that it is a one-time request. We also note that websites must be compliant with Section 508 of the Rehabilitation Act so that individuals can read sites and materials with screen reader technology. Also, as discussed in the August 30, 2017, HPMS memorandum titled, “Frequently Asked Questions Regarding Accessible Communications for Individuals with Disabilities, Pursuant to Section 504 of the Rehabilitation Act of 1973 (Section 504) and Section 1557 of the Affordable Care Act (Section 1557)”
Another commenter expressed that health plan materials should provide clear information on plan benefits to both enrollees and providers, and care coordinators and navigators should be available to discuss the options with enrollees. They noted that accountable care organizations (ACOs) can help with this, because they are more likely to have a longitudinal relationship with the patient and have a care team in place to help with outreach and coordination. The commenter also stated that ACOs and practices participating in advanced alternative payment models often have the infrastructure to use data to better identify, outreach, and successfully engage harder-to-reach patients, but they cannot do it as efficiently on their own. According to the commenter, the more standardization there is in how health plans communicate to patients and providers on how to access benefits and what resources are available to them, the better partners primary care physician practices can be in helping dually eligible individuals navigate the complex health care landscape.
In addition, we note that, per §§ 422.2267(e)(31) and 423.2267(e)(33), MA plans and Part D plans are required to include a multi-language insert with all required materials noting that free interpreter services are available in Spanish, Chinese, Tagalog, French, Vietnamese, German, Korean, Russian, Arabic, Italian, Portuguese, French Creole, Polish, Hindi, Japanese and any additional languages that meet the 5 percent service area threshold. In addition, §§ 422.2267(e)(35) and 423.2267(e)(36) requires a statement about the availability of accommodations for persons with special needs, including a telephone number; this notice must be in disclaimer form or within the body of the material on any advertisement of invitation to education and marketing events.
After considering the comments received and for the reasons outlined in our proposed rule and responses to comments, we are finalizing the proposed changes to re-designate current paragraph (a)(3) in §§ 422.2267 and 423.2267 to paragraph (a)(5) and to adopt a new paragraph (a)(3) in both regulations to require plans to provide required materials to enrollees on a standing basis in an non-English language or accessible format upon receiving a request for the materials in a non-English language or accessible format or when otherwise learning of the enrollee's primary language or need for accessible format.
Over 1.8 million individuals dually eligible for the Medicare and Medicaid programs speak a language other than English at home or do not speak English fluently.
Per the definition of specialized MA plans for special needs individuals in § 422.2, all SNPs must be MA-PDs that comply with both Part 422 and Part 423 requirements. Sections 422.2267(a)(2) and 423.2267(a)(2) require dual eligible special needs plans (D-SNPs), like all other MA-PD plans, to translate materials into any non-English language that is the primary language of at least 5 percent of the individuals in a plan benefit package service area. We proposed to amend §§ 422.2267 and 423.2267 with a new paragraph (a)(4) that requires that FIDE SNPs and HIDE SNPs, as defined at § 422.2, and applicable integrated plans (AIPs), as defined at § 422.561, translate all Medicare materials listed in §§ 422.2267(e) and 423.2267(e) into any languages required by the Medicaid translation standard as specified through their capitated Medicaid managed care contract in addition to the language(s) required by the Medicare translation standard at § 422.2267(a)(2). Generally, we expect that the Medicaid translation requirements would be the regulatory standard at § 438.10; however, a State may impose a higher or more stringent translation requirement on its Medicaid managed care plans than is required by § 438.10, so we believe referring to the capitated Medicaid managed care contract rather than § 438.10 is appropriate for this proposed new requirement. Specifically, § 438.10(d)(3) requires that entities make written materials that are critical to obtaining services available in the prevalent non-English languages in the service area. Section 438.10(a) defines prevalent as a non-English language determined to be spoken by a significant number or percentage of potential enrollees and enrollees that are limited English proficient. Section 438.10(d)(1) requires that the State establish a methodology for identifying the prevalent non-English languages spoken by enrollees and potential enrollees throughout the State. Under the definitions for FIDE SNP, HIDE SNP, and AIP, each of these types of plan has a companion or affiliated Medicaid managed care plan, which would itself be subject to § 438.10 and the applicable State's translation requirements for Medicaid materials described in § 438.10. We proposed to extend the translation standards applicable to the
The proposed modifications at §§ 422.2267 and 423.2267 would not create exceptions to other laws that govern translation of written materials provided to enrollees that we have previously described. Rather, our intent is to make it easier for dually eligible enrollees in FIDE SNPs, HIDE SNPs, or AIPs to understand the full scope of Medicare and Medicaid benefits available through such D-SNPs, which would increase their ability to make informed health care decisions. It would also reduce the likelihood of an enrollee receiving materials in different languages (for example, some in English and some in Spanish) depending on whether the materials are governed by Medicare or Medicaid requirements.
As explained in the propose rule, we considered applying the proposed new requirement to additional or different groups of D-SNPs, such as limiting the proposal to AIPs or to organizations with D-SNP-only contracts as described under § 422.107(e), or expanding the requirement to all D-SNPs and D-SNP look-alikes (that is, the MA plans that meet the standards in § 422.514(d)) during a period before the D-SNP look-alike plan is nonrenewed or terminated. We decided to focus our proposal on all FIDE SNPs and HIDE SNPs, as defined at § 422.2, and AIPs, as defined at § 422.561, because these plans have capitated contracts with State Medicaid agencies and must already translate Medicaid materials to comply with their Medicaid managed care contracts, and would likely either have staff that are capable of translating materials into these languages or contract with organizations to perform these translations. In addition, an increasing number of dually eligible individuals are in FIDE SNPs, HIDE SNPs, and AIPs where the same organization provides coverage of both the Medicare and Medicaid services for the enrollee.
We received the following comments, and our responses follow.
After considering the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the requirement at §§ 422.2267(a)(4) and 423.2267(a)(4) as proposed.
Currently, §§ 422.2267(e)(30)(vi) and 423.2267(e)(30)(vi) exclude the member ID card from the translation requirement under §§ 422.2267(a)(2) and 423.2267(a)(2). We proposed to amend the member ID card provision at §§ 422.2267(e)(30)(vi) and 423.2267(e)(30)(vi) to expand the exclusion for member ID cards to include the new paragraphs proposed in this section, §§ 422.2267(a)(3) and (a)(4) and §§ 423.2267(a)(3) and (a)(4), respectively.
We received no comments on this proposal. We are finalizing these revisions as proposed for the reasons outlined in the proposed rule.
In the December 2022 proposed rule, we proposed a number of changes to Subpart V of both §§ 422 and 423 regulations. These changes include submitting marketing materials into the Health Plan Management System, prohibiting the use of the Medicare name, CMS logo, and products or information issued by the Federal Government in a misleading way; prohibiting the use of superlatives (for example, words like “best” or “most”) in marketing without supporting data which reflects content for the current or
The regulatory changes for Subpart V of Parts 422 and 423 are applicable for the 2024 Contract Year and beyond; thus applying to marketing and communications materials and activities beginning for the 2024 Contract Year; current regulations require the distribution of 2024 materials beginning September 30, 2023.
Sections 1851(h) and 1851(j) of the Act, which address MA, provide CMS the authority to review marketing materials, develop marketing standards, and ensure that marketing materials are accurate and not misleading. These provisions also provide CMS with the authority to prohibit certain marketing activities. Section 1856(b)(1) of the Act authorizes CMS to adopt standards, through rulemaking, standards that are consistent with, implement and carry out the Medicare Advantage statutory provisions. In addition, sections 1876(i)(3)(D), 1857(e)(1) and 1860D-12(b)(3)(D) of the Act provide CMS the authority to adopt additional contract terms for cost plans, MA plans, and Part D plans when necessary and appropriate. Likewise, section 1860D-1(b)(1)(B)(vi) of the Act directs that the Secretary use rules similar to and coordinated with the MA rules at section 1851(h) of the Act for approval of marketing materials and application forms for Part D plan sponsors. Section 1860D-4(l) of the Act applies certain prohibitions under section 1851(h) of the Act to Part D sponsors in the same manner as such provisions apply to MA organizations. In addition, sections 1852(c) and 1860D-4(a) of the Act require organizations to provide certain materials to Medicare beneficiaries concerning MA and Part D plan choices, benefits coverage, and other information to make informed enrollment decisions. These statutory provisions help ensure Medicare beneficiaries are informed, and thus have sufficient knowledge to assist in protecting them when making an election to enroll in an MA (including MAPD) or Part D plan. We believe the changes proposed and adopted in this rulemaking strengthen CMS' ability to ensure MA and Part D marketing to beneficiaries is not misleading, inaccurate, and/or confusing. Additionally, under 42 CFR 417.428, most marketing requirements in subpart V of part 422 apply to section 1876 cost plans as well. (75 FR 19783 through 19785)
In accordance with regulations at §§ 422.2261(a) and 423.2261(a), MA organizations and Part D sponsors (MA organizations/Part D sponsors) must submit all marketing materials, all election forms, and certain designated communications materials for CMS review. The HPMS is CMS' system of record for marketing materials.
CMS believes these changes are beneficial to the MA and Part D programs, for CMS, and plans. By having the TPMO submit materials directly to CMS and MA organizations and Part D sponsors opting into the piece, CMS will know exactly which organizations the piece is being used to market. This will allow CMS to hold only those MA organizations and Part D sponsors accountable for inappropriate marketing. This also allows organizations to decide whether they want to be represented by the TPMO on a specific material. Prior to this change, if the marketing material was sent in by the one “lead” organization, the “non-lead” organizations were automatically included in the marketing piece.
This change to require TPMOs to submit the materials they develop ensures that all plans on whose behalf the TPMO is marketing, know what material is being submitted and that CMS knows which materials will be used by which plans. This process also allows for MA organizations and Part D sponsors to either opt into or opt out of each material, which allows CMS to see which organizations the TPMO material is being used for. With this new process CMS can better hold MA organizations and Part D sponsors responsible for the actions of their first tier, downstream, and related entities and, therefore, we believe that MA organizations and Part D sponsors should know and approve of the materials being used to market their products.
After review of the comments and for the reasons outlined in the proposed and our responses to comments, we are finalizing the provision to require TPMOs to submit marketing materials into HPMS as proposed. The benefits of ensuring that TPMO marketing materials are submitted into HPMS and are approved by each plan to permit the TPMO to use the material far outweigh any additional effort made by TPMOs.
CMS proposed to add a new sub-subparagraph (xix) to § 422.2262(a)(1) and a new sub-subparagraph (xviii) to § 423.2262(a)(1) to address the use of the Medicare name, CMS logo, and products or information issued by the Federal Government, including the Medicare card. CMS is aware of concerns from external stakeholders about marketing activities and documents that appear to be from Medicare, CMS, or the Federal Government. Through beneficiary complaints and CMS surveillance activities over the years, we have seen the word “Medicare” in names of store fronts, on notices or postcards where “Medicare” is in large font while disclaimers are miniscule, and in television advertisements where a beneficiary could assume that the advertising is coming from CMS or the Medicare program in general. We have also seen logos that are very similar to the Health and Human Services (HHS) logo, on websites and print materials. These logos have featured circles with writing around the circle and a bird, wings, or other images that appear to be the same image used by the Federal Government. There are also numerous third-party internet sites with “Medicare” in the URL or a logo similar to the HHS logo, potentially causing a beneficiary to click on a private site when they intend to go to Medicare.gov or are seeking official Medicare information or access. Often, it appears as if the materials urging the beneficiary to “take action” are from Medicare, or that these third parties represent Medicare or the Federal Government. With the increase of third parties in the marketplace, based on CMS' surveillance and complaints received (especially through 1-800-MEDICARE), we are concerned that an increasing number of beneficiaries are being misled into believing the entity they are contacting is Medicare or the Federal Government. One specific example, provided by a Medicare beneficiary, is a postcard with the beneficiary-named address with “Medicare Notice” in large, bold letters at the top along with “Personal & Confidential” and “Important Medicare Information.” This postcard also had a “Medicare Information” box listing a “Customer ID,” formatted to look like an official Medicare beneficiary number. This misleading postcard appeared to be an official document disseminated by the Federal Government. In our review of complaints received through 1-800 MEDICARE, CMS discovered other examples of beneficiaries who mistakenly believed they were calling Medicare rather than a private MA or Part D plan or its agent or broker, likely based on the receipt of a flyer using the word “Medicare” in a way that conveyed to the beneficiary that they must call the telephone number on the mailer. These complaints illustrate that the use of the Medicare name is at times confusing and misleading to Medicare beneficiaries. CMS can see no value or purpose in a non-governmental entity's use of the Medicare logo or HHS logo except for the express purpose of sowing confusion and misrepresenting itself as the government.
A top CMS priority, consistent with sections 1851(h)(2) and 1860D-01(b)(1)(B)(vi) of the Act and CMS's implementing regulations at §§ 422.2262 and 423.2262, is to ensure that MA organizations and Part D sponsors, and their first tier and downstream entities, disseminate information to beneficiaries that is accurate and not misleading. We are therefore concerned that the use of the term “Medicare” in situations like those, as previously described, erroneously leads beneficiaries to believe that Medicare-related communications or advertising are disseminated or endorsed by Medicare or the Federal Government, when in actuality such communications are being disseminated by the MA organizations/Part D sponsors themselves, or by entities operating on behalf of the MA organizations or Part D sponsors. Although the types of plan communications, previously described, that feature the word “Medicare” typically include disclaimers that state the information presented is not connected to or endorsed by the Federal Government or the Medicare program, these disclaimers are often tiny, difficult to read, and are mixed in with other CMS-required disclaimers as well as plan-developed, non-required, disclaimers. While CMS already prohibits inaccurate or misleading information under §§ 422.2262(a)(1)(i) and 423.2262(a)(1)(i), we believe it is important to specifically prohibit the misleading use of the Medicare name, CMS logo, and products or information issued by the Federal Government, as well as prohibiting the use of the Medicare card unless previously approved by CMS in §§ 422.2262(a)(1) and 423.2262(a)(1). We are not including the Medicare Part D mark, as CMS gives Part D sponsors contractual permission to use the mark. With these proposals, we intended to firmly and clearly prohibit the improper use of these terms and logos. Therefore, we proposed adding a new paragraph (xix) to § 422.2262(a)(1) and a new (xviii) to § 423.2262(a)(1), which specifically prohibits the use of the Medicare name, CMS logo, or products or information issued by the Federal Government, including the Medicare card, in a misleading manner. We acknowledge that reasons exist to use the Medicare card image, which we will permit with authorization from CMS.
Since CMS contracts with MA organizations and Part D sponsors and those contracts incorporate requirements to comply with part 422 and part 423 regulations, CMS holds these organizations accountable for the actions of their first tier, downstream and related entities (FDR), per §§ 422.504(i) and 423.505(i); in addition, CMS requires MA organizations and Part D sponsors to include in their contracts with first tier, downstream and related entities that any services or activities conducted by the first tier, downstream or related entity are performed in accordance with the MA organization's or Part D sponsor's obligations under its contract with CMS. If CMS determines that the Medicare name, CMS logo, or official products like the Medicare card, have been used in a misleading manner by an FDR, CMS would address the issue with the MA organization or Part D sponsor on whose behalf the FDR was operating and hold the sponsoring organization accountable for the misleading information.
Disclaimers or taglines that are prominently placed, in a font size and color to be readily noticed, and that clearly explain that an entity or website is not affiliated with, endorsed by, or otherwise somehow related to the federal government, CMS, HHS, and/or Medicare are essential. Additional information or factors may contribute to, or alternatively, actually eliminate the potential for use of the Medicare name, CMS logo, and products and information issued by the federal government to be confusing or misleading to enrollees or potential enrollees. It is necessary to consider and evaluate the facts, when using the Medicare name, CMS logo, and products or information issued by the Federal Government to determine whether the use of them violates this provision we are finalizing. Plans and their TPMOs need to take the necessary steps to ensure that their marketing and communication materials and activities comply.
Based on the comments, CMS is finalizing the proposal, with a minor modification, to prohibit the use of the Medicare name, logo, or products in a misleading manner when used in marketing of MA and Part D plans. The modification is to permit use of the Medicare card image with CMS authorization.
In our January 2021 final rule, we prohibited plan use of unsubstantiated statements except those used in taglines and logos in 42 CFR 422.2262(a)(1)(ii) and 423.2262(a)(1)(ii). Prior to the January 2021 final rule, we had prohibited the use of unsubstantiated superlatives and pejoratives, except when used in logos and taglines, through our Medicare Communications and Marketing Guidelines. In the
CMS believes it is critical to provide current, reliable, and valid data or documentation, such as reports or studies, as the basis for a superlative statement in order for beneficiaries to review and understand the context and reference point for the superlative. This documentation and/or data can be referenced through footnotes explaining the basis, noting the source (with enough information for a beneficiary to locate), or providing the actual comparison done to determine the superlative. For example, if an organization stated that they have the lowest premiums, the organization must identify the specific MA or Part D plan and their premium and the premiums of other plans in the service area, or reference a study, review, or other documentation that supports the superlative and with which the beneficiary can make accurate comparisons between plans.
We also proposed to add a requirement that the supportive documentation and/or data be based on current data. Our proposed regulation text requires that the supportive documentation or data must reflect data, reports, studies, or other documentation to have been published either in the existing contract year or the prior contract year. For example, a plan could not make the statement in CY 2022 that they have the largest provider network in an area using 2018 data. Rather, in CY 2022, the statement that a plan has the largest network (of providers or pharmacies) in an area must be supported by documentation and/or data published January 1, 2021 or thereafter. Data and the underlying situations can be dynamic and change over time, therefore, CMS proposed that recent data, meaning the current or the prior contract year data, are the only data that may be used to substantiate superlatives. We believe any data older than the prior contract year may be misleading, given the age of the data and the potential that the data has changed. Based on this, we proposed to modify paragraphs §§ 422.2262(a)(1)(ii) and 423.2262(a)(1)(ii) to prohibit the use of superlatives, unless sources of documentation and/or data supportive of the superlative is also referenced in the material, and to provide that such supportive documentation and/or data must reflect data, reports, studies, or other documentation that has been published in either the current contract year or the prior contract year.
After consideration of the comments we received and for the reasons outlined in the proposed rule and our responses to the comments, we are finalizing the proposal with two minor modifications. First, we are finalizing the regulatory revision using language that more clearly requires supporting documentation or data to be about, from or based on the current or prior contract year, instead of requiring the data to have been
In §§ 422.2263(b) and 423.2263(b), we proposed adding a new (8) which prohibits organizations from advertising benefits not available in a service area, unless doing so is unavoidable in a local market. This prohibition is codifying our previous guidance outlined in section 30.1 of the 2016 Medicare Marketing Guidelines (MMG),
Over the past few years, CMS has seen a significant increase in national marketing which promotes benefits such as dental, vision, and money back on a beneficiary's Social Security check. While many of these benefits are available to a large number of beneficiaries, they are not available in all service areas, or to all Medicare beneficiaries in the amounts often advertised. For example, in 2021 there were national advertisements that claimed a beneficiary “could get up to $144 back” on their Social Security check, which would be accomplished through a reduction in the beneficiary's Medicare Part B premium. A premium reduction of this magnitude would have covered most of the standard 2021 Part B premium of $148.50. However, during CYs 2021 and 2022, the only states or territories that had plans with a reduction of $140 or more were California, Florida, and Puerto Rico. Further, the plans offering the $140 or more premium reduction were not available in all counties in those locations. Since beneficiaries in more than 60 percent of states only had access to plans that offer a Part B premium reduction of $99.00 or less in CY 2022, advertising on a national or even a regional level that a beneficiary can get up to—or even close to—the full amount is potentially misleading. And although MA plans in over 30 percent of states and territories offered a Part B premium reduction of $100 or more in CY 2022, those plans were not available in all counties in those locations. These national advertisements publicize that a beneficiary can get up to a certain dollar amount (for example, $144) even if there are no plans available in the state or location where the advertisement runs that offer any dollar amount close to $144. CMS believes that if a plan offering “up to” the top dollar amount is advertised as available for enrollment, then such a plan should be available to beneficiaries who are receiving or exposed to the advertisement where they reside. A beneficiary calling, based on an advertisement touting up to $144 back, would expect that plans would be available that provide a reasonable Part B premium reduction. However, the actual reduction available for many beneficiaries in various locations may be minimal, anywhere from $1 to $25, significantly below the “up to” advertised amount; or in other cases, there may not even be a Part B premium reduction in that particular service area. We believe this practice is a misleading tactic to entice beneficiaries to call the number and potentially enroll or switch them into another plan, regardless of whether the plan offers any Part B premium reduction or a reduction of the scope that is advertised, resulting in a plan choice that may not be well-suited to meet the beneficiary's health care needs.
A similar issue exists for other MA benefits such as dental, vision, and hearing, as well as Part D benefits, non-formulary medications, and over-the-counter medications. In the past, national advertisements have promoted plans with high dollar amounts for certain benefits, for example, a $2,500 dental benefit on a national level. While many beneficiaries have access to MA plans with some level of additional dental, vision, and hearing benefits, CMS believes advertising that high dollar amount is misleading when some markets may not have access to a plan with any dental benefit, while others may only have access to a plan with limited dental benefits (for example, $500).
Based on CMS' marketing surveillance of recorded calls,
When a plan advertises benefits that are not available to beneficiaries in the service area where the advertisement airs, that type of marketing is misleading. Therefore, we proposed a new paragraph (8) at §§ 422.2263(b) and 423.2263(b) that provides that MA organizations and Part D sponsors may not engage in marketing that advertises benefits that are not available to beneficiaries in the service area where the marketing appears, unless unavoidable in a local market.
One example of unavoidable marketing would be a newspaper advertisement in a metropolitan area which is distributed to beneficiaries that live within the metropolitan area, but the beneficiaries do not live within the service area of the plan for which the particular benefits are being marketed. For example, an MA organization advertises dental benefits up to $3,000 in a Washington, DC newspaper. This benefit is only applicable to the plans being sold by the MA organization in Washington, DC. However, the local distribution of this newspaper encompasses Washington, DC, parts of Maryland, and parts of Virginia. In this case, the marketing of benefits that are not available to the full scope is unavoidable since the “normal” distribution of the local newspaper is greater than the service area of the plan, about which the benefits are being advertised.
Another example would be a local television commercial airing in a specific market, but that may be picked up in an adjacent market. For example, Baltimore television channels can be seen in parts of the Washington, DC market and vice versa. An MA organization advertising benefits available through plans with service areas that encompass Baltimore on a Baltimore television station would result in unavoidable marketing for those beneficiaries in the Washington, DC market who are able to access Baltimore stations.
The exception we are finalizing for unavoidable marketing does not apply for any national marketing, so new paragraph (b)(8) includes an exception only for marketing in local media that covers the service area(s) for the benefits. Since the advertised benefits must be available in the area in which the marketing is occurring, the “unless unavoidable” standard in our regulation is only applicable to advertising that is occurring in a limited area. National advertisements cannot be tailored to only market benefits available to specific service areas, especially since Medicare Advantage is not available in every county in the United States and its territories.
A company, especially a TPMO, that advertises that most plans offer dental, vision, and hearing is providing very little specific information relevant to the beneficiary and what plans are available in the beneficiary's service area and the actual benefits offered. There may be no plans in a beneficiary's service area that offer hearing benefits, making this marketing inaccurate for this beneficiary, even though hearing is available in 80 percent of the plans the TPMO offers. In addition, even if vision, dental, and hearing benefits were all available, it is important to provide the value of these benefits that are available to the beneficiaries that are exposed to these advertisements and marketing, so that the beneficiaries have the information that is useful in making an informed decision about their health care. For example, the vision benefit advertised nationally in a generic way could be $50 per year and the dental benefit may only include cleanings. We have seen vague ads, which we believe are leading or at least have significant potential to lead beneficiaries to believe the benefit available in their area is a more valuable benefit, covering dental covering fillings, root canals, and dentures, when the benefit is actually of lesser value.
To make the advertising of benefits useful for beneficiaries to choose the best plan for their needs, organizations would need to provide a benefit amount associated with the benefits offered. For example, if a TPMO advertised that 85 percent of the plans represented by a TPMO may offer hearing benefits, the plans offering hearing benefits may be limited to one geographic region, while plans in other regions do not offer hearing. Another concern is advertising that plans may have hearing benefits up to $3,000. In this case there may only be one plan that offers more than $1,000 in hearing benefits, while all of the other plans offer $1,000 or less in hearing benefits. To permit the advertising of up to a certain amount, even if it states the beneficiary “may” be eligible could lead a beneficiary to believe the benefits available to them are far greater than the benefits actually available.
CMS recognizes the majority of the advertisements discussed here are tailored to Part C benefits. However, we believe it is necessary to include this proposal in the Part D regulations as well to account for the instances where a Part D plan does or may advertise benefits that are not available in a particular service area. After review of the comments received and for the reasons outlined in the proposed rule and our responses to the comments, we are finalizing new paragraph (b)(8) in §§ 422.2263 and 423.2263 as proposed.
We proposed a new paragraph (9) at §§ 422.2263(b) and 423.2263(b) to prohibit marketing unless the names of the MA organizations or Part D sponsors that offer the benefits being advertised
There are specific reasons for advertisements to contain the MA organization's and Part D sponsor's names. We believe including the names in the advertisement will help the beneficiary understand that they are calling a plan, a plan representative (including an independent agent) and not Medicare or another non-profit, neutral agency such as a State Health Insurance Program (SHIP). Adding the names of specific organizations or sponsors provides the necessary information for a prospective enrollee to know if they reach out because of the advertisement they saw, they are contacting an individual connected to a particular MA or Part D plan. In addition, when an advertisement provides a name, a prospective enrollee can do additional research on the plan before reaching out to the plan, including reviewing their Star Ratings and complaint rates. The prospective enrollee could also discuss the plan with relatives or friends, whom they trust to help make health care decisions. All of these factors allow a prospective enrollee to make a more informed decision on whether they want to contact the particular plan's agent to learn more.
Not only does this proposed policy assist beneficiaries, it will also assist CMS and MA organizations and Part D sponsors to ensure the marketing reflects the appropriate MA organizations and Part D sponsors. CMS also proposed (and finalized in section III.I.1) to require, instead of permitting, TPMO developed marketing to be submitted into HPMS. Under both policies, the TPMO must ensure each MA organization or Part D sponsor on whose behalf the materials were created or will be used was reviewed. Under the revisions to §§ 422.2261(a)(2) and 423.2261(a)(2), as proposed and finalized, once TPMO materials are submitted, each MA organization or Part D sponsor would decide whether they want the TPMO to use that particular marketing material on their behalf. Even though organizations have already reviewed the piece prior to the TPMO submission, we are providing an organization the ability to decide if they want the TPMO to use the piece. If an MA organization or Part D sponsor “opts into” the material, the TPMO may then use it on their behalf and market those organizations. If the MA organization or Part D sponsor “opts out” of the marketing material, then the TPMO would not have permission to market
By requiring MA organization and Part D sponsor names in marketing materials, both CMS and the organization would then be able to ensure that only those MA organizations and Part D sponsors who opted into the TPMO using the material are being advertised in that material. And CMS oversight and review of marketing materials would be more effective and efficient. If CMS determines a material is misleading, we will then be able to identify the organizations from the advertisement, compare them to the ones that opted in and address the issue with those organizations who opted into the TPMO material. This will allow CMS to quickly notify the MA organization or Part D sponsor of the issues, have the organization resolve the issues, and get the misleading materials out of circulation quickly.
Therefore, we proposed a new paragraph (9) at §§ 422.2263(b) and 423.2263(b) to prohibit MA organizations and Part D sponsors from marketing any products or plans, benefits, or costs, unless the MA organization's or Part D sponsor's name or marketing name(s) (as listed in HPMS of the entities offering the referenced products or plans) are identified in the marketing material. By requiring the name of the organization, beneficiaries will have knowledge of who they are contacting.
In addition, we proposed requirements regarding the display and identification in marketing materials of sponsoring organizations' names. In reviewing television, print, and online marketing, CMS has noted that the disclaimers are often small, not displayed long enough, read too fast, or are difficult to find. We proposed including requirements in this new paragraph (9) to ensure the information is comprehensible and visible. We proposed adding that in print advertisements must display the MA organization, Part D sponsor, or marketing name in 12-point font and the MA organization, Part D sponsor, or marketing name may not be only be displayed in the disclaimer or fine print. We use the phrase “fine print” as it is generally defined to mean printed matter in small type or print displayed in an inconspicuous manner. For television, online, or social media-based advertisements, we proposed that these names must either be displayed during the entire advertisement in the same font size as displayed benefits and phone numbers, or be read within the advertisement at the same pace as advertised benefits or phone numbers. For radio or other advertisements that are voice-based only, we proposed that these names must be read at the same speed as the phone number. To implement these new requirements, we proposed new paragraphs (b)(9)(i), (ii), and (iii), respectively. (In the proposed rule, we mistakenly identified these as paragraphs (b)(9)(A), (B), and (C) but use the correct references here.)
After review of the comments received and for the reasons outlined in the proposed rule and our responses to the comments, we are finalizing as proposed with minor modifications to paragraphs (9)(ii) and (iii) to require the marketing names to be read or displayed at the same pace or in the same font as the phone number or contact information included in the advertisement.
We proposed to add a new paragraph (10) to §§ 422.2263(b) and 423.2263(b) to address the marketing of “savings” for beneficiaries. As part of our marketing surveillance and reviews, CMS has seen advertisements touting that a beneficiary can save $9,000 or more on their prescription drugs, or over $7,000 in health care expenses, if they join a particular Part D plan or MA plan. In the example referring to savings for prescription drugs, advertisements included a small disclaimer stating that the “savings” figure is based on the usual and customary price that someone without prescription drug insurance would pay. In other examples, MA organizations, Part D sponsors, or TPMOs have marketed dual eligible special needs plans (D-SNPs) that provide a “savings” of over $7,000. In this instance, the “savings” described in the advertisement refers to the Part B Medicare premium and cost sharing amounts that are covered by Medicaid for full-benefit dually eligible beneficiaries, or are the costs saved through a prescription drug savings program, in which the eligibility for the program is based on income. However, with both of these examples, most beneficiaries are not saving the advertised amount of money because they would never have incurred many of those out-of-pocket expenses. Specifically, a beneficiary who already has prescription drug coverage (such as a current Part D plan or other creditable prescription coverage from before the individual became eligible for Medicare) would not save $9,000 in out-of-pocket costs by switching to the advertised plan because they already had coverage for their drugs through a different plan. This advertised “savings” is only applicable if the beneficiary currently had no drug coverage, meaning they had to pay the retail cost for all of their drugs out-of-pocket. In the case of significant savings on Part C benefits, some of these advertised savings required dual eligibility, but only included information about this requirement in fine print stating that the individual may need to be income eligible or Medicare and Medicaid eligible in order to receive the advertised savings. However, since dually eligible beneficiaries already have Medicaid coverage or may already be enrolled in a D-SNP, those individuals would not be saving the full $7,000, because they never paid the full $7,000 in their previous or current plan. Further, if the beneficiary is eligible for Medicaid to pay certain costs on the beneficiary's behalf (such as payment of Part B premiums) or is protected from paying cost sharing by § 422.504(g)(1)(iii), the advertised savings are not specific to the advertised plan because the same “savings” would accrue if the individual enrolled in any available D-SNP.
We believe that these commercials and other types of advertising (for example, direct mailers) using these techniques and descriptions of “savings” are used to entice a beneficiary into calling a 1-800 number to get information about or enroll in plan X, mistakenly believing that the beneficiary will save thousands of dollars by switching plans, switching from original Medicare, or enrolling into plan X as a new Medicare beneficiary. However, as identified in the previous examples, these “savings” are not actual savings since the beneficiary would not have incurred these costs in any case. To address these concerns, we proposed to add a new paragraph (b)(10) at §§ 422.2263 and 423.2263 to prohibit MA organizations and Part D sponsors from including information about savings available to potential enrollees that are based on a comparison of typical expenses borne by uninsured individuals, unpaid costs of dually eligible beneficiaries, or other unrealized costs of a Medicare beneficiary.
After review of the comments received, particularly the extensive support for the proposed change and for the reasons outlined in the proposed rule and our responses to the comments, CMS is finalizing the revision to add a new (10) to §§ 422.2263(b) and 423.2263(b) as proposed.
We proposed adding a new paragraph (A) to §§ 422.2264(a)(2)(i) and 423.2264(a)(2)(i) to add to the current prohibition of unsolicited door-to-door solicitation. Business Reply Cards (BRC) and other types of documents where the beneficiary requests additional information are intended to allow the agent to reach out to the beneficiary via telephone, email, or direct mail. We do not believe a beneficiary filling out a BRC indicates a beneficiary's intention to permit an agent to show up unannounced, at the individual's home, requesting to market MA or Part D plans to that beneficiary. CMS considers this activity to be unsolicited door-to-door solicitation. Therefore, we proposed adding a new (A) to §§ 422.2264(a)(2)(i) and 423.2264(a)(2)(i) which provides that contacting a beneficiary at the individual's home is unsolicited door-to-door contact unless an appointment at the beneficiary's home at the applicable date and time was previously scheduled.
After considering the strong support for this proposed change and for the reasons outlined in the proposed rule and our response to comments, we are finalizing the changes to add a new paragraph (A) to §§ 422.2264(a)(2)(i) and 423.2264(a)(2)(i) largely as proposed but without the phrase “considered to be.”
Currently, regulations at §§ 422.2264(b) and 423.2264(b) permit MA organizations and Part D sponsors to contact existing members, and to a limited extent, former members, to discuss plan business. In §§ 422.2264(b) and 423.2264(b), we define plan business to include calling current members to discuss Medicare products. In addition, in §§ 422.2264(b)(2) and 423.2264(b)(2), we currently require that MA organization and Part D sponsors provide beneficiaries an opportunity to opt out of being contacted concerning plan business. However, we have interpreted and implemented this regulation as requiring MA organizations and Part D sponsors to present enrollees with a one-time opt-out opportunity, regardless of how many subsequent contacts an enrollee receives. Therefore, we proposed to amend §§ 422.2264(b)(2) and 423.2264(b)(2) to require each MA organization and Part D sponsor to provide the opt-out information to all its enrollees, regardless of plan intention to contact, at least annually in writing, instead of just one time. Over time, beneficiaries may realize that having plans contact them regarding marketing is not necessary. By only receiving only a one-time opportunity to opt-out of plan business contacts, a beneficiary may not realize that they have the option to opt out at any time. By requiring a written annual notification from plans that an enrollee may opt-out of plan business contacts, our proposed new requirement ensures beneficiaries are reminded that they may decide at any time to opt out of being contacted by their MA organization/Part D sponsor about plan business.
Under the proposal, we defer to plans on how best to communicate this, so long as it is in writing, as we believe that plans are in the best position to develop appropriate language based on the plan business they conduct. In addition, we are not proposing the specific written format that plans must utilize when communicating this information during the year, nor specifying when the plan must provide this information during each contract year. MA organizations/Part D sponsors may provide this opt-out notification as a single letter, in a welcome packet, or another method of written communication. Under this proposal, as with the current regulation, the enrollee's decision to opt out of contacts for purposes of plan business will remain in effect until an enrollee chooses to opt in. We solicited comments on whether CMS should expand the existing and proposed notice requirements in some way to ensure that MA organizations and Part D sponsors do not market their products in a way that could be equivalent to prohibited cold calling.
Based on the numerous comments supporting this proposal, we are finalizing as proposed.
Our regulations at §§ 422.2264(c) and 423.2264(c) describe what marketing activities are permitted at sales and educational events, as well as any conduct that is prohibited at these events. Currently, MA organizations and Part D sponsors, including the agents and brokers with which they contract, may not market specific MA/Part D plans or benefits at educational events. However, CMS currently permits MA organizations and Part D sponsors participating in educational events to set up future personal marketing appointments and to collect beneficiary contact information, including Business Reply Cards (BRCs), or Scope of Appointment forms (SOA) at educational events. Our regulations also permit marketing events to immediately follow an educational event, provided the beneficiary is made aware of the change in events and is given an opportunity to leave prior to the beginning of the marketing event.
In 2018, prior to the implementation of §§ 422.2264(c) and 423.2264(c), our sub-regulatory guidance prohibited many of these activities, such as holding marketing events following an
We proposed, in §§ 422.2264(c) and 423.2264(c), to reinstate the prohibition on accepting SOA cards or the collection of beneficiary contact information at educational events. Section 1851(j)(1) of the Act prohibits sales and marketing to take place at educational events. Such events are meant to provide information on the basics of Medicare, including information about coverage options through Traditional Medicare, Medigap plans, as well as Part C and Part D. These events are aimed at informing beneficiaries on what Medicare covers and the different options beneficiaries have when they are Medicare-eligible, or are looking at the options should they wish to change the way they receive their Medicare benefits. In other words, these events are meant to provide generic, factual, non-biased information about different coverage options, rather than information designed to persuade beneficiaries to enroll in a particular type of plan (for example, MA-PD or Medigap), or in a plan offered by a specific organization.
Although the collection of beneficiary information through SOAs or BRCs was has been permitted at educational events, we now believe that agents should be permitted to receive contact information at educational events, if the beneficiary chooses to provide their information. As discussed in our May 2022 final rule, the number of marketing complaints received by CMS has increased significantly over the past few years. Specifically, a significant portion of these complaints involve unsolicited contact. A likely contributor to these unsolicited contacts is a beneficiary not realizing the contact form they have completed at an educational event gives an agent permission to contact the beneficiary in the future. CMS has also heard from advocacy groups requesting that CMS reinstitute the beneficiary protections from our previous sub-regulatory guidance that were not included in the January 2021 final rule, including limits on distributing SOA and BRCs at educational events.
Beneficiaries attend educational events to learn about Medicare, unlike a sales event where a beneficiary has decided that they want to look further into a particular plan (or sponsoring organization) in which to enroll. Collecting contact information at educational events may unduly pressure a beneficiary into providing their personal information. Agents passing out SOA or BRC cards, possibly watching beneficiaries until they fill these forms out, and then collecting them may put a beneficiary in an uncomfortable position of having to decide whether the individual wants to oblige the agent by completing the form, or draw attention to the individual by declining to complete them. This especially may be the case if the beneficiary believes they should provide this information in exchange for attending the educational event, which could include the provision of a meal and helpful question and answer opportunities. We believe the beneficiary needs to be in charge of and in control of whether or not they want to be contacted, by whom, and in what form. Therefore, to ensure such decisions remain with the beneficiary, we proposed amending the regulations that list the activities that are permissible to include in educational events (§§ 422.2264(c)(1)(ii) and 423.2264(c)(1)(ii)) by removing the paragraphs that authorize obtaining beneficiary contact information, including Scope of Appointment forms.
The current regulations at §§ 422.2264(c)(1)(ii)(C) and 423.2264(c)(1)(ii)(C) also permit agents to set up future personal marketing appointments at educational events. Similar to SOAs and contact information, we believe that beneficiaries should be in charge of with whom they speak, when they meet with an agent, and what products they want to discuss with that agent. In the case of educational events, the beneficiary generally attends the event to learn about Medicare, not to facilitate a marketing meeting where the beneficiary is encouraged to enroll in a plan. Once an agent speaks with a beneficiary at an educational event, the beneficiary may believe they are being pressured into setting up a marketing appointment. The “on the spot” request at an educational event for the beneficiary to schedule a future meeting does not provide the beneficiary enough time to consider whether they want someone to come to their home and market a plan to them for the purpose of enrollment. We believe that an educational event should be solely for education and not for lead generation or future marketing opportunities for agents. Therefore, we also proposed removing §§ 422.2264(c)(1)(ii)(C) and 423.2264(c)(1)(ii)(C), which currently permit organizations and agents to set up future marketing appointments at educational events.
However, we do not want to unnecessarily burden beneficiaries. Our proposal is to ensure the beneficiary is making the decision to reach out to an agent. Given the comments, we are modifying this proposal to permit BRCs to be made available and received by agents at educational events but are still prohibiting the collection of SOAs at educational events.
After reviewing the comments and for the reasons outlined in the proposed rule and responses to comments, CMS is finalizing the proposed policies with changes that we believe are in the best interest of the program and of beneficiaries. First, we are finalizing changes to §§ 422.2264(c)(1)(ii) and 423.2264(c)(1)(ii) to prohibit the collection of SOAs and prohibit agents from setting up future marketing appointments at educational events. This is accomplished by removing paragraph (c)(1)(ii)(C) from both regulations as proposed and redesignating current paragraph (c)(1)(ii)(D) (permitting the distribution of business cards) as paragraph (c)(1)(ii)(C). Second, we are redesignating current paragraph (c)(1)(ii)(E) as paragraph (c)(1)(ii)(D) and revising it to permit organizations (and their agents) to make available and receive beneficiary contact information, including Business Reply Cards, but not including Scope of Appointment forms. The permission for using BRCs at educational events is similar to how CMS allows plan materials to be located in common areas of a provider's office and we intend to interpret and apply the new regulation that way.
CMS is also concerned about marketing events directly following an educational event. Educational events are meant to provide information on how Medicare works, including material on the options of Original Medicare, Medigap plans, Part C, and Part D, and are not meant to persuade beneficiaries to enroll in a plan. Beneficiaries attending an educational event directly followed by a marketing event may believe that they are being pressured, at the conclusion of the educational event, into staying for the marketing event. For example, an agent may hold an educational event providing free meals and desserts, and then directly follow that educational event with a marketing event. Beneficiaries may believe that they are being pressured into staying for the marketing event because of the free meal they received at the preceding educational event. Although our current regulations require there be an opportunity for a beneficiary to leave the educational event prior to the start of the marketing event, we do not regulate how much time must elapse between an educational and a marketing event, nor do we prescribe what the agent can or cannot say at the educational event about the marketing event that will follow. Beneficiaries may believe that there is an obligation to stay for a variety of reasons, including not having enough time to gather their belongings or feeling awkward leaving when others are staying. The belief of an obligation may add pressure for a beneficiary to stay and possibly enroll in an MA or Part D plan, even though they only came to the event to be educated about Medicare and the options available to them. Furthermore, attending a marketing event right after an educational event may raise the risk of beneficiaries being confused that the benefits of an MA or Part D plan in general are actually unique to the specific plan options that are being marketed. For example, a factual and impartial statement like, “It is important to consider your out-of-pocket costs and which drugs you take when deciding on your enrollment options” in the educational event could be followed up in the marketing event that uses the same phrasing and terms in describing a specific plan's benefits. The beneficiary might conflate these issues if the educational and marketing meetings are held so close in time. For example, the beneficiary may believe that the plan being touted at the marketing event is the best, or even only plan available, taking into account the individual's costs and drug needs.
In the past, CMS permitted marketing events to immediately follow educational events because at the time we were concerned if these events were separated by time and location, beneficiaries might have to travel to separate educational and marketing events at different times, and potentially different locations. Over the past few years, CMS has witnessed a significant increase in the use of technology replacing the need for individuals to physically travel to locations to attend educational or marketing events and receive information. The COVID-19 pandemic resulted in fewer face-to-face communications and more technology-based marketing, such as Zoom calls and live education events on the internet and has lessened travel to physical locations. The use of technology may have in these instances provided more options for some beneficiaries to be educated about Medicare. We note that because of the policy to require MA organizations to evaluate the need for and provide digital literacy education to their enrollees addressed elsewhere in this rule, we expect digital literacy among enrollees to improve as well. As a result, we believe that the need for sales events to immediately follow educational events because of travel considerations has become less critical.
By separating educational events from marketing events, beneficiaries are afforded the time to consider all their questions and options before making any decisions about their health care and without any pressure to decide on the spot with the agent present. By mandating a specific time between an educational event and a marketing event, CMS believes it is allowing beneficiaries needed time to carefully consider their health care coverage options and whether or not they want to reach out to the agent and learn more about the particular plan(s) the agent is selling. CMS believes this proposal to separate marketing from educational events will alleviate the pressure a beneficiary may believe that they are being pressured to stay for a marketing event after an educational event, and will protect beneficiaries from potential undue pressures to enroll in a plan that does not best meet their health care needs. Based on this, we proposed to prohibit marketing events from taking place within 12 hours of an educational event in the same location. We proposed
After considering the comments, and for the reasons outlined in the proposed rule and the final rule, we are finalizing these provisions as proposed.
Sections 1851(j)(2)(A) and 1860D-4(l)(2) of the Act require an advance agreement with a prospective enrollee on the scope of the marketing appointment, which must be documented. Our regulations at §§ 422.2264(c)(3)(i) and 423.2264(c)(3)(i) reiterate this requirement, designating this requirement as a Scope of Appointment (SOA). Both the statute and the current regulations require an advance agreement between the beneficiary and the agent. Previously, we interpreted this standard of agreement in advance in our marketing (MCMG) guidance as meaning as 48 hours prior the appointment when practicable. We proposed codifying our previous marketing (MCMG) guidance by prohibiting personal marketing appointments from taking place until after 48 hours have passed since the time the SOA was completed by the beneficiary. However, we did not propose to include “when practicable
CMS, under its delegated authority from the Secretary, is authorized to set limitations and standards for the marketing by plans. Section 1851(h) of the Act requires compliance by plans with fair marketing standards adopted by the Secretary, which must include that plans engage in activities described in section 1851(j)(2) “in accordance with the limitations established under that subsection. Section 1851(j)(2)(A) of the Act requires that the Secretary establish certain limitations on marketing activating “with respect to
Based on comments, we are convinced that a categorical prohibition on having a personal meeting less than 48 hours after the SOA is set is too strict and that exceptions are necessary. Therefore, we are finalizing the revisions to §§ 422.2264(c)(3)(i) ad 423.2264(c)(3)(i) with modifications from our proposal to provide two exceptions to the 48-hour requirement. The first exception is for beneficiaries who are approaching the end of a valid enrollment period. This could be the end of the AEP, the OEP, an SEP or the ICEP. For these beneficiaries, we will not apply the 48-hour rule if the SOA is completed during the last four days of the election period. For example, the AEP ends on December 7th of each year so if an SOA is completed on or after December 3rd, the personal marketing appointment can occur during the period between December 3rd and December 7th. If an election period ends on the 31st of the month, the SOA must have been completed no earlier than the 27th of that month.
The other exception we will be for walk-ins. Beneficiaries who walk into an agent's office, a kiosk, a plan's office or any other walk in will not be subject to the 48-hour rule. This exception will assist beneficiaries who have transportation issues and those that have traveled long distances to see an agent. Because this exception is tied to an unscheduled in-person meeting initiated by a beneficiary, we are finalizing an additional change to use the phrase “personal marketing appointment or meeting” in paragraph (c)(3)(i) of §§ 422.2264 and 423.2264.
After review of the comments and for the reasons outlined in the proposed rule and our responses to comments, we are revising §§ 422.2264(c)(3)(i) and 423.2264(c)(3)(i), including the addition of new paragraphs (c)(3)(i)(A) and (B), to require that a plan (or agent or broker, as applicable) agrees upon and records a Scope of Appointment with a beneficiary at least 48 hours prior to a personal marketing appointment or meeting, except in two situations: (A) When a beneficiary requests an appointment within four days of the end of a valid election period, including the AEP, OEP, SEP, ICEP or the month, based on eligibility; and (B) When a beneficiary initiates an in-person meeting.
Regulations at §§ 422.2264(c)(3)(iii) and 423.2264(c)(3)(iii) prohibit an MA organization/Part D sponsor, including their agents and brokers and other first tier and downstream entities, from marketing a health care product during a personal marketing appointment beyond the scope agreed upon by the beneficiary. Sections §§ 422.2274(g)(1) and 423.2274(g)(1) require that MA organizations/Part D sponsors ensure TPMOs (which includes agents and brokers) acting on their behalf adhere to any requirements that apply to the plan itself. Therefore, the requirement for noting the scope of a personal marketing appointment (SOA) is applicable to TPMOs. Currently, CMS requires permission by the beneficiary to be granted and completed in the SOA, concerning the products that will be discussed, prior to the marketing discussion. The existing regulations do not stipulate a timeframe in which the beneficiary may be contacted after an SOA is completed or an expiration date after which the SOA is invalid.
CMS also is aware that MA organizations, Part D sponsors and TPMOs encourage beneficiaries to fill out business reply cards (BRC) or similar mechanisms so the MA organization/Part D sponsor or TPMO has permission to contact the beneficiary at a later date. BRCs are different from SOAs in that the SOA must list all the products to be discussed at the appointment on the document, while many times the BRC is simply a process for obtaining contact information for a beneficiary (that is, name, phone number, address, email). While SOAs are required by statute to identify the types of products that will be discussed, BRCs are not required to specify the products expected to be discussed. Because BRCs like SOAs, often are open-ended and without expiration, they allow an MA organization, Part D sponsor or TPMO to contact a beneficiary at any point in the future. For example, a beneficiary could fill out a BRC in October of one year and be contacted by the MA organization/Part D sponsor or TPMO 24 months later, well beyond the timeframe a beneficiary might reasonably expect to be contacted about their plan choices when they first filled out the card.
CMS proposed to modify the current regulations at §§ 422.2264(c)(3)(iii)(A), 422.2264(c)(3)(iii)(B), 423.2264(c)(3)(iii)(A) and 423.2264(c)(3)(iii)(B) to limit the time period when the SOAs and BRCs are valid in §§ 422.2264(c)(3)(iii)(A) and 423.2264(c)(3)(iii)(A), and the SOAs in §§ 422.2264(c)(3)(iii)(B) and 423.2264(c)(3)(iii)(B), to six months from the beneficiary's signature date or the beneficiary's request for more information. A beneficiary's permission to allow contact by an MA organization/Part D sponsor or a TPMO is not, and should not be, open-ended. Beneficiaries who request information regarding MA organizations/Part D sponsors are requesting information at that present time. Since the purpose of the SOA or BRC is for beneficiaries to discuss plan products applicable for the present or following contract year, having the SOA or BRC expire after 6 months satisfies that purpose, and would prevent agents from using it in perpetuity and thus avoiding the statutory and regulatory prohibitions on
After considering the comments, and for the reasons outlined in the final rule, we are modifying the proposal to extend the timeframe from six months to 12 months.
In accordance with § 422.2265(b)(4), MA organizations are required to have a searchable provider directory on their website. The current regulations do not identify the elements by which the provider directory can be searched, leaving that up to each organization. We proposed to modify § 422.2265(b)(4) by requiring the organization's provider directory be searchable by every element, such as name, location, and specialty, required in CMS' model provider directory. We believe this proposal is necessary to assist beneficiaries in finding particular providers. For example, if an organization only provides a beneficiary with the ability to search by location, the beneficiary would have significant difficulties finding a particular specialty or a particular provider. In section III.A.3. of this final rule, we are adding a new requirement to § 422.111(b)(3)(i) to require that provider directories include providers' cultural and linguistic capabilities. The amendment to § 422.2265(b)(4) will require the organization's provider directory be searchable by this new element. By requiring website provider directories be searchable by every element, our proposal would ensure that a beneficiary would be able to locate specific provider specialties, as well as providers by names, addresses, or other elements the organization has listed in the online provider directory.
After considering the comments, and for the reasons outlined in the proposed rule and the final rule, we are finalizing this provision as proposed.
CMS proposed to modify the pre-enrollment checklist (PECL) requirements at §§ 422.2267(e)(4) and 423.2267(e)(4). First, we proposed to add new paragraphs at §§ 422.2267(e)(4)(viii) and 423.2267(e)(4)(viii), to add “Effect on current coverage” to the list of references currently provided within §§ 422.2267(e)(4)(i)-(vii) and 423.2267(e)(4)(i)-(vii). Second, we proposed to update §§ 422.2267(e)(4) and 423.2267(e)(4) to require that plans review the PECL with the prospective enrollee during telephonic enrollments.
The PECL contains important information prospective enrollees need to know prior to enrolling in an MA or Part D plan. It ensures beneficiaries understand important documents and what information is in such documents, such as the Evidence of Coverage, which provides all costs, benefits, and plan coverage. The PECL also includes information designed to help beneficiaries, such as a reminder to make sure their doctors, pharmacies, and prescriptions are either in the plan's network or covered in their formulary. Finally, the existing PECL reminds beneficiaries of certain plan rules,
In §§ 422.2267(e)(4)(viii) and 423.2267(e)(4)(viii), we proposed to add “Effect on current coverage” to the list of information that must be referenced as part of the PECL. During most of 2021 and all of 2022, CMS engaged in an in-depth review of 1-800-MEDICARE complaints. Our reviews revealed numerous beneficiary complaints that they were not aware their current coverage, such as an existing MA plan, a Medigap plan, or their Tri-care plan, would end once they enrolled in an MA plan. Thus, CMS proposed to add “effect on current coverage” to the list of information that plans must provide to prospective enrollees in the PECL, as we believe it will provide additional education to beneficiaries on the implications of choosing an MA or Part D plan and ensure beneficiaries are fully aware that this selection will cause their existing coverage to end.
In §§ 422.2267(e)(4) and 423.2267(e)(4), we also proposed that the PECL be reviewed with the prospective enrollee during telephonic enrollments as well as provided when hard-copy enrollment forms are provided. As previously discussed, the PECL provides information necessary for beneficiaries to understand the details of the plan for which they are enrolling. Although the PECL must be provided with an enrollment form, CMS' review of telephonic enrollments revealed that the neither the PECL nor its substance was being conveyed to beneficiaries during most telephonic enrollments. Specifically, complaints received by 1-800-MEDICARE included beneficiaries who called 1-800-MEDICARE to inform the Agency via the toll-free line that agents failed to inform the beneficiary that the individual's doctors were not in the MA plan's network, were inaccurately told that there would be no costs, or were inappropriately told that their existing coverage would not be affected by enrolling into a new MA or Part D plan. During CMS' review of telephonic enrollment audio recordings between beneficiaries and agents, it was clear that some beneficiaries were confused when they were told that their current coverage would be ending. It also was clear that some were misled by the agent and were told that their existing benefits would not change, and others were never informed by the agent that enrollment into an MA or Part D plan would cancel the beneficiary's current coverage. There also were cases where the agent failed to go over the beneficiary's current providers or Part D drugs. In addition, few, if any, of the calls with agents we reviewed included explanations that all of the benefits and cost sharing for the plan could be found in the plan's Evidence of Coverage.
By requiring the PECL to be reviewed with prospective enrollees as part of telephonic enrollments, we intend to ensure that beneficiaries are better informed about the details surrounding the plan for which they are enrolling. Under this proposal, MA organizations and Part D sponsors would decide whether they would require their contracted agents and brokers to read the PECL in its entirety or to require that each item contained on the PECL be discussed. It is CMS's expectation that the agent ensures the beneficiary understands the items in the PECL. Agents may confirm this understanding by receiving an affirmative answer to whether the prospective enrollee understands the information provided, as well as asking the prospective enrollee if she or he has any questions. CMS believes that an actual review of the PECL elements with prospective enrollees will decrease inaccurate information and misunderstandings, resulting in fewer 1-800-MEDICARE complaints and higher beneficiary satisfaction.
Therefore, CMS proposed to add the reference to “Effect on current coverage” to §§ 422.2267(e)(4)(viii) and 423.2267(e)(4)(viii) and requiring, in §§ 422.2267(e)(4) and 423.2267(e)(4), that the PECL be reviewed with the prospective enrollee during telephonic enrollments.
After considering the comments, and for the reasons outlined in the proposed rule and the final rule, we are finalizing these provisions as proposed.
CMS also proposed a change to § 422.2267(e)(5)(ii)(A) to require that the Summary of Benefits (SB) list medical benefits on the top half of the first page and in the order currently listed in §§ 422.2267(e)(5)(ii)(A)(1) through 422.2267(e)(5)(ii)(A)(10). Currently, § 422.2267(c)(2) states that model materials, like the SB, must follow CMS' order of content when specified. This existing regulation permits CMS to specify the order of content presented in MA required model materials. CMS has already specified the order of information on medical benefits in the SB instructions, mirroring the regulatory list of medical benefits provided at § 422.2267(e)(5)(ii)(A)(1) through (10). By requiring all plans to list certain benefits in the same location and in a specified order, beneficiaries will be able to more easily compare benefits across different plans and in a more standardized way. The ability for beneficiaries to review and compare benefits across different MA plans will assist beneficiaries in making a more informed health care choice.
After considering the comments, and for the reasons outlined in the proposed rule and the final rule, we are finalizing this provision as proposed.
We proposed a change to 42 CFR 422.2267(e)(10) and 423.2267(e)(13), which provides that the non-renewal notice is a model communications material through which plans must provide the information required under §§ 422.506 and 423.507, respectively. Per §§ 422.2267(c) and 423.2267(c), model materials and content are those required materials and content created by CMS as an example of how to convey information to beneficiaries. CMS provides model materials in the form of an example document and/or a list of required content. Modifications to model materials, including the non-renewal notice, can be made at the MA organization's/Part D sponsor's discretion within certain limits outlined in §§ 422.2267(c) and 423.2267(c). Although our regulations list the non-renewal notice as a model notice, we have always implemented it as a standardized notice; plans are not permitted to make any changes to standardized materials, except where noted. To ensure accuracy and consistency, we proposed to update §§ 422.2267(e)(10) and 423.2267(e)(13) to specify that the non-renewal notice is a “standardized communications material” so that it is clear these materials must be used without modification except where noted in the standardized material. This is necessary to ensure that the vital information contained in the non-renewal notice about a beneficiary's alternative health care options and the timing for the beneficiary to make an enrollment decision is conveyed in a way that CMS has determined is accurate and understandable. Beneficiaries receiving the non-renewal notice are provided a Special Enrollment Period (SEP) (as per § 422.62(b)(1)) with deadlines to make new health plan choices. This notice provides beneficiaries with information about the SEP, as well as information regarding other plans that may be available to them. As a model notice, currently, MA organizations/Part D sponsors can place information about SEPs and other plan options anywhere in the document. As a result, MA organizations/Part D sponsors have the ability to highlight their own plan options, instead of providing equal prominence to all health plan options including those offered by competitor organizations. Our proposal would eliminate that possibility.
We are finalizing this provision as proposed.
In the May 2022 final rule, CMS implemented a Third Party Marketing Organization (TPMO) disclaimer at §§ 422.2267(e)(41) and 423.2267(e)(41). The required disclaimer states, “We do not offer every plan available in your area. Any information we provide is limited to those plans we do offer in your area. Please contact
Although TPMOs may contract with one or more MA organizations and Part D sponsors, they do not necessarily contract with all available options in a service area. When a beneficiary contacts a TPMO that does not contract with all MA organizations or Part D sponsors in a particular service area, the beneficiary may not know that the TPMO does not sell or represent all of the available options. To ensure beneficiaries in this situation are aware that other enrollment options exist, the disclaimers at §§ 422.2267(e)(41) and 423.2267(e)(41) currently require TPMOs to notify the beneficiary that a complete list of available plans can be obtained from 1-800-MEDICARE or
In addition, CMS proposed that TPMOs disclose the names of the MA organizations or Part D sponsors with which they contract when speaking with a beneficiary. This ensures that beneficiaries are aware of all of their choices when communicating with a TPMO. In CMS's review of hundreds of sales, marketing, and enrollment audio calls, CMS found over 80 percent of the calls only discussed one plan option from one MA organization. The audio reviews CMS conducted also showed that agents rarely, if ever, informed the beneficiary that there were multiple plans available in the service area. Although the agent may have researched other plans on behalf of the beneficiary they were assisting, the agent rarely communicated information about those plan options to the beneficiary, and thus the beneficiary may not have known about their other options to make an informed decision about the plan that best meets their needs.
CMS proposed to revise the existing TPMO disclaimer at §§ 422.2267(e)(41) and 423.2267(e)(41) to require TPMOs that do not contract with every available MA organization or Part D sponsor in a service area to include a list of the MA organizations or Part D sponsors with which they do contract in the beneficiary's service area. In addition, because the existing TPMO disclaimer at §§ 422.2267(e)(41) and 423.2267(e)(41) does not apply to TPMOs that contract with every MA organization or Part D sponsor in a given service area, CMS also proposed to revise §§ 422.2267(e)(41) and 423.2267(e)(41) to include a new disclaimer for TPMOs that do contract with every MA organization or Part D sponsor in the service area. This new disclaimer would need to be provided within the first minute of the call, the same as what is required for TPMOs that do not contract with MA organization or Part D sponsor in a service area. As with the existing TPMO disclaimer, this new disclaimer would need to be electronically conveyed when communicating with a beneficiary through email, online chat, or other electronic means, prominently displayed on the TPMO's website, and included in any TPMO marketing
The first disclaimer, proposed for TPMOs that do not sell for all MA organizations or Part D sponsors in a service area, would read, “We do not offer every plan available in your area. Any information we provide is limited to those plans we do offer in your area which are plans offered by [insert list of MA organizations here]. Please contact
We received comments on this proposal and respond to them as follows:
After consideration of the comments received and for the reasons outlined in the proposed rule and this final rule, we are finalizing the first disclaimer as proposed by adding the addition of
We proposed a technical change to § 423.2267(e) to add new paragraphs (e)(43) and (e)(44), to include the comprehensive medication review (CMR) written summary which, in accordance with § 423.153(d)(1)(vii)(B) and (D), Part D sponsors must provide to all MTM program enrollees who receive a CMR, as well as the safe disposal information that, in accordance with § 423.153(d)(1)(vii)(E), Part D sponsors must provide to all plan enrollees targeted for MTM. We received no comments on this proposed technical change and, for the reasons outlined in the proposed rule, we are finalizing the addition of new paragraphs § 423.2267(e)(43) and (e)(44) as proposed.
Based on our review of beneficiary complaints and audio calls between agents and beneficiaries, we are concerned about the level of oversight that MA organizations and Part D sponsors maintain over their contracted agents and brokers. In our review of complaints and our discussions with MA organizations and Part D sponsors, we have determined that MA organizations and Part D sponsors appear to be reactive instead of proactive in addressing inappropriate agent and broker behavior. CMS has received complaints through 1-800-MEDICARE as well as other CMS staff. Once a complaint is received, the complaint is shared with the applicable MA organization or Part D sponsor to review, investigate, and take appropriate action. However, this method of oversight is reactive, and requires organizations and sponsors to respond to issues that CMS is already aware of. As a result, we are concerned that inappropriate behavior by agents and brokers is not being sufficiently curtailed and corrected by MA organizations and Part D sponsors. In §§ 422.2272 and 423.2272, we proposed requiring sponsoring organizations have an agent and broker monitoring and oversight plan that ensures agents and brokers are adhering to CMS requirements and that the MA organization or Part D sponsor is actively monitoring and reporting those agents and brokers to CMS who are not compliant with CMS requirements.
We believe a thorough oversight and monitoring plan will assist in identifying and stopping poor performing agents and brokers more quickly, whether they are independent, captive, or employed agents or brokers. To that end, CMS requires MA organizations and Part D sponsors to oversee the agents and brokers with whom they contract (§§ 422.2274(c) and 423.2274(c)). At a minimum, a proper oversight program would include the review of internal grievances and 1-800-MEDICARE complaints, reviewing a random samplings of past audio sales/marketing/enrollment calls, listening to sales/marketing/enrollment calls in real-time, secretly shopping in-person education and sales events, and secretly shopping web-based education and sales events. These types of activities would improve the plans' overall marketing and sales activities. MA organizations and Part D sponsors should be able to identify areas where agents and brokers have not been adequately trained, agents and brokers who may not fully understand the product offerings they sell, and agents and brokers who improperly market to beneficiaries. MA organizations and Part D sponsors can then quickly act, with such activities as tailored training or disciplinary measures, based on the specific issues for each agent or broker. We also proposed that MA organizations and Part D sponsors be required to report specific agent or broker non-compliance to CMS. Such oversight and monitoring plans would assist plans and sponsors in gauging the scope of marketing issues, and help plans and sponsors in developing methods to stop inappropriate agent and broker activity. Therefore, we proposed to add a new paragraph (e) to §§ 422.2272 and 423.2272 to read, “Establish and implement an oversight plan that monitors agent and broker activities, identifies non-compliance with CMS requirements, and reports non-compliance to CMS.”
Organizations are required to ensure all first tier, downstream, and related entities adhere to all statutory and regulatory requirements. In order to ensure compliance, plans should be monitoring and overseeing agents and brokers. This proposal is requiring actions that plans should already be taking. For organizations that do not have an oversight plan in place there will be additional work; however, CMS believes that work is necessary in order to protect beneficiaries from inappropriate marketing by non-compliant agents and brokers.
After consideration of the comments received and for the reasons outlined in the proposed rule and this final rule, we are finalizing as proposed.
CMS proposed to adopt, at a new paragraph (c)(12) of §§ 422.2274 and 423.2274, additional standards for agents and brokers in their marketing of MA and Part D plans to beneficiaries to require that sponsoring organizations ensure that agents and brokers discuss specific topics and information with beneficiaries prior to enrollment. We believe that adopting these standards is consistent with and achieves a similar goal as the statutory requirement in section 1851(j)(2)(D) of the Act that compensation to agents and brokers create incentives for agents and brokers to enroll beneficiaries in the plan that best meets their health care needs. The provisions in section 1851(h)(4)(D) and (j)(2) regarding the marketing of MA plans apply as well to the marketing of Part D plans per section 1860D-4(l) of the Act. For an agent or broker to ensure the beneficiary is in a plan that best meets their needs, the agent or broker needs to obtain enough information to determine the health care needs of the beneficiary. If the agent or broker fails to have sufficient information to ensure that he or she is enrolling the beneficiary in a plan that best meets the beneficiary's health care needs, yet is still compensated for enrolling the beneficiary in a plan, we believe that section 1851(j)(2)(D) of the Act is undermined. CMS is concerned that agents and brokers too often fail to adequately determine the kind of health plan a beneficiary wishes to enroll in, such as a plan that offers a lower premium and higher copays, one that has specific providers in their network, or one that provides coverage for a certain durable medical equipment. Therefore, in §§ 422.2274(c) and 423.2274(c), we proposed that all agents and brokers (employed, captive, and independent agents) go through a CMS-developed list of items that must be discussed during the marketing and sale of an MA plan or Part D plan.
CMS has listened to hundreds of marketing and enrollment audio calls. In the majority of these calls (over 80 percent), agents and brokers failed to ask pertinent questions to help a beneficiary enroll in a plan that best meets the individual's needs. CMS listened to calls where the agent or broker only asked about primary care providers and/or prescription drugs. There were also calls that CMS listened to where the agent or broker only discussed “extra benefits” such as dental and vision. During many of the calls CMS reviewed, the agent or broker failed to ask important questions, such as whether there was a specialist that the beneficiary wished to see (or currently sees) and whether that specialist was in the plan's network, whether the beneficiary would prefer lower copays and a higher premium or vice versa, which hospitals the beneficiary preferred, or whether the beneficiary wanted dental and hearing benefits. Some calls were under twenty (20) minutes in length. This short time period led CMS to question whether an agent or broker could have realistically obtained the necessary information from the beneficiary in order to adequately determine their needs and wants, review available options, and complete the enrollment.
To properly assist a beneficiary in choosing a Medicare health and/or drug plan, the agent or broker must have sufficient information about the beneficiary's needs and goals. We do not believe a beneficiary can be enrolled in a plan that best meets the individual's needs when, for example, an agent or broker fails to ask the beneficiary about their current providers or medications, including specialists and preferred hospitals or other facilities. To ensure a beneficiary's needs are reviewed, CMS proposed to add a new (12) to §§ 422.2274(c) and 423.2274(c), requiring an MA organization or Part D sponsor ensure that the agent's/broker's marketing call goes over each CMS required question or topic, including information regarding primary care providers and specialists (that is, whether or not the beneficiary's current providers are in the plan's network), prescription drug coverage and costs (including whether or not the beneficiary's current prescriptions are covered), costs of health care services, premiums, benefits, and specific health care needs. We explained in the proposed rule that CMS would provide in sub-regulatory guidance more detailed questions and areas to be covered based on these general topics.
If agents and brokers are required to ask beneficiaries certain questions, or cover certain topics, prior to beginning the enrollment process, we expect that beneficiaries will be more knowledgeable about the plans that are available to them and whether those plans fit their needs; this would, in turn, better enable beneficiaries to make an informed choice about their Medicare benefits and how to receive them. We did not propose that agents or brokers would be required to read standardized questions or statements regarding the topics discussed here. Rather, we proposed to require that certain required topics are addressed, prior to the enrollment, specifically topics about providers and whether a beneficiary's current or preferred providers or pharmacies are in-network, costs and premiums for prescription drug coverage and health care coverage, benefits, and the beneficiary's specific health care needs and current medications.
After consideration of the comments received and for the reasons outlined in the proposed rule and this final rule, we are finalizing the addition of a new paragraph (c)(12) to §§ 422.2274 and 423.2274.
Currently, §§ 422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) require TPMOs to record all calls with beneficiaries. This requirement helps ensure that TPMOs, including agents and brokers, are appropriately marketing to beneficiaries by ensuring adequate records are available for oversight and monitoring. This requirement for recording all calls with beneficiaries was proposed in a January 2022 proposed rule, and finalized in the May 2022 final rule (CMS 4192-F). The requirement to record all calls was pre-dated by CMS's requirement to record enrollment calls. As indicated in § 1851(c)(2)(A) of the Social Security Act, a person with Medicare enrolls in an MA plan or Part D plan by filing an appropriate election form with the organization. CMS has established models for this election form, providing different formats depending on the type of MA or Part D plan as well as the format of the election itself (paper, electronic, telephonic, etc.). The telephonic model includes language establishing the enrollee's agreement to abide by the rules of the plan into which they are enrolling as well as recording this agreement. That recording (that is, the physical recording of the telephone conversation) is the record of the enrollee's request to enroll. As such, CMS has required recording of telephonic enrollment since the incipience of the telephonic enrollment process as a requirement of the encompassing enrollment process. This requirement is reflected in § 422.60(c)(2) which states that an MA plan must file and retain elections forms for the period specified in CMS's instructions and § 422.504(e) requires MA plans to provide access to enrollment and disenrollment records for the current contract period and 10 prior periods. Similar requirements apply to Part D sponsors at §§ 423.136 and 423.505(e).
As previously stated, CMS's experience in reviewing beneficiary complaints and listening to recorded calls between agents and brokers and beneficiaries revealed many instances where agents and brokers failed to provide enough information, and, most concerning, provided inaccurate information about plan benefits. In some cases, the agents and brokers led beneficiaries to believe the beneficiaries were calling Medicare rather than an insurance agent. We received few pertinent comments to this proposal in the January 2022 proposed rule prior to the requirement being finalized at §§ 422.2274(g)(2)(ii) and 423.2274(g)(2)(ii). However, following the May 2022 final rule, CMS heard from trade organizations and plans, as well as individual agents, regarding the obligation to record all calls. Many of these post-final rule questions and comments centered around whether “smaller” agent companies had to record conversations. Some of the comments received after the final rule requested clarification on whether all calls really needed to be recorded.
In the December 2022 proposed rule, CMS did not propose to change the requirement that TPMOs, including agents and brokers, regardless of their size, must record calls. However, we proposed to limit calls that must be recorded from all calls to only those calls regarding sales, marketing, and enrollment by amending §§ 422.2274(g)(2)(ii) and 423.2274(g)(2)(ii). We explained in the proposed rule a concern that current requirement is too broad because calls placed to merely set up an in-person meeting, or to confirm a beneficiary received a plan welcome packet, or calls to provide a beneficiary the opportunity to ask non-marketing questions, such as when the plan will be effective, must all be recorded. We believe requiring the recording of these types of calls is an unnecessary burden and not aligned with our goal to obtain call recordings to ensure the marketing, sales, and enrollment activities conducted by agents, brokers and TPMOs meet the applicable regulatory requirements. Therefore, we proposed to modify §§ 422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) to limit the calls that must be recorded in their entirety to marketing, sales, and enrollment calls. We explained that the definition of marketing in §§ 422.2260 and 423.2260 would apply to the use of the term in new paragraph (g)(2)(ii) and that we intended the words “sales” and “enrollment” to include the plain meaning of those terms.
After consideration of the comments and for the reasons outlined in the proposed rule, we are finalizing the amendments to §§ 422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) as proposed.
In addition to modifying §§ 422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) to only require marketing, sales, and enrollment calls to be recorded, we also proposed to add language to clarify that web-based technology is included in the call recording requirements. Since the May 2022 final rule, we have received questions asking whether technology-based meetings (for example, Zoom meetings between an agent and a beneficiary) need to be recorded. CMS considers meetings taking place on Zoom, Facetime, Skype, or other technology-based platforms to be the same as telephonic calls that present the same concerns about inappropriate marketing as has been found during telephonic calls. Technology is changing the way people interact, and Medicare beneficiaries aging into the program are more likely to have experience with newer technologies and may be more comfortable using such
We proposed to modify §§ 422.2274(g)(2)(ii) and 423.2274(g)(2)(ii) to read “Record all marketing, sales, and enrollment calls, including calls occurring via web-based technology, in their entirety.”
After considering the comments on the inclusion of web-based technology meetings, and for the reasons outlined in the proposed rule, we are finalizing this change largely as proposed but with the clarification that the requirement applies only to the audio portion of web-based calls.
MA plans must cover Medicare Part A and Part B benefits, excluding hospice, kidney acquisitions for transplant, and certain changes in benefits due to a National Coverage Determination (NCD) or a legislative change. We proposed to adopt regulations regarding MA coverage of clinical trials covered by Medicare to ensure clarity on these coverage rules for MA plans. These coverage rules implement section 1852 of the Act and are within our rulemaking authority for the MA program. These proposals generally codify guidance currently specified in section 10.7 of Chapter 4 of the Medicare Managed Care Manual for clinical trials covered under National Coverage Determination (NCD) 310.1; A and B investigational device trials (A-B IDE); and National Coverage Determinations with coverage with evidence development (NCD-CED). We received several comments supporting our proposals in general. We address comments on specific proposals in the appropriate sections of this rule.
Clinical trials may include some items and services that would not be covered by Medicare, absent the trial. For clinical trials covered under the Clinical Trials National Coverage Determination 310.1 (NCD) (NCD manual, Pub. 100-03, Part 4, section 310), long-standing CMS policy has been that traditional Medicare (that is, the Medicare FFS program) covers the routine costs of qualifying clinical trials for all Medicare enrollees who volunteer to participate in the approved trial, including those enrolled in MA plans. CMS has discussed this policy in several Advance Notices and Rate Announcements, including the advance notices of methodological changes in Part C payments issued for 2004, 2007, 2008, 2009, 2011, 2017, and 2019, and in the announcements of capitation rates and payment policies for Part C in 2009, 2011, 2012, and 2017. NCD 310.1 is the current statement of the Medicare coverage of routine costs associated with clinical trial participation. As specified in the NCD, routine costs associated with a clinical trial include:
• Items or services that are typically provided by Medicare absent a clinical trial (for example, conventional care);
• Items or services required solely for the provision of the investigational item or service (for example, administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
• Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.
Although MA plans must follow all NCDs, section 1852(a)(5) of the Act, which CMS has implemented in § 422.109(b), provides that if an NCD or new legislative benefit introduced in the middle of a plan year is considered a significant cost as determined by the
Traditional Medicare pays for all routine costs of clinical trials for MA enrollees and, as explained in the CY 2011 Rate Announcement,
MA plans are responsible for paying the difference between traditional Medicare cost-sharing incurred for qualifying clinical trial items and services and the MA plan's in-network cost-sharing for the same category of items and services. We proposed to codify this requirement for MA plans to pay the difference between traditional Medicare and plan's cost sharing in § 422.109(e)(3). We also proposed in § 422.109(e)(4) to codify that the enrollee's in-network cost-sharing portion must be included in the plan's maximum out-of-pocket (MOOP) calculation. As the clinical trial costs within the scope of NCD 310.1 are covered by Part A and/or Part B, these are basic benefits within the scope of the MOOP requirements in §§ 422.100(f)(4) and (5) and 422.101(d)(2) and (3), but for clarity we proposed to codify at § 422.109(e)(4) the requirement that the enrollee's in-network cost-sharing must be included in the plan's MOOP calculation. In requiring MA organizations to provide in-network cost sharing for clinical trial services, CMS is requiring that MA plan enrollees have coverage for clinical trial services that is consistent with coverage they have for all other Medicare Part A and Part B services. In paragraph (e)(5), consistent with our guidance in section 10.7.1 of Chapter 4 of the Medicare Managed Care Manual, we proposed that MA plans may not require prior authorization for participation in a Medicare-qualified clinical trial not sponsored by the plan, nor may it create impediments to an enrollee's participation in a non-plan-sponsored clinical trial under NCD 310.1. This protection is necessary in order to ensure that MA enrollees have access to and coverage of clinical trials within the scope of NCD 310.1 to the same extent as Medicare beneficiaries enrolled in the traditional Medicare program. While MA plans are responsible for covering any differences in cost-sharing between traditional Medicare and MA plan in-network costs for services in the same category, traditional Medicare, through the MACs, is responsible for all other costs included in clinical trials within the scope of NCD 310.1. Finally, in accordance with § 422.109(c)(2), CMS requires MA organizations to provide coverage for: (1) services to diagnose conditions covered by clinical trial services; (2) most services furnished as follow-up care to clinical trial services; and (3) services already covered by the MA organization. Because § 422.109(c) adequately addresses how MA organizations are required to cover certain benefits and costs even when the traditional Medicare program pays for changes in benefits as a result of an NCD or legislative change, we do not believe that additional regulation text is necessary to apply those rules in the context of NCD 310.1.
After consideration of the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing § 422.109(e) as proposed with a minor modification to the heading for paragraph (e) to clarify the scope of the paragraph is limited to NCD 310.1.
The regulation at § 405.211 specifies Medicare coverage of Category A and B investigational device exemption (IDE) studies. Providers of device trials must submit evidence of an FDA approved IDE for the devices studied, as part of their application to CMS for approval of a trial. Once a trial has been approved by CMS, it is listed on the CMS website. In addition to including assessment of devices, IDE trials differ from clinical trials under NCD 310.1, as they are not covered as a result of an NCD nor are they subject to a significant cost assessment. As a result, MA organizations are responsible for payment of claims related to enrollees' participation in both Category A and B IDE studies that are covered under traditional Medicare. This is part of the MA organization's obligation to cover the items and services (other than hospice care or coverage for organ acquisitions for kidney transplants) for which benefits are available under Parts A and B for their enrollees under section 1852 of the Act.
MA plans are responsible for payment of routine care items and services in CMS-approved Category A and Category B IDE studies. An MA plan is also responsible for coverage of CMS-approved Category B devices. While CMS will cover routine care items and services, it will not approve coverage of Category A devices themselves because they are considered experimental and excluded from coverage under § 405.211(a). As with other benefits for which it is responsible for coverage, an MA plan may apply utilization management, including prior authorization, consistent with § 422.4(a)(1)(ii).
Section 10.7.2 of Chapter 4 of the Medicare Managed Care Manual addresses this policy. In order to clarify this scope of required coverage for MA plans and avoid any inadvertent confusion between the coverage requirements associated with clinical trials under NCD 310.1, we proposed to add § 422.109(f) to specify MA plan coverage of the routine items and services, including the Category B IDE device and related items and services in the context of a Category A and B IDE studies, that are covered by Medicare under §§ 405.211(a) and (b).
After consideration of the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing § 422.109(f) without modification.
As with other Part A and B benefits (aside from hospice and the cost of kidney acquisition for transplant), MA plans must cover items and services covered by Medicare under NCDs. This is true for NCDs that also have a trial or registry component that is required as part of the coverage, which is explained in section 10.7.3 of Chapter 4 of the Medicare Managed Care Manual. This is referred to as “coverage with evidence development” (CED), as authorized under section 1862(a)(1)(E) of the Act. CED is a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of CMS approved clinical studies or with the collection of additional clinical data (for example, registry). A list of NCD-CEDs with the coverage protocol for each is available at:
As in the proposed rule, we are merely reiterating here that MA plans must cover NCDs with CED and CMS has not proposed or finalized a change in coverage requirements or policy for MA plans on this topic. We solicited comment whether additional regulations are needed to address NCDs with CED; we believe that § 422.101(b) is sufficient that these NCDs are within the scope of the traditional Medicare benefits that MA plans must cover and that additional regulations are unnecessary. MA plans may apply utilization management, including prior authorization, to the Medicare benefits covered under these NCDs, consistent with § 422.4(a)(1)(ii) of the MA program regulations.
In cases of a new NCD or legislative change in benefits, CMS determines, consistent with § 422.109(b), whether the benefit or service is a significant cost to MA plans. As in the December 2022 proposed rule, CMS is including this discussion to make clear that significant cost requirements apply to all new NCDs, that is, that the significant cost assessment includes NCDs with CED. The thresholds for significant cost are specified in §§ 422.109(a)(1) and (a)(2). The assessment generally applies to each NCD or legislative change in benefits that occurs after the rate announcement for a contract year such that the change in costs was not incorporated into the capitation rates for the contract year. Costs are estimated for a particular NCD or legislative change in benefits so the thresholds specified in §§ 422.109(a)(1) and (a)(2) apply to each NCD or legislative change in benefits rather than to the aggregate number of such changes over the course of a contract year.
After considering the comments revised and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing this provision without modification.
We proposed a terminology update at § 423.154(c) to the outdated term “mentally retarded.” We inadvertently neglected to update this terminology in our regulations following two previous terminology updates found in the “Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction” final rule which appeared in the
We solicited comments on this proposal.
We proposed to make a technical correction to § 423.265(b)(2) to restore language on requirements for substantial differences between Medicare Part D sponsors' bids that was inadvertently removed in a recent revision of the section.
In the “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” final rule, which appeared in the
We added language placing limits on the number of Part D plan offerings as part of the final rule titled “Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly” which appeared in the
• Redesignate the regulatory text from our January 2021 final rule limiting the number of bids a Part D plan sponsor may submit currently at § 423.265(b)(2) as § 423.265(b)(3);
• Restore the language from our April 2018 final rule on substantial differences at § 423.265(b)(2)(i) and (ii); and
• Redesignate the regulatory text currently at § 423.265(b)(3) as paragraph (b)(4).
As described previously, all of the regulatory language that we proposed to restore at § 423.265(b)(2) has previously undergone the full notice and comment process. This proposal would merely correct a technical error made by the January 2021 final rule.
We received no comments on the proposed technical correction to § 423.265(b)(2) and are finalizing our proposal without modification.
Section 1860D-15(b)(3) of the Act defines “gross covered prescription drug costs” as, “with respect to a part D eligible individual enrolled in a prescription drug plan or MA-PD plan during a coverage year, the costs incurred under the plan, not including administrative costs, but including costs directly related to the dispensing of covered part D drugs during the year and costs relating to the deductible. Such costs shall be determined whether they are paid by the individual or under the plan, regardless of whether the coverage under the plan exceeds basic prescription drug coverage.” In our final rule, “Medicare Program; Medicare Prescription Drug Benefit,” which appeared in the
In light of certain provisions added to the Social Security Act by the Inflation Reduction Act of 2022 (IRA) that refer to “gross covered prescription drug costs as defined in section 1860D-15(b)(3) [of the Act]” (see sections 1191(c)(5) and 1860D-14C(g)(4)(D) of the Act), we revisited the regulatory definition of “gross covered prescription drug costs.” We proposed to revise the regulatory definition of “gross covered prescription drug costs” to mirror the language in the statutory definition and to remove any ambiguity that might arise from the current regulatory definition as it may now also be applicable outside of the reinsurance context. Specifically, we proposed to amend the definition of “gross covered prescription drug costs” at § 423.308 to remove the phrase “actually paid.”
As we explained in the proposed rule, the proposed revisions to the definition would not change the fact that Part D reinsurance is ultimately based on net drug costs or change the final reinsurance payment amount a Part D sponsor receives. Rather, allowable reinsurance costs would continue to be defined at § 423.308 as the subset of gross covered prescription drug costs actually paid. Thus, the revision would not constitute a change in policy or require a change in operations under Part D, and would not place any additional burden or reduce existing burden on Part D sponsors, nor result in government savings or costs.
The term “gross covered prescription drug costs” (hereinafter referred to as “GCPDC”) is defined and used at section 1860D-15(b) of the Act for the purpose of describing the methodology for calculating the reinsurance payment amount. As specified in section 1860D-15(b)(1)(A) of the Act, the reinsurance payment amount for a year preceding 2025 is equal to “80 percent of the allowable reinsurance costs (as specified in paragraph (2)) attributable to that portion of gross covered prescription drug costs as specified in paragraph (3) incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B).” Although the statutory definition of “allowable reinsurance costs” at paragraph (2) of section 1860D-15(b) of the Act specifies that such costs are the subset of GCPDC that are “actually paid (net of discounts, chargebacks, and average percentage rebates),” the statutory definition of GCPDC at paragraph (3) of section 1860D-15(b) of the Act does not use the phrase “actually paid” or otherwise specify that such costs must be net of all DIR. As we explained in the proposed rule, this distinction, coupled with the use of the modifier “gross” to describe these costs, indicates that the best reading of section 1860D-15(b)(3) of the Act is that GCPDC should reflect gross costs, not net costs that reflect all DIR that a Part D sponsor may receive. We also stated that CMS' use of the phrase “actually paid” in the current regulatory definition of GCPDC was intended to emphasize that all DIR would be netted out in the calculation of costs eligible for Part D reinsurance consistent with the plain language of the statute, which requires that the reinsurance payment amount be based on net drug costs. While the use of the phrase in the current regulatory definition of GCPDC is consistent with the statute for this reason, we recognized that it may have led to ambiguity as to when the DIR would be netted out. We also recognized that the use of the phrase could create ambiguity when GCPDC is referenced outside of the reinsurance context.
We further noted in the proposed rule that the statutory definition of GCPDC describes these costs as “not including administrative costs, but including costs directly related to the dispensing of covered Part D drugs during the year and costs relating to the deductible.” CMS has long held that costs directly related to the dispensing of covered Part D drugs are most logically calculated as the accumulated total of the negotiated prices that are used for purposes of determining payment to the pharmacy or other dispensing entity for covered Part D drugs, and which are required under section 1860D-2(d)(1) of the Act to be made available to Part D beneficiaries and are used to adjudicate the Part D benefit (that is, used to determine plan, beneficiary, manufacturer, and government liability during the course of the payment year).
As a supplement to the background we included in the NPRM, we also wish to clarify that in using Part D negotiated prices to calculate GCPDC, we currently include manufacturer discounts paid under the Coverage Gap Discount Program under section 1860D-14A of the Act and will continue to do so through 2024. Such manufacturer discounts are paid at the POS by the Part D sponsor on behalf of the manufacturer, and the manufacturer is required to reimburse the Part D sponsor on behalf of the Part D beneficiary, with the discounts counting as incurred costs as required by section 1860D-2(b)(4)(E) of the Act. Manufacturer discounts paid under the Coverage Gap Discount Program have been included in GCPDC since the beginning of the Coverage Gap Discount Program, and this practice is consistent with the current statutory
In the December 2022 proposed rule (87 FR 79612), we proposed to amend the definition of “gross covered prescription drug costs” at § 423.308 to mirror the statutory language in section 1860D-15(b)(3) of the Act and to remove any ambiguity that might arise from the current regulatory definition of GCPDC, as discussed in greater detail in this section of this final rule.
Consistent with the language of section 1860D-15(b) of the Act, CMS policy, including the current reporting requirements, and operations, including how the industry tracks and reports costs (that is, industry practice), we proposed to amend the definition of “gross covered prescription drug costs” at § 423.308 to remove the two references to “actually paid” to clarify that GCPDC are not net of all DIR.
We explained that the proposed change would have no impact on Part D payment calculations or reporting requirements. Consistent with section 1860D-15(b)(2), the reinsurance payment amount would continue to be calculated based on drug costs net of DIR. Outside of the reinsurance context, CMS' long-standing operational guidance has instructed plans to report costs without first netting out DIR applied after the POS, and thus, the guidance would not need to be adjusted as a result of this proposed change to the regulatory definition of GCPDC. For instance, the amounts reported in the Ingredient Cost, Dispensing Fee, Vaccine Administration, Sales Tax, GDCB, GDCA, and the TGCDC Accumulator fields on the PDE record are required to include costs incurred by the Part D sponsor and all amounts paid by or on behalf of an enrollee under a Part D plan. Further, CMS guidance instructs Part D sponsors to net out only plan administrative costs and any DIR applied at the POS when reporting GCPDC. Hence, a key step in calculating the Part D reinsurance payment amount is to determine the allowable reinsurance cost amount by subtracting from the GCPDC incurred in the catastrophic phase all DIR attributable to the proportion of catastrophic phase spending that was not already accounted for at the POS in order to determine the amount “actually paid” by the Part D plan and ensure that the reinsurance payment amount is ultimately calculated based on net drug costs. As we would continue to take this important step in determining allowable reinsurance costs for purposes of calculating the reinsurance payment amount even if “actually paid” were removed from the regulatory definition of GCPDC as proposed, there would be no change in the final reinsurance payment amount a Part D sponsor receives.
Moreover, we noted that no other rules or policies would be affected by this proposed change, including the rules regarding how to account for coverage not provided by the Part D sponsor, and instead provided by other payers, because they do not directly address the calculation of the reinsurance payment amount and thus do not rely on the current regulatory definition of GCPDC. For example, we explained that under rules regarding Medicare secondary payer (MSP) or subrogated claims, the amounts reported in the cost and payment fields of the PDE record reflect a reduction in the Part D plan's incurred cost for a drug resulting from other payer arrangements, which is currently captured in GCPDC and would continue to be captured in GCPDC under our proposed revisions.
We noted that in the 2022 final rule titled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” (87 FR 27833 through 27851) which appeared in the
While this proposed change to the regulatory definition would not be a change in policy and would not directly affect the way in which GCPDC are calculated and used for purposes of Part D, we stated that we believe it is important to revise the definition to remove any ambiguity regarding the meaning of the term “gross covered prescription drug costs.” As noted previously, the IRA added provisions to the Social Security Act that refer to “gross covered prescription drug costs as defined in section 1860D-15(b)(3) [of the Act].” Removing the phrase “actually paid” from the regulatory definition of GCPDC as proposed would eliminate any ambiguity in the regulation text and help to ensure there is a consistent understanding of the meaning of this term for purposes of both the Part D program and the relevant provisions of the IRA.
We further explained that nothing in the proposed change would place additional requirements on Part D sponsors or beneficiaries or change how CMS currently uses the GCPDC reported by the Part D sponsor on the PDE for purposes of determining payments under Part D. Rather the proposed change would be consistent with our current policy and operations, including the current reporting requirements. As such, the proposed change to the definition of “gross covered prescription drug costs” at § 423.308 would not place any additional burden on Part D sponsors, nor did we expect that the proposed change would result in savings. We received 19 pieces of correspondence containing one or more comments in response to our proposal to amend the regulatory definition of “gross covered prescription drug costs” at § 423.308 by removing the phrase “actually paid.”
Within the reinsurance context, as noted in the proposed rule, amending the regulatory definition of GCPDC as proposed creates no additional requirements or other burden on Part D sponsors or beneficiaries, nor does it change how CMS currently uses the GCPDC reported by the Part D sponsor on the PDE record for purposes of determining payments under Part D. Moreover, as discussed in the proposed rule, because we will continue to take the important step of removing all DIR in determining allowable reinsurance costs for purposes of calculating the reinsurance payment amount, there will be no change in the final reinsurance payment amount a Part D sponsor receives, and thus no change in government costs. We believe this analysis is a sufficient assessment of the impact of the proposed revisions to the
After considering all of the comments received, CMS is finalizing as proposed the revisions to the definition of “gross covered prescription drug costs” at § 423.308 and removing the two uses of the phrase “actually paid” and replacing the second use with “paid.”
CMS develops and publicly posts a 5-star rating system for Medicare Advantage (MA)/Part C and Part D plans based on the requirement to disseminate comparative information, including information about quality, to beneficiaries under sections 1851(d) and 1860D-1(c) of the Act and the collection of different types of quality data under section 1852(e) of the Act. The Part C and Part D Star Ratings system is used to determine quality bonus payment (QBP) ratings for MA plans under section 1853(o) of the Act and the amount of beneficiary rebates under section 1854(b) of the Act. Cost plans under section 1876 of the Act are also included in the Part C and Part D Star Ratings system, as codified at § 417.472(k). We use multiple data sources to measure quality and performance of contracts, such as CMS administrative data, surveys of enrollees, information provided directly from health and drug plans, and data collected by CMS contractors. Various regulations, including §§ 417.472(j) and (k), 422.152(b), 423.153(c), and 423.156, require plans to report on quality improvement and quality assurance and to provide data which help beneficiaries compare plans. The methodology for the Star Ratings system for the MA and Part D programs is codified at §§ 422.160 through 422.166 and 423.180 through 423.186, respectively, and we have specified the measures used in setting Star Ratings through rulemaking. In addition, the cost plan regulation at § 417.472(k) requires cost contracts to be subject to the Part 422 and 423 Part C and Part D Quality Rating System. (83 FR 16526-27). As a result, the policies adopted as final in this rule apply to the quality ratings for MA plans, cost plans, and Part D plans. We generally use “Part C” to refer to the quality measures and ratings system that applies to MA and cost plans. Where a cost plan covers Medicare Part D, it is treated like an MA-PD plan and therefore must also report Part D measures.
We are working to ensure that the Star Ratings program is aligned with the CMS Quality Strategy as that Strategy evolves over time. This includes reducing the weight of patient experience/complaints and access measures and codifying clarifications to the rules for calculating the Part C and D Star Ratings related to disasters and contract consolidations. The current CMS National Quality Strategy encourages the highest quality outcomes, safest care, equity, and accessibility for all individuals (
In this final rule, we are finalizing a health equity index reward to further incentivize Part C and D plans to focus on improving care for enrollees with specified social risk factors (SRFs), and to support CMS efforts to ensure attainment of the highest level of health for all people. We are also finalizing the following measure updates:
• Remove the Part C Diabetes Care—Kidney Disease Monitoring measure;
• Add the updated Part D Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), Medication Adherence for Cholesterol (Statins) measures; and
• Add the Part C Kidney Health Evaluation for Patients with Diabetes measure.
We are also finalizing several methodological changes:
• Reduce the weight of patient experience/complaints and access measures to further align the Part C and Part D Quality Rating System with other CMS quality programs;
• Add an additional basis for the subregulatory removal of Star Ratings measures; and
• Remove the 60 percent rule for the adjustment for extreme and uncontrollable circumstances (generally called the adjustment for disasters).
Finally, we are also finalizing a series of technical clarifications of the existing rules related to adjustments for disasters and contract consolidations, as well as a technical amendment to §§ 422.162(a)(2)(i) and 423.186(a)(2)(i) to fix a codification issue. Unless otherwise stated, the changes will apply (that is, data will be collected and performance measured) for the 2024 measurement period and the 2026 Star Ratings.
In addition, we proposed in the December 2022 proposed rule other policies to amend the Part C and D Star Ratings but are not addressing those proposals in this final rule; those other proposals will be addressed in a subsequent, second final rule. Any policies we proposed in the December 2022 proposed rule that are addressed in that subsequent rule would apply (that is, data will be collected and performance measured) for no earlier than the 2025 measurement period and the 2027 Star Ratings. CMS appreciates the feedback we received on our proposals.
In the sections that follow, we summarize the comments we received on each proposal we are finalizing and provide our responses.
We proposed to add the following definition for Part 422, Subpart D (for Part C plans) and Part 423, Subpart D (for Part D plans) in paragraph (a) of §§ 422.162 and 423.182, respectively.
We received no comments on this proposed definition in paragraph (a) of §§ 422.162 and 423.182 and are finalizing it without modification for the reasons in the proposed rule. This new definition is relevant for our policies discussed in section V.F. of this final rule and will be used in that context.
In the April 2018 final rule (83 FR 16440) at §§ 422.162(b) and 423.182(b), we codified the methodology for calculating the same overall and summary Star Ratings for all plan benefit packages (PBPs) offered under each MA-only, MA-PD, or PDP contract.
As different organization or contract types offer different benefits, the overall and summary Star Ratings differ across contract types when the set of required measures differs. For example, non-SNP contracts do not currently submit the following measures and, therefore, their overall and Part C summary ratings do not include them: SNP Care Management, Care for Older Adults—Medication Review, and Care for Older Adults—Pain Assessment.
We proposed to amend §§ 422.162(b)(1) and 423.182(b)(1) to add a sentence at the end to clarify that the overall and summary Star Ratings are calculated based on the measures required to be collected and reported for the contract type being offered for the Star Ratings year. This is our current practice and how the Star Ratings have historically been calculated. For example, the 2023 Star Ratings were calculated for the 2023 contract year using data primarily from measurement year 2021.
We solicited comments on this proposal.
After considering the comments we received and for the reasons outlined in the proposed rule, we are finalizing the clarification at §§ 422.162(b)(1) and 423.182(b)(1) regarding the scope of measures used in calculating the overall and summary ratings without modification. We are also finalizing a revision related to adoption of the health equity index and future removal of the reward factor, which is discussed in more detail in section V.F. of this final rule.
The process for calculating measure scores for contracts that consolidate is specified as a series of steps at §§ 422.162(b)(3) and 423.182(b)(3). As described in the April 2018 final rule (83 FR 16528 through 16531), we use the enrollment-weighted means of the measure scores of the consumed and surviving contract(s) to calculate the measure-level ratings for the first and second years following the contract consolidation. For all contracts, under §§ 422.164(f)(4) and 423.184(f)(4), the Part C and Part D improvement measures compare current contract-level measure scores with scores from the prior year across all measures included in the improvement measures calculations. Given there are no comparable prior year measure-level scores available for contracts in the first year of the consolidation, historically we have not calculated the Part C and D improvement measures for the first year after a consolidation.
We proposed to amend §§ 422.162(b)(3)(iv)(A)(
We proposed to revise the current regulation text at §§ 422.162(b)(3)(iv)(A)(
We solicited comments on this proposal.
After considering the comments we received and for the reasons outlined in the proposed rule, we are finalizing the clarification at §§ 422.162(b)(3)(iv)(A)(
The regulations at §§ 422.164 and 423.184 specify the criteria and procedure for adding, updating, and removing measures for the Star Ratings program. In the April 2018 final rule, at 83 FR 16532, we stated that we are committed to continuing to improve the Part C and Part D Star Ratings system and anticipated that over time measures would be added, updated, and removed. We also specified at §§ 422.164(d) and 423.184(d) rules for measure updates based on whether they are substantive or non-substantive. The regulations, at paragraph (d)(1), list examples of non-substantive updates. See also 83 FR 16534-37. Due to the regular updates and revisions made to measures, CMS does not codify a list in regulation text of the measures (and their specifications) adopted for the Part C and Part D Star Ratings program (83 FR 16537). CMS lists the measures used for the Star Ratings each year in the Medicare Part C & D Star Ratings Technical Notes or similar guidance issued with publication of the Star Ratings. We proposed measure changes to the Star Ratings program for performance periods beginning on or after January 1, 2024 unless noted otherwise. We also proposed a new rule for the removal of measures.
We proposed to remove the Diabetes Care—Kidney Disease Monitoring measure because it has been retired by the measure steward.
CMS proposed to permanently remove the Diabetes Care—Kidney Disease Monitoring measure starting with the 2024 Star Ratings because we will not have data to calculate the measure.
We solicited comments on removing this measure from the Star Ratings program.
After considering the comments we received and for the reasons outlined in the proposed rule, we are finalizing the removal of the Diabetes Care—Kidney Disease Monitoring measure from the Star Ratings program.
In the April 2018 final rule, we specified at §§ 422.164(d) and 423.184(d) rules for measure updates based on whether they are substantive or non-substantive. (83 FR 16534 and 16535). Where an update by the measure steward is substantive within the scope of §§ 422.164(d)(2) and 423.184(d)(2), CMS will initially solicit feedback on whether to make substantive measure updates through the process described for changes in and adoption of payment and risk adjustment policies in section 1853(b) of the Act and then engage in rulemaking to make substantive changes to a Star Ratings measure. Per §§ 422.164(d)(2) and 423.184(d)(2), CMS will place the updated measure on the display page for at least 2 years prior to using the updated measure to calculate and assign Star Ratings. This 2-year period for the updated measure to be on the display page may overlap with the period during which CMS solicits comment and engages in rulemaking. Further, the legacy measure may continue to be used in the Star Ratings during this period.
CMS proposed to implement risk adjustment (also sometimes referred to as case-mix adjustment) based on sociodemographic status (SDS) characteristics, a substantive update, to the three Part D medication adherence measures for the 2028 Star Ratings (2026 measurement year). The adherence measures would be adjusted for the following beneficiary-level SDS characteristics: age, gender, low-income subsidy/dual eligibility (LIS/DE) status, and disability status. Health outcomes are affected by patient-related and external factors such as existing clinical conditions and SDS. Currently, the three medication adherence measures (Diabetes, Hypertension, and Cholesterol) are included in the determination of the Star Ratings Categorical Adjustment Index (CAI) because they are not excluded by the criteria established in §§ 422.166(f)(2) and 423.186(f)(2); for example, the measures are not case-mix adjusted for socioeconomic status (SES). The CAI was implemented in the 2017 Star Ratings to adjust for average within-contract disparity in performance associated with the percentages of beneficiaries who receive LIS/DE and/or have disability status. The CAI was initially developed as an interim analytical adjustment to address concerns about disparities while longer-term solutions were explored, including engaging with measure stewards to examine if re-specification is warranted for measures used in the Star Ratings. The methodology for the CAI was codified at §§ 422.166(f)(2) and 423.186(f)(2); the factor is calculated as the mean difference in the adjusted and unadjusted ratings (overall, Part D for MA-PDs, and Part D for PDPs) of the contracts that lie within each final adjustment category for each rating type.
In addition, the National Quality Forum (NQF) convened an expert panel in 2014 and recommended that performance-based measures should be risk adjusted for SES and other socio demographic factors in 2017. On June 28, 2020, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) submitted a second Report to Congress;
CMS contracted with the Pharmacy Quality Alliance (PQA), the steward of these measures, to examine the medication adherence measures for potential risk adjustment. PQA recommended SDS risk adjustment for the Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), and Medication Adherence for Cholesterol (Statins) measures. PQA recommended and endorsed the following changes related to SDS in their Measure Manual:
• All three adherence measures should be risk adjusted for SDS characteristics to adequately reflect differences in patient populations.
• The measures should be adjusted for the following beneficiary-level SDS characteristics: age, gender, LIS/DE status, and disability status.
• The measures should be stratified by these four beneficiary-level SDS characteristics (listed in the prior bullet) to allow health plans to identify disparities and understand how their patient population mix is affecting their measure rates.
The PQA measure specifications were endorsed by NQF in the 2019 Spring cycle (NQF endorsed #0541) (CMIT ID: 00436-01-C-PARTD for Diabetes, 00437-01-C-PARTD for Hypertension, and 00435-01-C-PARTD for Cholesterol).
CMS has included stratifications by age, gender, LIS/DE status, and disability status in the Medication Adherence patient safety reports to Part D sponsors beginning with the 2019 measurement year.
We proposed to implement risk adjustment for the medication adherence measures based on the PQA specifications, which would be reflected in the Star Ratings. Additionally, because the medication adherence measures will be risk adjusted based on SDS characteristics (that is, for age, gender, LIS/DE status, and disability status), the medication adherence measures will be excluded from the CAI adjustment per §§ 422.166(f)(2)(ii)(A) and 423.186(f)(2)(ii)(A). We found in our analysis that implementing the SDS risk adjustment to the patient safety reports can be very time consuming and should be incorporated at one period of time. Therefore, since we proposed to implement the SDS risk adjustment to the medication adherence measures (which will remove these measures from the Star Ratings CAI determination), we intend to incorporate the SDS risk adjustment operationally to the medication adherence measures reported by CMS to Part D sponsors in the last monthly patient safety report for the measurement year.
In developing this proposal, we considered how this change might affect Star Ratings for MA-PD and PDP contracts. We calculated SDS risk adjusted medication adherence measure rates using year of service (YOS) 2019 measurement year data and recalculated the CAI values excluding these three adherence measures. We then recalculated the overall and Part D summary ratings using the SDS risk adjusted medication adherence measure rates, revised CAI values, the final 2021 Star Ratings for other measures, and the reward factor. In our analysis, we found that the threshold shifts for measure-level cut points with SDS risk adjustment were minimal for both MA-PD and PDP contracts, ranging from −2 to +1 percentage point(s) for MA-PD contracts and about −2 to +3 percentage points for PDP contracts. We found that for both MA-PD and PDP contracts, approximately 60-70 percent of contracts retained the same star level across the Medication Adherence for Hypertension (RAS Antagonists) and Medication Adherence for Cholesterol (Statins) measures. When a star level shift was observed, most of the MA-PD and PDP contracts shifted by one-star level and usually shifted upwards when the SDS risk adjustment was applied to the adherence measures. One percent of MA-PD contracts shifted two-star levels for the Medication Adherence for Hypertension (RAS Antagonists) and Medication Adherence for Cholesterol (Stains) measures. The two-star level shifts were primarily upwards, but one contract did shift down two stars in the Medication Adherence for Cholesterol (Stains) measure. For the Medication Adherence for Diabetes Medication measure, 82 percent of MA-PD contracts and 59 percent of PDP contracts retained the same star level. When a star level shift was observed for the Medication Adherence for Diabetes Medication measure, most MA-PD and PDP contracts saw a one-star downward movement with the SDS risk adjustment applied to the measure.
As previously noted, if CMS implements SDS risk adjustment for the three medication adherence measures, the measures would no longer be included in determining the Star Ratings CAI. Therefore, we also conducted an analysis to simulate calculating the CAI values without case-mix adjusting the three adherence measures for LIS/DE and disability; these simulated CAI values were used in the application of the simulated summary rating calculations. For most MA-PD contracts, this resulted in a negative shift in the CAI adjustment values for the overall and Part D summary ratings, and in contrast, most PDPs had a positive shift in values. Additionally, the analysis found a minimal change in reward factor thresholds, ranging from −0.07 to +0.02 for mean percentile thresholds and −0.08 to +0.008 for variance percentile thresholds. In the analysis of the overall and Part D summary rating, 91 percent of MA-PD contracts retained the same overall rating, 7 percent decreased by half a star, and 2 percent increased by half a star. We found that 81 percent of MA-PD contracts retained the same Part D summary rating, 11 percent decreased by half a star, and 7 percent increased by half a star. The impact on PDP contracts was neutral or positive; 63 percent of PDP contracts retained the same Part D summary rating star level while 37 percent increased by a half a star. No PDP contracts had a decrease in their Part D summary rating.
The Part C and Part D improvement measures were not recalculated for this simulation. The final 2021 Star Ratings for both improvement measures were used for the summary rating recalculations in the simulations to illustrate the impact of this proposed change to the three medication adherence measures. Additionally, the final 2020 Star Ratings for both improvement measures and for the three adherence measures were used for the CAI value recalculations in the simulations. It is possible that the simulated differences could vary if or when we are able to have two consecutive years of adjusted data for recalculating these components.
Per § 423.184(d)(2), the change to implement SDS risk adjustment for the three Part D medication adherence measures would be a substantive update. We signaled this potential update and solicited initial feedback on incorporating the SDS risk adjustment in the Advance Notice and Announcement of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies.
A majority of the comments submitted in response to the CY 2023 Advance Notice supported SDS risk adjustment for the medication adherence measures. Some of those comments also requested information on how the CAI will be affected by this update. We completed testing of the impact of the adjustment and are including the additional information about the simulations in this final rule, as summarized previously. If finalized, the legacy
In addition, to provide a more complete explanation of the changes in the specifications to the three medication adherence measures, the December 2022 proposed rule included a summary of non-substantive updates to the medication adherence measures. As noted in the proposed rule and in the Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, our intent was to implement the non-substantive changes regardless of whether we ultimately finalized changes to add risk adjustment for SDS factors to the three medication adherence measures. The non-substantive updates are to: (1) apply continuous enrollment (CE) instead of member-years (MYs) adjustment and (2) no longer adjust for stays in inpatient (IP) settings and skilled nursing facilities (SNFs). More information about the non-substantive updates is in section V.D.2.b. of this rule and in the Announcement of Calendar Year (CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies issued on March 31, 2023.
We solicited comments on this substantive update to incorporate SDS risk adjustment for the medication adherence measures. In addition, we summarize here the comments received regarding the non-substantive updates that specifically reference the proposed substantive measure updates to the medication adherence measures.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the implementation of the SDS risk adjustment to the three medication adherence measures (Medication Adherence for Diabetes Medication, Medication Adherence for Hypertension (RAS Antagonists), and Medication Adherence for Cholesterol (Statins)). We will first display the updated SDS risk adjusted medication adherence measures for the 2024 measurement year (2026 display page). Then, the updated SDS risk adjusted measures will replace the existing medication adherence measures beginning with the 2026 measurement year (2028 Star Ratings). The IP/SNF stay adjustment will be removed from the medication adherence measures starting with the 2026 measurement year (2028 Star Ratings). CMS will implement the CE to the medication adherence measures starting with the 2024 measurement year (2026 Star Ratings). Publishing the display measures for at least two years will allow Part D sponsors and CMS additional experience with contract-specific results using the new measure specifications.
As discussed in the December 2022 proposed rule, our analysis of the proposed substantive changes (to add risk adjustment for SDS for the three adherence measures) included two non-substantive changes to the adherence measures, based on the current PQA measure specifications, which are endorsed by NQF. While we did not need to propose non-substantive changes through rulemaking, given that we intend to make the non-substantive changes to the measures along with the proposed substantive changes to risk adjust the adherence measures, we described the non-substantive updates as well in the preamble to the proposed rule in order to provide a full picture of the changes to these measures. However, implementing these non-substantive updates was not dependent on finalizing the SDS risk adjustment proposal and was included in the Advance Notice of Methodological Changes for Calendar Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies. These specification changes are non-substantive in accordance with § 423.184(d)(1) because they narrow the denominator population or do not change the target population or intent of the measure: (1) apply continuous enrollment (CE) instead of member-years (MYs) adjustment and (2) no longer adjust for stays in inpatient (IP) settings and skilled nursing facilities
We are committed to continuing to improve the Part C and Part D Star Ratings system by focusing on improving clinical and other health outcomes. Consistent with §§ 422.164(c)(1) and 423.184(c)(1), we continue to review measures that are nationally endorsed and in alignment with the private sector. (83 FR 16521, 16533). For example, we regularly review measures developed by NCQA and PQA. CMS proposed to adopt the new measure described in this rule, which was developed by NCQA. The Kidney Health Evaluation for Patients with Diabetes (KED) measure has been collected from MA (including MA-only and MA-PDs) and cost plans since the 2020 measurement year.
We proposed to add the KED measure beginning with the 2024 measurement year and 2026 Star Ratings. This measure was introduced as a HEDIS measure for the 2020 measurement year. NCQA, in collaboration with the National Kidney Foundation, developed a kidney health evaluation measure, and NCQA tailored the measure specifically for health plans. The KED NCQA measure assesses whether adults who have diabetes received an annual kidney profile evaluation, defined by an estimated Glomerular Filtration Rate (eGFR)
CMS began reporting the KED measure on the display page for the 2022 Star Ratings. As provided at §§ 422.164 (c)(3) and (4) and 423.184(c)(3) and (4), as new performance measures are developed and adopted they are initially posted on the display page for at least 2 years.
We submitted the KED plan measure through the 2022 Measures Under Consideration process for review by the Measures Application Partnership, which is a multi-stakeholder partnership that provides recommendations to HHS on the selection of quality and efficiency measures for CMS programs, and the Measures Application Partnership provided support for this measure. The MIPS program had also submitted it to the 2021 Measures Under Consideration process and this measure will also be implemented for qualified health plans (QHPs).
We solicited comments on adding this measure to the 2026 Star Ratings program.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the addition of the KED measure to the 2026 Star Ratings.
Table 2 summarizes the additional and updated measures addressed in this final rule for the 2026 Star Ratings, unless otherwise noted. Due to the level of detail and changes in measure specifications, CMS does not list the measures and their specifications in the regulation text for the Part C and Part D Quality Star Ratings, but their final adoption and required use are addressed in this final rule. The measure descriptions listed in this table are high-level descriptions. The annual Star Ratings measure specifications supporting document, the Medicare Part C & D Star Ratings Technical Notes, provides detailed specifications for each measure. Detailed specifications include, where appropriate, more specific identification of a measure's: (1) numerator, (2) denominator, (3) calculation, (4) timeframe, (5) case-mix adjustment, and (6) exclusions. The Technical Notes document is updated annually. The annual Star Ratings are produced in the fall of the prior year. For example, Stars Ratings for the year 2026 will be produced in the fall of 2025. If a measurement period is listed as “the calendar year 2 years prior to the Star Ratings year” and the Star Ratings year is 2026, the measurement period is referencing the January 1, 2024 to December 31, 2024 period.
CMS proposed adding a new rule for measure removal. We proposed that CMS would have the authority to remove a measure from calculations of Star Ratings when a measure steward other than CMS retires the measure. CMS continually reviews measures that are used in calculations of Star Ratings. As codified at §§ 422.164(e)(1) and 423.184(e)(1), CMS may remove a measure when either (1) the clinical guidelines associated with the specifications of the measure change such that the specifications are no longer believed to align with positive health outcomes; or (2) a measure shows low statistical reliability. See also 83 FR 16533-16537. In both of these circumstances, as codified at §§ 422.164(e)(2) and 423.184(e)(2), CMS will announce the removal of any measure in advance of the measurement period through the process described for changes in and adoption of payment and risk adjustment policies in section 1853(b) of the Act.
We proposed adding a rule at §§ 422.164(e)(1)(iii) and 423.184(e)(1)(iii) to allow removal of a Star Ratings measure, without separate rulemaking, when a measure steward other than CMS (for example, NCQA or PQA) retires a measure. Under the proposal, which we are finalizing, CMS will have the authority to remove the measure from calculations of Star Ratings through the process described at §§ 422.164(e)(2) and 423.184(e)(2). When a measure steward such as NCQA retires a measure, they go through a process that includes extensive review by their various measurement panels and they solicit public comment regarding proposed measure retirements so health plans, purchasers, consumers, and other stakeholders have an opportunity to weigh in on the relevance and scientific soundness of any changes to the measurement set. This change will allow CMS to respond more quickly to measure removals by external measure stewards to ensure that measures included in Star Ratings are clinically meaningful, reliable, and up-to-date. We solicited comments on this proposal.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the additional rule at §§ 422.164(e)(1)(iii) and 423.184(e)(1)(iii) as proposed without modification.
CMS proposed to lower the weight of patient experience/complaints and access measures to 2 beginning with the 2026 Star Ratings covering the 2024 measurement period. The weight for the patient experience/complaints and access measures is codified at §§ 422.166(e)(1)(iii) and (iv) and 423.186(e)(1)(iii) and (iv). Process measures receive a weight of 1, outcome measures receive a weight of 3, and the Part C and D improvement measures receive a weight of 5. In the April 2018 final rule, we finalized an increase in the weight of patient experience/complaints and access measures from 1.5 to 2, starting with the 2021 Star Ratings. (83 FR 16575-77). These measures include the patient experience of care measures collected through the CAHPS survey, Members Choosing to Leave the Plan, Appeals, Call Center, and Complaints measures. We also stated in the April 2018 final rule (83 FR 16575-16576) that, given the importance of hearing the voice of patients when evaluating the quality of care provided, CMS intended to further increase the weight of patient experience/complaints and access measures in the future. In the June 2020 final rule, CMS finalized an additional increase in the weight of patient experience/complaints and access measures from 2 to 4 for the 2023 Star Ratings. At that time, we stated we were putting more weight on this category of measures that primarily reflect patient experience of care measures to put patients first and to emphasize CMS's goal of listening to the voice of the patient to identify opportunities to improve care delivery (85 FR 33837). We still believe these measures focus on critical aspects of care such as care coordination and access to care from the perspective of enrollees, but taking into consideration additional stakeholder feedback we have received and the effect of the policy on the 2023 Star Ratings, we have reconsidered our position from the June 2020 final rule and now believe these measures currently receive an undue weight in the Star Ratings program.
One of the guiding principles of the Part C and Part D Star Ratings program is to align with the CMS Quality Strategy (83 FR 16521). As part of the current CMS Quality Strategy, CMS is trying to create a resilient, high-value health care system that promotes quality outcomes, safety, equity, and accessibility for all individuals, as described at
The weighting of measures within the Star Ratings program is important as not all measures contribute equally to the goals of the program. Patient experience, complaints, and access to care have been linked to improved clinical outcomes and are important aspects of health care. For example, patient experience is associated with better patient adherence to recommended treatment, better clinical processes, better hospital patient safety culture, better clinical outcomes, reduced unnecessary health care use, and fewer inpatient complications (Anhang Price et al., 2014; Anhang Price et al., 2015; Quigley et al., 2021).
Subsequent to finalizing the weight of 4 for patient experience/complaints and access measures in the June 2020 final rule, we have received significant stakeholder feedback on this issue through the Part C and D Advance Notices, the 2023 Part C and D proposed rule (CMS-4192-P), the COVID-19 interim final rules (CMS-1744-IFC and CMS 3401-IFC), letters sent to CMS, and meetings with plans. A number of concerns have been raised by stakeholders related to a weight of 4, including devaluing measures of health outcomes, encouraging plans to abandon efforts to drive clinically appropriate care, sending the message that preventive care such as cancer screenings are not important, and not balancing appropriately clinical excellence and patient experience. Stakeholders have also raised concerns around disproportionately overweighting patient experience measures, which in turn diminishes the importance of other measures. MedPAC noted in their response to the CY 2021 and 2022 proposed rule (CMS-4190-P) that the increased weight would give disproportionate weight to patient experience measures relative to outcome measures and create an imbalance between the two most important measure groupings—outcome and patient experience measures. Stakeholders have continued to raise concerns about the disproportionate weight given to patient experience/complaints and access measures. Stakeholders have continued to suggest that clinical outcomes should count more than patient experience of care measures. Additionally, we have received feedback that cancer screenings, medication reconciliation, and other Star Ratings measures are critical areas of focus in particular in underserved communities but have a diminished role in the Star Ratings program due to the high weight of patient experience/complaints and access measures.
Given these concerns, as well as the impact of the weighting policy on the 2023 Star Ratings, CMS re-evaluated its decision to weight these measures higher than outcome measures. We were concerned that the higher weight of 4 may create incentives for plans to not focus as much on patient outcomes, screenings, and preventive care. This could lead to ineffective or inappropriate care and increased costs if providers primarily focus on patient experiences. Although patient experience/complaints and access to care measures have been linked to improved clinical outcomes and are important aspects of health care, we proposed to move back to a weight of 2 to more appropriately balance the value these measures contribute to achieving high quality care without weighting them higher than clinical outcome measures and to better align the total contribution of patient experience and outcome measures with other CMS quality reporting programs.
To better align the Part C and Part D Star Ratings with the current CMS Quality Strategy and other CMS quality programs and to better balance the contribution of the different types of measures in the Star Ratings program, we proposed to modify § 422.166 at paragraphs (e)(1)(iii) and (iv) and § 423.186 at paragraphs (e)(1)(iii) and (iv) to decrease the weight of patient experience, complaints, and access measures from 4 to 2 beginning with the 2026 Star Ratings. At a weight of 2, the patient experience, complaints, and access measures would be weighted higher than process measures but not as high as outcome measures. This is in line with the value these measures add to achieving high quality care without weighting them higher than clinical outcome measures. In addition, this would align more closely with the weight these types of measures are given in other CMS quality programs.
We solicited feedback on this proposed change.
Some commenters noted that they recognize the importance and value of patient experience/complaints and access measures, but agree that they should not account for more than half of the overall Star Ratings. A commenter noted that bringing patient experience, complaint, and access measures back to their prior weight of 2 rebalances the impact of different measure types, signals the critical importance of clinical outcome and process measures, which had been underweighted when the weighting was doubled, and ensures
A commenter noted that CAHPS patient experience of care and access measures help support an age-friendly health system that encourages age-
In addition to English, CMS provides survey materials in Chinese, Korean, Spanish, Tagalog, and Vietnamese. Offering the survey in multiple languages helps improve response rates for Asian and Pacific Islander and Hispanic respondents. CMS issues an annual HPMS memo about the Medicare CAHPS survey that includes strategies contracts can use to promote member participation in the survey, including providing survey vendors with language preference data and current phone numbers for all enrollees as well as avoiding fielding other surveys of beneficiaries during or close to the MA and PDP CAHPS survey administration period. Finally, the scoring methodology takes into account reliability, and there are extensive quality control checks to ensure programming is accurate. More information on CMS guidelines for MA and PDP CAHPS and recommendations to achieve high survey response rates is also available at
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the weight
As discussed in section III.A. of this final rule, advancing health equity is the first pillar of the 2022 CMS Strategic Plan and a goal of the CMS National Quality Strategy. In reports on accounting for social risk factors (SRFs) in value-based purchasing programs, the National Academies of Sciences, Engineering, and Medicine (NASEM) define SRFs as factors related to health outcomes that are evident before care is provided, are not consequences of the quality of care, and are not easily modified by health care providers.
As discussed in the proposed rule, the current approach to addressing SRFs in the Part C and Part D Star Ratings program has focused on adjusting for the average within-contract disparities in performance through the CAI, as described at §§ 422.166(f)(2) and 423.186(f)(2), in order to not inappropriately penalize or reward health and drug plans for factors that are difficult for plans to control. For certain current Star Ratings measures, it may be more difficult for most plans to achieve the same level of care for groups that are socioeconomically disadvantaged, disabled, or more complex due to a variety of issues, including transportation issues, lower health literacy, communication challenges, and residential instability. The CAI is a factor that can be positive or negative and is added to a contract's overall and summary Star Ratings and that adjusts for the average within-contract performance disparity based on a contract's composition of LIS/DE and disability status enrollees.
The CAI was implemented in the Part C and Part D Star Ratings program to address SRFs while measure stewards evaluated adjustment on a measure-specific basis. The CAI is a data-driven approach to account for within-contract disparities in performance associated with SRFs in Star Ratings measures that are not already adjusted according to the measure specifications developed by measure stewards. The CAI does not incentivize contracts to focus on reducing disparities. Although all contracts have incentives in the Star Ratings program to improve performance, prior to the proposed HEI reward, there were no methodological adjustments that specifically created incentives to address disparities of care among a contract's enrollees.
In addition to adjusting for within-contract disparities through the CAI, we also want to encourage MA organizations, cost plans, and Part D plan sponsors to better identify and then address disparities in care provided to enrollees with a particular SRF, with the ultimate goal of reaching equity by eliminating health disparities or differences in contract performance by SRFs, consistent with CMS efforts to advance health equity.
CMS developed a health equity index (HEI) factor that we proposed for use in the Part C and Part D Star Ratings to reward contracts for obtaining high measure-level scores for the subset of enrollees with specified SRFs. Our intent in implementing an HEI reward is to improve health equity by incentivizing MA, cost, and PDP contracts to perform well among enrollees with specified SRFs. The CAI is designed to improve the accuracy of performance measurement, while not masking true differences in performance between contracts; in contrast, our proposed HEI reward is specifically designed to create an incentive to reduce disparities in care. As discussed in the proposed rule, the HEI reward, therefore, would not replace the CAI but rather assist plan sponsors in better identifying and then addressing disparities in care provided to members with a particular SRF, with the ultimate goal of reaching equity in the level and quality of care provided to enrollees with SRFs. We explained in the proposed rule that there would be no changes to the current CAI with the implementation of the HEI reward.
We proposed to replace the current reward factor described at §§ 422.166(f)(1) and 423.186(f)(1) with the new HEI reward at proposed §§ 422.166(f)(3) and 423.186(f)(3) starting with the 2027 Star Ratings; the HEI reward for the 2027 Star Ratings would be calculated using data collected or used for the 2026 and 2027 Star Ratings (2024 and 2025 measurement years). As discussed in the preamble to the proposed rule, the current reward factor was included in the Part C and Part D Star Ratings program beginning with the 2009 Star Ratings with the purpose of creating additional incentives for high and stable relative performance across measures by discouraging contracts from having a lot of variation in performance across measures (that is, a mix of low performance and high performance across measures). We proposed that the removal of the current reward factor would be contingent on finalizing the addition of the proposed HEI reward.
CMS proposed to add the HEI reward as a methodological enhancement to the Part C and Part D Star Ratings program starting with the 2027 Star Ratings because, similar to the current reward factor, it provides a summary of how performance varies across existing Star Ratings measures. However, our proposed HEI reward is intended to be a methodological enhancement using data from existing Star Ratings measures rather than a new measure with additional burden for contracts. In the case of the HEI reward, however, this summary of performance would be based on performance related to a subset of enrollees with specified SRFs. Adding the HEI as a reward also would allow for the methodology to include a performance threshold below which contracts will not be eligible for the HEI reward, which would incentivize improved performance by contracts for their enrollees with the specified SRFs and help reduce disparities. CMS could also potentially increase this performance threshold over time to incentivize continued efforts to reduce disparities in care.
In developing the proposed HEI reward, we considered a number of goals to ensure the incentives of the HEI and the associated reward were in line with our intent. We aim to improve health equity by incentivizing MA plans, cost plans, and Part D plan sponsors to perform well among enrollees with certain SRFs. These goals include the following:
• Avoiding rewarding large contracts over small contracts that may be providing high quality care for enrollees with the SRFs included in the HEI but lack the number of enrollees needed to reliably calculate the HEI.
• Avoiding rewarding contracts that may do well among enrollees with the SRFs included in the HEI but serve very
• Only rewarding contracts that have high relative performance among enrollees with the SRFs included in the HEI compared to other contracts to incentivize high performance for enrollees with the SRFs included in the HEI.
• Ease of use and understanding for contracts and other interested parties.
• Minimizing the number of years of data needed to calculate the HEI and HEI reward such that the data used are as current as possible.
• Allowing for updates to the measure set included in the HEI and updates to accommodate the addition of other SRFs to the HEI over time.
• Promoting improvement in performance among individuals with certain SRFs and enrollment of individuals with certain SRFs in high quality MA plans, cost plans, and Part D plans.
• Accurately reflecting true performance among contracts serving enrollees with certain SRFs and minimizing sensitivity to measurement error.
The proposed HEI would summarize contract performance in relation to enrollees with certain SRFs across multiple existing Star Ratings measures into a single score using data from the most recent 2 measurement years. We proposed at §§ 422.166(f)(3)(i)(A) and 423.186(f)(3)(i)(A) to initially include LIS/DE or having a disability as the group of SRFs used to calculate the HEI. Prior research has shown that dual eligibility for Medicare and Medicaid is one of the most influential predictors of poor health outcomes, and disability is also an important risk factor linked to health outcomes.
We solicited feedback on potential additional ways to identify enrollees who have a disability that could be incorporated over time and whether the same process and standards should be used for the CAI adjustment as well. In particular, we noted our interest in how we could expand the definition to include enrollees who develop a disability after aging into the Medicare program. LIS/DE and disability are the SRFs that have been used in the CAI for many years and are included in the confidential Part C and D Stratified Reports provided to MA and Part D contracts in HPMS as of 2022. We proposed that enrollees with these SRFs would be identified for the HEI the same way they are identified for the CAI at §§ 422.166(f)(2)(i)(B) and 423.186(f)(2)(i)(B).
We also considered including the Area Deprivation Index (ADI) in the HEI. The ADI is a measure of socioeconomic neighborhood deprivation, including measures of income, employment, housing, education, social environment, and readmissions. As discussed in the preamble to the proposed rule, we will continue to explore the feasibility of adding other SRFs to the HEI over time. As we noted in the proposed rule, the addition of other SRFs or other mechanisms to identify enrollees with one or more of the SRFs that are part of the HEI reward methodology would be proposed through future notice-and-comment rulemaking.
We proposed that the HEI would examine performance among those with certain SRFs for all Star Ratings measures unless they meet one of the specified exclusions. As we proposed in §§ 422.166(f)(3)(ii)(A)-(D) and 423.186(f)(3)(ii)(A)-(D), measures would be excluded from the HEI if one or more of the following criteria are met:
• The focus of the measurement is not the enrollee but rather the plan or provider (for example, the appeals and call center measures focus on the plan and its operations rather than on the enrollee). Measures meeting this criterion would be excluded because enrollee-level SRF information for these measures is not available for inclusion in the HEI.
• The measure is retired, moved to display, or has a substantive specification change in either year of data used to construct the HEI. Measures meeting these criteria would be excluded because there are not enough data to calculate the HEI for these measures.
• The measure is applicable only to SNPs. Measures meeting this criterion would be excluded because these measures are not relevant for all contracts.
• At least 25 percent of contracts are unable to meet the criteria described at proposed paragraph (f)(3)(iv), which provides that a measure is only included for the HEI for a contract if the measure has a reliability of at least 0.7 for the contract when calculated for the subset of enrollees with the specified SRF(s) and the contract meets the measure denominator requirement when the measure is calculated for only the enrollees with the specified SRF(s) (that is, the SRFs included in the HEI). For Part D measures, these criteria are assessed separately for MA-PDs and cost contracts, and PDPs consistent with how the Part D measure cut points and CAI are calculated separately for MA-PDs and cost contracts, and PDPs for the Part D summary rating. We proposed to exclude any measures from the HEI that less than 25 percent of contracts can have reliably calculated because scores would be missing for most contracts.
We proposed, at §§ 422.166(f)(3)(iii) and 423.186(f)(3)(iii), that the measures being evaluated for inclusion in the HEI would be announced annually in the process described for changes in and adoption of payment and risk adjustment policies in section 1853(b) of the Act. These announcements (of the measures being evaluated for inclusion in the HEI) would not include the final list of measures used in the HEI for the upcoming Star Ratings because the data to determine that final set will not yet be available. In general, measures from HEDIS, HOS, and CAHPS would be included unless they meet one of the four exclusion criteria, proposed at §§ 422.166(f)(3)(ii)(A)-(D) and 423.186(f)(3)(ii)(A)-(D). Additionally, medication adherence, MTM Program Completion for CMR, and Statin Use in Persons with Diabetes measures would be included as long as they meet the requirements for inclusion for more than 25 percent of contracts as proposed at §§ 422.166(f)(3)(i)(B) and 423.186(f)(3)(i)(B).
We described in the proposed rule the five steps that CMS would take to analyze the measure-level scores for each contract and to roll up to the HEI scores in order to assess when an adjustment is available for a contract's ratings.
Step 1: For each measure included in the HEI, measure-level scores calculated for each contract among enrollees with the included SRFs (that is, all enrollees who are DE, LIS, or disabled combined into one group) would be combined over the two most recent measurement years. CMS carefully considered the
As proposed at §§ 422.166(f)(3)(i)(B) and 423.186(f)(3)(i)(B), the scores for the subset of enrollees with SRFs of interest included in the HEI would be calculated using a modeling approach that includes year (that is, an indicator for whether the data are from year 1 or year 2) as an adjustor to account for potential differences in performance across years and to adjust the data to reflect performance in the second of the 2 years of data used. Scores are adjusted for year to account for situations where mean scores were, for the average contract, different in the 2 years (for example, higher in year 2 than year 1, or vice versa) and for contracts that have measure sample sizes that differ across years. In the calculation of the HEI, the measure-level scores will be used for contracts that have data for only the most recent year of the 2 years, but measure-level scores will not be used for contracts that have data for only the first of the 2 years in order to ensure use of the most current data possible.
Step 2: Measures that are case-mix adjusted in the Star Ratings would be adjusted using all standard case-mix adjustors for the measure except for those adjusters that are the SRFs of interest in the index, are strongly correlated with the SRFs of interest, or are conceptually similar to the SRFs of interest. The CAHPS measures included in the Star Ratings are currently adjusted for DE and LIS but are not adjusted for disability as defined by the original reason of entitlement. For the proposed HEI, for the subset of enrollees who identified as having the SRFs of interest in Step 1 (that is, the enrollees who are DE or LIS), we would not include the case-mix adjustment for DE and LIS when calculating the scores over the 2-year period for the CAHPS measures. For the three Star Ratings medication adherence measures based on the PQA specifications that will be risk adjusted as described in section V.D.2.a. of this rule, we would not include the measure-based risk adjustment for DE, LIS, and disabled enrollees when calculating the scores for these measures over the 2-year period as described in Step 1 if these measures meet the inclusion criteria for the HEI.
Step 3: For a measure to be included in the HEI score for a specific contract, both of the following inclusion criteria in proposed §§ 422.166(f)(3)(iv) and 423.186(f)(3)(iv) would need to be met: (1) reliability of at least 0.7 when the measure is calculated for the combined subset of enrollees with the specified SRFs across 2 years of data, and (2) measure-specific denominator criterion (for example, most HEDIS measures require a minimum denominator of at least 30) is met when the measure is calculated for the combined subset of enrollees with the specified SRFs across 2 years of data. We proposed at paragraph (f)(3)(vi) that contracts would also need to have at least 500 total enrollees at the contract level in the most recent measurement year used in the HEI. We proposed a minimum in order to have reliable measure-level scores. For many of the Star Ratings measures (for example, HEDIS and HOS measures) at least 500 enrollees are needed to have a sufficient number of enrollees to reliably measure the performance of the contract.
Step 4: As we proposed in §§ 422.166(f)(3)(v) and 423.186(f)(3)(v), to calculate the HEI score assigned to a contract, the distribution of contract performance on each eligible measure among enrollees with the specified SRFs (that is, all enrollees who are DE, LIS, or disabled combined into one group) would be calculated and separated into thirds, with the top third of contracts receiving 1 point, the middle third of contracts receiving 0 points, and the bottom third of contracts receiving −1 point for each measure. For example, for the Breast Cancer Screening measure, we would calculate performance for all contracts for the enrollees with one or more of the specified SRFs (that is, for the enrollees who are DE, qualify for LIS, and/or are disabled) using the two most recent measurement years. We would then look at the distribution of scores for this measure for all contracts that have at least 0.7 reliability and meet the minimum denominator size for the measure. Contracts that score in the top third of all contracts would receive 1 point for this measure, the middle third of contracts would receive 0 points for this measure, and the bottom third of contracts would receive 1 negative point for this measure. The same analysis would be repeated for each measure included in the HEI.
Step 5: For each contract, the HEI would then be calculated as the weighted average of these points using the Star Ratings measure weights and including only measures for which the contract met all of the inclusion criteria specified at §§ 422.166(f)(3)(iv) and 423.186(f)(3)(iv). The weighted average would be the weighted sum of points across all included measures divided by the weighted sum of the number of included measures. We proposed to use the weight for the measure in the current Star Ratings year. For example, if the HEI were being calculated using data from the 2026 and 2027 Star Ratings year, the measure weight used would be the weight for the 2027 Star Ratings. To ensure that the HEI is not driven by a very small number of measures for some contracts, we proposed at §§ 422.166(f)(3)(vi) and 423.186(f)(3)(vi) that a contract must meet the reliability and denominator criteria for at least half of the measures included in the HEI in order to have the HEI calculated for the contract. Contract performance on the HEI will vary from −1.0 (performance was in the bottom third for each included measure) to 1.0 (performance was in the top third for each included measure).
Table 3 is a high-level summary of the steps CMS proposed to take to calculate the HEI.
As discussed in the proposed rule, the HEI would be calculated separately for the overall and summary ratings, as we proposed at §§ 422.166(f)(3)(i) and 423.186(f)(3)(i), since the set of included measures differs for the overall, Part C summary, and Part D summary ratings. The HEI calculated for the overall rating would be based on all of the Part C and Part D measures that meet the inclusion criteria for the HEI for each MA-PD contract. The HEI for the Part C summary rating would include all of the Part C measures that meet the inclusion criteria for the HEI for the contract. The HEI for the Part D summary rating would be calculated separately for MA-PD (including cost) and PDP contracts and would include all of the Part D measures that meet the inclusion criteria for the HEI for the contract.
In order to qualify for an HEI reward, we proposed at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii) that contracts must have a minimum rating-specific HEI score of greater than zero. We also proposed a tiered HEI reward structure based on the percentage of enrollees in each contract who have the specified SRFs. Requiring both a minimum HEI score and a minimum percentage of enrollees in a contract with the specified SRFs is intended to avoid rewarding contracts that serve very few enrollees with the specified SRFs or do not perform well among enrollees with the specified SRFs relative to other contracts.
We proposed that contracts that have percentages of enrollees with any of the specified SRFs in a given year that are greater than or equal to one-half of the contract-level median percentage of enrollees with the specified SRFs up to, but not including, the contract-level median would qualify for one-half of the potential HEI reward. Contracts that have percentages of enrollees with any of the specified SRFs greater than or equal to the contract-level median would qualify for the full potential HEI reward. Table 4 is a high-level summary of how we proposed that the HEI score would be converted into the HEI reward.
We also considered an alternative non-tiered HEI reward structure, where all contracts with percentages of enrollees with any of the specified SRFs greater than or equal to one-half of the contract-level median would qualify for the full HEI reward. As we discussed in the proposed rule preamble, both the tiered and non-tiered HEI reward structures align with our goal of not rewarding contracts that may do well among enrollees with SRFs but serve very few enrollees in this population, although the tiered HEI reward structure goes further in aligning with this goal. The non-tiered HEI reward structure aligns better with the goal of ease of use and understanding for contracts and other stakeholders.
We proposed at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii) that the contract percentages of enrollees with SRFs included in the HEI would be based on enrollment in the most recent of the 2 years of data used to calculate the HEI. For example, if the HEI includes data from measurement years 2024 and 2025, the enrollment used would be from 2025. We recognize D-SNP only contracts would meet the enrollment thresholds under either the tiered or non-tiered HEI reward structure; however, other plans that do not initially meet the thresholds can also work to increase enrollment of people with SRFs to meet the enrollment thresholds. D-SNP only contracts would also need to perform sufficiently well among enrollees with the specified SRFs to qualify for a reward based on the HEI. One consideration in developing the proposed thresholds for the minimum percentages of enrollees with SRFs included in the HEI needed to qualify for an HEI reward was that higher thresholds could potentially create geographic barriers in certain parts of the country to qualifying for the HEI reward because there is variation by State in the percent of enrollees who are LIS/DE or disabled. Both the tiered HEI reward and non-tiered HEI reward structures account for this as all states have percentages of LIS/DE/disabled enrollees that are greater than one-half the contract-level median based on 2019 data, although the non-tiered structure goes further in addressing this concern, as many states do not have percentages of LIS/DE/disabled enrollees that are greater than the contract-level median. As specified at §§ 422.166(f)(3)(vii) and 423.186(f)(3)(vii) the contract-level median and half of the contract-level median would be calculated and assessed separately for MA (that is, Part C) and standalone Part D (that is, PDP) contracts.
Because enrollees in Puerto Rico are not eligible for LIS, we believe that a different approach is necessary for contracts with services areas wholly located in Puerto Rico. We proposed at §§ 422.166(f)(3)(vii)(A) and (B) and 423.186(f)(3)(vii)(A) and (B) to use a modified calculation to determine the percentage of enrollees with SRFs included in the HEI for contracts with service areas wholly located in Puerto Rico. We proposed to limit this treatment to contracts with service areas wholly in Puerto Rico because our analysis indicates that for plans with service areas that include Puerto Rico and other locations, only a small portion of the enrollment is in Puerto Rico. We proposed to estimate the number of enrollees with the specified SRFs in these contracts differently. We would start with the percentage of DE/disabled enrollees calculated from administrative data, and then add the estimated percentage LIS by taking the LIS/DE percentage calculated for the CAI for contracts with service areas wholly in Puerto Rico as described at §§ 422.166(f)(2)(vi) and (vii) and 423.186(f)(2)(vi) and (vii) and subtracting the percentage of DE enrollees. We need to estimate the number of LIS enrollees because LIS is not available in Puerto Rico; we would use the estimated LIS/DE information from the CAI calculations since these are the only data available on the estimated percentage of enrollees in Puerto Rico contracts that would qualify for LIS. We would then add the estimated LIS percentage to the DE/disabled percentage calculated from administrative data to get the LIS/DE/disabled percentage of enrollees in Puerto Rico. This calculation could result in a slight overestimate since some disabled enrollees may also be captured in the estimated LIS percentage; therefore, contracts with service areas wholly in Puerto Rico would be excluded from our calculations to determine one-half of the contract-level median and the contract-level median of enrollees with SRFs included in the HEI. We believe that this approach would ensure equitable treatment of contracts with service areas outside of Puerto Rico. In our simulations of the HEI, we found that the slight overestimate had little impact on whether contracts with service areas wholly in Puerto Rico met the one-half of the contract-level median or contract-level median thresholds.
We also proposed that contracts would need to have an HEI score greater than zero on the HEI calculated for the given rating (overall or summary rating) to qualify for a reward for that rating. We proposed at §§ 422.166(f)(3)(i) and 423.186(f)(3)(i) that the HEI score for the overall rating would include the applicable Part C and D measures, the HEI score for the Part C summary rating would include only the applicable Part C measures, and the HEI score for the Part D summary rating would include only the applicable Part D measures. An HEI score of greater than zero means that the contract on average scored in the middle third or better across measures included in the HEI for enrollees with the SRF(s). HEI scores closer to 1.0 indicate better performance for enrollees with the SRFs included in
We proposed at §§ 422.166(f)(3)(viii) and 423.186(f)(3)(viii) that the HEI reward would vary from 0 to 0.4 on a linear scale for contracts that meet the threshold for the median percentage of enrollees with SRFs included in the HEI, with a contract receiving 0 reward if the contract received a score of 0 or less on the HEI and a 0.4 reward if the contract received a score of 1 on the HEI. Similarly, the HEI reward would vary from 0 to 0.2 on a linear scale for contracts that meet the threshold for one-half of the contract-level median percentage of enrollees with SRFs included in the HEI, but do not meet or exceed the contract-level median percentage of enrollees with SRFs included in the HEI. Contracts that cannot have an HEI score calculated (that is, contracts that do not have reliable measure scores or do not meet the denominator criteria for at least half of the measures included in the HEI or contracts that do not have at least 500 enrollees) would not receive an HEI reward.
As an example, if a contract meets the contract-level median percentage of LIS/DE/disabled enrollees and receives an HEI score of 0.722325, this would translate on a linear scale to a reward of 0.288930. That is, the size of the HEI reward would equal 0.4 times the difference between the HEI score and the threshold, divided by the difference between the maximum HEI score and the threshold. In this example, this would be 0.4*(0.722325−0)/(1−0), which equals 0.288930. As another example, if a contract meets one-half the contract-level median percentage of LIS/DE/disabled enrollees but does not meet the contract-level median percentage of LIS/DE/disabled enrollees and receives an HEI score of 0.722325, this would translate on a linear scale to a reward of 0.144465. That is, the size of the HEI reward would equal 0.2 times the difference between the HEI score and the threshold, divided by the difference between the maximum HEI score and the threshold. In this example, this would be 0.2*(0.722325−0)/(1−0), which equals 0.144465. The HEI reward would be rounded and displayed with 6 decimal places similar to how the CAI values are displayed.
As we proposed at §§ 422.166(f)(3)(ix) and 423.186(f)(3)(ix), once each of the HEI rewards are calculated, the applicable HEI reward would be added to the unrounded overall and Part C and D summary ratings after the addition of the CAI and the application of the improvement measures described in §§ 422.166(g)(1) and 423.186(g)(1) and before the final overall and Part C and D summary ratings are calculated by rounding to the nearest half star. For example, if the HEI reward was 0.288930, as previously described in the example, and the unrounded overall rating was 4.234210 after the addition of the CAI and the application of the improvement measure hold harmless rule, the unrounded overall rating would be 4.523140 (4.234210 + 0.288930) resulting in a final, rounded overall rating of 4.5.
We also proposed changes in the following sections to revise references to the existing reward factor or to limit application of the current reward factor to the Star Ratings through the 2026 Star Ratings: §§ 422.166(c)(1), 422.166(d)(1) 422.166(f)(1), 422.166(f)(2)(i), 422.166(g)(1), 423.186(c)(1), 423.186(d)(1) 423.186(f)(1), 423.186(f)(2)(i), and 423.186(g)(1). We proposed that the new HEI reward would be implemented for the 2027 Star Ratings covering primarily the 2024 and 2025 measurement years. The existing reward factor would continue to be calculated through the 2026 Star Ratings.
We simulated the impact of removing the current reward factor and adding the proposed HEI reward and summarized those results in the proposed rule. In simulations using data from the 2020 and 2021 Star Ratings,
We solicited comments on these proposals.
The HESS is a quality improvement tool developed by the CMS Office of Minority Health with a similar goal of improving health equity. The HESS differs from the HEI developed for the Part C and D Star Ratings program in that it currently focuses on CAHPS and HEDIS measures, while the HEI focuses on a broader set of measures included in the Part C and D Star Ratings. The HESS examines differences by race and ethnicity and LIS/DE status and assigns each contract composite scores for CAHPS and HEDIS (translated to diamonds, ranging from 1-5, with 5 being the best) based on a combination of current performance and improvement in performance over a four-year period. The HEI only requires two years of data and focuses on the specified SRFs. The HESS is separate from the Part C and D Star Ratings program and has no link to payment.
For a contract's HEI score, measures are included if the two criteria in paragraphs (f)(3)(iv)(A) and (B) are met. To meet the measure-level denominator and reliability criteria, a measure for a contract must have a reliability of at least 0.7 and meet the measure denominator requirement when calculated for the subset of enrollees with the specified SRFs across the two years of data. These criteria for determining when a measure would be used for a contract's HEI score are necessary to ensure the HEI is reliably calculated for each contract.
The current reward factor was included in the Part C and Part D Star Ratings program beginning with the 2009 Star Ratings with the purpose of creating additional incentives for high and stable relative performance across measures by discouraging contracts from having a lot of variation in performance across measures (that is, a mix of low performance and high performance across measures). At the beginning of the Star Ratings program, the distribution of ratings across contracts looked very different, with overall performance much lower than it is today. At that time, 38 percent of MA contracts received less than 3 stars for the Part C summary rating (the overall rating was not implemented yet at that time). Over time, we have established additional methodological enhancements to incentivize performance improvement across measures, such as the addition of the Health Plan Quality Improvement and the Drug Plan Quality Improvement measures as described at §§ 422.164(f) and 423.184(f). MA organizations have also responded to the incentive to perform well across measures as a result of the link between Star Ratings and QBP ratings for MA contracts. As contract performance has improved and stabilized over time, different incentives are needed to continue to drive quality improvement so that all Medicare beneficiaries are receiving high quality care. CMS believes that even with the removal of the current reward factor from the Star Ratings methodology, contracts will still have incentives to perform well and improve because high performance on individual Star Ratings measures, including the Health Plan Quality Improvement and the Drug Plan Quality Improvement measures, translates into better overall and summary ratings.
As noted in the April 2018 final rule, the Star Ratings are designed to provide information to beneficiaries that is a true reflection of plan quality and encompasses multiple dimensions of high quality care. The goals of the Star Ratings are to publicly display quality information to inform plan choice, to provide information for public accountability, incentivize quality improvement, provide information to oversee and monitor quality, and accurately measure and calculate scores and stars to reflect true performance. (83 FR 16519). QBPs, as defined in § 422.260(b), tie increases in payment benchmarks and rebate percentage to providing high quality care, as reflected in quality ratings and performance data. CMS's goal is to continue to evolve the Star Ratings methodology over time to ensure that the methodology encourages continued improved plan performance across beneficiaries.
In simulations using data from the 2023 Star Ratings, even before factoring in the HEI reward, the majority of contracts (80 percent of MA and cost contracts, and 82 percent of PDP contracts) would have no change in their overall rating as a result of taking away the reward factor, and no contracts would lose QBPs. Simulations replacing the current reward factor with the HEI reward using data from the 2021 Star Ratings show that no contracts would lose QBPs and only 9.4 percent of contracts would lose rebate dollars. Further, we note that the reward factor should not be seen as an extra funding source; removing the reward factor supports our efforts to continue to evolve the Star Ratings program to incentivize improved plan performance for all enrollees. We did not consider a transition or blend to use both the current reward and the new HEI reward over a period of time because that approach would dilute the impact of the health equity incentives and be methodologically complex to implement. Based on this, we are finalizing the proposed removal of the current reward factor with additional revisions to the regulation text at §§ 422.162(b)(1) and 423.182(b)(1) and to the definition of “highly rated contract” in §§ 422.162(a) and 423.182(a) to remove references to the current reward factor.
In the CY 2023 Advance Notice, we solicited feedback on the use of the ADI in the HEI reward methodology. At that time there was limited support for adding the ADI to the index. A number of concerns were raised, including that the ADI does not always reflect some of the more deprived areas; it does not adequately distinguish between areas that have both extreme poverty and extreme wealth; and it is not fully representative of systemic disparities for historically marginalized communities. There was also concern that including the ADI may create incentives for plans to focus on certain geographic areas versus focusing on improving care for those with the greatest needs.
The SVI was designed to identify communities at increased risk of negative impacts from natural disasters and infectious disease outbreaks that require community-level response and is calculated at both the census tract and county level. Similar to other geography-based measures of social risk, the SVI is constructed using census data on socioeconomic status, household composition and disability, minority status and language, and housing and transportation characteristics. The Social Deprivation Index (SDI) was developed to identify the extent of disadvantage in small geographic areas and assess the association of level of disadvantage with health outcomes and health inequities. The SDI is a composite of sociodemographic characteristics, including poverty, education, unemployment, housing characteristics, household composition, and car ownership.
Similar to our goals for the HEI reward in terms of creating incentives for MA plans, cost plans, and Part D plan sponsors to perform well among enrollees with certain SRFs, the MSSP adopted a health equity adjustment that will upwardly adjust an ACO's quality performance score to reward high quality performance across all populations served by an ACO; encourage all ACOs to treat underserved populations; provide an incentive for ACOs to provide high quality care to all of the populations they serve; and ensure there are not incentives for ACOs to avoid underserved populations as CMS transitions to all-payer eCQMs/MIPS CQMs as described at 87 FR 69839.
Additionally, based on current data, few contracts that do not meet the percentage of enrollees with the specified SRFs threshold serve a large number of LIS/DE/disabled enrollees. In simulations using data from the 2021 Star Ratings data, we see that, on average, 15 percent of enrollees are LIS/DE/disabled in MA and cost contracts that do not meet the minimum percentage of LIS/DE/disabled enrollees to be eligible for the HEI reward; 5 percent of enrollees are LIS/DE/disabled in PDP contracts that do not meet the minimum percentage of LIS/DE/disabled enrollees to be eligible for the HEI reward. Thus, most contracts that do not meet the percentage of enrollees with the specified SRFs threshold would also not meet a threshold based on a number of enrollees with the specified SRFs. Additionally, we note that contracts that serve a low percentage of LIS/DE/disabled enrollees tend to perform well in Star Ratings. Contracts are not penalized for not meeting the percentage of enrollees with the specified SRFs threshold. As the HEI reward only has an upside, we expect that these contracts will continue to perform well even if they do not qualify for the HEI reward. Contracts will still have the HEI score calculated and will be able to see how they perform on the HEI even if they do not meet the enrollment thresholds. To prepare health plans for implementation of the HEI reward, CMS will calculate the HEI reward beginning with the 2024 Star Ratings and will share the results in confidential contract-level reports in HPMS.
CMS does not intend to display these results as display measures. Since the HEI is not a measure, we believe that sharing the information through HPMS will allow us to provide contracts with more detailed information about the HEI for their quality improvement efforts. Sections 422.164(c)(3) and (d)(2) and 423.184(c)(3) and (d)(2) require only new measures and measures with substantive specifications changes to be on the display page for two years prior being in the Star Ratings. Historically, we have not displayed methodological changes on the display page since it would be confusing to the public to have two sets of ratings, one on Medicare Plan Finder on
In simulations using data from the 2021 Star Ratings, the percent of enrollees who have the specified SRFs for the HEI (that is LIS/DE/disability status) is 15 percent for MA and cost contracts and 5 percent for PDPs that do not meet the enrollment threshold to be eligible for a reward (that is, one-half of the contract-level enrollment median); 28 percent for MA and cost contracts and 10 percent for PDPs that meet one-half of the contract-level median up to but not including the median; and 61 percent for MA and cost contracts and 37 percent for PDPs that meet the median enrollment threshold. The percent of enrollees who are LIS/DE/disabled is 42 percent for MA and cost contracts and 13 percent for PDP contracts that received an HEI reward (that is, met an enrollment threshold to be eligible for a reward and received an HEI score of greater than zero).
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the removal of the reward factor and addition of the HEI reward to the 2027 Star Ratings as proposed, with additional revisions to §§ 422.162(a) and 423.182(a) to modify the definition of “highly-rated contract” to remove references to CAI and reward factor and to instead reference applicable adjustments in §§ 422.166(f) and 423.186(f); to §§ 422.162(b)(1) and 423.182(b)(1) to remove references to the current reward factor and to instead reference applicable adjustments in §§ 422.166(f) and 423.186(f); and to §§ 422.166(f)(3)(i)(B) and 423.186(f)(3)(i)(B) to clarify that, for purposes of calculating the HEI, measure-level scores are used for contracts that have data for only the most recent year of the 2 years, but measure-level scores are not used for contracts that have data for only the first of the 2 years. We are finalizing changes to the following sections to revise references to the reward factor or to limit application of the current reward factor to the Star Ratings through the 2026 Star Ratings: §§ 422.166(c)(1), 422.166(d)(1) 422.166(f)(1), 422.166(f)(2)(i), 422.166(g)(1), 423.186(c)(1), 423.186(d)(1) 423.186(f)(1), 423.186(f)(2)(i), and 423.186(g)(1). We are also finalizing the addition of the HEI reward at §§ 422.166(f)(3) and 423.186(f)(3).
Currently, the Star Rating for each non-CAHPS measure score is determined by applying a clustering algorithm to the numeric value scores from all contracts required to submit the measure. The cut points for non-CAHPS measures are derived from this clustering algorithm. As discussed in the April 2019 final rule and described at §§ 422.166(i)(9), 422.166(i)(10), 423.186(i)(7), and 423.186(i)(8), we exclude from this clustering algorithm and from the reward factor calculations (under §§ 422.166(f)(1) and 423.186(f)(1)) the numeric values for affected contracts with 60 percent or more of their enrollees in Federal Emergency Management Agency (FEMA) designated Individual Assistance areas at the time of an extreme and uncontrollable circumstance (84 FR 15776-15777). Affected contracts are contracts that meet all of the criteria in §§ 422.166(i)(1) and 423.166(i)(1). We generally call this the “60 percent rule” to distinguish it from the adjustments provided under §§ 422.166(i) and 423.186(i) for affected contracts with 25 percent or more of their enrollment residing in a FEMA-designated Individual Assistance area at the time of the extreme and uncontrollable circumstance.
This exclusion ensures that any impact of the extreme and
We proposed to limit to the 2025 and earlier Star Ratings, application of the rule at §§ 422.166(i)(9)(i), 422.166(i)(10)(i), 423.186(i)(7)(i), and 423.186(i)(8)(i) that excludes numeric values for affected contracts with 60 percent or more of their enrollees residing in FEMA-designated Individual Assistance areas at the time of an extreme and uncontrollable circumstance from cut point calculations and reward factor determinations. During the COVID-19 pandemic, we adopted a change to remove these rules temporarily since all contracts qualified for the extreme and uncontrollable circumstances policy as a result of COVID-19 in 2020; this change was adopted in the interim final rule titled “Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” which appeared in the
Beginning with the 2024 Star Ratings, measure scores that are extreme outliers will be removed through Tukey outlier deletion, a standard statistical method to remove extreme outliers, as codified at §§ 422.166(a)(2)(i) and 423.186(a)(2)(i), prior to applying the clustering methodology to determine the cut points. The combination of mean resampling (implemented with the 2022 Star Ratings and described at §§ 422.166(a)(2)(i) and 423.186(a)(2)(i)) and Tukey outlier deletion will alleviate the impact of any extreme outliers. Thus, if a contract is impacted by an extreme and uncontrollable circumstance and as a result has a significantly lower score on a measure, the score will be removed if it is an extreme outlier. Removing extreme outliers will eliminate the concern that other contracts are inappropriately impacted by changes in scores for contracts impacted by disasters. By removing the 60 percent rule, we will also simplify the Star Ratings calculations and continue to allow measure-level Star Ratings to be calculated if all or most contracts qualify for an extreme or uncontrollable circumstance in the future.
We proposed to amend §§ 422.166(i)(9)(i), 422.166(i)(10)(i), 423.186(i)(7)(i), and 423.186(i)(8)(i) to remove the 60 percent rule beginning with the 2026 Star Ratings for non-CAHPS measures, including the HOS measures, even though the measurement period is slightly different for these measures. We solicited comments on this proposal.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the revision at §§ 422.166(i)(9)(i), 422.166(i)(10)(i), 423.186(i)(7)(i), and 423.186(i)(8)(i) to remove the 60 percent rule beginning with the 2026 Star Ratings for non-CAHPS measures as proposed without modification.
We adopted regulations for how Star Ratings would be calculated in the event of extreme and uncontrollable circumstances in the April 2019 final rule. We explained in the April 2019 final rule (CMS-4185-F) that for most measures, the extreme and uncontrollable circumstance adjustment applies for disasters from 2 years prior to the Star Ratings year (that is, a disaster that begins
We solicited comments on this proposal.
For Part C measures derived from HOS, the disaster adjustment is three years after the extreme and uncontrollable circumstance. That is, contracts affected by an extreme and uncontrollable circumstance in the year prior to data collection are essentially “held harmless” and receive the higher of the previous or current year's Star Rating for each HOS and HEDIS-HOS measure (and corresponding measure score) for the Star Ratings 3 years after the eligible extreme and uncontrollable circumstance. For example, contracts affected by an extreme and uncontrollable circumstance in 2021 will receive the higher of their 2023 or 2024 measure-level Star Rating (and corresponding measure score) for each HOS and HEDIS-HOS measure in the 2024 Star Ratings as described at § 422.166(i)(3)(iv).
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the clarification at § 422.166(i)(3)(iv) as proposed without modification.
In the June 2020 final rule, we finalized use of Tukey outlier deletion effective for the Star Ratings issued in October 2023 and subsequent years. (85 FR 33833-36). In the rulemakings since that time, we have not proposed to eliminate the Tukey outlier deletion aspect of the Star Ratings methodology. In a final rule that appeared in the
We solicited comments on this proposal.
In addition, the June 2020 final rule adopting the Tukey outlier deletion step in the Star Ratings methodology (85 FR 33891-33893) adequately discussed the cost estimates for the implementation of Tukey outlier deletion. Those estimates were projected based on initial implementation for the 2024 Star Ratings, which the regulation text adopted in this rule at §§ 422.166(a)(2)(i) and 423.186(a)(2)(i) provides for, so the projected cost analysis remains relevant and accurate. We still measure performance in the same way at the measure-level and calculate the Star Ratings in a similar manner. We believe more recent data from 2020 and 2021 performance years would be less useful to simulate the impact of the Tukey outlier deletion process in future years. First, the performance data from the early years of the pandemic have been more impacted by COVID-19, and we would expect that there would be more fluctuations in scores during this time, including potentially more outliers. Second, some of the changes we made to the Star Ratings to account for the uncertainties caused by COVID-19, including expanding the existing hold harmless provision for the Part C and D improvement measures to include all contracts for the 2022 Star Ratings,
Additionally, we compared year over year stability of thresholds between simulations that included outlier deletion and simulations that did not remove outliers (without guardrails). The changes in thresholds between 2022 and 2023 were much smaller when outliers were removed as compared to when they were not removed. For 10 of the 20 non-CAHPS Part C measures, there were thresholds that changed by more than 5 percentage points if outliers were not removed, whereas only 5 measures had this property when outliers were removed. Outlier deletion does stabilize Part C cut points, and results in more year-to-year stability when outliers are deleted compared to simulations that do not use outlier deletion. For MA-PD contracts, 4 of 9 Part D measures had thresholds that change by more than 5 percentage points if outliers are not removed compared to only 2 measures with thresholds that change by more than 5 percentage points if outliers were removed. Outlier deletion stabilizes Part D cut points for MA-PD contracts, and results in more year-to-year stability when outliers are deleted compared to simulations that do not use outlier deletion. Outlier deletion had a smaller effect on Part D thresholds for PDP contracts.
Tukey outlier deletion refines measurement by ensuring cut points reflect true variation in performance and are not unduly influenced by low or high performance of a few outlying contracts. Lessening the influence of outliers on cut point formation leads to more reliable and stable cut points.
After considering the comments we received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the technical amendment to fix the Tukey outlier deletion codification error from the May 2022 final rule and the non-substantive technical change to move the sentence about removal of Tukey outer fence outliers earlier in §§ 422.166(a)(2)(i) and 423.186(a)(2)(i), since Tukey outlier deletion is applied prior to the other steps. The Tukey outlier deletion will be applied beginning with the 2024 Star Ratings.
Sections 1894(a)(9) and 1934(a)(9) of the Act define the trial period for PACE organizations as the first 3 contract years operating a PACE program under a PACE program agreement. Sections 1894(e)(4) and 1934(e)(4) of the Act require CMS, in cooperation with the State administering agency, to conduct a comprehensive annual review of the PACE organization's operation of the PACE program during the trial period to assure compliance with all significant requirements. The rule titled “Medicare and Medicaid Programs; Programs of All-Inclusive Care for the Elderly (PACE)”, which appeared in the November 24, 1999 issue of the
As discussed in the proposed rule (87 FR 79635), CMS is required to conduct comprehensive reviews during a PACE organization's trial period to assess all significant regulatory requirements, and these reviews must be conducted on an annual basis for the first 3 contract years. CMS must conduct the first trial period review (for example, audit) within the first contract year in order to comply with the statutory and regulatory requirements. However, CMS's ability to schedule and conduct the first trial period audit is limited by when a PACE organization enters into a program agreement, when the PACE organization begins enrolling participants during their first contract year, and the initial contract year timeframe in the current contract year definition in § 460.6. The timing of the initial contract year audit impacts the timing of subsequent audits, leaving CMS with increasingly narrow timeframes to audit within statutory and regulatory requirements.
We proposed to amend the definition of contract year at § 460.6 to state that a PACE organization's initial contract year may be 19 to 30 months, as determined by CMS, but in any event will end on December 31. Under the proposed contract year definition, although the duration of the initial contract year of the trial period would change, the initial contract year would continue to begin when the program agreement goes into effect on the first day of the relevant month and end on December 31 to ensure subsequent contract years follow the standard annual calendar year cycle. For PACE organizations with an initial contract year start date of January 1 through June 1, CMS would extend the initial contract year through the following year, and for PACE organizations with an initial contract year start date of July 1 through December 1, CMS would extend the initial contract year through the second succeeding year.
The proposed rule solicited comment on whether we should consider a different timeframe for the initial contract year, such as 25 to 36 months.
As explained in the proposed rule at 87 FR 79636, we do not believe revising the definition of contract year as proposed would create any additional burden for PACE organizations, as the effect of the proposed change would be to provide CMS with more flexibility when scheduling initial trial period audits without placing new requirements on CMS or PACE organizations, and we do not anticipate that the proposed change would have an impact on the Medicare Trust Fund.
In the final rule titled “Medicare and Medicaid Programs; Programs of All-Inclusive Care for the Elderly (PACE)” (84 FR 25610), which appeared in the June 3, 2019 issue of the
In circumstances where CMS has made a determination under § 460.50 that could lead to termination, CMS
As previously stated, in order for CMS to take any enforcement action (CMP, suspension of enrollment or payment, termination) on a PACE organization based on the grounds for termination set forth in § 460.50(b), the PACE organization must fail to develop and successfully initiate a plan to correct the deficiencies, or fail to continue implementation of the plan of correction within 30 days of receiving notice. Given that CMPs and suspensions of enrollment and/or payment are corrective in nature and imposed prior to termination, CMS believes that providing PACE organizations an opportunity to correct prior to imposing a CMP or suspensions of enrollment and/or payment is unnecessary and most importantly an impediment to CMS' ability to protect PACE participants from potential harm.
For these reasons, we proposed to revise § 460.40(b) by adding the following: “If CMS or the State administering agency determines that the circumstances in § 460.50(b)(1) exist, neither CMS nor the State administrating agency has to determine that the circumstances in 460.50(b)(2) exist prior to imposing a CMP or enrollment and/or payment suspension.”
We received comments on the following topics which were outside the scope of our proposal and to which we are therefore not responding: (1) the circumstances that exist prior to CMS imposing an enforcement action; and (2) the thresholds CMS uses in determining whether to impose an enforcement action.
After consideration of the comments received, we are finalizing our proposed changes to § 460.40(b) without modification.
As discussed in the proposed rule at 87 FR 79646, CMS originally included a list of required medical specialties at § 460.92 as part of the 1999 PACE interim final rule. The proposed rule explained that, in the 2006 final rule, CMS removed the list of medical specialties that appeared at § 460.92 based on the rationale that it was not possible to include an exhaustive list of all required services in PACE in the regulation and that PACE organizations might misconstrue the omission of any medical specialty from the list of required services at § 460.92 to mean that that type of specialty service was not required (
As explained in the proposed rule, we have seen through our monitoring and oversight efforts that some PACE organizations are not providing timely access to medical specialists (87 FR 79646). The proposed rule noted that we have found through our oversight activities that delays in accessing medical specialists sometimes occur as a result of PACE organizations not having contracts in effect for the medical specialties commonly utilized by PACE participants (
While we proposed to add a list of medical specialty services back into the PACE regulations, we continue to maintain that this is not an exhaustive list of all medical specialists that the PACE organization may be required to provide access to. For example, if the IDT determines that a participant needs to see a hematologist, the PACE organization would be required to provide access to that specialist in a timely manner. The specialties we proposed to add in § 460.70(a)(1) would represent a minimum requirement for all PACE organizations; each PACE organization should consider the needs of its participants to determine what additional medical specialists may be necessary for its network to be sufficient. While we proposed to add back into regulation the 25 medical specialty services identified in the original PACE protocol, we solicited comment on whether CMS should include the following additional specialty services in the list of minimum required services: endocrinology, hematology, immunology, neurology, colorectal surgery, palliative medicine, infectious disease, physical medicine and rehabilitation. Additionally, we solicited comment on whether the proposed list of medical specialties should include any types of behavioral health specialties in addition to psychiatry such as psychologists or licensed clinical social workers. When submitting comments on this proposal, we requested that commenters indicate whether they have any concerns with CMS adding any or all of the previously discussed specialty services to the list, and that commenters describe any such concerns with specificity to help us understand the nature and basis of those concerns. We believe a PACE organization must be able to provide access to all of these specialty services when a participant needs them and, based on our oversight experience, that additional specialty services are often necessary for the PACE population.
We proposed at new § 460.70(a)(2) to require a PACE organization to execute contracts with specialists prior to enrollment of participants, and to require the PACE organization to maintain such contracts on an ongoing basis to ensure participants receive appropriate and timely access to all necessary care and services. We clarified that we are not requiring PACE organizations to contract with individual specialists in situations where the PACE organization has contracted with a provider or practice that offers multiple specialties. In an instance of a medical provider or practice offering multiple specialties, the contract between the practice or provider, such as a hospital group, and the PACE organization would meet the requirement to have contracts in place for whatever specialties are included under the contract between the practice or provider group and the PACE organization. In the event a hospital group only contracts with a PACE organization to provide some of the specialty services it offers within its practice, the PACE organization would be expected to contract separately for any services not covered under the contract.
We believe it is appropriate for PACE organizations to be able to demonstrate that they have contracts in place that provide participants with sufficient and direct access to these commonly needed specialists prior to participants enrolling in the organization, and that PACE organizations maintain sufficient and direct access to these commonly needed specialists for enrolled participants on an ongoing basis. Through our auditing and oversight efforts, we have seen lengthy delays in specialist referrals when an organization has to contract with a new specialist, and waiting until a participant enrolls or has need of the specialist may create unreasonable delays in the participant being able to access that specialist. Additionally, as we noted in the 2006 PACE final rule (71 FR 71296), PACE organizations are financially responsible for all of their participants' health care needs, and delays in referrals for specialist services may have a significant impact on the PACE organization's financial viability. Failure to provide timely specialist referrals may lead to more expensive care, including the need for institutionalization, which can drive up operating costs for a PACE organization.
We proposed to establish at § 460.70(a)(3) that a PACE organization must make reasonable and timely attempts to contract with medical specialists. PACE organizations are responsible for ensuring that participants have reasonable and timely access to medical specialty services, and that PACE organizations are responsible for taking appropriate steps in ensuring that they have suitable contracts in place in order to facilitate timely access to medical specialty services. We did not propose to establish specific criteria for determining whether “reasonable” attempts have been made for purposes of proposed § 460.70(a)(3), as what is reasonable would depend on the facts and circumstances of the case. For example, in an area with multiple providers in a specific medical specialty, it would not be reasonable to only attempt to contract with a single provider, if that provider indicated they were unwilling to contract with the PACE organization.
We further proposed to establish at § 460.70(a)(3)(i) that if at any time a PACE organization is unable to directly contract with a specific entity to provide specialist services to participants, the PACE organization must still ensure ongoing access to necessary care and services that would otherwise be provided to participants by a contracted specialist, and that the participant's needs are met, through a different mechanism which may include hospitalization. As noted in the 2006 PACE final rule (71 FR 71296), we understand that in certain circumstances executing multiple contracts for a specific specialty may be difficult due, in part, to a limited number of specialists in certain geographic areas; however, we stress that PACE organizations continue to be responsible for meeting all of the participant's needs, even if there is not a direct contract in place. Additionally, under our proposal at § 460.70(a)(3)(ii) we expect an organization to promptly report any contracting problems to CMS and the SAA, and include information on what attempts were made, the reason why a contract was not effectuated, and the PACE organization's plan to provide access to the necessary services. This reporting may be initiated by the PACE organization when reasonable attempts to contract have been made, and were unsuccessful; or it may be done in response to CMS or the SAA inquiring as to the status of the contracts. For example, during the State readiness review, the SAA may inquire as to the status of the PACE organization's contracts with medical specialists. When reporting these contracting issues to CMS or the SAA, the PACE organization should be prepared to
Finally, in order to account for PACE organizations that may choose to employ some medical specialists directly, such as dentists and podiatrists, proposed § 460.70(a)(4) exempts a PACE organization from the contract requirements in § 460.70(a)(1) and (2) with respect to a particular medical specialty if a PACE organization employs one or more individuals prior to contracting who are legally authorized and, if applicable, board certified, in that medical specialty. While we generally expect that PACE organizations would have contracts in place for most of the specialties in this list, we understand that there are times when a PACE organization may directly employ a provider in one of the listed specialties. In those instances, assuming the participants have sufficient access to the type of specialist that is employed by the PACE organization, the PACE organization would not be required to contract with additional providers in that specialty. However, the organization must have the specialist actively employed prior to enrollment of participants in order for the exception to be met and cannot rely on future employment to satisfy this requirement. We believe that by modifying this provision as proposed we would not increase the burden on PACE organizations as they are already required to either obtain and maintain contracts with or employ medical specialists.
While we do not believe that telehealth services are prohibited in PACE, PACE organizations must ensure that all other regulatory requirements are met when providing services in that manner. For example, decisions to provide a service must be based on the participant's current medical, physical, emotional, and social needs as required under § 460.92(b)(1). When considering the participant's condition, the IDT should also consider the service in question. The IDT may determine telehealth is appropriate for one participant in one situation, but not another participant based on the participant's condition. For example, a dental visit would very rarely be appropriate for telehealth services; however, a behavioral health visit may be appropriate depending on the participant's condition. Additionally, the PACE organization would have to ensure all other regulatory requirements are met, including contracting requirements for telehealth providers, and the PACE organization would not be able to utilize telehealth for services that are specifically required to be in-person per the regulations, such as routine assessments under § 460.104.
Additionally, if a PACE organization determines that a participant needs a service, and the PACE organization does not have a long-term contract in place, organizations may utilize flexibilities such as Letters of Agreement or Memoranda of Understanding with out-of-network providers, in order to ensure participants have access to the care and services they need.
Additionally, in the proposed rule, we identified neurosurgery as one of the 25 required medical specialties; however, it was inadvertently left out of the proposed regulation text. We are therefore adding it back in to the regulation text at § 460.70(a)(1)(x).
The meaning of “timely access to services” also depends on the facts and circumstances of each case and the participant's condition and assessed needs. The PACE organization will need to consider the nature of the participant's condition and the urgency with which it must be treated when determining what constitutes “timely access to services.”
We also acknowledge that specialty provider availability continues to be a struggle across some health care settings. However, because of the time and effort required in negotiating contracts, we believe it is best practice to complete contract negotiations prior to participant enrollment to reduce additional delays in receiving services and that it is imperative for PACE organizations to maintain contracts on an ongoing basis to mitigate delays in participants receiving timely care.
After consideration of the comments received and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the changes at § 460.70(a)(2), (3), and (4) as proposed. We are finalizing the changes at § 460.70(a)(1) with two slight modifications: first, by adding neurosurgery, which was inadvertently left out of the proposed regulation text, and second, by adding palliative medicine to the list of required contracted services.
Sections 1894(b)(2)(B) and 1934(b)(2)(B) of the Act specify that PACE organizations must have in effect written safeguards of the rights of enrolled participants, including procedures for grievances and appeals. Along with the regulations at § 460.120 related to grievances, and § 460.122 related to appeals, CMS created a process for service determination requests, the first stage of an appeal, at § 460.121, including the extension requirements as specified in § 460.121(i)(1). In the February 2020 proposed rule (85 FR 9002), CMS proposed to add a requirement at § 460.121(i)(2) that required, in part, that the IDT notify the participant or the designated representative of a service determination request extension in writing. The proposed requirement was based on the MA organization determination requirements in § 422.568, which require written notification when an extension is taken. In response to our proposal, PACE organizations and industry advocacy groups recommended we modify the proposal to allow either oral or written notification when the IDT extends the timeframe for a service determination request, rather than requiring written notification only. When CMS responded to these comments in the January 2021 final rule, we expressed that we were not persuaded to modify the requirement to allow PACE organizations to notify participants orally instead of in writing, because we believed written notification of the extension was important in order to ensure the participant received a full explanation (86 FR 6022), and as a result, we finalized our proposal to require that the IDT notify the participant or their designated representative in writing when the IDT extends the timeframe for a service determination request.
As discussed in the December 2022 proposed rule preamble (87 FR 79670), since finalizing this requirement in the January 2021 final rule (86 FR 5864), CMS has received additional feedback from PACE organizations, particularly
Therefore, we proposed to revise the requirement at § 460.121(i)(2) to allow the IDT to provide notification either orally or in writing to the participant or their designated representative when the IDT extends the timeframe for a service determination request, as permitted under § 460.121(i)(1) (87 FR 79670). Additionally, the proposed rule discussed that allowing the IDT to provide either oral or written notice of service determination request extensions increases operational flexibility for PACE organizations (87 FR 79670).
As stated in the proposed rule (87 FR 79670), in order to ensure participants are fully informed of the reason(s) for an extension, CMS would expect oral notice of the service determination request extensions to meet the same requirements as written notice, including the expectations that notices will explain the reason(s) for the delay and be issued as expeditiously as the participant's condition requires, but no later than 24 hours after the IDT decides to extend the timeframe. CMS would expect that PACE organizations document the content of oral notifications of service determination request extensions in accordance with § 460.121(m). An IDT may choose to provide the extension notification both orally and in writing if it believes that is necessary to ensure the participant's understanding.
We estimate ongoing burden reduction due to the expected decrease in written notifications of service determination request extensions in favor of oral notification. We discuss and account for the burden reduction resulting from the expected decrease in written notification of service determination request extensions in the Collection of Information Requirements section. We will submit these changes to OMB for approval under control number 0938-0790 (CMS-R-244).
Under sections 1894(b) and 1934(b) of the Act, PACE organizations are required to provide all items and services covered under Medicare and Medicaid, and all additional items and services specified in regulations and determined necessary by the interdisciplinary team to improve and maintain the participant's overall health status. Currently, PACE organizations are required to safeguard data and records in accordance with § 460.200(d). PACE organizations must also maintain a single comprehensive medical record for each participant in accordance with accepted professional standards (§ 460.210(a)(1)).
In the February 2020 proposed rule (85 FR 9002), CMS proposed to add a new requirement at § 460.200(d)(2) for PACE organizations to maintain in the medical record all written communications received from participants or other parties in their original form when the communications relate to a participant's care, health, or safety in accordance with § 460.210(b)(6). We explained in that proposed rule that we had found through our monitoring of PACE organizations that they do not always maintain and safeguard important records such as communications related to a participant's care from family members, caregivers, and the participant's community (85 FR 9134). We stated that maintaining a comprehensive, complete, and accurate medical record allows a PACE organization to remain alert to all information that is relevant to a participant's care, health and safety, and to provide appropriate and timely care to the participant (85 FR 9140). Therefore, we also proposed a new requirement at § 460.210(b)(6) for PACE organizations to maintain in a participant's medical record original documentation of any written communication the PACE organization receives relating to the care, health or safety of a participant, in any format (for example, emails, faxes, letters, etc.) and including, but not limited to (i) communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participant's health or safety or both; and (ii) communications from an advocacy or governmental agency such as State-based Adult Protective Services.
In the January 2021 final rule, CMS summarized and responded to the comments received on these proposed record maintenance requirements (86 FR 6039 through 6040). We noted that some commenters recommended we allow PACE organizations to maintain original communications
Participants, their family members, and representatives have a longstanding right to file a grievance expressing dissatisfaction with the delivery of PACE services or the quality of care furnished as part of the PACE benefit package (see §§ 460.112(g)(1) and 460.120). A PACE organization must have a formal written process to evaluate and resolve medical and non-medical grievances by PACE participants (§ 460.120(a)). A PACE organization's grievance process must include a written procedure for maintaining the confidentiality of a participant's grievance (§ 460.120(c)(4)).
PACE participants routinely file grievances with a PACE organization under the assumption that the details of their grievance will be kept confidential. This is especially important to PACE participants when a grievance involves a particular staff member of the PACE organization (for example, a home care aide, a driver, or a specific member of the interdisciplinary team). PACE organizations have typically maintained confidentiality of this information by only allowing access to the information, that is, the details of the complaint, to a limited number of PACE organization staff and/or by storing this information outside of the medical record in a secure location (for example, a separate electronic application or paper-based system).
Since we finalized the January 2021 final rule, PACE organizations have had an opportunity to implement this provision, and we have continued to receive questions related to maintaining original communications in the medical record. These questions and comments indicate that as PACE organizations have begun to operationalize this requirement, they have been challenged with maintaining the confidentiality of grievances and managing the volume of these communications in the medical record. Other inquires include whether it would be permissible for PACE organizations to scan communications and store them electronically in the medical record.
In addition to the concerns around maintaining the confidentiality of grievances, PACE organizations have also pointed out that there are instances when written communications sent to the PACE organization by the individuals and entities listed at § 460.210(b)(6)(i) and (ii) may contain sensitive information about a PACE participant, their caregivers, and/or family members, and that these communications are often accompanied by a request to keep the information private. For example, information shared with a PACE organization may pertain to a caregiver's health, and may have implications for the participant's care, and the caregiver may only want the details of this information shared among employees and contractors who need to know the information rather than all individuals with access to the participant's medical record. There are also instances when the communications include contents or language that may be inappropriate for inclusion in the medical record, such as vulgar comments directed towards individual PACE staff. PACE organization staff have indicated that maintaining written communications related to participant grievances in the medical record allows access to the information by all PACE organization staff, thereby jeopardizing the confidentiality of such communications, and have therefore requested clarification from CMS on how to adhere to comply with the requirement in § 460.210(b)(6) when the original communication is part of a participant grievance and contains sensitive or confidential information.
Sections 1894(f)(3) and 1934(f)(3) of the Act provide authority for the establishment of certain additional beneficiary and program protections applicable to MA and Medicaid managed care programs under prepaid capitation agreements under section 1903(m) of the Act. Sections 1894(b)(2) and 1934(b)(2) of the Act require that the PACE program agreement have written safeguards of the rights of enrolled participants, including a bill of rights and procedures for grievances and appeals, in accordance with regulations and with other Federal and State laws designed for the protection of beneficiaries. This authority allows CMS to implement regulations to ensure that PACE participants' rights are protected, including the right to file a grievance anonymously.
To uphold participant rights and help PACE organizations to safeguard anonymity to the extent possible during the grievance process and in other circumstances that involve sensitive information, CMS proposed, using the authority at sections 1894(f)(3) and 1934(f)(3) of the Act, to amend the PACE regulations at §§ 460.200(d)(2) and 460.210(b)(6) to allow for more administrative flexibility in how PACE organizations maintain written communications relating to the care, health, or safety of a participant.
Specifically, we proposed to amend § 460.200(d)(2) to require that a PACE organization must maintain all written communications received in any format (for example, emails, faxes, letters, etc.) from participants or other parties in their original form when the communications relate to a participant's care, health, or safety, including, but not limited to, the following: (i) communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participant's care, health or safety; and (ii) communications from an advocacy or governmental agency, such as Adult Protective Services. This proposal moves and revises language located at § 460.210(b)(6) that requires PACE organizations to maintain original documentation, or an unaltered electronic copy, of any written communication the PACE organization receives relating to the care, health or safety of a participant, in any format. By moving this language to § 460.200(d)(2), with the proposed modifications, we retained the requirement for PACE organizations to maintain these important communications in their original form, while removing the requirement that these communications be stored in the participant's medical record. At § 460.210(b)(6), we proposed to replace the current language with a new requirement that states that original documentation or an unaltered electronic copy, of any written communication as described in § 460.200(d)(2), must be maintained in the participant's medical record unless the following requirements are met: (i) the medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication, (ii) original documentation of the communication is maintained outside of the medical record and is accessible by employees and contractors of the PACE organization when necessary, and in accordance with § 460.200(e), and (iii) original documentation of the communication is available to CMS and the SAA upon request. This provision continues to require PACE organizations ensure that these important communications relating to the care, health, or safety of a participant are included in the medical record, but it allows PACE organizations operational flexibility on how these communications are included. PACE organizations would be permitted, under this proposal, to summarize the information in the medical record, as long as the summary is accurate and thorough, and the original documentation of the communication is maintained outside the medical record and is accessible by the PACE organization's employees and contractors as needed, and available to CMS and the SAA upon request. We believe this proposal balances CMS' interest in ensuring these communications are safeguarded with PACE organizations' interest in ensuring the medical record is usable and that confidential information is protected to the extent possible. A PACE organization would be able to include a summary of the information but could now choose to exclude names or other potentially sensitive information, provided the requirements under proposed § 460.210(b)(6)(i) through (iii) are met.
We summarize the comments received on the proposals at §§ 460.200(d)(2) and 460.210(b)(6) and provide our responses to those comments in this section of this rule.
CMS believes that allowing these communications be stored outside of the medical record, when certain conditions are met, balances the need to keep grievance and sensitive information confidential, while appropriately maintaining communications related to participant care, health or safety, as part of the medical record. CMS also points out that PACE organizations may choose to maintain these communications outside of the medical record in a secure location when certain conditions are met, however, they can also choose to maintain the communications in the medical record in accordance with the new § 460.200(d)(2). PACE organizations have the option to exercise this flexibility, but are not required to do so. Lastly, CMS believes these changes will be welcomed by the industry.
After consideration of the comments received, we are finalizing our proposed changes to §§ 460.200(d)(2) and 460.210(b)(6) without modification.
We received comments on the following topics which were out of scope of our proposal and to which we are therefore not responding: (1) The passage of the 117th Congress' proposed legislation entitled “PACE Plus Act” (S. 1162/H.R. 6770), “PACE Part D Choice Act” (S. 5106/H.R. 4941), and “Improving Senior's Timely Access to Care Act” (S. 3018/H.R. 3173); and (2) Allowing the PACE program to utilize gift cards in marketing.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
On December 27, 2022 (87 FR 79452) we solicited public comment on each of these issues for the following sections of the proposed rule (CMS-4201-P, RIN 0938-AU96) that contained information collection requirements. Such comments were received as indicated under ICR #5 (Regarding [the] Clarifications of Coverage Criteria for Basic Benefits and Use of Prior Authorization) and ICR #11 (Regarding the PACE Service Determination Process) in this rule. This final rule is only finalizing some of the provisions of the proposed rule. The remaining provisions may be finalized in subsequent rulemaking.
For the provisions being finalized in this rule, the proposed rule's burden estimates are being carried over without change except that the beneficiary's wage is adjusted from $28.01/hr to $20.71/hr. The adjustment is based on internal review as we changed the source of the wage figure from BLS at $28.01/hr to HHS at $20.71/hr. See “Wage for Beneficiaries” and ICR #2, in this rule.
To derive average costs, we are using data from the most current U.S. Bureau of Labor Statistics' (BLS's) National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, except for enrollees, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and other indirect costs vary significantly from employer to employer and because methods of estimating these costs vary widely from study to study. We believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
We believe that the cost for beneficiaries undertaking administrative and other tasks on their own time is a post-tax wage of $20.71/hr. The Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices identifies the approach for valuing time when individuals undertake activities on their own time. To derive the costs for beneficiaries, a measurement of the usual weekly earnings of wage and salary workers of $998, divided by 40 hours to calculate an hourly pre-tax wage rate of $24.95/hr. This rate is adjusted downwards by an estimate of the effective tax rate for median income households of about 17 percent, resulting in the post-tax hourly wage rate of $20.71/hr. Unlike our private sector wage adjustments, we are not adjusting beneficiary wages for fringe benefits and other indirect costs since the individuals' activities, if any, would occur outside the scope of their employment.
The following ICRs are listed in the order of appearance within the preamble (see sections II. through VI.) of this final rule.
This rule adds a new paragraph at § 422.514(g) to clarify that the D-SNP look-alike contracting limitations at § 422.514(d) through (f) apply to segments of the MA plan. This new paragraph will address instances we have seen since adopting § 422.514(d) through (f) where a specific segment of an MA plan looks like a D-SNP look-alike and would be subject to the contracting prohibitions in § 422.514(d) if the segment were treated as an MA plan. We believe that by applying the D-SNP look-alike contracting limitations only at the MA plan level without applying it to segments of plans, our existing regulation has an unintended and unforeseen loophole through which D-SNP look-alikes could persist, contrary to the stated objectives in our prior rulemaking.
Based on January 2022 Monthly Membership Report data, we expect that this rule will result in three MA plan segments being identified as D-SNP look-alikes, and these D-SNP look-alikes would likely transition the approximately 3,000 current enrollees into another MA-PD plan offered by the same MA organization (or by another MA organization with the same parent organization as the MA organization) using the transition process described in § 422.514(e). Based on our analysis of proposed D-SNP look-alike transitions for contract year 2023, two D-SNP look-alikes in contract year 2022 are proposing to transition a combined total of approximately 7,000 D-SNP look-alike enrollees into two new non-SNP MA plan segments, which could create two new D-SNP look-alikes for contract year 2023.
In the June 2020 final rule (85 FR 33877 through 33880), we estimated each D-SNP look-alike would take a one-time effort of 2 hours for a business operations specialist to submit all enrollment changes to CMS necessary to complete the transition process. We also stated that, after the prohibition on D-SNP look-alikes was implemented, at most five plans per year would be identified as D-SNP look-alikes under § 422.514(d) due to meeting the enrollment threshold for dually eligible individuals or operating in a State that will begin contracting with D-SNPs or other integrated plans. In association with our June 2020 final rule, the requirement and burden estimates (5 respondents, 5 total responses, and 10 total hours) were approved by OMB under control number 0938-0753 (CMS-R-267).
This rule's clarification under § 422.514(g) does not change the transition process nor our currently approved burden estimates. Similarly, the addition of non-SNP MA plan segments to the contracting limitations at § 422.514 has no impact on our currently approved burden estimates that at most five plans (including PBP segments) per year would be identified as D-SNP look-alikes; therefore, the currently approved number of respondents and burden estimates in control number 0938-0753 would not change.
The following changes will be submitted to OMB for approval under control number 0938-1441 (CMS-10831). OMB will set out an expiration date upon their approval of this final rule's new collection of information request. The issuance of the expiration date can be monitored at
We did not receive any comments specific to the private sector proposed ICRs and, therefore, are finalizing the proposed private sector requirements and burden estimates as is. As previously indicated under Wage Data, we have adjusted the proposed beneficiary wage resulting in adjusted cost estimates under this final rule.
As described in section II.D.2 of this final rule, we expect that some beneficiaries will enroll in LI NET using
To estimate the total burden, we consider the burden for enrollees, pharmacists, and Part D sponsors separately. Each consideration entails counting the number of documents arising from point of sale enrollments, direct reimbursement forms, and LI NET application forms.
To estimate the information collection burden for beneficiaries, we have estimated the number of beneficiaries submitting information to LI NET and time related to handling the information. We have not included burden estimates for individuals who would not be providing documentation, such as those CMS automatically enrolls into LI NET, individuals whose eligibility for LI NET is confirmed independently by the LI NET sponsor, or for those who opt not to provide evidence.
When enrolling in LI NET at POS, possible forms of evidence for LIS eligibility include but are not limited to, a Medicaid card or a letter from the State or SSA showing LIS or “Extra Help” status. We estimate that it would take an individual approximately 15 minutes (0.25 hr) to gather supporting documentation. There are 36,722 individuals enrolled in the LI NET demonstration at POS in 2021 who applied at the point of sale. Based on our experience with the LI NET demonstration, we estimate approximately 250 beneficiaries would submit receipts for reimbursement for claims paid out of pocket. These beneficiaries may complete a direct reimbursement request form available online, and return by mail, email, or fax, together with their receipt, to the LI NET sponsor. In the LI NET demonstration, approximately ten beneficiaries per year completed the LI NET application form, which is available online, and returned it to the LI NET sponsor by mail, email, or fax. Thus, in total we expect 36,982 beneficiaries (36,722 at point of sale plus 250 through direct reimbursement plus 10 applying via the LI NET application form) to spend 15 minutes (0.25 hr) resulting in an aggregate burden of 9,246 hours (36,982 enrollees * 0.25 hr) at an aggregate cost of $191,485 (9,246 hr * $20.71/hr).
We estimate that it will take 2 minutes (0.0333 hr) for a pharmacy to fax the documentation to the LI NET sponsor. However, pharmacists will not process the forms of enrollees who use direct reimbursement or the LI NET application form. Thus, pharmacists will only process the 36,722 enrollees at point of sale. Thus, the aggregate burden for pharmacists is 1,223 hours (36,722 enrollees * 0.0333 hr) at an aggregate cost of $147,812 (1,223 hr * $120.86/hr).
The Part D sponsors will process the documents received from all 36,982 enrollees. Part D sponsors are estimated to spend about 2 minutes (0.0333 hr) to process information from point of sale, direct reimbursement requests, and application forms. Thus, the aggregate burden for Part D sponsors is 1,232 hours (36,982 enrollees * 0.0333 hr) at an aggregate cost of $93,878 (1,232 hr * $76.20/hr).
The following changes will be submitted to OMB for approval under control number 0938-1346 (CMS-10636).
To ensure that MA enrollees have access to provider networks sufficient to provide covered services, including behavioral health service providers, this rule adds new specialty types that will be subject to network adequacy evaluation under § 422.116. This rule adds Clinical Psychology and Clinical Social Work under § 422.116(b)(1). However, we are not finalizing our proposed addition of the Prescribers of Medication for Opioid Use Disorder specialty type.
Section 1262 of Division FF of the Consolidated Appropriations Act of 2023 (CAA) (Pub. L. 117-328) amended section 303(g) of the Controlled Substances Act to remove the statutory requirement for providers to obtain a valid waiver from SAMHSA and the DEA to administer, dispense, or prescribe MOUD. Therefore, we will not be finalizing this portion of our proposal. Because we planned to use SAMHSA's list of waivered providers to populate the Provider Supply file, we are no longer able to accurately track the providers that prescribe medications like buprenorphine in order to create and maintain a network adequacy standard.
We have determined that there is no cost for MA organizations in regards to reporting new specialty types to CMS for their network adequacy reviews as this rule requires. However, we have determined that there is a minimal one-time cost for MA organizations to update their policies and procedures associated with this rule.
First, regarding reporting the proposed new specialty types to CMS, MA organizations are already conducting ongoing work related to network adequacy reviews that happen during the initial or service area application, or every three years for the triennial review. Further, organizations should already have these specialty provider types within network, as these are services covered by Medicare Part A and B and which are furnished by these specialty types, so there is no burden related to contracting with new provider types. This will only require that the specialty types be added to the Health Services Delivery (HSD) tables during any network adequacy evaluation requested by CMS. As determined by our contractors, the time to conduct tasks related to adding additional specialty types on the HSD tables is negligible.
We understand that MA organizations will need to update their policies and procedures related to submission of HSD tables to ensure that the new required behavioral health specialty types are included. We estimate that a business operations specialist working at an hourly wage of $76.20/hr will take 5 minutes (0.0833 hr) for a one-time update of policies and procedures related to this task, at a cost of $6.35 (0.0833 hr * $76.20/hr). The aggregate burden is 62 hours (742 MA contracts * 0.0833) at a cost $4,724 (62 hr. * 76.20/hr).
We did not receive any comments specific to the proposed ICRs and, therefore, are finalizing the proposed requirements and burden estimates as is.
The following changes were submitted to OMB for review under control number 0938-0753 (CMS-R-267).
As described in section III.D. of this final rule, we are revising: (1) § 422.111(e) by establishing specific enrollee notification requirements for no-cause and for-cause provider contract terminations and adding specific and more stringent enrollee notification requirements when primary care and behavioral health provider contract terminations occur; and (2) § 422.2267(e)(12) to specify the requirements for the content of the notification to enrollees about a provider contract termination. We are finalizing this provision as proposed with some modifications based on public comment. We are modifying the proposed changes to § 422.111(e) by requiring only one telephonic notice attempt to enrollees who have not opted out of plan calls and by specifying a three-year lookback period to determine which enrollees of terminating primary care and behavioral health providers must be notified. However, these modifications have no impact on our proposed burden estimates.
This amendment to §§ 422.111(e) and 422.2267(e)(12) impacts MA organizations in terms of the burden required to identify those enrollees who must be notified of provider contract terminations per CMS requirements, to develop and send the required written notices, to develop the scripts for the required telephonic notices, and to make the required enrollee telephone calls. However, CMS does not currently collect data regarding the widely variable number of provider contract terminations an MA organization undergoes in a given contract year, nor the number of enrollees affected by each termination. Therefore, in the proposed rule, we did not have information that would have allowed us to estimate the extent of MA provider contract terminations, how many enrollees are affected and need to be notified per § 422.111(e), or how the MA program will be impacted as we see the effects of this regulation. Although we solicited comment, we received no comments to help us derive such estimates.
The actual direct burden of this provision arises from MA organization staff hours spent, resources purchased, and enrollee notifications provided. MA organizations may also differ in how their spending for the requirements evolves over time as they test strategies and redevelop their approaches to complying with the regulation.
Despite our inability to quantify certain burden for this provision, we were able to estimate the one-time burden on MA organizations to update their existing written provider termination notice in compliance with the new required notice content that we are finalizing at § 422.2267(e)(12)(ii). We stated in the proposed rule that we expect MA organizations to engage in some routine software development to update their notice template and related systems to incorporate the new requirements, which will be delineated in a provider termination model document developed by CMS staff (thus not incurring COI burden). This proposed model was posted for public review and comment in conjunction with the proposed rule's 0938-0753 ICR. We estimated that one or two software developers working at a wage of $92.92/hr will spend a total of 8 hours updating an MA organization's existing provider termination notice template and related systems based on CMS's model. With approximately 697 MA organizations impacted by this change, this results in a total of 5,576 hours (697 MA organizations * 8 hours), at an aggregate cost across all MA organizations of $518,122 (5,576 hours * $92.92/hr). In the proposed rule, we were unable to estimate the burden for the telephonic notice requirement at §§ 422.111(e)(1)(i) and 422.2267(e)(12)(iii) because the number of primary care and behavioral health provider contract terminations an MA organization undergoes in a given contract year is unknown, as are the number of affected enrollees per termination. We did not receive any comments related to our projected burden estimates for this provision, therefore, we are finalizing the proposed burden without change.
The following changes be submitted to OMB for approval under control number (0938-0753) (CMS-R-267).
As explained in section III.E. of this rule, MA plans must comply with national coverage determinations (NCD), local coverage determinations (LCD), and general coverage and benefit conditions included in Traditional Medicare statutes and regulations when making medical necessity determinations. Under this rule, MA plans must follow Traditional Medicare coverage criteria as specified in NCDs, LCD, or Medicare laws (that is, in Medicare statutes and regulations).
Additionally, MA organizations may create internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available when coverage criteria are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs.
This rule also provides that when creating these internal policies, MA organizations must provide in a publicly accessible way: the internal coverage criteria in use and a summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations; a list of the sources of such evidence; and an explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination, which includes, when applicable, identifying the general provisions that are being supplemented or interpreted and explaining how the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services.
We expect that each plan will have new policies that they create annually.
We believe that the public accessibility of a plan's internal coverage criteria, a summary of evidence that was considered; a list of the sources of such evidence; and an explanation of the rationale that supports the adoption of the coverage criteria will require 16 hours per contract. We believe this is an adequate estimate of time needed for a business operations specialist to make all postings. Thus the per contract burden is 16 hours at a cost of $1,219 (16 hr * $76.20) and the aggregate burden over 697 contracts is 11,152 hours (697 contracts * 16 hr/contract) at a cost of $849,782 (11,152 hr * $76.20/hr)
We invited stakeholder comment on all aspects of this proposal. More specifically, we questioned (1) is our assumption that plans are already complying with the requirement of creating new guidance correct? (2) is our assumption of 16 hours annually sufficient? (3) Are there any other aspects of this proposal or its estimates upon which stakeholders have comments?
Comments were received. Some commenters stated that publicly posting a summary of evidence considered during the development of the criteria would require significant administrative effort. However, we did not receive specific comments on our estimates and are therefore finalizing our burden estimates for public posting of guidance as proposed. However, the stakeholder comments of increased administrative burden are consistent with our statement in the preamble and RIA, that due to its complexity and many unknowns we cannot quantify the burden of the requirement to create new policies when existing guidance does not exist.
The following changes will be submitted to OMB for approval under control number 0938-0964 (CMS-10141) (reference to this package was inadvertently left out of the proposed rule). We are correcting that oversight in this final rule.
This rule adds protections to help ensure that beneficiaries maintain access to medically necessary Part A and B services and drugs, while permitting MA plans to use utilization management tools, such as prior authorization. This rule requires that MA plans establish and use a committee (similar to a P&T committee) that reviews UM policies annually to ensure the policies are consistent with current traditional Medicare coverage and guidelines in Medicare statutes and regulations, NCDs, and LCDs. This final rule also requires that the committee review all medical services that require PA and other utilization management policies, at least on an annual basis and to document their findings. Additionally, the committee will be responsible for revising and updating the MA plan's utilization management policies as needed.
In this rule, 422.137(c)(1) through (4) specifies that the UM committee must clearly articulate and document processes to determine that the committee membership requirements under 422.137(c)(1) through (4) have been met, including the determination by an objective party of whether disclosed financial interests are conflicts of interest and the management of any recusals due to such conflicts. We estimate it would take 1 hour at $76.20/hr for an UM Committee business specialist to perform the tasks enumerated in the previous paragraph and review and retain documentation and information on an annual basis. Additionally, at § 422.137(d)(4) and (5) specifies that the committee must document in writing the reason for its decisions regarding the development of UM policies and make this documentation available to CMS upon request. We estimate that it will take 2 hours at $76.20/hr for a UM Committee business specialist to capture and retain this required documentation on an annual basis.
In aggregate, the burden for 697 MA plans is 2,091 hours (697 plans * 3 hr) at a cost of $159,334 (2,091 hr * $76.20/hr).
We did not receive any comments related to our proposed provisions and projected burden estimates. Consequently, we are finalizing the proposed provisions and burden without change.
The following changes will be submitted to OMB for approval under control number 0938-0753 (CMS-R-267).
In section III.G. of this final rule, we are finalizing the proposal to strengthen the current requirement at §§ 422.566(d) and 422.629(k)(3) for who must review an organization determination or an integrated organization determination when the MA organization or AIP expects to issue a partially or fully adverse medical necessity decision.
Under this new requirement, the reviewing physician or health care professional must have expertise in the field appropriate to the requested service. This requirement will also apply to coverage denials from section 1876 cost plans and healthcare prepayment plans because §§ 417.600 and 417.840 require those plans to comply with the requirements in the MA regulations regarding organization determinations.
As stated in the proposed rule, we do not believe this requirement imposes additional staffing burden on plans. In light of existing review requirements applicable to organization determinations and integrated organization determinations, coupled with the requirements at § 422.152 for MA plans (including AIPs) to engage in ongoing quality improvement (including in processing requests for initial or continued authorization of services) and the contract requirement provisions at § 422.504, we believe plans already have the requisite expertise in staffing to satisfy this requirement. The requirement that the physician or other appropriate health care professional have expertise in the field appropriate to the requested service may at most result in plans reallocating staff resources in certain cases to ensure that someone with appropriate expertise is reviewing the request; however, we don't believe that this requirement will require additional staffing for MA organizations and AIPs.
This requirement is expected to yield savings due to fewer denied organization determinations getting into the appeals process as a result of enhanced medical necessity review by appropriate experts.
To estimate these savings we considered the following:
• Number of unfavorable pre-service organization determinations: The 2022 CMS-R-267 reports 1,786,733 (Row C of Table 6) which equals 5.7 percent (Row B), (the percent of unfavorable pre-service organization determinations), times 31,346,194 (Row A) (the total number of pre-service organization determinations.) We re-examined the underlying 2020 MA plan reported data and still believe this to be correct. You can find this computation in rows A-C of Table 6.
• Number of unfavorable pre-service organization determinations that are appealed. The 2022 CMS-R-267 comes up with 431 per plan or 242,653 appealed pre-service organization determinations. This number appeared excessively low to us. Additionally, this number was derived in the 2022 CMS-R-267 by taking 5% * 20% * 24,279,575. There is no documentation explaining the percentages or the number. Accordingly, we re-examined the underlying 2020 MA plan data. The aggregate percentage of unfavorable pre-service organization determinations that are appealed is 9 percent (Row D). Using this we calculate 160,806 (Row E) appealed unfavorable decisions (0.09 * 1,786,733). We note that 160,806 is in the ballpark of the 242,795 used in the 2022 CMS-R-267 package but as noted the documentation for the calculations is not presented and a reexamination of the data gives 160,806. Accordingly, we are correcting that number from the CMS-R-267 package in the base we use for impact. These calculations are also conveniently summarized in Table 6 in rows C-E.
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As just explained, according to 2020 MA plan reported data, 1,786,733 (5.7 percent of all 31,346,194 Medicare pre-service organization determination decisions) are unfavorable coverage decisions (the decision is fully or partially unfavorable to the enrollee). Of this universe of unfavorable pre-service organization determinations, 160,806 cases (9 percent * 1,786,733) are appealed and subject to reconsideration by the plan. Of the cases reviewed on appeal, 130,253 cases (81 percent * 160,806 cases) of the reconsiderations resulted in a plan overturning its unfavorable organization determination (Rows A-G of Table 6).
Thus, the total burden is 32,563 hr (Row I) (130,253 cases * 0.25 hr/case) at a cost of $2,481,317 (Row K) (32,563 hr * $76.20/hr for a business operations specialist).
While we don't know with certainty what the reduction in existing denied organization determinations will be under this new requirement, we believe
We received no comments on our proposed requirement and burden estimates and are finalizing them as is.
This rule requires that FIDE SNPs, HIDE SNPs, and AIPs translate materials into any languages required by the Medicare translation standard plus any additional languages required by the Medicaid translation standard as specified through their Medicaid capitated contracts.
This rule slightly modifies existing policy, so the impact to FIDE SNPs, HIDE SNPs, and AIPs depends upon whether, and to what extent, these plans are already translating materials in ways that would meet this rule's requirements. We note that translation requirements vary by State. Therefore, we expect no impact in States where the applicable Medicare and Medicaid translation requirements result in the same outcome. We expect marginal impacts where State requirements result in translation into languages not required by the current MA rules at §§ 422.2267(a)(2) and 423.2267(a)(2). However, even in these States, FIDE SNPs, HIDE SNPs, and AIPs (in combination with their affiliated Medicaid managed care plans) have translators on staff or access them via contractors because of existing Medicare and Medicaid translation requirements.
Consistent with our April 15, 2011 final rule (76 FR 21536), (CMS-4144-F, RIN 0938-AQ00), we continue to claim that the Medicare translation requirement is exempt from the requirements of the PRA since the time, effort, and financial resources necessary to comply with this rule's translation requirements is a usual and customary business practice (see 5 CFR 1320.3(b)(2)). FIDE SNPs, HIDE SNPs, and AIPs are already required to translate all Medicare materials listed in §§ 422.2267(e) and 423.2267(e) into language(s) required by the Medicare translation standard at § 422.2267(a) and meet obligations for translation or interpretation services under 45 CFR 92.101. The requirements we are finalizing as proposed at §§ 422.2267(a)(4) and 423.2267(a)(4) would require that these Medicare materials also be translated into any additional languages required by Medicaid. Since FIDE SNPs, HIDE SNPs, and AIPs are already translating these Medicare materials for enrollees on their language preferences as part of their usual and customary business practice, the finalized requirements do not establish any new disclosure, information collection, or record keeping requirements. For a full accounting of the translation burden, please see section IX.D.3.b. of this final rule.
The following changes will be submitted to OMB for approval under control number 0938-1442 (CMS-10837). The control number and expiration date have yet to be issued. The issuance can be monitored at
The proposed rule mistakenly set out CMS-10260 (0938-1051) as the collection of information request's CMS and OMB identification numbers, respectively. We are correcting that oversight in this final rule.
This rule sets forth several changes to the marketing policies in subpart V of parts 422 and 423. Each of these changes will require updates to policies and procedures on the part of a business operations specialist, entailing the addition of a phrase or sentence and, as such, not requiring much time.
For this rule's reinstatement of the prohibition on MAOs and Part D sponsors marketing outside of their service areas (unless unavoidable), we estimate 30 minutes (0.5 hr) to implement the change to policies and procedures (0.5 hr × $76.20/hr = $38.10).
For our reinstatement of the prohibition on sales presentations following educational events, we estimate 15 minutes (0.25 hr) to implement the change to policies and procedures (0.25 hr × $76.20/hr = $19.05).
For our reinstatement of the prohibition on distribution and collection of Scope of Appointment and Business Reply Cards by agents at educational events, we estimate 0.25 hours to implement the change to policies and procedures (0.25 hr. × $76.20/hr = $19.05).
For our reinstatement of the prohibition on conducting a sales/marketing or enrollment meeting with a beneficiary before 48 hours after the beneficiary's initial consent to the meeting (via scope of appointment), we estimate 0.25 hours to implement the change to policies and procedures (0.25 hr × $76.20/hr = $19.05).
For the clarification of the requirement of a plan to notify CMS of any agent that fails to adhere to CMS requirements, we estimate 0.5 hours to implement the change to policies and procedures (0.5 hr × $76.20/hr = $38.10). We estimate that this policy change does have burden, however we have no way of estimating the number of agents and frequency of which they will violate CMS requirements. Therefore, we cannot estimate it.
For the requirement that agents/brokers inform beneficiaries that the beneficiaries can obtain complete Medicare information from 1-800-MEDICARE, SHIPs, or
For the requirement that agents/brokers ask a standardized list of questions prior to enrolling the beneficiary in a plan, we estimate 0.5 hours to implement the change to policies and procedures (0.5 hr × $76.20/hr = $38.10). CMS has already developed the questions as part of the Pre-Enrollment Check List. CMS does not require agents/brokers to develop the questions themselves. As the questions were already developed, and the development was by CMS staff, development of the questions does not incur COI burden.
For the requirement that agents/brokers inform beneficiaries of all the plans the agent/broker actually sells, we estimate 0.25 hours to implement the
For the changes that clarify the prohibition of the use of the term “Medicare” or CMS's logos in a way that is misleading or confusing or which misrepresents the plan, we estimate
Thus, the total one-time burden per contract for these marketing provisions is 3.25 hours (0.5 hr + 0.25 hr + 0.25 hr + 0.25 hr + 0.5 hr + 0.5 hr + 0.5 hr + 0.25 hr + 0.25 hr for the time required to update policies and procedures on the prohibitions of marketing outside the service area, of sales following educational events, of distribution of business cards, as well as the required 48-hour wait time for agents, reporting to CMS delinquent agents, disclosing 800-Medicare, using a standardized list of questions, for agents to notify beneficiaries of all plans they represent, and to avoid misleading use of the Medicare log respectively) at $76.20/hr for a total of $247.65. The aggregate burden across 697 contracts is 2,265 hr (3.25 hr * 697 contracts) at a cost of $172,593 ($76.20/hr * 2,265 hr).
As discussed in section V. of this final rule, this rule adds, removes, and updates certain measures, replaces the current reward factor with a new HEI reward to further incentivize Part C and D plans to focus on improving care for enrollees with specific SRFs, reduces the weight of patient experience/complaints and access measures, adds a rule for the sub-regulatory removal of Star Ratings measures when a measure steward other than CMS retires the measure, and removes the 60 percent rule that is applied when adjusting Star Ratings for extreme and uncontrollable circumstances (for example, natural disasters like hurricanes or public health emergencies). The HEI is a different way for CMS to analyze existing data and will not increase plan burden. Most of the new measures will be calculated from administrative data and, as such, there will be no increase in plan burden. The other measure-level change we are finalizing in this rule entails moving an existing measure from the display page to Star Ratings, which also will have no impact on plan burden. This rule also sets out a series of technical clarifications related to adjusting Star Ratings for extreme and uncontrollable circumstances and consolidations. The provisions will not change any respondent requirements or burden pertaining to any of CMS's Star Ratings related PRA packages, including: OMB control number 0938-0732 for CAHPS (CMS-R-246), OMB control number 0938-0701 for HOS (CMS-10203), OMB control number 0938-1028 for HEDIS (CMS-10219), OMB control number 0938-1054 for Part C Reporting Requirements (CMS-10261), and OMB control number 0938-0992 for Part D Reporting Requirements (CMS-10185). Since the provisions will not impose any new or revised information collection requirements or burden, we are not making any changes under any of the aforementioned control numbers.
The following changes will be submitted to OMB for approval under control number 0938-0790 (CMS-R-244).
Section 460.121 currently includes the service determination process PACE organizations are required to follow and only allows PACE organizations to notify participants and/or their representatives of service determination extensions in writing. Per the burden estimate currently approved by OMB (CMS-R-244), we estimate the burden of the current extension notification requirements at § 460.121 to be 2,350 hours and $140,812 in aggregate. As discussed in section VI.E. of this final rule, we are finalizing our proposal to allow PACE organizations to notify the participant or their designated representative either orally or in writing when the PACE organization extends the timeframe for making a service determination. We expect that PACE organizations will prefer to provide oral notification more frequently than written notification, because oral notification is less time consuming. This belief is further supported by commenters on this proposal, who unanimously agreed the proposed change would reduce burden for PACE organizations. Due to PACE organizations' preference for oral notification over written notification and the 45 minutes per response reduction in burden oral notification offers, we estimate that the proposed change will reduce the burden of the extension notification requirements at § 460.121.
To estimate the decreased burden, we considered: (1) the annual number of extension notifications; (2) the estimated proportions of extension notifications that are provided orally or in writing; and (3) the estimated time required to complete oral and written notification.
First, we reviewed extended service determination requests (SDRs) from 2019 through 2021 and found that there were 6,564 total extended SDRs nationally (3,942 in 2019 + 773 in 2020 + 1,849 in 2021). Then we averaged the number of extended SDRs from 2019-2021 to calculate 2,188 extended SDRs annually (6,564 total extended SDRs/3 years), which is about 15 extended SDRs per PACE organization annually (2,188 extended SDRs annually/149 PACE organizations).
Secondly, we estimate, based on our experience with audits of similar areas of PACE requirements where PACE organizations have an option of oral or written notification, that 80 percent of extension notifications will be provided orally, at 15 minutes per notification, and 20 percent will be provided in writing at 1 hour per notification. The hourly wage for notification by an MSW in both cases is $59.92/hr. In aggregate, the new burden is 875 hours ((2,188 extension notifications * 0.2 written notifications * 1 hr) + (2,188 extension notifications * 0.8 oral notifications * 0.25 hr)) at a cost of $52,430 (875 hours * $59.92/hr).
Thus, the aggregate annual time and cost savings for the change is minus 1,475 hours (2,350 hours under current provisions minus 875 hours as documented in the pending OMB package) and minus $88,382 ($140,812 cost under current provisions minus $52,430 under the pending OMB package). Additionally, at the individual service determination request extension level, PACE organizations that choose to provide oral notification instead of written notification will save minus 0.75 hours and $44.94 per extension notification.
We did not receive any comments related to our proposed provisions and burden estimates. Consequently, we are finalizing them without change.
PACE organizations are currently required to retain original communications related to a participant's care, health, or safety in the medical record. In this proposal, we are removing the requirement that these communications be stored in the participant's medical record, provided certain conditions are met. Therefore, our burden estimates include costs incurred related to staff (1) training; (2) software development; (3) file cabinets for document storage; and (4) updating/
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The aggregate of this provision is a one-time impact of 13,410 hours (5,960 hours (training materials) + 5,960 hours (software development) + 1,490 hours (policy updates) at a cost of $1,282,191 ($434,484 (training materials) + $693,386 (software updates) + $44,700 (nonlabor purchase of storage) + $108,621 (policy updates).)
These changes will be submitted to OMB for approval under control number 0938-0790 (CMS-R-244). Since PACE organizations are already required to retain original communications related to a participant's care, health, or safety, and to make these communications accessible to CMS and the SAA upon request, this proposal does not impose any new information collection requirements for PACE organizations.
In this rule, we revise the Part D LIS income and resource standards at § 423.773 to expand eligibility for the full benefit to individuals who currently have the partial benefit and make a coordinating change in § 423.780. This will change the level of assistance that an individual could qualify for in paying their Part D premiums, copays and deductibles. While there will be no change in the number of individuals eligible for the Part D LIS, it will create a transition of people from partial subsidy status to full subsidy status.
The burden associated with determining eligibility for the Part D LIS is the time and effort for States or SSA to verify the income and resources and report eligibility to beneficiaries and CMS annually. Most individuals who qualify for the Part D LIS do so because they qualify for Medicaid or other assistance in their State. The burden for States to determine and report eligibility is currently approved by OMB under control number 0938-0467 (CMS-R-74) at 54 respondents, 3,241 annual responses, a variable amount of time per response, and 1,082 estimated annual hours.
We did not receive any comments related to our proposed provisions and burden estimates. Consequently, we are not making any changes to any of the requirements or burden estimates that are currently approved by OMB under control number 0938-0467.
The primary purpose of this final rule is to amend the regulations for the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) programs, and Programs of All-Inclusive Care for the Elderly (PACE). This final rule, besides codifying existing Part C and Part D sub-regulatory guidance also includes a number of new policies from the Bipartisan Budget Act (BBA) of 2018, the Consolidated Appropriations Act, 2021 (CAA), and the Inflation Reduction Act of 2022 (IRA), that would improve these programs.
We examined the impact of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), Executive Order 13272 on Proper Consideration of Small Entities in Agency Rulemaking (August 13, 2002), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)).
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). Section 3(f)(1) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities ; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
Based on our estimates, OMB's Office of Information and Regulatory Affairs has determined this rulemaking is significant per section 3(f)(1) as measured by having an annual effect of $100 million or more in any 1 year, and hence also a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act). Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.
Section 202 of UMRA also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2022, that threshold is approximately $177 million. This final rule is not anticipated to have an unfunded effect on State, local, or Tribal governments, in the aggregate, or on the private sector of $177 million or more.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. Since this final rule does not impose any substantial costs on State or local governments, preempt State law or have federalism implications, the requirements of Executive Order 13132 are not applicable.
If regulations impose administrative costs on reviewers, such as the time needed to read and interpret this final rule, then we should estimate the cost associated with regulatory review. There are currently 795 contracts (which includes MA, MA-PD, and PDP contracts), 55 State Medicaid Agencies, and 300 Medicaid MCOs. We also expect a variety of other organizations to review (for example, consumer advocacy groups, major PBMs). We expect that each organization will designate one person to review the rule. A reasonable maximal number is 2,000 total reviewers. We note that other assumptions are possible.
Using the BLS wage information for medical and health service managers (code 11-9111), we estimate that the cost of reviewing this final rule is $115.22 per hour, including fringe benefits, overhead, and other indirect costs (
Note that this analysis assumes one reader per contract. Some alternatives include assuming one reader per parent organization. Using parent organizations instead of contracts will reduce the number of reviewers. However, we believe it is likely that review will be performed by contract. The argument for this is that a parent organization might have local reviewers assessing potential region-specific effects from this final rule.
In accordance with the provisions of Executive Order 12866, this final rule was reviewed by OMB.
The RFA, as amended, requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.
We proposed a wide range of policies in the proposed rule. These policies codify, modify, and update current guidance governing MA organization bid requirements.
This rule has several affected stakeholders. They include: (1) MA organizations such as HMOs, local and regional PPOs, MSAs, PFFS and Part D sponsors, PACE plans, and Stand Alone Part D plans (PDP) (2) providers, including institutional providers, outpatient providers, clinical laboratories, and pharmacies; and (3) enrollees. Some descriptive data on these stakeholders are as follows:
• Pharmacies and Drug Stores, NAICS 446110, have a $30 million threshold for “small size” with 88 percent of pharmacies, those with under 20 employees, considered small.
• Direct Health and Medical Insurance Carriers, NAICS 524114, have a $41.5 million threshold for “small size,” with 75 percent of insurers having under 500 employees meeting the definition of small business. Several Medicare Advantage plans (about 30-40
• Ambulatory Health Care Services, NAICS 621, including about 2 dozen subspecialties, including Physician Offices, Dentists, Optometrists, Dialysis Centers, Medical Laboratories, Diagnostic Imaging Centers, have a threshold ranging from $8 to $35 million (Dialysis Centers, NAICD 621492, have a $41.5 million threshold). Almost all firms are big, and this also applies to sub-specialties. For example, for Physician Offices, NAICS 621111, receipts for offices with under 9 employees exceed $34 million.
• Hospitals, NAICS 622, including General Medical and Surgical Hospitals, Psychiatric and Substance Abuse Hospitals, Specialty Hospitals have a $41.5 million threshold for small size, with half of the hospitals (those with between 20-500 employees) considered small.
• Skilled Nursing Facilities (SNFs), NAICS 623110, have a $30 million threshold for small size, with half of the SNFs (those with under 100 employees) considered small.
We are certifying that this FC does not have a significant economic impact on a substantial number of small entities. To explain our position, we explain certain operational aspects of the Medicare program.
Each year, MA plans, including Part D sponsors, submit a bid for furnishing Part A and B benefits and the entire bid amount is paid by the government to the plan if the plan's bid is below an administratively set benchmark. If the plan's bid exceeds that benchmark, the beneficiary pays the difference in the form of a basic premium (note that a small percentage of plans bid above the benchmark, whereby enrollees pay basic premium, thus this percentage of plans is not “significant” as defined by the RFA and as justified in this section of this rule). The costs of stand-alone Part D plans, PDPs, is also covered by the Medicare Trust Fund. PACE plans have their costs covered by both the Medicare Trust Fund as well as the States they negotiate with.
MA plans and Part D Sponsors can also offer enhanced benefits, that is, benefits not covered under Original Medicare. These enhanced benefits are paid for through enrollee premiums, extra government payments or a combination. Under the statutory payment formula, if the bid submitted by an MA plan (including Part D sponsors) for furnishing Part A and B benefits is lower than the administratively set benchmark, the government pays a portion of the difference to the plan in the form of a rebate. The rebate must be used to provide supplemental benefits (that is, benefits not covered under Original Medicare) and or/lower beneficiary Part B or Part D premiums. Some examples of these supplemental benefits include vision, dental, and hearing, fitness and worldwide coverage of emergency and urgently needed services.
To the extent that the government's payments to plans for the bid plus the rebate exceeds costs in Original Medicare, those additional payments put upward pressure on the Part B premium which is paid by all Medicare beneficiaries, including those in Original Medicare who do not have the additional health services available in many MA plans.
Part D plans, including MA-PD plans, submit bids and those amounts are paid to plans through a combination of Medicare funds and beneficiary premiums. In addition, for enrolled low-income beneficiaries, Part D plans receive special government payments to cover most of premium and cost sharing amounts those beneficiaries would otherwise pay.
Thus, the cost of providing services by these insurers is funded by a variety of government funding and in some cases by enrollee premiums. As a result, MA plans, Part D plans, Prescription Drug Plans, and PACE plans are not expected to incur burden or losses since the private companies' costs are being supported by the government and enrolled beneficiaries. This lack of expected burden applies to both large and small health plans.
Small entities that must comply with MA regulations, such as those in this final rule, are expected to include the costs of compliance in their bids, thus avoiding additional burden, since the cost of complying with any final rule is funded by payments from the government and, if applicable, enrollee premiums.
For the insurance plans classified in category Direct Health and Medical Insurance Carriers, NAICS 524114, which include MA plans, Part D sponsors, standalone PDPs, and PACE plans, the plans estimate their costs for the upcoming year and submit bids and proposed plan benefit packages. Upon approval, the plan commits to providing the proposed benefits, and CMS commits to paying the plan either—(1) the full amount of the bid, if the bid is below the benchmark, which is a ceiling on bid payments annually calculated from original Medicare data; or (2) the benchmark, if the bid amount is greater than the benchmark.
If an MA plan or Part D sponsor bids above the benchmark, section 1854 of the Act requires the MA plan to charge enrollees a premium for that amount. Historically, only 2 percent of plans bid above the benchmark, and they contain roughly 1 percent of all plan enrollees. The CMS threshold for what constitutes a substantial number of small entities for purposes of the RFA is 3 to 5 percent. Since the number of plans bidding above the benchmark is 2 percent, this is not considered substantial for purposes of the RFA. Note that PACE plans while not submitting bids (except for Part D) in the same sense as MA plans, estimate their costs and these amounts are covered by a combination of funding from the Trust Fund and the States in which they operate.
The preceding analysis shows that meeting the direct cost of this final rule does not have a significant economic impact on a substantial number of small entities, as required by the RFA.
Besides the direct costs, as previously discussed, are certain indirect consequences of these provisions which also create impact. We have already explained that 98 percent of MA plans (including MA-PD plans) bid below the benchmark. Thus, their estimated costs for the coming year are fully paid by the Federal Government. However, the government additionally pays the plan a “beneficiary rebate” amount that is an amount equal to a percentage (between 50 and 70 percent depending on a plan's quality rating) multiplied by the amount by which the benchmark exceeds the bid. The rebate is used to provide additional benefits to enrollees in the form of reduced cost-sharing or other supplemental benefits, or to lower the Part B or Part D premiums for enrollees. (Supplemental benefits may also partially be paid by enrollee premiums.) However, as noted previously, the number of plans bidding above the benchmark to whom this burden applies do not meet the RFA criteria of a significant number of plans.
It is possible that if the provisions of this rule would otherwise cause bids to increase, plans will reduce their profit margins, rather than substantially change their benefit package. This may be in part due to market forces; a plan lowering supplemental benefits even for 1 year may lose its enrollees to competing plans that offer these supplemental benefits. Thus, it can be advantageous to the plan to temporarily reduce profit margins, rather than reduce supplemental benefits.
We note that we do not have definitive data on this. Plans do not report to CMS the strategies behind their bids. More specifically, when supplemental benefits are reduced, we
We next examine in detail each of the other stakeholders and explain how they can bear cost. Each of the following are providers (inpatient, outpatient, or pharmacy) that furnish plan-covered services to plan enrollees for: (1) Pharmacies and Drug Stores, NAICS 446110; (2) Ambulatory Health Care Services, NAICS 621, including about two dozen sub-specialties, including Physician Offices, Dentists, Optometrists, Dialysis Centers, Medical Laboratories, Diagnostic Imaging Centers, and Dialysis Centers, NAICD 621492; (3) Hospitals, NAICS 622, including General Medical and Surgical Hospitals, Psychiatric and Substance Abuse Hospitals, and Specialty Hospitals; and (4) SNFs, NAICS 623110.
If these providers are contracted with the plan, their aggregate payment for services is the sum of the enrollee cost sharing and plan payments.
The rules for non-contracted providers servicing plan enrollees depends on the plan type involved. Non-contracted providers in both MA and MA PD plans are not expected to incur burden from a final rule because the regulations (42 CFR 422.214 and sections 1852(k)(1) and 1866(a)(1)(O) of the Act) require they be paid at least the FFS Rate. PACE must provide only contracted providers to its participants (42 CFR 460.70(a)). Similarly non-contracted pharmacies are a sporadic issue in stand-alone drug plans which are encouraged to limit out of network access to those situations when it is required (42 CFR 423.124). PACE plan participants must obtain services either from the PACE organization of from its contracted providers (42 CFR 470(a)). Consequently, non-contracted providers have no additional cost burden above the already existing burden in original Medicare.
Consequently, consistent with our conclusions stated earlier, the Secretary has certified that this final rule will not have a significant impact on a substantial number of small entities.
Many provisions of this final rule have negligible impact either because they are technical provisions or are provisions that codify existing guidance. Other provisions have an impact that cannot be quantified or whose estimated impact is zero. Throughout the preamble, we have noted when we estimated that provisions have no impact. Additionally, this Regulatory Impact Analysis discusses several provisions with either zero impact or impact that cannot be quantified. The remaining provisions are estimated in section VIII of this final rule and in this Regulatory Impact Analysis. Where appropriate, when a group of provisions have both paperwork and non-paperwork impact, this Regulatory Impact Analysis cross-references impacts from section VIII. of this final rule in order to arrive at total impact. Additionally, this Regulatory Impact Analysis provides pre-statutory impact of several provisions whose additional current impact is zero because their impact has already been experienced as a direct result of the statute. For further discussion of what is estimated in this Regulatory Impact Analysis, see Tables 13 and 14 and the discussion afterwards.
This rule implements section 118 of the CAA, which amends section 1860D-14 of the Act, to establish the Limited Income Newly Eligible Transition (LI NET) Program as a permanent part of Medicare Part D. This will ensure that the transitional drug coverage currently provided to low-income Medicare beneficiaries under the LI NET demonstration will continue indefinitely. Therefore, we anticipate this rule will advance health equity by improving low income individuals' access to continuous, affordable health coverage, consistent with Executive Order 13985, issued January 20, 2021, on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. We also believe it will improve the customer service experience of low-income beneficiaries consistent with the goals of the Executive Order 14058, Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government.
Using drug cost data from 2021, the CMS Office of the Actuary (OACT) projects the following program costs (in millions of dollars) over the next 10 years:
We note that OACT has provided cost/savings estimates each year under the LI NET demonstration, and it has not altered its methodology based on the program becoming permanent. Therefore, these projected costs are the same as what the government would have incurred if the demonstration continued. Further, the costs of the payments provided for under the LI NET program will continue, as under the demonstration, to be covered through the Medicare Prescription Drug Account within the Federal Supplementary Medical Insurance (SMI) Trust Fund. Also note that we are classifying these payments of the Medicare Trust Fund as transfers from the Trust Fund to the LI NET sponsor.
We received no comments on this section and therefore are finalizing this provision without modification.
The provision that a physician or other health professional with expertise in the field of medicine appropriate to the requested service review any decision about medical necessity before an MA plan may issue an adverse organization determination was intended to provide a more meaningful clinical review informed by specific expertise. As stated in the proposed rule, we believe this enhanced level of review will reduce unnecessary appeals, delays in treatment and the potential for adverse outcomes.
In the proposed rule, we quantified the expected reduced appeals in the Collection of Information section, quantifying the costs of effects of delay in treatment and consequent possible adverse medical complications is not possible because we lack adequate data. In addition to requesting comment on these effects, we sought feedback on the opportunity cost of medical experts' time when reallocated for the purpose of compliance with this provision. We did not receive comments on this impact analysis. We are finalizing this provision without modification.
We proposed to specify in Medicare regulations that MA organizations, cost plans, and Part D sponsors must provide materials to enrollees on a standing basis in an accessible format or any non-English languages that is the primary language of at least 5 percent of the individuals in a plan benefit package service area upon receiving a request for the materials or otherwise learning of the enrollee's preferred language. The proposal would also extend to individualized plans of care for special needs plans.
Our final rule clarifies existing policy. Therefore, the impact to MA organizations, cost plans, and Part D plan sponsors depends on whether, and to what extent, they currently have processes in place to note an enrollee's language preference and need for an alternate format. As described in this section of this final rule, we believe many plans would not incur significant cost from the proposed requirement because plans currently comply with the proposal.
Enrollees who need translated materials or materials in an accessible format who are enrolled in MA, cost, or Part D plans that do not currently create a standing request for these materials would likely spend less time contacting their plan to request these materials as a result of this proposal. Any MA, cost, or Part D plan that has not created a standing request for enrollees requiring translated materials or materials in an accessible format would likely reduce their efforts to accept requests and resend the translated materials or materials in an accessible format.
CMS received information from Medicare-Medicaid Plans (MMPs) in Ohio and California about their requests for translated materials in 2021 and 2022. We include our assumptions from these discussions, but we sought comment on additional information that may better inform our estimates. Of the five MMPs in Ohio in 2021, only one of the plans accepted standing requests for translated materials or materials in an accessible format. A higher proportion (86 percent) of seven California MMPs that responded had established standing requests due to State oversight ensuring California MMPs followed the State-specific marketing guidance; however, we believe the Ohio MMPs landscape betters represents MA organizations as a whole. Therefore, we estimate that 20 percent or 171
Based on the information we received from MMPs, we are uncertain if establishing a standing request for translated material or materials in an accessible format will increase or decrease administrative cost for the estimated 683 MA organization, cost plan, and Part D plan sponsor contracts impacted by our proposal. Based on information from MMPs who have implemented a standing request, we believe establishing a process for standing requests would require about 200 hours of business operations specialist
We assume that this initial cost would be offset by a reduction in cost for MA organizations, cost plans, and Part D plan sponsors to resend materials in the correct translated or accessible format. We also expect that implementing a standing request process would reduce future costs to MA organizations, cost plans, and Part D sponsors by decreasing rework of sending two sets of information, one in the incorrect language or format and the other in the correct format. However, establishing a standing request for translated material or materials in an accessible format could result in more enrollees requesting to consistently receive these materials at an additional cost to MA organizations, cost plans, and Part D plan sponsors. We requested comment on our assumptions and the potential savings or costs to MA organizations, cost plans, and Part D plan sponsors.
We proposed to require that FIDE SNPs, HIDE SNPs, and AIPs translate materials into any languages required by the Medicare translation standard plus any additional languages required by the Medicaid translation standard as specified through their Medicaid capitated contracts.
Our final rule slightly modifies existing policy, so the impact to FIDE SNPs, HIDE SNPs, and AIPs depends upon whether, and to what extent, these plans are already translating materials in ways that would meet our proposed requirements. We note that translation requirements vary by State. Therefore, we expect no impact in States where the
For contract year 2022, MA organizations sponsor 292 FIDE SNPs, HIDE SNPs, and AIPs. We expect that some portion of these FIDE SNPs, HIDE SNPs, and AIPs already translate their Medicare materials in ways that meet our proposed requirement, but we do not have a good estimate of how many. While HPMS identifies the Medicare translation requirements for each MA and Part D plan sponsor at the plan level, we do not have a good source of the State-specific Medicaid translation requirements since they differ by State and there is no one source of information outlining these requirements. For purposes of this analysis, we estimate that 75 percent of the FIDE SNPs, HIDE SNPs, and AIPs currently translate their Medicare materials in ways that would meet our proposed requirement and 25 percent or 73 of these FIDE SNPs, HIDE SNPs, and AIPs do not.
Section 422.2267(e) requires MA plans to provide 29 materials to current and prospective MA plan enrollees, as applicable and § 423.2267(e) requires Part D sponsors to provide an additional 18 materials to current and prospective enrollees for a total of 47 materials. We estimate that the proposed provision would require 73 FIDE SNPs, HIDE SNPs, and AIPs to translate 47 materials into one additional language. On average, we expect these plans to translate materials into one additional language based on our experience with MMPs where, out of nine States, only two States (California and Rhode Island) required translation of materials into additional languages that exceeds the Medicare translation standard. California required MMPs to translate materials into nine additional languages in certain counties and Rhode Island required MMPs to translate materials into two additional languages. Collectively, these 47 materials include an estimated 253,311 words.
• 253,311 words for one set of 47 materials.
• 500 words translated per hour.
• 73 FIDE SNPs, HIDE SNPs, and AIPs.
• $56.16/hr wage.
Translating one set of 47 materials into one other language would cost an estimated $28,452 (253,311 words/500 words/hr * $28.08/hr * 2 (for 100 percent for fringe benefits)). Based on these assumptions, it would cost $2,076,996 for 73 FIDE SNPs, HIDE SNPs, and AIPs to translate one set of materials into one other language. Any additional documents needing translation would be a one-time cost with a smaller cost to update the documents in future contract years.
We also understand that some commenters are concerned about the cost of translating materials into several languages on a standing basis. Each fall, we release an HPMS memorandum announcing that plans can access in the HPMS marketing review module a list of all languages that meet the 5 percent threshold for plan service areas, which is the threshold for translation.
For auxiliary aids and services, section 504 of the Rehabilitation Act of 1973, section 1557 of the ACA, and the regulations at 45 CFR 92.102(b) already require plans to provide appropriate auxiliary aids and services in alternate formats to individuals with impaired
While we understand that plans may need to make some adjustments to vendor contracts and make system updates, plans should already have resources in place to provide these materials translated into the languages required currently under §§ 422.2267(a)(2) and 423.2267(a)(2) and accessible formats. In addition, plans should have systems in place that can be adjusted to track standing requests since they are already required to track a request for hard copy materials as described in §§ 422.2267(d)(2)(i)(E) and 423.2267(d)(2)(i)(E). We believe the benefit of ensuring access to materials that can be easily understood by enrollees so that they can receive timely access to care outweighs any additional effort that plans may need to undertake. As stated earlier in this section and in the proposed rule at 87 FR 79522, we believe it is a substantial burden for enrollees to have to request each material in a non-English language or request accessible formats for each material and that requiring enrollees to do so could cause a critical delay to timely access to care. Thus, we are finalizing the provisions at §§ 422.2267(a)(3) and 423.2267(a)(3) as proposed, without a delay in implementation.
We proposed to add, remove, and update certain measures and to make methodological clarifications (to codify current practice and policies) to the Part C and D Star Ratings program. These measure additions, removals, and updates and methodological clarifications are routine, and routine changes have historically had very little or no impact on the highest ratings (that is, overall rating for MA-PD contracts, Part C summary rating for MA-only contracts, and Part D summary rating for PDPs). Hence, we anticipate there will be no, or negligible, impact on the Medicare Trust Fund from these routine changes we are finalizing in this rule. Beyond the Trust Fund, there may be effects on supplemental benefits, premiums, and plan profits. These impacts will likely vary significantly from plan to plan (or contract to contract) based on the business strategies and the competitive landscape for each plan and contract.
We also proposed some methodological enhancements to the Star Ratings as follows: replacing the current reward factor with an HEI reward, reducing the weight of patient experience/complaints and access measures, adding a rule for the sub-regulatory removal of Star Ratings measures when a measure steward other than CMS retires the measure, and removing the 60 percent rule that is applied when adjusting Star Ratings for extreme and uncontrollable circumstances (for example, natural disasters like hurricanes or public health emergencies). We anticipate that removing the 60 percent rule and adding a rule for subregulatory measure removal would each have a negligible impact on the highest ratings. Two of our enhancements have the potential to cause a contract's Star Rating to change: (1) decreasing the weight of patient experience, complaints, and access measures from four to two; and (2) replacing the current reward factor with an HEI that would reward contracts for doing well serving enrollees with specified social risk factors.
We also simulated the cumulative impact of the proposed changes to the overall rating by geographical area—specifically, by state, DC, and Puerto Rico. Since the service area of a contract can include multiple states, we assigned to each enrollee the rating of their MA contract and calculated the average rating across all enrollees residing in each state. The average change in the overall rating is a decrease of 0.099, with the changes ranging from 0.01 to −0.33 across geographic areas. Table 9 below shows the simulated changes by state, DC, and Puerto Rico. The second column is the number of MA enrollees in each state in contracts that received the 2021 overall rating. In most cases, but not all, there are larger declines in areas that had on average higher 2021 overall ratings.
We calculated the cost impacts summarized in Tables 10 and 11 due to these proposed Star Ratings updates by quantifying the difference in the MA organization's (including Part D for MA-PDs) final Star Rating with the proposed changes and without the proposed changes. We assume Medicare Trust Fund impacts due to the Star Ratings changes associated with these two revisions to the methodology. The first change, decreasing the weight of patient experience, complaints, and access measures, will be effective for the 2026 Star Ratings and will impact the 2027 plan payments and 2027 Quality Bonus Payments. The introduction of the HEI reward in lieu of the current reward factor will impact the 2027 Star Ratings and will impact the 2028 plan payments and 2028 Quality Bonus Payments.
These impacts are considered transfers, but we requested comment on the extent to which provision of goods or services would increase or decrease in association with the payment changes. The impact analysis for the Star Ratings updates takes into consideration the final quality ratings for those contracts that would have Star Ratings changes under this final rule. There are two ways that Star Ratings changes will impact the Medicare Trust Fund:
• A Star Rating of 4.0 or higher will result in a Quality Bonus Payment for the MA contract, which, in turn, leads to a higher benchmark for the MA plans offered by the MA organization under that contract. MA organizations that achieve an overall Star Rating of at least 4.0 qualify for a Quality Bonus Payment that is capped at 5 percent (or 10 percent for certain counties).
• The rebate share of the savings will be higher for those MA organizations that achieve a higher Star Rating. The rebate share of savings amounts to 50 percent for plans with a rating of 3.0 or fewer stars, 65 percent for plans with a rating of 3.5 or 4.0 stars, and 70 percent for plans with a rating of 4.5 or 5.0 stars.
In order to estimate the impact of the Star Ratings updates, the Private Health Baseline assumptions are updated with the assumed Star Ratings changes described in this final rule. We first estimated the two changes to the Star Ratings calculations as independent of each other and, since there are likely overall Star Rating interactions between the two changes, the impacts, as shown in Table 10, should be viewed separately and should not be summed. The negative values in this section of this final rule represent net savings to the Medicare Trust Funds. The patient experience/complaints and access measure weight provision is expected to result in net savings of between $330 million in 2027 and $580 million in 2033, resulting in a 10 year savings estimate of $3.28 billion. This amount equates to 0.05 percent of the Private Health Baseline for 2024-2033. The replacement of the current reward factor with the HEI reward is expected to result in net savings of between $670 million in 2028 and $1,050 million in 2033 resulting in a 10-year savings estimate of $5.12 billion. $5.12 billion represents 0.08 percent of the Private Health Baseline for the years 2024-
We also estimated the cumulative impact of the changes to the Star Ratings calculations we are finalizing in this rule since there are interactions between those changes. The impacts are showing in Table 11. The negative values represent net savings to the Medicare Trust Funds. For the Star Ratings updates, net savings are estimated to be between $330 million in 2027 and $1.24 billion in 2033, resulting in a 10-year savings estimate of $6.41 billion, which equates to 0.10 percent of the Private Health Baseline for the years 2024 through 2033.
We did not received comments on our impact analysis and therefore are finalizing these provisions without modification.
In this final rule, we will revise the Part D LIS income and resource standards at § 423.773 to expand eligibility for the full benefit to individuals who currently have the partial benefit and make a coordinating change in § 423.780. This will change the level of assistance that an individual could qualify for in paying their Part D
The result of this change is the Federal Government providing more subsidies to low income Medicare beneficiaries for Part D coverage, which would result in additional costs to the Medicare Trust Fund. The following table reflects the scored government costs for expanding the full low income subsidy to the current partly subsidized LIS beneficiaries starting January 1, 2024. Included in this table are the breakdown of increases for both the low income cost-sharing subsidy (LICS) and the low income premium subsidy (LIPS). OACT arrived at the cost estimate by assuming that the ratio of post-LICS-out-of-pocket as a percentage to the total drug cost for the partial subsidy beneficiaries would be close, possibly equal, to the drug cost of the full subsidy beneficiaries. Therefore, the impact analysis assumed that the ratio (plan benefits + LICS)/total drug cost for the partial subsidy beneficiaries was the same as the ratio for the full subsidy beneficiaries., We are classifying these payments of the Medicare Trust Fund as transfers from the Trust Fund to the LI NET sponsors. We received no comments on our regulatory impact analysis and are finalizing this impact as is.
To ensure that MA enrollees have access to provider networks sufficient to provide covered services, including behavioral health service providers, this rule adds new specialty types that will be subject to network adequacy evaluation under § 422.116. This rule adds Clinical Psychology, Clinical Social Work and Prescribers of Medication for Opioid Use Disorder under § 422.116(b)(1). However, we are not finalizing our proposed addition of Prescribers of Medication for Opioid Use Disorder for the reasons presented in section VII.C.3.
To determine the potential burden regarding this proposal, we considered cost estimates for CMS making programming updates to the HPMS system, which is utilized to conduct automated reviews; additional burden, including updating policies and procedures, for CMS contractor; and additional burden, including updating policies and procedures, for MA organizations.
We have determined that there is a $0 cost for programming HPMS with regard to this rule. Adding new specialty types to the automated review conducted by HPMS would be covered under funding currently in place for updating the system.
The CMS contractor does not indicate any additional or reduced costs to carry out the work required by this rule; therefore, there is no impact.
In this section, CMS includes discussions of Alternatives Considered for several provisions. Several provisions of this final rule reflect a codification of existing policy where we have evidence, as discussed in the appropriate preamble sections, that the codification of this existing policy would not affect compliance. In such cases, the preamble typically discusses the effectiveness metrics of these provisions for public health. Also, in these cases, different enforcement methods and different levels of stringency, are not fully relevant since the provision is already being complied with adequately. Alternative analysis is not provided for these provisions.
Both the reasons for proposing the UM Committee requirement provisions and the alternatives they are intended to counteract are discussed in the respective preambles. Because we cannot quantify any of these we have not included a repetition of this analysis in the RIA. A brief summary is as follows:
• The finalized regulation adopts new and existing standards and requirements for coverage criteria for basic benefits by requiring MA plans to make medical necessity determinations based on Traditional Medicare coverage and benefit criteria as reflected in Medicare statutes and regulations, NCDs and LCDs and prohibiting the use of internal coverage criteria or additional medical necessity standards except in limited situations. This is major policy shift in which MA plans may only deny coverage for Medicare items and services based on Traditional Medicare coverage rules unless coverage criteria for the Part A or Part B benefit are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs. As stated elsewhere in this final rule, MA plans are still permitted to use utilization management policies, such as PA—within the scope of § 422.138(b)(1) through (3)—in situations where they are not permitted to use internal coverage criteria per 422.101(b)(2) and (b)(6). In situations where MA plans may not use internal coverage criteria, plans may still use PA to confirm criteria for determining whether an item or service is one for which benefits are available under Traditional Medicare. Additionally, while PA is still permitted, plans must use coverage criteria consistent with the rules being finalized at § 422.101(b)(2) and (b)(6) and plans must make medical necessity determinations consistent with the rules at 422.101(c). Finally, in regards to burden, we understand that this provision will create new burden which is difficult to quantify.
• The finalized regulation also requires plans to follow specific procedures as part of developing internal coverage policies and making this these coverage policies publicly
• The regulation requires a PA approval to be valid for as long as medically necessary pursuant to 422.101(c), to avoid disruptions in care . In combination with the requirements to limit when MA plans may deny coverage (or use internal coverage criteria that are not used in Traditional Medicare), this will limit an MA organization's ability to approve only part of what a provider has ordered or prescribed. In addition, the finalized requirements would minimize repetitive PA requirements for enrollees on an appropriate, chronic, stable therapy. It would be qualitatively beneficial for the enrollee.
• The finalized regulation establishes a minimum 90-day transition period when an enrollee switches to a new plan, or switches from FFS to an MA plan (including new MA plan members who are also new to Medicare as well) for any ongoing courses of treatment so that treatment may not be subjected to prior authorization. This was adopted from similar transition periods in Part D; we believe it is appropriate to align the transition period and scope with the current transition requirements in Part D. We lack adequate data to quantify this provision. Qualitatively, it may result, in certain cases, in more cost to plans; but the proposal is beneficial to the enrollee.
• The proposed regulation requires MA organizations to establish a committee (similar to a P&T committee), led by a plan's Medical Director, that reviews utilization management policies annually and keeps current of Medicare statutes and regulations, LCDs and NCDs. This is beneficial for the enrollee. It was modeled on similar committees used for Part B step therapy programs and by Part D plans. Its major effect is to ask plans to review their utilization management policies.
We re-emphasize that we are not able to fully quantify all of these and the discussion of reasons is discussed in the preamble.
As an alternative to our proposal to have a tiered health equity index reward, we considered a non-tiered approach. We proposed a tiered HEI reward structure based on the percentage of enrollees in each contract who have the specified social risk factors (SRFs). We proposed that contracts that have percentages of enrollees with any of the specified SRFs in a given year that are greater than or equal to one-half of the contract-level median percentage of enrollees with the specified SRFs up to, but not including, the contract-level median would qualify for one-half of the HEI reward. Contracts that have percentages of enrollees with any of the specified SRFs greater than or equal to the contract-level median would qualify for the full HEI reward.
We have also considered and solicited comment on an alternative non-tiered HEI reward structure, where all contracts with percentages of enrollees with any of the specified SRF greater than or equal to one-half of the contract-level median would qualify for the full HEI reward. Both the tiered and non-tiered HEI reward structures align with our goal of not rewarding contracts that may do well among enrollees with SRFs but serve very few enrollees in this population, although the tiered HEI reward structure goes further in aligning with these goals. The non-tiered HEI reward structure aligns better with the goal of ease of use and understanding for contracts and other stakeholders. Although the non-tiered approach would slightly increase the mean HEI reward, it does not impact the number of contracts qualifying for the reward. We received a few comments related to the tiered versus non-tiered approach summarized in Section V. of this rule. Most commenters did not comment on the tiered versus non-tiered approach and supported the HEI reward as proposed. For the reasons set forth in the proposed rule and our responses to the related comments summarized in Section V of this rule, we are finalizing the HEI reward as proposed without modification.
The following Table 14 summarizes costs and transfers by provision. As required by OMB Circular A-4 (available at
The following Table 13 summarizes costs, and transfers by provision and year and forms a basis for the accounting Table 13. In Table 14, costs are expressed as positive numbers while savings to the Medicare Trust Fund (reduced dollar spending) are expressed as negative numbers. All numbers are in millions. The costs in this table are true costs reflecting increased consumption of services and goods. However, the savings (reduced dollar spending) to the Medicare Trust Funds reflect a transfer from MA plans, Part D sponsors, and enrollees, who increase their spending, to the Trust Fund.
Table 14 combines related provisions. For example, all PACE provisions in the COI summary table are combined into one-line item. Similarly, all provisions dealing with prior authorization have been combined into one-line item in the summary table. Table 14, also combines the three provisions with transfers: The Star Ratings provisions reduce spending by the Trust Fund (TF) to MA plans; the low-income NET provision and the expansion of low-income subsidy provision both increase dollar spending by the TF to cover assistance through the LI NET sponsors to low-income beneficiaries who would otherwise have to pay for Prescription Drugs. Since the aggregate transfer over all three provisions is a reduction in dollar spending, Table H6, lists this transfer as a savings.
As indicated in Table 13 the finalized provisions of this rule in aggregate reduce dollar spending of the Medicare Trust Fund by $4.0 billion over 10 years, with the Star Ratings provisions being the primary driver of savings. Contrastively, the aggregate paperwork burden of this rule is small, in aggregate, $17.1 million over 10 years. Except for 2024, the annual cost is $0.3 million. The major driver of costs are the translation requirements, which although taking place in 2025, will probably be prepared for by most plans in 2024. Over an infinite horizon the aggregate costs of this rule expressed in 2016 dollars is $0.8 million per year. In accordance with requirements, this major rule has been reviewed by OMB.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on March 29, 2023.
Administrative practice and procedure, Grant programs—health, Health care, Health Insurance, Health maintenance organizations (HMO), Loan programs—health Medicare, and Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Incorporation by reference, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
Aged, Citizenship and naturalization, Civil rights, Health, Health care, Health records, Individuals with disabilities, Medicaid, Medicare, Religious discrimination, Reporting and recordkeeping requirements, Sex discrimination.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV and the Department of Health and Human Services amends 45 CFR part 170 as set forth below:
42 U.S.C. 1302 and 1395hh, and 300e, 300e-5, and 300e-9, and 31 U.S.C. 9701.
(e) * * *
(4) A COVID-19 vaccine and its administration described in section 1861(s)(10)(A) of the Act.
42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
(b) * * *
(26) The individual enrolls in Medicare premium-Part A or Part B using an exceptional condition SEP, as described in 42 CFR 406.27 and 407.23. The SEP begins when the individual submits their application for premium-Part A and Part B, or Part B only, if the individual is already entitled to Part A (or is enrolling in premium-free Part A within the timeframe for use of this SEP), and continues for the first 2 months beyond the premium-Part A and/or Part B entitlement date. The MA plan enrollment is effective the first of the month following the month the MA plan receives the enrollment request.
(n)
(1) The MA organization must make information about its digital health literacy screening and digital health education programs available to CMS upon request. Requested information may include, but is not limited to, statistics on the number of enrollees identified with low digital health literacy and receiving digital health education, manner(s) or method of digital health literacy screening and digital health education, financial impact of the programs on the MA organization, evaluations of effectiveness of digital health literacy interventions, and demonstration of compliance with the requirements of this section.
(2) [Reserved].
The revisions and addition read as follows:
(b) * * *
(2) General coverage and benefit conditions included in Traditional Medicare laws, unless superseded by laws applicable to MA plans. This includes criteria for determining whether an item or service is a benefit available under Traditional Medicare. For example, this includes payment criteria for inpatient admissions at 42 CFR 412.3, services and procedures that the Secretary designates as requiring inpatient care under 42 CFR 419.22(n), and requirements for payment of Skilled Nursing Facility (SNF) Care, Home Health Services under 42 CFR part 409, and Inpatient Rehabilitation Facilities (IRF) at 42 CFR 412.622(a)(3).
(6) MA organizations may create publicly accessible internal coverage criteria that are based on current evidence in widely used treatment guidelines or clinical literature when coverage criteria are not fully established in applicable Medicare statutes, regulations, NCDs or LCDs. Current, widely-used treatment guidelines are those developed by organizations representing clinical medical specialties, and refers to guidelines for the treatment of specific diseases or conditions. Acceptable clinical literature includes large, randomized controlled trials or
(i)
(A) additional, unspecified criteria are needed to interpret or supplement general provisions in order to determine medical necessity consistently. The MA organization must demonstrate that the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services;
(B) NCDs or LCDs include flexibility that explicitly allows for coverage in circumstances beyond the specific indications that are listed in an NCD or LCD; or
(C) There is an absence of any applicable Medicare statutes, regulations, NCDs or LCDs setting forth coverage criteria.
(ii)
(A) The internal coverage criteria in use and a summary of evidence that was considered during the development of the internal coverage criteria used to make medical necessity determinations;
(B) A list of the sources of such evidence; and
(C) An explanation of the rationale that supports the adoption of the coverage criteria used to make a medical necessity determination. When coverage criteria are not fully established as described in paragraph (6)(i)(A), the MA organization must identify the general provisions that are being supplemented or interpreted and explain how the additional criteria provide clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services.
(c) Medical necessity determinations and special coverage provisions—(1)
(A) Coverage and benefit criteria as specified at paragraphs (b) and (c) of this section and may not deny coverage for basic benefits based on coverage criteria not specified in paragraph (b) or (c) of this section.
(B) Whether the provision of items or services is reasonable and necessary under section 1862(a)(1) of the Act.
(C) The enrollee's medical history (for example, diagnoses, conditions, functional status), physician recommendations, and clinical notes.
(D) Where appropriate, involvement of the organization's medical director as required at § 422.562(a)(4).
(ii) [Reserved]
(2)
(e)
(2) MA enrollees are not charged traditional Medicare Part A and B deductibles for clinical trial coverage.
(3) MA plans are responsible for paying the difference between traditional Medicare cost-sharing incurred for qualifying clinical trial items and services and the MA plan's in-network cost-sharing for the same category of items and services.
(4) An enrollee's in-network cost-sharing portion must be included in the MA plan's maximum out-of-pocket calculation.
(5) MA plans may not require prior authorization for participation in a Medicare-qualified clinical trial not sponsored by the plan, nor may it create impediments to an enrollee's participation in a non-plan-sponsored clinical trial.
(f)
(2) MA plans are responsible for coverage of CMS-approved Category B devices that are covered under § 405.211(b) of this chapter.
(b) * * *
(3) * * *
(i) The number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services; each provider's cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider's office; any out-of-network coverage; any point-of-service option, including the supplemental premium for that option; and how the MA organization meets the requirements of §§ 422.112 and 422.114 for access to services offered under the plan.
(e)
(1) For contract terminations that involve a primary care or behavioral health provider:
(i) Provide written notice and make one attempt at telephonic notice to those enrollees identified in paragraph (e)(1)(iii) of this section who have not opted out of calls regarding plan business as described in § 422.2264(b),
(ii) At least 45 calendar days before the termination effective date, and
(iii) To all enrollees who are currently assigned to that primary care provider and to enrollees who have been patients of that primary care or behavioral health provider within the past three years.
(2) For contract terminations that involve specialty types other than primary care or behavioral health:
(i) Provide written notice,
(ii) At least 30 calendar days before the termination effective date, and
(iii) To all enrollees who are patients seen on a regular basis by the provider whose contract is terminating. The phrase “enrollees who are patients seen on a regular basis by the provider whose contract is terminating” means enrollees who are assigned to, currently receiving care from, or have received care within
The additions and revisions read as follows:
(a) * * *
(1) * * *
(i) * * * The network must include providers that specialize in behavioral health services.
(iii) Arrange for and cover any medically necessary covered benefit outside of the plan provider network, but at in-network cost sharing, when an in-network provider or benefit is unavailable or inadequate to meet an enrollee's medical needs.
(6) * * *
(i) Timeliness of access to care and member services that meet or exceed standards in this paragraph. The MA organization must continuously monitor access to care and member services and must take corrective action as necessary to ensure that appointment wait times in the provider network comply with these standards. The minimum standards for appointment wait times for primary care and behavioral health services are as follows for appointments:
(A) Urgently needed services or emergency—immediately;
(B) Services that are not emergency or urgently needed, but the enrollee requires medical attention—within 7 business days; and
(C) Routine and preventive care—within 30 business days.
(8)
(i) People with limited English proficiency or reading skills.
(ii) People of ethnic, cultural, racial, or religious minorities.
(iii) People with disabilities.
(iv) People who identify as lesbian, gay, bisexual, or other diverse sexual orientations.
(v) People who identify as transgender, nonbinary, and other diverse gender identities, or people who were born intersex.
(vi) People living in rural areas and other areas with high levels of deprivation.
(vii) People otherwise adversely affected by persistent poverty or inequality.
(b) * * *
(3) Programs for coordination of plan services with community and social services generally available through contracting or noncontracting providers in the area served by the MA plan, including nursing home and community-based services, and behavioral health services; and
(8)(i) With respect to basic benefits, policies for using prior authorization that at a minimum include that for enrollees undergoing an active course of treatment—
(A) Approval of a prior authorization request for a course of treatment must be valid for as long as medically necessary to avoid disruptions in care, in accordance with applicable coverage criteria, the individual patient's medical history, and the treating provider's recommendation; and
(B) A minimum 90-day transition period for any active course(s) of treatment when an enrollee has enrolled in an MA plan after starting a course of treatment, even if the service is furnished by an out-of-network provider. This includes enrollees new to a plan and enrollees new to Medicare. The MA organization must not disrupt or require reauthorization for an active course of treatment for new plan enrollees for a period of at least 90 days.
(ii) For purposes of this paragraph (b)(8), the following definitions apply:
(A)
(B)
(b) * * *
(1) * * *
(i)
The revisions and additions read as follows:
(b) * * *
(1) * * *
(xxviii) Clinical Psychology.
(xxix) Clinical Social Work.
(d) * * *
(2) * * *
(5) * * *
(xiii) Clinical Psychology.
(xxiv) Clinical Social Work.
(e) * * *
(3) * * *
(i) * * *
(C) * * *
(a)
(b)
(c)
(1) Include a majority of members who are practicing physicians.
(2) Include at least one practicing physician who is independent and free of conflict relative to the MA organization and MA plan.
(3) Include at least one practicing physician who is an expert regarding care of elderly or disabled individuals.
(4) Include members representing various clinical specialties (for example, primary care, behavioral health) to ensure that a wide range conditions are adequately considered in the development of the MA plan's utilization management policies.
(d)
(1) At least annually, review the policies and procedures for all utilization management, including prior authorization, used by the MA plan. Such review must consider:
(i) The services to which the utilization management applies;
(ii) Coverage decisions and guidelines for Traditional Medicare, including NCDs, LCDs, and laws; and
(iii) Relevant current clinical guidelines.
(2) Approve only utilization management policies and procedures that:
(i) Use or impose coverage criteria that comply with the requirements and standards at § 422.101(b);
(ii) For prior authorization policies, comply with requirements and standards at § 422.138;
(iii) Comply with the standards in § 422.202(b)(1); and
(iv) Apply and rely on medical necessity criteria that comply with § 422.101(c)(1).
(3) Revise the utilization management policies and procedures as necessary to comply with the standards in this regulation, including removing requirements for UM for services and items that no longer warrant UM.
(4) Clearly articulate and document processes to determine that the requirements under paragraphs (c)(1) through (4) of this section have been met, including the determination by an objective party of whether disclosed financial interests are conflicts of interest and the management of any recusals due to such conflicts.
(5) Document in writing the reason for its decisions regarding the development of UM policies and make this documentation available to CMS upon request.
(a)
(b)
(1) To confirm the presence of diagnoses or other medical criteria that are the basis for coverage determinations for the specific item or service; or
(2) For basic benefits, to ensure an item or service is medically necessary based on standards specified in § 422.101(c)(1), or
(3) For supplemental benefits, to ensure that the furnishing of a service or benefit is clinically appropriate.
(c)
(a) * * *
(5) Incorporate one or more activities that reduce disparities in health and health care. These activities must be broadly accessible irrespective of race, ethnicity, national origin, religion, sex, or gender. These activities may be based upon health status and health needs, geography, or factors not listed in the previous sentence only as appropriate to address the relevant disparities in health and health care.
The addition and revisions read as follows:
(a) * * *
(b) * * * (1)
(3) * * *
(iv) * * *
(A)(
(e) * * *
(1) * * *
(iii) The measure steward other than CMS retires a measure.
The revisions and addition read as follows:
(a) * * *
(2) * * *
(i) The method maximizes differences across the star categories and minimizes the differences within star categories using mean resampling with the hierarchal clustering of the current year's data. Effective for the Star Ratings issued in October 2023 and subsequent years, prior to applying mean resampling with hierarchal clustering, Tukey outer fence outliers are removed. Effective for the Star Ratings issued in October 2022 and subsequent years, CMS will add a guardrail so that the measure-threshold-specific cut points for non-CAHPS measures do not increase or decrease more than the value of the cap from 1 year to the next. The cap is equal to 5 percentage points for measures having a 0 to 100 scale (absolute percentage cap) or 5 percent of the restricted range for measures not having a 0 to 100 scale (restricted range cap). New measures that have been in the Part C and D Star Rating program for 3 years or less use the hierarchal clustering methodology with mean resampling with no guardrail for the first 3 years in the program.
(c) * * *
(1) CMS will calculate the Part C summary ratings using the weighted mean of the measure-level Star Ratings for Part C, weighted in accordance with paragraph (e) of this section and with the applicable adjustments provided in paragraph (f) of this section.
(d) * * *
(1) The overall rating for a MA-PD contract will be calculated using a weighted mean of the Part C and Part D measure-level Star Ratings, weighted in accordance with paragraph (e) of this section and with the applicable adjustments provided in paragraph (f) of this section.
(e) * * *
(1) * * *
(iii) Through the 2025 Star Ratings, patient experience and complaint measures receive a weight of 4. Starting with the 2026 Star Ratings and subsequent Star Ratings years, patient experience and complaint measures receive a weight of 2.
(iv) Through the 2025 Star Ratings, access measures receive a weight of 4. Starting with the 2026 Star Ratings and subsequent Star Ratings years, access measures receive a weight of 2.
(f) * * *
(1)
(2) * * *
(i) The CAI is added to or subtracted from the contract's overall and summary ratings and is applied after the reward factor adjustment described in paragraph (f)(1) of this section (if applicable).
(3)
(i) The health equity index (HEI) is calculated separately for the overall rating for MA-PDs and cost contracts including the applicable Part C and D measures; Part C summary rating for MA-only, MA-PD, and cost contracts including the applicable Part C measures; Part D summary rating for MA-PDs and cost contracts including the applicable Part D measures; and Part D summary rating for PDPs including the applicable Part D measures.
(A) The SRFs included in the HEI are receipt of the low income subsidy or being dually eligible for Medicare and Medicaid (LIS/DE), or having a disability. Enrollees will be identified as LIS/DE or as having a disability as specified in paragraph (f)(2)(i)(B) of this section. If a person meets the LIS/DE criteria for only one of the two measurement years included in the HEI, the data for that person for just that year are used. Measures that are case-mix adjusted in the Star Ratings are adjusted using all standard case-mix adjustors for the measure except for those adjusters that are the SRFs of interest in the index, are strongly correlated with the SRFs of interest, or are conceptually similar to the SRFs of interest.
(B) The HEI is calculated by combining measure-level scores for the subset of enrollees with SRFs of interest included in the HEI across the two most recent measurement years using a modeling approach that includes year as an adjustor to account for potential differences in performance across years and to adjust the data to reflect performance in the second of the 2 years of data used. Measure-level scores are used for contracts that have data for only the most recent year of the 2 years, but measure-level scores are not used for contracts that have data for only the first of the 2 years.
(ii) In determining the HEI scores, a measure will be excluded from the calculation of the index if the measure meets any of the following:
(A) The focus of the measurement is not the enrollee but rather the plan or provider.
(B) The measure is retired, moved to display, or has a substantive specification change in either year of data used to construct the HEI.
(C) The measure is applicable only to SNPs.
(D) At least 25 percent of contracts are unable to meet the criteria specified in paragraph (f)(3)(iv) of this section. For Part D measures, this criterion is assessed separately for MA-PDs and cost contracts, and for PDPs.
(iii) The Star Ratings measures that remain after the exclusion criteria in paragraph (f)(3)(ii) of this section have been applied will be included in the calculation of the HEI. CMS will announce the measures being evaluated for inclusion in the calculation of the HEI under this paragraph (f)(3) through the process described for changes in and adoption of payment and risk adjustment policies in section 1853(b) of the Act.
(iv) For a measure to be included in the calculation of a contract's HEI score, the measure must meet both of the following criteria:
(A) The measure must have a reliability of at least 0.7 for the contract when calculated for the combined subset of enrollees with the SRF(s) specified in paragraph (f)(3)(i)(A) of this section across 2 years of data.
(B) The measure-specific denominator criteria must be met for the contract using only the combined subset of enrollees in the contract with the SRF(s) specified in paragraph (f)(3)(i)(A) of this section across 2 years of data.
(v) To calculate the rating-specific HEI score, the distribution of contract performance on each eligible measure for the subset of enrollees that have one or more of the specified SRFs will be assessed and separated into thirds, with the top third of contracts receiving 1 point, the middle third of contracts receiving 0 points, and the bottom third of contracts receiving −1 point. The rating-specific HEI will then be calculated as the weighted sum of points across all measures included in the index using the Star Ratings measure weight for each measure divided by the weighted sum of the number of eligible measures for the given contract. The measure weight for each measure is the weight used for the measure in the current Star Ratings year as specified in paragraph (e) of this section.
(vi) To have the HEI calculated, contracts must have at least 500 enrollees in the most recent measurement year used in the HEI and have at least half of the measures included in the HEI meet the criteria specified under paragraph (f)(3)(iv) of this section.
(vii) In order to qualify for the full HEI reward, contracts must have percentages of enrollees with the specified SRFs combined greater than or equal to the contract-level median in the most recent year of data used to calculate the HEI and a rating-specific minimum index score of greater than zero. In order to qualify for one-half of the HEI reward, contracts must have percentages of enrollees with SRFs greater than or equal to one-half of the contract-level median up to, but not including, the contract-level median percentage of enrollees with SRFs in the most recent year of data used to calculate the HEI and a rating-specific minimum index score of greater than zero. One-half of the contract-level median and the contract-level median enrollment percentages are assessed separately for contracts that offer Part C and stand-alone Part D contracts.
(A) For contracts with service areas wholly located in Puerto Rico, the percentage of enrollees that are LIS/DE or disabled is calculated by adding the number of DE/disabled enrollees to the estimated LIS percentage calculated by taking the percentage LIS/DE as calculated at §§ 422.166(f)(2)(vi) and (vii) and 423.186(f)(2)(vi) and (vii) and subtracting the percentage of DE enrollees.
(B) Contracts with service areas wholly located in Puerto Rico are excluded from the calculation of one-half of the contract-level median and the contract-level median.
(viii) For contracts that have percentages of enrollees with SRFs greater than or equal to the contract-level median enrollment percentage, the HEI reward added to the contract's summary and overall ratings will vary from 0 to 0.4 on a linear scale, with a contract receiving 0 if the contract receives a score of 0 or less on the HEI and 0.4 if the contract receives a score
(ix) The HEI reward is calculated separately for, and then added to, the overall rating, Part C rating for MA-PDs and MA-only contracts (and cost contracts), Part D rating for MA-PDs (and cost contracts), and Part D rating for PDPs after the addition of the CAI as specified in paragraph (f)(2) of this section and application of the improvement measures as specified in paragraph (g) of this section and before the final overall and Part C and D summary ratings are calculated by rounding to the nearest half star.
(g) * * *
(1) CMS runs the calculations twice for the highest level rating for each contract-type (overall rating for MA-PD contracts and Part C summary rating for MA-only contracts), with the reward factor adjustment if applicable and the CAI adjustment, once including the improvement measure(s) and once without including the improvement measure(s). In deciding whether to include the improvement measures in a contract's final highest rating, CMS applies the following rules:
(i) * * *
(3) * * *
(iv) For an affected contract with at least 25 percent of enrollees in FEMA-designated Individual Assistance areas at the time of the extreme and uncontrollable circumstance, the affected contract receives the higher of the previous year's Star Rating or the current year's Star Rating (and corresponding measure score) for each HOS and HEDIS-HOS measure. The adjustment is for 3 years after the extreme and uncontrollable circumstance.
(9) * * *
(i) Through the 2025 Star Ratings, CMS excludes the numeric values for affected contracts with 60 percent or more of their enrollees in the FEMA-designated Individual Assistance area at the time of the extreme and uncontrollable circumstance from the clustering algorithms described in paragraph (a)(2) of this section.
(10) * * *
(i) Through the 2025 Star Ratings, CMS excludes the numeric values for affected contracts with 60 percent or more of their enrollees in the FEMA-designated Individual Assistance area at the time of the extreme and uncontrollable circumstance from the determination of the performance summary and variance thresholds for the reward factor described in paragraph (f)(1) of this section.
(b) * * *
(1) * * *
(i) Are based on current evidence in widely used treatment guidelines or clinical literature;
(e) * * *
(1) The contract will be amended to exclude any MA plan, MA plan segment, or State-licensed entity specified by CMS; and
(2) A separate contract for any such excluded plan, segment, or entity will be deemed to be in place when such a request is made.
(a) * * *
(19) Not to establish a segment of an MA plan that meets the criteria in § 422.514(d), as determined in the procedures described in § 422.514(e)(3), with the addition of the newly enrolled individuals.
(a) * * *
(4) * * *
(xvi) Meets the criteria in § 422.514(d)(1) or (2).
(d) * * *
(1) Enter into or renew a contract under this subpart, for plan year 2024 and subsequent years, for a MA plan that—
(i) Is not a specialized MA plan for special needs individuals as defined in § 422.2; and
(ii) Projects enrollment in its bid submitted under § 422.254 that 80 percent or more enrollees of the plan's total enrollment are enrollees entitled to medical assistance under a State plan under title XIX.
(g)
(d)
(b) * * *
(1) If the MA organization makes a reconsidered determination that is completely favorable to the enrollee, the MA organization must issue its reconsidered determination to the enrollee (and effectuate it in accordance with § 422.618(a)(2)) no later than 60 calendar days from the date it receives the request for a standard reconsideration.
(k) * * *
(3)
The revision reads as follows:
(a) * * *
(2) Materials must be submitted to the HPMS Marketing Module by the MA organization or, where materials have been developed by a Third Party Marketing Organization for multiple MA organizations or plans, by a Third Party Marketing Organization with prior review of each MA organization on whose behalf the materials were created or will be used.
(a) * * *
(1) * * *
(ii) Use of superlatives, unless sources of documentation or data supportive of the superlative is also referenced in the material. Such supportive documentation or data must reflect data, reports, studies, or other documentation that applies to the current or prior contract year.
(A) Including data older than the prior contract year is permitted provided the current and prior contract year data are specifically identified.
(B) [Reserved]
(xix) Use the Medicare name, CMS logo, and products or information issued by the Federal Government, including the Medicare card, in a misleading way. Use of the Medicare card image is permitted only with authorization from CMS.
(b) * * *
(8) Advertise benefits that are not available to beneficiaries in the service area(s) where the marketing appears, unless the advertisement is in local media that serves the service area(s) where the benefits are available and reaching beneficiaries who reside in other service areas is unavoidable.
(9) Market any products or plans, benefits, or costs, unless the MA organization or marketing name(s) as listed in HPMS of the entities offering the referenced products or plans, benefits, or costs are identified in the marketing material.
(i) MA organization or marketing names must be in 12-point font in print and may not be in the form of a disclaimer or fine print.
(ii) For television, online, or social media, the MA organization or marketing name(s) must be either read at the same pace as the phone number or must be displayed throughout the entire advertisement in a font size equivalent to the advertised phone number, contact information, or benefits.
(iii) For radio or other voice-based advertisements, MA organization or marketing names must be read at the same pace as the advertised phone numbers or other contact information. (10) MA organizations may not include information about savings available to potential enrollees that are based on a comparison of typical expenses borne by uninsured individuals, unpaid costs of dually eligible beneficiaries, or other unrealized costs of a Medicare beneficiary.
The additions and revisions read as follows:
(a) * * *
(2) * * *
(i) * * *
(A) Contact is unsolicited door-to-door contact unless an appointment, at the beneficiary's home at the applicable date and time, was previously scheduled.
(B) [Reserved].
(b) * * *
(2) If the MA organization reaches out to beneficiaries regarding plan business, as outlined in this section, the MA organization must provide notice to all beneficiaries whom the plan contacts as least once annually, in writing, of the individual's ability to opt out of future calls regarding plan business.
(c) * * *
(1) * * *
(ii) * * *
(D) Make available and receive beneficiary contact information, including Business Reply Cards, but not including Scope of Appointment forms
(c) * * *
(2) * * *
(i) Marketing events are prohibited from taking place within 12 hours of an educational event, in the same location. The same location is defined as the entire building or adjacent buildings.
(3) * * *
(i) At least 48 hours prior to the scheduled personal marketing, the MA plan (or agent or broker, as applicable) must agree upon and record the Scope of Appointment with the beneficiary(ies), except for:
(A) SOAs that are completed during the last four days of a valid election period for the beneficiary.
(B) Unscheduled in person meetings (walk-ins) initiated by the beneficiary.
(iii) * * *
(A) Market any health care related product during a marketing appointment beyond the scope agreed upon by the beneficiary, and documented by the plan in a Scope of Appointment, business reply card, or request to receive additional information, which is valid for 12 months following the date of beneficiary's signature date or the date of the beneficiary's initial request for information.
(B) Market additional health related lines of plan business not identified prior to an individual appointment without a separate Scope of Appointment, identifying the additional lines of business to be discussed; such Scope of Appointment is valid for 12 months following the beneficiary's signature date.
(b) * * *
(4) A provider directory searchable by every element required in the model provider directory, such as name, location, specialty.
The additions and revisions read as follows:
(a) * * *
(3) Be provided to enrollees on a standing basis in any non-English language identified in paragraphs (a)(2) and (4) of this section or accessible format upon receiving a request for the materials in anon-English language or accessible format or when otherwise learning of the enrollee's primary language or need for an accessible format. This requirement also applies to the individualized plans of care described in § 422.101(f)(1)(ii) for special needs plan enrollees.
(4) For any fully integrated dual eligible special needs plan or highly integrated dual eligible special needs plan, as defined at § 422.2, or applicable integrated plan, as defined at § 422.561, be translated into the language(s) required by the Medicaid translation standard as specified through their capitated Medicaid managed care contract in addition to the language(s) required by the Medicare translation standard in paragraph (a)(2) of this section.
(5) * * *
(e) * * *
(4)
(viii) Effect on current coverage.
(5) * * *
(ii) * * *
(A) Information on the following medical benefits, starting in the top half of the first page and in the order as identified in paragraphs (A)(1) through (A)(10), including—
(10)
(12)
(i) The written Provider Termination Notice must be provided in hard copy via U.S. mail (first class postage is recommended, but not required).
(ii) The written Provider Termination Notice must do all of the following:
(A) Inform the enrollee that the provider will no longer be in the network and the date the provider will leave the network.
(B) Include names and phone numbers of in-network providers that the enrollee may access for continued care (this information may be supplemented with information for accessing a current provider directory, including both online and direct mail options).
(C) Explain how the enrollee may request a continuation of ongoing medical treatment or therapies with their current provider.
(D) Provide information about the annual coordinated election period and the MA open enrollment period, as well as explain that an enrollee who is impacted by the provider termination may contact 1-800-MEDICARE to request assistance in identifying and switching to other coverage, or to request consideration for a special election period, as specified in § 422.62(b)(26), based on the individual's unique circumstances and consistent with existing parameters for this SEP.
(E) Include the MA organization's call center telephone number, TTY number, and hours and days of operation.
(iii) The telephonic Provider Termination Notice specified in § 422.111(e)(1)(i) must relay the same information as the written Provider Termination Notice as described in paragraph (e)(12)(ii) of this section.
(30) * * *
(vi) Is excluded from the translation requirement under paragraphs (a)(2) through (4) of this section; and
(41)
(i) Used by any TPMO, as defined under § 422.2260, that sells plans on behalf of more than one MA organization.
(ii) Verbally conveyed within the first minute of a sales call.
(iii) Electronically conveyed when communicating with a beneficiary through email, online chat, or other electronic means of communication.
(iv) Prominently displayed on TPMO websites.
(v) Included in any marketing materials, including print materials and television advertisements, developed, used or distributed by the TPMO.
(e) Establish and implement an oversight plan that monitors agent and broker activities, identifies non-compliance with CMS requirements, and reports non-compliance to CMS.
(c) * * *
(12) Ensure that, prior to an enrollment, CMS' required questions and topics regarding beneficiary needs in a health plan choice are fully discussed. Topics include information regarding primary care providers and specialists (that is, whether or not the beneficiary's current providers are in the plan's network), regarding pharmacies (that is, whether or not the beneficiary's current pharmacy is in the plan's network), prescription drug coverage and costs (including whether or not the beneficiary's current prescriptions are covered), costs of health care services, premiums, benefits, and specific health care needs.
(g) * * *
(2) * * *
(ii) Record all marketing, sales, and enrollment calls, including the audio portion of calls via web-based technology, in their entirety.
42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
The revision and addition read as follows:
(c) * * *
(16) The individual who is not entitled to premium free Part A and enrolls in Part B during the General Enrollment Period for Part B that starts January 1, 2023, is eligible to request enrollment in a Part D plan. The special enrollment period begins when the individual submits their Part B application and continues for the first 2 months of Part B enrollment. The Part D plan enrollment is effective the first of the month following the month the Part D sponsor receives the enrollment request.
(34) The individual enrolls in Medicare premium-Part A or Part B using an exceptional condition SEP, as described in 42 CFR parts 406.27 and 407.23. The SEP begins when the individual submits their premium-Part A or Part B application and continues for the first 2 months of enrollment in premium Part A or Part B. The Part D plan enrollment is effective the first of the month following the month the Part D plan receives the enrollment request.
(c)
The addition and revisions read as follows:
(a) * * *
(b) * * *
(1)
(3) * * *
(ii) * * *
(A)(
(e) * * *
(1) * * *
(iii) The measure steward other than CMS retires a measure.
The revisions and addition read as follows:
(a) * * *
(2) * * *
(i) The method maximizes differences across the star categories and minimizes the differences within star categories using mean resampling with the hierarchal clustering of the current year's data. Effective for the Star Ratings issued in October 2023 and subsequent years, prior to applying mean resampling with hierarchal clustering, Tukey outer fence outliers are removed. Effective for the Star Ratings issued in October 2022 and subsequent years, CMS will add a guardrail so that the measure-threshold-specific cut points for non-CAHPS measures do not increase or decrease more than the value of the cap from 1 year to the next. The cap is equal to 5 percentage points for measures having a 0 to 100 scale (absolute percentage cap) or 5 percent of the restricted range for measures not having a 0 to 100 scale (restricted range cap). New measures that have been in the Part C and D Star Rating program for 3 years or less use the hierarchal clustering methodology with mean resampling with no guardrail for the first 3 years in the program.
(c) * * *
(1) CMS will calculate the Part D summary ratings using the weighted mean of the measure-level Star Ratings for Part D, weighted in accordance with paragraph (e) of this section and with the applicable adjustments provided in paragraph (f) of this section.
(d) * * *
(1) The overall rating for a MA-PD contract will be calculated using a weighted mean of the Part C and Part D measure-level Star Ratings, weighted in accordance with paragraph (e) of this section and with the applicable adjustments provided in paragraph (f) of this section.
(e) * * *
(1) * * *
(iii) Through the 2025 Star Ratings, patient experience and complaint measures receive a weight of 4. Starting with the 2026 Star Ratings and subsequent Star Ratings years, patient experience and complaint measures receive a weight of 2.
(iv) Through the 2025 Star Ratings, access measures receive a weight of 4. Starting with the 2026 Star Ratings and subsequent Star Ratings years, access measures receive a weight of 2.
(f) * * *
(1)
(2) * * *
(i) The CAI is added to or subtracted from the contract's overall and summary ratings and is applied after the reward factor adjustment described in paragraph (f)(1) of this section (if applicable).
(3)
(i) The health equity index (HEI) is calculated separately for the overall rating for MA-PDs and cost contracts including the applicable Part C and D measures; Part C summary rating for MA-only, MA-PD, and cost contracts including the applicable Part C measures; Part D summary rating for MA-PDs and cost contracts including the applicable Part D measures; and Part D summary rating for PDPs including the applicable Part D measures.
(A) The SRFs included in the HEI are receipt of the low-income subsidy or being dually eligible for Medicare and Medicaid (LIS/DE), or having a disability. Enrollees will be identified as LIS/DE or as having a disability as specified in paragraph (f)(2)(i)(B) of this section. If a person meets the LIS/DE criteria for only one of the two measurement years included in the HEI, the data for that person for just that year are used. Measures that are case-mix adjusted in the Star Ratings are adjusted using all standard case-mix adjustors for the measure except for those adjusters that are the SRFs of interest in the index, are strongly correlated with the SRFs of interest, or are conceptually similar to the SRFs of interest.
(B) The HEI is calculated by combining measure-level scores for the subset of enrollees with SRFs of interest included in the HEI across the two most recent measurement years using a modeling approach that includes year as an adjustor to account for potential differences in performance across years and to adjust the data to reflect performance in the second of the 2 years of data used. Measure-level scores are used for contracts that have data for only the most recent of the 2 years, but measure-level scores are not used for contracts that have data for only the first of the 2 years.
(ii) In determining the HEI scores, a measure will be excluded from the calculation of the index if the measure meets any of the following:
(A) The focus of the measurement is not the enrollee but rather the plan or provider.
(B) The measure is retired, moved to display, or has a substantive specification change in either year of data used to construct the HEI.
(C) The measure is applicable only to SNPs.
(D) At least 25 percent of contracts are unable to meet the criteria specified in paragraph (f)(3)(iv) of this section. For Part D measures, this criterion is assessed separately for MA-PDs and cost contracts, and for PDPs.
(iii) The Star Ratings measures that remain after the exclusion criteria in paragraph (f)(3)(ii) of this section have been applied will be included in the calculation of the HEI. CMS will announce the measures being evaluated for inclusion in the calculation of the HEI under this paragraph (f)(3) of this section through the process described for changes in and adoption of payment
(iv) For a measure to be included in the calculation of a contract's HEI score, the measure must meet both of the following criteria:
(A) The measure must have a reliability of at least 0.7 for the contract when calculated for the combined subset of enrollees with the SRF(s) specified in paragraph (f)(3)(i)(A) of this section across 2 years of data.
(B) The measure-specific denominator criteria must be met for the contract using only the combined subset of enrollees with the SRF(s) specified in paragraph (f)(3)(i)(A) of this section across 2 years of data.
(v) To calculate the rating-specific HEI score, the distribution of contract performance on each eligible measure for the subset of enrollees that have one or more of the specified SRFs will be assessed and separated into thirds, with the top third of contracts receiving 1 point, the middle third of contracts receiving 0 points, and the bottom third of contracts receiving −1 point. The rating-specific HEI will then be calculated as the weighted sum of points across all measures included in the index using the Star Ratings measure weight for each measure divided by the weighted sum of the number of eligible measures for the given contract. The measure weight for each measure is the weight used for the measure in the current Star Ratings year as specified in paragraph (e) of this section.
(vi) To have the HEI calculated, contracts must have at least 500 enrollees in the most recent measurement year used in the HEI and have at least half of the measures included in the HEI meet the criteria specified under paragraph (f)(3)(iv) of this section.
(vii) In order to qualify for the full HEI reward, contracts must have percentages of enrollees with the specified SRFs combined greater than or equal to the contract-level median in the most recent year of data used to calculate the HEI and a rating-specific minimum index score of greater than zero. In order to qualify for one-half of the HEI reward, contracts must have percentages of enrollees with SRFs greater than or equal to one-half of the contract-level median up to, but not including, the contract-level median percentage of enrollees with SRFs in the most recent year of data used to calculate the HEI and a rating-specific minimum index score of greater than zero. One-half of the contract-level median and the contract-level median enrollment percentages are assessed separately for contracts that offer Part C and stand-alone Part D contracts.
(A) For contracts with service areas wholly located in Puerto Rico, the percentage of enrollees that are LIS/DE or disabled is calculated by adding the number of DE/disabled enrollees to the estimated LIS percentage calculated by taking the percentage LIS/DE as calculated at §§ 422.166(f)(2)(vi) and (vii) and 423.186(f)(2)(vi) and (vii) and subtracting the percentage of DE enrollees.
(B) Contracts with service areas wholly located in Puerto Rico are excluded from the calculation of one-half of the contract-level median and the contract-level median.
(viii) For contracts that have percentages of enrollees with SRFs greater than or equal to the contract-level median enrollment percentage, the HEI reward added to the contract's summary and overall ratings will vary from 0 to 0.4 on a linear scale with a contract receiving 0 if the contract receives a score of 0 or less on the HEI and 0.4 if the contract receives a score of 1 on the HEI. For contracts that have percentages of enrollees with SRFs greater than or equal to one-half the median percentage of enrollees with SRFs up to, but not including, the contract-level median percentage of enrollees with SRFs, the HEI reward added to the contract's summary and overall ratings will vary from 0 to 0.2 on a linear scale, with a contract receiving 0 if the contract receives a score of 0 or less on the HEI and 0.2 if the contract receives a score of 1 on the HEI. The HEI reward is rounded and displayed with 6 decimal places. Contracts that cannot have a HEI score calculated (that is, contracts that are not scored on at least half of the measures included in the index) will not receive an HEI reward.
(ix) The HEI reward is calculated separately for, and then added to, the overall rating, Part C rating for MA-PDs and MA-only contracts (and cost contracts), Part D rating for MA-PDs (and cost contracts), and Part D rating for PDPs after the addition of the CAI as specified in paragraph (f)(2) of this section and application of the improvement measures as specified in paragraph (g) of this section and before the final overall and Part C and D summary ratings are calculated by rounding to the nearest half star.
(g)
(1) CMS runs the calculations twice for the highest level rating for each contract-type (overall rating for MA-PD contracts and Part D summary rating for PDPs), with the reward factor adjustment if applicable and the CAI adjustment, once including the improvement measure(s) and once without including the improvement measure(s). In deciding whether to include the improvement measures in a contract's final highest rating, CMS applies the following rules:
(i) * * *
(7) * * *
(i) Through the 2025 Star Ratings, CMS excludes the numeric values for affected contracts with 60 percent or more of their enrollees in the FEMA-designated Individual Assistance area at the time of the extreme and uncontrollable circumstance from the clustering algorithms described in paragraph (a)(2) of this section.
(8) * * *
(i) Through the 2025 Star Ratings, CMS excludes the numeric values for affected contracts with 60 percent or more of their enrollees in the FEMA-designated Individual Assistance area at the time of the extreme and uncontrollable circumstance from the determination of the performance summary and variance thresholds for the reward factor described in paragraph (f)(1) of this section.
The additions read as follows:
(b) * * *
(2)
(ii)
(4)
(1) The share of actual costs (as defined by § 423.100 of this part) paid by the Part D plan that is received as reimbursement by the pharmacy, or other dispensing entity, reimbursement paid to indemnify an enrollee when the reimbursement is associated with an enrollee obtaining covered Part D drugs under the Part D plan, or payments made by the Part D sponsor to other parties listed in § 423.464(f)(1) of this part with which the Part D sponsor must coordinate benefits, including other Part D plans, or as the result of any reconciliation process developed by CMS under § 423.464 of this part.
(b) * * *
(22) Through the CMS complaint tracking system, address and resolve complaints received by CMS against the Part D sponsor.
The revisions and addition read as follows:
(b)
(1) Has income below 135 percent of the FPL applicable to the individual's family size or, with respect to a plan year beginning on or after January 1, 2024, has income below 150 percent of the FPL applicable to the individual's family size; and
(2) * * *
(iii) For plan years beginning on or after January 1, 2024, the amount of resources specified at paragraph (d)(2) of this section.
(d)
(d)
The revision reads as follows:
(a) * * *
(2) Materials must be submitted to the HPMS Marketing Module by the Part D sponsor or, where materials have been developed by a Third Party Marketing Organization for multiple Part D sponsors or plans, by a Third Party Marketing Organization with prior review of each Part D sponsor on whose behalf the materials were created or will be used.
(ii) Use of superlatives, unless sources of documentation or data supportive of the superlative is also referenced in the material. Such supportive documentation or data must reflect data, reports, studies, or other documentation that applies to the current contract year or prior contract year.
(A) Including data older than the prior contract year is permitted provided the current and prior contract year data are specifically identified.
(B) [Reserved]
(xviii) Use of the Medicare name, CMS logo, and products or information issued by the Federal Government, including the Medicare card in a misleading way. Use of the Medicare card image is permitted only with authorization from CMS.
(b) * * *
(8) Advertise benefits that are not available to beneficiaries in the service area(s) where the marketing appears, unless the advertisement is in local media that serves the service area(s) where the benefits are available and reaching beneficiaries who reside in other service areas is unavoidable.
(9) Market any products or plans, benefits, or costs, unless the Part D sponsor or marketing name(s) as listed in HPMS of the entities offering the referenced products or plans, benefits, or costs are identified in the marketing material.
(i) Part D sponsor or marketing names must be in 12-point font in print and may not be in the form of a disclaimer or in fine print.
(ii) For television, online, or social media, the Part D sponsor or marketing name(s) must be either read at the same pace as the phone number or must be displayed throughout the entire advertisement in a font size equivalent to the advertised phone number, contact information or benefits.
(iii) For radio or other voice-based advertisements, Part D sponsor or marketing names must be read at the same pace as phone numbers or contact information.
(10) Part D sponsors may not include information about savings available to potential enrollees that are based on a comparison of typical expenses borne by uninsured individuals, unpaid costs of dually eligible beneficiaries, or other unrealized costs of a Medicare beneficiary.
The addition additions and revisions read as follows:
(a) * * *
(2) * * *
(i) * * *
(A) Contact is unsolicited door-to-door contact unless an appointment, at the beneficiary's home at the applicable time and date, was previously scheduled.
(B) [Reserved]
(b) * * *
(2) If the Part D sponsor reaches out to beneficiaries regarding plan business, as outlined in this section, the Part D sponsor must provide notice to all beneficiaries whom the plan contacts as least once annually, in writing, of the individual's ability to opt out of future calls regarding plan business.
(c) * * *
(1) * * *
(ii) * * *
(D) Make available and receive beneficiary contact information, including Business Reply Cards, but not including Scope of Appointment forms
(c) * * *
(2) * * *
(i) Marketing events are prohibited from taking place within 12 hours of an educational event, in the same location. The same location is defined as the entire building or adjacent buildings.
(3) * * *
(i) At least 48 hours prior to the scheduled personal marketing appointment, the Part D plan (or agent or broker, as applicable) must agree upon and record the Scope of Appointment with the beneficiary(ies), except for:
(A) SOAs that are completed during the last four days prior of a valid election period for the beneficiary.
(B) Unscheduled in person visits (walk-ins) initiated by the beneficiary.
(iii) * * *
(A) Market any health care related product during a marketing appointment beyond the scope agreed upon by the beneficiary, and documented by the plan in a Scope of Appointment, business reply card, or request to receive additional information, which is valid for 12 months following the date of beneficiary's signature date or the date of the beneficiary's initial request for information.
(B) Market additional health related lines of plan business not identified prior to an individual appointment without a separate Scope of Appointment, identifying the additional lines of business to be discussed; such Scope of Appointment is valid for 12 months following the beneficiary's signature date.
The revisions and additions read as follows:
(a) * * *
(3) Be provided to enrollees on a standing basis in any non-English language identified in paragraphs (a)(2) and (4) of this section and/or accessible format using auxiliary aids and services upon receiving a request for the materials in a non-English language or accessible format or when otherwise learning of the enrollee's primary language and/or need for an accessible format. This requirement also applies to the individualized plans of care described in § 422.101(f)(1)(ii) of this chapter for special needs plan enrollees.
(4) For any fully integrated dual eligible special needs plan or highly integrated dual eligible special needs plan as defined at § 422.2 of this chapter, or applicable integrated plan as defined at § 422.561 of this chapter, be translated into the language(s) required by the Medicaid translation standard as specified through their capitated Medicaid managed care contract in addition to the language(s) required by the Medicare translation standard in paragraph (a)(2) of this section.
(e) * * *
(4)
(viii) Effect on current coverage.
(13)
(32) * * *
(vi) Is excluded from the translation requirement under paragraphs (a)(2) through (4) of this section; and
(41)
(i) Used by any TPMO, as defined under § 422.2260, that sells plans on behalf of more than one MA organization.
(ii) Verbally conveyed within the first minute of a sales call.
(iii) Electronically conveyed when communicating with a beneficiary through email, online chat, or other electronic means of communication.
(iv) Prominently displayed on TPMO websites.
(v) Included in any marketing materials, including print materials and television advertisements, developed, used or distributed by the TPMO.
(42) [Reserved]
(43)
(44)
(e) Establish and implement an oversight plan that monitors agent and broker activities, identifies non-compliance with CMS requirements, and reports non-compliance to CMS.
(c) * * *
(12) Ensure that, prior to an enrollment CMS' required questions and topics regarding beneficiary needs in a health plan choice are fully discussed. Topics include information regarding pharmacies (that is, whether or not the beneficiary's current pharmacy is in the plan's network), prescription drug coverage and costs (including whether or not the beneficiary's current prescriptions are covered), premiums, and other services or incentives.
(g) * * *
(2) * * *
(ii) Record all marketing, sales, and enrollment calls, including the audio portion of calls occurring via web-based technology, in their entirety.
(a)
(b)
(a)
(1)
(i) Has not yet enrolled in a prescription drug plan or an MA-PD plan; or
(ii) Has enrolled in a prescription drug plan or MA-PD plan but their coverage has not yet taken effect.
(2)
(3)
(i) A copy of the beneficiary's Medicaid card that includes their name and the eligibility date;
(ii) A copy of a letter from the State or SSA showing LIS or “Extra Help” status;
(iii) The date that a verification call was made to the State Medicaid Agency, the name and telephone number of the State staff person who verified the Medicaid period, and the Medicaid eligibility dates confirmed on the call;
(iv) A copy of a State document that confirms active Medicaid status;
(v) A screen-print from the State's Medicaid systems showing Medicaid status; or
(vi) Evidence at point-of-sale of recent Medicaid billing and payment in the pharmacy's patient profile.
(4)
(5)
(b)
(1)
(2)
(3)
(4)
(c)
(2) Retroactive LI NET coverage begins on the date an individual is identified as eligible for a low-income subsidy as a full-benefit dual eligible or an SSI benefit recipient, or 36 months prior to the date such individual enrolls in (or opts out of) Part D coverage, whichever is later. LI NET coverage ends with enrollment into a Part D plan or opting out of Part D coverage.
(d)
(1) The individual is auto-enrolled into a standalone Part D plan in accordance with the guidelines at § 423.34(d) and that coverage has taken effect.
(2) The individual elects another Part D plan and that coverage has taken effect.
(3) The individual voluntarily disenrolls from the LI NET program.
(4) The individual is involuntarily disenrolled under § 423.44(b).
(5) LIS eligibility for an individual in LI NET due to an immediate need cannot be confirmed within the period of LI NET coverage.
(a)
(b)
(c)
(1) Sections 423.153(b) and (c) for dispensing and point-of-sale safety edits;
(2) Section 423.154 for appropriate dispensing of prescription drugs in long-term care facilities;
(3) Sections 423.159 and 423.160 for electronic prescribing, excepting the requirements pertaining to formulary standards in § 423.160(b)(5);
(4) Section 423.162 for QIO activities; and
(5) Section 423.165 for compliance deemed on the basis of accreditation.
(d)
(2) LI NET beneficiaries under § 423.2504(a)(2) will pay the cost sharing associated with the category of non-institutionalized full-benefit dual eligible individuals with incomes above 100% of the Federal poverty level and full-subsidy-non-FBDE individuals. If the beneficiary is later confirmed to belong to a different LIS category, the LI NET sponsor must reimburse the beneficiary for the difference between the cost sharing they paid versus what they would have paid in their LIS category.
(e)
The LI NET program is administered by one or more Part D sponsor(s) that meet all of the requirements in paragraphs (a) through (c) of this section.
(a)
(2) The LI NET sponsor must meet the requirements for providing access to Part D drugs under § 423.120(a), (c), and (d).
(b)
(c)
(1) Have the technical capability and the infrastructure to provide immediate, current, and retroactive coverage for LI NET enrollees;
(2) Have the technical capability to develop the infrastructure necessary for verifying Medicaid dual eligibility status for presumed eligible LI NET enrollees.
(3) Identify, develop, and conduct outreach plans in consultation with CMS targeting key stakeholders to inform them about the LI NET program.
(4) Establish and manage a toll-free customer call center per § 423.128(d)(1) and fax line that can be accessed by pharmacy providers and beneficiaries, or others acting on their behalf, for purposes that include but are not limited to: handling inquiries about services under the LI NET program, providing the status of eligibility or claims, and having the ability to accept supporting documentation.
(5) Timely respond to beneficiary requests for reimbursement of claims by issuing reimbursement for eligible claims submitted by beneficiaries no later than 30 days after receipt, or, if the drug is not covered, the LI NET sponsor has 14 days to send communication to the beneficiary with a reason for the denial.
(6) Adjudicate claims from out-of-network pharmacies that are in good standing (as defined in § 423.2508(b)) according to the LI NET sponsor's standard reimbursement for their network pharmacies.
(a)
(b)
(1) Experience covering low-income beneficiaries, including but not limited to enrolling and providing coverage to low-income subsidy individuals as defined in § 423.34;
(2) Pharmacy access as outlined in § 423.120;
(3) Past performance, including Star Ratings (as detailed in § 423.186), previous intermediate sanctions (as detailed in § 423.750), and consistent with past performance in § 423.503(b); and
(4) Ability to meet the requirements listed in § 423.505 that are not waived under § 423.2536.
(c)
In the event it is determined that the LI NET sponsor violated its contract, CMS may impose intermediate sanctions as outlined in subpart O of this part.
(a)
(b)
(c)
(2) CMS sends notice of an immediate termination as specified at § 423.509(b)(2)(ii).
(d)
(a)
(b)
(2) The review, negotiation, and approval of the LI NET bid would follow the provisions in § 423.272(a) and (b)(1) and (4).
(3) Basic rule for bid. The bid must reflect the LI NET sponsor's estimate of its revenue needs for Payment Rates A and B per paragraph (c) of this section.
(c)
(1) Payment Rate A is an annual rate of payment for projected administrative costs. An annual percentage-based cap on Payment Rate A limiting the year over year increase to Payment Rate A is set as part of the bid review and negotiation under § 423.272(a).
(i) For the 2024 plan year, the LI NET sponsor includes in its bid the assumption that Payment Rate A cannot exceed a 2% increase from the prior year's Payment A, which is a figure CMS will provide to the LI NET sponsor.
(ii) For the 2025 plan year and subsequent plan years, the LI NET sponsor will specify its assumption for any increase needed to the prior year's Payment Rate A, submitting justification to CMS in their bid if the cap exceeds 2%.
(2) Payment Rate B reflects the projected net costs of the Part D drugs dispensed to individuals who receive the LI NET benefit.
(d)
(2)
(i) There will be no risk sharing in the symmetrical 1% risk corridor around the target amount as defined in § 423.308.
(ii) There will be symmetrical risk sharing of 0.1% beyond the 1% risk corridor.
(iii) To carry out this section, § 423.336(c) applies to LI NET.
(e)
(f)
(g)
CMS waives the following Part D program requirements for the LI NET program:
(a)
(b)
(c)
(1) Section 423.153(b) and (c) for dispensing and point-of-sale safety edits;
(2) Section 423.154 for appropriate dispensing of prescription drugs in long-term care facilities;
(3) Sections 423.159 and 423.160 for electronic prescribing, excepting the requirements pertaining to formulary standards in § 423.160(b)(5);
(4) Section 423.162 for QIO activities; and
(5) Section 423.165 for compliance deemed on the basis of accreditation.
(d)
(e)
(f)
(g)
(h)
(1) Section 423.2265(b)(4), (5), (11), and (13);
(2) Section 423.2265(c);
(3) Section 423.2266(a);
(4) Section 423.2267(e)(3) through (5), (9) through (12), (14) through (17), (25), (29), and (33); and
(5) Section 423.2274.
(i)
(j)
(k)
42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).
(b) If CMS or the State administering agency makes a determination under § 460.50 that could lead to termination of a PACE program agreement, CMS may impose any of the sanctions specified at §§ 460.42 and 460.46. If CMS or the State administering agency determines that the circumstances in § 460.50(b)(1) exist, neither CMS nor the State administrating agency has to determine that the circumstances in § 460.50(b)(2) exist prior to imposing a CMP or enrollment and/or payment suspension.
(a)
(1) At a minimum, except as noted in paragraph (a)(4) of this section, PACE organizations must have contracts in place for the following medical specialties:
(i) Anesthesiology.
(ii) Audiology.
(iii) Cardiology.
(iv) Dentistry.
(v) Dermatology.
(vi) Gastroenterology.
(vii) Gynecology.
(viii) Internal Medicine.
(ix) Nephrology.
(x) Neurosurgery.
(xi) Oncology.
(xii) Ophthalmology.
(xiii) Oral surgery.
(xiv) Orthopedic surgery.
(xv) Otorhinolaryngology.
(xvi) Palliative Medicine.
(xvii) Plastic surgery.
(xviii) Pharmacy consulting services.
(xviv) Podiatry.
(xx) Psychiatry.
(xxi) Pulmonology.
(xxii) Radiology.
(xxiii) Rheumatology.
(xxiv) General Surgery.
(xxv) Thoracic and vascular surgery.
(xxvi) Urology.
(2) Contracts with medical specialists must be executed prior to enrollment of participants and must be maintained on an ongoing basis to ensure participants receive appropriate and timely access to all medically necessary care and services.
(3) A PACE organization is responsible for making all reasonable and timely attempts to contract with medical specialists. If at any time a PACE organization is unable to directly contract or maintain a contract with a specific specialty, the PACE organization must—
(i) Ensure care and services that would otherwise be provided to participants by a contracted specialist are provided and that the participant's needs are met through a different mechanism to include hospitalization; and
(ii) Promptly report the contracting issue to CMS and the SAA, including the attempts made to contract, the reason why the contract was not effectuated, and the PACE organization's plan to provide access to the necessary services.
(4) A PACE organization is not required to have a contract with a particular medical specialty if the PACE organization directly employs one or more individuals prior to contracting who are legally authorized, and if applicable, board certified in the participant medical specialty.
(d) * * *
(2) Maintain all written communications received in any format (for example, emails, faxes, letters, etc.) from participants or other parties in their original form when the communications relate to a participant's care, health, or safety including, but not limited to the following:
(i) Communications from the participant, his or her designated representative, a family member, a caregiver, or any other individual who provides information pertinent to a participant's, care, health, or safety.
(ii) Communications from an advocacy or governmental agency such as Adult Protective Services.
(b) * * *
(6) Original documentation, or an unaltered electronic copy, of any written communication as described in § 460.200(d)(2) must be maintained in the participant's medical record unless the following requirements are met:
(i) The medical record contains a thorough and accurate summary of the communication including all relevant aspects of the communication,
(ii) Original documentation of the communication is maintained outside of the medical record and is accessible by employees and contractors of the PACE organization when necessary, and in accordance with § 460.200(e), and
(iii) Original documentation of the communication is available to CMS and the SAA upon request.