Agricultural Marketing Service
Animal and Plant Health Inspection Service
Forest Service
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Engineers Corps
Energy Information Administration
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Fish and Wildlife Service
Land Management Bureau
Alcohol, Tobacco, Firearms, and Explosives Bureau
Antitrust Division
Federal Aviation Administration
National Highway Traffic Safety Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Commodity Futures Trading Commission.
Final rule.
The Commodity Futures Trading Commission (“CFTC” or “Commission”) is adopting amendments to revise its regulations requiring covered persons to provide annual privacy notices to customers. The revisions implement the Fixing America's Surface Transportation Act's (“FAST Act”) December 2015 statutory amendment to the Gramm-Leach-Bliley Act (“GLB Act”) by providing an exception to the annual notice requirement under certain conditions.
This final rule is effective May 28, 2019.
Matthew Kulkin, Director, (202) 418-5213,
Title V, Subtitle A of the GLB Act
Consistent with Title V, part 160 requires that, generally, all FCMs, RFEDs, CTAs, CPOs, IBs, MSPs, and SDs that are subject to the jurisdiction of the Commission, regardless of whether they are required to register with the Commission (“Covered Persons”), provide a clear and conspicuous notice to customers that accurately reflects their privacy policies and practices not less than annually during the life of the customer relationship.
On December 4, 2015, Congress amended Title V as part of the FAST Act.
On December 10, 2018, the Commission published a Notice of Proposed Rulemaking (the “NPRM”)
In addition, because, as discussed in the Proposal, the GLB Act is silent as to when a financial institution that has relied on and no longer meets the requirements of the exception must next provide an annual privacy notice, the Commission proposed a framework for these circumstances. Specifically, proposed § 160.5(d)(2) stated that a Covered Person who has been excepted from delivering an annual privacy notice pursuant to § 160.5(d)(1) and who changes its policies or practices in such a way that it no longer meets the requirements for that exception, would, if such a change required a revised privacy notice pursuant to § 160.8,
As discussed in the Proposal, the Commission proposed this 100-day period because the Commission believes the annual privacy notice should be delivered within a relatively short time so that customers are informed of the change in a timely manner. Further, the Commission stated its belief that 100 days would allow a Covered Person to meet the notice requirement without imposing additional costs on Covered Persons; particularly, a 100-day delivery period would accommodate the inclusion of the notice with their quarterly statements.
In order to ensure that the Proposal, if adopted, achieved its stated purpose, the Commission requested comments generally on all aspects of the Proposal and the NPRM,
The Commission received one relevant comment,
The Commission is adopting the final rule (“Final Rule”) as proposed. Accordingly, the Commission is adopting the amendments to Commission regulation 160.5 as shown in the rule text in this document and for the reasons discussed in the Proposal and reiterated above.
The Regulatory Flexibility Act
As discussed in the Proposal, the Final Rule adds an exception to § 160.5's requirement that Covered Persons deliver annual privacy notices, as discussed above. The Final Rule affects Covered Persons (
As a Covered Person may continue to provide annual privacy notices and not avail itself of the exception to the annual privacy notice requirement in § 160.5, the Final Rule will not impose any new regulatory obligations on Covered Persons, including Covered Persons that may be small entities for purposes of the RFA. Rather, to the extent that a Covered person relies on the exception, it would simply avoid providing a privacy notice annually until such time as it is no longer eligible for the exception. The Final Rule's clarification that, once it is no longer eligible for the exception, the Covered Person needs to provide a privacy notice either in accordance with existing § 160.8 or within 100 days also does not result in any new burdens. Sections 160.5 and 160.8 are existing requirements to deliver annual privacy notices and revised privacy notices under certain circumstances. Further, the Commission endeavors to reduce any burdens for those Covered Persons utilizing the exception by allowing the 100-day period following loss of the exception to resume delivery of an annual privacy notice where a notice is not already required pursuant to § 160.8, as discussed above. The Commission does not, therefore, expect that any small entities that may be impacted by the rule to incur any additional costs as a result of the Final Rule.
Therefore, the Commission believes that the Final Rule will not have a significant economic impact on a substantial number of small entities, as defined in the RFA.
Accordingly, the Chairman, on behalf of the Commission, hereby certifies pursuant to 5 U.S.C. 605(b) that the Final Rule will not have a significant economic impact on a substantial number of small entities.
The Paperwork Reduction Act of 1995 (“PRA”)
As discussed in the Proposal, the Commission believes that the Final Rule will not impose any new recordkeeping or information collection requirements, or other collections of information that require approval of OMB under the PRA. However, by providing the exception to the requirement to provide annual privacy notices to customers discussed above, the Final Rule modifies a collection of information for which the Commission has previously received a control number from OMB. The title for this collection of information is “Privacy of Consumer Financial Information, OMB control number 3038-0055”.
Section 15(a) of the CEA requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA. Section 15(a) further specifies that the costs and benefits shall be evaluated in light of the following five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency, competitiveness, and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations. The Commission considers the costs and benefits resulting from its discretionary determinations with respect to the section 15(a) considerations.
As discussed above, the Commission is implementing the FAST Act's amendments to the GLB Act by amending § 160.5 to incorporate an exception to a Covered Person's obligation to provide an annual privacy notice under certain specified circumstances, consistent with section 503(f) of the GLB Act, and address when a Covered Person that has relied on and no longer meets the requirements of that exception must next provide an annual privacy notice.
Below, the Commission discusses the costs and benefits of the Final Rule.
The Commission anticipates that some Covered Persons may avail themselves of the exception in the Final Rule and not provide annual privacy notices. The Final Rule benefits these Covered Persons that are opting out of providing annual privacy notices by reducing their costs associated with sending such notices. Further, because no Covered Person is required to avail themselves of the exception in the Final Rule, as discussed above, the Commission believes that it is reasonable to conclude that only those Covered Persons that expect a net benefit from the Final Rule will stop providing annual privacy notices under the proposed exception.
The Commission recognizes that, as a result of the Final Rule, certain customers of Covered Persons may no longer receive privacy notices annually and therefore will not be made aware of the Covered Persons' policies and procedures as frequently. However, the scope of the exception is tailored such that customers of Covered Persons could only not receive an annual privacy notice to the extent that the Covered Person: (1) Provides nonpublic personal information to nonaffiliated third parties only in accordance with the provisions of §§ 160.13, 160.14, 160.15 and any other exceptions adopted by the Commission pursuant to section 504(b) of the GLB Act; and (2) has not changed its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 160.6(a)(2) through (5) and § 160.6(a)(9) in the most recent privacy notice provided to such customer pursuant to part 160 of the Commission's regulations. Thus, the Final Rule may reduce confusion among customers by providing them with disclosures when they would be most relevant,
In determining when to require the resumption of annual privacy notices following the loss of the exception in the Final Rule, the Commission endeavored to make its requirements consistent with existing timing requirements for privacy notices under current regulations, as discussed above, and to provide clarity to Covered Persons.
The requirements of § 160.5 protect market participants by ensuring that customers of Covered Persons are informed about such Covered Persons' practices and policies with respect to nonpublic personal information and certain other information described in § 160.6. As discussed above, the Commission recognizes that, as a result of the Final Rule, some customers of Covered Persons may no longer receive privacy notices annually and therefore will not be made aware of the Covered Persons' policies and procedures as frequently. However, the scope of the exception is tailored such that customers of Covered Persons could only not receive an annual privacy notice to the extent that the Covered Person: (1) Provides nonpublic personal information to nonaffiliated third parties only in accordance with the provisions of §§ 160.13, 160.14, 160.15 and any other exceptions adopted by the Commission pursuant to section 504(b) of the GLB Act; and (2) has not changed its policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 160.6(a)(2) through (5) and § 160.6(a)(9) in the most recent privacy notice provided to such customer pursuant to part 160 of the Commission's regulations. Further, as discussed above, the Final Rule may reduce confusion among customers by providing them with disclosures when they would be most relevant. In addition, the Commission believes that the requirements for the resumption of annual privacy notices following the loss of the exception in the Final Rule will allow customers of Covered Persons to receive annual privacy notices in a timely manner while not causing Covered Persons to incur any additional costs.
The Commission believes that the Final Rule may improve competition by reducing costs for Covered Persons that meet the requirements of the exception in § 160.5(d) to not deliver an annual privacy notice and elect to not deliver such notices. Specifically, the Commission expects that the Final Rule will likely result in fewer substantially similar annual privacy notices being delivered, which will reduce costs associated with producing and delivering such privacy notices. Further, to the extent that a Covered Person is no longer able to take advantage of the exception to providing annual privacy notices and is required to resume providing them, the Commission believes that a Covered Person will not incur any additional costs in doing so, as the Covered Person would simply need to resume sending annual privacy notices as currently required.
The Commission has not identified an impact on price discovery as a result of the Final Rule.
The Commission has not identified an impact on sound risk management as a result of the Final Rule.
The Commission has not identified an impact on other public interest considerations as a result of the Final Rule.
Section 15(b) of the CEA requires the Commission to take into consideration the public interest to be protected by the antitrust laws and endeavor to take the least anticompetitive means of achieving the purposes of the CEA, in issuing any order or adopting any Commission rule or regulation (including any exemption under section 4(c) or 4c(b)), or in requiring or approving any bylaw, rule, or regulation of a contract market or registered futures association established pursuant to section 17 of the CEA.
The Commission has considered this Final Rule to determine whether it is anticompetitive and has preliminarily identified no anticompetitive effects. The Commission requested and did not receive any comments on whether the Proposal was anticompetitive and, if it is, what the anticompetitive effects are.
Because the Commission has preliminarily determined that this Final Rule is not anticompetitive and has no anticompetitive effects and received no comments on its determination, the Commission has not identified any less anticompetitive means of achieving the purposes of the CEA.
Brokers, Consumer protection, Privacy, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, the Commodity Futures Trading Commission amends 17 CFR chapter I as follows:
7 U.S.C. 7b-2 and 12a(5); 15 U.S.C 6801,
(a)(1) * * * Except as provided by paragraph (d) of this section, you must provide a clear and conspicuous notice to customers that accurately reflects your privacy policies and practices not less than annually during the life of the customer relationship. * * *
(d)
(i) Provide nonpublic personal information to nonaffiliated third parties only in accordance with the provisions of §§ 160.13, 160.14, and 160.15 and any other exceptions adopted by the Commission pursuant to section 504(b) of the GLB Act; and
(ii) Have not changed your policies and practices with regard to disclosing nonpublic personal information from the policies and practices that were disclosed to the customer under § 160.6(a)(2) through (5) and § 160.6(a)(9) in the most recent privacy notice sent to the customer pursuant to this part.
(2)
(i)
(ii)
On this matter, Chairman Giancarlo and Commissioners Quintenz, Behnam, Stump, and Berkovitz voted in the affirmative. No Commissioner voted in the negative.
Environmental Protection Agency (EPA).
Final rule.
Under the Toxic Substances Control Act (TSCA), EPA is promulgating a rule to ensure that any discontinued uses of asbestos cannot re-enter the marketplace without EPA review, closing a loophole in the regulatory regime for asbestos.
This final rule is effective June 24, 2019.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0159, is available at
This restrictive rule is called a significant new use rule (SNUR) for asbestos, as the term asbestos is defined under the Asbestos Hazard Emergency Response Act. The restricted significant new uses of asbestos (including as part of an article) is manufacturing (including importing) or processing for uses that are neither ongoing nor already prohibited under TSCA. The Agency has found no information indicating that the following uses are ongoing, and therefore, the following uses are subject to this SNUR and cannot return to the marketplace without EPA review: Adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; cement products; extruded sealant tape and other tape; filler for acetylene cylinders; friction materials (with certain exceptions identified in Table 1); high-grade electrical paper; millboard; missile liner; packings; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; woven products; any other building material; and any other use of asbestos that is neither ongoing nor already prohibited under TSCA. This action prohibits these discontinued uses of asbestos from restarting without EPA having an opportunity to evaluate each intended use (
You may be potentially affected by this action if you manufacture (including import), process, or distribute in commerce asbestos as it is defined by TSCA Title II, section 202 (15 U.S.C. 2642) (including as part of an article). The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Construction (NAICS code 23);
• Manufacturing (NAICS codes 31—33);
• Wholesale Trade (NAICS code 42); and
• Transportation (NAICS code 48).
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA (15 U.S.C. 2601
In addition, asbestos, as defined in this rule, is already subject to TSCA section 6(a) (40 CFR part 763, subparts G and I) rules that trigger the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b); see also 40 CFR 721.20). Any person who exports or intends to export asbestos must comply with the export notification requirements in 40 CFR part 707, subpart D; however, although EPA makes inapplicable the exemption at 40 CFR 721.45(f) for persons who import or process any asbestos as part of an article in a category listed in Table 1, the Agency is not requiring export notification for articles containing asbestos, as further explained in Unit III.B. of this notice.
If you have any questions regarding the applicability of this action to a particular entity, consult the technical information contact listed under
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2) (see Unit IV.). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA prohibits the manufacturing (including importing) or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). Those actions could include a prohibition on a use of that chemical substance. As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.
EPA is promulgating a final SNUR for asbestos, using the definition in TSCA Title II, section 202, which defines asbestos as the “asbestiform varieties of six fiber types—chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.” The significant new use of asbestos (including as part of an article) is manufacturing (including importing) or processing for uses that are neither ongoing nor already prohibited under TSCA. The Agency found no information indicating that the following uses are ongoing, and
Table 1 below presents the significant new uses of asbestos (including as part of an article) subject to this rule and lists product categories of asbestos uses that are no longer ongoing (
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182, 130 Stat. 448) amended TSCA in June 2016. As amended, TSCA includes statutory requirements related to the risk evaluations of existing chemicals under their conditions of use. In December of 2016 (81 FR 91927, December 19, 2019) (FRL-9956-47), EPA designated asbestos as one of the first 10 chemical substances subject to the Agency's chemical risk evaluation rule, pursuant to TSCA section 6(b)(2)(A) (15 U.S.C. 2605(b)(2)(A)).
EPA is separately conducting a risk evaluation of asbestos under its conditions of use, pursuant to TSCA section 6(b)(4)(A). Through scoping and subsequent research for the asbestos risk evaluation, EPA identified several conditions of use of asbestos to include in the risk evaluation. However, through extensive research, review of public comments, and stakeholder engagement, the conditions of use of asbestos have been further refined since publication of the proposed Asbestos SNUR (83 FR 26922, June 11, 2018) (FRL-9978-76), and
EPA requested public comment on the proposed SNUR for information regarding any ongoing uses not identified by the Agency and additional uses no longer ongoing (83 FR 26922, June 11, 2018) (FRL-9978-76). The Agency did not receive any comments providing additional information regarding the ongoing uses or discontinued uses of asbestos. EPA did receive many comments (too numerous to cite individually) stating that the Agency should not allow otherwise prohibited asbestos uses to return to the marketplace. EPA's approach is consistent with these comments, and this rulemaking does not bring previously prohibited uses back to market. This SNUR regulates uses of asbestos that are no longer ongoing (
As explained in greater detail in the
EPA intends that the provisions of this rule be severable. In the event that any individual provision or part of this rule is invalidated, EPA intends that this would not render the entire rule invalid, and that any individual provisions that can continue to operate will be left in place.
This final SNUR will require timely advance notice to EPA of any future manufacturing (including importing) or processing of asbestos (including as part of an article) for the designated significant new uses that may produce changes in human and environmental exposures and to allow EPA to make an appropriate determination (relevant to the risks associated with such manufacturing (including importing), processing, and use) prior to the commencement of such manufacturing (including importing) or processing. This action is necessary to ensure that manufacturing (including importing) or processing for the significant new use cannot proceed until EPA has responded to the circumstances by taking the required actions under TSCA sections 5(e) or 5(f) in the event that EPA determines any of the following: (1) That the significant new use presents an unreasonable risk to health or the environment under the conditions of use (without consideration of costs or other non-risk factors, and including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA); (2) that the information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use; (3) that, in the absence of sufficient information, the manufacturing (including importing), processing, distribution in commerce, use, or disposal of the substance, or any combination of such activities, may present an unreasonable risk (without consideration of costs or other non-risk factors, and including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA); or (4) that there is substantial production and sufficient potential for environmental release or human exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)).
There is a strong causal association between asbestos exposure and lung cancer and mesotheliomas (tumors arising from the thin membranes that line the chest (thoracic) and abdominal cavities and surround internal organs) (Ref. 4; Ref. 5 Ref. 6; Ref. 7; Ref. 8; Ref. 9). In addition, other cancers, as well as non-cancer effects, such as respiratory and immune effects, have been associated with asbestos exposure (Ref. 10).
Agency research conducted in support of the TSCA risk evaluation of asbestos revealed that the use of asbestos has declined dramatically in the United States since the 1970s when asbestos use was at its peak. Nevertheless, EPA is concerned about the potential for adverse health effects of asbestos and believes this action will prevent former uses of asbestos from being reintroduced into commerce without the EPA being aware and having the opportunity to review and, as necessary, restrict those uses. EPA is taking action in this final rule to prohibit manufacturing (including importing) or processing for a significant new use of asbestos (including as part of an article) identified in Table 1 in the United States without prior notice, review, and, as necessary, regulation by EPA. The rationale and objectives for this final SNUR are explained in additional detail in Unit III. of the proposed rule (83 FR 26922, June 11, 2018) (FRL-9978-76).
EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers (including importers) and processors of asbestos, as defined in this rule. This Economic Analysis (Ref. 11), which is available in the docket, is discussed in Unit IX. and is briefly summarized here.
In the event that a SNUN is submitted, costs are estimated to be approximately $23,000 per SNUN submission for large business submitters and about $10,000 for small business submitters. Asbestos is already subject to TSCA section 6(a) rules (40 CFR part 763, subparts G and I) that trigger the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b); see also 40 CFR 721.20), and the Agency is not requiring export notifications for articles containing asbestos. Articles are generally excluded from the TSCA section 12(b) export notification requirements and the Agency is not lifting the article exemption for 12(b) export notification for asbestos articles for the reasons discussed in Unit III.B. Therefore, EPA assumes no additional costs under TSCA section 12(b) for this rule.
The rule may also affect firms that plan to import or process articles that may be subject to the SNUR. Although there are no specific requirements in the rule for these firms, they may choose to undertake some activity to assure themselves that they are not undertaking a significant new use. In the accompanying Economic Analysis for this final SNUR (Ref. 11), example steps (and their respective costs) that an importer or processor might take to identify asbestos in articles are provided. These steps can include gathering information through agreements with suppliers, declarations through databases or surveys, or use of a third-party certification system. Additionally, importers may require suppliers to provide certificates of testing analysis of the products or perform their own laboratory testing of certain articles. EPA is unable to predict, however, what, if any, particular steps an importer might take; thus, potential total costs were not estimated.
This SNUR applies to asbestos, using the definition in TSCA Title II, section 202, which defines asbestos as the “asbestiform varieties of six fiber types—chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.” This SNUR applies to the manufacturing (including importing) or processing of asbestos (including as part of an article) for uses that are neither ongoing nor already prohibited under TSCA. EPA found no information indicating that the following uses are ongoing, and therefore, the following uses are subject to this final SNUR: Adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; cement products; extruded sealant tape and other tape; filler for acetylene cylinders; friction materials (with certain exceptions identified in Table 1); high-grade electrical paper; millboard; missile liner; packings; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; woven products; any other building material; and any other use of asbestos that is neither ongoing nor already prohibited under TSCA. This action enables the Agency to protect public health because these significant new uses are not permitted to commence until EPA conducts a review and evaluates risks, and, as necessary, restricts the use(s).
Under this final SNUR, the exemption at 40 CFR 721.45(f) would not apply to persons who import or process asbestos as part of an article (which includes as a component of an article) because there is reasonable potential for exposure to asbestos if the substance is incorporated into articles and then imported or processed. Asbestos-containing articles subject to this SNUR are listed in Table 1.
Asbestos has not been mined or otherwise produced in the United States since 2002; therefore, any new raw bulk asbestos used in the United States is imported. According to the U.S. Geological Survey (USGS), approximately 750 metric tons of raw bulk asbestos was imported into the United States in 2018 (Ref. 12). Chrysotile is the only form of raw bulk asbestos currently imported, and the chlor-alkali industry is the only known importer (Ref. 12). EPA did not identify any domestic entity that uses raw bulk asbestos other than the chlor-alkali industry, which uses chrysotile asbestos to fabricate diaphragms for use in chlorine and sodium hydroxide production.
In an effort to identify national import volumes and conditions of use for the asbestos risk evaluation being conducted under TSCA section 6(b)(4)(A), EPA searched a number of available data sources including EPA's Chemical Data Reporting (CDR) database, USGS's Mineral Commodities Summary and the Minerals Yearbook, the U.S. International Trade Commission's Dataweb, the U.S. Customs and Border Protection's Automated Commercial Environment (ACE) system, and the
During the public comment period for the
On June 22, 2017, EPA published the
Asbestos was listed as a known human carcinogen in the National Toxicology Program's
Increases in lung cancer mortality have been reported in both workers and residents exposed to various asbestos fiber types as well as fiber mixtures (Ref. 7). There is evidence in
The greatest risk of exposure to asbestos occurs when the substance is in a friable state, meaning the fibers can be crumbled, pulverized, or reduced to a powder under hand pressure (Ref. 6). During use and over time, non-friable asbestos has the potential to become friable (Ref. 6). For example, testing has shown that non-friable asbestos-containing material can become friable during use such as cutting, crumbling, and tearing, and as a result of such use, asbestos fibers can be released into the air (Ref. 20). Similarly, non-friable asbestos-containing building materials can release fibers if disturbed during building repair or demolition (Ref. 21). Exposures to workers, consumers and the general population, as well as environmental receptors, may occur from industrial releases and use of asbestos-containing products. Based on EPA's research conducted during the early stages of the TSCA risk evaluation, most of the ongoing uses of asbestos pertain to industrial and commercial uses (Ref. 10).
The primary exposure route for asbestos is inhalation. Asbestos fibers can be released into the air during processing of raw bulk asbestos and asbestos-containing products. Weathering and the disturbance and/or degradation of asbestos-containing products can also cause asbestos fibers to be suspended in air (Ref. 6). Fibers can then enter the lungs through inhalation. Exposures to asbestos can potentially occur via oral and dermal routes; however, EPA anticipates that the most likely exposure route is inhalation.
As discussed in Unit II. and Unit III. of the proposed rule (83 FR 26922, June 11, 2018) (FRL-9978-76), EPA is concerned about the potential for adverse health effects of asbestos based on established sound scientific data indicating that asbestos is a known human carcinogen. Asbestos was listed as a human carcinogen in the National Toxicology Program's
Asbestos, in particular chrysotile asbestos, has several useful properties, including low electrical conductivity while maintaining high tensile strength, high friction coefficient, and high resistance to heat (Ref. 19). These properties made asbestos ideal for use in friction materials (
In 1989, EPA published a final rule
After the court's ruling in
A significant new use of asbestos includes all uses that were initiated on or before August 25, 1989 (and were not covered by the 1989 partial ban under TSCA section 6) for which manufacturing (including importing) and processing are no longer ongoing in the United States. This SNUR is designed to complement the existing prohibitions on asbestos and does not alter or displace those prohibitions.
As part of the current asbestos risk evaluation process, the Agency identified conditions of use to be considered under the TSCA risk evaluation. In the proposed Asbestos SNUR (83 FR 26922, June 11, 2018) (FRL-9978-76) and the
In an effort to obtain confirmation that asbestos-containing cement products are imported into the U.S., EPA contacted the last known foreign supplier to North America. After contacting them, the supplier informed the Agency that they do not export asbestos-containing cement to the United States (Ref. 23). The Agency also discussed the use of asbestos cement pipe in the U.S. with the trade organization American Water Works, who provided a written statement that, to their knowledge, asbestos cement pipe is no longer an ongoing use (Ref. 24).
Upon further review of import data, EPA determined that packings and “woven and knitted fabrics,” which are reported in USGS's 2016 Minerals Yearbook (Ref. 16) under Harmonized Tariff Schedule (HTS) codes 6812.99.0020 and 6812.99.0004 respectively, were misreported. EPA also determined that the import data suggesting that imported packings contain asbestos pertained to gaskets, not packings. The Agency contacted a potential exporter of asbestos-containing woven products, but the company stated that they do not have customers in the United States (Ref. 25). EPA has included woven products in this SNUR because there is no evidence of ongoing use of woven products.
Based on further outreach and investigation since June 2018, the refined conditions of use of asbestos currently undergoing risk evaluation include: Imported raw bulk chrysotile asbestos for the fabrication of diaphragms for use in chlorine and sodium hydroxide production; and several imported chrysotile asbestos-containing materials, including sheet gaskets for use in chemical products (
In the proposed SNUR, the Agency requested comment on the ongoing uses of asbestos as well as uses that are no longer ongoing (83 FR 26922, June 11, 2018) (FRL-9978-76). EPA received several comments suggesting that the SNUR be revised to include all product uses of asbestos that are no longer ongoing, and some commenters suggested targeting all uses of asbestos except ongoing uses currently under consideration for the asbestos TSCA section 6 risk evaluation (EPA-HQ-OPPT-2018-0159-1269; EPA-HQ-OPPT-2018-0159-1271; EPA-HQ-OPPT-2018-0159-5755; EPA-HQ-OPPT-2018-0159-5886). Considering that asbestos has been used in thousands of applications, EPA recognizes the public's comments on the significant new use rule as originally proposed and whether it covered all uses of asbestos that are no longer ongoing in the United States. The Agency's intent in this final SNUR is to cover all uses of asbestos that are neither ongoing in the United States nor already banned under TSCA. In response to public comment since proposal, the Agency is revising the regulatory text to add another broad use category to ensure all other uses of asbestos that are no longer ongoing and not already prohibited under TSCA are captured in this rulemaking. EPA is explicitly excluding from this rulemaking uses of asbestos that are already prohibited under TSCA through the 1989 partial ban under TSCA section 6 or are currently ongoing. Ongoing uses identified by EPA as conditions of use under consideration for the TSCA section 6 risk evaluation (
As explained in the proposed rule (83 FR 26922, June 11, 2018) (FRL-9978-76), as part of the information gathering activity associated with the current asbestos TSCA section 6 risk evaluation, the Agency researched market availability for the asbestos product categories subject to the 1989 TSCA section 6 ban that was later partially vacated and remanded to EPA. In addition to the asbestos product categories that EPA identified in the proposed SNUR where manufacturing (including importing) and processing for the use is no longer ongoing, the Agency has determined that the product category “friction materials” as defined in Table 1 (and with the exceptions noted in Table 1) is also a significant new use of asbestos. While this product category was in the 1989 Regulatory Impacts Analysis (Ref. 1), it was not included in the proposed SNUR because the broad category definition could be viewed as contradictory to uses not subject to the rule—brake blocks in particular. However, in response to public comments, the Agency is including friction materials as defined in Table 1 within the significant new use for asbestos, to encompass all uses that the Agency has determined to be neither ongoing in the United States nor already prohibited under TSCA. The Agency believes it is appropriate to include the product category of “friction materials” in the scope of this SNUR and doing so will not create confusion or potentially overlapping definitions.
Table 3 represents the conditions of use for asbestos which are undergoing risk evaluation under TSCA section 6. These uses are ongoing uses that are not covered under the 1989 partial ban under TSCA section 6 nor in this final SNUR. All of the remaining ongoing uses of asbestos are solely for chrysotile asbestos. Ongoing uses identified by EPA as conditions of use under consideration for the TSCA section 6 risk evaluation are not significant new uses of asbestos and therefore are not subject to this rulemaking and would not require a significant new use notice submission to the Agency.
As discussed in Unit 1.C., EPA is conducting a TSCA section 6 risk evaluation for the ongoing uses of
In the absence of this rule, the manufacturing (including importing) or processing of asbestos (including as part of an article) for the significant new uses identified in this rule may begin at any time and without prior notice to EPA. EPA is committed to protecting the public from asbestos risks and is concerned that the commencement of the manufacturing (including importing) or processing for the significant new uses of asbestos identified in Table 1 could increase the volume of manufacturing (including importing) and processing of asbestos as well as the magnitude and duration of exposure to humans over that which would otherwise exist currently. EPA has concluded that action on this chemical substance is warranted and therefore determined that any manufacturing (including importing) or processing of asbestos (including as part of an article), using the definition under Title II of TSCA, for any use identified in Table 1 is a significant new use.
The Agency received several public comments on the proposed rule requesting that disposal and recycling of asbestos-containing products (EPA-HQ-OPPT-2018-0159-0437; EPA-HQ-OPPT-2018-0159-4066) as well as asbestos mining (EPA-HQ-OPPT-2018-0159-4023; EPA-HQ-OPPT-2018-0159-5886) be addressed. The Agency does not interpret the disposal of asbestos-containing materials to be processing for a significant new use; therefore, such activity does not require a significant new use notice under this final rule. Disposal is considered to be the end of life for a product. By contrast, however, the Agency does interpret recyling to be processing under TSCA, and recycling of any asbestos-containing material for a significant new use of asbestos subject to this rulemaking requires a SNUN. For example, recycling asbestos building material, such as roofing tiles, for reuse is prohibited without notification, review, and, as necessary, regulation by EPA.
The Agency interprets mining to be production under the TSCA definition of manufacture. Therefore, mining asbestos for a significant new use as identified in this rule would require a SNUN. Mining for the ongoing uses of asbestos, however, would not require a significant new use notice.
Consistent with EPA's past practice for issuing SNURs under TSCA section 5(a)(2), EPA's decision to promulgate a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. If a person decides to begin manufacturing (including importing) or processing asbestos (including as part of an article) for a use identified in Table 1, the notice to EPA allows the Agency to evaluate the use according to the specific parameters and circumstances surrounding the conditions of use.
Chemical substances that are part of an article may still result in exposure if the chemical substance has certain physical-chemical properties—as in the case of asbestos, fibers can degrade with use and become friable over time where human exposures can occur leading to increased risks for disease (Ref. 6; Ref. 20; Ref. 21). During use and over time, non-friable asbestos has the potential to become friable (Ref. 6). For example, testing has shown that non-friable asbestos-containing material can become friable during use such as cutting, crumbling, and tearing, and as a result of such use, asbestos fibers can be released into the air (Ref. 20). Similarly, non-friable asbestos-containing building materials can release fibers if disturbed during building repair or demolition (Ref. 21). Therefore, EPA is making inapplicable the exemption at 40 CFR 721.45(f) for persons who import or process any asbestos as part of an article for the significant new uses of asbestos identified in Table 1. A person who imports or processes asbestos (including as part of an article) for a significant new use would be subject to the SNUN requirements in this rule. No person would be able to begin importing or processing asbestos (including as part of an article) for a significant new use without first submitting a SNUN to EPA and not before the Agency has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination, including a prohibition on use.
The Agency received several comments suggesting that exported asbestos-containing articles be subject to the notification requirement at TSCA section 12(b) (15 U.S.C. 2611(b)). Considering that this rulemaking addresses uses of asbestos (including as part of an article) that are no longer ongoing, the Agency sees no value in requiring export notification for the uses subject to this rule because such articles of asbestos are neither manufactured, imported, nor processed in the United States. Therefore, the Agency assumes that such articles are not exported. In the event EPA receives a notice for a significant new use of asbestos, the Agency will consider an export notification requirement for that significant new use at that time.
As for the ongoing uses of asbestos that are currently undergoing risk evaluation under TSCA section 6, the Agency feels it is appropriate to consider a TSCA section 12(b) export notification requirement as part of any risk management pursued after completion of the risk evaluation, if an unreasonable risk is determined.
Based on the considerations in Unit III.A., EPA wants to achieve the following objectives with regard to the significant new use of asbestos (including as part of an article) as designated in this rule:
1. EPA would receive notice of any person's intent to manufacture (including import) or process asbestos (including as part of an article) for the described significant new use before that activity begins.
2. EPA would have an opportunity to review and evaluate data submitted in a
SNUN before the notice submitter begins manufacturing (including importing) or processing asbestos (including as part of an article) for the described significant new use.
3. EPA would be able to either determine that the significant new use is not likely to present an unreasonable risk, or take necessary regulatory action associated with any other determination before the described significant new use of asbestos (including as part of an article) occurs.
According to TSCA section 5(a)(2), EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors including:
1. The projected volume of manufacturing and processing of a chemical substance.
2. The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
3. The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
4. The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
Both federal and state environmental protection agencies and occupational safety and health organizations provide existing regulation pertaining to certain aspects of the manufacturing (including importing), processing, use, and/or disposal of asbestos in order to protect consumers, workers, and the environment. EPA believes the significant new uses of asbestos identified in Table 1 could increase the volume of manufacturing (including importing) and processing of asbestos, as well as the duration and magnitude of human and environmental exposure to the substance and reintroduce exposure scenarios that have become obsolete over the past several decades. It is imperative that EPA be notified of any intended significant new use of asbestos identified in Table 1 and be provided the opportunity to evaluate such intended new use. Once a SNUR is finalized, failure to notify EPA and file a SNUN prior to manufacturing (including importing) or processing for a significant new use would constitute a violation of TSCA and would be subject to TSCA section 16 penalties, accordingly.
To determine what would constitute a significant new use of asbestos as discussed in this unit, EPA considered relevant information about the toxicity or expected toxicity of the substance, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2). In addition to the factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
The article exemption at 40 CFR 721.45(f) is based on an assumption that people and the environment will generally not be exposed to chemical substances in articles (Ref. 26). However, even when contained in an article, asbestos can become friable over time with use (Ref. 6; Ref. 20; Ref. 21). Based on this understanding, upon receipt of a SNUN, EPA intends to evaluate the potential risk of exposure to human health and the environment for any intended significant new use of asbestos (including as part of an article). This understanding warrants making the article exemption for submitting a SNUN at 40 CFR 721.45(f) inapplicable to importers or processors of articles containing asbestos. Considering the potential friability of asbestos, even when incorporated in articles, and the health risks associated with exposure to asbestos, EPA affirmatively finds under TSCA section 5(a)(5) that notification is justified by the reasonable potential for exposure to asbestos through the articles subject to this SNUR. EPA intends to evaluate such potential uses whether in the form of an article, or not, for any associated risks or hazards that might exist before those uses would begin. EPA has reason to anticipate that importing or processing asbestos as part of an article would create the potential for exposure to asbestos, and that EPA should have an opportunity to review the intended use before such use could occur.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, and exemptions to reporting requirements. Provisions relating to user fees appear in 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacturing (including importing) or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the
EPA designates June 1, 2018 (the date of web posting of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule. In developing this rule, EPA has recognized that, given EPA's general practice of posting proposed and final SNURs on its website a week or more in advance of
Persons who began commercial manufacturing (including importing) or processing of the chemical substance (to include importing or processing articles and components thereof containing the chemical substance) for a significant new use as of June 1, 2018 would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacturing (including importing) or processing have been satisfied (see 55 FR 17376, April 24, 1990 (FRL-3658-5) and 81 FR 85472, November 28, 2016 (FRL-9945-53) for additional information).
EPA recognizes that TSCA section 5 does not usually require developing new information (
In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required to submit only information in their
Submitting a SNUN that does not itself include information sufficient to permit a reasoned evaluation may increase the likelihood that EPA will either respond with a determination that the information available to the Agency is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use or, alternatively, that in the absence of sufficient information, the manufacturing (including importing), processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs and define the terms of any potentially necessary controls if the submitter provides detailed information on human exposure and environmental releases that may result from the significant new uses of the chemical substance.
EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what information may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available electronically at
The Agency received several public comments on the proposed asbestos SNUR requesting more explanation regarding the review process of a significant new use notice (EPA-HQ-OPPT-2018-0159-0437; EPA-HQ-OPPT-2018-0159-3224) and the opportunity for public comment on submitted SNUN applications, if any, as well as the Agency's significant new use determinations, if any, for asbestos (EPA-HQ-OPPT-2018-0159-4021; EPA-HQ-OPPT-2018-0159-1270; EPA-HQ-OPPT-2018-0159-5889). The SNUN submission and review process is explained in detail in the Response to Comments document (Ref. 3) and in this unit.
Anyone who plans to manufacture, import, or process asbestos (including as part of an article) for a significant new use identified in the rule is required by TSCA section 5 to provide EPA with notice at least 90 days before initiating the activity. A SNUN submission follows the same process as a PMN for new chemicals. Upon receipt of a significant new use notice, EPA is required by TSCA section 5(d)(2) to publish notification of the intended significant new use in the
In general, TSCA section 5 notices require that all reasonably ascertainable information on chemical identity, production volume, byproducts, use, environmental release, disposal practices, and human exposure be included in the notice. In addition, EPA requires that the following information be submitted with the notice: Any health and environmental information in the possession or control of the submitter, parent company or affiliates, and a description of any other applicable information known to or reasonably ascertainable by the submitter (see 40 CFR 720.45 and 40 CFR 720.50 for specific requirements).
EPA risk assessors consider all of this information during the EPA significant new use review process and conduct a detailed analysis with the ultimate goal of identifying and controlling unreasonable risks. EPA uses an integrated approach that draws on knowledge and experience across disciplines to identify and evaluate concerns regarding human health and environmental effects, exposures and releases and impacts. EPA has developed assessment methods, databases, and predictive tools to evaluate what happens to chemicals when they are used and released to the environment and how workers, citizens, and the environment might be exposed to and affected by these chemicals. These tools are helpful when laboratory studies or monitoring data are not available or need to be supplemented. The Agency can take a range of actions, including prohibition, to ensure the use of the chemical does not present an unreasonable risk to human health or the environment.
SNUNs are reported using the standard electronic PMN form, which allows manufacturers of TSCA chemical substances to use the internet through EPA's Central Data Exchange (CDX), to submit TSCA section 5 notices to EPA (instructions available at
EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers (including importers) and processors of the chemical substance included in this rule (Ref. 11). In the event that a SNUN is submitted, average costs are estimated at approximately $23,000 per SNUN submission for large business submitters and about $10,000 for small business submitters. These estimates include the cost to prepare and submit the SNUN (averaging about $7,300), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $16,000 user fee required by 40 CFR 700.45(c)(2)(ii), or, if they are a small business, a reduced user fee of $2,800 (40 CFR 700.45(c)(1)(ii)). Businesses that submit a SNUN are also estimated to incur average costs of $65 for rule familiarization. First time submitters will incur an average cost of $123 for CDX registration and associated activities. Companies manufacturing, importing, or processing asbestos or articles containing asbestos will incur an average cost of $79 for notifying their customers of SNUR regulatory activities. EPA's complete economic analysis is
Under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D, exporters must notify EPA if they export or intend to export a chemical substance or mixture for which, among other things, a rule has been proposed or promulgated under TSCA section 5. As explained in Unit I. and Unit III.B., export notifications are required for asbestos, but not for articles containing asbestos. Asbestos-containing articles are not subject to the export notification requirements; therefore, EPA assumes no additional costs under TSCA section 12(b) for this rule.
In making inapplicable the exemption relating to persons that import or process certain chemical substances as part of an article, this action may affect firms that plan to import or process types of articles that may contain the asbestos. Some firms have an understanding of the contents of the articles they import or process. However, EPA acknowledges that importers and processors of articles may have varying levels of knowledge about the chemical content of the articles that they import or process. These parties may need to become familiar with the requirements of the rule. And, while not required by the SNUR, these parties may take additional steps to determine whether the subject chemical substance is part of the articles they are considering for importing or processing. This determination may involve activities such as gathering information from suppliers along the supply chain and/or testing samples of the article itself. Costs vary across the activities chosen and the extent of familiarity a firm has regarding the articles it imports or processes. Cost ranges are presented in the document entitled
Before proposing this SNUR, EPA considered the following alternative regulatory action: Promulgate a TSCA section 8(a) Reporting Rule.
Under a TSCA section 8(a) rule, EPA could, among other things, generally require persons to report information to the Agency when they manufacture (including import) or process a chemical substance for a specific use or any use. However, for asbestos, the use of TSCA section 8(a) rather than SNUR authority would have several limitations. First, if EPA were to require reporting under TSCA section 8(a) instead of TSCA section 5(a), that action would not ensure that EPA receives timely advance notice of future manufacturing (including importing) or processing of asbestos (including as part of an article and components thereof) for new uses that may produce changes in human and environmental exposures. Nor would action under 8(a) ensure that an appropriate determination (relevant to the risks of such manufacturing (including importing) or processing) has been issued prior to the commencement of such manufacturing (including importing) or processing. Furthermore, a TSCA section 8(a) rule would not ensure that manufacturing (including importing) or processing for the significant new use cannot proceed until EPA has responded to the circumstances by taking the required actions under TSCA sections 5(e) or 5(f) in the event that EPA determines any of the following: (1) That the significant new use presents an unreasonable risk under the conditions of use (without consideration of costs or other non-risk factors, and including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA); (2) that the information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use; (3) that in the absence of sufficient information, the manufacture (including import), processing, distribution in commerce, use, or disposal of the substance, or any combination of such activities, may present an unreasonable risk (without consideration of costs or other non-risk factors, and including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA); or (4) that there is substantial production and sufficient potential for environmental release or human exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)).
In view of the level of health concerns about asbestos if used for a significant new use, EPA believes that a TSCA section 8(a) rule for this substance would not meet EPA's regulatory objectives.
EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the science standards required under TSCA section 26(h), as applicable, to determine whether a particular use would be a significant new use, based on relevant factors including those listed under TSCA section 5(a)(2). As noted in Unit III., EPA's decision to promulgate a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use.
The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this significant new use rule, in Unit II. and in the references cited throughout the preamble of this rule. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitively. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.
The Agency received a total of 17,912 comments in response to the proposed rule under docket ID number EPA-HQ-OPPT-2018-0159. The public comment period began on June 11, 2018 and ended August 10, 2018. Of the 17,912 public comments received, 11,732 are part of a mass mail campaign, 240 are from a second mass mail campaign, 67 are not posted in the public docket due to inappropriate language, and 5,873 individual comments are identified by
Over 90% (5,386) of the individual comments received on the proposed Asbestos SNUR are anonymous. The majority of comments are generally considered not germane to the proposed rule considering the purpose and effect of the action, but, where appropriate, they are associated with one of the comment topics and addressed in EPA's Response to Comments document (Ref. 3). Upon careful review, EPA has identified the following seven general themes throughout the public comments:
1. The purpose of the proposed Asbestos SNUR.
2. Extend the comment period.
3. Ban asbestos.
4. Explain EPA's review process of Significant New Use Notices.
5. Provide clarification: Recycling and disposal.
6. Broaden the scope of the SNUR.
7. Economic Analysis.
EPA received thousands of comments pertaining to the purpose of the proposed Asbestos SNUR as well as the request that EPA ban the use of asbestos in the United States. Due to the overwhelming number of comments on these two topics, the Agency does not cite each relevant comment by ID number in the Response to Comments document. As for the other public comment topics of the proposed rule listed earlier in this unit, the Agency specifically cites in the Response to Comments document 17 substantive public comments, which may address multiple aspects of the proposed rule.
The following is a listing of the documents that are specifically referenced in this document. The docket, EPA-HQ-OPPT-2018-0159, includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011, and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action is not expected to be a regulatory action subject to Executive Order 13771 (82 FR 9339, February 3, 2017), because this action is not a significant regulatory action under Executive Order 12866.
According to PRA, 44 U.S.C. 3501
This action does not impose any burden requiring additional OMB approval. Burden is defined in 5 CFR 1320.3(b). The information collection activities associated with existing chemical SNURs are already approved under OMB control number 2070-0038 (EPA ICR No. 1188); and the information collection activities associated with export notifications are already approved under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity were to submit a SNUN to the Agency, the burden is estimated to be approximately 100 hours per response (slightly less for submitters who have already registered to use the electronic submission system). This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required information.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not send any completed regulatory submissions to this address.
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601
A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. Since this SNUR will require a person who intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemical substances, the Agency receives only a handful of notices per year. During the six-year period from 2005-2010, only three submitters self-identified as small in their SNUN submissions (Ref. 11). EPA believes the cost of submitting a SNUN is relatively small compared to the cost of developing and marketing a chemical new to a firm or marketing a new use of the chemical and that the requirement to submit a SNUN generally does not have a significant economic impact.
Therefore, EPA believes that the potential economic impact of complying with this SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the Agency presented its general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities.
Based on EPA's experience with SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government would be impacted by this rulemaking. As such, the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.
This action will not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effect on 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.
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have any effect on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in Executive Order 12866, and because EPA does not
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have any effect on energy supply, distribution, or use.
This rulemaking does not involve any technical standards and is therefore not subject to considerations under section 12(d) of NTTAA, 15 U.S.C. 272 note.
This action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action does not affect the level of protection provided to human health or the environment.
This action is subject to the CRA, 5 U.S.C. 801-808, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Reporting and recordkeeping requirements.
Environmental protection, Chemicals, Hazardous substances, Imports, Labeling, Occupational safety and health, Reporting and recordkeeping requirements.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
7 U.S.C. 135
15 U.S.C. 2604, 2607, and 2625(c).
(a)
(2) Except as provided by paragraph (a)(3) of this section, the significant new use of the chemical substance identified in paragraph (a)(1) of this section is: Manufacturing (including importing) or processing for any of the following uses:
(i) Adhesives, sealants, roof and non-roof coatings;
(ii) Arc chutes;
(iii) Beater-add gaskets;
(iv) Cement products;
(v) Extruded sealant tape and other tape;
(vi) Filler for acetylene cylinders;
(vii) Friction materials;
(viii) High grade electrical paper;
(ix) Millboard;
(x) Missile liner;
(xi) Packings;
(xii) Pipeline wrap;
(xiii) Reinforced plastics;
(xiv) Roofing felt;
(xv) Separators in fuel cells and batteries;
(xvi) Vinyl-asbestos floor tile;
(xvii) Woven products;
(xviii) Other building products; or
(xix) Any other use of asbestos.
(3)
(A) Diaphragms for use in chorine and sodium hydroxide production;
(B) Sheet gaskets for use in chemical manufacturing;
(C) Brake blocks in oil drilling equipment;
(D) Aftermarket automotive brakes/linings;
(E) Other vehicle friction products; or
(F) Other gaskets.
(ii) The significant new use does not include the manufacture (including importation) or processing of the asbestos-containing products identified in § 763.165, which continue to be prohibited pursuant to 40 CFR part 763, subpart I.
(b)
(2) Any person who submits a significant new use notice for the substance identified in paragraph (a)(1) of this section for the significant new
In rule document 2018-14806 appearing on pages 34478-34492 in the issue of July 20, 2018, make the following correction:
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notification of data availability.
The U.S. Department of Energy (DOE) is informing the public of its collection of shipment data and creation of spreadsheet models to provide comparisons between 2018 unit sales and benchmark estimate unit sales of five lamp types (
April 25, 2019.
The spreadsheet is available online at:
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies, EE-2J, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-1604. Email:
Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-9496. Email:
The Energy Independence and Security Act of 2007 (EISA 2007; Pub. L. 110-140) was enacted on December 19, 2007. Among the requirements of subtitle B (Lighting Energy Efficiency) of title III of EISA 2007 were provisions directing DOE to collect, analyze, and monitor unit sales of five lamp types (
On December 18, 2008, DOE issued a notification of data availability (NODA) for the
EISA 2007 also amended section 325(l) of EPCA by adding paragraphs (4)(D) through (4)(H), which state that if DOE finds that the unit sales for a given lamp type in any year between 2010 and 2025 exceed the benchmark estimate of unit sales by at least 100 percent (
As in the 2008 analysis and previous comparisons, DOE uses manufacturer shipments as a surrogate for unit sales in this NODA because manufacturer shipment data are tracked and aggregated by the trade organization, NEMA. DOE believes that annual shipments track closely with actual unit sales of these five lamp types, as DOE presumes that retailer inventories remain constant from year to year. DOE believes this is a reasonable assumption because the markets for these five lamp types have existed for many years, thereby enabling manufacturers and retailers to establish appropriate inventory levels that reflect market demand. In addition, increasing unit sales must eventually result in increasing manufacturer shipments. This is the same methodology presented in DOE's 2008 analysis and subsequent annual comparisons, and DOE did not receive any comments challenging this assumption or the general approach.
Section 321(a)(1)(B) of EISA 2007 amended section 321(30) of EPCA by adding the definition of a “rough service lamp.” A “rough service lamp” means a lamp that—(i) has a minimum of 5 supports with filament configurations that are C-7A, C-11, C-17, and C-22 as listed in Figure 6-12 of the 9th edition of the IESNA [Illuminating Engineering Society of North America] Lighting handbook, or similar configurations where lead wires are not counted as supports; and (ii) is designated and marketed specifically for “rough service” applications, with—(I) the designation appearing on the lamp packaging; and (II) marketing materials that identify the lamp as being for rough service. (42 U.S.C. 6291(30)(X))
As noted above, rough service incandescent lamps must have a minimum of five filament support wires (not counting the two connecting leads at the beginning and end of the filament), and must be designated and marketed for “rough service” applications. This type of incandescent lamp can be used in applications where the lamp would be subject to mechanical shock or vibration while it is operating. Other incandescent lamps have only two support wires (which also serve as conductors), one at each end of the filament coil. When operating (
Section 321(a)(1)(B) of EISA 2007 amended section 321(30) of EPCA by adding the definition of a “vibration service lamp.” A “vibration service lamp” means a lamp that—(i) has filament configurations that are C-5, C-7A, or C-9, as listed in Figure 6-12 of the 9th Edition of the IESNA Lighting Handbook or similar configurations; (ii) has a maximum wattage of 60 watts; (iii) is sold at retail in packages of 2 lamps or less; and (iv) is designated and marketed specifically for vibration service or vibration-resistant applications, with—(I) the designation appearing on the lamp packaging; and (II) marketing materials that identify the lamp as being vibration service only. (42 U.S.C. 6291(30)(AA))
The statute mentions three examples of filament configurations for vibration service lamps in Figure 6-12 of the
Section 321(a)(1)(B) of EISA 2007 amended section 321(30) of EPCA by adding the definition of a “3-way incandescent lamp.” A “3-way incandescent lamp” includes an incandescent lamp that—(i) employs 2 filaments, operated separately and in combination, to provide 3 light levels; and (ii) is designated on the lamp packaging and marketing materials as being a 3-way incandescent lamp. (42 U.S.C. 6291(30)(Y))
Three-way lamps are commonly found in wattage combinations such as 50, 100, and 150 watts or 30, 70, and 100 watts. These lamps use two filaments (
The statute does not provide a definition of “2,601-3,300 Lumen General Service Incandescent Lamps;” however, DOE is interpreting this term to be a general service incandescent lamp
Section 321(a)(1)(B) of EISA 2007 amended section 321(30) of EPCA by adding the definition of a “shatter-resistant lamp, shatter-proof lamp, or shatter-protected lamp.” “Shatter-resistant lamp, shatter-proof lamp, and shatter-protected lamp” mean a lamp that—(i) has a coating or equivalent technology that is compliant with NSF/ANSI 51 [National Sanitation Foundation/American National Standards Institute] and is designed to contain the glass if the glass envelope of the lamp is broken; and (ii) is designated and marketed for the intended application, with—(I) the designation on the lamp packaging; and (II) marketing materials that identify the lamp as being shatter-resistant, shatter-proof, or shatter-protected. (42 U.S.C. 6291(30)(Z)) Although the definition provides three names commonly used to refer to these lamps, DOE simply refers to them collectively as “shatter-resistant lamps.”
Shatter-resistant lamps incorporate a special coating designed to prevent glass shards from being dispersed if a lamp's glass envelope breaks. Shatter-resistant lamps incorporate a coating compliant with industry standard NSF/ANSI 51,
In the 2008 analysis, DOE reviewed each of the five sets of shipment data that was collected in consultation with NEMA and applied two curve fits to generate unit sales estimates for the five lamp types after calendar year 2006. One curve fit applied a linear regression to the historical data and extended that line into the future. The other curve fit applied an exponential growth function to the shipment data and projected unit sales into the future. For this calculation, linear regression treats the year as a dependent variable and shipments as the independent variable. The linear regression curve fit is modeled by minimizing the differences among the data points and the best curve-fit linear line using the least squares function.
For 3-way incandescent lamps, 2,601-3,300 lumen general service incandescent lamps, and shatter-resistant lamps, DOE found that the linear regression and exponential growth curve fits produced nearly the same estimates of unit sales (
On October 18, 2016, DOE published a notification announcing that the actual unit sales for rough service lamps were 219.7 percent of the benchmark estimate for the 2015 calendar year. 81 FR 71794, 71800.
DOE stated in the December 2017 final rule that it will continue to collect and model data for rough service lamps for two years after the effective date of January 25, 2018 (calendar years 2018 and 2019), in accordance with 42 U.S.C. 6295(l)(4)(I)(ii). 82 FR 60845, 60846 (December 26, 2017). For the 2018 calendar year, the exponential growth forecast projected the benchmark unit sales estimate for rough service lamps to be 4,268,000 units. The NEMA-provided shipment data reported shipments of 3,881,000 units in 2018, which is 90.9 percent of the benchmark estimate. DOE will complete its obligation to collect and model data for rough service lamps after the 2019 calendar year.
On April 7, 2016, DOE published a notification announcing that the actual unit sales for vibration service lamps were 272.5 percent of the benchmark estimate for the 2015 calendar year. 81 FR 20261. Similar to rough service lamps, since unit sales for vibration service lamps exceeded 200 percent of the benchmark estimate in 2015, and DOE did not complete an energy conservation standards rulemaking for these lamps by the end of calendar year 2016, the backstop requirement was triggered. DOE published a final rule on December 26, 2017 to adopt the statutory backstop requirements for vibration service lamps which require that vibration service lamps: (I) Have a
DOE stated in the December 2017 final rule that it will continue to collect and model data for vibration service lamps for two years after the effective date of January 25, 2018 (calendar years 2018 and 2019), in accordance with 42 U.S.C. 6295(l)(4)(I)(ii). 82 FR 60845, 60846 (December 26, 2017). For the 2018 calendar year, the exponential growth forecast projected the benchmark unit sales estimate for vibration service lamps to be 2,229,000 units. The NEMA-provided shipment data reported shipments of 4,723,000 units in 2018, which is 211.9 percent of the benchmark estimate. DOE will complete its obligation to collect and model data for vibration service lamps after the 2019 calendar year.
For 3-way incandescent lamps, the exponential growth forecast projected the benchmark unit sales estimate for 2018 to be 47,121,000 units. The NEMA-provided shipment data reported shipments of 22,098,000 units in 2018. As the NEMA-provided shipment data reported is only 46.9 percent the benchmark estimate, DOE will continue to track 3-way incandescent lamp sales data and will not initiate an accelerated standards rulemaking for this lamp type at this time.
For 2,601-3,300 lumen general service incandescent lamps, the exponential growth forecast projected the benchmark unit sales estimate for 2018 to be 34,373,000 units. The NEMA-provided shipment data reported shipments of 2,465,000 units in 2018. As the NEMA-provided shipment data reported is only 7.2 percent of the benchmark estimate, DOE will continue to track 2,601-3,300 lumen general service incandescent lamp sales data and will not impose statutory requirements for this lamp type at this time.
For shatter-resistant lamps, the exponential growth forecast projected the benchmark unit sales estimate for 2018 to be 1,688,000 units. The NEMA-provided shipment data reported shipments of 400,000 units in 2018. As the NEMA-provided shipment data reported is only 23.7 percent of the benchmark estimate, DOE will continue to track shatter-resistant lamp sales data and will not initiate an accelerated standards rulemaking for this lamp type at this time.
This NODA compares the 2018 shipments against benchmark unit sales estimates for rough service lamps, vibration service lamps, 3-way incandescent lamps, 2,601-3,300 lumen general service incandescent lamps, and shatter-resistant lamps. For 3-way incandescent lamps, 2,601-3,300 lumen general service incandescent lamps, and shatter-resistant lamps, the 2018 sales are not greater than 200 percent of the forecasted estimates. The 2018 unit sales for vibration service lamps are greater than 200 percent of the benchmark unit sales estimate. The 2018 unit sales for rough service lamps are below the benchmark unit sales estimate. DOE will continue to monitor these lamp types and will assess 2019 unit sales next year.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of oxides of nitrogen (NO
Any comments must arrive by May 28, 2019.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2019-0176 at
Rynda Kay, EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105, (415) 947-4118,
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the measure addressed by this proposal with the date that it was adopted by the California Air Resources Board (CARB). We refer to this measure as the “South Coast Incentive Measure.”
On November 4, 2018, the submittal for the South Coast Incentive Measure was deemed by operation of law to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.
There are no previous versions of the South Coast Incentive Measure in the SIP.
Emissions of NO
On July 18, 1997, the EPA revised the national ambient air quality standard (NAAQS or “standards”) for ozone to establish an 8-hour ozone standard of 0.08 parts per million (ppm).
On April 27, 2017, CARB submitted the “Final 2016 Air Quality Management Plan,” March 2017 (“2016 AQMP”) and the “Revised Proposed 2016 State Strategy for the State Implementation Plan,” March 7, 2017 (“State SIP Strategy”), which contain, inter alia, a revised attainment demonstration and revised commitments to achieve specific amounts of emission reductions by 2023 for the 1997 ozone NAAQS. The 2016 AQMP also contains an attainment demonstration and commitments to achieve specific amounts of emission reductions by 2031 for the 2008 ozone NAAQS, in addition to revised attainment plan components for the 1979 1-hour ozone NAAQS. The purpose of the South Coast Incentive Measure is to satisfy a portion of the State's emission reduction commitments for the 1997 ozone NAAQS.
The South Coast Incentive Measure is a set of enforceable commitments by CARB to, among other things, monitor the SCAQMD's implementation of 1,300 on-road heavy-duty compression ignition truck repower and replacement projects during the 2019-2022 timeframe in the South Coast in accordance with specified portions of the Carl Moyer Program Guidelines, 2017 Revisions, approved April 27, 2017 (“2017 Carl Moyer Guidelines”). These program requirements ensure, among other things, that older, dirtier truck engines currently in operation in the South Coast will be replaced with less-polluting engines.
The South Coast Incentive Measure obligates CARB to achieve specific amounts of NO
We are proposing to approve the South Coast Incentive Measure into the California SIP and to make the obligations stated therein enforceable by the EPA and by citizens under the CAA. The State relies on the measure to achieve 1 ton per day of NO
Generally, SIP control measures must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).
The CAA explicitly provides for the use of economic incentive programs (EIPs) as one tool for states to use to achieve attainment of the NAAQS.
The EPA's guidance documents addressing EIPs and other nontraditional programs provide for some flexibility in meeting established SIP requirements for enforceability and quantification of emission reductions, provided the State takes clear responsibility for ensuring that the emission reductions necessary to meet applicable CAA requirements are achieved. Accordingly, the EPA has consistently stated that nontraditional emission reduction measures submitted to satisfy SIP requirements under the Act must be accompanied by appropriate “enforceable commitments” from the State to monitor emission reductions achieved and to rectify
Guidance documents that we use to evaluate discretionary EIPs and other nontraditional emission reduction programs include the following:
• “Guidance on Incorporating Voluntary Mobile Source Emission Reduction Programs in State Implementation Plans (SIPs),” Richard D. Wilson, Acting Assistant Administrator for Air and Radiation, October 24, 1997 (“1997 VMEP”).
• “Improving Air Quality with Economic Incentive Programs” January 2001 (EPA-452/R-01-001) (“2001 EIP Guidance”).
• “Incorporating Emerging and Voluntary Measure in a State Implementation Plan (SIP),” Stephen D. Page, OAQPS, October 4, 2004 (“2004 Emerging and Voluntary Measures Guidance”).
• “Guidance on Incorporating Bundled Measures in a State Implementation Plan,” Stephen D. Page, OAQPS, and Margo Oge, OTAQ, August 16, 2005 (“2005 Bundled Measures Guidance”).
• “Diesel Retrofits: Quantifying and Using Their Emission Benefits in SIPs and Conformity: Guidance for State and Local Air and Transportation Agencies,” February 2014 (EPA-420-B-14-007) (“2014 Diesel Retrofits Guidance”).
The South Coast Incentive Measure contains clear, mandatory obligations that are enforceable against CARB and ensure that information about the emission reductions achieved through the program will be readily available to the public through CARB's submission of annual reports to the EPA. Our approval of the South Coast Incentive Measure would make these obligations enforceable by the EPA and by citizens under the CAA. The South Coast Incentive Measure obligates the State to implement a program that achieves quantifiable, surplus, permanent, and enforceable NO
We are proposing to find that the South Coast Incentive Measure satisfies CAA requirements for enforceability, SIP revisions, and nontraditional emission reduction programs as interpreted in EPA guidance documents. The TSD contains more information on our evaluation of this measure.
The EPA proposes to fully approve the submitted measure under CAA section 110(k)(3) based on a conclusion that the measure satisfies all applicable requirements. We will accept comments from the public on this proposal until May 28, 2019. If we take final action to approve the submitted measure, our final action will incorporate this measure into the federally enforceable SIP.
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the CARB measure described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• 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);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• 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 Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the 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 and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to determine that the West Central Pinal County nonattainment area attained the 2006 24-hour national ambient air quality standard (NAAQS) for particulate matter with a diameter of 2.5 micrometers or smaller (PM
Written comments must arrive on or before May 28, 2019.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2019-0068 at
Jerry Wamsley, EPA Region IX, (415) 947-4111,
Throughout this document, “we,” “us” and “our” refer to the EPA.
This proposed action is related to the ongoing efforts of states and the EPA to implement the PM
On July 18, 1997, the EPA established the first NAAQS for PM
On October 17, 2006, the EPA strengthened the 24-hour PM
On February 3, 2011, the EPA designated a portion of state lands in Pinal County, Arizona (“West Central Pinal County”) as nonattainment for the 2006 PM
On March 2, 2012, the EPA issued its “Implementation Guidance for the 2006 24-Hour Fine Particle (PM
On January 4, 2013, the U.S. Court of Appeals for the D.C. Circuit issued its decision regarding the NRDC's legal challenge to the EPA's 2007 PM
Given the result of the
Consistent with the
On September 4, 2013, EPA issued a clean data determination for the West Central Pinal County 2006 24-hour PM
For an area classified as Moderate under the CAA, section 188(c) states that the statutory attainment date is “as expeditiously as practicable, but no later than the end of the sixth calendar year after the area's designation as nonattainment.” Therefore, the applicable attainment date for West Central Pinal County, designated nonattainment in 2011 and classified as Moderate in 2014, was December 31, 2017.
Under 40 CFR part 50, section 50.13 and in accordance with Appendix N, a nonattainment area meets the 2006 24-hour PM
The EPA's proposal is pursuant to the Agency's statutory obligation, under CAA section 188(b)(2), to determine whether the West Central Pinal County nonattainment area has attained the 2006 24-hour PM
In accordance with 40 CFR part 50, Appendix N, a finding of attainment of the 2006 24-hour PM
The PM
The EPA's determination as to whether an area has attained the PM
In January 2016, Pinal County relocated the PM
The EPA's evaluation of whether the West Central Pinal County nonattainment area has met the 2006 PM
Today, in accordance with section 188(b)(2) of the CAA, the EPA is proposing to determine that the West Central Pinal County Moderate nonattainment area attained the 2006 24-hour PM
If our proposal is finalized as proposed, West Central Pinal County will remain a Moderate nonattainment area and will not be reclassified to a Serious nonattainment area. A final rule determining that West Central Pinal County attained the 2006 24-hour PM
This action proposes to determine that the West Central Pinal County has met the 2006 24-hour PM
• 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);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because this action is not significant under Executive Order 12866;
• 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 Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed determination is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed determination does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Nitrogen dioxides, Fine particulate matter, Ammonia, Sulfur dioxides, Volatile organic compounds, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Federal Communications Commission.
Proposed rule.
In this document, the Wireline Competition Bureau reopens the secure data enclave, supplements the record in the business data services (BDS) and USTelecom proceedings with additional tables and information placed in the secure data enclave, and seeks focused comment on whether the additional data informs the extent of competition for transport.
Comments are due May 9, 2019 and reply comments are due May 16, 2019.
Participants in the price cap BDS proceedings previously authorized to access the secure data enclave
For participants in the USTelecom Forbearance Petition proceeding, the forthcoming protective order governing access to the secure data enclave for that proceeding will include instructions on requesting access to the secure data enclave and an Acknowledgement of Confidentiality that parties must execute and send to
Filings can be sent by hand or messenger delivery, 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.
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
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 445 12th Street SW, Washington, DC 20554.
Christopher Koves, Pricing Policy Division, Wireline Competition Bureau at 202-418-8209 or by email at
This is a summary of a document, WC Docket Nos. 18-141, 17-144, 16-143, 05-25; RM-10593, released on April 15, 2019. A full-text version of this document can be obtained at the following internet address:
1. The Wireline Competition Bureau (Bureau) makes several announcements regarding the above-referenced dockets. First, the Bureau announces that it is supplementing the record in the price cap business data services (BDS) proceedings with tables and accompanying information prepared by the Office of Economics and Analytics, derived from highly confidential data from the
2. Second, to allow parties access to the
3. Third, pending the resolution of any objections to the Bureau incorporating the
4. Fourth, the Bureau also seeks comment in the USTelecom Forbearance Petition proceeding on the extent to which the
5. The Bureau will place the
6. Participants in the price cap BDS proceedings previously authorized to access the secure data enclave pursuant to the Protective Orders in the price cap BDS proceedings may request renewed
7. For participants in the USTelecom Forbearance Petition proceeding, the forthcoming protective order governing access to the secure data enclave for that proceeding will include instructions on requesting access to the secure data enclave and an Acknowledgement of Confidentiality that parties must execute and send to
8.
9.
10. For further information, please contact Christopher Koves, Pricing Policy Division, Wireline Competition Bureau, at (202) 418-8209 or via email at
Agricultural Marketing Service, USDA.
Notice: Request for information.
The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA), is soliciting comments on the feasibility of establishing a livestock dealer statutory trust.
Comments must be received by June 24, 2019.
Interested persons are invited to submit written comments via the internet at
Please be advised that all comments submitted in response to this notice will be included in the record and will be made available to the public on the internet via
S. Brett Offutt, Chief Legal Officer/Policy Advisor, Packers and Stockyards Division, Fair Trade Practices Program, Agricultural Marketing Service, U.S. Department of Agriculture, telephone (202) 690-4355, email
Section 12103 of the Agriculture Improvement Act of 2018 (Pub. L. 115-334), the 2018 Farm Bill, charged the Secretary with conducting a study to determine the feasibility of establishing a livestock dealer statutory trust. Section 12103 requires that the study: (1) Analyze how the establishment of a livestock dealer statutory trust would affect buyer and seller behavior in markets for livestock (as defined in section 2(a) of the Packers and Stockyards Act, 1921 (7 U.S.C. 182)); (2) Examine how the establishment of a livestock dealer statutory trust would affect seller recovery in the event of a livestock dealer payment default; (3) Consider what potential effects a livestock dealer statutory trust would have on credit availability, including impacts on lenders and lending behavior and other industry participants; (4) Examine unique circumstances common to livestock dealers and how those circumstances could impact the functionality of a livestock dealer statutory trust; (5) Study the feasibility of the industry-wide adoption of electronic funds transfer or another expeditious method of payment to provide sellers of livestock protection from nonsufficient funds payments; (6) Assess the effectiveness of statutory trusts in other segments of agriculture, whether similar effects could be experienced under a livestock dealer statutory trust, and whether authorizing the Secretary to appoint an independent trustee under the livestock dealer statutory trust would improve seller recovery; (7) Consider the effects of exempting dealers with average annual purchases under a de minimis threshold from being subject to the livestock dealer statutory trust; and (8) Analyze how the establishment of a livestock dealer statutory trust would affect the treatment of sellers of livestock as it relates to preferential transfer in bankruptcy.
The study will be conducted by the U.S. Department of Agriculture's Agricultural Marketing Service (AMS). AMS has regulatory authority over two statutes that contain statutory trusts: The Packers and Stockyards (P&S) Act and the Perishable Agricultural Commodities Act (PACA). The statutory PACA trust (7 U.S.C. 449e(c)) requires commission merchants, dealers, and brokers to hold perishable agricultural commodity inventory, products, receivables, and proceeds in trust for the benefit of unpaid produce sellers. The P&S Act currently includes two trusts: The packer trust (7 U.S.C. 196), which requires packers to hold livestock, inventory, receivables and proceeds in trust for unpaid cash sellers of livestock; and the poultry trust (7 U.S.C. 197), which requires live poultry dealers to hold poultry, inventories, receivables, and proceeds in trust for unpaid cash sellers or poultry growers.
The P&S Act also regulates the business practices of livestock dealers, but livestock dealers are not currently subject to a statutory trust provision. Section 301(d) of the P&S Act (7 U.S.C. 201), defines a “dealer” as “any person, not a market agency, engaged in the business of buying or selling in commerce livestock, either on his own account or as the employee or agent of the vendor or purchaser.”
AMS is seeking comments to assist it in determining the feasibility of establishing a livestock dealer statutory trust. Commenters may address any or all of the eight (8) key components of the study by responding to the following questions:
(1) How would the establishment of a livestock dealer statutory trust affect buyer and seller behavior in markets for livestock?
(2) How would the establishment of a livestock dealer statutory trust affect seller recovery in the event of a livestock dealer payment default?
(3) What potential effects would a livestock dealer statutory trust have on credit availability, including impacts on lenders and lending behavior and other industry participants?
(4) How would the unique circumstances common to livestock dealers impact the functionality of a livestock dealer statutory trust?
(5) Is industry-wide adoption of electronic funds transfer or another expeditious method of payment feasible, and would such adoption provide sellers of livestock with protection from nonsufficient funds payments?
(6) How effective are statutory trusts in other segments of agriculture? Could similar effects be experienced under a
(7) Should dealers with average annual purchases under a de minimis threshold be exempt from being subject to the livestock dealer statutory trust? What purchase level should be considered for exemption? What effect would such an exemption have on the effectiveness of a livestock dealer statutory trust?
(8) How would the establishment of a livestock dealer statutory trust affect the treatment of sellers of livestock as related to preferential transfers in bankruptcy?
This notice provides for a 60-day period for interested parties to comment on the components of the study.
Sec. 12103, Pub. L. 115-334, 132 Stat. 4490.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the 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 burden 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 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.
Comments regarding this information collection received by May 28, 2019 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Animal and Plant Health Inspection Service, USDA.
Reinstatement of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request the reinstatement of an information collection to conduct the National Animal Health Monitoring System's Swine 2020 Study.
We will consider all comments that we receive on or before June 24, 2019.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the Swine 2020 Study, contact Mr. Bill Kelley, Program Analyst, Center for Epidemiology and Animal Health, VS, 2150 Centre Avenue, Building B, Fort Collins, CO 80524; (970) 494-7270. For more
In connection with this mission, APHIS operates the National Animal Health Monitoring System (NAHMS), which collects, on a national basis, statistically valid and scientifically sound data on the prevalence and economic importance of livestock, poultry, and aquaculture disease risk factors.
NAHMS' studies have evolved into a collaborative industry and government initiative to help determine the most effective means of preventing and controlling diseases of livestock. APHIS is the only agency responsible for collecting data on livestock health. Participation in any NAHMS study is voluntary, and all data are confidential.
APHIS plans to conduct the Swine 2020 Study as part of an ongoing series of NAHMS studies on the U.S. livestock population. This study will support the following objectives: (1) Describe current U.S. large-scale swine production practices for gestation, farrowing, nursery, grower/finisher, and wean-to-finish phases, specifically as they relate to housing, productivity, biosecurity, and morbidity and mortality prevention; (2) Describe current U.S. small-scale production practices including general management practices, housing practices, productivity, disease prevention, and mortality; (3) Determine the producer-reported prevalence of select respiratory, neurologic, gastrointestinal, systemic, and foodborne pathogens found in weaned market pigs; (4) Describe large-scale swine production antimicrobial-use patterns in pigs from post-weaning to market age; (5) Evaluate the presence of select pathogens and characterize isolated organisms from biological specimens (feces, oral fluids) in large-scale swine production; (6) Describe trends in small-scale swine health and disease management practices; (7) Describe trends in small-scale swine production system movements, marketing, and slaughter channels; and (8) Describe potential overlaps between small-scale swine production system movements with those of larger total confinement/commercial operations.
The two components of the study will be in-person questionnaire based surveys for large swine operations and computer-assisted telephone interviews for small swine operations. The large swine operation component will consist of two phases. In Phase I, the National Agricultural Statistics Service (NASS) will contact producers by telephone and personal interviews to collect operational level data and subordinate swine production site (locations where the animals are raised) contact information. NASS data collectors will follow up with producers at each swine production site by telephone and personal interviews to collect site level data and respondent consent to be contacted for Phase II of the study. In Phase II, APHIS data collectors will contact consenting respondents to administer questionnaires and perform biologic sampling. The small swine operation component of the study will consist of NASS sending producers questionnaires and following up via computer-assisted telephone interviews with those who do not respond.
The information collected through the Swine 2020 Study will be analyzed and used to predict or detect national and regional trends in disease emergence and movement such as the prevalence of clinical signs of coronavirus (
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Forest Service, USDA.
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the new information
Comments must be received in writing on or before June 24, 2019 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Comments concerning this notice should be addressed to Director, Lands and Realty Management, USDA Forest Service, 1400 Independence Ave. SW, Mailstop Code: 1124, Washington, DC 20250-1124. Comments also may be submitted via facsimile to 703-605-5117 or by email to:
The public may inspect comments received at the Office of the Director, Lands, 1st Floor South East, Sidney R. Yates Federal Building, 201 14th Street SW, Washington, DC, during normal business hours. Visitors are encouraged to call ahead to 202-205-3563 to facilitate entry to the building.
Mark Chandler, Realty Specialist, Lands and Realty Management, at 202-205-1117. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 between 8 a.m. and 8 p.m. Eastern Standard Time, Monday through Friday.
In addition, the Department of the Interior (DOI) statutes for the Bureau of Land Management (BLM), Fish and Wildlife Service (FWS), National Park Service (NPS), and Bureau of Reclamation (BOR) along with the statutes for the U.S. Army Corp of Engineers (USACE), and the General Services Administration (GSA) authorize their collection of information who will utilize form SF-299 “Application for Transportation, Utility Systems, Telecommunications and Facilities on Federal Lands and Property.”
Several statutes authorize the Forest Service to issue and administer authorizations for use and occupancy of NFS lands and collect information from the public for those purposes. The laws authorizing the collection of this information include the Organic Administration Act of 1897 (16 U.S.C. 551); Title V of the Federal Land Policy and Management Act of 1976 (FLPMA, 43 U.S.C. 1761-1771); Act of March 4, 1915 (16 U.S.C. 497); Alaska Term Permit Act of March 30, 1948 (16 U.S.C. 497a); Act of September 3, 1954 (68 Stat. 1146; 43 U.S.C. 931c, 931d); National Forest Ski Area Permit Act (16 U.S.C. 497b); section 28 of the Mineral Leasing Act (30 U.S.C. 185); National Forest Roads and Trails Act (FRTA, 16 U.S.C. 532-538); section 7 of the Granger-Thye Act (16 U.S.C. 580d); Act of May 26, 2000 (16 U.S.C. 460l-6d); Federal Lands Recreation Enhancement Act (16 U.S.C. 6801-6814); Archeological Resource Protection Act of October 31, 1979 (16 U.S.C. 470aa-470mm); and the Rural Electrification Act of 1936, as amended.
Forest Service regulations implementing these authorities, found at 36 CFR part 251, subpart B, contain information collection requirements, including submission of applications, execution of forms, and imposition of terms and conditions that entail information collection requirements, such as the requirement to submit annual financial information, to prepare and update an operating plan; to prepare and update a maintenance plan, and to submit compliance reports and information updates.
The information helps the Forest Service identify the environmental and social impacts of special uses for purposes of compliance with the National Environmental Policy Act and program administration.
Information collection occurs via application forms, as well as terms and conditions in special use authorizations and operating plans. Information is required from proponents and applicants to evaluate proposals and applications to use or occupy NFS lands.
Special use authorizations encompass a variety of activities ranging from individual private uses to large-scale commercial facilities and public services. Examples of authorized special uses include public and private road rights-of-way, apiaries, domestic water supply conveyance systems, telephone and electric service rights-of-way, oil and gas pipeline rights-of-way, communications facilities, hydroelectric power-generating facilities, ski areas, resorts, marinas, municipal sewage treatment plants, and public parks and playgrounds.
SF-299,
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.
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 (FACA) that the Minnesota Advisory Committee (Committee) to the Commission will meet via conference call to discuss civil rights concerns in the State.
The meetings will be held on
• Wednesday May 15, 2019, at 2:30 p.m. CDT.
• Wednesday June 26, 2019, at 12 p.m. CDT.
Carolyn Allen at
This meetings are available to the public through the above toll-free call-in number. Any interested member of the public may call this number and listen to the meetings. Callers can expect to incur 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. Persons with hearing impairments 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 conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the U.S. Commission on Civil Rights, Regional Programs Unit, 230 S. Dearborn, Suite 2120, Chicago, IL 60604. They may be faxed to the Commission at (312) 353-8324, or emailed Carolyn Allen at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting on the Federal Advisory Committee database (facadatabase.gov), under the Minnesota Advisory Committee link. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website,
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Materials Technical Advisory Committee will meet on May 9, 2019, 10:00 a.m., Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues NW, Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials and related technology.
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
For more information, call Yvette Springer at (202) 482-2813.
The Materials Technical Advisory Committee will meet on May 9, 2019, 10:00 a.m., Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues NW, Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials and related technology.
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on April 19, 2019, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and the U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 § § 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable April 25, 2019.
Carrie Bethea at (202) 482-1491 (India), and Thomas Schauer at (202) 482-0410 (the People's Republic of China (China)), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On March 13, 2019, the Department of Commerce (Commerce) initiated countervailing duty (CVD) investigations of imports of carbon and alloy steel threaded rod from China and India.
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) The petitioner
On March 29, 2019, the petitioner submitted timely requests that Commerce postpone the preliminary CVD determinations.
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that T.T. International Co., Ltd. (TTI) sold hydrofluorocarbon blends (HFCs) from the People's Republic of China (China) at less than normal value (NV) during the period of review (POR), February 1, 2016, through July 31, 2017.
Applicable April 25, 2019.
Andrew Medley or Manuel Rey, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4987 or (202) 482-5518, respectively.
Commerce published the
The products subject to this order are HFC blends. HFC blends covered by the scope are R-404A, a zeotropic mixture consisting of 52 percent 1,1,1 Trifluoroethane, 44 percent Pentafluoroethane, and 4 percent 1,1,1,2-Tetrafluoroethane; R-407A, a zeotropic mixture of 20 percent Difluoromethane, 40 percent Pentafluoroethane, and 40 percent 1,1,1,2-Tetrafluoroethane; R-407C, a zeotropic mixture of 23 percent Difluoromethane, 25 percent Pentafluoroethane, and 52 percent 1,1,1,2-Tetrafluoroethane; R-410A, a zeotropic mixture of 50 percent Difluoromethane and 50 percent Pentafluoroethane; and R-507A, an azeotropic mixture of 50 percent Pentafluoroethane and 50 percent 1,1,1-Trifluoroethane also known as R-507. The foregoing percentages are nominal percentages by weight. Actual percentages of single component refrigerants by weight may vary by plus or minus two percent points from the nominal percentage identified above.
In the Issues and Decision Memorandum, we addressed all issues raised in parties' case and rebuttal briefs. Appendix I to this notice provides a list of the issues raised by parties. The Issues and Decision Memorandum is a public document and
Based on our review of the record and comments received from interested parties regarding our
In the
Further, we determined in the
The statute and our regulations do not address the rate to be assigned to respondents not selected for individual examination when we limit our examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, we look to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Section 735(c)(5)(A) of the Act articulates a preference for not calculating an all-others rate using rates which are zero,
For the final results, we calculated a rate only for TTI. Therefore, for these final results, following the practice described above, we have assigned the rate calculated for TTI to the companies that have not been individually examined but have demonstrated their eligibility for a separate rate.
In the
Because Arkema, Dongyang Weihua, Sinochem Taicang, Weitron, Zhejiang Lantian, and Zhejiang Quzhou did not demonstrate that they are entitled to a separate rate, Commerce finds these six companies to be part of the China-wide entity. Because no party requested a review of the China-wide entity, and Commerce no longer considers the China-wide entity as an exporter conditionally subject to administrative reviews,
For companies subject to this review and established their eligibility for a separate rate, Commerce determines that the following weighted-average dumping margins exist for the period February 1, 2016, through July 31, 2017:
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP 15 days
For TTI, we calculated importer-specific
Pursuant to Commerce's assessment practice, for entries that were not reported in the U.S. sales data submitted by TTI, we will instruct CBP to liquidate such entries at the China-wide rate.
For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the weighted-average dumping margin determined for TTI in the final results of this administrative review.
For the companies found to be part of the China-wide entity, because Commerce determined that these companies did not qualify for a separate rate, we will instruct CBP to assess dumping duties on the companies' entries of subject merchandise at the rate of 216.37 percent.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margin established in the final results of this review; (2) for previously investigated or reviewed China and non-China exporters not listed above that currently have a separate rate, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding where the exporter received that separate rate; (3) for all China exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the China-wide entity, 216.37 percent; and (4) for all non-China exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the China exporter that supplied that non-China exporter. These deposit requirements, when imposed, shall remain in effect until further notice.
We intend to disclose the calculations performed to parties in this proceeding within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) 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 the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice 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 return or 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 these results of review in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers/exporters of passenger vehicle and light truck tires from the People's Republic of China (China) during the period of review (POR) January 1, 2016, through December 31, 2016.
Applicable April 25, 2019.
Andrew Huston, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-4261.
Commerce published the
The products covered by the order are certain passenger vehicle and light truck tires from the China. A full description of the scope of the order is contained in the Issues and Decision Memorandum.
All issues raised in interested parties' briefs are addressed in the Issues and Decision Memorandum accompanying this notice. A list of the issues raised by interested parties and to which we responded in the Issues and Decision Memorandum is provided in 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 case briefs, and all supporting documentation, we made certain changes from the
Commerce conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we find that there is a subsidy,
In accordance with 19 CFR 351.221(b)(5), we calculated a countervailable subsidy rate for the mandatory respondents, Cooper and Sentury. For the non-selected companies subject to this review,
We will disclose to the parties in this proceeding the calculations performed for these final results within five days of the date of publication of this notice in the
Consistent with 19 CFR 351.212(b)(2), we intend to issue assessment instructions to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of these final results of review, to liquidate shipments of subject merchandise entered, or withdrawn from warehouse, for consumption, on or after January 1, 2016, through December 31, 2016, at the
In accordance with section 751(a)(1) of the Act, we intend to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for each of the respective companies listed above. These cash deposit requirements, when imposed, shall remain in effect until further notice.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). 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 sanctionable violation.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.
NMFS has received a request from Avangrid Renewables, LLC for authorization to take marine mammals incidental to high-resolution geophysical (HRG) survey investigations associated with marine site characterization activities off the coast of North Carolina in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0508) (the Lease Area) and the coastal waters off North Carolina and Virginia where one or more cable route corridors will be established. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in
Comments and information must be received no later than May 28, 2019.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Rob Pauline, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the monitoring and reporting of such takings must be set forth.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
NMFS is preparing an Environmental Assessment (EA) to consider the environmental impacts associated with the issuance of the proposed IHA. NMFS' EA will be made available at
We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.
On October 4, 2018, NMFS received a request from Avangrid for an IHA to take marine mammals incidental to HRG survey investigations off the coast of North Carolina in the OCS-A 0508 Lease Area and in the coastal waters of Virginia and North Carolina where one or more cable route corridors will be established to support the development of an offshore wind project. The application was deemed adequate and complete on February 21, 2019. Avangrid's request is for take of small numbers of nine species by Level B harassment only. Neither Avangrid nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
The purpose of the marine site characterization survey is to support the siting, design, and deployment of up to three meteorological data buoy deployment areas and obtain a baseline assessment of seabed/sub-surface soil conditions in the Lease Area and cable route corridors to support the siting of a proposed wind farm. Underwater sound resulting from use of HRG equipment for site characterization purposes can have the potential to result in incidental take of marine mammals. The survey area extends along the coast from near the mouth of the Chesapeake Bay to Currituck, North Carolina. Up to 37 days of active HRG survey operations are planned and could take place at time during the one year authorization period. This take of marine mammals is anticipated to be in the form of harassment only; no serious injury or mortality is anticipated, nor is any proposed for authorization here.
HRG Surveys are anticipated to commence no earlier than June 1, 2019, and will last for approximately 37 days. This survey schedule is based on 24-hour operations and includes estimated weather down time. The proposed surveys are planned to take place during the summer months. The IHA would be effective for one year.
Avangrid's survey activities will occur in the approximately 122,317-acre Lease Area located approximately 31.3 nautical miles off the coast of Currituck, North Carolina, in Federal waters of the United States (see Figure 1 in Application). In addition, multiple cable route corridors will be surveyed within the area identified in Figure 1 in the Application. Each survey corridor is anticipated to be 30 to 70 nautical miles and extend from the lease area to landfall locations to be determined. For the purpose of this proposed IHA, the survey area is considered to be the Lease Area and cable route corridors. Water depths across the survey area are relatively shallow. Lease Area depths range from approximately 20 to 50 m (66 to 164 feet (ft)) while the cable route corridors will extend to shallow water close to landfall.
HRG surveys are employed to detect geohazards, archaeological resources, certain types of benthic communities, and to assess seafloor suitability for supporting structures such as platforms, pipelines, cables, and wind turbines. These surveys for renewable energy occur in shallow waters. HRG surveys typically use only electromechanical sources such as side-scan sonars; boomer, sparker, and chirp sub-bottom profilers; and multibeam depth sounders, some of which are expected to be beyond the functional hearing range of marine mammals or would be detectable only at very close range.
Marine site characterization surveys will include the following HRG survey activities:
• Multibeam echosounder use to determine site bathymetry and elevations;
• Seafloor imaging (sidescan sonar survey) for seabed sediment classification purposes, to identify natural and man-made acoustic targets resting on the bottom as well as any anomalous features;
• Shallow penetration sub-bottom profiler (pinger/chirp) to map the near surface stratigraphy (top 0 to 5 m (0 to 16 ft) of soils below seabed);
• Medium penetration sub-bottom profiler (sparker) to map deeper subsurface stratigraphy as needed (soils down to 75 to 100 m (246 to 328 ft) below seabed);
• Magnetic intensity measurements for detecting local variations in regional magnetic field from geological strata and potential ferrous objects on and below the bottom; and
• Benthic Drop-down Video (DDV) and grab samples to inform and confirm geophysical interpretations and to provide further detail on areas of potential benthic and ecological interest.
Note that take of marine mammals is not associated with use of magnetic intensity measurement devices, DDV, or grab sample equipment.
A technical report conducted by the Naval Undersea Warfare Center (NUWC), through support from the Bureau of Ocean Energy Management (BOEM) and the United States Geological Survey, published measurements of the acoustic output from a variety of sources used during HRG surveys (Crocker and Fratantonio,
Note that the operating frequencies of both the multibeam echo sounder and side-scan sonar occur outside the hearing range of marine mammals. Since there are no impacts to cetaceans associated with use of this equipment, these sources are not considered further in this document.
The survey activities will be supported by a vessel, or vessels, capable of maintaining course and a survey speed of approximately 4 nautical miles per hour (knots, 7 kilometers per hour (km/hr)) while transiting survey lines. Surveys will be conducted along tracklines spaced 150 m (98 ft) apart, with tie-lines spaced every 500 m (1640 ft). Several survey vessels may be used simultaneously, but it is more likely that only a single vessel would conduct surveys at any one time.
To minimize cost, the duration of survey activities, and the period of potential impact on marine species while surveying, Avangrid has proposed conducting continuous HRG survey operations 24 hours per day. Based on 24-hour operations, the estimated duration of the HRG survey activities would be approximately 37 days. Additional time (up to 30 days) may be required to obtain full multibeam coverage in shallow water areas, however the multibeam sensor operates at frequencies above the functional hearing ranges of marine mammals; therefore take of marine mammals is not expected as a result of multibeam-only survey activity, and multibeam-only survey activity is not analyzed further in this document.
The deployment of HRG survey equipment, including the use of sound-producing equipment operating below 200 kHz (
NMFS has previously issued IHAs for HRG surveys conducted in the Atlantic Ocean, off the east coast of the United States. Most of these have occurred in the coastal waters of southern New England, although NMFS recently issued an IHA for an HRG survey investigating unexploded ordnance (UXO) off the coast of Virginia as part of an offshore wind project (83 FR 39062, August 8, 2018). Marine mammal monitoring reports submitted after completion of HRG surveys indicated that authorized take numbers have never been exceeded.
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (SARs;
Table 2 lists species with expected potential for take in the survey area and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2018). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality or serious injury is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. Atlantic SARs (
Three marine mammal species that are listed under the Endangered Species Act (ESA) may be present in the survey area: The North Atlantic right whale, fin whale, and sei whale. However, NMFS is not proposing authorized take of any of these species. The proposed authorization of take for 10 species (with 11 managed stocks) is described in the
The North Atlantic right whale was listed as a Federal endangered species in 1970. The right whale is a strongly migratory species, with some portion of the population moving annually between high-latitude feeding grounds and low latitude calving and breeding grounds. The present range of the western North Atlantic right whale population extends from the southeastern United States, which is utilized for wintering and calving by some individuals, to summer feeding and nursery grounds between New England and the Bay of Fundy and the Gulf of St. Lawrence (Kenney 2002; Waring
The proposed survey area is part of a migratory Biologically Important Area (BIA) for North Atlantic right whales; this important migratory area is comprised of the waters of the continental shelf offshore the East Coast of the United States and extends from Florida through Massachusetts. Additionally, NMFS' regulations at 50 CFR 224.105 impose vessel speed limits in designated Seasonal Management Areas (SMA) in nearshore waters of the Mid-Atlantic Bight. SMAs were developed to reduce the threat of collisions between ships and right whales around their migratory route and calving grounds. NMFS requires that all vessels 65 ft (19.8 m) or longer must travel at 10 knots or less within the right whale SMA from November 1 through April 30 when right whales are most likely to pass through these waters (NOAA 2010). A small section of the cable routing area overlaps spatially with the Chesapeake Bay SMA.
The western North Atlantic population demonstrated overall growth of 2.8 percent per year between 1990 and 2010 and no growth between 1997 and 2000 (Pace
Elevated North Atlantic right whale mortalities have occurred since June 7, 2017. A total of 20 confirmed dead stranded whales (12 in Canada; 8 in the United States), have been documented to date. This event has been declared an Unusual Mortality Event (UME), with human interactions (
Humpback whales are found worldwide in all oceans. In 1973, the
Since January 2016, elevated humpback whale mortalities have occurred along the Atlantic coast from Maine through Florida. The event has been declared a UME. Partial or full necropsy examinations have been conducted on approximately half of the 88 known cases. A portion of the whales have shown evidence of pre-mortem vessel strike; however, this finding is not consistent across all of the whales examined so more research is needed. NOAA is consulting with researchers that are conducting studies on the humpback whale populations, and these efforts may provide information on changes in whale distribution and habitat use that could provide additional insight into how these vessel interactions occurred. More detailed information is available at
During winter, the majority of humpback whales from North Atlantic feeding areas mate and calve in the West Indies, where spatial and genetic mixing among feeding groups occurs, though significant numbers of animals are found in mid- and high-latitude regions at this time and some individuals have been sighted repeatedly within the same winter season, indicating that not all humpback whales migrate south every winter (Waring
Fin whales are common in waters of the U. S. Atlantic Exclusive Economic Zone (EEZ), principally from Cape Hatteras northward (Waring
Present threats to fin whales are similar to other whale species, namely fishery entanglements and vessel strikes. Fin whales seem less likely to become entangled than other whale species. Glass
Fin whales are present in the Mid-Atlantic region during all four seasons, although sightings data indicate that they are more prevalent during winter, spring, and summer (Waring et al 2012). While fall is the season of lowest overall abundance off Virginia and North Carolina, they do not depart the area entirely.
The sei whale is a widespread species in the world's temperate, subpolar, subtropical, and tropical marine waters. NOAA Fisheries considers sei whales occurring from the U.S. East Coast to Cape Breton, Nova Scotia, and east to 42° W as the “Nova Scotia stock” of sei whales (Waring
There is limited information on the stock identity of sei whales in the North Atlantic and insufficient data to determine trends of the Nova Scotian sei whale population (Hayes
Minke whales can be found in temperate, tropical, and high-latitude waters. The Canadian East Coast stock can be found in the area from the western half of the Davis Strait (45° W) to the Gulf of Mexico (Waring
Since January 2017, elevated minke whale strandings have occurred along the Atlantic coast from Maine through South Carolina, with highest numbers in Massachusetts, Maine, and New York. As of September 30, 2018, partial or full necropsy examinations have been conducted on more than 60 percent of the 57 known cases. Preliminary findings in several of the whales have shown evidence of human interactions or infectious disease. These findings are not consistent across all of the whales examined, so more research is needed. As part of the UME investigation process, NOAA is assembling an independent team of scientists to coordinate with the Working Group on Marine Mammal Unusual Mortality Events to review the data collected, sample stranded whales, and determine the next steps for the investigation. More information is available at:
Both the long-finned and short-finned pilot whale could occur in the survey
The bottlenose dolphin occurs in oceans and peripheral seas at both tropical and temperate latitudes. In North America, bottlenose dolphins are found in surface waters with temperatures ranging from 10 to 32° C (50 to 90 °F).
There are two distinct bottlenose dolphin morphotypes: Coastal and offshore. The coastal morphotype resides in waters typically less than 65.6 ft (20 m) deep, along the inner continental shelf (within 7.5 km (4.6 miles) of shore), around islands, and is continuously distributed south of Long Island, New York into the Gulf of Mexico. These coastal populations are subdivided into seven stocks based largely upon spatial distribution (Waring
The Southern Migratory Coastal stock may also overlap to some degree with the western North Atlantic Offshore stock of common bottlenose dolphins. A combined genetic and logistic regression analysis that incorporated depth, latitude, and distance from shore was used to model the probability that a particular common bottlenose dolphin group seen in coastal waters was of the coastal versus offshore morphotype (Garrison
The biggest threat to the population is bycatch because they are frequently caught in fishing gear, gillnets, purse seines, and shrimp trawls (Waring
The short-beaked common dolphin is found world-wide in temperate to subtropical seas. In the North Atlantic, short-beaked common dolphins are commonly found over the continental shelf between the 100-m and 2,000-m isobaths and over prominent underwater topography and east to the mid-Atlantic Ridge. Common dolphins have been noted to be associated with Gulf Stream features (CETAP 1982; Selzer and Payne 1988; Waring
White-sided dolphins are found in temperate and sub-polar waters of the North Atlantic, primarily in continental shelf waters to the 100-m depth contour from central West Greenland to North Carolina (Waring
There are two species of spotted dolphin in the Atlantic Ocean, the Atlantic spotted dolphin (
The Atlantic spotted dolphin ranges from southern New England, south through the Gulf of Mexico and the Caribbean to Venezuela (Leatherwood
Risso's dolphins are distributed worldwide in tropical and temperate seas and in the Northwest Atlantic occur from Florida to eastern Newfoundland. Off the northeastern U.S. coast, Risso's dolphins are distributed along the continental shelf edge from Cape Hatteras northward to Georges Bank during spring, summer, and autumn. In winter, the range is in the mid-Atlantic Bight and extends outward into oceanic waters. In general, the population occupies the mid-Atlantic continental shelf edge year round (Hayes
The harbor porpoise inhabits shallow, coastal waters, often found in bays, estuaries, and harbors. In the western Atlantic, they are found from Cape Hatteras north to Greenland. During summer (July to September), harbor porpoises are concentrated in the northern Gulf of Maine and southern Bay of Fundy region, generally in waters less than 150 m deep with a few sightings in the upper Bay of Fundy and on Georges Bank. During fall (October-December) and spring (April-June), harbor porpoises are widely dispersed from New Jersey to Maine, with lower densities farther north and south. They are seen from the coastline to deep waters (>1800 m) although the majority of the population is found over the continental shelf. During winter (January to March), intermediate densities of harbor porpoises can be found in waters off New Jersey to North Carolina, and lower densities are found in waters off New York to New Brunswick, Canada. There does not appear to be a temporally coordinated migration or a specific migratory route to and from the Bay of Fundy region. However, during the fall, several satellite-tagged harbor porpoises did favor the waters around the 92-m isobaths (Hayes
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (
• Low-frequency cetaceans (mysticetes): generalized hearing is estimated to occur between approximately 7 Hz and 35 kHz;
• Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Generalized hearing is estimated to occur between approximately 150 Hz and 160 kHz;
• High-frequency cetaceans (porpoises, river dolphins, and members of the genera Kogia and Cephalorhynchus; including two members of the genus Lagenorhynchus, on the basis of recent echolocation data and genetic data): Generalized hearing is estimated to occur between approximately 275 Hz and 160 kHz.
For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information. Twelve marine mammal species, all cetaceans, have the reasonable potential to co-occur with the proposed survey activities. Please refer to Table 2. Of these cetacean species, 5 are classified as low-frequency cetaceans (
This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The
Sound is a physical phenomenon consisting of minute vibrations that travel through a medium, such as air or water, and is generally characterized by several variables. Frequency describes the sound's pitch and is measured in Hz or kHz, while sound level describes the sound's intensity and is measured in dB. Sound level increases or decreases exponentially with each dB of change. The logarithmic nature of the scale means that each 10-dB increase is a 10-fold increase in acoustic power (and a 20-dB increase is then a 100-fold increase in power). A 10-fold increase in acoustic power does not mean that the sound is perceived as being 10 times louder, however. Sound levels are compared to a reference sound pressure (micro-Pascal) to identify the medium. For air and water, these reference
HRG survey equipment use during the geophysical surveys may temporarily impact marine mammals in the area due to elevated in-water sound levels. Marine mammals are continually exposed to many sources of sound. Naturally occurring sounds such as lightning, rain, sub-sea earthquakes, and biological sounds (
When sound travels (propagates) from its source, its loudness decreases as the distance traveled by the sound increases. Thus, the loudness of a sound at its source is higher than the loudness of that same sound a kilometer away. Acousticians often refer to the loudness of a sound at its source (typically referenced to one meter from the source) as the source level and the loudness of sound elsewhere as the received level (
As sound travels from a source, its propagation in water is influenced by various physical characteristics, including water temperature, depth, salinity, and surface and bottom properties that cause refraction, reflection, absorption, and scattering of sound waves. Oceans are not homogeneous and the contribution of each of these individual factors is extremely complex and interrelated. The physical characteristics that determine the sound's speed through the water will change with depth, season, geographic location, and with time of day (as a result, in actual active sonar operations, crews will measure oceanic conditions, such as sea water temperature and depth, to calibrate models that determine the path the sonar signal will take as it travels through the ocean and how strong the sound signal will be at a given range along a particular transmission path). As sound travels through the ocean, the intensity associated with the wavefront diminishes, or attenuates. This decrease in intensity is referred to as propagation loss, also commonly called transmission loss.
Marine mammals may experience temporary or permanent hearing impairment when exposed to loud sounds. Hearing impairment is classified by temporary threshold shift (TTS) and permanent threshold shift (PTS). There are no empirical data for onset of PTS in any marine mammal; therefore, PTS-onset must be estimated from TTS-onset measurements and from the rate of TTS growth with increasing exposure levels above the level eliciting TTS-onset. PTS is considered auditory injury (Southall
TTS is the mildest form of hearing impairment that can occur during exposure to a loud sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises and a sound must be stronger in order to be heard. At least in terrestrial mammals, TTS can last from minutes or hours to (in cases of strong TTS) days, can be limited to a particular frequency range, and can occur to varying degrees (
Marine mammal hearing plays a critical role in communication with conspecifics and in interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin, beluga whale, harbor porpoise, and Yangtze finless porpoise) exposed to a limited number of sound sources (
Scientific literature highlights the inherent complexity of predicting TTS onset in marine mammals, as well as the importance of considering exposure duration when assessing potential impacts (Mooney
Marine mammals in the survey area during the HRG survey are unlikely to incur TTS hearing impairment due to the characteristics of the sound sources, which include low source levels (208 to 221 dB re 1 µPa-m) and generally very short pulses and duration of the sound. Even for high-frequency cetacean species (
Masking is the obscuring of sounds of interest to an animal by other sounds, typically at similar frequencies. Marine mammals are highly dependent on sound, and their ability to recognize sound signals amid other sound is important in communication and detection of both predators and prey (Tyack, 2000). Background ambient sound may interfere with or mask the ability of an animal to detect a sound signal even when that signal is above its absolute hearing threshold. Even in the absence of anthropogenic sound, the marine environment is often loud. Natural ambient sound includes contributions from wind, waves, precipitation, other animals, and (at frequencies above 30 kHz) thermal sound resulting from molecular agitation (Richardson
Background sound may also include anthropogenic sound, and masking of natural sounds can result when human activities produce high levels of background sound. Conversely, if the background level of underwater sound is high (
Although masking is a phenomenon which may occur naturally, the introduction of loud anthropogenic sounds into the marine environment at frequencies important to marine mammals increases the severity and frequency of occurrence of masking. For example, if a baleen whale is exposed to continuous low-frequency sound from an industrial source, this would reduce the size of the area around that whale within which it can hear the calls of another whale. The components of background noise that are similar in frequency to the signal in question primarily determine the degree of masking of that signal. In general, little is known about the degree to which marine mammals rely upon detection of sounds from conspecifics, predators, prey, or other natural sources. In the absence of specific information about the importance of detecting these natural sounds, it is not possible to predict the impact of masking on marine mammals (Richardson
Marine mammal communications would not likely be masked appreciably by the sub-bottom profiler signals given the directionality of the signal and the brief period when an individual mammal is likely to be within its beam.
Classic stress responses begin when an animal's central nervous system perceives a potential threat to its homeostasis. That perception triggers stress responses regardless of whether a stimulus actually threatens the animal; the mere perception of a threat is sufficient to trigger a stress response (Moberg, 2000; Seyle, 1950). Once an animal's central nervous system perceives a threat, it mounts a biological response or defense that consists of a combination of the four general biological defense responses: Behavioral responses, autonomic nervous system responses, neuroendocrine responses, or immune responses.
In the case of many stressors, an animal's first and sometimes most economical (in terms of biotic costs) response is behavioral avoidance of the potential stressor or avoidance of continued exposure to a stressor. An animal's second line of defense to stressors involves the sympathetic part of the autonomic nervous system and the classical “fight or flight” response which includes the cardiovascular system, the gastrointestinal system, the exocrine glands, and the adrenal medulla to produce changes in heart rate, blood pressure, and gastrointestinal activity that humans commonly associate with “stress.” These responses have a relatively short duration and may or may not have significant long-term effect on an animal's welfare.
An animal's third line of defense to stressors involves its neuroendocrine systems; the system that has received the most study has been the hypothalamus-pituitary-adrenal system (also known as the HPA axis in mammals or the hypothalamus-pituitary-interrenal axis in fish and some reptiles). Unlike stress responses associated with the autonomic nervous system, virtually all neuro-endocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction (Moberg, 1987; Rivier, 1995), altered metabolism (Elasser
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and distress is the biotic cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose a risk to the animal's welfare. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other biotic function, which impairs those functions that experience the diversion. For example, when mounting a stress response diverts energy away from growth in young animals, those animals may experience stunted growth. When mounting a stress response diverts energy from a fetus, an animal's reproductive success and its fitness will suffer. In these cases, the animals will have entered a pre-pathological or pathological state which is called “distress” (Seyle, 1950) or “allostatic loading” (McEwen and Wingfield, 2003). This pathological state will last until the animal replenishes its biotic reserves sufficient to restore normal function. Note that these examples involved a long-term (days or weeks) stress response exposure to stimuli.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses have also been documented fairly well through controlled experiments; because this physiology exists in every vertebrate that has been studied, it is not surprising that stress responses and their costs have been documented in both laboratory and free-living animals (for examples see, Holberton
Studies of other marine animals and terrestrial animals would also lead us to expect some marine mammals to experience physiological stress responses and, perhaps, physiological responses that would be classified as “distress” upon exposure to high frequency, mid-frequency and low-frequency sounds. For example, Jansen (1998) reported on the relationship between acoustic exposures and physiological responses that are indicative of stress responses in humans (for example, elevated respiration and increased heart rates). Jones (1998) reported on reductions in human performance when faced with acute, repetitive exposures to acoustic disturbance. Trimper
Hearing is one of the primary senses marine mammals use to gather information about their environment and to communicate with conspecifics. Although empirical information on the effect of sensory impairment (TTS, PTS, and acoustic masking) on marine mammals remains limited, it seems reasonable to assume that reducing an animal's ability to gather information about its environment and to communicate with other members of its species would be stressful for animals that use hearing as their primary sensory mechanism. Therefore, we assume that acoustic exposures sufficient to trigger onset PTS or TTS would be accompanied by physiological stress responses because terrestrial animals exhibit those responses under similar conditions (NRC, 2003). More importantly, marine mammals might experience stress responses at received levels lower than those necessary to trigger onset TTS. Based on empirical studies of the time required to recover from stress responses (Moberg, 2000), we also assume that stress responses are likely to persist beyond the time interval required for animals to recover from TTS and might result in pathological and pre-pathological states that would be as significant as behavioral responses to TTS. NMFS does not expect that the generally short-term, intermittent, and transitory HRG surveys would create conditions of long-term, continuous noise and chronic acoustic exposure
Behavioral responses to sound are highly variable and context-specific. An animal's perception of and response to (in both nature and magnitude) an acoustic event can be influenced by prior experience, perceived proximity, bearing of the sound, familiarity of the sound, etc. (Southall
Southall
Studies that address responses of low-frequency cetaceans to sounds include data gathered in the field and related to several types of sound sources, including: vessel noise, drilling and machinery playback, low-frequency M-sequences (sine wave with multiple phase reversals) playback, tactical low-frequency active sonar playback, drill ships, and non-pulse playbacks. These studies generally indicate no (or very limited) responses to received levels in the 90 to 120 dB re: 1µPa range and an increasing likelihood of avoidance and other behavioral effects in the 120 to 160 dB range. As mentioned earlier, though, contextual variables play a very important role in the reported responses and the severity of effects do not increase linearly with received levels. Also, few of the laboratory or field datasets had common conditions, behavioral contexts, or sound sources, so it is not surprising that responses differ.
The studies that address responses of mid-frequency cetaceans to sounds include data gathered both in the field and the laboratory and related to several different sound sources, including: pingers, drilling playbacks, ship and ice-breaking noise, vessel noise, acoustic harassment devices (AHDs), acoustic deterrent devices (ADDs), mid-frequency active sonar, and non-pulse bands and tones. Southall
The studies that address responses of high-frequency cetaceans to sounds include data gathered both in the field and the laboratory and related to several different sound sources, including: Pingers, AHDs, and various laboratory non-pulse sounds. All of these data were collected from harbor porpoises.
Marine mammals are likely to avoid the HRG survey activity, especially harbor porpoises. However, because the sub-bottom profilers and other HRG survey equipment operate from a moving vessel, and the assumed behavioral harassment distance is small (see
We have also considered the potential for severe behavioral responses such as stranding and associated indirect injury or mortality from Avangrid's use of HRG survey equipment, on the basis of a 2008 mass stranding of approximately one hundred melon-headed whales in a Madagascar lagoon system. An investigation of the event indicated that use of a high-frequency mapping system (12-kHz multibeam echosounder) was the most plausible and likely initial behavioral trigger of the event, while providing the caveat that there is no unequivocal and easily identifiable single cause (Southall
The report also notes that prior use of a similar system in the general area may have sensitized the animals and also concluded that, for odontocete cetaceans that hear well in higher frequency ranges where ambient noise is typically quite low, high-power active sonars operating in this range may be more easily audible and have potential effects over larger areas than low frequency systems that have more typically been considered in terms of anthropogenic noise impacts. It is,
Numerous studies have shown that underwater sounds from industrial activities are often readily detectable by marine mammals in the water at distances of many kilometers. However, other studies have shown that marine mammals at distances more than a few kilometers away often show no apparent response to industrial activities of various types (Miller
Ship strikes of marine mammals can cause major wounds, which may lead to the death of the animal. An animal at the surface could be struck directly by a vessel, a surfacing animal could hit the bottom of a vessel, or a vessel's propeller could injure an animal just below the surface. The severity of injuries typically depends on the size and speed of the vessel (Knowlton and Kraus, 2001; Laist
The most vulnerable marine mammals are those that spend extended periods of time at the surface in order to restore oxygen levels within their tissues after deep dives (
An examination of all known ship strikes from all shipping sources (civilian and military) indicates vessel speed is a principal factor in whether a vessel strike results in death (Knowlton and Kraus, 2001; Laist
There are no feeding areas, rookeries, or mating grounds known to be biologically important to marine mammals within the proposed project area with the exception of a migratory BIA for right whales which was described previously. There is also no designated critical habitat for any ESA-listed marine mammals. NMFS' regulations at 50 CFR 224.105 designated the nearshore waters of the Mid-Atlantic Bight as the Mid-Atlantic SMA for right whales in 2008. Mandatory vessel speed restrictions are in place in that SMA from November 1 through April 30 to reduce the threat of collisions between ships and right whales around their migratory route and calving grounds.
We are not aware of any available literature on impacts to marine mammal prey species from HRG survey equipment. However, because the HRG survey equipment introduces noise to the marine environment, there is the potential for avoidance of the area around the HRG survey activities by marine mammal prey species. Any avoidance of the area on the part of marine mammal prey species would be expected to be short term and temporary. Because of the temporary nature of the disturbance, the availability of similar habitat and resources (
This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
As described previously, no mortality is anticipated or proposed to be authorized for this activity. Below we describe how the take is estimated.
Generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (
Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2018 Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficient.
Previously we explained that auditory injury of marine mammals is unlikely given the higher level of sound and/or longer durations of exposure necessary to cause PTS and the small zone within which sound levels would exceed criteria for onset of PTS. The information provided in Tables 4 and 5 support this position and demonstrate that the proposed mitigation measures are based on a highly conservative evaluation of potential acoustic impacts.
When the NMFS Technical Guidance was first published in 2016, in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which may result in some degree of overestimate of Level A harassment take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available. NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For mobile sources, including the HRG survey equipment, the User Spreadsheet predicts the closest distance at which a stationary animal would not incur PTS if the sound source traveled by the animal in a straight line at a constant speed. Note however, that use of the spreadsheet is generally not appropriate for use in assessing potential for Level A harassment for very highly directional sources, such as the Innomar SES-2000, for reasons explained below. Inputs used in the User Spreadsheet and the resulting isopleths are reported below.
Note that the Innomar SES-2000 is a specialized type of HRG sub-bottom profiler that uses the principle of “parametric” or “nonlinear” acoustics to generate short narrow-beam sound pulses. As no field data currently exists for the Innomar sub-bottom profiler acoustic modeling was completed using a version of the U.S. Naval Research Laboratory's Range-dependent Acoustic Model (RAM) and BELLHOP Gaussian beam ray-trace propagation model (Porter and Liu 1994). Calculations of the ensonified area are conservative due to the directionality of the sound sources. Due to the short sound pulses and the highly directional sound pulse transmission (1° beamwidth) of parametric sub-bottom profilers, the volume of area affected is much lower than using conventional (linear) acoustics devices such as sparker and chirp systems. Level A harassment zones of less than 5 meters (Table 5) for HF cetaceans were calculated for this HRG equipment in the proposed survey area while Level B harassment isopleths were found to range from 120 to 135 meters (Table 6).
Distances to Level B harassment noise thresholds were calculated using the conservative practical spreading model (transmission loss (TL) equation: TL = 15log
The 200 m distance to the medium penetration sub-bottom profiler represents the largest distance and is likely a very conservative estimate based on sound source field verification assessments of similar sparker electrode equipment.
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations. The data used as the basis for estimating cetacean density (“D”) for the survey area are sightings per unit effort (SPUE) derived by Duke University (Roberts
Here we describe how the information provided above is brought together to produce a quantitative take estimate. In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in harassment, radial distances to predicted isopleths corresponding to harassment thresholds are calculated, as described above. Those distances are then used to calculate the area(s) around the HRG survey equipment predicted to be ensonified to sound levels that exceed harassment thresholds. The area estimated to be ensonified to relevant thresholds in a single day of the survey is then calculated, based on areas predicted to be ensonified around the HRG survey equipment and the estimated survey vessel trackline distance traveled per day.
The survey activities that have the potential to cause Level B harassment (160 dB
The estimated distance of the daily vessel trackline was determined using the estimated average speed of the vessel (4 knots) and the 24-hour operational period. Using the maximum distance to the Level B harassment threshold of 200 m (656 ft) and estimated daily vessel track of approximately 177.8 km (110.5 mi), estimates of take by survey equipment has been based on an ensonified area around the survey equipment of 71.2 km
The parameters in Table 7 were used to estimate the potential take by incidental harassment for each segment of the HRG survey. Density data from Roberts
Since the calculated take value for pilot whales (2) is less than the mean group size (9.4), NMFS assumed that take of at least one group of pilot whales could occur (Silva et al, 2014). For bottlenose dolphin densities, Roberts
For Risso's dolphins, NMFS adjusted the calculated take number to account for group size. These dolphins are usually seen in groups of 12 to 40, but loose aggregations of 100 to 200 or more are seen occasionally (Reeves
The three ESA-listed large whales that could potentially be present in the survey area occur at very low densities, and the calculated numbers of potential acoustic exposures above the 160-dB threshold are small,
In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or
(2) the practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
Avangrid's application included a list of proposed mitigation measures during site characterization surveys utilizing HRG survey equipment. NMFS proposes the additional measure of establishing an exclusion zone of 200 m for sei and fin whales. The mitigation measures outlined in this section are based on protocols and procedures that have been successfully implemented and previously approved by NMFS (DONG Energy, 2016, ESS, 2013; Dominion, 2013 and 2014).
Visual monitoring of designated exclusion and Level B harassment zones will ensure that (1) Any take of ESA-listed species would be limited; (2) exposure to underwater noise does not result in injury (Level A harassment), and (3) the number of instances of take does not exceed the authorized amounts. PSOs will coordinate to ensure 360° visual coverage around the vessel and conduct visual observations while free from distractions and in a consistent, systematic, and diligent manner. Visual PSOs shall immediately communicate all observations of marine mammals to the on-duty acoustic PSO(s), including any determination by the PSO regarding species identification, distance, and bearing and the degree of confidence in the determination. Any observations of marine mammal species by crew members aboard any vessel associated with the survey shall be relayed to the PSO team.
PSOs will establish and monitor applicable exclusion zones. During use of HRG acoustic sources (
• 500 m (1,640 ft) exclusion zone for North Atlantic right whales;
• 200 m (656 ft) exclusion zone for sei and fin whales; and
• 100 m (328 ft) exclusion zone for other large cetaceans (
The Level B harassment zone represents the zone within which marine mammals would be considered taken by Level B harassment and will encompass a distance of 200 m (656 ft) from survey equipment for all marine mammal species.
Avangrid will implement a 30-minute clearance period of the exclusion zones. This will help ensure marine mammals are not in the exclusion zones prior to startup of HRG equipment. During this period the exclusion zones will be monitored by the PSOs, using the appropriate visual technology for a 30-minute period. The intent of pre-clearance observation is to ensure no marine mammal species are observed within the exclusion zones prior to the beginning of operation of HRG equipment. A PSO conducting pre-clearance observations must be notified immediately prior to initiating start of HRG equipment and the operator must receive confirmation from the PSO to proceed.
Activation of HRG equipment may not be initiated if any marine mammal is observed within the applicable exclusion zones as described above. If a marine mammal is observed within the applicable exclusion zone during the 30 minute pre-clearance period, activation of HRG equipment may not begin until the animal(s) has been observed exiting the zones or until an additional time period has elapsed with no further sightings (15 minutes for small delphinoid cetaceans and 30 minutes for all other species). Activation of HRG equipment may occur at times of poor visibility, including nighttime, if continuous visual observation and has occurred with no detections of marine mammals in the 30 minutes prior to beginning of start-up.
An immediate shutdown of the HRG survey equipment will be required if a marine mammal is sighted at or within its respective exclusion zone to minimize or avoid behavioral impacts to ESA-listed species. The vessel operator must comply immediately with any call for shutdown by the lead PSO. The operator must establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the acoustic source to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch. When shutdown is called for by a PSO, the acoustic source must be immediately deactivated and any dispute resolved only following deactivation.
Should there be any uncertainty regarding identification of a marine mammal species (
Subsequent restart of the survey equipment can be initiated if the animal has been observed exiting its respective exclusion zone within 30 minutes of the shutdown or an additional time period has elapsed with no further sighting (
If the acoustic source is shut down for reasons other than mitigation (
In order to avoid striking animals, vessel operators and crews must maintain a vigilant watch for all marine mammal species and slow down, stop their vessel, or alter course, as appropriate and regardless of vessel size. A visual observer aboard the vessel must monitor a vessel strike avoidance zone around the vessel (distances stated below). Visual observers monitoring the vessel strike avoidance zone may be third-party observers (
• All vessels (
• Vessel speeds must also be reduced to 10 knots or less, regardless of location, when mother/calf pairs, pods, or large assemblages of cetaceans are observed near a vessel;
• All vessels must maintain a minimum separation distance of 500 m from right whales. If a whale is observed but cannot be confirmed as a species other than a right whale, the vessel operator must assume that it is a right whale and take appropriate action;
• All vessels must maintain a minimum separation distance of 100 m from all other baleen whales and sperm whales;
• All vessels must, to the maximum extent practicable, attempt to maintain a minimum separation distance of 50 m from all other marine mammals, with an understanding that at times this may not be possible (
• When marine mammals are sighted while a vessel is underway, the vessel shall take action as necessary to avoid violating the relevant separation distance,
• These requirements do not apply in any case where compliance would create an imminent and serious threat to a person or vessel or to the extent that a vessel is restricted in its ability to maneuver and, because of the restriction, cannot comply.
Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
Visual monitoring shall be conducted by NMFS-approved PSOs. PSO resumes shall be provided to NMFS for approval prior to commencement of the survey. Avangrid must use independent, dedicated, trained PSOs, meaning that the PSOs must be employed by a third-party observer provider, must have no tasks other than to conduct observational effort, collect data, and communicate with and instruct relevant vessel crew with regard to the presence of marine mammals and mitigation requirements (including brief alerts regarding maritime hazards).
Observations shall take place from the highest available vantage point on the survey vessel. General 360-degree scanning shall occur during the monitoring periods, and target scanning by the PSO shall occur when alerted of a marine mammal presence. An observer team comprising a minimum of four NMFS-approved PSOs, operating in shifts, will be stationed aboard the survey vessel. PSO's will work in shifts such that no one monitor will work more than 4 consecutive hours without a 2-hour break or longer than 12 hours during any 24-hour period. During daylight hours the PSOs will rotate in shifts of 1 on and 3 off, and during nighttime operations PSOs will work in pairs.
PSOs must have all equipment (including backup equipment) needed to adequately perform necessary tasks, including accurate determination of distance and bearing to observed marine mammals. PSOs will be equipped with binoculars and have the ability to estimate distances to marine mammals located in proximity to their established zones using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. Cameras of appropriate quality will be used for photographs and video to record sightings and verify species identification. Each PSO must have a camera and backup cameras should be available. During night operations, night-vision equipment (night-vision goggles with thermal clip-ons) and infrared technology will be used. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting. Radios for each PSO are required in order to communicate among vessel crew and PSOs. PSO must also have compasses and any other tools necessary to perform other PSO tasks.
PSOs shall be responsible for visually monitoring and identifying marine mammals approaching or entering the established monitoring zones as well as beyond the monitoring zones to the maximum extent possible. PSOs will record animals both within and beyond the monitoring zones during survey activities.
Data on all PSO observations must be recorded based on standard PSO collection requirements. PSOs must use standardized data forms, whether hard copy or electronic. This shall include the following:
• Vessel names (source vessel and other vessels associated with survey), vessel size and type, maximum speed capability of vessel, port of origin, and call signs;
• PSO names and affiliations;
• Dates of departures and returns to port with port name;
• Date and participants of PSO briefings;
• Dates and times (Greenwich Mean Time) of survey effort and times corresponding with PSO effort;
• Vessel location (latitude/longitude) when survey effort begins and ends; vessel location at beginning and end of visual PSO duty shifts;
• Vessel heading and speed at beginning and end of visual PSO duty shifts and upon any line change;
• Environmental conditions while on visual survey (at beginning and end of PSO shift and whenever conditions change significantly), including wind speed and direction, Beaufort sea state, Beaufort wind force, swell height, weather conditions, cloud cover, sun glare, and overall visibility to the horizon;
• Factors that may be contributing to impaired observations during each PSO shift change or as needed as environmental conditions change (
• Survey activity information, such as acoustic source power output while in operation, and any other notes of significance (
• If a marine mammal is sighted, the following information should be reported:
(a) Watch status (sighting made by PSO on/off effort, opportunistic, crew, alternate vessel/platform);
(b) PSO who sighted the animal;
(c) Time of sighting;
(d) Vessel location at time of sighting;
(e) Water depth;
(f) Direction of vessel's travel (compass direction);
(g) Direction of animal's travel relative to the vessel;
(h) Pace of the animal;
(i) Estimated distance to the animal and its heading relative to vessel at initial sighting;
(j) Identification of the animal (
(k) Estimated number of animals (high/low/best);
(l) Estimated number of animals by cohort (adults, yearlings, juveniles, calves, group composition, etc.);
(m) Description (as many distinguishing features as possible of each individual seen, including length, shape, color, pattern, scars or markings, shape and size of dorsal fin, shape of head, and blow characteristics);
(n) Detailed behavior observations (
(o) Animal's closest point of approach and/or closest distance from the center point of the acoustic source;
(p) Platform activity at time of sighting (
(q) Description of any actions implemented in response to the sighting (
Within 90 days after completion of survey activities, a final report will be provided to NMFS that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, estimates the number of marine mammals estimated to have been taken during survey activities, and provides an interpretation of the results and effectiveness of all mitigation and monitoring. All raw observational data shall be made available to NMFS. The draft report must be accompanied by a certification from the lead PSO as to the accuracy of the report, and the lead PSO may submit directly to NMFS a statement concerning implementation and effectiveness of the required mitigation and monitoring. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS. A final report must be submitted within 30 days following resolution of any comments on the draft report.
In the unanticipated event that the specified HRG activities lead to an injury of a marine mammal (Level A harassment) or mortality (
• Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Status of all sound source use in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
Activities would not resume until NMFS is able to review the circumstances of the event. NMFS would work with Avangrid to minimize reoccurrence of such an event in the future. Avangrid would not resume activities until notified by NMFS.
In the event that Avangrid discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (
In the event that Avangrid discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities authorized in the IHA (
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, this introductory discussion of our analyses applies to all the species listed in Table 8, given that many of the anticipated effects of this project on different marine mammal stocks are expected to be relatively similar in nature. Where there are meaningful differences between species or stocks, or groups of species, in anticipated individual responses to activities, impact of expected take on the population due to differences in population status, or impacts on habitat, they are described independently in the analysis below.
As discussed in the “Potential Effects of the Specified Activity on Marine Mammals and Their Habitat” section, PTS, masking, non-auditory physical effects, and vessel strike are not expected to occur. Marine mammal habitat may be impacted by elevated sound levels but these impacts would be short term. Feeding behavior is not likely to be significantly impacted. Prey species are mobile, and are broadly distributed throughout the survey area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the availability of similar habitat and resources in the surrounding area, and the lack of important or unique marine mammal habitat, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations. Additionally, there are no feeding areas or mating grounds known to be biologically important to marine mammals within the proposed project area with the exception of a migratory BIA for North Atlantic right whales described below.
The proposed survey area includes a biologically important migratory area for North Atlantic right whales (effective March-April and November-December) that extends from Massachusetts to Florida (LaBrecque,
A UME is defined under the MMPA as a stranding that is unexpected; involves a significant die-off of any marine mammal population; and demands immediate response. Two UMEs are ongoing and under investigation relevant to the HRG survey area for species for which authorization of take is proposed. These involve humpback whales and minke whales. There is currently no direct connection between the UMEs, as there is no evident cause of stranding or death that is common across the species involved in the UMEs. Additionally, strandings across the two species are not clustering in space or time. We are proposing to take only limited numbers of humpback (10) and minke whale (17) by Level B harassment in the form of minor, short-term behavioral modifications that are unlikely to directly or indirectly result in strandings or mortality.
Based on the foregoing preliminary information, direct physical interactions (ship strikes and entanglements) appear to be responsible for many of the UME mortalities recorded. The HRG survey with the proposed mitigation and monitoring is not likely to result in any mortalities. Fishing gear and in-water lines will not be employed by the survey vessel, and ship speed and avoidance mitigation measures will minimize risk of ship strikes.
The proposed mitigation measures are expected to reduce the number and/or severity of takes by preventing animals from being exposed to sound levels that have the potential to cause Level B harassment during HRG survey activities. Vessel strike avoidance requirements will further mitigate potential impacts to marine mammals during vessel transit to and within the survey area.
Avangrid did not request, and NMFS is not proposing to authorize, take of marine mammals by serious injury or mortality. NMFS expects that most takes would primarily consist of short-term Level B behavioral harassment in the form of temporary vacating of the area or decreased foraging (if such activity were occurring). These reactions are considered to be of low severity and with no lasting biological consequences (
In summary, and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• No mortality or injury is anticipated or authorized;
• Feeding behavior is not likely to be significantly impacted as effects on species that serve as prey species for marine mammals from the proposed survey are expected to be minimal;
• The availability of alternate areas of similar habitat value for marine mammals to temporarily vacate the survey area during the planned survey to avoid exposure to sounds from the activity;
• Take is anticipated to be by Level B behavioral harassment only, consisting of brief startling reactions and/or temporary avoidance of the survey area;
• While the survey area is within areas noted as biologically important for migration of the North Atlantic right whale, migration would not be affected since project activities would occur in such a comparatively small area. In addition, mitigation measures will be required to shut down sound sources at 500 m to further minimize any potential for effects to this species; and
• The proposed mitigation measures, including visual monitoring and shutdowns, are expected to minimize potential impacts to marine mammals, particularly in light of the small size of the take zones.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under Sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities relative to the species.
The numbers of marine mammals that we propose for authorization to be taken, for all species and stocks, would be considered small relative to the relevant stocks or populations (less than 3 percent for the bottlenose dolphin Western North Atlantic, southern migratory coastal stock and less than one percent for all other species and stocks proposed for authorization). See Table 8. Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the population sizes of the affected species or stocks.
There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to Avangrid for HRG survey activities during geophysical survey activities off the Coast of Virginia and North Carolina from June 1, 2019, through May 31, 2020, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. A draft of the proposed IHA can be found at
We request comment on our analyses, the proposed authorization, and any other aspect of this Notice of Proposed IHA for the proposed HRG survey. We also request comment on the potential for renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform our final decision on the request for MMPA authorization.
On a case-by-case basis, NMFS may issue a one-year IHA renewal with an expedited public comment period (15 days) when (1) another year of identical or nearly identical activities as described in the Specified Activities section is planned or (2) the activities would not be completed by the time the IHA expires and a second IHA would allow for completion of the activities beyond that described in the Dates and Duration section, provided all of the following conditions are met:
• A request for renewal is received no later than 60 days prior to expiration of the current IHA.
• The request for renewal must include the following:
(1) An explanation that the activities to be conducted under the proposed Renewal are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor (
(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.
Consumer Financial Protection Bureau.
Notice of public meeting.
Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Academic Research Council (ARC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.
The meeting date is Friday, May 10, 2019, 10:30 a.m.-12:00 p.m. eastern standard time.
The meeting is being held via conference call. RSVP is requested to receive the conference dial-in.
Kim George, Outreach and Engagement Associate, at 202-435-7884, or
Section 2 of the of the ARC Charter provides that the pursuant to the executive and administrative powers conferred on the Bureau by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Academic Research Council under agency authority. Section 3 of the ARC Charter states:
The committee will (1) provide the Bureau with advice about its strategic research planning process and research agenda, including views on the research that the Bureau should conduct relating to consumer financial products or services, consumer behavior, cost-benefit analysis, or other topics to enable the agency to further its statutory purposes and objectives; and (2) provide the Office of Research with technical advice and feedback on research methodologies, data collection strategies, and methods of analysis, including methodologies and strategies for quantifying the costs and benefits of regulatory actions.
The Academic Research Council will discuss methodology and direction for consumer finance research at the Bureau.
Persons who need a reasonable accommodation to participate should contact
Written comments will be accepted from interested members of the public and should be sent to
The Council's agenda will be made available to the public on April 25, 2019 via
A recording and transcript of this meeting will be available after the meeting on the Bureau's website
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of open Federal advisory committee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the U.S. Army Corps of Engineers, Inland Waterways Users Board (Board). This meeting is open to the public. For additional information about the Board, please visit the committee's website at
The Army Corps of Engineers, Inland Waterways Users Board will meet from 8:00 a.m. to 12:00 p.m. on May 23, 2019. Public registration will begin at 7:15 a.m.
The Inland Waterways Users Board meeting will be conducted at The Westin New Orleans Canal Place, 100 Rue Iberville, New Orleans, Louisiana 70130, 504-566-7006.
Mr. Mark R. Pointon, the Designated Federal Officer (DFO) for the committee, in writing at the Institute for Water Resources, U.S. Army Corps of Engineers, ATTN: CEIWR-GM, 7701 Telegraph Road, Casey Building, Alexandria, VA 22315-3868; by telephone at 703-428-6438; and by email at
The committee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before May 28, 2019.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Darcalyn Darling, 202-245-7542.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education 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.
U.S. Energy Information Administration (EIA), Department of Energy (DOE).
Notice and request for comments.
EIA requests a three-year extension, with changes to the Electric Power & Renewable Electricity Surveys (EPRES) as required under The Paperwork Reduction Act of 1995. The EPRES consists of nine surveys, including annual, monthly and a daily survey. These surveys collect data from entities involved in the production, transmission, delivery, and sale of electricity, and in maintaining the reliable operation of the power system. The data collected are the primary source of information on the nation's electric power system. The renewable energy survey collects information on the manufacture, shipment, import, and export of photovoltaic cells and modules, and is the primary national source of information on these topics.
EIA must receive all comments on this proposed information collection no later than June 24, 2019. If you anticipate any difficulties in submitting your comments by the deadline, contact the person listed in the
Send your comments to Sara Hoff, Office of Electricity, Renewables, and Uranium Statistics, U.S. Energy Information Administration, Forrestal Building, U.S. Department of Energy, 1000 Independence Ave. SW, EI-23, Washington, DC 20585. Submission via email to
Sara Hoff, (202) 586-1242 email:
This information collection request contains:
(1)
(2)
(3)
(4)
Form EIA-63B
Form EIA-411
Form EIA-860,
Form EIA-860M,
Form EIA-861,
Form EIA-923,
Form EIA-930,
(4a)
EIA proposes to discontinue the use of Form EIA-411. Data reported on Form EIA-411 are collected by NERC and sent to EIA. NERC annually publishes an Electricity Supply and Demand (ES&D) public-use database at
(5)
(6)
(7)
(8)
15 U.S.C. 772(b) and 42 U.S.C. 7101
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 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 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 PRA comments should be submitted on or before June 24, 2019. 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 Commission adopted a voluntary path for rate-of-return carriers to receive model-based support in exchange for making a commitment to deploy broadband-capable networks meeting certain service obligations to a pre-determined number of eligible locations in a state. By creating a voluntary pathway to model-based support, the Commission will spur new broadband deployment in rural areas. In several subsequent orders and public notices, the Commission has further refined this voluntary pathway, and in the December 2018 Rate-of-Return Reform Order, the Commission adopted a second pathway for carriers that did not elect the first pathway. Connect America Fund; ETC Annual Reports and Certifications; Establishing Just and Reasonable Rates for Local Exchange Carriers; Developing a Unified Intercarrier Compensation Regime, WC Docket Nos. 10-90, 14-58, 07-135, 05-337, 03-109; CC Docket Nos. 01-92, Report and Order, Further Notice of Proposed Rulemaking, and Order on Reconsideration, FCC 18-176 (
Federal Maritime Commission.
Notice.
The Adjusted Cap amount will be effective June 24, 2019.
Sandra L. Kusumoto, Director, Bureau of Certification and Licensing, 202-523-5787,
In accordance with the Final Rule published in the
The formula used to determine the percent change is as follows:
Based on the percent change calculated, the Escalation Formula for the cap adjustment is calculated. The formula uses a Base Cap of $30 million set from April 2, 2015, as the cap upon which all subsequent cap adjustment calculations will be determined. The calculation for the Adjusted Cap is then rounded to the nearest $1 million. The following is the Escalation Formula used to determine the Adjusted Cap:
The index percent change for use in 2019 was calculated to be 5.945 and the Adjusted Cap was calculated to be $31.8 million. The Adjusted Cap rounded to the nearest $1 million is $32 million. The current cap of $30 million remains in effect until the Adjusted Cap of $32 million becomes effective. Thereafter and until the next adjustment, the cap for financial responsibility for indemnification of passengers for nonperformance of transportation shall increase to $32 million. The next adjustment will be conducted in 2021.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary by email at
The notificants listed below have applied under the Change in Bank Control Act (“Act”) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 10, 2019.
1.
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 applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 23, 2019.
1.
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, and the Determination of the Chief Operating Officer, CDC, pursuant to Public Law 92-463. 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.
The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
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, and the Determination of the Chief Operating Officer, CDC, pursuant to Public Law 92-463. 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.
The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
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, and the Determination of the Chief Operating Officer, CDC, pursuant to Public Law 92-463. 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.
The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
The National Descriptive Study (of the National Evaluation of the SRAE Program) has multiple components. This information collection request only pertains to the Early Implementation Study, which will provide an early catalogue of SRAE programs' implementation. ACF seeks approval to collect the following information:
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 government public health and emergency response stakeholders entitled “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.” This document provides guidance to government stakeholders on testing to extend the expiration date—under the Federal Food, Drug, and Cosmetic Act (FD&C Act)—of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer's labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other nonemergency purpose. This guidance finalizes the draft guidance issued in April 2017.
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
Frederick Ensor, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 240-402-2733.
FDA is announcing the availability of a guidance for government public health and emergency response stakeholders entitled “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.” A number of government public health and emergency response stakeholders maintain stockpiles of doxycycline tablets or capsules for post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of an anthrax emergency. States have asked FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality (
This guidance applies to both doxycycline monohydrate and doxycycline hyclate tablets and capsules equivalent to 50 milligrams (mg) and 100 mg of doxycycline that are indicated for PEP or treatment of inhalational anthrax. Where doxycycline is mentioned throughout this guidance, it is meant to include both the hyclate and monohydrate forms of the drug that are indicated for PEP or treatment of inhalational anthrax.
This guidance finalizes the draft guidance issued in April 2017. Those comments received on the draft guidance did not result in any policy changes but in some instances did result in clarifying language in the final guidance document.
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 “Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.” 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 requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information has been approved under OMB control number 0910-0595.
Persons with access to the internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.” The draft guidance, when finalized, will represent the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biologics, focusing on randomized clinical trials with continuous endpoints.
Submit either electronic or written comments on the draft guidance by June 24, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance 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 the draft 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, or 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Scott N. Goldie, Center for Drug Evaluation and Research, Office of Biostatistics, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3557, Silver Spring, MD 20993-0002, 301-796-2055, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.” This guidance provides recommendations for the use of analysis of covariance (ANCOVA) in randomized clinical trials.
The target population for a new drug or biologic usually includes individuals with diverse prognostic factors, and the population studied in clinical trials should reflect this diversity. However, baseline differences in prognostic factors impair the detection and estimation of treatment effects. Incorporating prognostic factors in the statistical analysis of clinical trial data can mitigate this impairment and can result in a more efficient use of data to demonstrate and quantify the effects of treatment. The International Council for Harmonisation guidance for industry entitled “E9 Statistical Principles for Clinical Trials” briefly addresses these issues (
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.” 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 requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft guidance 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. 3501-3520). The collections of information in 21 CFR 312.23 for investigational new drug application content and format have been approved under OMB control number 0910-0014.
Persons with access to the internet may obtain the draft guidance 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(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Sickle Cell Disease Advisory Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, 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
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Josh Geyer, Office of Environment and Energy, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email
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.
• Form HUD-2530, Previous Participation Certification, is completed by the Intermediary. The Intermediary submits the form to HUD via
• ***SF-424 family of forms (SF-424A-D, as applicable), Application for Federal Assistance and Assurances, is completed by the Intermediary. The Intermediary submits this family of forms to HUD via
• Form HUD-2880, Applicant/Recipient Disclosure/Update Report, is completed by the Intermediary. The Intermediary submits the from to HUD via the
• Form HUD 424-CBW (excel spreadsheet), Detailed Budget Worksheet, is completed by the Intermediary. The Intermediary submits this form to HUD via email or U.S. mail for approval. The type of information collected includes a detailed description of budget as it pertains to each participating property. The Intermediary submits this form to HUD in program phases for completion of the retrofits in all participating properties in the PFS program.
• Form HUD-9250, Funds Authorization, is completed by the Owner. The Owner submits this form by email or by U.S. mail to HUD for approval. The type of information collected includes Owner's name, address, mortgagee, etc. Owners are required to submit this form to HUD to request withdrawal from the Reserve for Replacements or Residual Receipts Funds.
• Certification of Owner Eligibility, Owner must complete this form to be eligible to participate in the Pay for Success pilot. Owner submits certification to HUD for approval via email or by U.S. mail. The type of information collected includes Owner's name, iREMS number, address, signature, etc. Owners must provide a certification to HUD that they and the property meet HUD eligibility requirements in order to be able to participate in the Pilot.
• Cooperative Agreement is administered by HUD's Office of Multifamily Housing Programs, which will have oversight of the Intermediaries, ensuring compliance with all included provisions and authorizing payments when and if required conditions are met. The type of information collected includes Date agreement was entered with Intermediary, total of units HUD awarded intermediary, signature and HUD official. The form is submitted to HUD/Intermediary via email or by U.S. mail.
• Site-Specific Environment Review (Part 1 of 2), this form should be used only to initiate site-specific reviews for individual HUD-assisted properties undertaking energy and water conservation retrofits under the Multifamily Energy and Water Conservation Pay for Success Pilot. Intermediary completes the form and any relevant documents for each site identified to participate in the PFS Pilot and submits it to HUD to upload in the HUD Environmental Review Online System (HEROS).
• Office of Multifamily Housing Pay for Success Program Narrative Template is completed by the Intermediary and is submitted to HUD via
HUD is authorized under this legislation to establish a competitive process for selecting one or more qualified applicants to serve as Intermediaries who will, per agreements with HUD, be responsible for initiating and managing an energy and water conservation retrofit program at eligible properties. For the purpose of this program, applicants are defined as entities applying to participate. The documents that are the subject of this notice are those used by applicants applying to participate in this program. This information will allow applicants to submit their proposal and for the government to evaluate this information.
I. ***
II.
III.
IV.
V.
VI.
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 comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Information Officer, HUD.
Notice.
In accordance with the Paperwork Reduction Act of 1995, HUD has requested from the Office of Management and Budget (OMB) emergency approval of the information collection described in this notice.
Comments Due Date: May 9, 2019.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email Colette Pollard at
This notice informs the public that HUD has submitted to OMB a request for approval of 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,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of initiation of reviews; request for information.
We, the U.S. Fish and Wildlife Service, are initiating 5-year status reviews under the Endangered Species Act for two plant and four animal species. A 5-year status review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any such information that has become available since the last review for the species.
To ensure consideration, please send your written information by June 24, 2019. However, we will continue to accept new information about any listed species at any time.
For instructions on how to submit information for each species, see the table in the
To request information, contact the appropriate person in the table in the
We are initiating 5-year status reviews under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
Under the ESA, we maintain Lists of Endangered and Threatened Wildlife and Plants (which we collectively refer to as the List) in the Code of Federal Regulations (CFR) at 50 CFR 17.11 (for animals) and 17.12 (for plants). Section 4(c)(2)(A) of the ESA requires us to review each listed species' status at least once every 5 years. Our regulations at 50 CFR 424.21 require that we publish a notice in the
A 5-year review considers the best scientific and commercial data that have become available since the current listing determination or most recent status review of each species, such as:
(A) Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;
(B) Habitat conditions, including but not limited to amount, distribution, and suitability;
(C) Conservation measures that have been implemented that benefit the species;
(D) Threat status and trends in relation to the five listing factors (as defined in section 4(a)(1) of the ESA); and
(E) Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.
New information will be considered in the 5-year review and ongoing recovery programs for the species.
This notice announces our active 5-year status reviews of the species in the following table.
To ensure that a 5-year review is complete and based on the best available scientific and commercial information, we request new information from all sources. See
If you wish to provide information for any species listed above, please submit your comments and materials to the appropriate contact in the table above. You may also direct questions to those contacts. Individuals who are hearing impaired or speech impaired may call the Federal Relay Service at 800-877-8339 for TTY assistance.
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.
Comments and materials received will be available for public inspection, by appointment, during normal business hours at the offices where the comments are submitted.
We publish this notice under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice.
In accordance with Mineral Leasing Act of 1920 as Amended, Flatirons Resources LLC filed a timely petition for reinstatement of oil and gas lease UTU87659 for lands in Grand County, Utah. The petition was accompanied by all required rentals and royalties accruing from January 1, 2016, the date of termination. No leases were issued that affect these lands. The Bureau of Land Management proposes to reinstate this lease.
Kent Hoffman, Deputy State Director, Lands and Minerals, Utah State Office, Bureau of Land Management, 440 West 200 South, Suite 500, Salt Lake City, Utah, 84101, phone (801) 539-4063, Email:
The lessee has agreed to the new lease terms:
• Original term and conditions of the lease;
• Increased rental of $10 per acre;
• Increased royalty of 16-2/3 percent;
• $159 cost of publishing this Notice; and
• $500 cost of administrative fee.
The lease includes the following described lands in Grand County, Utah:
The area described contains 802.31 acres.
The lessee has met all the requirements for reinstatement of the lease per Section 31(d) and (e) of the Mineral Leasing Act of 1920 as Amended. The BLM is proposing to reinstate the lease 30 days following publication of the notice, with the effective date of January 1, 2016, subject to the:
43 CFR 3108.2-3.
United States International Trade Commission.
May 1, 2019 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed collection OMB 1140-0014 (Application for Tax Paid Transfer and Registration of Firearm—ATF Form 4 (5320.4)), is being revised to accommodate additional questions, include definition of new terminology, and changes to the instructions.
Comments are encouraged and will be accepted for 60 days until June 24, 2019.
If you have additional comments, regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please contact: James Chancey, National Firearms Act Division either by mail at 244 Needy Road, Martinsburg, WV 25405, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection OMB 1140-0015 (Application for Tax Exempt Transfer and Registration of Firearm—ATF Form 5 (5320.5)), is being revised due to material changes to the form, including additional questions, definition of terminology used in the collection instrument, and updates to the instructions.
Comments are encouraged and will be accepted for 60 days until June 24, 2019.
If you have additional comments, regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please contact: James Chancey, National Firearms Act Division either by mail at 244 Needy Road, Martinsburg, WV 25405, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection OMB 1140-0011 (Application to Make and Register a Firearm—ATF Form 1 (5320.1)), is being revised to include formatting changes, additional questions, and updates to the instructions.
Comments are encouraged and will be accepted for 60 days until June 24, 2019.
If you have additional comments, regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please contact: James Chancey, National Firearms Act Division either by mail at 244 Needy Road, Martinsburg, WV 25405, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection OMB 1140-0107 (National Firearms Act (NFA) Responsible Person Questionnaire—ATF Form 5320.23), is being revised to include additional questions and updates to the instructions including definition of new terminology.
Comments are encouraged and will be accepted for 60 days until June 24, 2019.
If you have additional comments, regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please contact: James Chancey, National Firearms Act Division either by mail at 244 Needy Road, Martinsburg, WV 25405, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.
Notice is hereby given pursuant to the Antitrust Procedures and Penalties Act, 15 U.S.C. § 16(b)-(h), that one comment was received concerning the proposed Final Judgment in this case, and that comment together with the Response of the United States to Public Comment have been filed with the United States District Court for the Southern District of New York in
Pursuant to the requirements of the Antitrust Procedures and Penalties Act (the “APPA” or “Tunney Act”), 15 U.S.C. § 16(b)-(h), the United States hereby responds to the one public comment received regarding the proposed Final Judgment in this case. After careful consideration of the submitted comment, the United States continues to believe that the proposed Final Judgment will provide an effective and appropriate remedy for the antitrust violations alleged in the Complaint. The United States will move the Court for entry of the proposed Final Judgment after the public comment and this response have been published pursuant to 15 U.S.C § 16(d).
On December 13, 2017, The Walt Disney Company (“Disney”) entered into an agreement to acquire certain assets and businesses from Twenty-First Century Fox, Inc. (“Fox”) (collectively, “Defendants”), including Fox's ownership of, or interests in, its regional sports networks (“RSNs”), FX cable networks, National Geographic cable networks, television studio, Hulu, film studio, and international television businesses (collectively, the “Fox Sale Assets”). On June 20, 2018, the Defendants amended the agreement to increase Disney's consideration for the Fox Sale Assets to approximately $71.3 billion. On July 27, 2018, Disney's and Fox's respective shareholders voted to approve the transaction.
On June 27, 2018, the United States filed a civil antitrust Complaint, seeking to enjoin Disney from acquiring the Fox Sale Assets. The Complaint alleges that the proposed acquisition by Disney of certain cable sports programming assets from Fox, including Fox's ownership of, or interest in, twenty-two RSNs, would violate Section 7 of the Clayton Act, 15 U.S.C. § 18.
Simultaneously with the filing of the Complaint, the United States filed a proposed Final Judgment and a Hold Separate Stipulation and Order signed by Plaintiff and Defendants consenting to entry of the proposed Final Judgment after compliance with the requirements of the Tunney Act, 15 U.S.C. § 16. Pursuant to those requirements, the United States filed a Competitive Impact Statement (“CIS”) on August 7, 2018, describing the transaction and the proposed Final Judgment. The United States published the Complaint, proposed Final Judgment, and CIS in the
The Complaint alleged that Disney's acquisition of the Fox RSNs would lessen competition in the licensing of cable sports programming to distributors in local markets where Disney and Fox compete. The proposed Final Judgment remedies this concern by requiring Disney to divest the twenty-two Fox RSNs it would have acquired as part of the Fox Sale Assets.
Disney's acquisition of the Fox Sale Assets would have combined two of the most valuable cable sports television networks: Fox's twenty-two RSNs and Disney's ESPN franchise of networks. Cable sports television networks compete to be carried in the programming packages that distributors, such as cable companies (e.g., Charter Communications and Comcast), direct broadcast satellite services (e.g., DISH Network and AT&T's DirecTV), fiber optic networks services (e.g., Verizon's Fios and CenturyLink's Prism TV), and online distributors of linear cable programming (e.g., Hulu Live and DISH's Sling TV), offer to their subscribers. For RSNs, the carriage license typically is limited to the Designated Market Area (“DMA”) comprising the “home” territory of the team or teams carried on the RSN; whereas, licenses for national television networks, such as ESPN, typically comprise all DMAs in a distributor's footprint. Disney's and Fox's cable sports television programming compete head-to-head to be carried by distributors in each DMA that is the home territory of Fox's RSNs: Phoenix, AZ; Los Angeles, CA; San Diego, CA; Miami, FL; Orlando, FL; Tampa, FL; Atlanta, GA; Indianapolis, IN; Kansas City, KS; New Orleans, LA; Detroit, MI; Minneapolis, MN; St. Louis, MO; New York, NY; Charlotte, NC; Raleigh-Durham, NC; Cincinnati, OH; Cleveland, OH; Columbus, OH; Oklahoma City, OK; Nashville, TN; Memphis, TN; Dallas, TX; San Antonio, TX; and Milwaukee, WI (collectively, the “DMA Markets”).
After Disney announced its plans to acquire the Fox Sale Assets, the United States conducted an investigation into the competitive effects of the proposed transaction. The United States considered the potential competitive effects of the transaction on cable sports programming in DMAs throughout the United States. As a part of its investigation, the United States obtained documents and information from the merging parties and others and conducted interviews with customers, competitors, and other individuals knowledgeable about the industry.
Based on the evidence gathered during its investigation, the United States concluded that Disney's acquisition of Fox's RSNs would likely (1) substantially lessen competition in the licensing of cable sports programming in each of the DMA Markets; (2) eliminate actual and potential competition among Disney and Fox in the licensing of cable sports programming in each of the DMA Markets; and (3) cause prices for cable sports programming in each of the DMA Markets to increase.
At the same time the Complaint was filed, the United States filed a Hold Separate Stipulation and Order (“Hold Separate”) and proposed Final Judgment, which are designed to eliminate the likely anticompetitive effects of the Transaction. Under the proposed Final Judgment, Disney is required to divest all of Fox's interests in the Fox RSNs, including all assets necessary for the operation of each Fox RSN as a viable, ongoing cable sports programming network, to one or more buyers acceptable to the United States in its sole discretion. Under the terms of the Hold Separate, Disney and Fox have taken certain steps to ensure that each Fox RSN continues to operate as an ongoing, economically viable, competitive cable sports programming network that will remain independent and uninfluenced by the consummation of the Transaction, and that competition is maintained during the pendency of the ordered divestiture.
The United States and Defendants have stipulated that the proposed Final Judgment may be entered after compliance with the APPA. Entry of the proposed Final Judgment would terminate this action, except the Court would retain jurisdiction to construe, modify, or enforce the provisions of the proposed Final Judgment and to punish violations thereof. Nothing in the APPA or the parties' filings in this case prohibit Defendants from closing and consummating the Transaction during the pendency of the Tunney Act proceedings or prior to the Court's entry of the proposed Final Judgment.
The Clayton Act, as amended by the APPA, requires that proposed consent judgments in antitrust cases brought by the United States be subject to a 60-day comment period, after which the court shall determine whether entry of the proposed Final Judgment “is in the public interest.” 15 U.S.C. § 16(e)(1). In making that determination, the court, in accordance with the statute as amended in 2004, is required to consider:
(A) the competitive impact of such judgment, including termination of alleged violations, provisions for enforcement and modification, duration of relief sought, anticipated effects of alternative remedies actually considered, whether its terms are ambiguous, and any other competitive considerations bearing upon the adequacy of such judgment that the court deems necessary to a determination of whether the consent judgment is in the public interest; and
(B) the impact of entry of such judgment upon competition in the relevant market or markets, upon the public generally and individuals alleging specific injury from the violations set forth in the complaint including consideration of the public benefit, if any, to be derived from a determination of the issues at trial.
As this Court has held, under the APPA a court considers, among other things, “the relationship between the complaint and the remedy secured, the decree's clarity, whether there are any
[t]he balancing of competing social and political interests affected by a proposed antitrust consent decree must be left, in the first instance, to the discretion of the Attorney General. The court's role in protecting the public interest is one of insuring that the government has not breached its duty to the public in consenting to the decree. The court is required to determine not whether a particular decree is the one that will best serve society, but whether the settlement is “
In determining whether a proposed settlement is in the public interest, a district court “is not permitted to reject the proposed remedies merely because the court believes other remedies are preferable.”
Moreover, under
Finally, in the 2004 amendments to the APPA, Congress addressed the Tunney Act review process, adding the unambiguous instruction that “[n]othing in this section shall be construed to require the court to conduct an evidentiary hearing or to require the court to permit anyone to intervene.” 15 U.S.C. § 16(e)(2);
During the 60-day comment period, the United States received only one comment from the American Cable Association (“ACA”), an organization that represents more than 700 small and medium-sized cable operators (Exhibit 1). Upon review, the United States believes that nothing in the comment warrants a change to the proposed Final Judgment or supports an inference that the proposed Final Judgment is not in the public interest. As required by the APPA, the comment and the United
In its comment, the ACA commends the proposed Final Judgment, noting that it “solves one significant antitrust problem . . . by requiring Disney to divest the Fox RSNs.” Exhibit 1 at 1. However, it warns that a divestiture to a same-market, big-four broadcaster or a same-market distributor “threatens to create a
The United States considers the existing terms of the proposed Final Judgment—which require the sale of the Fox RSNs “to one or more Acquirers acceptable to the United States, in its sole discretion,” Proposed Final Judgment,
The Court should reject the ACA's invitation to substitute its judgment for the United States' judgment of the acceptability of divestiture buyers and the overall effect of the divestitures on competition. Approving divestiture buyers is the type of action that is properly within the United States' discretion. S
After reviewing the public comment, the United States continues to believe that the proposed Final Judgment, as drafted, provides an effective and appropriate remedy for the antitrust violations alleged in the Complaint, and is therefore in the public interest. The United States will move this Court to enter the proposed Final Judgment after the comment and this response are published in the
Dated: April 5, 2019
Respectfully submitted,
The American Cable Association, which represents more than 700 small and medium-sized cable operators, hereby submits its Tunney Act comments regarding the proposed Final Judgment filed in
More specifically, it would be contrary to the public interest to permit the divestiture of the Fox RSNs either to a same-market, big-four broadcaster or to a same-market multichannel video programming distributor (“MVPD”):
• Permitting such a broadcaster to purchase a Fox RSN would create the very problem the Antitrust Division identified here. It would allow a single firm to threaten to withhold two sets of must-have programming, thereby leading to increased MVPD licensing fees.
• Permitting such an MVPD to purchase an RSN would create the “vertical integration” problem the Division identified in blocking the AT&T-Time Warner merger. The combined entity would have greater leverage to threaten to withhold RSN programming from rival MVPDs than would a stand-alone RSN owner, thereby leading to increased MVPD licensing fees.
The Competitive Impact Statement described the problem that an ACA member would face in negotiating with a newly combined ESPN-Fox RSN—losing both sets of programming simultaneously is far worse than losing each set of programming individually:
Prior to the Transaction, an MVPD's failure to reach a licensing agreement with Disney would result in the blackout of Disney's networks, including ESPN, and threaten some subscriber loss for the MVPD, including those subscribers that value ESPN's content. But because the MVPD still would be able to offer its subscribers the local Fox RSN, many MVPD subscribers simply would watch the local RSN instead of cancelling their MVPD subscriptions. In the event of a Fox RSN blackout, many subscribers likely would switch to watching ESPN. After the Transaction, an MVPD negotiating with Disney would be faced with the prospect of a dual blackout of significant cable sports programming, a result more likely to cause the MVPD to lose incremental subscribers (that it would not have lost in a pre-transaction blackout of only ESPN or the Fox RSN) and therefore accede to Disney's demand for higher licensing fees. For these reasons, the loss of competition between ESPN and the Fox RSN in each DMA Market would likely lead to an increase in MVPD licensing fees in those markets. Some of these increased programming costs likely would be passed onto consumers, resulting in higher MVPD subscription fees for millions of U.S. households.
An ACA member would face this exact problem in negotiating simultaneously with a Fox RSN and a same-market, big-four broadcaster,
While divestiture of Fox's RSNs to a broadcaster would replicate the problem that the Division identified in
Pre-merger, a blackout of Turner programming on Charter (for example) cost Time Warner license fees from Charter and advertising revenue from reduced viewership, and it cost Charter current and potential customers because its service is less attractive without the desirable Turner programming. Crucially, post-merger, that same blackout is less costly to AT&T than it had been to Time Warner alone because some Charter subscribers will switch to AT&T's DirecTV or UVerse. . . . It is precisely because of this diversion to DirecTV (which would have the competitively valuable Turner content) that the costs of blackouts to the merged entity would be lower than absent the merger. Because—solely as a result of the merger—the costs of not reaching a deal are reduced, Time Warner will have increased leverage to negotiate better terms with rival distributors. Exercising that leverage will result in increased programming fees for those rival distributors—lessening competition among DirecTV and its rivals—and ultimately increasing prices for millions of American consumers.
So too if Fox RSNs are divested to a same-market MVPD.
Of course, as the
Again, we very much appreciate the Division's efforts to address concerns related to the combination of Fox's RSN assets and Disney's ESPN.
Respectfully submitted,
Michael Nilsson
Mark Davis
On April, 19, 2019, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Colorado in the lawsuit entitled
The lawsuit seeks injunctive relief and civil penalties for violations of the Clean Air Act, the Colorado Air Pollution Prevention and Control Act (“Colorado Act”), Colorado's federally approved State Implementation Plan (“Colorado SIP”), and Colorado Air Quality Control Commission Regulation Number 7 (“Regulation No. 7”) at tank batteries (referred to in the consent decree as “Tank Systems”) that are, or were until recently, owned and operated by HighPoint Operating Corporation (“HighPoint”) in a portion of the Denver-Julesburg Basin in Colorado (known as the “8-Hour Ozone Control Area”) designated as non-attainment with the National Ambient Air Quality Standards for ground-level ozone. The violations relate to alleged failures to adequately design, operate, and maintain vapor control systems at the Tank Systems, resulting in emissions of volatile organic compounds (“VOC”) and other pollutants to the atmosphere.
The proposed Consent Decree covers HighPoint's Tank Systems in the 8-Hour Ozone Control Area equipped with vapor control systems pursuant to Regulation No. 7 to achieve required system-wide emission reductions (50 tank batteries). Under the terms of the proposed Consent Decree HighPoint will ensure vapor control systems adequately capture and control potential VOC emissions from storage tanks by performing engineering evaluations of the vapor control systems and either making any necessary modifications to ensure adequate capture and control or installing an automated system that will monitor Tank System pressure and automatically control oil and gas flow rates into the Tank Systems and shut in equipment (including wells) to avoid excess emissions. HighPoint will also conduct monthly optical gas-imaging infrared camera (IR camera) inspections of all Tank Systems and implement a directed inspection and preventative maintenance program. The Decree will result in substantial reductions in VOC emissions from HighPoint Tank Systems throughout the ozone nonattainment area. The EPA and Colorado Department of Health and Environment (“CDPHE”) estimate the Decree's injunctive relief requirements to modify vapor control system design, improve operations and maintenance practices, and increase monitoring will reduce emissions from HighPoint's tank systems by approximately 350 tons per year (tpy). Additionally, HighPoint will complete a mitigation project it estimates will reduce emissions of VOC by approximately another 50 tpy.
HighPoint will pay a civil penalty of $330,000, of which $275,000 will go to the United States, and $55,000 to Colorado. Colorado and HighPoint have agreed that HighPoint will perform a state-only supplemental environmental project (to be designated) that will cost up to $220,000. Entering into and fully complying with the proposed Consent Decree will release HighPoint from past civil liability at the Tank Systems and associated vapor control systems for violations of the Colorado SIP and Regulation No. 7 relating to VOC emissions from condensate storage tanks.
The publication of this notice opens a period for public comment on the 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 Consent Decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $34.75 (25 cents per page reproduction cost) payable to the United States Treasury for a copy of the Consent Decree without appendices. For a paper copy without the appendices, the cost is $21.25.
Office of the Assistant Secretary for Policy, Chief Evaluation Office, Department of Labor.
Notice of information collection; request for comment.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). 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 is properly assessed. Currently, the Department of Labor is soliciting comments concerning the collection of data about the Reemployment Services and Eligibility Assessments (RESEA) Program Implementation Study. A copy of the proposed Information Collection Request (ICR) can be obtained by contacting the office listed below in the addressee section of this notice.
Written comments must be submitted to the office listed in the addressee section below on or before June 24, 2019.
You may submit comments by either one of the following methods:
Megan Lizik by email at
•
○ Evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility;
○ evaluate the accuracy of the agency's burden estimate of the proposed information collection, including the validity of the methodology and assumptions;
○ 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—for example, permitting electronic submissions of responses.
Comments submitted in response to this request will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
The Members of the National Council on Disability (NCD) will hold a quarterly hold business meeting and community forum on Friday, May 24, 2019, 9:00 a.m.-4:00 p.m., Atlantic Standard Time (Same as Eastern Daylight Time), in San Juan, Puerto Rico. Registration is not required.
This meeting will occur at San Juan Marriott, located at 1309 Ashford Avenue, San Juan, Puerto Rico 00907-1324. Interested parties may join the meeting in person at the meeting location or may join by phone in a listening-only capacity (other than the period allotted for public comment noted below) using the following call-in information: Teleconference number: 1-866-556-2308; Conference ID: 8457105; Conference Title: NCD Meeting; Host Name: Neil Romano. In the event of teleconference disruption or failure, attendees can follow the meeting by accessing the Communication Access Realtime Translation (CART) link provided. CART is text-only translation that occurs real time during the meeting and is not an exact transcript.
The Council will receive agency updates on policy projects, finance, governance, and other business. Following agency updates, the
Anne Sommers, NCD, 1331 F Street NW, Suite 850, Washington, DC 20004; 202-272-2004 (V), 202-272-2074 (TTY), or
To help reduce exposure to fragrances for those with multiple chemical sensitivities, NCD requests that all those attending the meeting in person refrain from wearing scented personal care products such as perfumes, hairsprays, and deodorants. Flash photography and video documentation may occur during the meeting. Please alert staff if you are affected by photo sensitivity. Attendance at the meeting indicates consent to be photographed and recorded for NCD public affairs activities.
Due to last-minute confirmations or cancellations, NCD may substitute agenda items without advance public notice.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. 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),
1.
2.
3.
4.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 19, 2019, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 19, 2019, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 19, 2019, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 19, 2019, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1)
The Exchange proposes to delete NYSE Arca Rule 8.800-E setting forth the requirements for the NYSE Arca ETP Incentive Program (the “Incentive Program”), which expired on July 31, 2017, and a related outdated reference to the Incentive Program in the Exchange's Schedule of Fee and Charges. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization 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 those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to delete NYSE Arca Rule 8.800-E setting forth the requirements for the Incentive Program, which expired on July 31, 2017, and a related outdated reference to the Incentive Program in the Exchange's NYSE Arca Equities Schedule of Fee and Charges.
In June 2013, the Securities and Exchange Commission (the “Commission”) approved the Incentive Program as a one-year pilot program for issuers of certain exchange-traded products (“ETPs”) listed on the Exchange.
The Exchange proposes to delete NYSE Arca Rule 8.800-E in its entirety as obsolete. As noted above, the Incentive Program expired at the end of July 2017. The Exchange proposes a related change to the NYSE Arca Equities Schedule of Fee and Charges to delete a reference to the Incentive Program in the portion of the fee schedule setting forth LMM transaction fees and credits.
The proposed rule change is consistent with Section 6(b) of the Act,
The proposed rule change is a non-substantive change that eliminates obsolete material from the Exchange's rulebook. The Exchange believes that the proposed rule change would enable the Exchange to continue to be so organized as to have the capacity to carry out the purposes of the Exchange Act and comply and enforce compliance with the provisions of the Act by its members and persons associated with its members, because ensuring that the Exchange's rules and fee schedule are accurate and do not contain obsolete material would contribute to the orderly operation of the Exchange by adding clarity and transparency to such documents.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because it is not designed to address any competitive issue or have any competitive impact, but rather serve to update the Exchange's rulebook to promote clarity and consistency, thereby alleviating possible market participant confusion.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
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 an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to modify the NYSE Arca Options Fee Schedule (“Fee Schedule”). The Exchange proposes to implement the fee change effective April 8, 2019.
In its filing with the Commission, the self-regulatory organization 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 those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The purpose of this filing is to modify the Fee Schedule, effective April 8, 2019, to modify the criteria for achieving various credits.
The Exchange currently provides a number of incentives for OTP Holders and OTP Firms (collectively, “OTPs”) designed to encourage OTPs to direct additional order flow to the Exchange to achieve more favorable pricing and higher credits. Among these incentives are enhanced posted liquidity credits based on achieving certain percentages of NYSE Arca Equity daily activity, also known as “cross-asset pricing.” Similarly, because the Exchange allows Market Makers (“MMs”) to aggregate their volume executed on NYSE Arca with affiliated or Appointed Order Flow Providers (“OFPs”), MMs may encourage an increased level of activity from these participants to qualify for various incentives. As a result, NYSE Arca becomes a more attractive venue for Customer (and Professional Customer) orders offering enhanced rebates.
Pursuant to the Customer Penny Pilot Posting Credit Tiers (the “Penny Credit Tiers”), Customer and Professional Customer orders that post liquidity and are executed on the Exchange earn a base credit of $0.25 per contract, and may be eligible for increased credits based on the participant's activity. Currently, there are 7 Penny Credit Tiers, with increasing minimum volume thresholds (as well as increasing credits) associated with each tier.
The Exchange proposes to modify the minimum volume thresholds for Tier 5, but will not modify the $0.48 per contract credit associated with this Tier. Specifically, the Exchange proposes to modify Tier 5 to require that an OTP achieve at least 0.22% (decreased from 0.35%) of Total Customer Average Daily Volume (“TCADV”) from Customer Posted interest in all issues, plus Executed ADV of at least 0.90% (increased from 0.80%) of U.S. Equity Market Share Posted and Executed on NYSE Arca Equity Market.
The Exchange also offers a Customer Incentive Program (the “Incentive Program”), which offers OTPs the ability to earn one additional credit by achieving one of the five alternative minimum thresholds. The Exchange proposes to modify one of the alternatives. Specifically, the Exchange proposes that an OTP must achieve Executed ADV of 0.90% (increased from 0.80%) of U.S. Equity Market Share Posted and Executed on NYSE Arca Equity Market to be eligible for the associated $0.03 per contract credit (which credit is not changing). This proposed change is designed to encourage increased trading on NYSE Arca Equity Market.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act, in general, and furthers the objectives of Sections 6(b)(4) and (5) of the Act, in particular, because it provides for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities and does not unfairly discriminate between customers, issuers, brokers or dealers.
The Exchange believes that the proposed modifications to the Penny Credit Tiers and the Incentive Program are reasonable, equitable, and not unfairly discriminatory because they are designed to encourage more participants to qualify for the various Tiers or Incentives, particularly those with a cross-asset pricing component. The Exchange believes these proposed changes should result in more order flow being directed to the Exchange, including from affiliated or Appointed OFPs. The proposed modification to Tier 5 should incent OTPs to increase trading on the equities market, while making it easier to meet the requisite volume threshold in options trading. The Exchange notes that OTPs are still eligible to qualify for Tier 5 under the existing alternative (
To the extent that order flow that adds liquidity is increased by the proposal, market participants will increasingly compete for the opportunity to trade on the Exchange, including sending more orders to reach higher Tiers or achieve alternative Incentives. The resulting increased volume and liquidity would provide more trading opportunities and tighter spreads to the investing public and, thus, would promote just and equitable principles of trade and remove impediments to, and perfect the mechanism of, a free and open market.
The Exchange also believes the proposed changes would be available to all similarly-situated market participants on an equal and non-discriminatory basis. The Exchange believes the proposed modifications are reasonable, equitable and not unfairly discriminatory because they encourage participants to enhance their order flow to qualify for the various incentives, including encouraging more participants to have affiliated or appointed order flow directed to the Exchange, which potential increase in order flow would benefit the investing public by improving order execution and price discovery, which promotes just and equitable principles of trade and removes impediments to, and perfects the mechanism of, a free and open market.
In accordance with Section 6(b)(8) of the Act, the Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Instead, the Exchange believes that the proposed changes would encourage
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
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 an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Rule 7130. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at
In its filing with the Commission, the self-regulatory organization 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 self-regulatory organization has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
BOX Rule 7130(a)(4) governs the criteria for order matching and trade execution priority on BOX. BOX Rule 7130(a)(4)(iv), Options Participant Match Trade Prevention, describes an exception to the order matching and
The Exchange now proposes to amend Rule 7130 to remove the Options Participant Match Trade Prevention rule discussed above and adopt three forms of Self-Trade Prevention modifiers. Specifically, the Exchange proposes the Cancel Newest, Cancel Oldest, and Cancel Both Self-Trade Prevention modifiers. Under this proposal, a BOX Participant may elect for all of its orders to be marked with a Self-Trade modifier.
The Exchange also proposes IM-7130-2(c). This provision states that Participants who elect for Self-Trade Prevention modifiers may also elect for all of their resting interest to be “skipped over.”
Below are examples of each Self-Trade Prevention modifier (some which include the election for resting interest to be “skipped over”):
First, the Exchange proposes the STP Cancel Newest (“STPN”) modifier.
Next, the Exchange proposes the STP Cancel Oldest (“STPO”) modifier. If a Participant chooses this modifier, any incoming order submitted by a Participant will not execute against opposite side resting interest from the same Participant ID. When a Participant submits an incoming order that would trade against opposite side resting interest from the same Participant ID, the opposite side interest will be cancelled back to the Participant.
Lastly, the Exchange proposes the STP Cancel Both (“STPC”) modifier. If a Participant chooses this modifier, any incoming order submitted by a Participant will not execute against opposite side resting interest from the same Participant ID. When a Participant submits an incoming order that would trade against opposite side resting interest from the same Participant ID, the entire size of both orders (or order and resting quote) will be cancelled back to the originating Participant ID.
As explained above, orders may skip over orders or quotes from the Same Participant ID and trade against eligible orders or quotes with lower priority that originate from Another Participant, provided the prices are the same. Therefore, the Exchange proposes to add IM-7130-2(d) to provide that in instances in which the Self-Trade Prevention modifiers are implicated, the Self-Trade Prevention modifier rules will supersede other allocation methods only for the purpose of preventing self-trades as described in the Self-Trade Prevention modifier rule. The Exchange notes that this rule is similar to another rule that was in place at another exchange.
The Exchange notes that the proposed modifiers discussed herein are similar to modifiers used at other options exchanges.
As proposed, the STP modifiers would not be applicable to Qualified Contingent Cross (“QCC”) Orders, auctions (COPIP, Facilitation and Solicitation) and Qualified Open Outcry (“QOO”) Orders. Both QCC Orders and auctions are paired orders intended to serve a particular investment purpose that are contingent on the execution of the options legs, in the case of a QCC Order, and the execution of both sides of an auction order. Because the non-execution of a leg of a QCC Order or an auction order is contrary to the investment purpose of such orders, the Exchange has determined not to apply the STP modifiers in a manner that would prevent the execution of a QCC Order or an auction. Similarly, QOO Orders on the BOX Trading Floor are paired orders. The Exchange has determined not to apply the STP modifiers in a manner that would prevent the execution of such orders.
The Exchange anticipates implementing the proposed change during the second quarter of 2019. The Exchange will provide notice of the exact implementation date, via Circular, prior to implementing the proposed change.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
The Exchange believes that proposed IM-7130-2(c) is reasonable as a similar rule was in place at another exchange.
Further, the Exchange believes that adding proposed IM-7130-2(d) to provide that, in instances in which the Self-Trade Prevention modifiers are implicated, the Self-Trade Prevention modifier rules will supersede other allocation methods only for the purposes of preventing self-trades, as described in the proposed rule perfects the mechanism for a free and open national market system and protects investors and the public interest by removing any potential confusion regarding priority and allocation methods.
The Exchange does not believe that the proposed rule will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is designed to enhance the Exchange's current Match Trade Prevention rule and will benefit Participants that wish to protect their orders and quotes against trading with other orders that originate from the same Participant ID. This new functionality, which is similar to functionality offered on other Exchanges, is also voluntary and the Exchange therefore does not believe that providing an enhanced offering to prevent against self-trading will have any significant impact on competition. The Exchange believes the proposed rule change is evidence of the competitive environment in the options industry where exchanges must continually improve their offerings to maintain competitive standing.
The Exchange has neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or 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 an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
BNSF Railway Company (BNSF) has filed a verified notice of exemption under 49 CFR pt. 1152 subpart F—
BNSF has certified that: (1) No local traffic has moved over the Line since prior to 2008; (2) there is no overhead traffic on the Line; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line either is pending with the Surface Transportation Board (Board) or any U.S. District Court or has been decided in favor of a complainant within the two-year period; and (4) the requirements at 49 CFR 1105.12 (newspaper publication), 49 CFR 1152.50(d)(1) (notice to governmental agencies), and 49 CFR 1105.7 and 1105.8 (environment and historic report), have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA)
A copy of any petition filed with Board should be sent to BNSF's representative, Peter Denton, Steptoe &
If the verified notice contains false or misleading information, the exemption is void ab initio.
BNSF has filed a combined environmental and historic report that addresses the potential effects of the abandonment on the environment and historic resources. OEA will issue an environmental assessment (EA) by April 30, 2019. The EA will be available to interested persons on the Board's website, by writing to OEA, or by calling OEA at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Relay Service at (800) 877-8339. Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), BNSF shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line. If consummation has not been effected by BNSF's filing a notice of consummation by April 25, 2020, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available at
By the Board, Allison C. Davis, Acting Director, Office of Proceedings.
The Athens Line, LLC (Athens Line), has filed a verified notice of exemption under 49 CFR pt. 1152 subpart F—
Athens Line has certified that: (1) No local traffic has moved over the Line for at least two years; (2) no overhead traffic has moved over the Line for at least two years; (3) no formal complaint filed by a user of rail service on the Line (or a state or local government entity acting on behalf of such user) regarding cessation of service over the Line either is pending before the Surface Transportation Board (Board) or any U.S. District Court or has been decided in favor of the complainant within the two-year period; and (4) the requirements at 49 CFR 1105.12 (newspaper publication) and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the discontinuance of service shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA)
A copy of any petition filed with Board should be sent to Athens Line's representative, Richard H. Streeter, Law Office of Richard H. Streeter, 5255 Partridge Lane NW, Washington, DC 20016.
If the verified notice contains false or misleading information, the exemption is void ab initio.
Board decisions and notices are available at
By the Board, Allison C. Davis, Acting Director, Office of Proceedings.
Union Pacific Railroad Company (UP) has filed a verified notice of exemption under 49 CFR 1180.2(d)(7) to acquire trackage rights from Norfolk Southern Railway Company (NSR). UP states that NSR, pursuant to a written trackage rights agreement, has agreed to grant UP overhead trackage rights over approximately 288 miles of NSR's rail line between the UP/NSR connection at Control Point West MC at Birmingham, Mo., near milepost S266.3 and the UP/NSR connection at Control Point Iles at Springfield, Ill., near milepost DH 416.5.
The verified notice states that the proposed transaction will provide UP with an alternative route between Kansas City, Mo., and Springfield, thereby increasing efficiency in operations.
The transaction may be consummated on or after May 9, 2019, the effective date of the exemption (30 days after the verified notice of exemption was filed).
As a condition to this exemption, any employees affected by the trackage rights will be protected by the conditions imposed in
If the notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not
An original and 10 copies of all pleadings, referring to Docket No. FD 36290, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on UP's representative, Jeremy M. Berman, General Attorney, 1400 Douglas Street, Stop 1580, Omaha, NE 68179.
According to UP, this action is categorically excluded from environmental review under 49 CFR 1105.6(c), and from historic reporting under 49 CFR 1105.8(b)(3).
Board decisions and notices are available at
By the Board, Allison C. Davis, Acting Director, Office of Proceedings.
Federal Aviation Administration (FAA), DOT.
Notice of Commercial Space Transportation Advisory Committee meeting.
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given of a meeting of the Commercial Space Transportation Advisory Committee (COMSTAC).
The meeting will take place on May 30, 2019 from 9:00 a.m. to 5:00 p.m.
Department of Transportation (DOT) Headquarters, 1200 New Jersey Avenue SE, Washington, DC. Guests should allow time for security screening when entering the building.
Di Reimold, COMSTAC Executive Director; email
The preliminary schedule for the COMSTAC meeting on May 30 is below:
Attendance is open to the public but limited to the space available. Please confirm your attendance with the person listed in the
For persons participating by telephone, please contact the person listed in the
If you are in need of assistance or require a reasonable accommodation for this meeting, please contact the person listed in the
Interested members of the public may submit relevant written statements for the COMSTAC members to consider under the advisory process. Statements may concern the issues and agenda items mentioned above and/or additional issues that may be relevant for the U.S. commercial space transportation industry. Interested parties wishing to submit written statements should contact the person listed below in writing (mail or email) 10 DAYS IN ADVANCE OF MEETING so that the information can be made available to COMSTAC members for their review and consideration before the meeting. Written statements should be supplied in the following formats: One hard copy with original signature and/or one electronic copy via email. Portable Document Format (PDF) attachments are preferred for email submissions. A detailed agenda will be posted on the FAA website at
Federal Aviation Administration (FAA), DOT.
Notice of Intent of Waiver with respect to land.
The Federal Aviation Administration (FAA) is considering a proposal from the Johnson County Airport Commission (sponsor), New Century, KS, to release 623.74+ acres of land from the federal obligation dedicating it to aeronautical use and to authorize this parcel to be used for revenue-producing, non-aeronautical purposes.
Comments must be received on or before May 28, 2019.
Comments on this application may be mailed or delivered to the FAA at the following address: Lynn D. Martin, Airports Compliance Specialist, Federal Aviation Administration, Airports Division, ACE-610C, 901 Locust Room 364, Kansas City, MO 64106.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to: Aaron Otto, Executive Director, Johnson County Airport Commission, 1 New Century Parkway, New Century, KS 66031, (913) 715-6002.
Lynn D. Martin, Airports Compliance Specialist, Federal Aviation Administration, Airports Division, ACE-610C, 901 Locust Room 364, Kansas City, MO 64106, Telephone number (816) 329-2644, Fax number (816) 329-2611, email address:
The FAA invites public comment on the request to change approximately 623.74+ acres of airport property at the New Century AirCenter Airport (IXD) from aeronautical use to non-aeronautical for revenue producing use. These parcels will be used for commercial/industrial operations.
No airport landside or airside facilities are presently located on these parcels, nor are airport developments
The following is a brief overview of the request:
The New Century AirCenter Airport (IXD) is proposing the release of five parcels, for a total of 623.74 acres, more or less from aeronautical to non-aeronautical. The release of land is necessary to comply with Federal Aviation Administration Grant Assurances that do not allow federally acquired airport property to be used for non-aviation purposes. The rental of the subject property will result in the land at the New Century AirCenter Airport (IXD) being changed from aeronautical to nonaeronautical use and release the lands from the conditions of the Airport Improvement Program Grant Agreement Grant Assurances. In accordance with 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the airport will receive fair market rental value for the property. The annual income from rent payments will generate a long-term, revenue-producing stream that will further the Sponsor's obligation under FAA Grant Assurance number 24, to make the New Century AirCenter Airport as financially self-sufficient as possible.
Following is a legal description of the subject airport property at the New Century AirCenter Airport (IXD):
All that part of the Northeast Quarter of Section 7, Township 14 South, Range 23 East of the 6th Principle Meridian in Johnson County, Kansas, described as follows:
Commencing at the Southwest corner of the Northeast Quarter of said Section 7, thence North 88 degrees 01 minute 18 seconds East along the South line of the Northeast Quarter of said Section 7, a distance of 685.58 feet to the point of beginning; thence North 01 degree 55 minutes 50 seconds West, a distance of 2013.43 feet; thence North 87 degrees 53 minutes 18 seconds East, a distance of 494.00 feet; thence North 01 degree 55 minutes 50 seconds West, a distance of 564.26 feet to a point on the South right-of-way line of 151st street; thence Easterly along a curve to the right having an initial tangent bearing of North 89 degrees 47 minutes 42 seconds East, a radius of 11399.16 feet, a central angle of 0 degrees 47 minutes 58 seconds and an arc length of 159.05 feet; thence South 89 degrees 24 minutes 16 seconds East along the South right-of-way line of 151st street, a distance of 200.00 feet; thence Easterly along a curve to the left having a radius of 11519.16 feet, a central angle of 0 degrees 52 minutes 35 seconds and an arc length of 176.19 feet; thence South 0 degrees 38 minutes 01 seconds East along the West right-of-way line of New Century Parkway, now established, a distance of 455.68 feet; thence Southerly along a curve to the right having a radius of 1410 feet, a central angle of 6 degrees 27 minutes 44 seconds and an arc length of 159.03 feet, along said West right-of-way; thence Southerly along a curve to the right having a radius of 1279.30 feet an initial tangent bearing of South 07 degrees 05 minutes 55 seconds East, a central angle of 17 degrees 38 minutes 15 seconds and an arc length of 393.81 feet, along said West right-of-way line; thence along a curve to the right along said West right-of-way line, having a radius of 4479.10 feet, an initial tangent bearing of South 11 degrees 07 minutes 59 seconds West, a central angle of 03 degrees 30 minutes 19 seconds and an arc length of 273.81 feet; thence South 16 degrees 10 minutes 16 seconds West along said West right-of-way line, a distance of 272.86 feet; thence South 88 degrees 04 minutes 00 seconds West along said West right-of-way line, a distance of 94.51 feet; thence South 10 degrees 27 minutes 51 seconds East along said West right-of-way line, a distance of 200.38 feet; thence South 16 degrees 10 minutes 16 seconds West along said West right-of-way line, a distance of 873.28 feet to a point on the South line of the Northeast Quarter of said Section 7; thence South 88 degrees 01 minutes 18 seconds West along the South line of the Northeast Quarter of said Section 7, a distance of 490.09 feet to the point of beginning, containing 1,900,212.00 Sq. Ft. or 43.62 Ac. more or less, subject to that part in roads and easements.
All that part of the Northeast Quarter of Section 7, Township 14 South, Range 23 East of the 6th Principle Meridian in Johnson County, Kansas, described as follows:
Commencing at the Northeast corner of the Northeast Quarter of said Section 7; thence South 01 degree 54 minutes 48 seconds East along the East line of the Northeast Quarter of said Section 7, a distance of 108.06 feet; thence South 88 degrees 05 minutes 12 seconds West, a distance of 20.00 feet to a point on the South right-of-way line of 151st Street also being the point of beginning; thence South 01 degree 54 minutes 48 seconds East parallel and 20 feet West of the East line of the Northeast Quarter of said Section 7, a distance of 1513.90 feet; thence South 88 degrees 04 minutes 00 seconds West, a distance of 1036.47 feet to a point of the East right-of-way line of New Century Parkway, now established, thence North 16 degrees 10 minutes 16 seconds East along said East right-of-way line, a distance of 247.77 feet; thence Northerly along a curve to the left having an initial tangent bearing of North 14 degrees 38 minutes 56 seconds East, a radius of 4559.10 feet, a central angle of 16 degrees 27 minutes 02 seconds and an arc length of 1309.00 feet to a point of the South right-of-way line of 151st Street; thence along a curve to the right having an initial tangent bearing of North 88 degrees 58 minutes 57 seconds East, a radius of 11519.16 feet, a central angle of 01 degree 05 minutes 35 seconds and an arc length of 219.76 feet; thence North 87 degrees 53 minutes 18 seconds East along the said South right-of-way line, a distance of 217.56 feet; thence South 83 degrees 34 minutes 45 seconds East along said South right-of-way line, a distance of 101.12 feet; thence North 87 degrees 53 minutes 18 seconds East along said South right-of-way line, a distance of 200.00 feet; thence North 83 degrees 39 minutes 33 seconds East along the South right-of-way line of 151st Street, a distance of 33.16 feet to the point of beginning, containing 1,305,862.08 Sq. Ft. or 29.97 Ac. more or less, subject to that part in roads and easements.
All that part of the West half of Section 8, Township 14 South, Range 23 East of the 6th Principle Meridian in Johnson County, Kansas, described as follows:
Commencing at the Northeast corner of the Northwest Quarter of said Section 8; thence South 01 degree 50 minutes 43 seconds East along the East line of the Northwest Quarter of said Section 8, a distance of 95.00 feet to the point of beginning; thence continuing South 01 degree 50 minutes 43 seconds East along the said East line, a distance of 2550.52 feet to the Southeast corner of the Northwest Quarter of said Section 8; thence South 01 degree 51 minutes 09 seconds East along the East line of the Southwest Quarter of said Section 8, a distance of 664.19 feet; thence South 87 degrees 54 minutes 11 seconds West, a distance of 1394.30 feet; thence South 01 degrees 50 minutes 55 seconds East, a distance of 1951.05 feet to a point on the Northerly right-of-way line of 159th Street; thence South 87 degrees 54 minutes 29 seconds West along said Northerly right-of-way line, a distance of 189.54 feet; thence Northerly along a curve to the right having an initial tangent bearing of South 87 degrees 49 minutes 35 seconds West, a radius of 222.50 feet, a central angle of 90 degrees 15 minutes 47 seconds and an arc length of 350.52 feet to a point of the East right-of-way line of North Loop Road, as now established; thence North 01 degree 54 minutes 38 seconds West along said Easterly right-of-way line, a distance of 574.67 feet; thence North 01 degree 54 minutes 53 seconds West along said East right-of-way line, a distance of 1135.60 feet; thence Northerly along a curve to the left having initial tangent bearing of North 01 degree 35 minutes 50 seconds West, a radius of 611.09 feet, a central angle of 85 degrees 20 minutes 32 seconds and an arc length of 910.22 feet; thence North 06 degrees 35 minutes 50 seconds East, a distance of 68.55 feet to a point on the South line of the Northwest Quarter of said Section 8; thence continuing North 06 degrees 35 minutes 50 seconds East, a distance of 1037.49 feet; thence South 88 degrees 04 minutes 00 seconds West, a distance of 514.85 feet to a point on the West line of said Northwest Quarter, said point being 1027.04 feet North
All that part of Section 17, Township 14 South, Range 23 East of the 6th Principle Meridian in Johnson County, Kansas, described as follows:
Commencing at the Southeast corner of the Northeast Quarter of said Section 17; thence South 87 degrees 57 minutes 21 seconds West along the South line of the Northeast Quarter of said Section 17, a distance of 34.99 feet to the point of beginning; thence South 87 degrees 57 minutes 21 seconds West along the South line of the Northeast Quarter of said Section 17, a distance of 1324.62 feet to the Northeast corner of the West half of the Southeast Quarter of said Section 17; thence South 01 degree 41 minutes 01 second East along the East line of the West half of the Southeast Quarter of said Section 17, a distance of 2645.79 feet to the Southeast corner of the West half of the Southeast Quarter of said Section 17; thence South 88 degrees 03 minutes 28 seconds West along the South line of the Southeast Quarter of said Section 17, a distance of 1355.59 feet to the Southwest corner of the Southeast Quarter of said Section 17; thence South 88 degrees 03 minutes 36 seconds West along the South line of the Southwest Quarter of said Section 17, a distance of 2100.15 feet to a point 608.93 feet East of the Southwest corner of the Southwest Quarter of said Section 17; thence North 01 degree 41 minutes 15 seconds West, a distance of 1581.43 feet; thence North 45 degrees 03 minutes 45 seconds East, a distance of 2876.30 feet to a point on the West line of the Northeast Quarter of said Section 17; thence North 01 degree 45 minutes 46 seconds West along the said West line, a distance of 681.35 feet; thence North 45 degrees 08 minutes 14 seconds East, a distance of 1492.49 feet to a point on the South right-of-way line of 159th Street; thence North 87 degrees 40 minutes 07 seconds East along the South right-of-way line of 159th Street, a distance of 1278.56 feet; thence South 81 degrees 05 minutes 55 seconds East along the South right-of-way line of 159th Street, a distance of 255.11 feet to a point on the West right-of-way line of US 56 Highway; thence South 15 degrees 35 minutes 22 seconds East along said West right-of-way, a distance of 272.13 feet to a point 35 feet West of the East line of the Northeast Quarter of said Section 17; thence South 01 degree 46 minutes 14 seconds East along a line parallel to the East line of said Northeast Quarter, a distance of 2288.80 feet to the point of beginning, containing 15,369,040.89 Sq. Ft. or 352.82 Ac. more or less, subject to that part in roads and easements.
All that part of the Southeast Quarter of Section 19, Township 14 South, Range 23 East 29.97 of the 6th Principle Meridian in Johnson County, Kansas, described as follows:
Commencing at the Southeast corner of the Southeast Quarter of said Section 19; thence South 88 degrees 00 minutes 41 seconds West along the South line of the Southeast Quarter of said Section 19, a distance of 367.09 feet; thence North 02 degrees 26 minutes 53 seconds West, a distance of 34.03 feet to the point of beginning thence North 01 degree 56 minutes 45 seconds West, a distance of 188.77 feet to a point on the South right-of-way line of US 56 highway; thence North 87 degrees 56 minutes 15 seconds East along the South right-of-way line of US 56 Highway, a distance of 60.00 feet; thence South 01 degree 56 minutes 45 seconds East, a distance of 178.30 feet to a point on the North right-of-way line of Santa Fe Street; thence South 78 degrees 02 minutes 42 seconds West along the North right-of-way line of Santa Fe Street, a distance of 60.93 feet to the point of beginning, containing 11,011.72 Sq. Ft. or 0.25 Ac. more or less, subject to that part in roads and easements.
Any person may inspect, by appointment, the request in person at the FAA office listed above
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice and request for comments on an extension of a previously-approved information collection.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below will be forwarded to the Office of Management and Budget (OMB) for review, and requests comments on the ICR. The
Comments must be submitted on or before May 28, 2019.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for NHTSA, 725 17th Street NW, Washington, DC 20503.
For additional information or access to background documents, contact Barbara Rhea, State Data Reporting Systems Division (NSA-120), Room W53-304, 1200 New Jersey Avenue SE, Washington, DC 20590. Ms. Rhea can be reached via email at
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). In compliance with these requirements, this notice announces that the following
A Federal Register notice with a 60-day comment period soliciting comments on the information collection was published on February 1, 2019 (84 FR 1270). There were no comments received.
The OMB approval for the survey is scheduled to expire on April 30, 2019. NHTSA seeks an extension of this approval to obtain this crash data vital to FARS' function.
There are 52 State “respondents” reporting on approximately 34,748 fatal crash cases per year. The State employee (or employees depending on the number of fatal crashes per year occurring in the State) acquires and codes the required information as fatal crashes occur. Approximately 3.00 hours per case are necessary to complete the FARS forms. This results in an estimated annual burden of 104,244 hours.
FARS data is collected from the State governments from the 50 States, DC, and Puerto Rico.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.95.
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before May 28, 2019 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained from Jennifer Quintana by emailing
44 U.S.C. 3501
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before May 28, 2019 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for
Copies of the submissions may be obtained from Jennifer Quintana by emailing
44 U.S.C. 3501
Notice.
The Department of Veterans Affairs (VA) is seeking nominations of qualified candidates to be considered for appointment as a member of the Veterans and Community Oversight and Engagement Board (herein-after referred in this section to as “the Board”) for the VA West Los Angeles Campus in Los Angeles, CA (“Campus”). The Board is established to coordinate locally with the Department of Veterans Affairs to identify the goals of the community and Veteran partnership; provide advice and recommendations to the Secretary to improve services and outcomes for Veterans, members of the Armed Forces, and the families of such Veterans and members; and provide advice and recommendations on the implementation of the Draft Master Plan approved by the Secretary on January 28, 2016, and on the creation and implementation of any other successor master plans.
Nominations for membership on the Board must be received no later than 5:00 p.m. EST on June 15, 2019.
All nominations should be mailed to the Veterans Experience Office, Department of Veterans Affairs, 810 Vermont Avenue NW (30), Washington, DC 20420; or sent electronically to the Advisory Committee Management Office mailbox at
Eugene W. Skinner Jr., Designated Federal Officer, Veterans Experience Office, Department of Veterans Affairs, 810 Vermont Avenue NW (30), Washington, DC 20420, telephone 202-631-7645 or via email at
In carrying out the duties set forth in the West LA Leasing Act, the Board shall: (1) Provide the community with opportunities to collaborate and communicate by conducting public forums; and (2) Focus on local issues regarding the Department that are identified by the community with respect to health care, implementation of the Master Plan, and any subsequent plans, benefits, and memorial services at the Campus. Information on the Master Plan can be found at
The Board is a statutory committee established as required by Section 2(i) of the West Los Angeles Leasing Act of 2016, Public Law 114-226 (the West LA Leasing Act). The Board operates in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2.
The members of the Board are appointed by the Secretary of Veterans Affairs from the general public, from various sectors and organizations, and shall meet the following qualifications, as set forth in the West LA Leasing Act:
(1) Not less than 50% of members shall be Veterans; and
(2) Non-Veteran members shall be:
a. Family members of Veterans,
b. Veteran advocates,
c. Service providers,
d. Real estate professionals familiar with housing development projects, or
e. Stakeholders.
The Board members may also serve as Subcommittee members.
In accordance with the Board Charter, the Secretary shall determine the number, terms of service, and pay and allowances of Board members, except that a term of service of any such member may not exceed two years. The Secretary may reappoint any Board member for additional terms of service.
To the extent possible, the Secretary seeks members who have diverse professional and personal qualifications including but not limited to subject matter experts in the areas described above. We ask that nominations include any relevant experience and information so that VA can ensure diverse Board membership.
(1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (
(2) The nominee's contact information, including name, mailing address, telephone numbers, and email address;
(3) The nominee's curriculum vitae, not to exceed three pages and a one-page cover letter; and
(4) A summary of the nominee's experience and qualifications relative to the membership criteria and professional qualifications criteria listed above.
The Department makes every effort to ensure that the membership of VA Federal advisory committees is diverse in terms of points of view represented and the committee's capabilities. Appointments to this Board shall be made without discrimination because of a person's race, color, religion, sex,
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal Platform (SBE-FPs). It finalizes changes that will allow greater flexibility related to the duties and training requirements for the Navigator program and changes that will provide greater flexibility for direct enrollment entities, while strengthening program integrity oversight over those entities. It finalizes a change intended to reduce the costs of prescription drugs. This final rule also includes changes to Exchange standards related to eligibility and enrollment; exemptions; and other related topics.
These regulations are effective on June 24, 2019.
Jeff Wu, (301) 492-4305, Kiahana Brooks, (301) 492-5229, Ken Buerger, (410) 786-1190, or Abigail Walker, (410) 786-1725, for general information.
David Mlawsky, (410) 786-6851, for matters related to guaranteed renewability.
Avareena Cropper, (410) 786-3794, for matters related to sequestration.
Allison Yadsko, (410) 786-1740, for matters related to risk adjustment.
Jacalyn Boyce, (301) 492-5122, for matters related to Federally-facilitated Exchange and State-based Exchange on the Federal Platform user fees.
Abigail Walker, (410) 786-1725, Alper Ozinal, (301) 492-4178, Allison Yadsko, (410) 786-1740, or Adam Shaw, (410) 786-1091, for matters related to risk adjustment data validation.
Ken Buerger, (410) 786-1190, or LeAnn Brodhead, (410) 786-3943, for matters related to the opioid crisis.
Amir Al-Kourainy, (301) 492-5210, for matters related to Navigators.
Carly Rhyne, (301) 492-4188, for matters related to special enrollment periods.
Amanda Brander, (202) 690-7892, for matters related to exemptions.
Daniel Brown, (434) 995-5886, for matters related to direct enrollment.
Leigha Basini, (301) 492-4380, for matters related to health insurance issuer drug policy, essential health benefits, and qualified health plan certification requirements.
Abigail Walker, (410) 786-1725, for matters related to the required contribution percentage, cost-sharing parameters, and the premium adjustment percentage.
American Health Benefit Exchanges, or “Exchanges” are entities established under the Patient Protection and Affordable Care Act
On January 20, 2017, the President issued an Executive Order which stated that, to the maximum extent permitted by law, the Secretary of HHS and heads of all other executive departments and agencies with authorities and responsibilities under the PPACA should exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the PPACA that would impose a fiscal burden on any state or a cost, fee, tax, penalty, or regulatory burden on individuals, families, health care providers, health insurers, patients, recipients of health care services, purchasers of health insurance, or makers of medical devices, products, or medications. This rule will, within the limitations of the current statute, reduce fiscal and regulatory burdens across different program areas and provide stakeholders with greater flexibility.
Over time, issuer market exits and increasing insurance rates have threatened the stability of the individual and small group market Exchanges in many geographic areas. These dynamics have put coverage out of reach for many, notably those consumers enrolling outside of the Exchanges, who do not benefit from the PPACA's advance payments of the premium tax credit (APTC).
In previous rulemaking, we have established provisions and parameters to implement many PPACA requirements and programs. In this rule, we amend these provisions and parameters, with a focus on maintaining a stable regulatory environment to provide issuers with greater
Risk adjustment continues to be a core program in the individual and small group markets both on and off the Exchanges, and we are finalizing recalibrated parameters for the HHS-operated risk adjustment methodology. We are finalizing several changes related to the risk adjustment data validation program that are intended to ensure the integrity of the results of risk adjustment, and others intended to alleviate issuer burden associated with complying with risk adjustment data validation requirements.
As we do every year in the HHS notice of benefit and payment parameters, we are finalizing updated parameters applicable in the individual and small group markets. We are finalizing the user fee rate for issuers participating on Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs) for 2020 to be 3.0 and 2.5 percent of premiums, respectively. These rates are a decrease from past years, which will increase affordability for consumers. We are finalizing updates to the premium adjustment percentage methodology and amount, and consequently the maximum annual limitations on cost sharing for the 2020 benefit year, including those for cost-sharing reduction plan variations.
We are finalizing changes to the requirements regarding Navigators to reduce burden, increase flexibility, and enable Exchanges to more easily and cost-effectively operate Navigator programs. Streamlining the Navigator training requirements and authorizing but not requiring assisters to provide certain types of assistance, including post-enrollment assistance, will allow assisters to allocate their resources in a manner that best meets community needs, consumer demands, and organizational resources.
We are finalizing a number of changes in this rule that are intended to reduce the burden for consumers by making it easier to enroll in affordable coverage through the Exchanges. First, we are finalizing a policy that would provide additional flexibility to those in need of a hardship exemption that currently must be obtained by filing an application with an Exchange, by expanding the types of hardship exemptions that consumers may claim for 2018 through the tax filing process. Second, we believe consumers should have greater flexibility in how they shop for coverage, including the avenues through which they enroll in QHPs. As such, we have been working to expand opportunities for individuals to directly enroll in Exchange coverage through the websites of certain third parties, called direct enrollment entities, rather than having to visit
We requested comment on automatic re-enrollment processes and capabilities, as well as additional policies or program measures that would reduce eligibility errors and potential government misspending for potential action in future rulemaking applicable not sooner than plan year 2021.
In the proposed rule, we discussed why we believe increased transparency is a critical component of a consumer driven health care system, and expressed our interest to receive comments discussing ways to provide consumers with greater transparency with regards to their own health care data, QHP offerings on the FFEs, and the cost of health care services. We continue to believe that when consumers have access to relevant, meaningful, and consumer-friendly information, they are empowered to make more informed decisions with regards to their care.
The proposed rule discussed a future opportunity for public input on ways to increase the interoperability of patient-mediated health care data across health care programs, including in coverage purchased through the Exchanges. To that end, in the March 4, 2019
Additionally, we sought comment on ways to further implement section 1311(e)(3) of the PPACA, as implemented by 45 CFR 156.220(d), where a QHP issuer must make available the amount of enrollee cost sharing under the individual's plan or coverage for the furnishing of a specific item or service by a participating provider in a timely manner upon the request of the individual. We were particularly interested in input regarding what types of data will be most useful to improving consumers' abilities to make informed health care decisions, including decisions related to their coverage.
We also expressed our interest in ways to improve consumers' access to information about health care costs. We stated that we believe that consumers would benefit from a greater understanding of what their potential out-of-pocket costs would be for various services, based on which QHP they are enrolled in and which provider they see. We stated that we believe that such a policy would promote consumers' ability to shop for covered services, and to play a more active role in their health care.
We also are finalizing our proposal to create a limited data set file using masked enrollee-level data submitted to HHS from the External Data Gathering Environment (EDGE) servers for issuers of risk adjustment covered plans in the individual and small group (including merged) markets, with one modification: We will not make this limited data set available for public health or health care operations purposes. Thus, we are finalizing our proposal to make this file available to requestors who seek the data for research purposes only. In addition, we are finalizing our proposal to broaden the permissible HHS uses of the enrollee-level EDGE data currently submitted for purposes of risk adjustment. We believe this will increase understanding of these markets and contribute to greater transparency.
We sought comment on ways that we can promote the offering and take-up of high deductible health plans (HDHPs) that can be paired with health savings accounts (HSAs), which can serve as an effective and tax-advantageous method for certain consumers to manage their health care expenditures. We also sought comments for ways to increase the visibility of HSA-eligible HDHPs on
In furtherance of the Administration's priority to reduce prescription drug costs and to align with the President's American Patients First blueprint, we proposed a series of changes regarding prescription drug benefits, to the extent permitted by applicable state law. These proposals included provisions that would allow issuers to adopt mid-year formulary changes to incentivize greater
Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added a new title XXVII to the Public Health Service Act (PHS Act) to establish various reforms to the group and individual health insurance markets, including a guaranteed renewability requirement in the individual, small group, and large group markets.
Subtitles A and C of title I of the PPACA reorganized, amended, and added to the provisions of part A of title XXVII of the PHS Act relating to group health plans and health insurance issuers in the group and individual markets.
Section 1302 of the PPACA provides for the establishment of an essential health benefits (EHB) package that includes coverage of EHB (as defined by the Secretary), cost-sharing limits, and actuarial value requirements. The law directs that EHBs be equal in scope to the benefits provided under a typical employer plan, and that they cover at least the following 10 general categories: Ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.
Section 1301(a)(1)(B) of the PPACA directs all issuers of QHPs to cover the EHB package described in section 1302(a) of the PPACA, including coverage of the services described in section 1302(b) of the PPACA, adherence to the cost-sharing limits described in section 1302(c) of the PPACA, and meeting the actuarial value (AV) levels established in section 1302(d) of the PPACA. Section 2707(a) of the PHS Act, which is effective for plan or policy years beginning on or after January 1, 2014, extends the requirement to cover the EHB package to non-grandfathered individual and small group health insurance coverage, irrespective of whether such coverage is offered through an Exchange. In addition, section 2707(b) of the PHS Act directs non-grandfathered group health plans to ensure that cost sharing under the plan does not exceed the limitations described in sections 1302(c)(1) of the PPACA.
Section 1311(d)(3)(B) of the PPACA permits a state, at its option, to require QHPs to cover benefits in addition to the EHB. This section also requires a state to make payments, either to the individual enrollee or to the issuer on behalf of the enrollee, to defray the cost of these additional state-required benefits.
Section 1302(d) of the PPACA describes the various levels of coverage based on AV. Consistent with section 1302(d)(2)(A) of the PPACA, AV is calculated based on the provision of EHB to a standard population. Section 1302(d)(3) of the PPACA directs the Secretary to develop guidelines that allow for
Section 1311(b)(1)(B) of the PPACA directs that the Small Business Health Options Program assist qualified small employers in facilitating the enrollment of their employees in QHPs offered in the small group market. Sections 1312(f)(1) and (2) of the PPACA define qualified individuals and qualified employers. Under section 1312(f)(2)(B) of the PPACA, beginning in 2017, states have the option to allow issuers to offer QHPs in the large group market through an Exchange.
Section 1311(d)(4)(B) of the PPACA requires an Exchange to provide for the operation of a toll-free telephone hotline to respond to requests for assistance.
Sections 1311(d)(4)(K) and 1311(i) of the PPACA direct all Exchanges to establish a Navigator program.
Section 1311(c)(6)(C) of the PPACA establishes special enrollment periods and section 1311(c)(6)(D) of the PPACA establishes the monthly enrollment period for Indians, as defined by section 4 of the Indian Health Care Improvement Act.
Section 1312(c) of the PPACA generally requires a health insurance issuer to consider all enrollees in all health plans (except grandfathered health plans) offered by such issuer to be members of a single risk pool for each of its individual and small group markets. States have the option to merge the individual and small group market risk pools under section 1312(c)(3) of the PPACA.
Section 1312(e) of the PPACA directs the Secretary to establish procedures under which a state may permit agents and brokers to enroll qualified individuals and qualified employers in QHPs through an Exchange and to assist individuals in applying for premium tax credits and cost-sharing reductions for QHPs sold through an Exchange.
Section 1321(a) of the PPACA provides broad authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, QHPs and other components of title I of the PPACA. Section 1321(a)(1) of the PPACA directs the Secretary to issue regulations that set standards for meeting the requirements of title I of the PPACA for, among other things, the establishment and operation of Exchanges.
Section 1311(c) of the PPACA provides the Secretary the authority to issue regulations to establish criteria for the certification of QHPs. Section 1311(e)(1) of the PPACA grants the Exchange the authority to certify a health plan as a QHP if the health plan meets the Secretary's requirements for certification issued under section 1311(c) of the PPACA, and the Exchange determines that making the plan available through the Exchange is in the interests of individuals and employers in the state.
Sections 1313 and 1321 of the PPACA provide the Secretary with the authority to oversee the financial integrity of State Exchanges, their compliance with HHS standards, and the efficient and non-discriminatory administration of State Exchange activities. Section 1321 of the PPACA provides for state flexibility in the operation and enforcement of Exchanges and related requirements.
When operating an FFE under section 1321(c)(1) of the PPACA, HHS has the authority under sections 1321(c)(1) and 1311(d)(5)(A) of the PPACA to collect and spend user fees. Office of Management and Budget (OMB) Circular A-25 establishes federal policy regarding user fees and specifies that a user charge will be assessed against each identifiable recipient for special
Section 1321(d) of the PPACA provides that nothing in title I of the PPACA should be construed to preempt any state law that does not prevent the application of title I of the PPACA. Section 1311(k) of the PPACA specifies that Exchanges may not establish rules that conflict with or prevent the application of regulations issued by the Secretary.
Section 1343 of the PPACA establishes a permanent risk adjustment program to provide payments to health insurance issuers that attract higher-than average risk populations, such as those with chronic conditions, funded by payments from those that attract lower-than-average risk populations, thereby reducing incentives for issuers to avoid higher-risk enrollees.
Section 1402 of the PPACA provides for, among other things, reductions in cost sharing for EHB for qualified low- and moderate-income enrollees in silver level health plans offered through the individual market Exchanges. This section also provides for reductions in cost sharing for Indians enrolled in QHPs at any metal level.
Section 5000A of the Internal Revenue Code (the Code), as added by section 1501(b) of the PPACA, requires individuals to have minimum essential coverage (MEC) for each month, qualify for an exemption, or make an individual shared responsibility payment. Under the Tax Cuts and Jobs Act, which was enacted on December 22, 2017, the individual shared responsibility payment is reduced to $0, effective for months beginning after December 31, 2018.
The Protecting Affordable Coverage for Employees Act (Pub. L. 114-60, enacted on October 7, 2015) amended the definition of small employer in section 1304(b) of the PPACA and section 2791(e) of the PHS Act to mean, in connection with a group health plan for a calendar year and a plan year, an employer who employed an average of at least 1 but not more than 50 employees on business days during the preceding calendar year and who employs at least 1 employee on the first day of the plan year. It also amended these statutes to make conforming changes to the definition of large employer, and to provide that a state may treat as a small employer, for a calendar year and a plan year, an employer who employed an average of at least 1 but not more than 100 employees on business days during the preceding calendar year and who employs at least 1 employee on the first day of the plan year.
In the July 15, 2011
In the December 2, 2013
In the November 26, 2014
In the December 2, 2015
In the September 6, 2016
In the November 2, 2017
In the July 30, 2018
In the August 10, 2018
In the June 19, 2013
An interim final rule relating to the HIPAA health insurance reforms was published in the April 8, 1997
A proposed rule relating to Exchanges and Insurance Market Standards for 2015 and Beyond was published in the March 21, 2014
We published a request for comment relating to Exchanges in the August 3, 2010
We established additional standards for SHOP in the 2014 Payment Notice and in the Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 interim final rule, published in the March 11, 2013
In a final rule published in the March 27, 2012
In an interim final rule, published in the May 11, 2016
On December 16, 2011, HHS released a bulletin
In the February 1, 2013
In the November 26, 2014
HHS consulted with stakeholders on policies related to the operation of Exchanges, including the SHOP, and the risk adjustment and risk adjustment data validation programs. We held a number of listening sessions with consumers, providers, employers, health plans, and the actuarial community to gather public input. We solicited input from state representatives on numerous topics, particularly essential health benefits, QHP certification, Exchange establishment, and risk adjustment. We consulted with stakeholders through regular meetings with the National Association of Insurance Commissioners (NAIC), regular contact with states through the Exchange Establishment grant and Exchange Blueprint approval processes, and meetings with Tribal leaders and representatives, health insurance issuers, trade groups, consumer advocates, employers, and other interested parties. We considered all public input we received as we developed the policies in this final rule.
The regulations outlined in this final rule will be codified in 45 CFR parts 146, 147, 148, 153, 155, and 156.
The changes to 45 CFR parts 146, 147, and 148 make a non-substantive technical correction to the guaranteed renewability regulations.
The changes to the HHS risk adjustment program established under 45 CFR part 153 relate to the determination of the final coefficients for the 2020 benefit year, and the data sources used to calculate those coefficients. This final rule addresses high-cost risk pooling, where we finalize the same parameters that applied to the 2018 and 2019 benefit years to the 2020 benefit year and future benefit years unless changed in future rulemaking. The finalized provisions in part 153 also relate to the risk adjustment user fee for the 2020 benefit year and modifications to risk adjustment data validation requirements.
The final regulations in 45 CFR part 155 will provide more flexibility related to the training requirements for Navigators by streamlining 20 existing specific training topics into 4 broad categories. They also provide more flexibility to FFE Navigators by making the provision of certain types of assistance, including post-enrollment assistance, permissible for FFE Navigators, but not required.
The final regulations in 45 CFR part 156 set forth provisions related to cost sharing, including the premium adjustment percentage, the maximum annual limitation on cost sharing, and the reductions in the maximum annual limitation for cost-sharing plan variations for 2020. As we do every year in the HHS notice of benefit and payment parameters, we are finalizing updates to the premium adjustment percentage, which helps determine the required contribution percentage, the maximum annual limitation on cost sharing, and the reduced maximum annual limitation on cost sharing based on the premium adjustment percentage.
We finalize the FFE and SBE-FP user fee rates for 2020 to be 3.0 and 2.5 percent of premiums, respectively. The final regulations in part 156 also include a policy to incentivize the use of generic drugs. In addition, the final rule at part 156 includes changes related to direct enrollment to conform to the changes finalized to 45 CFR part 155.
In the January 24, 2019
In this final rule, we provide a summary of certain proposed provisions, a summary of the public comments received that directly related to those proposals, our responses to
We sought comment on ways to further implement section 1311(e)(3) of the PPACA, as implemented by § 156.220(d), to enhance enrollee cost-sharing transparency. We also sought comment on whether there are any existing regulatory barriers that stand in the way of privately led efforts at price transparency, and ways that we can facilitate or support increased private innovation in price transparency.
We requested comment on automatic re-enrollment processes and capabilities, as well as additional policies or program measures that would reduce eligibility errors and potential government misspending for potential action in future rulemaking.
We sought comment on ways that we can promote the offering and take-up of HDHPs that can be paired with HSAs. We also sought comments for ways to increase the visibility of HSA-eligible HDHPs on
For a discussion of the provisions in this final rule related to part 146, please see the preamble to part 147.
Section 147.106 implements the guaranteed renewability requirements under the PPACA (applicable to non-grandfathered plans), and §§ 146.152 and 148.122 implement the guaranteed renewability requirements enacted by HIPAA (applicable to both grandfathered and non-grandfathered
In the 2016 Payment Notice, we expressed concerns about the impact on consumers of mid-year formulary changes. We noted that, under guaranteed renewability requirements and the definitions of “product” and “plan,” issuers generally may not make plan design changes, other than at the time of plan renewal. However, we also stated that certain mid-year changes to drug formularies related to the availability of drugs in the market may be necessary and appropriate.
In the proposed rule, we proposed to add § 147.106(e)(5) to set parameters in the individual, small group, and large group markets, for plan years beginning on or after January 1, 2020, for certain mid-year formulary changes, if permitted by applicable state law. At § 147.106(e)(5), we proposed allowing issuers, for plan years beginning on or after January 1, 2020, to make formulary changes during the plan year when a generic equivalent of a prescription drug becomes available on the market, within a reasonable time after that drug becomes available. We proposed that the issuer be permitted to modify its plans' formularies to add the generic equivalent drug. At that time, the issuer would also be permitted to remove the equivalent brand drug from the formulary or move the equivalent brand drug to a different cost-sharing tier on the formulary. We proposed that any mid-year formulary changes would have to be consistent with the standards applicable to uniform modifications in paragraph (e)(2) or (e)(3).
We proposed that issuers, including issuers of grandfathered plans, would also be required to provide enrollees the option to request coverage for a brand drug that was removed from the formulary through the applicable coverage appeal process under § 147.136 or the drug exception request process under § 156.122(c).
Under our proposal, before removing a brand drug from the formulary or moving it to a different cost-sharing tier, a health insurance issuer would be required to notify all plan enrollees of the change in writing a minimum of 60 days prior to initiating the change. This notice would identify the name of the brand drug that is the subject of the change, disclose whether the brand drug will be removed from the formulary or placed on a different cost-sharing tier, provide the name of the generic equivalent that will be made available, specify the date the changes will become effective, and state that under the appeals processes outlined in § 147.136 or the exceptions processes outlined in § 156.122(c), enrollees and dependents may request and gain access to the brand drug when clinically appropriate and not otherwise covered by the health plan.
We also proposed changes to § 147.106(a) to reflect that paragraph (e) currently provides an exception to the general rule on guaranteed renewability. This is merely a technical correction, not a substantive change. We similarly proposed technical corrections to §§ 146.152(a) and 148.122(b).
We sought comment on these proposals related to prescription drug benefits and coverage, including whether to limit the proposal related to mid-year formulary changes to the individual and small group markets, and whether a different advance notice period, such as 90 days or 120 days, would be more appropriate.
Many other commenters stated the proposal would improperly allow mid-year formulary changes and opposed the proposal because they noted it would hurt consumers. These commenters stated, for example, that consumers choose their plans based on the formulary composition at the beginning of the plan year and that changing formularies could result in patient safety and health issues such as additional emergency room visits, additional outpatient appointments, and higher medical costs. A few commenters stated that these dangers could occur notwithstanding the availability of an exceptions or appeals process. Many commenters stated that mid-year formulary changes arbitrarily eliminate an EHB.
We do not agree that mid-year formulary changes arbitrarily eliminate an EHB. Rather, we remind issuers that all requirements in § 156.122 related to EHB as applied to prescription drug coverage continue to apply in the context of mid-year formulary changes. For example, a health plan does not provide EHB unless it covers the greater of one drug in every United States Pharmacopeia (USP) category and class or the same number of prescription drugs in each category and class as the EHB-benchmark plan. Additionally, the EHB regulations at § 156.122(a)(3) require the use of a pharmacy and therapeutics committee to establish and manage the formulary drug list throughout the year. Issuers required to provide EHB must continue to meet these requirements.
We also are not finalizing any changes to the definitions of “plan” and “product” at § 144.103—which incorporate by reference the uniform modification standards—with regard to determining whether a product and plan that have undergone formulary changes are considered the same product and plan. This definition provides that, among other things, within a product, each plan must have the same cost-sharing structure as before the modification, except for any variation in cost sharing solely related to changes in cost and utilization of medical care, or to maintain the same metal level of coverage. We interpret this provision to mean that for modifications of prescription drug formularies, each tier must continue to have the same cost-sharing structure, or any changes to the tier structure must be related to changes in cost or utilization of medical care, or to maintain the same metal level, to be considered a uniform modification of coverage, regardless of any changes made to the placement of drugs within the formulary. Additionally, the product must provide the same covered benefits, except for any changes in benefits that cumulatively impact the plan-adjusted index rate for any plan within the product within an allowable variation of ±2 percentage points (not including changes pursuant to applicable federal or state requirements). Given the nature of formulary changes, our expectation is that generally, any changes to which drugs are covered under the formulary would not be of a magnitude that would exceed the allowable variation of ±2 percentage points of the plan-adjusted index rate. However, if formulary changes do result in a change to the plan-adjusted index rate outside this permitted variation, such changes would result in the product being considered to have been discontinued, and a new product to have been issued.
We received no comments on the proposed technical corrections to
For a discussion of the provisions in this final rule related to part 148, please see the preamble to part 147.
In accordance with the OMB Report to Congress on the Joint Committee Reductions for Fiscal Year 2019,
HHS, in coordination with the OMB, has determined that, under section 256(k)(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (Pub. L. 99-177, enacted on December 12, 1985), as amended, and the underlying authority for the reinsurance and risk adjustment programs, the funds that are sequestered in fiscal year 2019 from the reinsurance and risk adjustment programs will become available for payment to issuers in fiscal year 2020 without further Congressional action. If Congress does not enact deficit reduction provisions that replace the Joint Committee reductions, these programs will be sequestered in future fiscal years, and any sequestered funding will become available in the fiscal year following that in which it was sequestered.
In subparts A, B, D, G, and H of part 153, we established standards for the administration of the risk adjustment program. The risk adjustment program is a permanent program created by section 1343 of the PPACA that transfers funds from lower-than-average risk, risk adjustment covered plans to higher-than-average risk, risk adjustment covered plans in the individual and small group markets (including merged markets), inside and outside the Exchanges. In accordance with § 153.310(a), a state that is approved or conditionally approved by the Secretary to operate an Exchange may establish a risk adjustment program, or have HHS do so on its behalf. HHS did not receive any requests from states to operate risk adjustment for the 2020 benefit year. Therefore, HHS will operate risk adjustment in every state and the District of Columbia for the 2020 benefit year.
The HHS risk adjustment models predict plan liability for an average enrollee based on that person's age, sex, and diagnoses (also referred to as hierarchical condition categories (HCCs)), producing a risk score. The current structure of these models is described in the 2019 Payment Notice.
The enrollment-weighted average risk score of all enrollees in a particular risk adjustment covered plan (also referred to as the plan liability risk score or PLRS) within a geographic rating area is one of the inputs into the risk adjustment state payment transfer formula, which determines the state payment or charge that an issuer will receive or be required to pay for that plan. Thus, the HHS risk adjustment models predict average group costs to account for risk across plans, in keeping with the Actuarial Standards Board's Actuarial Standards of Practice for risk classification.
In this final rule, we are making a technical correction to the definition of a risk adjustment covered plan under § 153.20 by correcting a citation in the definition of “risk adjustment covered plan” from § 146.145(c) to § 146.145(b). Specifically, this definition was finalized in the final rule entitled Standards Related to Reinsurance, Risk Corridors and Risk Adjustment,
We used the 3 most recent years of MarketScan® data available to recalibrate the 2016, 2017, and 2018 benefit year risk adjustment models. For the 2019 benefit year, we recalibrated the models using 2 years of MarketScan® data (2014 and 2015) and 2016 enrollee-level EDGE data. The 2019 benefit year was the first recalibration year in which enrollee-level EDGE data was used for this purpose. This approach used blended (averaged) coefficients from 3 years of separately solved models to provide stability for the risk adjustment coefficients year-to-year, while reflecting the most recent years' claims experience available. For the 2020 benefit year, we proposed to blend the 2 most recent years of enrollee-level EDGE data available (2016 and 2017) with the most recent year of MarketScan® data available (2017). We also noted that if we are unable to publish the final coefficients in the final rule, consistent with § 153.320(b)(1)(i), and as we have done for certain prior benefit years,
We did not propose to make any changes to the categories included in the HHS risk adjustment models for the 2020 benefit year from those finalized in the 2019 benefit year models. That is, we proposed to maintain the same age, sex, enrollment duration, HCC, RXC, and severity categories for the 2020 benefit year models as those used for the 2019 benefit year models.
We are not finalizing our proposal to blend the most recent year of MarketScan® data (2017) with the 2 most recent years of enrollee-level EDGE data (2016 and 2017) for 2020 risk adjustment model recalibration. We are instead finalizing an approach that would blend 3 consecutive years of data—one year of data from MarketScan® (2015) with the 2 most recent years of enrollee-level EDGE data (2016 and 2017), an approach that more closely aligns with the approach we used to recalibrate risk adjustment models for the 2016, 2017, 2018, and 2019 benefit years. This approach maintains our previously finalized policy of blending coefficients from 3 years of separately solved models and promotes stability for the risk adjustment coefficients year-to-year. Accordingly, we have incorporated the 2015 MarketScan® data with 2016 and 2017 benefit year enrollee-level EDGE data for the final 2020 benefit year risk adjustment coefficients presented in this final rule. Additionally, we are finalizing the pricing adjustment to the plan liability simulation for the Hepatitis C RXC, as proposed, and are not otherwise making changes to the categories included in the HHS risk adjustment models for the 2020 benefit year from those finalized for the 2019 benefit year models.
The following is a summary of the public comments we received on the risk adjustment model recalibration proposals.
Due to the availability of data and our ability to execute the model regressions, this year, we are able to provide the final recalibrated coefficients for 2020 benefit year in the tables below. In the future, we will continue to look for opportunities to update our processes to obtain and process the recalibrated coefficients as soon as practical. However, if data is not available or if we are unable to calculate the coefficients for the risk adjustment models for a benefit year in time for publication in the applicable final annual HHS notice of benefit and payment parameters, then we will publish the draft factors to be employed in the models in the final rule, including demographic factors, diagnostic factors, and utilization factors, and the datasets to be used to calculate the final coefficients.
Additionally, we have been continuously assessing the availability of drugs in the market and the associated mapping of those drugs to RXCs in the adult risk adjustment model. As a results of this on-going assessment, we make quarterly updates to the RXC Crosswalk
Overall, we also continue to regularly evaluate the individual and small group markets (including merged markets) and assess whether updates to the HHS-operated risk adjustment program could improve the assessment of plan actuarial risk. We also regularly review the impact of the risk adjustment program on the markets. We expect to continue to review the risk adjustment program and propose changes as necessary.
We believe the pricing adjustment, as finalized, is appropriate based on our review of published expectations for plan liability associated with Hepatitis C drugs. Additionally, we agree with commenters that due to the high cost of these drugs, without a pricing adjustment to plan liability, issuers would be overcompensated for the Hepatitis C RXC in the 2020 benefit year and could be incentivized to “game” risk adjustment or encourage overprescribing practices. We appreciate the commenters' view that plans generally do not influence prescribing patterns. However, to avoid perverse incentives to influence overprescribing behavior, we are finalizing the pricing adjustment as proposed. This pricing adjustment leads to Hepatitis C RXC coefficients that better reflect anticipated actual 2020 benefit year plan liability associated with Hepatitis C drugs.
As such, we are finalizing our proposed pricing adjustment to make a pricing adjustment to more closely reflect the expected average additional plan liability of the Hepatitis C RXC for the 2020 benefit year. In making this determination, we consulted our clinical experts to assess whether the lower cost Hepatitis C drugs are substitutable to ensure that plans that cover various treatments would continue to be compensated for their incremental plan liability. We found that due to the generic entrant, prices for all variations of Hepatitis C drugs are expected to be significantly lower in the 2020 benefit year than those observed in the currently available datasets (which reflect prior benefit years). We believe this approach to estimating the Hepatitis
We did not propose and are not making any change to the current enrollment duration factors used in the adult risk adjustment models at this time. Our goal is to continue to analyze enrollee-level EDGE data; we will consider proposing changes to how partial year enrollees are accounted for in the risk adjustment models for future benefit years in notice-and-comment rulemaking. We intend to solicit feedback and recommendations in the future for potential updates to how partial year enrollees are accounted for in the risk adjustment models, including adjustments to the enrollment duration factors and the use of separate enrollment duration factors for individual and small group markets and may consider whether such factors should be incorporated in the child models.
HHS finalized a high-cost risk pool adjustment in the 2018 Payment Notice to account for the incorporation of risk associated with high-cost enrollees in the HHS risk adjustment models.
Additionally, beginning with the 2018 benefit year, we added to the HHS risk adjustment methodology additional transfer terms to reflect the payments and charges assessed for the high-cost risk pool. To account for costs associated with exceptionally high-risk enrollees, we added transfer terms (a payment term and a charge term) that are calculated separately from the state payment transfer formula in the HHS-operated risk adjustment transfer methodology. Beginning for the 2018 benefit year, we finalized the addition of a term that reflects 60 percent of costs above $1 million (
Similar to the 2019 benefit year, consistent with the proposed adoption of the same high-cost risk pool parameters (that is, a $1 million threshold and 60 percent coinsurance rate), we proposed to add a term that would reflect 60 percent of costs above $1 million (
We are finalizing the high-cost risk pool parameters and the additional terms to account for the high-cost risk pool in the risk adjustment transfer methodology as proposed for the 2020 benefit year and for future benefit years unless changed in notice-and-comment rulemaking. The following is a summary of the public comments we received on our proposal on the high-cost risk pool parameters and how to account for the high-cost risk pool in the risk adjustment transfer methodology.
We also believe that maintaining the same threshold and coinsurance rate from year-to-year will help promote stability and predictability for issuers, and for all of these reasons, we are finalizing the $1 million threshold and 60 percent coinsurance rate for 2020 benefit year and beyond without requiring notice and comment on the high-cost risk pool thresholds each year. We intend to release information about the 2018 benefit year high-cost risk pool payment amounts, and the percent of premium charged by the high-cost risk pool in the 2018 benefit year summary risk adjustment report released under § 153.310(e), and would follow a similar approach for future benefit years. We appreciate the comments suggesting various potential changes to the high-cost risk pool methodology. Once we have results and experience from the initial years of the high-cost risk pool in the HHS risk adjustment program, we intend to analyze those results including considering the geographic variation within those results. If we were to seek to make changes to these parameters for benefit years beyond 2020, we would do so through notice-and-comment rulemaking prior to any changes being implemented.
We encourage states considering a state-based reinsurance program to consider the interplay between the high-cost risk pool adjustment in the HHS-operated risk adjustment program and any state-based reinsurance program. We have provided technical guidance to states considering state-based reinsurance programs to assist them in designing such programs in a manner that avoids double compensating for costs that would otherwise be compensated under the risk adjustment methodology, including the high-cost risk pool adjustment.
The factors resulting from the equally weighted blended factors from the 2015 MarketScan® data and the 2016 and 2017 enrollee-level EDGE data separately solved models, including the finalized constraints for the Hepatitis C RXC coefficient, are shown in Tables 1, 3, and 4. For the purposes of the below coefficients, the adult, child, and infant models have been truncated to account for the high-cost risk pool payment parameters by removing 60 percent of costs above the $1 million threshold.
Table 1 contains factors for each adult model, including the age-sex, HCCs, RXCs, RXC-HCC interactions, and enrollment duration coefficients. Table 2 contains the HHS HCCs in the severity illness indicator variable. Table 3 contains the factors for each child model. Table 4 contains the factors for each infant model. Tables 5 and 6 contain the HCCs included in the infant model maturity and severity categories, respectively.
We proposed to continue including an adjustment for the receipt of cost-sharing reductions (CSRs) in the risk adjustment models to account for increased plan liability due to increased utilization of health care services by enrollees receiving CSRs in all 50 states and the District of Columbia. For the 2020 benefit year, to maintain stability and certainty for issuers, we proposed to maintain the CSR factors finalized in the 2019 Payment Notice.
Consistent with the approach finalized in the 2017 Payment Notice,
To evaluate risk adjustment model performance, we examined each model's R-squared statistic and predictive ratios. The R-squared statistic, which calculates the percentage of individual variation explained by a model, measures the predictive accuracy of the model overall. The predictive ratios also measure the predictive accuracy of a model for different validation groups or subpopulations. The predictive ratio for each of the HHS risk adjustment models is the ratio of the weighted mean predicted plan liability for the model sample population to the weighted mean actual plan liability for the model sample population. The predictive ratio represents how well the model does on average at predicting plan liability for that subpopulation. A subpopulation that is predicted perfectly will have a predictive ratio of 1.0. For each of the HHS risk adjustment models, the R-squared statistic and the predictive ratios are in the range of published estimates for concurrent risk adjustment models.
We defined the calculation of plan average actuarial risk and the calculation of payments and charges in the Premium Stabilization Rule. In the 2014 Payment Notice, we combined those concepts into a risk adjustment state payment transfer formula.
The risk adjustment state payment transfer formula generally calculates the difference between the revenues required by a plan, based on the health risk of the plan's enrollees, and the revenues that the plan can generate for those enrollees. These differences are then compared across plans in the state market risk pool and converted to a dollar amount based on the statewide average premium. HHS chose to use statewide average premium and normalize the risk adjustment state payment transfer formula to reflect state average factors so that each plan's enrollment characteristics are compared to the state average and the calculated payment amounts equal calculated charges in each state market risk pool. Thus, each plan in the risk pool receives a risk adjustment payment or charge designed to compensate for risk for a plan with average risk in a budget-neutral manner. This approach supports the overall goals of the risk adjustment program, which are to encourage issuers to rate for the average risk in the applicable state market risk pool, to stabilize premiums, and to avoid the creation of incentives for issuers to operate less efficiently, set higher prices, or develop benefit designs or create marketing strategies to avoid high-risk enrollees. Such incentives could arise if we used each issuer's plan's own premium in the risk adjustment state payment transfer formula, instead of statewide average premium.
In the absence of additional funding, we established through notice-and-comment rulemaking
In light of the budget-neutral framework, HHS uses statewide average premium as the cost-scaling factor in the state payment transfer formula under the HHS-operated risk adjustment methodology, rather than a different parameter, such as each plan's own premium, which would not have automatically achieved equality between risk adjustment payments and charges in each benefit year. As set forth in prior discussions,
In the HHS risk adjustment transfer methodology, the state payment transfer formula is designed to provide a per member per month (PMPM) transfer amount. The PMPM transfer amount derived from the state payment transfer formula is multiplied by each plan's total billable member months for the applicable benefit year to determine the payment due to or charge owed by the issuer for that plan in a rating area. The payment or charge under the state payment transfer formula is thus calculated to balance the state market risk pool in question.
Although we did not seek comment on this topic, we summarize and respond to the comments on statewide average premium and plan's own premium received in response to the proposed rule below. Given the volume of exhibits, court filings, white papers (including all corresponding exhibits), and comments on other rulemakings incorporated by reference, we are not able to separately address each of those documents. Instead, we summarize and respond to the significant comments and issues raised by the commenters that are within the scope of this rulemaking.
Some commenters opposed the use of statewide average premiums. These commenters stated that the current risk adjustment state payment transfer formula's use of statewide average premiums penalizes efficient plans, and is a biased estimate of enrollee medical costs and actuarial risk that perversely penalize efficient, high-performing issuers. These commenters requested that HHS adopt alternatives to the existing risk adjustment methodology. One commenter supported the use of each plan's own premium as the cost scaling factor. This commenter stated that the risk adjustment state payment transfer formula does not need to operate as budget neutral, as section 1343 of the PPACA does not require that the program be budget neutral, and funds are available to HHS for the risk adjustment program from the CMS Program Management account to offset any potential shortfalls. The commenter also disagreed with HHS' rationale for using statewide average premium to achieve budget neutrality, and stated that even if budget neutrality is required, any risk adjustment payment shortfalls that may result from using a plan's own premium in the state payment transfer formula could be addressed through pro rata adjustments to risk adjustment transfers. This commenter further stated that use of statewide average premium is not predictable for issuers trying to set rates and compared the predicted risk adjustment results issuers set out in their respective rate filings with HHS' published actual risk adjustment results for a state, concluding that the risk adjustment program is failing to achieve its goal because its analysis found that issuers are failing to accurately forecast their risk adjustment results in their rate filings.
Conversely, other commenters expressed concerns about alternatives to statewide average premium. One commenter specifically opposed using a plan's own premium stating that it would undermine the risk adjustment program, create incentives for issuers to avoid enrolling high-cost individuals, and would not automatically balance transfers to zero. This commenter noted that the PPACA's risk adjustment statute requires states, or HHS on behalf of the states, to assess a charge on plans with lower than the average actuarial risk in the state market risk pool, and to make payments to plans with higher than the average actuarial risk in the state market risk pool. This commenter also agreed that absent Congressional action to appropriate additional funds, the risk adjustment program must operate in a budget-neutral manner. Additionally, the commenter concurred that if HHS were to require states operating their own risk adjustment programs to operate the programs to cover any shortfall between collections and payments for a benefit year, HHS would be effectively imposing an unfunded mandate on states. This commenter noted that analyses by the American Academy of Actuaries and Oliver Wyman indicated that the risk adjustment program is working as intended by compensating issuers that enroll higher-than-average risk enrollees and protecting against adverse selection.
As we detailed in the 2018 Payment Notice and the 2017 and 2018 Risk Adjustment Final Rules,
Some comments suggested proposed improvements to the HHS risk adjustment program generally. A few commenters expressed a desire for broad risk adjustment changes, including an exemption for new and fast-growing plans from risk adjustment for 3 to 5 years, applying a credibility-based approach to participation in risk adjustment based on membership size or market share, and placing an upper bound on the amount of a plan's risk adjustment transfer charge or using two-stage adult models that HHS proposed in the 2018 Payment Notice proposed rule. One commenter suggested HHS look at steps some states have taken to correct market distortions and consider the possibility of incorporating similar changes into the HHS risk adjustment models and state payment transfer formula. One commenter noted that HHS is aware of risk adjustment bias, has acknowledged its distortion, and has ignored the “fix” to switch the risk scores that were used by HHS with risk scores that more accurately represent the actual HCC costs or adopt another model that would eliminate estimated bias. This commenter also suggested HHS give states the option, at their discretion, to use a graduated cap on risk adjustment charges to reduce volatility and increase predictability of results, to establish a cap based on a percentage of premium to protect small issuers from the impact of large risk adjustment charges, or to allow states to consider structures in which caps shift at smaller more graduated intervals based on issuer size, to lower the risk that small enrollment shifts will tip an issuer between various caps.
We continuously evaluate whether improvements are needed to the HHS risk adjustment methodology, and will continue to do so as additional years' data become available. For example, beginning with the 2018 benefit year, we adopted a 14 percent reduction to the statewide average premium to account for administrative costs that are unrelated to the claims risk of the enrollee population.
However, at this time, we decline to amend the risk adjustment methodology to include a CME index or a similar care coordination adjustment. As we previously noted,
In addition, there are many reasons why an issuer could have lower-than-average premiums. For example, the low premium could be the result of efficiency, mispricing, a strategy to gain market share, or some combination thereof. As such, we disagree with the comment that the risk adjustment state payment transfer formula unfairly results in enrollees that choose narrow networks subsidizing enrollees in broader networks, including enrollees in plans issued by dominant carriers. Networks are just one of many plan design characteristics that are captured through the use of the statewide average premium in the state payment transfer formula, which is designed to discourage the creation of plan designs and marketing strategies to avoid high-risk enrollees, in keeping with the goals of the risk adjustment program. Thus, to the extent certain plan network designs attract sicker-than-average enrollees, the risk adjustment program assesses the level of risk and compensates those plans for the incremental risk.
We have previously considered other model changes, including the adoption of a two-stage adult model. Specifically, as discussed in the 2018 Payment Notice proposed rule,
We continue to evaluate ways to improve the risk prediction of the HHS risk adjustment models under various approaches to model estimation that might more precisely account for the non-linearities in plan liability as referenced in the 2016 Risk Adjustment White Paper.
We continue to evaluate alternative modeling approaches while considering several important trade-offs between making improvements to risk prediction and the year-to-year predictability of the models. We also are examining any shortcomings of the potential alternatives that include additional complexity, lack of transparency, and potential upcoding incentives. For example, because issuers would receive an incremental additional factor for coding another HCC, there might be an incentive for upcoding, particularly with a count model. We believe that these alternative approaches require further investigation prior to making any of these types of changes to the models. For these reasons, we intend to solicit comments in the future on potential proposed improvements to the current models, as well as alternative modeling methods involving either non-linear or count models for potential use in future benefit years of HHS-operated
In the 2019 Payment Notice, we provided states the flexibility to request a reduction to the otherwise applicable risk adjustment transfers calculated under the HHS-operated risk adjustment methodology, which is calibrated on a national dataset, for the state's individual, small group, or merged markets, by up to 50 percent to more precisely account for differences in actuarial risk in the applicable state's market(s). We finalized that any requests received will be published in the respective benefit year's proposed notice of benefit and payment parameters, and the supporting evidence for the request will be made available for public comment.
In accordance with § 153.320(d)(2), beginning with the 2020 benefit year, states must submit such requests with the supporting evidence and analysis outlined under § 153.320(d)(1) by August 1st of the calendar year that is 2 calendar years prior to the beginning of the applicable benefit year. If approved by HHS, state reduction requests will be applied to the plan PMPM payment or charge transfer amount (T
We proposed to amend § 153.320(d)(3) to add language to provide that if the state requests that HHS not make publicly available certain supporting evidence and analysis because it contains trade secrets or confidential commercial or financial information within the meaning of the HHS Freedom of Information Act (FOIA) regulations at 45 CFR 5.31(d), HHS will do so, making available on the CMS website only the supporting evidence submitted by the state that is not a trade secret or confidential commercial or financial information. Similar to the rate review program established under section 2794 of the PHS Act, HHS would release only information that is not a trade secret or confidential commercial or financial information as defined under the HHS FOIA regulations.
We are finalizing our amendment to § 153.320(d)(3) to add language to provide that if the state requests that HHS not make publicly available certain supporting evidence and analysis because it contains trade secrets or confidential commercial or financial information within the meaning of the HHS FOIA regulations at 45 CFR 5.31(d), HHS will make available on the CMS website only the supporting evidence submitted by the state that is not a trade secret or confidential commercial or financial information by posting a redacted version of the state's supporting evidence. In light of comments received, we are not finalizing our proposal to apply requests for individual market risk adjustment transfer reductions to both the catastrophic and non-catastrophic individual market risk pools within the state, unless the state requested otherwise.
For the 2020 benefit year, HHS received a request to reduce risk adjustment transfers for the Alabama small group market by 50 percent. Alabama's request states that the presence of a dominant carrier in the small group market precludes the HHS-operated risk adjustment program from working as precisely as it would with a more balanced distribution of market share. The state regulators stated that their review of the risk adjustment payment issuers' financial data suggested that any premium increase resulting from a reduction to risk adjustment payments of 50 percent in the small group market for the 2020 benefit year will not exceed 1 percent, the
The following is a summary of the public comments we received on our proposals regarding state flexibility requests under § 153.320(d), and on Alabama's 2020 benefit year reduction request.
We reviewed Alabama's supporting evidence regarding the state's unique small group market dynamics that it believes warrant an adjustment to the HHS calculated risk adjustment small group market transfers for the 2020 benefit year. Alabama provided information demonstrating the presence of a dominant carrier in the small group market precludes the HHS-operated risk adjustment transfer methodology from working as precisely as it would with a more balanced distribution of market share. Alabama state regulators noted they do not assert that the HHS formula is flawed, only that it results in imprecise results in the state's small group market that could further reduce competition and increase costs for consumers. The state regulators also provided information demonstrating that the request would have a
Based on our review, we agree that any necessary premium increase for issuers likely to receive payments as a result of a 50 percent reduction to risk adjustment transfers in the Alabama small group market for the 2020 benefit year would not exceed 1 percent. HHS has determined that the state has demonstrated the existence of relevant state-specific factors that warrant an adjustment to more precisely account for relative risk differences and that the adjustment would have a
We also note that state regulators seeking a reduction to risk adjustment transfers in the state's individual catastrophic risk pool, individual non-catastrophic risk pool, small group market or a merged market for the 2021 benefit year should submit supporting materials to HHS as established under § 153.320(d). We will review any requests received on an annual basis, will make the supporting evidence publicly available for comment in the proposed notice of benefit and payment parameters for the respective benefit year, and will consider the relevant comments in our review of the state request for the applicable benefit year.
Although the proposed HHS risk adjustment transfer methodology for the 2020 benefit year is unchanged from what was finalized in the 2019 Payment Notice (83 FR 16954 through 16961), we believe it is useful to republish the calculation in its entirety. Additionally, we are republishing the description of the administrative cost reduction to the statewide average premium and high-cost risk pool factors, although these factors and terms also remain unchanged in this final rule.
The denominator will be summed across all risk adjustment covered plans in the risk pool in the market in the state.
The difference between the two premium estimates in the state payment transfer formula determines whether a plan pays a risk adjustment charge or receives a risk adjustment payment. The value of the plan average risk score by itself does not determine whether a plan will be assessed a charge or receive a payment—even if its risk score is greater than 1.0, it is possible that the plan will be assessed a charge if the premium
We defined the cost scaling factor, or the statewide average premium term, as the sum of the average premium per member month of plan i (P
The high-cost risk pool adjustment amount will be added to the state payment transfer formula to account for: (1) The payment term, representing the portion of costs above the threshold reimbursed to the issuer for high-cost risk pool payments (
The total plan transfers for a given benefit year will be calculated as the product of the plan PMPM's transfer amount (T
As we noted above, we approved Alabama's small group market reduction request for the 2020 benefit year. The approved reduction percentage (50 percent) will be applied to the 2020 benefit year plan PMPM payment or charge transfer amount (T
In the 2018 Payment Notice,
In the 2018 Payment Notice, we also stated that we would consider using this enrollee-level EDGE data in the future to calibrate other HHS programs in the individual and small group markets, and to produce a public use file to help governmental entities and independent researchers better understand these markets. We noted that a public use file derived from these data would be de-identified in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) requirements, would not include proprietary issuer or plan identifying data, and would adhere to HHS rules and policies regarding protected health information (PHI) and personally identifiable information (PII). We also described in guidance the data elements in the enrollee-level EDGE data set and
Under the HIPAA safe harbor for de-identification of data at 45 CFR 164.514(b)(2), public use files are considered de-identified if they exclude 18 specific identifiers that could be used alone or in combination with other information to identify an individual who is a subject of the information. To make the enrollee-level EDGE data available as a public use file that comports with the requirements of § 164.514(b)(2), we would have to remove dates (other than the year) and ages for enrollees ages 90 or older,
Thus, in the proposed rule, we proposed to create and make available by request a limited data set file rather than a public use file, as we believe a limited data set file will be more useful to requestors for research, public health, or health care operations purposes. We noted that, under this proposal, we would make enrollee-level EDGE data, beginning with the 2016 benefit year, available as a “limited data set” file under § 164.514(e). This limited data set file would not include the direct identifiers of the individual or of relatives, employers, or household members of the individual, which are required to be removed under the limited data set definition at § 164.514(e)(2) and which issuers do not submit to their EDGE servers. We also proposed to limit disclosures of the limited data set to requestors who seek these data for research, public health, or health care operations purposes, as those terms are defined under § 164.501. We stated that we would require qualified requestors to sign a data use agreement to ensure these data will be maintained, used, and disclosed only as permitted under the HIPAA Privacy Rule, and to ensure that any inappropriate uses or disclosures are reported to HHS. We noted that HHS components would also be able to request the limited data set file for research, public health, or health care operations purposes, as those terms are defined under § 164.501. We also clarified that, if the proposal is finalized, we would make a limited data set file available on an annual basis, reflecting enrollee-level data from the most recent benefit year available on EDGE servers. We stated that if we finalize the proposal to make a limited data set file available, HHS would not offer a public use file based on the enrollee-level EDGE data. We sought comment on this proposal.
In addition, we explained in the proposed rule that we received feedback in response to the guidance describing the data elements to be made available as part of the public use file for research requests
We also sought specific comment on the other data elements outlined in the proposed rule that commenters requested be part of the enrollee-level EDGE dataset, but that issuers do not currently submit to their EDGE servers (for example, enrollees' income level, provider identifier, provider's geographic location, hashed claim identifier,
Finally, we proposed to extend the use of enrollee-level EDGE data and reports extracted from issuers' EDGE servers (including data reports and ad hoc querying tool reports) to calibrate and operationalize our individual and small group (including merged) market programs (for example, the HHS-operated risk adjustment program, the AV calculator and methodology, and the out-of-pocket calculator), as well as to conduct policy analysis for the individual and small group (including merged) markets (for example, to assess the market impacts of policy options being deliberated). We explained that we believe these additional uses of the enrollee-level EDGE data would enhance our ability to develop and set policy for the individual and small group (including merged) markets and avoid burdensome data collections from issuers.
To further our commitment to increasing transparency in health care markets and help the public better understand these markets, we are finalizing our proposal with one modification. Under our final policy, we will create and make available, on an annual basis, enrollee-level EDGE data as a limited data set file for qualified requestors who seek these data for research purposes. We will not make this limited data set available to requestors for public health or health care operations activities. While these purposes are permitted by the HIPAA Privacy Rule, in light of comments received and HHS' operational limitations, HHS will not make this limited data set file available to requestors for public health or health care operations activities at this time. We note that we may consider exploring the use of the public health and heath care operations pathways for making the limited data set file available in the future. We did not propose to extract state and rating area information from issuers' EDGE servers or collect additional data elements, and based on comments received, at this time, we do not believe the benefits from additional data element extractions or collections would outweigh the costs of potential increased risk to issuers' proprietary information and increased issuer burden. As noted in the proposed rule, we will include the grouped claims identifier beginning with the 2017 benefit year enrollee-level EDGE limited data set file, as that is the first year that data element is available. We are finalizing our proposal to allow HHS to use the enrollee-level EDGE data and reports extracted from issuers' EDGE servers (including data reports and ad hoc querying tool reports) to calibrate and operationalize our individual and small group (including merged) market programs, including to conduct recalibration of the HHS risk adjustment program and to make updates to the AV Calculator, and to conduct policy analysis for the individual and small group (including merged) markets. We believe these additional uses of the enrollee-level EDGE data and reports will enhance our ability to develop and set policy for the individual and small group (including merged) markets and avoid burdensome data collections from issuers. We clarify that our policies regarding HHS uses of the enrollee-level EDGE data apply to the HHS components that currently receive and use such data for purposes of the HHS risk adjustment program. As we stated in the proposed rule, other HHS components will be able to request the EDGE limited data set file for research purposes, as that term is defined under § 164.501. We also note that the enrollee-level EDGE data may be subject to disclosure as otherwise required by law.
We agree with commenters that using geographic information for the AV Calculator and methodology is neither required nor would enhance the current methodology. For AV Calculator and methodology updates in future years, we will continue to use enrollee-level EDGE data in its current format (without the state or rating area information).
HHS may use the enrollee-level EDGE data to help inform which of various policies related to the individual and small group (including merged) markets will further HHS' goals to promote transparency, support innovation in the private sector, reduce burden on stakeholders, and improve program integrity. Generally, policies that could be informed by these data would be developed or revised through the notice-and-comment rulemaking process. We do not believe using the enrollee-level EDGE data and reports extracted from issuers' EDGE servers for the purposes we have outlined is inconsistent with the intent of using a distributed data environment for the HHS operated risk adjustment program. In the 2014 payment notice, we finalized the distributed data model for data collection for the risk adjustment and reinsurance programs when HHS operates those programs on behalf of a State.
As described below, we are finalizing a change to the timeline for publication of the 2017 benefit year risk adjustment data validation results and the
As noted in this rule, if a state is not approved to operate, or chooses to forgo operating its own risk adjustment program, HHS will operate a risk adjustment program on its behalf. For the 2020 benefit year, HHS will operate a risk adjustment program in every state and the District of Columbia. As described in the 2014 Payment Notice,
OMB Circular No. A-25R established federal policy regarding user fees, and specified that a user charge will be assessed against each identifiable recipient for special benefits derived from federal activities beyond those received by the general public. The risk adjustment program will provide special benefits as defined in section 6(a)(1)(B) of Circular No. A-25R to issuers of risk adjustment covered plans because it mitigates the financial instability associated with potential adverse risk selection. The risk adjustment program also contributes to consumer confidence in the health insurance industry by helping to stabilize premiums across the individual, merged, and small group markets.
In the 2019 Payment Notice,
We estimated the total cost for HHS to operate the risk adjustment program for the 2020 benefit year to be approximately $50 million, and the risk adjustment user fee would be $2.16 per billable member per year, or $0.18 PMPM. The updated cost estimates attribute all costs related to the EDGE server data collection and data evaluation (quantity and quality evaluations) activities to the risk adjustment program rather than sharing them with the reinsurance program, which is no longer operational.
We received one comment on the proposed risk adjustment user fee for the 2020 benefit year, which supported our proposal to establish a risk adjustment user fee for the 2020 benefit year of $2.16 per billable member per year, or $0.18 PMPM. We are finalizing the risk adjustment user fee rate for the 2020 benefit year as proposed.
We conduct risk adjustment data validation under §§ 153.630 and 153.350 in any state where HHS is operating risk adjustment on the state's behalf, which for the 2020 benefit year is all 50 states and the District of Columbia. The purpose of risk adjustment data validation is to ensure issuers are providing accurate and complete risk adjustment data to HHS, which is crucial to the purpose and
The following is a summary of the general public comments we received related to risk adjustment data validation requirements when HHS operates risk adjustment. Additional comments related to the error estimation methodology and negative error outliers are discussed later in this rule.
In the 2014 Payment Notice, we established the risk adjustment data validation program that HHS uses when operating risk adjustment on behalf of a state. Consistent with § 153.350(a), HHS is required to ensure proper validation of a statistically valid sample of risk adjustment data from each issuer that offers at least one risk adjustment covered plan in that state. The current enrollee sample size selected for the initial validation audit is 200 enrollees statewide (that is, combining an issuer's individual, small group, and merged market enrollees (as applicable) in risk adjustment covered plans in the state) for each issuer's Health Insurance Oversight System (HIOS) ID, based on sample size precision analyses we conducted using proxy data from the Medicare Advantage program. Those analyses calculated a range of sample sizes to target a 10 percent precision at a 95 percent confidence level. The resulting range of sample sizes were between 100 and 300, and we selected 200 as a midpoint.
The current initial validation audit sample size of 200 was selected to achieve an estimated 10 percent precision, assuming a distribution of risk score errors similar to that found in the Medicare Advantage risk adjustment data validation program. However, since the HCC group failure rate approach to error estimation (referred to as the HCC failure rate methodology) was implemented beginning with the 2017 benefit year of risk adjustment data validation, we anticipate that the calculated precision would differ from the estimate we used, which was based on the Medicare Advantage error rate data. Therefore, beginning with the 2019 benefit year of risk adjustment data validation,
After consideration of the comments submitted, we are not finalizing any increase to the initial validation audit sample size at this time. We will continue to consider potential changes to initial validation audit sample sizes for future benefit years of risk adjustment data validation. We may revisit these proposals, and may also consider additional alternatives, following further consultation with stakeholders and further analysis of actual enrollee data and non-pilot year risk adjustment data validation results.
However, many other commenters did not support the proposal to vary sample size based on HCC failure rates, sample precision, and issuer size. One commenter stated HHS should only do so once there is sufficient credible experience with the HHS risk adjustment data validation program, citing concerns with making such changes based on 2017 benefit year data validation results, the first non-pilot risk adjustment data validation year under the HHS program. Another commenter did not support this proposal as they stated it effectively disincentives issuers from focusing on reducing their HCC failure rate because any issuer that is an outlier below the confidence interval threshold would be penalized by an increased sample size. The same commenter also noted the potential for annual variation in sample size would make it difficult for issuers to plan for staffing and resource needs.
Other commenters did not support varying the sample size based only on issuer size, expressing concerns over undue administrative burden related to obtaining medical records and substantiating diagnoses, the financial burden of increased administrative costs, and the resulting disruption to plans and the provider community without improving the quality of the data validation results. Yet another commenter stated that until electronic health record interoperability and widespread data sharing is implemented, increasing the sample size would create undue administrative burden.
Another commenter opposed allowing issuers to request a larger sample size, stating that allowing such requests could provide opportunities for issuers to intentionally affect the data validation results of other issuers and disproportionately affect HCC failure rates and confidence intervals.
Several commenters suggested alternative approaches to vary the initial validation audit sample size. One commenter suggested adopting sample sizes based on statistical significance with a 90 percent confidence interval and suppression of positive outlier resampling for issuers that have demonstrated a low HCC error rate over multiple years. Another commenter stated HHS should replace the current random sample of 200 enrollees with a data-driven targeted process that identifies situations that warrant investigation. Another commenter recommended HHS evaluate ways to ensure providers' timely submission of the needed information and documentation to validate the diagnoses captured on the medical record(s). Another commenter did not agree that HHS should continue to use the Medicare Advantage risk score error rate data to determine precision, and recommended that HHS use the available commercial risk adjustment data starting with the 2020 benefit year of risk adjustment data validation. Another commenter stated that if larger sample sizes were adopted, issuers with plans in multiple states should be given the option to use the existing sample sizes for the initial validation audit.
In the initial years of risk adjustment data validation, we constrained the “10th stratum” of the initial validation audit sample—that is, enrollees without HCCs selected for the initial validation audit sample—to be one-third of the sampled initial validation audit enrollees. Under this current approach, the remaining 9 age-risk strata were selected using a Neyman allocation
In the proposed rule, we proposed to extend the Neyman allocation sampling methodology to also include the 10th stratum of enrollees without HCCs, such that samples will be assigned to all 10 strata using a Neyman allocation. Since a Neyman allocation approach is expected to provide a more optimal sample size allocation, we explained that we believe using the Neyman allocation for all strata would optimize issuers' initial validation samples and yield better precision than the one-third/two-thirds approach currently used in the enrollee initial validation audit sample. Further, an approach that permits for a larger portion of the sample to be allocated to the HCC strata as compared to the two-thirds allocation used in the current approach would result in a more robust HCC sample in support of the measurement of HCC failure rates under the HCC failure rate methodology finalized in the 2019 Payment Notice.
Under § 153.630(d)(2), issuers have 30 calendar days to confirm the findings of the second validation audit or the calculation of the risk score error rate, or file a discrepancy report, in the manner set forth by HHS, to dispute the foregoing. We proposed to amend paragraph (d)(2) to shorten the window to confirm the findings of the second validation audit (if applicable) or the calculation of the risk score error rate, or file a discrepancy, to within 15 calendar days of the notification by HHS, beginning with the 2018 benefit year risk adjustment data validation. In light of comments received, we will not shorten the timeframe under § 153.630(d)(2) to 15 calendar days at this time, and will maintain the existing 30-calendar day window for issuers to confirm the findings of the second validation audit (if applicable) or the calculation or the risk score error rate.
We also clarified in the proposed rule that there are two discrepancy reporting windows under § 153.630(d)(2). First, at the conclusion of the second validation audit, we will distribute to issuers their second validation audit findings in the event there is insufficient agreement between the initial and second validation audit results during the pairwise means analysis, and the second validation audit findings will be used for the risk score error rate calculation. The window for issuers who receive second validation audit findings to confirm the findings or file a discrepancy, in a manner set forth by HHS, would begin when the second validation audit findings reports are issued. Second, at the conclusion of the risk score error rate calculation process, we will distribute the risk score error rate calculation results to all issuers for the given benefit year. Once the risk score error rate calculation results are distributed, the window to confirm the results or file a discrepancy, in the manner set forth by HHS, would begin.
We reiterated, consistent with the approach finalized in the 2018 Payment Notice, that issuers are not permitted to appeal the resolution of any discrepancy disputing the initial validation audit sample, or to file a discrepancy or appeal the results of the initial validation audit.
Finally, we proposed to amend § 153.630(d)(2) to replace the phrase “audit and error rate” for which an issuer must confirm or file a discrepancy that appears at the end of the provision with “the findings of the second validation audit (if applicable) or the calculation of a risk score error rate as a result of risk adjustment data validation.” We are finalizing the amendments to § 153.630(d)(2) as proposed, except for the proposed shortening of the applicable timeframe from 15 to 30 calendar days.
The following is a summary of the public comments we received on our proposals regarding the second validation audit findings and risk score error rate discrepancy reporting windows under § 153.630(d)(2).
Under § 153.630(b)(10), if an issuer of a risk adjustment covered plan fails to engage an initial validation auditor or submit initial validation audit results, we impose a “default data validation charge,” which the regulation currently refers to in paragraph (b)(10) as a “default risk adjustment charge.” As explained in the 2015 Payment Notice, the default data validation charge is calculated in the same manner as the default risk adjustment charge under § 153.740(b).
In the 2015 Payment Notice at 79 FR 13790, we provided that
Third, we proposed to amend the allocation approach for distribution of default data validation charges among issuers. We proposed to allocate a default data validation charge to the risk adjustment data validation issuers that were part of the same benefit year risk pool(s) as the noncompliant issuer. However, we would not allocate default data validation charges to any other noncompliant issuers in the same benefit year risk pool(s). This approach is consistent with the methodology for allocating the default risk adjustment charges under § 153.740(b), and includes all issuers in the same benefit year risk pool(s) that could be subject to a risk score adjustment as the result of other issuers' risk adjustment data validation results. Issuers in the same benefit year risk pool(s) that are exempt from the risk adjustment data validation requirements would also be included in the allocation of any default data validation charges. Therefore, we proposed to allocate any default data validation charges collected from noncompliant issuers among the compliant and exempt issuers in the same benefit year risk pool(s) in proportion to their respective market shares and risk adjustment transfer amounts for the benefit year being audited for risk adjustment data validation.
As an illustrative example, assume there are 4 issuers (A, B, C, and D) in the individual non-catastrophic risk pool in state X for the 2017 benefit year, and an additional issuer, E, in the 2018 benefit year individual non-catastrophic risk pool in state X. Assume:
• Issuer A does not comply with risk adjustment data validation requirements for the 2017 benefit year and is assessed a default data validation charge.
• Issuer B was exempt from risk adjustment data validation for the 2017 benefit year because it was a small issuer (that is, it had 500 or fewer billable member months statewide in state X).
• Issuers C and D complied with applicable 2017 benefit year risk adjustment data validation requirements.
• Issuer E was not in the individual non-catastrophic risk pool in state X for 2017.
Issuer A's default data validation charge would be allocated to issuers B, C, and D in proportion to their 2017 benefit year transfer amounts and market shares. While Issuer B was not subject to risk adjustment data validation for the 2017 benefit year, it was still part of the same state market risk pool and would be subject to possible risk score adjustments due to the risk adjustment data validation results of Issuers C and D. Since Issuers C and D also participated in the individual non-catastrophic risk pool in state X for 2017 and complied with applicable data validation requirements, they would also receive part of Issuer A's default data validation charge. However, Issuer E was not part of the individual non-catastrophic risk pool in state X until the 2018 benefit year, and therefore, would not receive any part of Issuer A's 2017 benefit year default data validation charge.
In the proposed rule, we noted that we intend to publish the default data validation charge information in the benefit year's report(s) released under § 153.310(e) in which transfers are adjusted based on risk adjustment data validation results. We also explained that, following release of the report under § 153.310(e), these amounts would then be included as part of the monthly payment and collection processes described in § 156.1215 alongside the collection of risk adjustment charges and payments calculated under the HHS risk adjustment methodology for the applicable benefit year.
Fourth, we clarified that a default data validation charge under § 153.630(b)(10) is separate from risk adjustment transfers for a given benefit year, unlike a default risk adjustment charge under § 153.740(b), which replaces the issuer's transfer amount for that benefit year. For example, if an issuer fails to submit initial validation audit results for the 2017 benefit year, it would receive a default data validation charge based on 2017 benefit year data calculated in accordance with the formula outlined in this final rule. This default data validation charge for the 2017 benefit year would be in addition to, and separate from, the issuer's 2018 benefit year risk adjustment payment or charge amount as calculated under the HHS-operated risk adjustment methodology. This means that an issuer may owe both a risk adjustment charge and a default data validation charge (for example, an issuer could owe a risk adjustment charge for the 2018 benefit year and a default data validation charge for the 2017 benefit year risk adjustment data validation). Similarly, an issuer may owe a default risk adjustment charge for a given benefit year, alongside a default data validation charge for the benefit year being audited (for example, an issuer could owe a default risk adjustment charge for the 2018 benefit year, as well as a default data validation charge for the 2017 benefit year).
We offered these proposals and clarifications about how HHS will assess and allocate the default data validation charge at this time to allow issuers to better understand the
We are finalizing the amendments to § 153.630(b)(10), as well as the proposed changes to the calculation and allocation of the default data validation charge, as proposed. As outlined further below, we are modifying the timing for publication, collection and distribution of the default data validation charges.
We clarify that if an issuer is in a state market risk pool with a noncompliant issuer in a given benefit year, and then exits the state market risk pool in the subsequent benefit year, it will still be eligible to receive its portion of the allocation from the noncompliant issuer's default data validation charge. This approach is consistent with the general policy established in the 2019 Payment Notice
In the 2014 Payment Notice, we provided that a second validation audit will be conducted by an entity retained by HHS to verify the accuracy of the findings of the initial validation audit.
Based on the results of the second validation audit for the 2016 risk adjustment data validation pilot year, we proposed to modify the statistical subsampling methodology to further expand the comparison of results between the initial and second validation audits. Specifically, when the larger subsample (of up to 100 enrollees) results indicate a statistically significant difference, we believe that further sampling by the second validation auditor is necessary and appropriate to determine whether the second validation audit results from the full sample should be used in place of the initial validation audit results. Therefore, we proposed that, if a statistically significant difference is found based on the second validation audit of the larger subsample (of up to 100 enrollees), HHS would expand its sample to the full initial validation audit sample to consider whether the second validation audit results of the full sample or the subsample (of up to 100 enrollees) results should be used in place of initial validation audit results. Allowing the further testing of the sample provides assurance and confidence in the second validation audit results and the associated error estimation rate that will ultimately be used to adjust risk scores and transfers.
To determine whether to expand the second validation audit to the full initial validation audit sample, we proposed to use a precision analysis. We proposed to use precision metrics, including the standard error and confidence intervals, to determine if the second validation audit review of the larger subsample (of up to 100 enrollees) is of high or low precision. If the results of the second validation audit precision analysis determined that the precision level is high, we proposed that HHS would use the second validation audit results for the larger subsample (of up to 100 enrollees) in place of the initial validation audit results for the error estimation and calculation of adjustments for plan average risk score, as applicable. However, if the second validation audit precision analysis for a larger subsample (of up to 100 enrollees) determined that the precision level was low, the second validation audit would expand and use the full initial validation audit sample of 200 enrollees for error estimation and calculation of adjustments for plan average risk score.
We are finalizing this approach as proposed.
In the proposed rule, we proposed several options for incorporating RXCs in the risk adjustment data validation processes beginning with the 2018 benefit year risk adjustment data validation. Because the incorporation of payment RXCs into the risk adjustment models for adults began with the 2018 benefit year, we discussed whether modification was appropriate to the error estimation methodology to take into account the RXC failure rates as part of the HHS risk adjustment data validation process and we proposed various ways to incorporate RXCs into risk adjustment data validation processes, including adding RXCs to the error estimation methodology by treating RXCs similar to HCCs.
The first proposal that we outlined would incorporate RXCs into the HCC failure rate methodology by adding each RXC as a separate factor, similar to an “HCC”, for classification into the low, medium, and high HCC groups determined by the national failure rates for each RXC. To apply this change to the error estimation methodology finalized in the 2019 Payment Notice, we proposed the definition of superscript
HHS would then create three “HCC/RXC” groups based on the HCC failure rates and RXC failure rates derived in the above calculation. These “HCC/RXC” failure rate groups would rank all HCC failure rates and RXC failure rates to assign each unique HCC and RXC in the initial validation audit samples to a high, medium, or low failure rate group. To assign each HCC and RXC to a “HCC/RXC” failure rate group, we proposed to use the current HCC failure rate ranking methodology that ranks each HCC/RXC failure rate divided into three groupings based on weighted total observations or frequencies of that HCC/RXC across all issuers' initial validation sample, or assigning HCCs and RXCs failure rates by taking into consideration the ranking of related HCCs and RXCs in the grouping. Under this approach, we would maintain a single classification for HCC and RXC high, medium, or low groups, instead of creating two separate classifications of RXCs and single component HCCs.
Alternatively, we proposed incorporating RXCs as a separate “HCC” grouping in the error estimation methodology. Under this approach, we would keep the 128 HCCs in the three groups, but combine all RXCs into an additional, fourth separate group. Therefore, separate RXC and HCCs groups would be created, and their failure rates would be computed within those four groupings. This approach to group RXCs would be the same as for HCC groupings, which is based on the failure rates
While we assumed that RXCs may be easier to validate, this proposed approach could take into consideration the potential differing failure rates within the RXC groupings as opposed to the single component HCC groupings, or isolate the RXC failure rates to a separate grouping from HCCs before applying those failure rates to the error rate calculation. This alternative approach would have also resulted in an additional grouping in the error estimation methodology, and having more groupings means that the number of groupings where it is possible for an issuer to be an outlier would increase. Further, in the event that all RXCs do not have similar, low failure rates, the confidence interval for an RXC-only group could be quite large, resulting in a significant difference between the outliers' failure rates to the group's failure rate mean, and by extension, could result in a larger failure rate adjustment factor for the RXC-only group.
In addition to adopting one of the above approaches to group RXCs as part of the error estimation methodology, we would also need to incorporate RXCs into the error rate calculation under the error estimation methodology. To do so, we proposed three alternative approaches to incorporate and adjust for RXCs and RXC-HCC interaction factors in the error rate calculation.
One option that we proposed to incorporate the RXCs in the error rate calculation was to add RXCs to the current methodology of calculating error rates, without accounting for any HCC-RXC interaction factors. To incorporate RXCs in the current error rate calculation under this option, we proposed to modify the formula to calculate an enrollee's adjustment
The purpose of this second alternative for incorporating RXCs in the error rate calculation was to capture the sampled enrollee's characteristics and interaction between the single component HCC and RXC that may provide a more accurate calculation than not accounting for any interaction between the single component HCC and RXC. However, this approach would have added an additional step to the error rate calculation, whereby the risk score coefficient for a condition would be adjusted by the interaction coefficients between the single component HCC and the RXC and would have taken into account the full interaction coefficient separately for the HCC and RXC, which may result in an over-adjustment for the interaction terms.
A third alternative to incorporating RXCs as part of the error rate calculation would be to adjust the risk score coefficient for a single component HCC and RXC by a modified interaction coefficient between the single component HCC and RXC indicator, if the coefficient exists. If there is no coefficient, the single component HCC and the RXC would not be adjusted by an interaction coefficient. This alternative approach was intended to capture a sampled enrollee's specific characteristics and interaction between HCC and RXC and modify the interaction such that the total adjustments are equal to the total interaction term value.
We also generally solicited comment on how to weight risk score coefficients and account for the interaction terms between the single component HCC and the RXCs in calculating the error rate under these alternative proposed approaches. Additionally, in the error estimation methodology finalized in the 2019 Payment Notice, we did not include the severity illness indicator interactions for HCCs as they can be triggered by multiple combinations of HCCs, which would be overly complex to implement. As part of our current evaluation of the impact of adjusting for the RXC-HCC interactions in the error estimation methodology, we also sought comment on whether we should similarly not adjust for the RXC-HCC interactions.
We solicited comment on all of these proposed approaches for incorporating RXCs into the error estimation methodology and error rate calculation, including whether we should consider alternative options.
Finally, as an alternative to the aforementioned proposed policies, we stated that we were also considering methods for incorporating RXCs (or all drugs) into the risk adjustment data validation process other than as part of the error estimation methodology and error rate calculation. We proposed an option to treat RXC errors as a data submission issue. Specifically, under this approach, we would incorporate RXCs or all drugs into risk adjustment data validation as a method of discovering materially incorrect EDGE server data submissions in the same or similar manner to how we address demographic and enrollment errors discovered during risk adjustment data validation.
After consideration of the comments received, we are finalizing an approach under which we will incorporate RXCs into risk adjustment data validation as a method of discovering materially incorrect EDGE server data submissions in a manner similar to how we address demographic and enrollment errors discovered during risk adjustment data validation, and will pilot the incorporation of these drugs into the risk adjustment data validation process for the 2018 benefit year. As a pilot year, the identification of RXC errors during the 2018 benefit year risk adjustment data validation process will not be used to adjust 2018 risk scores or transfers.
Additionally, in response to comments, we are finalizing a policy to treat the incorporation of RXCs into 2018 benefit year risk adjustment data validation as a pilot year to allow HHS and issuers to gain experience in validating RXCs before RXCs are used to adjust issuers' risk scores. This approach will also allow for HHS and issuers to primarily focus efforts and resources on validating HCCs in the 2018 benefit year risk adjustment data validation and understanding the first year of risk adjustment data validation results, which issuers will receive later this year (reflecting 2017 benefit year data validation results).
We believe that this type of approach to RXCs will be an effective approach for validating that issuers are providing accurate RXC claims information while limiting the burden on issuers and other stakeholders involved in the risk adjustment data validation process. Specifically, to validate RXCs in risk adjustment data validation, we will conduct a claims-based validation to evaluate the accuracy of RXC data submissions. Under this approach, similar to how we confirm demographic and enrollment data during the risk adjustment data validation process, we will not require the issuer to obtain a valid prescription for the RXC and will only subject issuers' source system documentation of pharmacy claims or medical claims to the initial validation auditor and second validation auditor review, thereby limiting the burden on issuers to validate the RXCs.
Furthermore, in a non-pilot year, we would only adjust issuer risk scores for RXC errors in cases where an issuer has materially incorrect EDGE server RXC data submissions, and these discovered RXC errors would be the basis for an adjustment to the applicable benefit year transfer amount for the state market risk pools in question. We will work with these issuers to resolve potential discrepancies in a manner similar to the EDGE data submission discrepancy process.
This approach will target materially incorrect RXC data and will not target an isolated RXC data error, which is similar to the goal of the error estimation methodology for HCCs finalized in the 2019 Payment Notice—to avoid adjusting all issuers' risk adjustment transfers for expected variation. The approach is also similar to how demographic and enrollment validation is occurring where the review involves the identification of errors that could result in the initiation of a discrepancy process for adjustments.
Under the risk adjustment data validation program, adjustments to transfers are generally made in the benefit year following the benefit year that was audited. For issuers that exit the market following the benefit year being audited, and therefore do not have transfers to adjust during the following benefit year, we previously finalized an exception to this general rule such that we will adjust the exiting issuer's prior year risk scores and associated transfers where it has been identified as an outlier through the HCC failure rate methodology during risk adjustment data validation.
Further, we proposed that to be considered an exiting issuer under this policy, the issuer would have to exit all of the markets and risk pools in the state (that is, not selling or offering any new plans in the state). If an issuer only exits some markets or risk pools in the state, but continues to sell or offer new plans in others, it would not be considered an exiting issuer under this policy. Finally, we clarified that under this proposed policy, a small group market issuer with off-calendar year coverage who exits the market but has only carry-over coverage that ends in the next benefit year (that is, carry-over of run out claims for individuals enrolled in the previous benefit year, with no new coverage being offered or sold) would be considered an exiting issuer and would also be exempt from risk adjustment data validation for the benefit year with the carry-over coverage. Individual market issuers offering or selling any new individual market coverage in the subsequent benefit year would be subject to risk adjustment data
For an issuer that is the sole issuer in a state market risk pool in a benefit year, there are no risk adjustment transfers under the state payment transfer formula and thus, no payment or financial accountability to other issuers for that risk pool.
As discussed in the proposed rule if an issuer is a negative error rate outlier, its risk score will be adjusted upwards. Assuming no changes to risk scores for the other issuers in the state market risk pool, this upward adjustment would reduce the issuer's risk adjustment charge or increase its risk adjustment payment for the applicable benefit year, leading to an increase in risk adjustment charges or a decrease in risk adjustment payments for the other issuers in the state market risk pool. If an issuer is a positive error rate outlier, its risk score will be adjusted downwards. Assuming no changes to risk scores for the other issuers in the state market risk pool, this downward adjustment would increase the issuer's charge or decrease its payment for the applicable benefit year, leading to a decrease in charges or an increase in payments for the other issuers in the state market risk pool. The
However, we sought comment on the impact of the current approach under the error estimation methodology and the outlier adjustment policy for negative error rate outlier issuers, or issuers with significantly lower-than-average HCC failure rates, on other issuers in a state market risk pool, the incentives that negative error rate adjustments may create, and potential modifications to the error rate estimation methodology or the outlier adjustment policy, such as to utilize the state mean failure rate instead of the national mean failure rate, to modify the error rate calculation to the confidence interval instead of the mean, to exclude negative error rate outliers or to use other methods of lessening the impact of negative error rate issuers on affected risk pools, beginning with the 2018 benefit year of risk adjustment data validation or later.
However, other commenters stated that issuers generally did not expect the significant financial impact of risk adjustment data validation to be as large as indicated by the 2016 pilot results that were released by HHS in July 2018,
Several commenters expressed concern about the impact of the negative error rate outliers in cases where the issuer had a zero error rate, particularly given the potential distributive effect of the adjustments to transfers based on market share. Another commenter stated that the exiting issuer proposal on negative error rates should be extended to all issuers such that no issuer's risk score would be increased because of a negative error rate. The commenter believes that this would avoid the creation of significant uncertainty in financial projections and pricing for issuers in the same state market risk pool whose transfers could be negatively affected by another issuer's increased risk score.
One commenter questioned HHS' authority to apply the current risk adjustment data validation error estimation methodology to 2018 risk scores. Another commenter stated its belief that HHS has the authority to make adjustments to the risk adjustment data validation methodology finalized in the 2019 Payment Notice. Some commenters suggested that HHS treat the 2017 benefit year as another pilot year or postpone the implementation of the risk adjustment data validation adjustments to risk scores and transfers until later benefit years (for example, 2020 and beyond).
Many commenters recommended HHS convene a joint industry stakeholder workgroup to develop effective solutions to ensure the risk adjustment program achieves its goals and fulfills its intended purpose. Other commenters recommended broader changes to the risk adjustment data validation process, such as using a targeted data-driven approach to risk adjustment data validation, dividing the audits into individual and small group to separate the impact on transfers, or creating a process to exempt issuers from validating HCCs for which a provider refuses to supply a medical record (when the issuer has demonstrated good faith in trying to obtain that record).
While the current error estimation methodology was not finalized until April 2018, it was applied prospectively to risk adjustment data validation for the 2017 benefit year. We have also been transparent about the potential for adjustments based on risk adjustment data validation results, including the two-sided nature of such adjustments, since the inception of the program. Consistent with § 153.350(c), as finalized in the final rule Standards Related to Reinsurance, Risk Corridors and Risk Adjustment,
However, as detailed in the 2019 Payment Notice, we recognized that many issuers would experience some variation and error because providers' documentation of enrollee health status varies across provider types and groups. Our experiences with the Medicare Advantage risk adjustment data validation program and the HHS-operated risk adjustment data validation pilot years reinforced this belief. As a result, to avoid adjusting transfers for any and all failures, we adopted the HCC failure rate methodology, which results in adjustments to an issuer's risk score only when the issuer's failure rate is statistically different from the weighted mean failure rate, or total failure rate, for all issuers that submitted initial validation audits (that is, the issuer is identified as an outlier). Similar to the original methodology finalized in the 2015 Payment Notice, when there is an outlier issuer, the transfers for other issuers in the state market risk pool will also be adjusted due to the budget neutral nature of the HHS-operated risk adjustment program. We further note that, based on our analysis of the 2016 benefit year risk adjustment data validation results and our analysis of the initial estimated 2017 benefit year risk adjustment data validation results, we have found that the HCC failure rate approach to error estimation significantly reduces the overall transfer impact of adjustments when compared with results under the original methodology.
Additionally, as detailed above, the identification of positive and negative error rate outliers and the resulting adjustments under the HCC failure rate methodology is consistent with the two-sided adjustment approach adopted under the original risk adjustment methodology finalized in the 2015 Payment Notice. Except as provided elsewhere in this final rule for negative error rate outliers resulting from exiting issuers, we continue to believe that adjusting for both negative and positive error rate outliers ensures that issuers' actual actuarial risk is reflected and that the HHS-operated risk adjustment program assesses charges to issuers with plans with lower-than-average actuarial risk while making payments to issuers with plans with higher-than-average actuarial risk. It also incentivizes issuers to achieve the most accurate EDGE data submissions for initial risk adjustment transfer calculations. For all these reasons, we do not believe that further changes are needed to the error estimation methodology or the outlier adjustment policy at this time. We will apply the current methodology and outlier adjustment policy to both the 2017 benefit year and 2018 benefit year of risk adjustment data validation. We intend to solicit further comments and work with stakeholders regarding potential changes for future benefit years.
However, as explained above, while issuers have been on notice since 2012 that adjustments based on risk adjustment data validation results could occur,
We anticipate adhering to a similar timeline in future years for the collection and payment of risk adjustment data validation adjustments to risk adjustment transfers (along with default data validation charges and allocations), such that risk adjustment transfers without risk adjustment data validation adjustments would be reported by June 30th of the year after the applicable benefit year, and issuers would report those amounts in the medical loss ratio reports submitted by July 31st of the year after the applicable benefit year. The preliminary risk adjustment data validation adjustments that could impact that benefit year's transfers, along with information on default data validation charges and allocations for the applicable benefit year, would be reported after the June 30 report is published, and we would collect and disburse risk adjustment data validation adjustments and default data validation charges and allocations two years after the announcement. Issuers would be instructed to reflect those final adjustment amounts and default data validation charges and allocations in the medical loss ratio reporting year in which collections and payments of those amounts occur, and would be permitted to reflect those amounts in rate setting for that same benefit year. For example, 2018 benefit year risk adjustment data validation adjustments and default data validation charges and allocations would be collected and paid in 2022; issuers could account for the impacts of those amounts in rate setting for the 2022 benefit year, and issuers would report the adjustments and default data validation charges and allocations in the 2022 benefit year medical loss ratio reporting year. Furthermore, given these timeline changes for collecting and paying risk adjustment data validation adjustments being finalized in this final rule and in response to comments that we received indicating that some issuers had difficulty obtaining medical records, we are also considering options to extend the timeline for conducting and completing the risk adjustment data validation processes for issuers and HHS. We believe that this additional time may help issuers in completing the operational processes in future benefit years. Therefore, we intend to seek input on an updated risk adjustment data validation timeline beginning with the 2018 benefit year to provide more time for medical record collection during the initial validation audits and more time for the completion of the second validation audit.
Several commenters recommended that outlier issuers' error rates be calculated based on the ends of the confidence interval instead of the mean to eliminate the “payment cliff” under the current methodology. Some of these commenters preferred adjusting outliers to the nearest ends of the confidence intervals as a short term solution to reduce the negative financial impact on other issuers in the state market risk pool because, for example, they believe the nationwide weighted average provides an adjustment that is too large in states where the statewide group failure rate is lower than the nationwide average. Some of these commenters also noted that adjusting to the confidence intervals would minimize unexpected impacts on transfers and remove the extreme impact of small adjustments in HCC accuracy for issuers whose failure rates are near the edges of the confidence interval.
Massachusetts issuers will receive 2017 benefit year risk adjustment data validation error rate results, but these issuers will not have their 2018 benefit year risk adjustment risk scores or transfers for Massachusetts state market risk pools adjusted based on 2017 risk adjustment data validation results. Furthermore, Massachusetts issuers' failure rates will not be included in the calculation of the national metrics for the 2017 benefit year risk adjustment data validation to avoid the potential distortion in the national metrics that will be applied to issuers in other state market risk pools. All other issuers in all other states and the District of Columbia will have their 2018 benefit year risk adjustment risk scores and transfers adjusted based on 2017 benefit year risk adjustment data validation results in accordance the current error estimation methodology finalized in the 2019 Payment Notice. In addition, to the extent that a Massachusetts issuer also offered risk adjustment covered plans in other state market risk pools, its 2018 benefit year risk adjustment risk scores and transfers for those other state market risk pools will be adjusted based on 2017 benefit year risk adjustment data validation results.
In previous rules,
In the 2019 Payment Notice, we finalized that beginning with 2017 benefit year HHS-operated risk adjustment data validation, issuers with 500 billable member months or fewer statewide in the benefit year being audited that elect to establish and submit data to an EDGE server will not be subject to the requirement to hire an initial validation auditor or submit initial validation audit results.
Second, in the 2018 Payment Notice, HHS finalized a materiality threshold for risk adjustment data validation to ease the burden of annual audit requirements for smaller issuers of risk adjustment covered plans.
We proposed to codify the materiality threshold exemption at § 153.630(g)(2), providing that an issuer of a risk adjustment covered plan would be exempt from the data validation requirements in § 153.630(b) if the issuer is at or below the materiality threshold defined by HHS and is not selected by HHS to participate in the data validation requirements in an applicable benefit year under a random and targeted sampling conducted approximately every 3 years (barring any risk-based triggers due to experience that warrant more frequent participation in risk adjustment data validation).
Consistent with the materiality threshold finalized in the 2019 Payment Notice,
We noted that if an issuer of a risk adjustment covered plan within the materiality threshold is not exempt from the data validation requirements for a given benefit year (that is, the issuer is selected by random and targeted sampling), and fails to engage an initial validation auditor or to submit the results of an initial validation audit to HHS, the issuer would be subject to a default data validation charge in accordance with § 153.630(b)(10), and may be subject to other enforcement action.
We are codifying this exemption at § 153.630(g)(2), including the establishment of a $15 million threshold that will continue to apply until such time as it may be changed through notice-and-comment rulemaking as proposed. Consistent with the original policy finalized in the 2018 Payment Notice, this exemption is available beginning with 2018 benefit year risk adjustment data validation.
Lastly, as noted in this rule, HHS released guidance on April 9, 2018 indicating our intention to propose in future rulemaking an exemption from risk adjustment data validation requirements for certain issuers in liquidation or that will enter liquidation. The purpose of exempting these issuers is similar to the reasons outlined in this rule for smaller issuers and those below the materiality threshold—to recognize the burdens and costs associated with the risk adjustment data validation requirements on these issuers, given their reduced financial and staff resources. Under this proposal, certain issuers in liquidation or that will enter liquidation would be exempt from the requirement to hire an initial validation auditor and submit initial validation audit results, as well as the second validation audit requirements, and would not be subject to enforcement action for non-compliance with risk adjustment data validation requirements or be assessed the default data validation charge under § 153.630(b)(10).
We proposed codifying at § 153.630(g)(3) that an issuer would be exempt from the applicable benefit year of risk adjustment data validation if the issuer is in liquidation as of April 30th of the year when transfer adjustments based on data validation results are made (that is, 2 benefit years after the benefit year being audited). For the 2018 benefit year and beyond, we proposed that to qualify for the exemption, the issuer must also not be a positive error rate outlier in the prior benefit year of risk adjustment data validation (that is, the issuer is not a positive error rate outlier under the error estimation methodology in the prior year's risk adjustment data validation) as outlined in proposed paragraph (g)(3)(ii). If an issuer in liquidation or that will enter liquidation by the applicable date was a positive error rate outlier in the previous year's risk adjustment data validation, we proposed not to exempt the issuer from the subsequent benefit year's risk adjustment data validation, and the issuer would be required to participate in risk adjustment data validation or receive the default data validation charge in accordance with § 153.630(b)(10) unless another exemption applies.
To qualify for this exemption in any year, we proposed under paragraph (g)(3)(i) that the issuer must provide to HHS, in a manner and timeframe to be specified by HHS, an attestation that the issuer is in or will enter liquidation no later than April 30th 2 years after the benefit year being audited that is signed by an individual with the authority to legally and financially bind the issuer. In proposed paragraph (g)(3)(iii), we proposed to define liquidation as meaning that a state court has issued an order of liquidation for the issuer that fixes the rights and liabilities of the issuer and its creditors, policyholders, shareholders, members, and all other persons of interest. Our intention with this policy was to align the definition of liquidation with state law on liquidation of health insurance issuers and the National Association of Insurance Commissioners' Model Act on receivership where possible.
While we understood the exact date of a liquidation order may be uncertain in specific circumstances, we proposed that the individual signing the attestation must be reasonably certain that the issuer will enter liquidation by April 30th 2 benefit years after the benefit year being audited.
Under our proposal, we would accept an attestation from a representative of the state's department of insurance, an appointed liquidator, or other appropriate individual who can legally and financially bind the issuer. HHS would verify the issuers' liquidation status with the applicable state regulators for issuers who submitted an attestation under § 153.630(g)(3). We also proposed that, because the April 30th 2 benefit years after the benefit year being audited is after the deadline for completing the initial validation audit for a given benefit year, an issuer who submits an attestation for this exemption but is determined by HHS to not meet the criteria for the exemption would receive a default data validation charge in accordance with § 153.630(b)(10) if the issuer fails to complete or comply with the risk adjustment data validation process within the established timeframes for
Additionally, we noted that any issuer that qualifies for any of the three exemptions in proposed § 153.630(g) would not have its risk score and its associated risk adjustment transfers adjusted due to its own risk score error rate, but that issuer's risk score and its associated risk adjustment transfers could be adjusted if other issuers in that state market risk pool were outliers and received risk score error rates for that benefit year's risk adjustment data validation.
We are also finalizing the codification of the liquidation exemption at § 153.730(g)(3) as proposed for the 2018 benefit year. For 2017 benefit year risk adjustment data validation, we intend to work with issuers in liquidation and will exercise our enforcement discretion, where appropriate, to provide relief consistent with the criteria outlined in the April 9, 2018 guidance
We proposed to amend § 155.20 to add definitions of “direct enrollment technology provider,” “direct enrollment entity,” “direct enrollment entity application assister,” and “web-broker.” After consideration of the comments received, we are finalizing the adoption of these new definitions as proposed. For further discussion, please see the preamble to §§ 155.220, 155.221, and 155.415.
Section 1311(d)(4)(B) of the PPACA requires an Exchange to provide for the operation of a toll-free telephone hotline to respond to requests for assistance. In the 2017 Payment Notice, we explained the distinction between a toll-free call center and a toll-free hotline, for purposes of specifying the different requirements for SBE-FPs and other Exchanges.
Under this approach, FF-SHOP call center volume has been extremely low. Given this experience, we proposed to amend § 155.205(a) to allow SHOPs operating in the leaner fashion described in the 2019 Payment Notice to operate a toll-free telephone hotline, as required by section 1311(d)(4)(B) of the PPACA, and to eliminate the requirement to operate a more robust call center. We proposed to amend the interpretation provided in the 2017 Payment Notice of what is required to establish a toll-free hotline, as required by section 1311(d)(4)(B) of the PPACA. There, we stated that a toll-free hotline includes the capability to provide information to consumers and appropriately direct consumers to the federally operated call center or HealthCare.gov to apply for, and enroll in, coverage through the Exchange. Given that SHOPs that operate in the leaner fashion no longer offer online enrollment and to reflect the option for such SHOPs to provide a toll-free hotline, rather than a more robust call center, we proposed that a toll-free hotline include the capability to provide information to consumers about eligibility and enrollment processes, and to appropriately direct consumers to the applicable Exchange website and other applicable resources.
The toll-free hotline provided by such SHOPs would consist of a toll-free number linked to interactive voice response capability, with prompts to pre-recorded responses to frequently asked questions, information about locating an agent and broker in the caller's area, and the ability for the caller to leave a message regarding any additional information needed. We stated our belief that this hotline would adequately address the needs of potential FF-SHOP consumers requesting assistance, and appropriately direct consumers to services to apply for, and enroll in, FF-SHOP coverage.
Section 1311(d)(4)(K) and 1311(i) of the PPACA require each Exchange to establish a Navigator program under which it awards grants to entities to conduct public education activities to raise awareness of the availability of QHPs, distribute fair and impartial information concerning enrollment in QHPs, and the availability of premium tax credits, and cost-sharing reductions; facilitate enrollment in QHPs; provide referrals to any applicable office of health insurance consumer assistance or health insurance ombudsman established under section 2793 of the PHS Act, or any other appropriate state agency or agencies for any enrollee with a grievance, complaint, or question regarding their health plan, coverage, or a determination under such plan or coverage; and provide information in a manner that is culturally and linguistically appropriate to the needs of the population being served by the Exchange. The statute also requires the Secretary to develop standards to ensure that information made available by Navigators is fair, accurate, and impartial. We have implemented the
Further, section 1311(i)(4) of the PPACA requires the Secretary to establish standards for Navigators to ensure that Navigators are qualified, and licensed, if appropriate, to engage in the Navigator activities described in the statute. This provision has been implemented at § 155.210(b) (for all Exchanges) and at § 155.215(b) (for Navigators in FFEs).
Section 155.210(e)(9) specifies that an Exchange may require or authorize Navigators to provide assistance with a number of topics not specifically mentioned in the statute, including certain post-enrollment activities. This section specifies that Navigators operating in FFEs are authorized to provide assistance on these topics and are required to do so under Navigator grants awarded in 2018 or later.
We acknowledge that HHS added these duties 2 years ago to ensure the availability of more robust consumer assistance; however, since that time, there have been programmatic and health care coverage policy changes that have caused us to reflect further. We stated our belief that consumers would be better served by allowing more flexibility for Navigators to tailor their services to make the most of their resources and to fit the needs of their communities.
In the proposed rule, we emphasized that FFE Navigators would be authorized to continue to provide assistance with any of the topics listed under § 155.210(e)(9). Under the proposed approach, if FFE Navigator grantees choose to provide any of the assistance specified in § 155.210(e)(9), we will continue to expect them to assess their communities' needs and build competency in the assistance activities in which they are engaging. It is important to note that the current FFE Navigator training for annual certification or recertification might continue to include training on some of the § 155.210(e)(9) topics. To supplement the required FFE Navigator training, we also plan to continue providing FFE Navigators with additional information related to these assistance activities through informal webinars, newsletters, and technical assistance resources such as fact sheets and slide presentations. FFE Navigator grantees that opt to carry out any of the assistance activities in § 155.210(e)(9) will be expected to draw upon these materials to ensure their staff and volunteers are adequately prepared to provide that assistance. Our proposal also retained SBE autonomy to determine whether requiring or authorizing the SBE's Navigators to perform the activities listed in § 155.210(e)(9) best meets the state's needs and resources.
We recognize that the time FFE Navigators currently spend providing assistance with the § 155.210(e)(9) topics varies.
To better understand the future impact of removing this requirement, we requested comment on how many hours per month FFE Navigator grantees and individual Navigators currently spend providing the assistance activities described at § 155.210(e)(9), what percentage of their current work involves providing these types of assistance, and how that amount of work would be impacted if providing these types of assistance would no longer be required. We also requested comment on how FFE Navigator grantees and individual Navigators might reprioritize work and spend time fulfilling their other duties, if not required to provide the types of assistance described under § 155.210(e)(9).
In addition to proposing to increase FFE Navigator flexibility with regard to the types of assistance they provide, we also proposed to provide more flexibility related to the training requirements that Exchanges establish for Navigators. Sections 155.210(b)(2) and 155.215(b)(2) establish Navigator training standards consistent with section 1311(i)(4) of the PPACA. Section 155.210(b)(2) specifies that Exchanges must develop and publicly disseminate a set of training standards to be met by all entities and individuals carrying out Navigator functions under the terms of a Navigator grant, to ensure expertise in several specific topic areas.
To provide more flexibility related to the training requirements for Navigators, we proposed to streamline both the requirement in § 155.210(b)(2) for all Exchanges to develop and disseminate Navigator training standards on specific topics, and the list of required training topics for FFE Navigators in § 155.215(b)(2). We proposed to amend the requirement at § 155.210(b)(2) to require Exchanges to develop and publicly disseminate training standards to ensure that the entities and individuals are qualified to engage in Navigator activities, including in the four major areas currently specified at § 155.210(b)(2)(i) through (iv). This would eliminate the training requirements at current § 155.210(b)(2)(v)-(ix) that correspond to the activities outlined in § 155.210(e)(9), since those activities would no longer be required. We also proposed to replace the current list of fifteen additional FFE Navigator training topics at § 155.215(b)(2) with a cross-reference to the amended § 155.210(b)(2) topics.
This approach would provide Exchanges greater flexibility in designing their Navigator training programs to ensure coverage of the most instructive and timely topics and to align the training with future changes in the Navigator program or the operation of the Exchanges, while still ensuring that Navigators are qualified to carry out their required duties. This additional flexibility would also allow Exchanges to focus on training areas they determine to be most relevant to the populations they serve and on the policy and operations of the Exchange in which they operate.
Furthermore, Exchanges could opt to provide more training than would be required under these proposed amendments. For example, in addition to the FFE annual Navigator training, required for Navigator certification under § 155.215(b), Navigators in FFEs are provided with training throughout the year that serves as a supplement to the annual FFE Navigator training by covering timely and appropriate training topics that might not be included in the annual FFE Navigator training. This additional training provided by FFEs, is consistent with the requirement that FFE Navigators obtain continuing education, as specified at § 155.215(b)(1)(iv), and we intend to continue this practice.
Currently, HHS provides SBEs, including SBE-FPs, the flexibility to decide whether they will require or authorize their Navigators to provide assistance on any or all of the areas described at § 155.210(e)(9). The changes that we are finalizing in this final rule do not change that flexibility. If SBEs choose to authorize or require their Navigators to provide assistance in any of the areas listed at § 155.210(e)(9), they will still be required to ensure that their Navigators are qualified to provide this assistance.
Under our amendments, any SBEs opting to authorize or require their Navigators to provide any or all of the types of assistance listed at § 155.210(e)(9) will have the flexibility to determine effective approaches to training their Navigators on performing these types of assistance based on local experience. We believe each Exchange is best positioned to determine the training that is most appropriate for the activities of their Navigators.
These proposals are intended to increase program flexibility within Exchanges and decrease regulatory burden related to Navigator training while maintaining standards that will ensure that Navigators are sufficiently prepared to carry out all required or authorized activities. We solicited comments on these proposals and received a range of comments in favor and not in favor of finalizing this policy. Streamlining the Navigator training requirements will allow Exchanges and Navigators to prioritize their training resources on those tasks that will best serve their state markets and Exchanges. HHS will continue to provide training on all current Navigator training topics. The format of the provided training may include other methods of technical assistance, but HHS is still committed to providing training on all of the streamlined Navigator training topics. We are finalizing these changes as proposed.
Finally, we proposed allowing, but not requiring, Navigators to assist consumers with applying for eligibility for insurance affordability programs and QHP enrollment through web-broker websites under certain circumstances. We are not finalizing this proposal. For further discussion of that proposal, please see the preamble to § 155.220.
The streamlined training requirements will still cover how to serve vulnerable and underserved consumers as a required topic, and still require that Exchanges develop and publicly disseminate a set of training standards for Navigators to ensure Navigators are qualified to engage in Navigator activities. Additionally, the required Navigator certification and recertification trainings will not be the only source of training that HHS will provide to best educate Navigators in the FFEs on the complexities of the enrollment process, how to best serve vulnerable and underserved consumers, and how to serve consumers in ways which are culturally and linguistically appropriate. In addition to the required training, HHS will continue to provide training through other channels. These channels include webinars, policy briefs, job aids, newsletters, and fact sheets. HHS is committed to providing Navigators with sufficient training, and will continue to identify and provide trainings in areas in which it may be needed.
• An overview of anti-discrimination laws such as section 1557 of the PPACA, Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act and the Americans with Disabilities Act;
• Navigators' legal responsibility to comply with the above laws;
• Best practices for how to do so; and
• How to serve underserved and vulnerable consumers, including those who serve consumers who may have disabilities, chronic illness, or a Limited English Proficiency (LEP).
We will monitor implementation of the revised Navigator trainings and their impact to ensure that these underserved and vulnerable populations continue to be properly served by the Navigator program. If HHS sees significant evidence that the capacity of Navigators to serve these populations and comply with anti-discrimination laws has eroded after these changes are implemented, we are open to reconsidering our approach.
Commenters also stated that because of the trusted relationships Navigators build with consumers during the enrollment process, Navigators are best suited to provide the post-enrollment assistance that those consumers need.
We also received comments that if providing certain types of assistance, including post-enrollment assistance, became optional rather than required, consumer health literacy and health equity may be impacted.
We believe that, just like in the SBEs, Navigator grantees themselves, rather than the federal government, are in the best position to determine the particular needs of the communities they serve, and the type of assistance that is required to meet those needs. We also are committed to improving health equity, and encourage Navigators to continue their important efforts to reduce health disparities in the communities which they serve.
This final rule provides Navigator grantees with flexibility to serve their consumers according to consumer demand, community needs, and organizational resources; and allows Navigators to prioritize their work accordingly.
If Navigator grantees decide to continue to provide the types of assistance that will no longer be required, they and the Exchange are required to ensure that they are appropriately trained to provide that assistance. The FFEs will continue to provide training on post-enrollment assistance via webinars, policy briefs, job aids, newsletters, fact sheets, and other resources, as needed, and urge those Navigators to review those resources and attend those trainings.
For a discussion of the provisions of this final rule related to standards applicable to Navigators subject to
Throughout the preamble for §§ 155.220 and 155.221, we proposed to use the term “web-broker” to refer to an individual agent or broker, a group of agents or brokers, or an agent or broker business entity, registered with an Exchange under § 155.220(d)(1) that develops and hosts a non-Exchange website that interfaces with an Exchange to assist consumers with the selection of and enrollment in QHPs offered through the Exchange, a process referred to as direct enrollment. We have used the term “web-broker” in the preamble of prior rules, as well as in guidance, and proposed to generally replace the previously used informal definition with the one proposed in this rulemaking.
As described in the preamble to § 155.221, we proposed significant changes to § 155.221 to streamline and consolidate the requirements applicable to all direct enrollment entities—both issuers and web-brokers—in one regulation. To reflect these changes, we also proposed several amendments to § 155.220. First, we proposed to move certain requirements that apply to all direct enrollment entities from § 155.220 to § 155.221. Specifically, we proposed to move the requirements currently captured in § 155.220(c)(3)(i)(K) and (L), and to amend the requirement currently in (L), which as described further below, are now at § 155.221(b)(4) and (d), respectively. We are finalizing these changes as proposed.
We proposed conforming edits throughout § 155.220 to incorporate the use of the term “web-broker,” as proposed to be defined, in applicable paragraphs to more clearly identify which FFE requirements extend to web-brokers. In the introductory text to paragraphs (a), (c), and (d), and in paragraphs (c)(1), (c)(5), (e), (f)(1), (f)(2), (f)(3), (f)(3)(i), (f)(4), (g)(1), (g)(2), (g)(2)(iii), (g)(2)(iv), (g)(4), (g)(5)(i)(A), (g)(5)(i)(B), (g)(5)(ii), (g)(5)(iii),
We also proposed to amend § 155.220(c)(3)(i) to add a new paragraph (c)(3)(i)(K) that requires web-broker websites to comply with the applicable requirements in § 155.221 when an internet website of a web-broker is used to complete the QHP selection. We noted this new proposed requirement would also apply when an internet website of a web-broker is used to complete the Exchange eligibility application, through the existing cross reference to paragraph (c)(3)(i) in paragraph (c)(3)(ii)(A), but the applicable requirements under § 155.221 may differ depending on whether the non-Exchange website is used to complete the Exchange eligibility application or is used to complete the QHP selection. We are finalizing this amendment as proposed. Please see the preamble discussion related to § 155.221 for further details.
We also proposed to amend § 155.220(c)(3)(i) to add a new requirement at new paragraph (c)(3)(i)(L) that prohibits web-broker websites from displaying recommendations for QHPs based on compensation the web-broker, agent, or broker receives from QHP issuers. In the proposed rule, the term “compensation” would include commissions, fees, or other incentives as established in the relevant contract between an issuer and the web-broker. In the proposed rule, we recognized that web-broker websites often ask for certain information from consumers to assist with the display and sorting of QHP options on their non-Exchange websites. This may include estimated annual income, preferences regarding health care providers, prescription drugs the consumer takes, expected frequency of doctors' visits, or other information. We also acknowledged that web-brokers sometimes display QHP recommendations or assign scores to QHPs using the information they collect. We expressed support for the development and use of innovative consumer-assistance tools to help consumers shop for and select QHPs that best fit their needs, consistent with applicable requirements. However, we noted that we believe such recommendations should not be based on compensation web-brokers, agents, or brokers may receive from QHP issuers when consumers enroll in QHPs offered through Exchanges using web-broker non-Exchange websites. We are finalizing this amendment as proposed with the following clarification in response to comments. The definition of the term “compensation” for this
We also proposed to amend § 155.220(c)(4)(i)(A) to require a web-broker to provide HHS with a list of the agents or brokers who, through a contract or other arrangement, use the web-broker's non-Exchange website to assist consumers with completion of QHP selection or for the Exchange eligibility application, in a form or manner to be specified by HHS. We explained that authority currently exists for HHS to request this information for agents or brokers who, through a contract or other arrangement, use the non-Exchange website to complete the QHP selection process.
Currently, § 155.20 defines an “agent or broker” as a person or entity licensed by the state as an agent, broker, or insurance producer. Under § 155.220(d), an agent or broker that enrolls individuals in QHPs in a manner that constitutes enrollment through the Exchange or assists individuals with applying for APTC or cost-sharing reductions must execute an agreement with the Exchange, register with the Exchange, receive training, and comply with the Exchange's privacy and security standards. When these regulatory provisions were originally drafted, it was anticipated that agents and brokers were predominantly individuals. However, with the expansion of direct enrollment, there are more FFE agents and brokers, including web-brokers, that have obtained FFE registration in their capacities as licensed business entities, and not in their individual capacities as licensed agents or brokers (non-individual entities). As noted in the proposed rule, certain regulatory requirements, such as those regarding training are less suited for these non-individual types of licensed agents or brokers. For example, to comply with the requirement to complete training at § 155.220(d)(2), we currently require agents or brokers that are registered with the FFEs as non-individual entities to designate an individual to take training on the entity's behalf, even though all individual agents or brokers assisting FFE consumers through the entity have to complete the training as individual agents and brokers. Because the training is not designed for representatives of a non-individual entity who are not providing direct assistance to FFE consumers, we explained that we believed it is appropriate to remove this requirement for licensed agent or broker non-individual entities. Therefore, we proposed to amend § 155.220(d)(2) to exempt from the training requirement a licensed agent or broker entity that registers with the FFE in its capacity as a business organized under the laws of a state, and not as an individual person. We also explained that we did not intend for this change to alter the requirement that individual agents or brokers must complete training, as applicable, as part of the annual FFE registration process. Therefore, all individual agents and brokers interacting with individual market FFE or SBE-FP consumers, whether working independently or with a non-individual agent or broker entity, including web-brokers, would continue to be required to complete annual training. Individual agents or brokers interacting with FFE-SHOP or SBE-FP-SHOP consumers would continue to be encouraged to take FFE training on an annual basis. We also proposed to include language in § 155.220(d)(2) to clarify that direct enrollment technology providers will not be required to complete FFE annual training because these non-individual entities will not be interacting with individual market FFE or SBE-FP consumers without the assistance of an individual agent or broker; they are
To improve program integrity, we proposed to delete the existing § 155.220(g)(3) and add new paragraphs (g)(3)(i) and (ii) to allow HHS to immediately terminate an agent's or broker's agreement with the FFEs for cause with notice to the agent or broker if an agent or broker fails to comply with the requirement to maintain the appropriate license under state law in every state in which the agent or broker actively assists consumers with selecting or enrolling in QHPs offered through the FFEs or SBE-FPs. We noted that the FFE agreements required under §§ 155.220(d) and 155.260(b) that agents and brokers execute with the FFEs as part of the annual FFE registration process include the requirement to maintain valid licensure in every state that the agent or broker assists Exchange consumers. State licensure as an agent, broker, or insurance producer is a critical consumer protection to ensure that when assisting Exchange consumers these individuals and entities are familiar with rules and regulations applicable in all states in which they provide assistance to FFE or SBE-FP consumers. Licensure in every state where the agent or broker is actively assisting FFE or SBE-FP consumers is a predicate requirement to registering with the FFEs to provide such assistance. We explained that allowing for immediate termination of an agent's or broker's agreements with the FFEs for failure to adhere to the applicable state licensure requirements ensures that an unlicensed individual may not continue to possess the agent/broker role that enables access to the FFEs or SBE-FPs to provide assistance to Exchange consumers as an agent or broker during the advance 30-day notice period that would otherwise apply under the current § 155.220(g)(3). We explained that we believed allowing for immediate termination in these circumstances is appropriate to protect consumers, as well as Exchange operations and systems. Under this proposal, we would confirm information about licensure (or the lack thereof) with the applicable state regulators prior to taking action under the new paragraph (g)(3)(ii). In addition, we proposed that an agent or broker whose agreements with the FFEs are immediately terminated for cause under the new proposed paragraph (g)(3)(ii) would be able to request reconsideration under § 155.220(h). We further proposed amendments to paragraph (g)(4), such that, consistent with other terminations for cause under paragraph (g)(3), immediate terminations under the new proposed paragraph (g)(3)(ii) would result in the agent or broker not being registered with the FFEs or permitted to assist with or facilitate enrollment of qualified individuals, qualified employers or qualified employees in QHPs through the FFEs or SBE-FPs or assist individuals in applying for APTC and cost-sharing reductions (CSRs) for QHPs after the applicable period has elapsed. However, in these circumstances, the agent or broker would be required to continue to protect any personally identifiable information accessed during the term of his or her or its agreements with the FFEs. We also proposed to create a new paragraph (g)(3)(i) to retain the existing language describing the current notification process and timelines for termination for cause under paragraph (g) with advance 30-days' notice, except that we proposed a clarifying edit to reflect that the new paragraph (g)(3)(ii) would constitute an exception to the current process described in existing paragraph (g)(3). As detailed earlier in this preamble, we also proposed to add a reference to web-broker to the existing paragraph (g)(3) (proposed as new paragraph (g)(3)(i)) to clarify this paragraph also applies to web-brokers. We are finalizing these amendments as proposed.
To promote information technology system security in the FFEs and SBE-FPs, including the protection of consumer data, we proposed to amend § 155.220(k) by adding a new paragraph (k)(3) that would continue to allow HHS to immediately suspend an agent's or broker's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems until the incident or breach is remedied or sufficiently mitigated to HHS' satisfaction. We noted that this proposed language was identical to an existing provision that applies when an internet website of an agent or broker is used to complete QHP selection at current § 155.220(c)(3)(i)(L)
To further improve program integrity, we proposed in a new § 155.220(m) several additional areas in which we proposed to regulate web-brokers differently from agents or brokers. We explained that we believe these additional proposed changes in new paragraph (m) are important to further protect against potential fraudulent enrollment activities, including the improper payment of APTC and CSRs, to safeguard consumer data and Exchange operations and systems, and to ensure direct enrollment remains a safe and consumer-friendly enrollment pathway.
At § 155.220(m)(1), we proposed to allow a web-broker's agreement(s) to be suspended or terminated for cause under § 155.220(g), or a web-broker to be denied the right to enter into agreements with the FFEs under § 155.220(k)(1)(i), based on the actions
At § 155.220(m)(2), we proposed to allow a web-broker's agreement to be suspended or terminated under § 155.220(g) or to deny it the right to enter into agreements with the FFEs under § 155.220(k)(1)(i), if it is under the common ownership or control, or is an affiliated business, of another web-broker that had its agreement suspended or terminated under § 155.220(g). In general, for purposes of this provision, we proposed to define “common ownership or control” based on whether there is significant overlap in the leadership or governance of the entities. We also proposed to collect data during the web-broker onboarding process to assist with the analysis of whether the web-broker is under the common ownership or control, or is an affiliated business, of another web-broker that had its agreement suspended or terminated under § 155.220(g).
At § 155.220(m)(3), we proposed allowing the Exchange to collect information from a web-broker during its registration with the Exchange, or at another time on an annual basis, in a form and manner to be specified by HHS, sufficient to establish the identities of the individuals who comprise its corporate leadership and to ascertain any corporate or business relationships it has with other entities that may seek to register with the FFE as web-brokers. We explained these provisions were important to maintain program integrity, because they will provide authority to collect information that will be used to minimize the risk that an individual or entity can circumvent an Exchange suspension or termination or other enforcement action related to non-compliance. We are finalizing the amendments to create new paragraphs (m)(1), (m)(2), and (m)(3) as proposed.
As noted in the proposed rule, the use of direct enrollment through websites other than HealthCare.gov has expanded, as have the requirements on web-brokers seeking to participate in FFEs and SBE-FPs. For those reasons, we proposed to modify prior policy that prohibited Navigators and certified application counselors (together referred to here as “assisters”) from using web-broker websites to assist with QHP selection and enrollment. Our proposal would have permitted, but not required, assisters in FFEs and SBE-FPs, to the extent permitted by state law, to use web-broker websites to assist consumers with QHP selection and enrollment, if the website met certain conditions designed to ensure that assisters were able to use it while still meeting their statutory and regulatory obligations to provide fair, accurate, and impartial information and assistance to consumers. To promote state flexibility and autonomy under this proposal, SBEs other than SBE-FPs would have had discretion to permit their assisters to use web-broker websites, so long as the web-broker websites that assisters were permitted to use in SBEs, at a minimum, adhered to the standards outlined in the proposal. Also, SBEs could instead have chosen to preserve the prohibition on assister use of web-broker websites.
The expansion of direct enrollment and the implementation of enhanced direct enrollment increased interest in allowing assisters to use web-broker websites to assist consumers with selection and enrollment in QHPs offered through Exchanges. As detailed in the proposed rule, some web-brokers supported this idea, because of the unique role assisters serve in many communities. Some assisters also expressed a desire to use web-broker websites to provide an improved consumer experience by leveraging unique consumer assistance tools many web-brokers developed, such as those that provide access to real-time information on the status of submitted applications and enrollments.
In the proposed rule, we explained that the implementation of enhanced direct enrollment by some web-brokers also presents consumers with an additional method of applying for insurance affordability programs, selecting and enrolling in QHPs offered through Exchanges, and receiving post-enrollment support services. We explained that we believe this new option should be available to all FFE and SBE-FP assisters who provide application and enrollment assistance, provided that the information and assistance the assister provides will remain fair, accurate, and impartial. We also expressed hope that allowing FFE and SBE-FP assisters to use web-broker websites to enroll consumers would encourage collaboration between assisters and web-brokers to the benefit of consumers by providing consumers the most appropriate support at each stage of the Exchange application and QHP selection and enrollment processes. To further support the use of web-broker websites by assisters, we also proposed to amend and replace § 155.220(c)(3)(i)(D) with new requirements for web-broker websites to display all QHP data provided by the Exchange, consistent with the requirements of § 155.205(b)(1) and (c), for such websites to be eligible for use by assisters when otherwise permitted under state law. For FFEs and SBE-FPs, we proposed an optional annual certification process for web-brokers that would have been integrated into the existing annual web-broker registration process, or could have occurred during another time of year, during which a web-broker could have been certified by the Exchange by attesting to its compliance with the QHP data display requirements. We also proposed that if a web-broker website did not facilitate enrollment in all QHPs, it would be required to identify to consumers the QHPs, if any, for which the web-broker website did not facilitate enrollment by prominently displaying a standardized disclaimer provided by the Exchange, in a form and manner specified by the Exchange, stating that the consumer could enroll in such QHPs through the Exchange website, and display a link to the Exchange website. However, after consideration of comments, we are not finalizing the proposed modification to the prior policy that prohibited assisters from using web-broker websites or the accompanying proposals to amend and replace § 155.220(c)(3)(i)(D). The current policy, which prohibits the use of web-broker websites by assisters, remains in effect. We are also retaining the existing requirement at § 155.220(c)(3)(i)(D), which requires the display of all QHP data provided by the Exchange on non-Exchange websites used to complete QHP selection and/or the Exchange eligibility application.
The following is a summary of the comments received on the proposed amendments, policies and clarifications related to § 155.220. Comments related to the accompanying proposals under § 155.221 are discussed later in this rule.
We also clarify that under § 155.220(c)(3)(i)(A), a web-broker website used to complete QHP selection or the Exchange eligibility application must disclose and display all QHP
We also believe the data collected must include information about all agents and brokers that are able to use a web-broker's website for direct enrollment, whether or not they have done so recently, since agents and brokers with this access are equally able to access the systems and engage in misconduct that we may need to investigate. In terms of the scope of information that will have to be reported, we clarify it extends only to those agents and brokers that have a current contractual or other arrangement with a web-broker to use its website to assist consumers with the completion of an Exchange eligibility application or QHP selection in the FFE or SBE-FP. Persons or entities only referring consumers to the web-broker's website would not be subject to this requirement.
As explained in the proposed rule, the intent of these changes is to provide additional tools for HHS to guard against fraudulent activities, protect consumer data and Exchange operations and systems, and address serious cases of misconduct. Web-broker business entities participating or seeking to participate in direct enrollment are proliferating. In addition, the complexity of web-brokers' technical integrations with Exchange systems are increasing, providing greater access to sensitive consumer data and growing dependencies between Exchange and web-broker systems. After several years of experience observing web-broker operations and participation in the FFEs and SBE-FPs, we found it was necessary to update our oversight and enforcement authority to add tools to combat fraud to align with these changes.
We do not expect this authority will be used against the vast majority of web-brokers that make a good-faith effort to comply with applicable requirements. Further, we anticipate these provisions will have limited impact as they are designed to provide HHS greater flexibility to address the limited instances where there is evidence of significant misconduct or non-compliance by a web-broker, its officers, employees, contractors, or agents. We clarify that “agent” as referred to in § 155.220(m)(1) is intended to refer to an individual or entity with a business relationship with a web-broker such that the entity or individual is authorized to act on behalf of the web-broker. “Agent” in this context may or may not refer to a licensed agent or broker registered with the FFEs to assist Exchange consumers, unless the licensed agent or broker is also authorized to act on behalf of the web-broker. We believe this new authority will close some current gaps in oversight of web-brokers, such as those that exist when an individual or entity registered with the FFEs is denied the right to enter into FFE agreements for future benefit years under § 155.220(k)(1)(i) due to misconduct and the individual or entity tries to avoid the implications of the enforcement action by creating a new web-broker business entity that seeks to register with the FFEs before the expiration of the penalty under § 155.220(k)(1)(i). Examples of the types of activities that could give rise to enforcement action under these new authorities are a web-broker's officer instructing his agent/broker employees to falsify data submitted on consumers' Exchange applications, a documented pattern by a web-broker entity of misusing Exchange consumer data, or the failure to adopt procedures to properly secure data and comply with applicable privacy and security requirements. As these examples illustrate, the activities for which an enforcement action may be taken under this authority are not limited to activities related only to the operation of a web-broker's website.
While each enforcement action is fact-specific, we generally clarify that if a registered agent or broker is believed to have engaged in noncompliance that we discover through our oversight of web-broker websites, and there is no evidence that the web-broker was part of the noncompliance activities, we would take the enforcement action against the agent or broker (and not the web-broker). However, if the investigation reveals facts that indicate the web-broker was involved in the non-compliance, then we may also take action under this new authority against the web-broker (in addition to taking appropriate action for the agent or broker involved). We may consider expanding this authority to non-web-broker agent or broker business entities in the future. However, the specific concerns and potential risks the proposals were intended to mitigate are posed most acutely by web-brokers by virtue of the more direct and expansive access they have to Exchange systems and consumer data. Therefore, we proposed and are finalizing this authority as limited to web-brokers at this time.
Some commenters supported prohibiting web-broker websites from recommending QHPs if this proposal was finalized. One commenter suggested that assisters should only be permitted to use web-broker websites that exclusively market QHPs, and web-brokers should not receive commissions for consumers enrolled in QHPs through a web-broker website if the consumers received support from assisters. Another commenter advocated for mandatory certification of web-broker websites before assisters may use them. One commenter supported requiring web-broker websites to develop a separate pathway exclusively for assisters to use. One commenter recommended allowing web-brokers to compensate assisters to supplement federal funding for assisters, and noted that the compensation should be unrelated to whether the web-broker received a commission associated with the assistance provided to the consumer by the assister, and should include
Some commenters supported specific elements of the proposal. Several commenters supported the flexibility proposed to be provided to SBEs, other than SBE-FPs, to either permit their assisters to use web-broker websites or to instead preserve the prohibition on assister use of these non-Exchange websites. One commenter supported the proposed requirement that web-broker websites display all QHP data provided by the Exchange before assisters could use the websites. One commenter that generally supported the proposal described a potential outcome of the proposal would be the development of new consumer-assistance tools that assisters would be able to leverage when using a web-broker website to assist consumers.
Direct enrollment is a mechanism for third parties to directly enroll consumers seeking QHPs through a non-Exchange website in a manner considered to be through the Exchange. Direct enrollment was created to provide consumers different options to shop for and enroll in QHPs offered through the Exchange. The entities that have been authorized to offer direct enrollment pathways to date are QHP issuers, as well as agents and brokers that develop and host non-Exchange websites to facilitate consumer selection of and enrollment in QHPs, referred to as web-brokers. As described above, in this rule we finalized a new definition for the term “web-broker.” Consistent with this new definition, we use the term web-broker throughout this final rule when we are referring to agents and brokers that develop and host non-Exchange websites to facilitate consumer selection of and enrollment in QHPs offered through an Exchange, otherwise known as direct enrollment, as well as direct enrollment technology providers. The original version of direct enrollment, or classic direct enrollment, is still in operation. It utilizes a double redirect from a direct enrollment entity's website where QHP shopping occurs, to HealthCare.gov where the eligibility application is completed, and back to the entity's website to finalize the selection of the QHP. Classic direct enrollment allows QHP issuers and web-brokers who meet applicable requirements to design and host a plan shopping experience, and assist consumers with the QHP selection process using relatively simple and limited application programming interfaces (APIs). The FFE direct enrollment program has expanded beyond the classic (that is, double-redirect) direct enrollment pathway as the FFEs' technical capabilities have significantly increased, beginning with proxy direct enrollment for plan year 2018
As detailed in the proposed rule, the entities that have been permitted to offer direct enrollment pathways to date have been QHP issuers and web-brokers that develop and host non-Exchange websites to facilitate selection of and enrollment in QHPs offered through an FFE or SBE-FP. Direct enrollment regulatory provisions have likewise been divided into sections separately applicable to QHP issuers participating in direct enrollment and web-brokers. As direct enrollment has evolved with the implementation of enhanced direct enrollment, many of the requirements applicable to QHP issuers performing direct enrollment and web-brokers have become increasingly similar. Therefore, we proposed to revise § 155.221 to apply to all types of direct enrollment entities and to expand the requirements captured in this regulation beyond audits of direct enrollment entities. To reflect this change we also proposed to revise the section heading of § 155.221 to “Standards for direct enrollment entities and for third-parties to perform audits of direct enrollment entities.”
As detailed above, we also proposed to amend § 155.20 to include definitions of several terms we proposed to use in § 155.221 including: “direct enrollment entity” and “web-broker.” Specifically, we proposed to define “direct enrollment entity” as an entity that an Exchange permits to assist consumers with direct enrollment in QHPs offered through the Exchange in a manner considered to be through the Exchange as authorized by §§ 155.220(c)(3), 155.221, or 156.1230. We proposed to define “web-broker” as an individual agent or broker, group of agents or brokers, or business entity registered with an Exchange under § 155.220(d)(1) that develops and hosts a non-Exchange website that interfaces with an Exchange to assist consumers with direct enrollment in QHPs offered through the Exchange as described in §§ 155.220(c)(3) and 155.221. As explained elsewhere in this preamble, we also proposed to define the term “web-broker” to include direct enrollment technology providers. We explained that it is important to distinguish “web-brokers” from other agents and brokers utilizing a non-Exchange website to assist consumers with direct enrollment in QHPs offered through the Exchanges when they did not develop and do not host the non-Exchange website. Stated differently, agents and brokers using a non-Exchange website developed and hosted by a web-broker are not themselves necessarily web-brokers. For the reasons outlined in the preamble to § 155.220, we are of the view that it is appropriate to impose different requirements on web-brokers and agents and brokers who are not web-brokers. The proposed definition and the proposed changes to §§ 155.220 and 155.221 reflect this approach and would enable web-brokers, agents, and brokers to more clearly identify when requirements are applicable to only web-brokers.
We also proposed to amend § 155.20 to define “direct enrollment technology provider” as a type of web-broker business entity that is not a licensed agent, broker, or producer under state law and has been engaged or created by, or is owned by, an agent or broker to provide technology services to facilitate participation in direct enrollment as a web-broker in accordance with §§ 155.220(c)(3) and 155.221. This definition captures instances when an individual agent or broker, a group of agents or brokers, or an agent or broker business entity, engages the services of or creates a technology company that is not licensed as an agent, broker, or producer to assist with the development and maintenance of a non-Exchange website that interfaces with an Exchange to assist consumers with direct enrollment in QHPs offered through the Exchanges as described in §§ 155.220(c)(3) and 155.221. When the technology company is not itself licensed as an insurance agency or brokerage, but otherwise is functioning as a web-broker, we proposed that these technology companies would be considered a type of web-broker that must comply with applicable web-broker requirements under §§ 155.220 and 155.221, unless indicated otherwise.
We proposed to generally maintain the current requirements in § 155.221 that describe the standards for third-parties to perform audits of direct enrollment entities. However, to accommodate new content we proposed to add to this regulation, we proposed to redesignate the existing paragraphs (a) through (c) as paragraphs (e) through (g), respectively.
We also proposed some amendments to existing requirements currently captured in paragraphs (a) through (c), as described more fully below. In addition, throughout the redesignated paragraphs (e), (f), (f)(2), (f)(3), (f)(4), (f)(6), (f)(7), and (g), we proposed conforming edits to change references to agents, brokers, and issuers to direct enrollment entities. We also proposed to update the regulatory cross-references in the redesignated paragraph (f)(6) and (f)(7) from § 155.221(a) to § 155.221(e) to align with other proposed streamlining changes to this regulation. We also proposed to add paragraph headings throughout this revised regulation for further clarity. In paragraph (e), we also proposed to add language to require that the third-party entities that conduct annual reviews of direct enrollment entities to demonstrate operational readiness consistent with new § 155.221(b)(4)
We also proposed to clarify in paragraph (e) that an initial audit is required, in addition to subsequent annual audits, and that these audits must include review of the entity's compliance with applicable direct enrollment requirements. These clarifications do not represent a change from the current approach, as direct enrollment entities are currently required to demonstrate operational readiness before their websites may be used to complete QHP selections,
We proposed to maintain the last sentence that currently appears in § 155.221(a) as the last sentence of the new paragraph (e) that states the third-party entity will be the downstream or delegated entity of the agent, broker, or issuer that participates or wishes to participate in direct enrollment, replacing the references to agent, broker,
We also proposed to require under new paragraph (f) that a written agreement must be executed between the direct enrollment entity and its auditor stating that the auditor will comply with the standards outlined in paragraph (f). We proposed this new requirement because we believe the most effective way to ensure a direct enrollment entity has the necessary control and oversight over its auditor to ensure compliance with the applicable standards in § 155.221 is for those standards to be memorialized in a written agreement between the parties. We proposed to delete the provision in current paragraph (c) that refers to each third-party entity having to satisfy the standards outlined in current paragraph (b), to avoid duplication with a nearly identical provision in proposed paragraph (f).
We proposed to maintain, in the redesignated new paragraph (g), the provision that clarifies that direct enrollment entities may engage multiple third-party entities to conduct the operational readiness audits under proposed § 155.221(e).
We proposed a new paragraph (a) in § 155.221 that will establish the types of entities the FFEs will permit to assist consumers with direct enrollment in QHPs offered through an Exchange in a manner that is considered to be through the Exchange, to the extent permitted by state law. We proposed to capture in § 155.221(a) the two types of entities that are already permitted by the FFEs to use and offer a non-Exchange website to facilitate direct enrollment: QHP issuers that meet the requirements in § 156.1230 and web-brokers that meet the requirements in § 155.220. New proposed paragraph (a) also reflected that these entities would be required to comply with the applicable requirements outlined in the new proposed § 155.221, which we proposed to capture the direct enrollment requirements that would apply to both web-brokers and QHP issuers participating in direct enrollment. For the remaining requirements that only apply to web-brokers or only apply to QHP issuers participating in direct enrollment, we proposed to retain those requirements in §§ 155.220 and 156.1230, respectively.
In the proposed rule, we described guidance that details several existing display standards applicable to issuers or web-brokers participating in direct enrollment.
We explained that we received feedback from issuers and web-brokers suggesting there was some confusion about the current standards and guidance related to the display of QHPs and non-QHPs on non-Exchange websites used to facilitate direct enrollment. In an effort to clarify expectations, achieve greater uniformity in standards for all direct enrollment entities, and provide flexibility for innovation, we proposed to establish requirements under § 155.221(b) for the FFEs, which would apply to all FFE direct enrollment entities. As noted elsewhere in preamble, some of the proposed requirements in § 155.221(b) were intended to streamline existing web-broker and QHP issuer direct enrollment requirements that are currently separately imposed under §§ 155.220 and 156.1230 by capturing these similar requirements in one regulation. Other proposed standards in § 155.221(b) are new regulatory requirements and are proposed to clarify or otherwise address compliance questions that have arisen under the existing regulations and guidance.
At new § 155.221(b)(1), we proposed to require direct enrollment entities to display and market QHPs and non-QHPs on separate website pages on their respective non-Exchange websites. We explained that this proposal was intended to balance the goals of minimizing consumer confusion about distinct products with substantially different characteristics, and allowing marketing flexibility and opportunities for innovation. At § 155.221(b)(2), we proposed to require direct enrollment entities to prominently display a standardized disclaimer in the form and manner provided by HHS.
In § 155.221(c), we proposed FFE requirements related to direct enrollment entity application assisters. Please see the preamble to § 155.415 for further details.
In § 155.221(d), we proposed to consolidate and amend the existing parallel provisions in §§ 155.220(c)(3)(i)(L) and 156.1230(b)(1) to authorize HHS to immediately suspend the direct enrollment entity's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations or Exchange information technology systems until such circumstances are resolved, remedied or sufficiently mitigated to HHS' satisfaction. We proposed to remove the provisions from §§ 155.220(c)(3)(i)(L) and 156.1230(b)(1) as part of our efforts to streamline and consolidate the requirements applicable to direct enrollment entities in one regulation. The proposal captured in § 155.221(d) includes language that will extend the authority to suspend the ability to transact information with the Exchange to also include discovery of circumstances by HHS that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations. This addition was necessary and appropriate as enhanced direct enrollment allows direct enrollment entities to collect and transmit the application data that the Exchanges use to complete eligibility determinations.
Lastly, to account for direct enrollment entities that may be assisting consumers in SBE-FP states, we proposed a new § 155.221(h) to clarify that such entities are also required to comply with applicable standards in § 155.221.
We sought comment on all of these proposals. After consideration of the comments received, we are finalizing all of the amendments to § 155.221, as proposed.
As described in the proposed rule and above, the requirements at § 155.221(b)(1) through (3) are intended to provide flexibility for direct enrollment entities to market valuable additional coverage that complements QHP coverage, while also allowing HHS to establish important parameters around the manner and type of non-QHPs that direct enrollment entities may market as part of a single shopping
We proposed allowing, but not requiring, certified application counselors to assist consumers with applying for eligibility for insurance affordability programs and QHP enrollment through web-broker websites under certain circumstances. We are not finalizing this proposal. For a discussion of the provisions of this final rule related to that proposal, please see the preamble to § 155.220.
In the first Program Integrity Rule,
In adopting this approach, we recognized that, in some states, a license may be required to assist an applicant applying for an eligibility determination or redetermination. We deferred to existing state laws related to enrollment assistance when deciding which individuals may assist applicants and enrollees as authorized under § 156.1230(a)(2), and whether licensure would be required to provide such assistance. We stated that if state law requires a license to enroll applicants in coverage, then issuers and their application assisters would need to follow state law for licensure requirements. We also recognized that there were certain functions that issuers generally had their staff perform prior to the issuance of the first Program Integrity Rule, such as answering general information about plans, and we wanted to allow those individuals to continue to perform those functions, without meeting additional standards, if permitted by state law. We indicated that, if an issuer wants those individuals to perform additional functions, such as helping consumers as they apply for an eligibility determination or redetermination for coverage through the Exchange, or as they apply for insurance affordability programs, or as they report changes to an Exchange, those individuals could assist consumers with applications subject to the standards in § 156.1230(a)(2), so long as providing such assistance did not otherwise conflict with state law. Additionally, we stated that facilitating selection of a QHP may be a typical function of issuer staff and issuer staff will be able to perform post-eligibility functions such as plan compare and selection, if permitted by state law, without being subject to the standards of § 156.1230(a)(2). As currently codified, the application assister definition and accompanying requirements only apply to issuer application assisters.
As described in the proposed rule, we believe providing parity for direct enrollment entities, when possible, promotes fair competition and maximizes consumer choice. In addition, there was no apparent reason why issuer staff are more qualified to assist consumers with the Exchange eligibility application than the staff of other direct enrollment entities, assuming all receive appropriate training and when otherwise permitted under applicable state law. Therefore, we proposed to expand the flexibility to employ or contract with application assisters to all direct enrollment entities, to create parity between issuers and other types of direct enrollment entities. Accordingly, we proposed changes to several regulatory sections. Specifically, we proposed to amend § 155.20 by adding the term “direct enrollment entity application assister,” which we proposed to define as an employee, contractor, or agent of a direct enrollment entity who is not licensed as an agent, broker, or producer under state law and who assists individuals in the individual market with applying for a determination or redetermination of eligibility for coverage through the Exchange or for insurance affordability programs. We proposed to adopt the same approach for direct enrollment entity application assisters as the existing one for issuer application assisters. In other words, under our proposal, these application assisters would need to comply with applicable state law, including any licensure requirements, and we would continue to defer to existing state laws related to enrollment assistance when deciding which individuals may assist applicants and enrollees and whether licensure is required to provide such assistance.
We also proposed to revise § 155.415(a) to authorize an Exchange, to the extent permitted by state law, to permit issuer and direct enrollment entity application assisters, as defined at § 155.20, to assist individuals in the individual market with applying for a determination or redetermination of eligibility for coverage through the Exchange and insurance affordability programs. Additionally, we proposed to maintain language in § 155.415(a) to mandate that all direct enrollment entities who seek to use application assisters, and not just QHP issuers, must ensure that their application assisters meet the standards currently captured in § 156.1230(a)(2), which we proposed to move to new paragraphs (b)(1) through (3) of § 155.415, with two proposed amendments. Currently, § 156.1230(a)(2)(i) requires all QHP issuer application assisters to receive training on QHP options and insurance affordability programs, eligibility, and benefits rules and regulations. In the proposed rule, we noted that licensed agents and brokers currently assisting consumers with QHP enrollment through the FFEs and SBE-FPs must have credentials to access FFE systems to offer that assistance. Those credentials are obtained during the FFE registration and training processes for agents and brokers. For application assisters to have similar access to FFE systems, so that they are also able to assist consumers as described in this
We sought comment on these proposed changes. We are finalizing these amendments as proposed, with technical edits to § 155.415(b)(3) to clarify that the reference at the end of the subparagraph to “confidentiality and conflicts of interest” is referring to such standards as are imposed under State law. We further note that HHS will permit application assisters to perform the assistance functions outlined in § 155.415 to assist consumers using the FFEs and SBE-FPs, to the extent allowed under state law, beginning with the 2021 open enrollment period. HHS needs additional time to implement the registration and training processes necessary to operationalize this proposal while maintaining safeguards to protect consumer data and Exchange systems. SBEs that do not rely on the federal platform can implement these provisions sooner, to the extent otherwise permitted under state law. We intend to release future guidance about the form and manner of the registration and training processes under § 155.415(b)(1) for application assisters participating in the FFEs or SBE-FPs.
Under our current rules, individuals who are enrolled in employer-sponsored coverage or coverage purchased through an Exchange are eligible for a special enrollment period if they become newly eligible for APTC. However, no comparable special enrollment period exists for individuals who are enrolled in off-Exchange individual market coverage. We believe this may present a significant barrier for some individuals to remain in continuous coverage for the full plan year. Therefore, we proposed to amend § 155.420(d) to add new paragraph (d)(6)(v) to authorize Exchanges, at their option, to provide a special enrollment period to enroll in Exchange coverage for off-Exchange individual market enrollees who experience a decrease in household income and receive a new determination of eligibility for APTC by an Exchange. We proposed to make this special enrollment period available to qualified individuals and their dependents who experience circumstances that result in a decrease in household income if the qualified individual or his or her dependent are both (1) newly determined eligible for APTC by an Exchange, and (2) had MEC in which they were enrolled in and entitled to receive benefits as described in 26 CFR 1.5000A-1(b) for one or more days during the 60 days preceding the change in circumstances. We cite 26
We sought to provide individuals with more health coverage options and to empower them to enroll in the health coverage that best meets their needs and the needs of their families. For individuals and families with household incomes greater than 400 percent of the federal poverty level (FPL) who are not eligible for APTC, this may mean that they choose to purchase health insurance coverage outside of the Exchange during the annual open enrollment period or another eligible enrollment period, especially if the market outside of the Exchange offers additional plan options at more affordable prices. However, these individuals or families may experience a change in household income during the benefit year that makes their current health coverage no longer affordable. While paragraphs (d)(6)(iii) and (d)(6)(iv) currently provide special enrollment periods for individuals whose employer-sponsored coverage becomes unaffordable or does not provide minimum value, resulting in the employee becoming newly eligible for APTC, and for individuals previously in the coverage gap who become newly eligible for APTC as a result of a change in household income or move, respectively, there is no current pathway to Exchange coverage for enrollees in off-Exchange individual market plans who are newly eligible for APTC. Since no pathway to Exchange coverage currently exists, we believe that unsubsidized individual market enrollees whose household income has decreased may no longer be able to afford their unsubsidized health plans and may decide to terminate coverage mid-year. Therefore, the special enrollment period in paragraph (d)(6)(v) will address this issue by establishing a pathway to Exchange coverage for qualified individuals enrolled in off-Exchange coverage who experience a decrease in household income and are newly determined eligible for APTC. We believe that this policy will help promote continuous enrollment in health coverage and bring additional stability to the individual market risk pool, which will likely have a positive impact on health insurance premiums.
Individuals seeking to access the special enrollment period will not be current Exchange enrollees and will receive a new determination of eligibility for APTC through the Exchange's consumer application. For the FFEs, an individual's current household income and eligibility for APTC will be verified through the FFE's eligibility system and data matching issue resolution process, in accordance with the requirements in § 155.320(c). To ensure that the special enrollment period is available to the intended population while mitigating risks of adverse selection and inappropriate use, we proposed to require the individual seeking access to the special enrollment period to provide evidence of both a change in household income and of prior health coverage. Verifying that a decrease in household income occurred will prevent individuals who enrolled in health coverage off-Exchange, but have not experienced a financial change, from attempting to use this special enrollment period for the sole purpose of purchasing a more or less comprehensive level of coverage mid-year. To protect the individual market risk pool from adverse selection, as mentioned in this rule, we proposed to include a prior coverage requirement, which will protect against individuals who opted not to enroll in health coverage during the annual open enrollment period from using this special enrollment period to enroll in Exchange coverage mid-year. Additionally, this prior coverage requirement will promote continuous coverage. The prior-coverage requirement aligns with existing prior-coverage requirements for special enrollment periods at § 155.420(d)(2)(i) and (d)(7). We envision leveraging existing pre-enrollment verification procedures
We recognize that State Exchanges maintain flexibility to determine whether and how to implement pre-enrollment verification of eligibility for special enrollment periods and may not have the operational capacity to immediately implement and verify eligibility for this special enrollment period. Some State Exchanges may also determine there is insufficient need among off-Exchange consumers for this special enrollment period because of the rating and pricing practices specific to their state markets. Therefore, we proposed to make this special enrollment period available at the option of the Exchange.
This special enrollment period is intended only for individuals not currently enrolled in Exchange coverage, since current Exchange enrollees who experience a decrease in household income mid-year may already qualify for a special enrollment period under paragraphs (d)(6)(i) and (ii), or may enroll in off-Exchange plans if they become newly ineligible for APTC under § 147.104(b)(2)(i)(B).
Paragraph (a)(4)(iii) of § 155.420 generally limits the plans into which an enrollee who qualifies for a special enrollment period or is adding a dependent through a special enrollment period may enroll. Several special enrollment periods are excluded from this limitation. However, we proposed that the new special enrollment period will be subject to the rule in paragraph (a)(4)(iii). Therefore, should a qualified individual who qualifies for the special enrollment period in paragraph (d)(6)(v) already have members of his or her household enrolled in Exchange coverage and those enrollees do not qualify for another special enrollment period at the same time that provides them with additional plan enrollment flexibilities, the Exchange must allow
We also proposed to modify the types of coverage that may satisfy the prior coverage requirement by amending § 155.420(a)(5) to include the coverage types described in paragraphs (d)(1)(iii) and (iv) of this section, such as pregnancy Medicaid, CHIP unborn child, and Medically Needy Medicaid, in addition to MEC described in 26 CFR 1.5000A-1(b). We believe that this clarification is necessary to ensure consistency across our special enrollment period regulations for the types of coverage that qualify an individual for a special enrollment period. We already treat certain types of coverage, including pregnancy Medicaid, CHIP unborn child, and Medically Needy Medicaid, although not independently designated as MEC under 26 CFR 1.5000A-1(b), as MEC for purposes of qualifying for the loss of MEC special enrollment period described in § 155.420(d)(1). However, individuals currently enrolled in these types of coverage will not qualify for special enrollment periods that require prior coverage. To avoid treating the same types of coverage differently for purposes of eligibility for different special enrollment periods, we proposed an aligning edit to paragraph (a)(5).
Lastly, we proposed to clarify certain terms in § 155.420(b)(2)(iv), which addresses the coverage effective dates that apply to the special enrollment periods in § 155.420(d)(1), (d)(3), (d)(6)(iii), (d)(6)(iv), and (d)(7). Specifically, we proposed to replace the word “consumer” with the phrase “qualified individual, enrollee, or dependent, as applicable,” to align with the terminology used at § 155.420(d) to describe special enrollment period triggering events. We do not anticipate that this wording change will create additional cost or burden for Exchanges or for any other stakeholders.
Individuals can claim hardship exemptions through the tax filing process for hardships described in § 155.605(e)(1) through (4), which include most hardship exemptions, but not the general hardship types described in paragraph (d)(1) of this section. Allowing the general hardship exemption types to be claimed through the IRS will increase flexibility and decrease burdens for individuals seeking hardship exemptions. Therefore, we proposed to amend § 155.605(e), which describes the exemptions that can be claimed through the IRS tax filing process without an individual having to obtain an exemption certificate number from an Exchange, to add a new paragraph (e)(5) that will allow individuals to claim through the tax filing process hardship exemptions within all of the categories described in paragraph (d)(1) of this section on a federal income tax return
This rule aligns with HHS guidance published on September 12, 2018, entitled, “Guidance on Claiming a Hardship Exemption through the Internal Revenue Service (IRS)”
Under section 5000A of the Code, an individual must have MEC for each month, qualify for an exemption, or make an individual shared responsibility payment. Under § 155.605(d)(2), an individual is exempt from the requirement to have MEC if the amount that he or she will be required to pay for MEC (the required contribution) exceeds a particular percentage (the required contribution percentage) of his or her projected household income for a year. Although the Tax Cuts and Jobs Act reduces the individual shared responsibility payment to $0 for months beginning after December 31, 2018, the required contribution percentage is still used to determine whether individuals above the age of 30 qualify for an affordability exemption that will enable them to enroll in catastrophic coverage under § 155.305(h).
The initial 2014 required contribution percentage under section 5000A of the Code was 8 percent. For plan years after 2014, section 5000A(e)(1)(D) of the Code and Treasury regulations at 26 CFR 1.5000A-3(e)(2)(ii) provide that the required contribution percentage is the percentage determined by the Secretary of HHS that reflects the excess of the rate of premium growth between the preceding calendar year and 2013, over the rate of income growth for that period. The excess of the rate of premium growth over the rate of income growth is also used for determining the applicable percentage in section 36B(b)(3)(A) of the Code and the required contribution percentage in section 36B(c)(2)(C) of the Code.
As discussed elsewhere in this preamble, we proposed as the measure for premium growth a 2020 premium adjustment percentage of 1.2969721275 (or an increase of about 29.7 percent over the period from 2013 to 2019). We are finalizing the new premium growth measure that would be composed of individual market premium growth and employer-sponsored insurance premium growth. Therefore, as noted later in this preamble, we are finalizing a premium adjustment percentage of 1.2895211380 for the 2020 benefit year.
As the measure of income growth for a calendar year, we established in the 2017 Payment Notice that we will use per capita personal income (PI). Under the approach finalized in the 2017 Payment Notice, using the National Health Expenditure Account (NHEA) data, the rate of income growth for 2020 is the percentage (if any) by which the most recent projection of per capita PI for the preceding calendar year ($56,261 for 2019) exceeds per capita PI for 2013 ($44,922), carried out to ten significant digits. The ratio of per capita PI for 2019 over the per capita PI for 2013 is estimated to be 1.2524152976 (that is, per capita income growth of about 25 percent).
Using the 2020 premium adjustment percentage finalized in this final rule, the excess of the rate of premium growth over the rate of income growth for 2013 to 2019 is 1.2895211380/1.2524152976, or 1.0296274251. This results in a required contribution percentage of 8.00* 1.0296274251 or 8.24 percent for the 2020 benefit year, which when rounded to the nearest one-hundredth of one percent, represents a decrease of 0.07 of a percentage point from 2019 (8.23702-8.30358).
We also requested comment on whether we should exclude any government transfers (that is, Social Security, Medicare, unemployment insurance, workers' compensation, etc.) from per capita PI, but we did not receive any comments in response to this request.
We are defining the term “generic” in part 156 in response to comments requesting a definition related to the proposal that amounts paid toward cost sharing using any form of direct support offered by drug manufacturers to insured patients to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have a generic equivalent not be required to be counted toward the annual limitation on cost sharing. For a discussion of that proposal and the related definition we are finalizing at § 156.20, please see the preamble to § 156.130.
Section 1311(d)(5)(A) of the PPACA permits an Exchange to charge assessments or user fees on participating health insurance issuers as a means of generating funding to support its operations. If a state does not elect to operate an Exchange or does not have an approved Exchange, section 1321(c)(1) of the PPACA directs HHS to operate an Exchange within the state. Accordingly, in § 156.50(c), we specified that a participating issuer offering a plan through an FFE or SBE-FP must remit a user fee to HHS each month that is equal to the product of the annual user fee rate specified in the annual HHS notice of benefit and payment parameters for FFEs and SBE-FPs for the applicable benefit year and the monthly premium charged by the issuer for each policy where enrollment is through an FFE or SBE-FP.
OMB Circular No. A-25R established federal policy regarding user fees; it specifies that a user fee charge will be assessed against each identifiable recipient of special benefits derived from federal activities beyond those received by the general public. Activities performed by the federal government that do not provide issuers participating in an FFE with a special benefit are not covered by this user fee. As in benefit years 2014 through 2019, issuers seeking to participate in an FFE in the 2020 benefit year will receive two special benefits not available to the general public: (1) The certification of their plans as QHPs; and (2) the ability to sell health insurance coverage through an FFE to individuals determined eligible for enrollment in a QHP. For the 2020 benefit year, issuers participating in an FFE will receive special benefits from the following federal activities:
• Provision of consumer assistance tools;
• Consumer outreach and education;
• Management of a Navigator program;
• Regulation of agents and brokers;
• Eligibility determinations;
• Enrollment processes; and
• Certification processes for QHPs (including ongoing compliance verification, recertification, and decertification).
Based on estimated costs, enrollment, and premiums for the 2020 benefit year, we proposed a 2020 benefit year user fee rate for all participating FFE issuers of 3.0 percent of total monthly premiums. This rate is lower than the 3.5 percent FFE user fee rate that we had established for benefit years 2014 through 2019. The lower user fee rate for the 2020 benefit year reflects our estimates of premium increases and enrollment decreases for the 2020 benefit year. We sought comment on this proposal.
As discussed, OMB Circular No. A-25R established federal policy regarding user fees, and specified that a user charge will be assessed against each identifiable recipient for special benefits derived from federal activities beyond those received by the general public. SBE-FPs enter into a Federal platform agreement with HHS to leverage the systems established for the FFEs to perform certain Exchange functions, and to enhance efficiency and coordination between state and federal programs. Accordingly, in § 156.50(c)(2), we specified that an issuer offering a plan through an SBE-FP must remit a user fee to HHS, in the timeframe and manner established by HHS, equal to the product of the monthly user fee rate specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year and the monthly premium charged by the issuer for each policy where enrollment is through an SBE-FP, unless the SBE-FP and HHS agree on an alternative mechanism to collect the funds from the SBE-FP or state instead of direct collection from SBE-FP issuers. The benefits provided to issuers in SBE-FPs by the federal government include use of the federal Exchange information technology and call center infrastructure used in connection with eligibility determinations for enrollment in QHPs and other applicable state health subsidy programs, as defined at section 1413(e) of the PPACA, and QHP enrollment functions under § 155.400. The user fee rate for SBE-FPs is calculated based on the proportion of user fee eligible FFE costs that are associated with the FFE information technology infrastructure, the consumer call center infrastructure, and eligibility and enrollment services, and allocating a share of those costs to issuers in the relevant SBE-FPs. Based on this methodology, we proposed to charge issuers offering QHPs through an SBE-FP a user fee rate of 2.5 percent of the
We are finalizing the FFE and SBE-FP user fee rates for the 2020 benefit year at 3.0 and 2.5 percent of monthly premiums, respectively, as proposed.
User fee eligible costs are estimated in advance of the benefit year and are based upon contract costs that are not yet finalized. We will continue to outline user fee eligible functional areas in the Payment Notice, and will evaluate contract activities related to operation of the federal Exchange user fee eligible functions.
Section 1402 of the PPACA requires issuers to provide CSRs to help make coverage affordable for certain low- and moderate-income consumers who enroll in silver level QHPs, as well as Indians who enroll in QHPs at any metal level. Section 1402 of the PPACA further states that HHS will reimburse issuers for the cost of providing CSRs. Until October 2017, the federal government relied on the permanent appropriation at 31 U.S.C. 1324 as the source of funds for federal CSR payments to issuers. However, on October 11, 2017, the Attorney General of the United States provided HHS and the Department of the Treasury with a legal opinion indicating that the permanent appropriation at 31 U.S.C. 1324 cannot be used to fund CSR payments to insurers. In light of this opinion—and in the absence of any other appropriation that could be used to fund CSR payments—HHS directed CMS to discontinue CSR payments to issuers until Congress provides an appropriation. In response to the termination of CSR payments to issuers, many issuers increased premiums in 2018 and 2019 only on silver level QHPs to compensate for the cost of CSRs—a practice sometimes referred to as “silver loading” or “actuarial loading.” Because premium tax credits are generally calculated based on the second-lowest cost silver plan offered through the Exchange, this practice has led to consumers receiving higher premium tax credits. The cost of these higher premium tax credits are being borne by taxpayers.
Silver loading is the result of Congress not appropriating funds to pay CSRs, with the result being an increase to the premiums of benchmark plans used to calculate premium tax credits, and the federal deficit.
Some commenters suggested that HHS should phase in a limitation on silver loading after permanent and stable funding is provided, to mitigate significant out-of-pocket costs for eligible enrollees who would see the amount of their premium tax credit reduced.
In the 2019 Payment Notice, we finalized options for states to select new EHB-benchmark plans starting with the 2020 benefit year. Under § 156.111, a state may modify its EHB-benchmark plan by:
(1) Selecting the EHB-benchmark plan that another state used for the 2017 plan year;
(2) Replacing one or more EHB categories of benefits in its EHB-benchmark plan used for the 2017 plan year with the same categories of benefits from another state's EHB-benchmark plan used for the 2017 plan year; or
(3) Otherwise selecting a set of benefits that would become the state's EHB-benchmark plan.
Under any of these three options, the EHB-benchmark plan will also have to meet additional standards, including scope of benefits requirements. These options were intended to provide states with more flexibility in the selection of their EHB-benchmark plan than had previously existed. In the 2019 Payment Notice, we encouraged states to consider the potential impact on vulnerable populations as they select their new EHB-benchmark plans, and the need to educate consumers on benefit design changes. We also remind states to inform issuers of such changes should they select a new EHB-benchmark plan.
In the proposed rule, we stated that we believe that the three new options—the third in particular—may provide states with additional flexibility to address the opioid epidemic. For example, Illinois made changes to its EHB-benchmark plan for plan year 2020 that aim to reduce opioid addiction and overdose by including in its EHB-benchmark plan alternative therapies for chronic pain, restricting access to prescription opioids, and expanded coverage of mental health and substance use disorder treatment and services.
Additionally, the 2019 Payment Notice stated that we would propose subsequent EHB-benchmark plan submission deadlines in the HHS annual Notice of Benefit and Payment Parameters. Accordingly, we proposed May 6, 2019 as the deadline for states to submit the required documents for the state's EHB-benchmark plan selection for the 2021 plan year. We noted that this deadline would be delayed, if necessary, to be on or after the effective date of this final rule. To give advance notice to states and issuers, we simultaneously proposed May 8, 2020 as the deadline for states to submit the required documents for the state's EHB-benchmark plan selection for the 2022 plan year. Although not a requirement, we recommend states submit applications at least 30 days prior to the submission deadlines to ensure completion of their documents by the proposed deadlines. We recognize that these deadlines are earlier in the year than the July 2, 2018 deadline for the state's EHB-benchmark plan selection for the 2020 plan year. These deadlines would allow for an earlier finalization of a state's EHB-benchmark plan and a longer time period for issuers to develop plans that adhere to their state's new EHB-benchmark plan. States would have to have completed the required public comment period and submit a complete application by the deadlines.
In the 2019 Payment Notice, we also finalized a policy through which states may opt to permit issuers to substitute benefits between EHB categories. In the preamble to that rule, we stated that the deadlines applicable to state selection of a new benchmark plan would also apply to this state opt-in process. We therefore proposed May 6, 2019 as the deadline for states to notify us that they wish to permit between-category substitution for the 2021 plan year and May 8, 2020 as the deadline for states to notify us that they wish to permit between-category substitution for the 2022 plan year. We noted that the 2021 plan year deadline would be delayed, if necessary, to be on or after the effective date of this final rule. States wishing to make such an election must do so via the EHB Plan Management Community.
At new § 156.122(d)(3), we proposed that for plan years beginning on or after January 1, 2020, QHP issuers in the FFEs would be required to notify HHS annually in an HHS-specified format of any mid-year formulary changes made in the prior plan year consistent with the proposed changes to § 147.106(e). QHP issuers in the FFEs would be required to report the name of the drug being removed from the formulary, dosage, name of the generic equivalent, the Rx Norm Concept Unique Identifier
We solicited comments on two additional drug policies intended to consider the potential of therapeutic substitution. First, the prescription drug market became more efficient after several states passed laws that allowed for generic substitution. Similarly, therapeutic substitution, which consists of substituting chemically different compounds within the same class for one another,
Second, the majority of issuers, employers, and pharmacy benefit managers negotiate price discounts and rebates from pharmaceutical manufacturers by implementing tiered formularies, which link patients' cost-sharing obligations to the list price of each drug. Tiered formularies have been successful in attenuating the growth in pharmaceutical spending and overall drug spending. However, in recent years, drug spending has again increased. Reference-based pricing is one strategy for attenuating increases in pharmaceutical spending. Reference-based drug pricing occurs when an issuer in a commercial market covers a group of similar drugs, such as within the same therapeutic class, up to a set price, with the enrollee paying the difference in cost if the enrollee desires a drug that exceeds the set (reference) price.
One commenter supported the concept of reference-based pricing, but noted that implementation must be carefully considered. Commenters who opposed reference-based pricing stated they were not confident that there were transparency measures in place to enable reference-based pricing to be successful.
Two commenters requested that HHS postpone its consideration of implementing reference-based pricing until greater transparency is achieved throughout the entire pharmaceutical supply chain. One commenter noted that if HHS were to implement reference-based pricing, it should allow patients to request an exception from the balance billing requirement if a medication is medically necessary but exceeds the reference price. Two commenters were receptive to a policy related to reference-based pricing, noting that implementation could have a positive impact on pharmacy spending, but cautioned that because this type of pricing model may be somewhat new in the pharmacy space, it could initially cause member confusion. Some commenters cautioned that implementation of this initiative would require extensive member communication. Additionally, one commenter noted that HHS should study the various ways group benefit plans are already employing reference-based pricing before acting on regulatory requirements or incentives and cautioned against defining reference-based pricing explicitly before actually engaging in any formal regulatory activity concerning this practice, as premature definitions can be limiting.
Opioid misuse and addiction is a serious national crisis that affects public health, as well as social and economic welfare. More than 115 people in the United States die each day from opioid
Several factors have influenced the opioid crisis, including: the opioid pharmaceutical manufacturing and supply chain industry; deficient patient and provider pain management education; rogue pharmacies and unethical physician prescribing; and the insufficient availability of treatment services, including Medication-Assisted Treatment (MAT).
MAT is the use of medication approved by the FDA for addiction detoxification, relapse prevention, or maintenance treatment, in combination with counseling and behavioral therapies to treat substance use disorders and prevent overdose through detoxification, relapse prevention, and maintenance treatment.
Despite this evidence, and despite the attention paid to the nationwide opioid Public Health Emergency, there is not comprehensive, nationwide coverage of the drugs used in MAT, at least among QHP issuers. A review of QHP issuer formularies in the 39 FFE and SBE-FP states for which we have data reveals that, while many QHPs cover all four MAT drugs, not all do. Specifically, for plan year 2018, 2,553 QHPs (95 percent) in these 39 FFE and SBE-FP states cover all four of these drugs; 105 QHPs (4 percent) cover three; and 25 QHPs (<1 percent) cover two. Given the effectiveness of MAT and the severity of the nationwide opioid Public Health Emergency, we encourage every health insurance plan to provide comprehensive coverage of MAT, even if the applicable EHB-benchmark plan does not require the inclusion of all four MAT drugs on a formulary. In the proposed rule, we encouraged issuers to take every opportunity to address opioid use disorder, including increasing access to MAT and destigmatizing its use.
In addition, we stated that we have become aware that a MAT drug's inclusion on a formulary does not necessarily ensure coverage of that drug when administered for MAT. We stated that we are aware that some issuers utilize plan designs which exclude coverage of certain drugs when used for MAT while the same drugs are covered for other medically necessary purposes, such as analgesia or alcohol use disorder. Under § 156.125, which implements the provision prohibiting discrimination, an issuer does not provide EHB if its benefit design, or the implementation of its benefit design, discriminates based on an individual's age, expected length of life, present or predicted disability, degree of medical dependency, quality of life, or other health conditions.
We reminded issuers that any indication of a reduction in the generosity of a benefit in some manner for subsets of individuals that is not based on clinically indicated, reasonable medical management practices is potentially discriminatory. As is the case for any EHB, issuers are expected to impose limitations and exclusions on the coverage of benefits to treat opioid use disorder, including the drugs used for MAT or any associated benefit such as counseling or drug screenings, based on clinical guidelines and medical evidence, and are expected to use reasonable medical management. If a plan excludes certain treatment of opioid use disorder, but covers the same treatment for other medically necessary purposes, the issuer must be able to justify such an exclusion with supporting documentation explaining how such a plan design is not discriminatory.
We noted that a similar standard is imposed under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) (section 2726 of the PHS Act).
We also noted that federal civil rights laws, such as title II of the Americans with Disabilities Act and section 504 of the Rehabilitation Act, prohibit discrimination against individuals who participate in or have completed substance use disorder treatment, including MAT.
A number of comments outside the scope of this rule encouraged HHS and states to take aggressive enforcement actions against all discriminatory benefit designs, including plan designs that may violate MHPAEA. A number of commenters suggested that discriminatory benefit designs exist with regards to women's health benefits and benefits for the treatment of sexually transmitted diseases.
Section 1302(c)(4) of the PPACA directs the Secretary to determine an annual premium adjustment percentage, a measure of premium growth that is used to set the rate of increase for three parameters detailed in the PPACA: (1) The maximum annual limitation on cost sharing (defined at § 156.130(a)); (2) the required contribution percentage used to determine eligibility for certain exemptions under section 5000A of the Code (defined at § 155.605(d)(2)); and (3) the employer shared responsibility payment amounts under section 4980H(a) and (b) of the Code (see section 4980H(c)(5) of the Code). Section 1302(c)(4) of the PPACA and § 156.130(e) provide that the premium adjustment percentage is the percentage (if any) by which the average per capita premium for health insurance coverage for the preceding calendar year exceeds such average per capita premium for health insurance for 2013, and the regulations provide that this percentage will be published in the annual HHS notice of benefit and payment parameters. To calculate the premium adjustment percentage for the 2020 benefit year, we calculate the percentage by which the average per capita premium for health insurance coverage for 2019 exceeds the average per capita premium for health insurance for 2013, and round the resulting percentage to 10 significant digits. The resulting premium index reflects cumulative, historic growth in premiums from 2013 onwards.
The 2015 Payment Notice (79 FR 13743) and 2015 Market Standards Rule (79 FR 30240) established a methodology for estimating the average per capita premium for purposes of calculating the premium adjustment percentage for the 2015 benefit year and beyond. Beginning with the 2015 benefit year, the premium adjustment percentage was calculated based on the estimates and projections of average per enrollee employer-sponsored insurance premiums from the NHEA, which are calculated by the CMS Office of the Actuary. In the proposed 2015 Payment Notice, we proposed that the premium adjustment percentage be calculated based on the projections of average per enrollee private health insurance premiums. Based on comments received, we finalized the 2015 Payment Notice to instead use per enrollee employer-sponsored insurance premiums in the methodology for calculating the premium adjustment percentage. We chose employer-sponsored insurance premiums because they reflected trends in health care costs without being skewed by individual market premium fluctuations resulting from the early years of implementation of the PPACA market reforms. We adopted this methodology in subsequent Payment Notices for 2016 through 2019, but noted in the 2015 Payment Notice that we may propose to change our methodology after the initial years of implementation of the market reforms, once the premium trend is more stable.
As discussed in the 2015 Payment Notice, we considered four criteria when finalizing the premium adjustment percentage methodology for the 2015 benefit year: (1) Comprehensiveness—the premium adjustment percentage should be calculated based on the average per capita premium for health insurance coverage for the entire market, including the individual and group markets, and both fully insured and self-insured group health plans; (2) Availability—the data underlying the calculation should be available by the summer of the year that is prior to the calendar year so that the premium adjustment percentage can be published in the annual HHS notice of benefit and payment parameters in time for issuers to develop their plan designs; (3) Transparency—the methodology for estimating the average premium should be easily understandable and predictable; and (4) Accuracy—the methodology should have a record of accurately estimating average premiums. We continue to consider these criteria as we evaluate other sources of premium data that could be used in calculating the premium adjustment percentage.
To date, the NHEA projections of per enrollee employer-sponsored insurance premiums have also been used by the Department of the Treasury and the IRS for determining the applicable percentage in section 36B(b)(3)(A) of the Code and the required contribution percentage in section 36B(c)(2)(C) of the Code.
The required contribution percentage in section 36B(c)(2)(C) of the Code is used to determine whether an offer of employer-sponsored insurance is considered affordable for an individual, which relates to eligibility for the premium tax credit because an individual with an offer of affordable employer-sponsored insurance that
Section 36B(b)(3)(A)(ii) of the Code generally provides that the applicable percentages are to be adjusted after 2014 to reflect the excess of the rate of premium growth over the rate of income growth for the preceding year. Section 36B(c)(2)(C) of the Code provides that the required contribution percentage is to be adjusted after 2014 in the same manner as the applicable percentages are adjusted in section 36B(b)(3)(A)(ii) of the Code. As noted in this rule, the Department of the Treasury and the IRS have issued guidance providing that the rate of premium growth for purposes of these section 36B provisions is based on per enrollee spending for employer-sponsored insurance as published in the NHEA.
In the proposed rule, we proposed to modify the premium growth measure that we used to calculate the premium adjustment percentage for the 2020 benefit year and beyond. We proposed to use a more comprehensive premium measure that captures increases across the market, including individual market premiums and employer-sponsored insurance premiums, for purposes of calculating the premium adjustment percentage. Specifically, we proposed to calculate the premium growth measures for 2013 and 2019 as private health insurance premiums minus premiums paid for Medigap insurance and property and casualty insurance, divided by the unrounded number of unique private health insurance enrollees, excluding all Medigap enrollees.
This premium measure is an adjusted private individual and group market health insurance premium measure, which is similar to NHEA's private health insurance premium measure. NHEA's private health insurance premium measure includes premiums for employer-sponsored insurance, “direct purchase insurance,” which includes individual market health insurance purchased directly by consumers from health insurance issuers, both on and off the Exchanges, and Medigap insurance, and the medical portion of accident insurance (“property and casualty” insurance). The measure we proposed to use is published by NHEA and includes NHEA estimates and projections of employer-sponsored insurance and direct purchase insurance premiums, but we proposed to exclude Medigap and property and casualty insurance from the premium measure since these types of coverage are not considered primary medical coverage for individuals who elect to enroll. We proposed to use per enrollee premiums for private health insurance (excluding Medigap and property and casualty insurance) so that the premium growth measure more closely reflects premium trends for all individuals primarily covered in the private health insurance market since 2013, and we anticipated that the proposed change to use per enrollee premiums for private health insurance (excluding Medigap and property and casualty insurance) would additionally reduce federal premium tax credit expenditures, if the Department of the Treasury and the IRS were to adopt the proposed change.
Using the private health insurance premium measure (excluding Medigap and property and casualty insurance), we proposed that the premium adjustment percentage for 2020 be the percentage (if any) by which the most recent NHEA projection of per enrollee premiums for private health insurance (excluding Medigap and property and casualty insurance) for 2019 (when proposed, $6,468) exceeds the most recent NHEA estimate of per enrollee premiums for private health insurance (excluding Medigap and property and casualty insurance) for 2013 (when proposed, $4,987).
We are finalizing the proposal to use per enrollee private health insurance premiums (excluding Medigap and property and casualty insurance) in the premium adjustment percentage calculation. As we discussed in the proposed rule, immediate application of this change will result in a faster premium growth rate for the foreseeable future than if we continued to use only employer-sponsored insurance premiums as in prior benefit years. We anticipate that this change will have several impacts on the health insurance market. As explained in this rule, the premium adjustment percentage is used to set the rate of increase for the maximum annual limitation on cost sharing, the required contribution percentage used to determine eligibility for certain exemptions under section 5000A of the Code, and the employer shared responsibility payment amounts under section 4980H(a) and (b) of the Code. Accordingly, a premium adjustment percentage that reflects a faster premium growth rate would result in a higher maximum annual limitation on cost sharing, a higher required contribution percentage, and higher employer shared responsibility payment amounts than if the current premium adjustment percentage premium measure (employer-sponsored insurance only) were adopted for the 2020 benefit year.
In the proposed rule, we stated that, if we finalize a change to the premium measure used in the premium adjustment percentage for the 2020 benefit year, we expect the Department of the Treasury and the IRS to issue additional guidance to adopt the same premium measure for purposes of future indexing of the applicable percentage and required contribution percentage under section 36B of the Code. Additionally, the Health Insurance Providers Fee established under section 9010 of the PPACA also takes the measure of premium growth used for the applicable percentage in section 36B(b)(3)(A)(ii) of the Code into consideration for purposes of calculating the fee for 2019 and beyond.
We have updated the impact estimates in the Regulatory Impact Analysis of this final rule to reflect impact estimates provided by the Department of the Treasury, pending their anticipated adoption of the premium measure finalized in this rule.
Although commenters expressed concern about the impacts resulting from this change, as discussed later in the preamble of this final rule, we are finalizing the change as proposed—to use per enrollee private health insurance premiums (excluding Medigap and property and casualty insurance) as the premium growth measure for purposes of calculating the premium adjustment percentage. This approach allows us to achieve the statutory and regulatory goals of a more comprehensive and accurate measure of premium costs across the private market.
Using the proposed premium measure, the premium adjustment percentage is calculated as the difference between the percentage (if any) by which the most recent NHEA projection of per enrollee premiums for private health insurance (excluding Medigap and property and casualty insurance) for 2019 ($6,436) exceeds the most recent NHEA estimate of per enrollee premiums for private health insurance (excluding Medigap and property and casualty insurance) for 2013 ($4,991), carried out to 10 significant digits.
Several commenters noted that individual market premiums should not be used to measure premium growth since 2013 because premiums have increased due to PPACA market reforms and federal policy and legislative changes, including changes in the composition of the individual market risk pool that occurred with the elimination of pre-existing condition exclusions, the inclusion of a richer benefit package and lower cost-sharing than typically provided in the individual market in 2013, the cessation of CSR payments, the reduction of the individual shared responsibility penalty to $0, and the ending of the reinsurance program. Commenters stated these premium increases should not be included in the measure of premium growth because they are not based on utilization or cost of medical services.
Several commenters noted our methodology is flawed because the proposal starts with 2013 as the base year, but the indexing provisions of section 1401 of the PPACA start with “the calendar year after 2014” (2015) and then use the preceding year, or 2014 as the base year. They state that since EHB did not go into effect until 2014, utilizing a base year earlier than 2014 does not compare the prices of like individual insurance products. Several commenters recommended HHS use a base year no earlier than 2018 (rather than 2013) to avoid inclusion of premium increases resulting from PPACA market reforms and other federal policy and legislative decisions. Some commenters noted that HHS considered and rejected adopting using individual market premiums in the premium measure for the premium adjustment percentage for the 2015 benefit year because the premium trend was not stable, and the premium trend is still not stable, citing the PPACA policy and legislative changes mentioned in this rule and that 2019 is the first year new rules have taken effect regarding short-term, limited-duration insurance (STLDI) plans and association health plans (AHP), which may further disrupt the market and increase premiums. One commenter recommended only using individual market premium increases for underlying medical trends (in other words, not including premium increases resulting from federal policy and legislative changes), while a few commenters indicated that the change is not statutorily required, and urged HHS to delay the change until the premium trend is more stable.
Several commenters stated HHS's justification provided for this change is inadequate and contrary to the legislative intent of the financial assistance structure of the PPACA. One commenter noted that the primary purpose of providing APTC to Exchange enrollees is so that the federal government, rather than low-income individuals and families, bears the burden of any premium increases in the individual market. A few commenters urged HHS to consider other ways to reduce federal expenditures, or to focus on efforts at lowering the overall cost of health care, rather than placing the burden on households. One commenter supported keeping federal costs reasonable, but was concerned about HHS doing so by way of reducing PTC to consumers, which will increase the number of uninsured individuals. Another commenter noted that while the proposed change will result in federal PTC savings (a decreased taxpayer burden), consumers receiving APTC are taxpayers, and that the negative effects of reducing their APTC would outweigh the benefits of lower tax burden.
Another commenter noted that the proposed change will impact the coverage “affordability” percentages
As stated in the 2015 Payment Notice, we previously excluded premiums from the individual market because they were most affected by the significant changes in benefit design and market composition in the early years of implementation of the PPACA market rules and were most likely to be subject to risk premium pricing. However, the PPACA is now past the initial years of implementation and issuers have had the opportunity to collect data on the risk composition of the individual market and adjust pricing accordingly. We have concluded, based on the general trend of stabilizing average premiums in the individual market,
While the PPACA does contain financial assistance provisions that shift costs from consumers to the federal government as noted by commenters, it also requires the Secretary to measure premium growth, so that the effects of premium growth can be reflected in other payment parameters. As such, although we are sensitive to commenters' concerns about the potential impact on consumers, we continue to believe that a premium growth measure that affects cost-sharing and payment parameters in the employer group markets and individual health insurance market should comprehensively reflect premium growth in all affected markets, and should not be limited to employer-sponsored insurance growth. In effect, this change is a technical correction for measuring premium growth, as the previous exclusion of individual market data was not the most comprehensive method of premium growth measurement, but was deemed necessary as a result of the premium instability in the individual market immediately following implementation of the PPACA market reforms.
Additionally, while we recognize comments noting that recipients of PTC are also taxpayers, reducing federal expenditures is not strictly a benefit to the federal government, but to all taxpayers, which includes those who are not PTC recipients. Further, we understand that the premium adjustment percentage is relevant to determine the affordability of plans offered by applicable large employers for purposes of the employer shared responsibility provisions. We will continue to work closely with the Department of the Treasury and the IRS to timely release information on the indexing of the various PPACA provisions.
With respect to the comments requesting we use a different base year, the applicable statute, section 1302(c)(4) of the PPACA, requires the Secretary of HHS to establish a premium adjustment percentage that measures premium growth between the preceding calendar year (2019, in this case) and 2013. It is not legally permissible to change the base year to any year other than 2013, including the base year reflected in the PPACA section cited by commenters, section 1401.
One commenter expressed that the proposed change will be doubly punitive to its state residents because as part of the state's market stabilization efforts, residents are subjected to a penalty for not carrying insurance. Additionally, the commenter noted that states that developed section 1332 waivers will be unduly penalized by this change because it will result in a reduction of premium tax credits. Another commenter noted that if more states implement section 1332 waivers, then a premium adjustment percentage that incorporates individual market premium changes would also reflect the impact of these waivers (that is, reduced individual market premiums) and could result in additional federal expenditures on premium tax credits through reduced required contributions. The commenter noted there could be challenges for states seeking new waivers to reflect the impact of this consideration when evaluating compliance with the deficit neutrality guardrail and the available amount of federal pass-through funding in their waiver applications.
Based on the final 2020 premium adjustment percentage, we are finalizing the following cost-sharing parameters for benefit year 2020.
Under § 156.130(a)(2), for the 2020 calendar year, cost sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2020. For other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50.
In the proposed rule, we proposed that the 2020 maximum annual limitation on cost sharing would be $8,200 for self-only coverage and $16,400 for other than self-only coverage, based on the previously proposed premium adjustment percentage of 1.2969721275 for 2020, and the 2014 maximum annual limitation on cost sharing of $6,350 for self-only coverage, which was published by the IRS on May 2, 2013.
Sections 1402(a) through (c) of the PPACA direct issuers to reduce cost sharing for EHBs for eligible individuals enrolled in a silver-level QHP. In the 2014 Payment Notice, we established standards related to the provision of these cost-sharing reductions. Specifically, in part 156, subpart E, we
As discussed in this rule, the finalized 2020 maximum annual limitation on cost sharing will be $8,150 for self-only coverage and $16,300 for other than self-only coverage. We analyzed the effect on AV of the reductions in the maximum annual limitation on cost sharing described in the statute to determine whether to adjust the reductions so that the AV of a silver plan variation will not exceed the AV specified in the statute. In this rule, we describe our analysis for the 2020 plan year and our proposed results.
Consistent with our analysis in the Payment Notices for 2014 through 2019, we developed three test silver-level QHPs, and analyzed the impact on AV of the reductions described in the PPACA to the proposed estimated 2020 maximum annual limitation on cost sharing for self-only coverage ($8,200). The test plan designs are based on data collected for 2019 plan year QHP certification to ensure that they represent a range of plan designs that we expect issuers to offer at the silver level of coverage through the Exchanges. For 2020, the test silver-level QHPs included a PPO with typical cost-sharing structure ($8,200 annual limitation on cost sharing, $2,575 deductible, and 20 percent in-network coinsurance rate); a PPO with a lower annual limitation on cost sharing ($5,250 annual limitation on cost sharing, $3,500 deductible, and 20 percent in-network coinsurance rate); and an HMO ($8,200 annual limitation on cost sharing, $4,300 deductible, 20 percent in-network coinsurance rate, and the following services with copayments that are not subject to the deductible or coinsurance: $500 inpatient stay per day, $500 emergency department visit, $25 primary care office visit, and $55 specialist office visit). All three test QHPs meet the AV requirements for silver level health plans.
We then entered these test plans into the proposed 2020 AV Calculator and observed how the reductions in the maximum annual limitation on cost sharing specified in the PPACA affected the AVs of the plans. We found that the reduction in the maximum annual limitation on cost sharing specified in the PPACA for enrollees with a household income between 100 and 150 percent of FPL (
We tested again using the numbers based on the final premium adjustment percentage, which are reflected below, and arrived at the same conclusions. We are therefore not considering any changes to the level of the reductions at this time.
In prior years we found, and we continue to find, that for individuals with household incomes of 250 to 400 percent of FPL, without any change in other forms of cost sharing, any reduction in the maximum annual limitation on cost sharing will cause an increase in AV that exceeds the maximum 70 percent level in the statute. As a result, we did not propose to reduce the maximum annual limitation on cost sharing for individuals with household incomes between 250 and 400 percent of FPL.
We note that for 2020, as described in § 156.135(d), states are permitted to submit for approval by HHS state-specific datasets for use as the standard population to calculate AV. No state submitted a dataset by the September 1, 2018 deadline.
We proposed several policy changes to cost-sharing requirements, including a policy change as to what is included as EHB, which would affect the annual out-of-pocket limitation under PHS Act section 2707(b) and the annual and lifetime dollar limit prohibition under PHS Act section 2711. Although large group market coverage and self-insured group health plans are not required to cover all EHB, non-grandfathered group health plans and health insurance issuers are subject to PHS Act section 2707(b), and all group health plans and group health insurance issuers are subject to PHS Act section 2711, which are incorporated by reference in the Employee Retirement Income Security Act of 1974 (ERISA) and the Code.
In 2014, the Departments of Labor, HHS, and the Treasury
The FAQ also states that for non-grandfathered health plans in the individual and small group markets that must provide coverage of EHB, additional requirements apply.
Given the increase in the cost of prescription drugs, and particularly brand drugs, in the proposed rule, we stated that HHS believes additional flexibility is needed for health plans in the individual and small group markets that must provide coverage of the EHB to encourage consumers to use more cost effective generic drugs. We proposed, subject to applicable state law, to allow a plan that covers both a brand prescription drug and its generic equivalent, for plan years beginning on or after January 1, 2020, to consider the brand drug to not be EHB, if the generic drug is available and medically appropriate for the enrollee, unless coverage of the brand drug is determined to be required under an exception process at § 156.122(c).
Under such circumstances, if an enrollee purchases the brand drug when the generic equivalent was available and medically appropriate, we proposed that the issuer would be permitted to not count the difference in cost sharing between that which is paid for the brand drug and that which would be paid for the generic equivalent drug toward the annual limitation on cost sharing under § 156.130, but would still be required to attribute the cost sharing that would have been paid for the generic equivalent toward the annual limitation on cost sharing under § 156.130. This would maintain a balance between incentivizing the use of lower-cost drugs and the consumer protection provided by the annual limitation on cost sharing.
We further proposed that for a plan to do so, the plan must have an exception process in place in accordance with § 156.122(c) for the enrollee to request coverage of the brand drug.
If finalized, this interpretation would have permitted all group health plans and group health insurance issuers to impose lifetime and annual dollar limits on such brand drugs because they would no longer be considered EHB and not be subject to the prohibition on such limits.
HHS also considered an alternate proposal, under which an issuer would have been permitted to except the entire amount paid by a patient for a brand drug for which there is a medically appropriate generic alternative from the annual limitation on cost sharing at § 156.130. Because this alternate proposal also relied on an interpretation of what is considered EHB, the alternate proposal would have also applied to non-grandfathered group health plans and health insurance issuers subject to the annual limit on cost-sharing provision under PHS Act 2707(b), and in ERISA section 715 and Code section 9815.
We proposed that these changes to the annual limitations on cost sharing would be effective starting with the 2020 plan year. We solicited comments on these alternatives, both of which we proposed to apply to group health plans, group health insurance coverage, and individual market coverage, regardless of whether they are required to cover EHBs.
An issuer taking advantage of this proposed flexibility would be excluding the brand drug from coverage as EHB. Therefore, the issuer also could have imposed annual or lifetime dollar limits on coverage of the brand drug under those circumstances. Additionally, PTC (and APTC) could not be applied to any portion of the premium attributable to coverage of brand name drugs not covered as EHB, so issuers of QHPs would be required to calculate that portion of QHPs' premiums and report it to the applicable Exchange.
We also solicited comments on any limitation on group health plans' and health insurance issuers' information technology systems being able to accumulate the cost sharing consistent with this policy, whether this proposed policy should be subject to or preempt any state law regarding the application of cost sharing between the generic and branded version of a drug that would prevent the application of this proposed policy, and whether an issuer not attributing cost-sharing to the annual limitation on cost sharing under this approach should be considered an adverse coverage determination and subject to the coverage appeals processes under § 147.136.
Finally, we sought comment regarding whether we should
Drug manufacturers often offer coupons to patients to reduce patient out-of-pocket costs. Drug manufacturers may offer these coupons for various reasons: To compete with another brand name drug in the same therapeutic class, to compete with a generic equivalent when released, or to assist consumers whose drug costs would otherwise be extremely high due to a rare or costly condition.
We recognize that copayment support may help beneficiaries by encouraging adherence to existing medication regimens, particularly when copayments may be unaffordable to many patients. However, the availability of a coupon may cause physicians and beneficiaries to choose an expensive brand-name drug when a less expensive and equally effective generic or other alternative is available. When consumers are relieved of copayment obligations, manufacturers are relieved of a market constraint on drug prices which can distort the market and the true costs of drugs. Such coupons can add significant long-term costs to the health care system that may outweigh the short-term benefits of allowing the coupons, and counter-balance issuers' efforts to point enrollees to more cost effective drugs.
The Administration has identified high and rising out-of-pocket costs for prescription drugs, among other issues, as a challenge to consumers. In some cases, manufacturer coupons may be increasing overall drug costs and can lead to unnecessary spending by issuers, which is passed on to all patients in the form of increased premiums and reduced coverage of other potentially useful health care interventions. While the PPACA does not speak directly to the accounting and use of drug manufacturer coupons to the annual limitation on cost sharing, we believe that the overall intent of the law was to establish annual limitations on cost sharing that reflect the actual costs that are paid by the enrollee. The proliferation of drug coupons supports higher cost brand drugs when generic alternatives are available which in turn supports higher drug prices and increased costs to all Americans and for other federal health programs.
For these reasons, at new § 156.130(h)(2), we proposed, for plan years beginning on or after January 1, 2020, notwithstanding any other provision of the annual limitation on cost sharing regulation, that amounts paid toward cost sharing using any form of direct support offered by drug manufacturers to insured patients to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have a generic equivalent are not required to be counted toward the annual limitation on cost sharing. Not counting such amounts toward the annual limitation
We noted that this proposal, which is permissive, would also apply to non-grandfathered group health plans, to which the annual out-of-pocket limitation applies under PHS Act section 2707(b) as incorporated into the Code and ERISA.
We sought comment on this proposal and whether states should be able to decide how coupons are treated. Additionally, we sought comment on whether it would be difficult for issuers to carve out direct support offered by drug manufacturers from their calculation of enrollees' payments toward their annual limitation on cost sharing, and to carve out exceptions (for when a generic equivalent is not available, for example), when cost sharing paid by direct support offered by drug manufacturers will be counted toward the annual limitation on cost sharing, including whether information technology systems could be easily updated for this purpose. We also sought comment on issuers' ability to differentiate between drug manufacturer coupons and other drug coupons, whether their information technology systems would need modifications to make such differentiation, what a reasonable implementation date would be if implementation barriers exist, and how drug discount programs (as opposed to coupons) should be treated under this proposal. Finally, we sought comment regarding whether this policy should be limited to QHPs only.
We are finalizing the policy as proposed, subject to the modifications discussed in the following responses to comments and a non-substantive grammatical correction. In addition, for consistency with the terminology currently used in § 156.130, we are making a non-substantive modification to the finalized regulatory text from “insured patients” to “enrollees”. This modification is not intended to reflect a change in policy. Under this final rule, issuers are permitted to utilize this policy only to the extent permissible by applicable state law.
We believe that standardizing drug manufacturer coupon and discount programs is outside the scope of this rulemaking. We will consider these and other comments as we develop future policy in this area.
At § 156.280(c)(3), we proposed that, beginning with plan year 2020, if a QHP issuer provides coverage of non-Hyde abortion services
Regulatory reform and reducing regulatory burden are high priorities for us. To lower health care costs, enhance patient care, and reduce the regulatory burden on the health care industry, including for health plan issuers and the providers who deliver services through their plans, in October 2017, we launched the Meaningful Measures Initiative.
The Meaningful Measures Framework is a strategic tool for putting patients over paperwork by identifying the highest priority areas for quality measurement and quality improvement, to assess the core quality of care issues that are most vital to advancing our work to improve patient outcomes. This initiative is a new approach to quality measures that will foster operational efficiencies that include decreasing data collection and reporting burden while focusing on quality measurement aligned with meaningful outcomes.
By including Meaningful Measures in our quality reporting and quality improvement programs such as the Quality Rating System, QHP Enrollee Experience Survey and the Quality Improvement Strategy, we believe that we can also address the following cross-cutting measure criteria:
• Eliminating disparities;
• Tracking measurable outcomes and impact;
• Safeguarding public health;
• Achieving cost savings;
• Improving access for rural communities; and
• Reducing burden.
We encourage QHP issuers to use performance measures aligned with the Meaningful Measures Initiative in fulfilling their certification requirement to implement a Quality Improvement Strategy that provides increased reimbursement or other market-based incentives for improving health outcomes of plan enrollees.
In addition, we will continue to assess quality measures in our programs including the Quality Rating System and the QHP Enrollee Experience Survey, to ensure that we are using a parsimonious set of the most meaningful measures for patients, clinicians, and health plans in those quality programs. If we propose any changes or removal of measures, we will include those for public comment in the Annual Call Letter for the QRS and QHP Enrollee Survey,
As described in the preamble to §§ 155.220, 155.221, and 155.415, we proposed significant changes to these regulations to streamline and consolidate the requirements applicable to all direct enrollment entities—both QHP issuers and web-brokers. To reflect these changes, we also proposed conforming changes in § 156.1230(a)(2)
Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 30-day notice in the
• 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.
We solicited public comment on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements.
To derive wage estimates, we generally used data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for fringe benefits and overhead) for estimating the burden associated with the ICRs.
As indicated, employee hourly wage estimates have been adjusted by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly across employers, and because methods of estimating these costs vary widely across studies. Nonetheless, there is no practical alternative, and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
In this final rule, we are codifying § 153.630(g)(3), under which an issuer will be exempt from risk adjustment data validation, beginning with the 2018 benefit year of risk adjustment data validation, if an issuer is in liquidation, or will enter liquidation no later than April 30th of the benefit year that is 2 benefit years after the benefit year being audited, provided that the issuer meets certain requirements. To qualify for this exemption, the issuer must provide to HHS, in a manner and timeframe to be specified by HHS, an attestation that the issuer will enter liquidation no later than April 30th of the benefit year that is 2 benefit years after the benefit year being audited that is signed by an individual who can legally and financially bind the issuer. To qualify for the exemption, an issuer also could not have been a positive error rate outlier in the prior benefit year's risk adjustment data validation. We continue to anticipate that fewer than 10 issuers will submit this information to HHS annually. Under 5 CFR 1320.3(c)(4), this ICR will not be subject to the PRA, as it will affect fewer than 10 entities in a 12-month period.
We are finalizing the proposal to codify at § 153.630(g)(1) and (2) two exemptions for certain issuers from risk adjustment data validation that were finalized in the 2018 and 2019 Payment Notices. The reduction in burden for issuers who meet the criteria to be exempted under proposed § 153.630(g)(1) and (2) was estimated in those rules, and have been incorporated into OMB Control Number 0938-1155 (CMS-10401—“Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment). Codifying these policies as part of HHS regulations as finalized in this rulemaking will not affect current burden estimates.
We are finalizing the requirement at § 155.220(c)(4)(i)(A), for web-brokers to provide HHS a list of agents or brokers that by contract or other arrangement use the web-broker's website to assist consumers with QHP selection or completion of the Exchange eligibility application, in a form and manner to be specified by HHS. Currently, § 155.220(c)(4)(i)(A) requires the provision of this information if requested by HHS. The burden on a web-broker to comply with this requirement is covered by the information collection currently approved under OMB control number 0938-1349 (CMS-10650—State Permissions for Enrollment in Qualified Health Plans in the Federally Facilitated Exchange & Non-Exchange Entities).
We are finalizing the provision at § 155.220(g)(3)(ii), to allow HHS to immediately terminate an agent's or broker's agreement(s) with the FFEs for cause with notice if an agent or broker fails to comply with the requirement to maintain the appropriate licensure in every state in which the agent or broker actively assists consumers with enrolling in QHPs on the FFEs or SBE-FPs. An agent or broker whose agreement(s) with the FFEs are immediately terminated for cause under
We are finalizing the proposal at § 155.220(m)(3), that the Exchange may collect from a web-broker during its registration with the Exchange under § 155.220(d)(1) or at another time on an annual basis, in a form and manner specified by HHS, information sufficient to identify the individuals who comprise the entity's corporate leadership or ownership, as well as any corporate or business relationships with other entities that may seek to register with the FFE as a web-broker. We believe the burden on a web-broker to comply with these requirements is covered by the information collection currently approved under OMB control number 0938-1349 (CMS-10650—State Permissions for Enrollment in Qualified Health Plans in the Federally Facilitated Exchange & Non-Exchange Entities). In the supporting statement for that information collection, we stated web-brokers will also be required to provide other documentation as requested in response to emerging compliance issues, for HHS to monitor compliance. The information we proposed to collect based on proposed § 155.220(m)(3) is the type of information we anticipated when we referenced other documentation in response to emerging compliance issues.
We are finalizing the proposed provision at § 155.221(b)(2) to require direct enrollment entities (both QHP issuers and web-brokers) to prominently display a standardized disclaimer, in the form and manner provided by HHS, to assist consumers in distinguishing between direct enrollment entity website pages that display QHPs and those that display non-QHPs during a single shopping experience. HHS will provide the exact text for this disclaimer and the language will not need to be customized. As described in the preamble, we will provide further information on the text and other display details for the standardized disclaimer in guidance. At that time, we will estimate the burden associated with this requirement, solicit public comment, and request OMB approval in accordance with the PRA, as may be necessary.
We are finalizing the proposed special enrollment period at § 155.420(d)(6)(v), which will be subject to pre-enrollment verification of eligibility for the FFEs. Where possible, the FFE makes every effort to verify an individual's eligibility for the applicable special enrollment period through automated electronic means instead of through an applicant's submission of documentation. Consistent with other special enrollment periods subject to pre-enrollment verification, individuals will be required to provide supporting documentation
We estimate an additional 4,700 consumers will submit documents annually to verify their eligibility to enroll through the proposed special enrollment period in the FFE, and that a consumer will, on average, spend approximately 1 hour gathering and submitting required documentation. Using the average hourly wage for all occupations (at an hourly rate of $48.68), we estimate the opportunity cost to a consumer completing this task to be approximately $48.68. We estimate the total annual burden on those consumers submitting documentation will be approximately 4,700 hours with an equivalent cost of approximately $228,796.
We are revising the information collection currently approved under OMB control number 0938-1207 (CMS-10468—Medicaid and Children's Health Insurance Programs: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment) to account for this additional burden. SBEs that choose to operationalize the proposed special enrollment period are encouraged to follow the same approach for pre-enrollment verification of special enrollment period eligibility.
We do not anticipate that the amendment to § 155.605(e) will create additional costs on, or burdens to, the Exchanges. We anticipate it will decrease burden on those consumers who, when applying for a hardship exemption, choose to apply for the exemption through the IRS for 2018, saving them approximately 16 minutes since they will not be required to complete the exemption application or submit supporting documentation. HHS will continue to process exemptions under current regulations for all SBEs that elect this option, and anticipates a decrease in the volume of exemptions processed.
Based on historical data of the exemptions program and anticipating a decrease in individuals applying for exemptions as a result of the Tax Cuts and Jobs Act that reduced to $0 the individual shared responsibility payment for months beginning after December 31, 2018, we estimate that approximately 50,000 individuals will apply for a hardship exemption annually through the FFE.
We estimate that the annual reduction in burden for the expected 30,000 hardship exemptions through the IRS for 2018 will be approximately 8,100 hours. Using the average hourly wage for all occupations (at an hourly rate of $48.68 per hour) we estimate that the annual reduction in cost for each consumer will be approximately $13, and the annual cost reduction for all consumers applying for hardship exemptions through the IRS for 2018 will be approximately $394,308.
We anticipate the burden will also be reduced for those consumers who currently apply through Connecticut.
We will revise the information collection currently approved under OMB control number 0938-1190 (CMS-10466—Patient Protection and Affordable Care Act: Exchange Functions Eligibility for Exemptions) to account for this burden reduction.
We have submitted a copy of this final rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the collections discussed in this rule, please visit CMS' website at
We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the
ICR-related comments are due May 28, 2019.
This final rule finalizes standards related to the risk adjustment program for the 2020 benefit year, clarifications and improvements to the risk adjustment data validation program, as well as certain modifications that will promote transparency, innovation in the private sector, reduce burden on stakeholders, and improve program integrity. The Premium Stabilization Rule, previous Payment Notices, and final risk adjustment
We have examined the impacts 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), section 202 of the Unfunded Mandates Reform Act of 1995 (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)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for rules with economically significant effects ($100 million or more in any 1 year).
Section 3(f) 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 (also referred to as “economically significant”); (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. A RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a “significant” regulatory action is subject to review by OMB. HHS has concluded that this final rule is likely to have economic impacts of $100 million or more in at least 1 year, and therefore, meets the definition of “significant rule” under Executive Order 12866. Therefore, HHS has provided an assessment of the potential costs, benefits, and transfers associated with this final rule. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
The provisions in this final rule aim to ensure taxpayer money is more appropriately spent and that states have additional flexibility and control over their insurance markets. They will reduce regulatory burden, and reduce administrative costs for consumers and direct enrollment entities.
HHS anticipates that the provisions of this final rule will help further the HHS' goal of ensuring that all consumers have access to quality and affordable health care and are able to make informed
In accordance with OMB Circular A-4, Table 12 depicts an accounting statement summarizing HHS' assessment of the benefits, costs, and transfers associated with this regulatory action.
This final rule implements standards for programs that will have numerous effects, including providing consumers with access to affordable health insurance coverage, reducing the impact of adverse selection, and stabilizing premiums in the individual and small group health insurance markets and in an Exchange. We are unable to quantify all benefits and costs of this final rule. The effects in Table 12 reflect qualitative impacts and estimated direct monetary costs and transfers resulting from the provisions of this final rule for health insurance issuers and consumers. The annualized monetized costs described in Table 12 reflect direct administrative costs and savings to health insurance issuers and consumers as a result of the provisions regarding special enrollment periods, use of direct enrollment entity application assisters to carry out responsibilities currently performed by agents or brokers, and applying for hardship exemptions. The annualized monetized transfers described in Table 12 include changes to costs associated with the risk adjustment user fee paid to HHS by issuers, the potential increase in PTC for those qualifying individuals that use the new special enrollment period, and the potential decrease in PTC and increase in health insurance provider fees and employer shared responsibility payments due to the change in the premium adjustment percentage, and the corresponding changes the Department of the Treasury and the IRS are expected to make with regard to their policies on calculating these parameters. We are finalizing the risk adjustment user fee of $2.16 per billable member per year for the 2020 benefit year to operate the risk adjustment program on behalf of states,
This RIA expands upon the impact analyses of previous rules and utilizes the Congressional Budget Office's (CBO) analysis of the PPACA's impact on federal spending, revenue collection, and insurance enrollment. The PPACA transitional reinsurance and temporary risk corridors programs ended after the 2016 benefit year. Therefore, the costs associated with those programs are not included in Tables 12 or 13 for fiscal years 2020-2023. Table 13 summarizes the effects of the risk adjustment program on the federal budget from fiscal years 2019 through 2023, with the additional, societal effects of this final rule discussed in this RIA. We do not expect the provisions of this final rule to significantly alter CBO's estimates of the budget impact of the risk adjustment program that is described in Table 13. We note that transfers associated with the risk adjustment program were previously estimated in the Premium Stabilization Rule; therefore, to avoid double-counting, we do not include them in the accounting statement for this final rule (Table 12).
In addition to utilizing CBO projections, HHS conducted an internal analysis of the effects of its regulations on enrollment and premiums. Based on this internal analysis, we anticipate that the quantitative effects of the provisions in this final rule are consistent with our previous estimates in the 2019 Payment Notice for the impacts associated with the APTC, the premium stabilization programs, and FFE user fee requirements.
The risk adjustment program is a permanent program created by section 1343 of the PPACA that collects charges from issuers with lower-than-average risk populations and uses those funds to make payments to issuers with higher-than-average risk populations in the individual, small group, and merged markets (as applicable), inside and outside the Exchanges. We established standards for the administration of the risk adjustment program in subparts A, B, D, G, and H of 45 CFR part 153.
A state approved or conditionally approved by the Secretary to operate an Exchange may establish a risk adjustment program, or have HHS do so on its behalf. Consistent with § 153.610(f), if HHS operates risk adjustment on behalf of a state, it will fund its risk adjustment program operations by assessing a risk adjustment user fee on issuers of risk adjustment covered plans. For the 2020 benefit year, we estimated that the total cost for HHS to operate the risk adjustment program on behalf of all states will be approximately $50 million, and that the risk adjustment user fee will be approximately $2.16 per billable member per year, or $0.18 PMPM. The updated cost estimates attribute all costs related to the EDGE server data collection and data evaluation (quantity and quality evaluations) activities to the risk adjustment program, rather than sharing
We believe that the approach of blending (or averaging) 3 years of separately solved coefficients from the 2016 and 2017 benefit year enrollee-level EDGE data with the 2015 MarketScan® data will provide stability within the risk adjustment program and minimize volatility in changes to risk scores from the 2019 benefit year to the 2020 benefit year due to differences in the datasets' underlying populations. Furthermore, we are finalizing the use of enrollee-level EDGE data and reports extracted from issuer EDGE servers to calibrate and operationalize HHS programs for the individual and small group (including merged) market programs, as well as to more broadly conduct policy analysis for the individual and small group (including merged) markets.
Under § 153.630, we proposed a few changes to the requirements for risk adjustment data validation.
We are finalizing the changes to the pairwise means test that will increase the second validation audit sample to the full 200 enrollee sample size (rather than 100) in certain cases. We do not believe this policy will increase the burden on issuers because the second validation audit is conducted by HHS, not issuers, and issuers are already required to provide the initial and second validation audit entities with the documentation necessary to complete the audits for all 200 enrollees sampled. Instead, we believe that increasing the second validation audit sample size to the full initial validation sample of 200 enrollees, in certain cases, may increase the costs to the federal government of conducting the second validation audit, as HHS will now review the documentation submitted for all 200 enrollees, rather than only 100 in certain cases. However, we believe that the benefits from improving the process for validating the second validation audit results and the accompanying precision it will bring to risk score error rate adjustments will outweigh the increased costs to the federal government and better ensure the integrity of the risk adjustment program.
We are finalizing our proposal to incorporate prescription drugs into risk adjustment data validation as part of the data validation process. We believe that it is important that prescription drugs are validated as part of risk adjustment data validation, as the HHS-operated risk adjustment methodology started incorporating prescription drug factors beginning with the 2018 benefit year. HHS previously estimated the burden of incorporating drugs in risk adjustment data validation in the 2018 Payment Notice.
The exemptions in this final rule for risk adjustment data validation codify two policies finalized in the 2018 and 2019 Payment Notices and also include one new exemption policy for issuers in or entering liquidation. The impact of the previously finalized exemptions was addressed in the 2018 and 2019 Payment Notices. We believe that the number of issuers that will qualify for the exemption for issuers in liquidation will be very small each year, and therefore, we believe that the overall reduction in burden will be limited. However, those issuers that are exempted from risk adjustment data validation will have less burden and administrative costs than an issuer subject to these requirements.
In § 155.220(c)(3)(i), the new paragraph (c)(3)(i)(L) prohibits web-brokers from displaying QHP recommendations on their websites based on compensation a web-broker, agent, or broker receives from QHP issuers. Web-brokers often collect certain information from consumers and on the basis of that information display or sort QHPs, or apply a score to all available QHPs, indicating which QHP they believe is the best option for those consumers. We support the development and use of innovative consumer-assistance tools that may help consumers select QHPs that best fit their needs. However, we believe such recommendations should be based on information consumers have provided to web-brokers and not based on compensation received from QHP issuers when consumers enroll in their plans. We are not aware of any web-brokers currently recommending QHPs based on compensation received from QHP issuers, so we expect the impact of this provision to be very limited.
We are finalizing the requirement in § 155.220(c)(4)(i)(A) for web-brokers to provide HHS with a list of agents or brokers who, through a contract or other arrangement, use the web-brokers' websites to assist consumers with QHP selection or completion of the Exchange eligibility application, in a form or manner to be specified by HHS. The authority currently exists for HHS to obtain this information by request. However, due to the trend of increased use and expansion of direct enrollment pathways, we believe it is appropriate and necessary to collect this information proactively, so that we may respond more efficiently and effectively to any potential instances of noncompliance that may involve use of a web-broker's direct enrollment pathway. Having this information will, for example, enable us to identify more quickly whether noncompliance is attributable to a specific individual or individuals, instead of the web-broker entity. We will release guidance that provides details on the form and manner of these submissions. We anticipate that it will require the list to include, at minimum, each agent's or broker's name, state(s) of licensure, and National Producer Number. We believe the burden associated with this data collection will be relatively limited, as we understand that web-brokers collect and store this information as part of their normal business operations to identify individual agents or brokers utilizing their systems. The burden related to this provision is discussed previously in the Collection of Information Requirements section.
Under new § 155.220(g)(3)(ii), HHS is allowed to immediately terminate an agent's or broker's agreement if the agent or broker fails to maintain
In § 155.220(k) a new paragraph (k)(3) is added that will allow HHS to immediately suspend an agent's or broker's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems until the incident or breach is remedied or sufficiently mitigated to HHS' satisfaction. This language is identical to an existing provision that applies to web-brokers at § 155.220(c)(3)(i)(L) and a similar provision applicable to QHP issuers participating in direct enrollment at § 156.1230(b)(1). Those provisions are being replaced with a very similar new requirement that applies to both types of direct enrollment entities in new § 155.221(d). Because the potential risks posed by agents and brokers with access to FFE systems are similar to those posed by web-brokers and QHP issuers participating in direct enrollment, we believe this change is necessary and appropriate to provide a uniform process and ability to protect Exchange systems and operations from unacceptable risks, as well as to protect sensitive consumer data. We note that agents and brokers whose ability to transact information with the Exchange is suspended under this authority will remain registered and authorized to assist consumers using the Marketplace (or side-by-side) pathway, unless and until their agreements are suspended or terminated under § 155.220(f) or (g). We believe this authority will be used infrequently and only in cases where there will likely be the reasonable basis to suspend their agreements under § 155.220(g)(5)(i) but there is a need to take immediate action to protect sensitive consumer data or Exchange systems and operations. Therefore its effect on agents and brokers is expected to be relatively limited.
In § 155.220(m)(1), we are finalizing the provision to allow a web-broker's agreement to be suspended or terminated for cause under § 155.220(g), and a web-broker to be denied the right to enter into agreements with the FFEs under paragraph (k)(1)(i) of this section based on the actions of its officers, employees, contractors, or agents, even if those persons are not agents or brokers registered with the FFE. In § 155.220(m)(2), we are finalizing the provision to allow a web-broker's agreement to be suspended or terminated under § 155.220(g), and for the entity to be denied the right to enter into agreements with the FFEs under § 155.220(k)(1)(i), if it is under the common ownership or control, or is an affiliated business, of another web-broker that has had its agreement suspended or terminated for cause. We expect these provisions to have limited impact, as they are designed to protect program integrity and will only be utilized in limited cases when there is evidence of significant misconduct or non-compliance. In those cases, we anticipate benefits to consumers stemming from our enhanced ability to address program integrity concerns and non-compliance issues. In § 155.220(m)(3), we are finalizing the requirement for the Exchange to collect information from a web-broker sufficient to establish the identities of individuals who comprise its corporate leadership and to determine any business relationships with other entities that may seek to register with the Exchange as web-brokers. These provisions are also intended to protect program integrity by enabling the Exchange to have information necessary to determine if any individuals seeking to be web-brokers are attempting to circumvent a previous termination or suspension for cause of FFE agreements. The burden related to this provision is discussed in the Collection of Information Requirements section.
The changes to § 155.220 are discussed above. In § 155.221, we amend and redesignate the existing paragraphs (a), (b) and (c) to new paragraphs (e), (f), and (g). In new § 155.220(e), we add language to require that the third-party entities that conduct annual reviews of direct enrollment entities to demonstrate operational readiness consistent with new § 155.221(b)(4)
In the new § 155.221(a), we are codifying in regulation the types of entities the FFEs permit to offer non-Exchange websites to facilitate direct enrollment in coverage offered through the Exchange in a manner that is considered to be through the Exchange. There are two types of entities that are authorized by the FFEs to offer direct enrollment pathways: QHP issuers and web-brokers. We expect this provision to have little or no impact as QHP issuers and web-brokers are already authorized by the FFEs to participate in direct enrollment.
In the new § 155.221(b), we establish and consolidate certain requirements that apply to all direct enrollment entities. Specifically, we add in § 155.221(b)(1) that QHPs and non-
In the new § 155.221(c), the authority to use application assisters and the corresponding requirements when doing so apply for all issuers and direct enrollment entities and not solely QHP issuers. We are finalizing a new definition of “direct enrollment entity application assister” in § 155.20 that mirrors the existing definition of “issuer application assister”, as well as finalizing amendments to § 155.415 to capture the requirements for entities using application assisters that align with the existing requirements currently in § 156.1230(a)(2) for QHP issuer application assisters. There is one significant deviation from the existing requirements for application assisters. Currently, § 156.1230(a)(2)(i) requires all application assisters to receive training on QHP options and insurance affordability programs, eligibility, and benefits rules and regulations. Licensed agents and brokers currently assisting consumers with QHP enrollment through the FFEs or SBE-FPs must have credentials to access FFE systems to offer that assistance. Those credentials are obtained during the FFE registration and training processes for agents and brokers. For application assisters to have similar access to FFE systems, so that they are also able to assist consumers as described here and in the preamble in this rule, they will need credentials similar to those obtained by agents and brokers during FFE registration and training. Therefore, we require that application assisters providing assistance in the FFEs and SBE-FPs comply with this training requirement by completing a similar registration and training process, in a form and manner to be specified by HHS, so that they will have the necessary credentials to provide consumer assistance. This new training and registration requirement for application assisters is captured in the new § 155.415(b)(1). The burden placed on application assisters to complete the FFE training may exceed what may have otherwise existed if direct enrollment entities were developing and managing their own training programs. However, by requiring the FFE training to be completed by application assisters assisting consumers in the FFEs and SBE-FPs, it will relieve direct enrollment entities from the burdens associated with having to develop and manage their own training programs. Importantly, FFE systems will require this approach to comply with system security requirements and to enable application assisters to meaningfully be able to assist consumers in the FFEs and SBE-FPs. Therefore, taken together, we believe the net burden associated with this requirement will be minimal and will be acceptable to participating direct enrollment entities that elect to use application assisters, when permitted under state law. The reason we believe the net burden will be minimal is because the bulk of time associated with application assisters completing the training requirement will likely be comparable whether the training is developed and administered by direct enrollment entities or by HHS. However, there will likely be a small increase in the amount of time application assisters will have to devote to the registration process apart from training, specifically to creating an FFE account and completing identity proofing. In contrast, there will likely be a substantial reduction in burden on direct enrollment entities, because they will not have to develop and manage their own training programs. Instead they will be able to simply confirm their application assisters have completed the FFE registration and training process.
We anticipate that allowing QHP issuers to use application assisters in the FFEs and SBE-FPs, and expanding that option to other issuers and web-brokers will provide cost savings to these entities. It is difficult to precisely estimate the number of applications for which a direct enrollment entity application assister provided help may be submitted. However, based on available data, we estimate that approximately 980,000 agent or broker-assisted direct enrollment applications will be submitted in plan year 2019. We estimate that it will take an insurance sales agent
In the new § 155.221(d), we consolidate existing authority to immediately suspend a direct enrollment entity's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to the Exchange's ability to make accurate eligibility determinations, or Exchange operations or systems until such circumstances are remedied or sufficiently mitigated to HHS' satisfaction. We expect little or no impact from this proposal, since this is largely based on an existing authority.
We also codify new definitions for the following terms in § 155.20: “direct enrollment entity”, “direct enrollment technology provider”, and “web-broker”. We define “direct enrollment entity” as an entity that an Exchange permits to assist consumers with direct enrollment in QHPs offered through an Exchange in a manner considered to be through the Exchange as authorized by §§ 155.220(c)(3), 155.221, or 156.1230. We expect no impact from this provision as it merely codifies a definition for the term in such a way that the entities that are currently authorized by the FFE to host a direct enrollment environment are direct enrollment entities. We also amend § 155.20 to define “direct enrollment technology provider” as a type of web-broker business entity that is not a licensed agent, broker, or producer under state law and has been engaged or created by, or is owned by, an agent or broker, to provide technology services to facilitate participation in direct enrollment as a web-broker in accordance with §§ 155.220(c)(3) and 155.221. There may be instances when an individual agent or broker, a group of agents or brokers, or an agent or broker business entity engages the services of or creates a technology company that is not licensed as an agent or broker to assist with the development and maintenance of a non-Exchange website that interfaces with an Exchange to assist consumers with direct enrollment in QHPs offered through the Exchanges as described in §§ 155.220(c)(3) and 155.221. In such cases, when the technology company is not itself licensed as an insurance agency or brokerage, these technology companies will be considered a type of web-broker that must comply with applicable web-broker requirements under §§ 155.220 and 155.221, unless noted otherwise. We expect no new burden associated with this requirement as it merely allows some flexibility in terms of how licensed agents or brokers may organize their businesses or pursue business relationships when seeking to become web-brokers. We also codify a definition of “web-broker” as an individual agent or broker, group of agents or brokers, or business entity registered with an Exchange under § 155.220(d)(1) that develops and hosts a non-Exchange website that interfaces with an Exchange to assist consumers with direct enrollment in QHPs offered through the Exchanges as described in §§ 155.220(c)(3) and 155.221. As explained in the preamble, we also define the term “web-broker” to generally include direct enrollment technology providers. Importantly, this definition will replace HHS' current web-broker definition, which is slightly different. However, we expect no impact, because all existing web-brokers will fall within the new proposed definition of web-broker.
Conforming edits were also made to § 156.1230 as part of the effort to streamline and consolidate similar requirements that apply to all direct enrollment entities in one regulation. We amend § 156.1230(b) to add a new paragraph (b)(1) that requires issuers participating in direct enrollment to comply with the applicable requirements in § 155.221. There were minimal substantive changes to the underlying requirements applicable to issuers participating in direct enrollment. We therefore expect no new impact to issuers except to the extent previously discussed. We also delete and reserve § 156.1230(a)(2) to align with the changes, described in this rule, to § 155.415 regarding application assisters.
Since implementing the direct-to-issuer enrollment system in plan year 2018, we have seen a marked decrease (greater than fifty percent) in the volume of SHOP Call Center calls. We anticipate that the SHOP Call Center volume will continue to decrease in plan year 2020, as employers will be in the third year of enrolling in SHOP directly with issuers, often with the assistance of agents and brokers. In addition, agents and brokers and small employers can now resolve most issues directly with impacted issuers using well-established issuer call centers and small group processes unique to each market. We anticipate a minimal number of new appeals of SHOP eligibility and special enrollment periods given anticipated employer participation and our observation that very few employers ever appeal SHOP determinations.
In short, we will maintain a toll-free telephone hotline that the statute requires (at present 12 full-time equivalent employees are devoted to SHOP Call Center operations). We envision minimal contractor and staff support to maintain the hotline content and to respond to very few voicemail messages. Although we will maintain language translation service and incur the associated costs, we anticipate that such costs will be minimal given call volume. Moving to an interactive voice response system will eliminate staffing for 12 full-time equivalent employees required at the call center under the SHOP Plan Aggregate and Call Center contract and will provide a net savings to the government of approximately $2 million annually.
We provide more flexibility to FFE Navigators by making the provision of certain types of assistance, including post-enrollment assistance, permissible for FFE Navigators, not required. The amendment of § 155.210 to remove the requirement that Navigators in FFEs provide the assistance specified at § 155.210(e)(9) will reduce regulatory burden and allow FFE Navigators to better prioritize work according to consumer demand, community needs, and organizational resources. Under the provision, Navigators in FFEs may continue to provide the types of assistance listed at § 155.210(e)(9), but will not be required to do so.
The time FFE Navigators currently spend providing assistance with the § 155.210(e)(9) topics varies. To help quantify this burden reduction, we requested comment on how many hours per month FFE Navigator grantees and individual Navigators currently spend providing the assistance activities in § 155.210(e)(9), what percentage of their current work involves providing these types of assistance, and how that amount of work would be impacted if providing these types of assistance would no longer be required. We also requested comment on how Navigator grantees and individual Navigators might reprioritize work and spend time fulfilling their other duties, if not required to provide the types of assistance described under § 155.210(e)(9). In particular, we sought comment on what tasks Navigators might prioritize and complete during the time they otherwise might have provided these types of assistance.
Commenters stated that the amount of time Navigators reported that they spent providing post-enrollment assistance varied widely. One commenter stated
We amend Navigator training requirements at §§ 155.210(b)(2) and 155.215(b)(2) to provide greater flexibility to Exchanges in designing their Navigator training programs to ensure coverage of the most instructive and timely topics in a streamlined fashion and to align the training with future changes in the Navigator program or the operation of the Exchanges, while still ensuring that Navigators are qualified to carry out their activities as required by the Navigator statute and regulations. This additional flexibility will allow Exchanges to focus on training areas they determine to be most relevant to the populations in the Exchange service area, while still addressing all required or authorized Navigator functions. Because it will provide greater flexibility to tailor the training to current, local conditions in each Exchange, the revised approach might also help to ensure cost-effective use of Exchange Navigator funding.
Moreover, we believe these changes will also grant greater flexibility to SBEs, including SBE-FPs, in designing their respective Navigator training, since SBEs that decide to authorize or require their Navigators to provide the assistance specified under § 155.210(e)(9) will not have corresponding training topics prescribed, but will have the flexibility to decide how best to prepare their Navigators to provide such assistance. This is similar to the flexibility SBEs have for creating training for other required Navigator duties. We believe granting SBEs the flexibility to focus on the topics they find best suited to prepare their Navigators for assisting consumers will allow for a more effective training program, and will reduce the regulatory compliance burden on these Exchanges.
However, the burden reduction that this will achieve cannot be estimated since these changes are not intended to reduce the total number of hours of Navigator training annually and we are uncertain how each Exchange will choose to structure its respective Navigator training given this increase in flexibility. We continue to believe that each Exchange is in the best position to determine the training that is most appropriate for the activities of its Navigators.
We anticipate that amended § 155.420 will impose moderate costs on Exchanges that opt to implement the proposed special enrollment period to update their user interfaces and make changes to their eligibility systems, but also acknowledge that Exchanges may choose to offer the special enrollment period through their call center or other existing enrollment avenues that could greatly reduce implementation costs to an Exchange. Additionally, we anticipate that verification requirements will impose costs relating to special enrollment period pre-enrollment verification systems, caseloads, and consumer messaging for Exchanges that perform pre-enrollment verification of special enrollment period eligibility. We expect utilization of the special enrollment period may vary among Exchanges depending on total Exchange enrollment and Exchange plan rates and pricing practices. Given these variable factors, we requested comments regarding anticipated costs, benefits and implementation approaches among Exchanges to assist in forming a future estimate.
We do not anticipate this provision to significantly increase regulatory burden on issuers, but acknowledge issuers may encounter marginal costs associated with processing new enrollments and terminations related to the special enrollment period, and direct enrollment entities may also face minor implementation costs associated with updating their applications and systems to include the new special enrollment period. We estimate that it will take a mid-level software developer
Because this policy provides improved pathways to continuous coverage for special enrollment period-eligible consumers, we anticipate that the proposal will promote continuous coverage for consumers and thereby have a positive effect on the individual market risk pool. Additionally, we anticipate that eligible consumers may experience reduced out-of-pocket costs related to health care expenses resulting from access to more affordable health plans and a new pathway to maintaining continuous health care coverage, compared to if they had to drop out of off-Exchange coverage and pay out-of-pocket for all health care expenses incurred for the remainder of the year. We estimate that approximately 4,700 new consumers will use this special enrollment period on an annual basis to enroll in Exchange coverage, and that these consumers will be enrolled for an average of 6 months of Exchange coverage during the benefit year. Using the plan year 2019 average monthly APTC amount of $544, we estimate total APTC transferred to consumers as a result of the proposed special enrollment period will be approximately $15,340,800 annually.
We invited comments on the potential costs and savings to Exchanges, issuers, direct enrollment entities, and consumers associated with the proposed special enrollment period. We did not receive comments on the cost estimates contained in these proposal.
We do not anticipate that the amendment to § 155.605(e) will create additional costs or burdens on Exchanges, and we anticipate it will decrease burden on consumers. The addition of § 155.605(e)(5) will enable individuals to claim a general hardship exemption on their federal income tax return for 2018 without an exemption certificate number from an Exchange. This policy will allow for more flexibility and will not result in any additional costs or burdens for issuers. The reduction in burden to consumers is discussed in the Collection of Information Requirements section.
To support the operation of FFEs, we require in § 156.50(c) that a participating issuer offering a plan through an FFE or SBE-FP must remit
In the preamble to § 156.125, we discuss a potentially discriminatory benefit design under § 156.125: the exclusion of MAT drugs for the treatment of opioid use disorder while covering the same drugs for other medically necessary purposes, such as analgesia or alcohol use disorder. Because we did not propose a change to this policy, we do not anticipate any additional burden on states or issuers. However, to the extent this clarification causes issuers to cease prohibited discriminatory practices, the clarification could help consumers obtain needed MAT, lead to better health outcomes, and reduce the burden and out-of-pocket costs individuals may have otherwise incurred in attempts to obtain MAT.
We are finalizing a premium adjustment percentage of 1.2895211380 for the 2020 benefit year. The annual premium adjustment percentage is used to set the rate of increase for several parameters detailed in the PPACA, including: the annual limitation on cost sharing (defined at § 156.130(a)), the required contribution percentage used to determine eligibility for certain exemptions under section 5000A of the Code (defined at § 155.605(d)(2)), and the employer shared responsibility payments under sections 4980H(a) and 4980H(b) of the Code.
Additionally, we finalized other cost-sharing parameters using an index based on the final premium adjustment percentage for the 2020 benefit year. In § 155.605(d)(2), we are finalizing a required contribution of 8.24 percent for the 2020 benefit year, which reflects the premium adjustment percentage calculation for the 2020 benefit year detailed in preamble.
As noted in Table 14, we expect that the proposed change in measure of premium growth used to calculate the premium adjustment percentage for the 2020 benefit year may result in:
• Net premium increases of approximately $181 million per year, which is approximately one percent of 2018 benefit year net premiums, for the 2020 through 2023 benefit years. Net premiums are calculated for Exchange enrollees as premium charged by issuers minus APTC. Gross premiums will be virtually unchanged.
• A decrease in federal PTC spending of $980 million to $1.15 billion between 2020 and 2023, due to an increase in the PTC applicable percentage and a decline in Exchange enrollment of approximately 70,000 individuals in each benefit year, based on an assumption that the Department of the Treasury and the IRS will adopt the use of the same premium measure proposed for the calculation of the premium adjustment percentage in this final rule for purposes of calculating the indexing of the PTC applicable percentage and the required contribution percentage under section 36B of the Code.
• Increased Health Insurance Providers Fees on health insurance issuers of approximately $50 million in 2020, and $70 million in years 2021 to 2023, based on an assumption that the Department of the Treasury and the IRS will adopt the use of the same premium measure proposed for the calculation of the premium adjustment percentage in this final rule for purposes of calculating the indexing of the Health Insurance Providers Fee.
• Increased Employer Shared Responsibility Payments of $100 million in 2020, and $110 million each year between 2021 and 2023.
Some of the 70,000 individuals estimated to not enroll in Exchange coverage each year as a result of the proposed change in the measure of premium growth used to calculate the premium adjustment percentage may purchase short-term, limited-duration insurance or join a spouse's plan, though a majority is likely to become uninsured. Either transition may result in greater exposure to health care costs, which previous research suggests reduces utilization of health care services.
As noted in this rule, the premium adjustment percentage is the measure of premium growth that is used to set the rate of increase for the maximum annual limitation on cost sharing, defined at § 156.130(a). In § 156.130(a)(2), we proposed a maximum annual limitation on cost sharing of $8,200 for self-only coverage. We are finalizing a maximum annual limitation on cost sharing of $8,150. Additionally, we proposed and are finalizing reductions in the maximum annual limitation on cost sharing for silver plan variations. Consistent with our analyses in previous Payment Notices, we developed three test silver level QHPs and analyzed the impact on their AVs of the reductions described in the PPACA to the estimated 2020 maximum annual limitation on cost sharing for self-only coverage. We do not believe the finalized changes to the reductions in the maximum annual limitation on cost sharing for silver plan variations will result in a significant economic impact.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this final rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the final rule, we assume that the total number of unique commenters on the proposed rule will be the number of reviewers of this final rule. We acknowledge that this assumption may understate or overstate the proposed rule in detail, and it is also possible that some reviewers chose not to comment on the rule. For these reasons we thought that the number of past commenters will be a fair estimate of the number of reviewers of this final rule.
We are required to issue a substantial portion of this final rule each year under our regulations and we estimate that approximately half of the remaining provisions will cause additional regulatory review burden that stakeholders do not already anticipate. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this final rule, and therefore, for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule, excluding the portion of the rule that we are required to issue each year.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this final rule is $107.38 per hour, including overhead and fringe benefits.
In developing the policies contained in this final rule, we considered numerous alternatives to the presented proposals. In this rule, we discuss the key regulatory alternatives to the finalized provisions that we considered.
In proposing the risk adjustment model recalibration in part 153, we considered multiple alternatives such as maintaining the prior year's recalibration methodology of recalibrating the models using 2 years of MarketScan® data and the most recent year of EDGE data. We also considered recalibrating the models using the most recent year of MarketScan® data available (2017) and the 2 most recent years of enrollee-level EDGE data (2016 and 2017). However, we are finalizing recalibration of the models using 3 years of blended data from the following sources: the 2 most recent years of enrollee-level EDGE data (2016 and 2017) available and 2015 MarketScan® data.
Regarding proposed changes to §§ 155.210 and 155.215, we considered taking no action to amend certain Navigator training requirements and duties, but determined that the proposed changes regarding training requirements will provide Exchanges
In proposing revisions to § 155.221, we considered maintaining the existing regulatory framework that established standards for issuers and web-brokers participating in direct enrollment in separate sections, but we believe streamlining and consolidating the requirements applicable to all direct enrollment entities, when possible, improves clarity and promotes fair competition. For the display requirements at § 155.221(b), we contemplated maintaining the current standards in regulations and guidance, but based on feedback received from direct enrollment entities, we believe the current framework may have caused confusion and limited innovation. Therefore, we determined that the establishment of clarified standards for the marketing and display of QHPs and non-QHPs is the best way to provide greater clarity for direct enrollment entities about what is required to minimize the potential for consumer confusion, while allowing direct enrollment entities more flexibility to be innovative in the marketing of non-QHPs to consumers who are interested in those products. For the addition of a new § 155.221(c), we considered continuing to limit the authority to use application assisters to QHP issuers. However, to promote fair competition for all direct enrollment entities and issuers, we believe a better approach is to expand this authority to include all direct enrollment entities and all issuers.
In proposing revisions to § 155.420 governing Exchange special enrollment periods, we considered broader eligibility requirements for the special enrollment period proposed at § 155.420(d)(6)(v). We considered if a special enrollment period could be offered without a decrease in household income to all Exchange applicants who were enrolled in MEC and determined eligible for APTC by the Exchange, or if changes in the applicant's household size could be considered in the eligibility criteria for this special enrollment period. We determined that eliminating the criteria for a decrease in household income will be problematic because it eliminates a triggering event for the special enrollment period and could allow for consumers who are potentially APTC-eligible to avoid the metal level restrictions in paragraph (a)(4) of this section by initially enrolling in off-Exchange coverage and then later choosing to buy a higher or lower level of coverage mid-year. We also determined that verification of household size changes will be operationally problematic, as electronic data sources will not reflect recent changes to household size. Further, the special enrollment periods at § 155.420(d)(2)(i) are currently available to qualified individuals whose household size changes due to gaining or becoming a dependent and already provides a pathway to Exchange coverage for individuals in this situation.
We also considered if the special enrollment period proposed at § 155.420(d)(6)(v) could be offered without a prior coverage requirement and determined that this requirement is necessary to ensure the special enrollment period is only available to the intended population, to promote continuous coverage among individual market enrollees, and to protect the individual market risk pools against adverse selection. Finally we considered the impact of not proposing this special enrollment period. Without the proposed special enrollment period at § 155.420(d)(6)(v), unsubsidized off-Exchange consumers who experience a decrease in household income midyear and are determined APTC eligible will remain without a pathway to Exchange coverage. These consumers will remain at risk of terminating their unsubsidized coverage midyear because it is unaffordable, rather than maintaining continuous enrollment in health coverage by transitioning to an Exchange plan.
Regarding the proposed change to § 155.605(e) to allow consumers to claim all general hardship exemptions through the federal tax filing process for the 2018 tax year, we considered that without the recommended revisions to § 155.605(e), individuals may experience a general hardship that prevents them from obtaining qualifying health coverage, and may experience undue burden to apply and qualify for an exemption from the individual shared responsibility provision. This change allows for more flexibility for individuals to claim these exemptions through the IRS tax filing process for the 2018 tax year.
We are finalizing our proposed change to the premium measure used in the premium adjustment percentage calculation under § 156.130 to use a private health insurance premium measure (excluding Medigap and property and casualty insurance) in addition to employer sponsored health insurance premiums. However, we considered other alternatives to the final premium measure and methodology for calculating the premium adjustment percentage for the 2020 benefit year. We considered finalizing our proposed method with a gradual phase-in. We also considered maintaining our previous process of using employer-sponsored insurance premium amounts. In addition, we considered using NHEA estimates and projections of private health insurance premium measure, which includes premiums for employer-sponsored insurance, direct purchase insurance (which includes Medigap insurance), and property and casualty insurance. However, we ultimately decided not to propose or finalize the use of a private health insurance measure that included Medigap insurance because we believed it was inappropriate to include Medigap premiums in the measure as this type of coverage is not considered primary coverage for those enrollees who supplement their Medicare coverage with these plans. Moreover, although total spending for private health insurance in the NHEAs includes the medical portion of accident insurance (property and casualty insurance), we did not believe it would be appropriate to include those expenditures for this purpose as they are associated with policies that do not serve as a primary source of health insurance coverage. For the reasons explained in more detail in the preamble for § 156.130, we ultimately decided to finalize the proposal as proposed.
At § 156.130 we also proposed that plans not be required to count drug manufacturer coupons toward the annual limitation on cost sharing, starting with plan years beginning on or after January 1, 2020. We considered not proposing this flexibility, as these coupons may result in lower costs to individual consumers. However, manufacturer coupons may incentivize selection of higher-cost drugs when a less costly therapeutic equivalent is available which can distort the market and the true costs of drugs, adding significant long-term costs to the health care system.
The Regulatory Flexibility Act, (5 U.S.C. 601,
In this final rule, the standards for the risk adjustment and risk adjustment data validation programs are intended to stabilize premiums. Because we believe that insurance firms offering comprehensive health insurance policies generally exceed the size thresholds for “small entities” established by the SBA, we do not believe that an initial regulatory flexibility analysis is required for such firms.
We believe that health insurance issuers and group health plans would be classified under the North American Industry Classification System code 524114 (Direct Health and Medical Insurance Carriers). According to SBA size standards, entities with average annual receipts of $38.5 million or less would be considered small entities for these North American Industry Classification System codes. Issuers could possibly be classified in 621491 (HMO Medical Centers) and, if this is the case, the SBA size standard would be $32.5 million or less.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This final rule will not affect small rural hospitals. Therefore, the Secretary has determined that this will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a rule that includes any federal mandate that may result in expenditures in any 1 year by a state, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2019, that threshold is approximately $154 million. Although we have not been able to quantify all costs, we expect the combined impact on state, local, or Tribal governments and the private sector to be below the threshold.
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a rule that imposes substantial direct costs on state and local governments, preempts state law, or otherwise has Federalism implications.
In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have Federalism implications or limit the policy making discretion of the states, we have engaged in efforts to consult with and work cooperatively with affected states, including participating in conference calls with and attending conferences of the National Association of Insurance Commissioners, and consulting with state insurance officials on an individual basis.
While developing this final rule, we attempted to balance the states' interests in regulating health insurance issuers with the need to ensure market stability. By doing so, it is our view that we have complied with the requirements of Executive Order 13132.
Because states have flexibility in designing their Exchange and Exchange-related programs, state decisions will ultimately influence both administrative expenses and overall premiums. States are not required to establish an Exchange or risk adjustment program. For states that elected previously to operate an Exchange, or risk adjustment program, much of the initial cost of creating these programs was funded by Exchange Planning and Establishment Grants. After establishment, Exchanges must be financially self-sustaining, with revenue sources at the discretion of the state. Current State Exchanges charge user fees to issuers.
In our view, while this final rule will not impose substantial direct requirement costs on state and local governments, this regulation has Federalism implications because it finalizes a change to the Alabama risk adjustment program in the small group market based upon a proposal provided by the state. We also proposed to make the special enrollment period at § 155.420(d)(6)(v) at the option of Exchanges, to give states flexibility in whether they choose to implement it.
This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801,
Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. Section 2(a) of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment, or otherwise issues, a new regulation. In furtherance of this requirement, section 2(c) of Executive Order 13771 requires that the new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.
This final rule is an E.O. 13771 deregulatory action.
The analysis in this rule, together with the remainder of this preamble, provides a Regulatory Impact Analysis.
In accordance with the provisions of Executive Order 12866, this regulation
Health care, Health insurance, Reporting and recordkeeping requirements.
Health care, Health insurance, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health care, Health insurance, Insurance companies, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health care, Health insurance, Health records, Intergovernmental relations, Organization and functions (Government agencies), Reporting and recordkeeping requirements.
Administrative practice and procedure, Advertising, Brokers, Conflict of interests, Consumer protection, Grants administration, Grant programs—health, Health care, Health insurance, Health maintenance organizations (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Intergovernmental relations, Loan programs—health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, Technical assistance, Women and youth.
Administrative practice and procedure, Advertising, Advisory committees, Brokers, Conflict of interests, Consumer protection, Grant programs—health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs—health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, State and local governments, Sunshine Act, Technical assistance, Women, Youth.
For the reasons set forth in the preamble, under the authority at 5 U.S.C. 301, the Department of Health and Human Services amends 45 CFR as set forth below.
42 U.S.C. 300gg-1 through 300gg-5, 300gg-11 through 300gg-23, 300gg-91, and 300-gg-92.
(a)
42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92 as amended.
(a)
42 U.S.C. 300gg through 300gg-63, 300gg-11 300gg-91, and 300-gg92, as amended.
(b) * * *
(1) Except as provided in paragraphs (c) through (g) of this section, an issuer must renew or continue in force the coverage at the option of the individual.
42 U.S.C. 18031, 18041, and 18061 through 18063.
(d)
(1)
(i) Supporting evidence and analysis demonstrating the State-specific factors that warrant an adjustment to more precisely account for the differences in actuarial risk in the State market risk pool;
(ii) The adjustment percentage of up to 50 percent requested for the State individual catastrophic, individual non-catastrophic, small group, or merged market risk pool; and
(iii) A justification for the reduction requested demonstrating the State-specific factors that warrant an adjustment to more precisely account
(2)
(3)
(4)
(A) That State-specific rules or other relevant factors warrant an adjustment to more precisely account for relative risk differences in the State's individual catastrophic, individual non-catastrophic, small group, or merged market risk pool and support the percentage reduction to risk adjustment transfers requested; or
(B) That State-specific rules or other relevant factors warrant an adjustment to more precisely account for relative risk differences in the State's individual catastrophic, individual non-catastrophic, small group, or merged market risk pool and the requested reduction would have
(ii) HHS may approve a reduction amount that is lower than the amount requested by the State if the supporting evidence and analysis do not fully support the requested reduction amount. HHS will assess other relevant factors, including the premium impact of the transfer reduction for the applicable State market risk pool.
The revisions and addition read as follows:
(b) * * *
(10) If an issuer of a risk adjustment covered plan fails to engage an initial validation auditor or to submit the results of an initial validation audit to HHS, HHS will impose a default data validation charge.
(d) * * *
(2) Within 30 calendar days of the notification by HHS of the findings of a second validation audit (if applicable) or the calculation of a risk score error rate, in the manner set forth by HHS, an issuer must confirm the findings of the second validation audit (if applicable) or the calculation of the risk score error rate as a result of risk adjustment data validation, or file a discrepancy report to dispute the findings of a second validation audit (if applicable) or the calculation of a risk score error rate as a result of risk adjustment data validation.
(g)
(1) The issuer has 500 or fewer billable member months of enrollment in the individual, small group and merged markets (as applicable) for the applicable benefit year, calculated on a Statewide basis;
(2) The issuer is at or below the materiality threshold as defined by HHS and is not selected by HHS to participate in the data validation requirements in an applicable benefit year under random and targeted sampling conducted approximately every 3 years (barring any risk-based triggers based on experience that will warrant more frequent audits); or
(3) The issuer is in liquidation, or will enter liquidation no later than April 30th of the benefit year that is 2 benefit years after the benefit year being audited, provided that:
(i) The issuer provides to HHS, in the manner and timeframe specified by HHS, an attestation that the issuer is in liquidation or will enter liquidation no later than April 30th of the benefit year that is 2 benefit years after the benefit year being audited that is signed by an individual with the authority to legally and financially bind the issuer; and
(ii) The issuer is not a positive error rate outlier under the error estimation methodology in risk adjustment data validation for the prior benefit year of risk adjustment data validation.
(iii) For purposes of this paragraph (g)(3), liquidation means that a State court has issued an order of liquidation for the issuer that fixes the rights and liabilities of the issuer and its creditors, policyholders, shareholders, members, and all other persons of interest.
42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083.
(a)
(1) An Exchange described in this paragraph is one that enters into a Federal platform agreement through which it relies on HHS to operate its eligibility and enrollment functions, as applicable.
(2) An Exchange described in this paragraph is a SHOP that does not provide for enrollment in SHOP coverage through an online SHOP enrollment platform, but rather provides for enrollment through SHOP issuers or agents and brokers registered with the Exchange.
The revisions read as follows:
(b) * * *
(2) A set of training standards, to be met by all entities and individuals carrying out Navigator functions under the terms of a Navigator grant, to ensure the entities and individuals are qualified to engage in Navigator activities, including training standards on the following topics:
(iii) The range of QHP options and insurance affordability programs; and
(iv) The privacy and security standards applicable under § 155.260.
(e) * * *
(9) The Exchange may require or authorize Navigators to provide information and assistance with any of the following topics. In Federally-facilitated Exchanges, Navigators are required to provide information and assistance with all of the following topics under Navigator grants awarded in 2018, and will be authorized to provide information and assistance with all of the following topics under Navigator grants awarded in 2019 or any later year.
(b) * * *
(2)
The additions and revisions read as follows:
(a)
(c)
(1) The agent, broker, or web-broker ensures the applicant's completion of an eligibility verification and enrollment application through the Exchange internet website as described in § 155.405, or ensures that the eligibility application information is submitted for an eligibility determination through the Exchange-approved web service subject to meeting the requirements in paragraphs (c)(3)(ii) and (c)(4)(i)(F) of this section;
(3)(i) When an internet website of a web-broker is used to complete the QHP selection, at a minimum the internet website must:
(A) Disclose and display all QHP information provided by the Exchange or directly by QHP issuers consistent with the requirements of § 155.205(b)(1) and (c), and to the extent that not all information required under § 155.205(b)(1) is displayed on the web-broker's internet website for a QHP, prominently display a standardized disclaimer provided by HHS stating that information required under § 155.205(b)(1) for the QHP is available on the Exchange website, and provide a Web link to the Exchange website;
(K) Comply with the applicable requirements in § 155.221; and
(L) Not display QHP recommendations based on compensation the agent, broker, or web-broker receives from QHP issuers.
(ii) When an internet website of a web-broker is used to complete the Exchange eligibility application, at a minimum the internet website must:
(4) When an agent or broker, through a contract or other arrangement, uses the internet website of a web-broker to help an applicant or enrollee complete a QHP selection or complete the Exchange eligibility application in the Federally-facilitated Exchange:
(i) The web-broker who makes the website available must:
(A) Provide HHS with a list of agents and brokers who enter into such a contract or other arrangement to use the
(E) Report to HHS and applicable State departments of insurance any potential material breach of the standards in paragraphs (c) and (d) of this section, or the agreement entered into under § 155.260(b), by the agent or broker accessing the internet website, should it become aware of any such potential breach. A web-broker that provides access to its website to complete the QHP selection or the Exchange eligibility application or ability to transact information with HHS to another web-broker website is responsible for ensuring compliance with applicable requirements in paragraph (c)(3) of this section for any web pages of the other web-broker's website that assist consumers, applicants, qualified individuals, and enrollees in applying for APTC and CSRs for QHPs, or in completing enrollment in QHPs, offered in the Exchanges.
(F) When an internet website of a web-broker is used to complete the Exchange eligibility application, obtain HHS approval verifying that all requirements in this section are met.
(ii) HHS retains the right to temporarily suspend the ability of a web-broker making its website available to transact information with HHS, if HHS discovers a security and privacy incident or breach, for the period in which HHS begins to conduct an investigation and until the incident or breach is remedied to HHS' satisfaction.
(5) HHS or its designee may periodically monitor and audit an agent, broker, or web-broker under this subpart to assess its compliance with the applicable requirements of this section.
(d)
(2) Receives training in the range of QHP options and insurance affordability programs, except that a licensed agent or broker entity that registers with the Federally-facilitated Exchange in its capacity as a business organized under the laws of a State, and not as an individual person, and direct enrollment technology providers are exempt from this requirement; and
(e)
(f) * * *
(1) An agent, broker, or web-broker may terminate its agreement with HHS by sending to HHS a written notice at least 30 days in advance of the date of intended termination.
(2) The notice must include the intended date of termination, but if it does not specify a date of termination, or the date provided is not acceptable to HHS, HHS may set a different termination date that will be no less than 30 days from the date on the agent's, broker's, or web-broker's notice of termination.
(3) Prior to the date of termination, an agent, broker, or web-broker should—
(i) Notify applicants, qualified individuals, or enrollees that the agent, broker, or web-broker is assisting, of the agent's, broker's, or web-broker's intended date of termination;
(4) When the agreement between the agent, broker, or web-broker and the Exchange under paragraph (d) of this section is terminated under paragraph (f) of this section, the agent, broker, or web-broker will no longer be registered with the Federally-facilitated Exchanges, or be permitted to assist with or facilitate enrollment of qualified individuals, qualified employers or qualified employees in coverage in a manner that constitutes enrollment through a Federally-facilitated Exchange, or be permitted to assist individuals in applying for advance payments of the premium tax credit and cost-sharing reductions for QHPs. The agent's, broker's, or web-broker's agreement with the Exchange under § 155.260(b) will also be terminated through the termination without cause process set forth in that agreement. The agent, broker, or web-broker must continue to protect any personally identifiable information accessed during the term of either of these agreements with the Federally-facilitated Exchanges.
(g) * * *
(1) If, in HHS' determination, a specific finding of noncompliance or pattern of noncompliance is sufficiently severe, HHS may terminate an agent's, broker's, or web-broker's agreement with the Federally-facilitated Exchange for cause.
(2) An agent, broker, or web-broker may be determined noncompliant if HHS finds that the agent, broker, or web-broker violated—
(iii) Any State law applicable to agents, brokers, or web-brokers, as required under paragraph (e) of this section, including but not limited to State laws related to confidentiality and conflicts of interest; or
(iv) Any Federal law applicable to agents, brokers, or web-brokers.
(3)(i) Except as provided in paragraph (g)(3)(ii) of this section, HHS will notify the agent, broker, or web-broker of the specific finding of noncompliance or pattern of noncompliance made under paragraph (g)(1) of this section, and after 30 days from the date of the notice, may terminate the agreement for cause if the matter is not resolved to the satisfaction of HHS.
(ii) HHS may immediately terminate the agreement for cause upon notice to the agent or broker without any further opportunity to resolve the matter if an agent or broker fails to maintain the appropriate license under State law as an agent, broker, or insurance producer in every State in which the agent or broker actively assists consumers with applying for advance payments of the premium tax credit or cost-sharing reductions or with enrolling in QHPs through the Federally-facilitated Exchanges.
(4) After the applicable period in paragraph (g)(3) of this section has elapsed and the agreement under paragraph (d) of this section is terminated, the agent, broker, or web-broker will no longer be registered with the Federally-facilitated Exchanges, or be permitted to assist with or facilitate enrollment of a qualified individual, qualified employer, or qualified employee in coverage in a manner that constitutes enrollment through a Federally-facilitated Exchange, or be permitted to assist individuals in applying for advance payments of the premium tax credit and cost-sharing reductions for QHPs. The agent's, broker's, or web-broker's agreement with the Exchange under § 155.260(b)(2) will also be terminated through the process set forth in that agreement. The agent, broker, or web-broker must continue to protect any personally
(5) * * *
(i)(A) If HHS reasonably suspects that an agent, broker, or web-broker may have may have engaged in fraud, or in abusive conduct that may cause imminent or ongoing consumer harm using personally identifiable information of an Exchange enrollee or applicant or in connection with an Exchange enrollment or application, HHS may temporarily suspend the agent's, broker's, or web-broker's agreements required under paragraph (d) of this section and under § 155.260(b) for up to 90 calendar days. Suspension will be effective on the date of the notice that HHS sends to the agent, broker, or web-broker advising of the suspension of the agreements.
(B) The agent, broker, or web-broker may submit evidence in a form and manner to be specified by HHS, to rebut the allegation during this 90-day period. If the agent, broker, or web-broker submits such evidence during the suspension period, HHS will review the evidence and make a determination whether to lift the suspension within 30 days of receipt of such evidence. If the rebuttal evidence does not persuade HHS to lift the suspension, or if the agent, broker, or web-broker fails to submit rebuttal evidence during the suspension period, HHS may terminate the agent's, broker's, or web-broker's agreements required under paragraph (d) of this section and under § 155.260(b) for cause under paragraph (g)(5)(ii) of this section.
(ii) If there is a finding or determination by a Federal or State entity that an agent, broker, or web-broker engaged in fraud, or abusive conduct that may result in imminent or ongoing consumer harm, using personally identifiable information of Exchange enrollees or applicants or in connection with an Exchange enrollment or application, HHS will terminate the agent's, broker's, or web-broker's agreements required under paragraph (d) of this section and under § 155.260(b) for cause. The termination will be effective starting on the date of the notice that HHS sends to the agent, broker, or web-broker advising of the termination of the agreements.
(iii) During the suspension period under paragraph (g)(5)(i) of this section and following termination of the agreements under paragraph (g)(5)(i)(B) or (g)(5)(ii) of this section, the agent, broker, or web-broker will not be registered with the Federally-facilitated Exchanges, or be permitted to assist with or facilitate enrollment of qualified individuals, qualified employers, or qualified employees in coverage in a manner that constitutes enrollment through a Federally-facilitated Exchange, or be permitted to assist individuals in applying for advance payments of the premium tax credit and cost-sharing reductions for QHPs. The agent, broker, or web-broker must continue to protect any personally identifiable information accessed during the term of either of these agreements with the Federally-facilitated Exchanges.
(h) * * *
(1)
(2)
(3)
(i)
(j) * * *
(1) An agent, broker, or web-broker that assists with or facilitates enrollment of qualified individuals, qualified employers, or qualified employees, in coverage in a manner that constitutes enrollment through a Federally-facilitated Exchange, or assists individuals in applying for advance payments of the premium tax credit and cost-sharing reductions for QHPs sold through a Federally-facilitated Exchange, must—
(3) If an agent, broker, or web-broker fails to provide correct information, he, she, or it will nonetheless be deemed in compliance with paragraphs (j)(2)(i) and (ii) of this section if HHS determines that there was a reasonable cause for the failure to provide correct information and that the agent, broker, or web-broker acted in good faith.
(k) * * *
(1) If HHS determines that an agent, broker, or web-broker has failed to comply with the requirements of this section, in addition to any other available remedies, that agent, broker, or web-broker—
(2) HHS will notify the agent, broker, or web-broker of the proposed imposition of penalties under paragraph (k)(1)(i) of this section as part of the termination notice issued under paragraph (g) of this section and, after 30 calendar days from the date of the notice, may impose the penalty if the agent, broker, or web-broker has not requested a reconsideration under paragraph (h) of this section. The proposed imposition of penalties under paragraph (k)(1)(ii) of this section will follow the process outlined under § 155.285.
(3) HHS may immediately suspend the agent's or broker's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems until the incident or breach is remedied or sufficiently mitigated to HHS' satisfaction.
(l)
(m)
(2) A web-broker's agreement executed under paragraph (d) of this section may be suspended or terminated under paragraph (g) of this section, and a web-broker may be denied the right to enter into agreements with the Federally-facilitated Exchanges under paragraph (k)(1)(i) of this section, if it is under the common ownership or control or is an affiliated business of another web-broker that had its agreement suspended or terminated under paragraph (g) of this section.
(3) The Exchange may collect information from a web-broker during its registration with the Exchange under paragraph (d)(1) of this section, or at another time on an annual basis, in a form and manner to be specified by HHS, sufficient to establish the identities of the individuals who comprise its corporate ownership and leadership and to ascertain any corporate or business relationships it has with other entities that may seek to register with the Federally-facilitated Exchange as web-brokers.
The revisions and additions read as follows:
(a)
(1) QHP issuers that meet the applicable requirements in this section and § 156.1230 of this subchapter; and
(2) Web-brokers that meet the applicable requirements in this section and § 155.220.
(b)
(1) Display and market QHPs and non-QHPs on separate website pages on its non-Exchange website;
(2) Prominently display a standardized disclaimer in the form and manner provided by HHS;
(3) Limit marketing of non-QHPs during the Exchange eligibility application and QHP plan selection process in a manner that minimizes the likelihood that consumers will be confused as to what products are available through the Exchange and what products are not;
(4) Demonstrate operational readiness and compliance with applicable requirements prior to the direct enrollment entity's internet website being used to complete an Exchange eligibility application or a QHP selection; and
(5) Comply with applicable Federal and State requirements.
(c)
(d)
(e)
(f)
(2) Adheres to HHS specifications for content, format, privacy, and security in the conduct of an operational readiness review, which includes ensuring that direct enrollment entities are in compliance with the applicable privacy and security standards and other applicable requirements;
(3) Collects, stores, and shares with HHS all data related to the third-party entity's audit of direct enrollment entities in a manner, format, and frequency specified by HHS until 10 years from the date of creation, and complies with the privacy and security standards HHS adopts for direct enrollment entities as required in accordance with § 155.260;
(4) Discloses to HHS any financial relationships between the entity and individuals who own or are employed by a direct enrollment entity for which it is conducting an operational readiness review;
(6) Ensures, on an annual basis, that appropriate staff successfully complete operational readiness review training as established by HHS prior to conducting audits under paragraph (e) of this section;
(7) Permits access by the Secretary and the Office of the Inspector General or their designees in connection with their right to evaluate through audit, inspection, or other means, to the third-party entity's books, contracts, computers, or other electronic systems, relating to the third-party entity's audits of a direct enrollment entity's obligations in accordance with standards under paragraph (e) of this section until 10 years from the date of creation of a specific audit; and
(g)
(h)
(a)
(b)
(1) Receives training on QHP options and insurance affordability programs, eligibility, and benefits rules and regulations, and for application assisters providing assistance in the Federally-facilitated Exchanges or a State Exchange using the Federal platform, the assisters must fulfill this requirement by completing registration and training in a form and manner to be specified by HHS;
(2) Complies with the Exchange's privacy and security standards adopted consistent with § 155.260; and
(3) Complies with applicable State law related to the sale, solicitation, and negotiation of health insurance products, including any State licensure laws applicable to the functions to be performed by the issuer application assister or direct enrollment entity application assister, as well as State law related to confidentiality and conflicts of interest.
The addition reads as follows:
(a) * * *
(5)
(b) * * *
(2) * * *
(iv) If a qualified individual, enrollee, or dependent, as applicable, loses coverage as described in paragraph (d)(1) or (d)(6)(iii) of this section, gains access to a new QHP as described in paragraph (d)(7) of this section, becomes newly eligible for enrollment in a QHP through the Exchange in accordance with § 155.305(a)(2) as described in paragraph (d)(3) of this section, or becomes newly eligible for advance payments of the premium tax credit in conjunction with a permanent move as described in paragraph (d)(6)(iv) of this section, and if the plan selection is made on or before the day of the triggering event, the Exchange must ensure that the coverage effective date is the first day of the month following the date of the triggering event. If the plan selection is made after the date of the triggering event, the Exchange must ensure that coverage is effective in accordance with paragraph (b)(1) of this section or on the first day of the following month, at the option of the Exchange.
(d) * * *
(6) * * *
(v) At the option of the Exchange, the qualified individual, or his or her dependent—
(A) Experiences a decrease in household income;
(B) Is newly determined eligible by the Exchange for advance payments of the premium tax credit; and
(C) Had minimum essential coverage as described in 26 CFR 1.5000A-1(b) for one or more days during the 60 days preceding the date of the financial change.
(e) * * *
(5)
42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, and 26 U.S.C. 36B.
(h)
(1) Notwithstanding any other provision of this section, and to the extent consistent with state law, amounts paid toward cost sharing using any form of direct support offered by drug manufacturers to enrollees to reduce or eliminate immediate out-of-pocket costs for specific prescription brand drugs that have an available and medically appropriate generic equivalent are not required to be counted toward the annual limitation on cost sharing (as defined in paragraph (a) of this section).
(2) [Reserved]
The revisions read as follows:
(a) * * *
(2) [Reserved]
(b) * * *
(1) The QHP issuer must comply with applicable requirements in § 155.221 of this subchapter.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year 2020. This rule proposes to rebase the continuous home care, general inpatient care, and the inpatient respite care per diem payment rates in a budget-neutral manner to more accurately align Medicare payments with the costs of providing care. In addition, this rule proposes to modify the election statement by requiring an addendum that includes information aimed at increasing coverage transparency for patient under a hospice election. Finally, this rule proposes changes to the Hospice Quality Reporting Program.
In commenting, refer to file code CMS-1714-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
For general questions about hospice payment policy, send your inquiry via email to:
This rule proposes updates to the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2020, as required under section 1814(i) of the Social Security Act (the Act). This rule proposes to rebase the continuous home care (CHC), general inpatient care (GIP), and inpatient respite care (IRC) per diem payment rates in a budget neutral manner to more accurately align payments with the costs of providing care, using the hospice payment reform authority under section 1814(i)(6) of the Act. This rule also proposes a change to the hospice wage index to remove the 1-year lag in data by using the current year's hospital wage data to establish the hospice wage index. In addition, this rule proposes to modify the hospice election statement by requiring an addendum that includes information aimed at increasing coverage transparency for patients under a hospice election. Finally, this rule proposes changes to the Hospice Quality Reporting Program.
Section III.A of this proposed rule describes the FY 2020 hospice per diem payment rebasing methodology, cost reports and calculations. Using the hospice payment reform authority under section 1814(i)(6) of the Act, section III.A.3 proposes to rebase the FY 2020 per diem payment rates for CHC, IRC, and GIP levels of care. As required in section 1814(i)(6)(D)(ii) of the Act, any changes to hospice payment rates must be done in a budget neutral manner. As such, section III.A.3 also proposes a reduction to the routine home care (RHC) payment amounts for FY 2020 in order to maintain overall budget neutrality. Section III.B.1 of this proposed rule proposes to eliminate the 1-year lag of the pre-floor, pre-reclassified hospital wage index that is used in calculating the hospice wage index. Section III.B.2 proposes updates to the hospice wage index and makes the application of the updated wage data budget neutral for all four levels of hospice care. In section III.B.4 of this proposed rule, we discuss the proposed FY 2020 hospice payment update percentage of 2.7 percent. Section III.B.5 outlines the proposed FY 2020 hospice payment rates that result from the policies proposed in section III.A. Section III.B.6 of this proposed rule updates the hospice cap amount for FY 2020 by the hospice payment update percentage discussed in section III.B.4 of this rule. Section III.C proposes to modify the hospice election statement content requirements at § 418.24(b) to increase coverage transparency for patients under a hospice election by notifying beneficiaries if there are services that will not be covered by the hospice.
In addition, section III.D describes a request for information (RFI) as it relates to the Medicare Fee-For-Service (FFS) Hospice benefit and coordination of care at end-of-life. Finally, in section III.E of this proposed rule, we discuss updates to the Hospice Quality Reporting Program (HQRP), including: The development of claims-based and outcome measures, measure concepts, and the hospice assessment tool. We also provide updates on the public reporting change for the “Hospice Visits When Death is Imminent” measure pair, the posting of publicly available government data to the CMS Hospice Compare website and the CAHPS® Hospice Survey.
The overall economic impact of this proposed rule is estimated to be $540
Hospice care is a comprehensive, holistic approach to treatment that recognizes the impending death of a terminally ill individual and warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. Medicare regulations define “palliative care” as patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice (42 CFR 418.3). Palliative care is at the core of hospice philosophy and care practices, and is a critical component of the Medicare hospice benefit.
The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through a collaboration of professionals and other caregivers, with the goal of making the beneficiary as physically and emotionally comfortable as possible. Hospice is compassionate beneficiary and family/caregiver-centered care for those who are terminally ill.
As referenced in our regulations at § 418.22(b)(1), to be eligible for Medicare hospice services, the patient's attending physician (if any) and the hospice medical director must certify that the individual is “terminally ill,” as defined in section 1861(dd)(3)(A) of the Act and our regulations at § 418.3; that is, the individual's prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course. The regulations at § 418.22(b)(3) require that the certification and recertification forms include a brief narrative explanation of the clinical findings that support a life expectancy of 6 months or less.
Under the Medicare hospice benefit, the election of hospice care is a patient choice and once a terminally ill patient elects to receive hospice care, a hospice interdisciplinary group is essential in the seamless provision of services. These hospice services are provided primarily in the individual's home. The hospice interdisciplinary group works with the beneficiary, family, and caregivers to develop a coordinated, comprehensive care plan; reduce unnecessary diagnostics or ineffective therapies; and maintain ongoing communication with individuals and their families about changes in their condition. The beneficiary's care plan will shift over time to meet the changing needs of the individual, family, and caregiver(s) as the individual approaches the end of life.
If, in the judgment of the hospice interdisciplinary team, which includes the hospice physician, the patient's symptoms cannot be effectively managed at home, then the patient is eligible for general inpatient care (GIP), a more medically intense level of care. GIP must be provided in a Medicare-certified hospice freestanding facility, skilled nursing facility, or hospital. GIP is provided to ensure that any new or worsening symptoms are intensively addressed so that the beneficiary can return to his or her home and continue to receive routine home care. Limited, short-term, intermittent, inpatient respite care (IRC) is also available because of the absence or need for relief of the family or other caregivers. Additionally, an individual can receive continuous home care (CHC) during a period of crisis in which an individual requires continuous care to achieve palliation or management of acute medical symptoms so that the individual can remain at home. Continuous home care may be covered for as much as 24 hours a day, and these periods must be predominantly nursing care, in accordance with our regulations at § 418.204. A minimum of 8 hours of nursing care, or nursing and aide care, must be furnished on a particular day to qualify for the continuous home care rate (§ 418.302(e)(4)).
Hospices must comply with applicable civil rights laws,
Coverage under the Medicare Hospice benefit requires that hospice services must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. Section 1861(dd)(1) of the Act establishes the services that are to be rendered by a Medicare-certified hospice program. These covered services include: Nursing care; physical therapy; occupational therapy; speech-language pathology therapy; medical social services; home health aide services (now called hospice aide services); physician services; homemaker services; medical supplies (including drugs and biologicals); medical appliances; counseling services (including dietary counseling); short-term inpatient care in a hospital, nursing facility, or hospice inpatient facility (including both respite care and procedures necessary for pain control and acute or chronic symptom management); continuous home care during periods of crisis, and only as necessary to maintain the terminally ill individual at home; and any other item or service which is specified in the plan of care and for which payment may otherwise be made under Medicare, in accordance with Title XVIII of the Act.
Section 1814(a)(7)(B) of the Act requires that a written plan for providing hospice care to a beneficiary who is a hospice patient be established before care is provided by, or under arrangements made by, that hospice program; and that the written plan be periodically reviewed by the beneficiary's attending physician (if any), the hospice medical director, and an interdisciplinary group (described in section 1861(dd)(2)(B) of the Act). The services offered under the Medicare hospice benefit must be available to beneficiaries as needed, 24 hours a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act).
Upon the implementation of the hospice benefit, the Congress also expected hospices to continue to use volunteer services, though these services are not reimbursed by Medicare (see section 1861(dd)(2)(E) of the Act). As stated in the FY 1983 Hospice Wage Index and Rate Update proposed rule (48 FR 38149), the hospice interdisciplinary group should comprise paid hospice employees as well as hospice volunteers, and that “the hospice benefit and the resulting Medicare reimbursement is not intended to diminish the voluntary
Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of the Act, and our regulations in 42 CFR part 418, establish eligibility requirements, payment standards and procedures; define covered services; and delineate the conditions a hospice must meet to be approved for participation in the Medicare program. Part 418, subpart G, provides for a per diem payment in one of four prospectively-determined rate categories of hospice care (RHC, CHC, IRC, and GIP), based on each day a qualified Medicare beneficiary is under hospice care (once the individual has elected). This per diem payment is to include all of the hospice services and items needed to manage the beneficiary's care, as required by section 1861(dd)(1) of the Act. There has been little change in the hospice payment structure since the benefit's inception. The per diem rate based on level of care was established in 1983, and this payment structure remains today with some adjustments, as noted below.
Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) amended section 1814(i)(1)(C) of the Act and provided changes in the methodology concerning updating the daily payment rates based on the hospital market basket percentage increase applied to the payment rates in effect during the previous federal fiscal year.
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) established that updates to the hospice payment rates beginning FY 2002 and subsequent FYs be the hospital market basket percentage increase for the FY.
The FY 1998 Hospice Wage Index final rule (62 FR 42860), implemented a new methodology for calculating the hospice wage index and instituted an annual Budget Neutrality Adjustment Factor (BNAF) so aggregate Medicare payments to hospices would remain budget neutral to payments calculated using the 1983 wage index.
The FY 2010 Hospice Wage Index and Rate Update final rule (74 FR 39384) instituted an incremental 7-year phase-out of the BNAF beginning in FY 2010 through FY 2016. The BNAF phase-out reduced the amount of the BNAF increase applied to the hospice wage index value, but was not a reduction in the hospice wage index value itself or in the hospice payment rates.
Starting with FY 2013 (and in subsequent FYs), the market basket percentage update under the hospice payment system referenced in sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act is subject to annual reductions related to changes in economy-wide productivity, as specified in section 1814(i)(1)(C)(iv) of the Act.
In addition, sections 1814(i)(5)(A) through (C) of the Act, as added by section 3132(a) of the Patient Protection and Affordable Care Act (PPACA) (Pub. L. 111-148), required hospices to begin submitting quality data, based on measures specified by the Secretary of the Department of Health and Human Services (the Secretary), for FY 2014 and subsequent FYs. Beginning in FY 2014, hospices that fail to report quality data have their market basket percentage increase reduced by 2 percentage points.
Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2) of the PPACA, required, effective January 1, 2011, that a hospice physician or nurse practitioner have a face-to-face encounter with the beneficiary to determine continued eligibility of the beneficiary's hospice care prior to the 180th day recertification and each subsequent recertification, and to attest that such visit took place. When implementing this provision, we finalized in the FY 2011 Hospice Wage Index final rule (75 FR 70435) that the 180th day recertification and subsequent recertifications would correspond to the beneficiary's third or subsequent benefit periods. Further, section 1814(i)(6) of the Act, as added by section 3132(a)(1)(B) of the PPACA, authorized the Secretary to collect additional data and information determined appropriate to revise payments for hospice care and other purposes. The types of data and information suggested in the PPACA could capture accurate resource utilization, which could be collected on claims, cost reports, and possibly other mechanisms, as the Secretary determined to be appropriate. The data collected could be used to revise the methodology for determining the payment rates for RHC and other services included in hospice care, no earlier than October 1, 2013, as described in section 1814(i)(6)(D) of the Act. In addition, we were required to consult with hospice programs and the Medicare Payment Advisory Commission (MedPAC) regarding additional data collection and payment revision options.
In the FY 2012 Hospice Wage Index final rule (76 FR 47308 through 47314) we announced that beginning in 2012, the hospice aggregate cap would be calculated using the patient-by-patient proportional methodology, within certain limits. We allowed existing hospices the option of having their cap calculated through the original streamlined methodology, also within certain limits. As of FY 2012, new hospices have their cap determinations calculated using the patient-by-patient proportional methodology. If a hospice's total Medicare payments for the cap year exceed the hospice aggregate cap, then the hospice must repay the excess back to Medicare.
The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50452) finalized a requirement that the Notice of Election (NOE) be filed within 5 calendar days after the effective date of hospice election. If the NOE is filed beyond this 5-day period, hospice providers are liable for the services furnished during the days from the effective date of hospice election to the date of NOE filing (79 FR 50474). Similar to the NOE, the claims processing system must be notified of a beneficiary's discharge from hospice or hospice benefit revocation within 5 calendar days after the effective date of the discharge/revocation (unless the hospice has already filed a final claim) through the submission of a final claim or a Notice of Termination or Revocation (NOTR).
The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50479) also finalized a requirement that the election form include the beneficiary's choice of attending physician and that the beneficiary provide the hospice with a signed document when he or she chooses to change attending physicians.
In addition, the FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50496) provided background, eligibility criteria, survey respondents,
Finally, the FY 2015 Hospice Wage Index and Rate Update final rule required providers to complete their aggregate cap determination not sooner than 3 months after the end of the cap year, and not later than 5 months after, and remit any overpayments. Those hospices that failed to timely submit their aggregate cap determinations had their payments suspended until the determination is completed and received by the Medicare contractor (79 FR 50503).
The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185) became law on October 6, 2014. Section 3(a) of the IMPACT Act mandated that all Medicare certified hospices be surveyed every 3 years beginning April 6, 2015 and ending September 30, 2025. In addition, section 3(c) of the IMPACT Act requires medical review of hospice cases involving beneficiaries receiving more than 180 days of care in select hospices that show a preponderance of such patients; section 3(d) of the IMPACT Act contains a new provision mandating that the cap amount for accounting years that end after September 30, 2016, and before October 1, 2025 be updated by the hospice payment update rather than using the consumer price index for urban consumers (CPI-U) for medical care expenditures.
In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47172), we created two different payment rates for RHC that resulted in a higher base payment rate for the first 60 days of hospice care and a reduced base payment rate for subsequent days of hospice care. We also created a Service Intensity Add-on (SIA) payment payable for services during the last 7 days of the beneficiary's life, equal to the CHC hourly payment rate multiplied by the amount of direct patient care provided by a registered nurse (RN) or social worker that occurs during the last 7 days (80 FR 47177).
In addition to the hospice payment reform changes discussed, the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47186) implemented changes mandated by the IMPACT Act, in which the cap amount for accounting years that end after September 30, 2016 and before October 1, 2025 is updated by the hospice payment update percentage rather than using the CPI-U. This was applied to the 2016 cap year, starting on November 1, 2015 and ending on October 31, 2016. In addition, we finalized a provision to align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the fiscal year for FY 2017 and thereafter. Finally, the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47144) clarified that hospices must report all diagnoses of the beneficiary on the hospice claim as a part of the ongoing data collection efforts for possible future hospice payment refinements.
In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52160), we finalized several new policies and requirements related to the HQRP. First, we codified our policy that if the National Quality Forum (NQF) made non-substantive changes to specifications for HQRP measures as part of the NQF's re-endorsement process, we would continue to utilize the measure in its new endorsed status, without going through new notice-and-comment rulemaking. We would continue to use rulemaking to adopt substantive updates made by the NQF to the endorsed measures we have adopted for the HQRP; determinations about what constitutes a substantive versus non-substantive change would be made on a measure-by-measure basis. Second, we finalized two new quality measures for the HQRP for the FY 2019 payment determination and subsequent years: Hospice Visits when Death is Imminent Measure Pair and Hospice and Palliative Care Composite Process Measure-Comprehensive Assessment at Admission (81 FR 52173). The data collection mechanism for both of these measures is the HIS, and the measures were effective April 1, 2017. Regarding the CAHPS® Hospice Survey, we finalized a policy that hospices that receive their CMS Certification Number (CCN) after January 1, 2017 for the FY 2019 Annual Payment Update (APU) and January 1, 2018 for the FY 2020 APU will be exempted from the Hospice Consumer Assessment of Healthcare Providers and Systems (CAHPS®) requirements due to newness (81 FR 52182). The exemption is determined by CMS and is for 1 year only.
Since the implementation of the hospice benefit in 1983, there has been substantial growth in hospice utilization. The number of Medicare beneficiaries receiving hospice services has grown from 513,000 in FY 2000 to over 1.5 million in FY 2018. Medicare hospice expenditures have risen from $2.8 billion in FY 2000 to approximately $18.7 billion in FY 2018. CMS' Office of the Actuary (OACT) projects that hospice expenditures are expected to continue to increase, by approximately 8.5 percent annually, reflecting an increase in the number of Medicare beneficiaries, more beneficiary awareness of the Medicare hospice benefit for end-of-life care, and a growing preference for care provided in home and community-based settings.
As a part of our ongoing analysis of hospice utilization trends, we examined the distribution of total hospice days by level of care. A review of claims over the last 10 years shows that RHC remains the highest utilized level of care, accounting for an average of 97.6 percent of total hospice days; GIP accounting for 1.7 percent of total hospice days; CHC accounting for 0.4 percent of total hospice days; and, IRC accounting for 0.3 percent of total hospice days.
There have also been notable changes in the diagnosis patterns among Medicare hospice enrollees. At the time of the implementation of the Medicare hospice benefit, cancer diagnoses were the most frequently reported diagnoses. However, there has been a significant increase in the reporting of neurologically-based diagnoses, including Alzheimer's disease, which has been the top-reported diagnosis on hospice claims since 2014. The increase in the reporting of neurological conditions as the principal diagnosis on hospice claims corresponds to a clarification in the FY 2014 hospice final rule (78 FR 48242) on diagnosis reporting where “debility” and “adult failure to thrive” are no longer permitted to be reported as principal diagnosis codes on hospice claims. Our ongoing analysis of diagnosis reporting trends finds that neurological and organ-based failure conditions remain top-reported principal diagnoses.
In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47201), we clarified that hospices are to report all diagnoses identified in the initial and comprehensive assessments on hospice claims, whether related or unrelated to the terminal prognosis of the individual, effective October 1, 2015. Analysis of FY 2018 hospice claims show that 100 percent of claims included at least one diagnosis, 90.3 percent of claims included at least two
Finally, we examined hospice trends relating to hospice length of stay. The number of days that a hospice beneficiary receives care under a hospice election is referred to as the hospice length of stay (LOS). Length of stay can be analyzed in several ways. Total
Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of the Act, and our regulations in part 418, establish eligibility requirements, payment standards and procedures; define covered services; and delineate the conditions a hospice must meet to be approved for participation in the Medicare program. Part 418, subpart G, provides for a per diem payment in one of four prospectively-determined rate categories of hospice care (routine home care (RHC), continuous home care (CHC), inpatient respite care (IRC) and general inpatient care (GIP)), based on each day a qualified Medicare beneficiary is under a hospice election. These per diem payments include reimbursement for all of the hospice services and items needed to manage the beneficiary's care, as required by section 1861(dd)(1) of the Act. There has been little change in the hospice payment structure since the benefit's inception. The per diem rate based on level of care was established in 1983, and this payment structure remains today.
We originally set the base payment rates for each level of care in 1983 using information from a relatively small set (n=26) of hospices that were participating in a CMS hospice demonstration. As a result of technological changes to providing hospice care that have occurred since the early 1980's, as well as changes in the patient population that uses the hospice benefit, it is possible that the current per diem payment rates for the Medicare hospice benefit do not align accurately with the costs of providing care. Since the establishment of the base payment rates, they have been updated through the years to primarily account for inflation, but we have not implemented any large scale changes to reflect non-inflationary changes in cost over time, with the exception of the bifurcation of the RHC payment rate and the creation of the SIA payment finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule for implementation on January 1, 2016 (80 FR 47142).
For over a decade, MedPAC and other organizations reported findings that suggested that the hospice benefit's fixed per-diem payment system was inconsistent with the true variance of service costs over the course of an episode. Specifically, MedPAC cited both academic and non-academic studies, as well as its own analyses (as summarized and articulated in MedPAC's 2002,
Hospices are paid per day, regardless of whether any services are provided to a hospice patient on any given day. The CHC level of care is paid based on an hourly rate when a hospice patient, who is not in an inpatient facility, receives hospice care consisting predominantly of nursing care on a continuous basis at home. The hospice must provide a minimum of 8 hours of care in a 24 hour period in order for such services to be covered as CHC. The GIP level of care is a day in which a hospice patient receives care in an inpatient facility for pain control or acute or chronic symptom management that cannot be managed in other settings. The IRC level of care is short-term care provided only when necessary to relieve the family members or other persons caring for the hospice patient at home. IRC can be provided for up to 5 consecutive days.
While hospices must provide all levels of care to meet the hospice Conditions of Participation (CoPs), there is much lower utilization of CHC, IRC, and GIP compared to RHC. As part of our ongoing reform work, we analyzed the trends in hospice days and payments by level of care. Our analysis found that between FY 2009 and FY 2018 RHC days as a percent of total hospice days increased from 97.2 percent to 98.2 percent. Conversely, during this time frame CHC and GIP days as a percent of total hospice days decreased. CHC days as a percent of total hospice days decreased by half, and in FY 2018, CHC was only 0.2 percent of total hospice days compared to 0.4 percent in FY 2009. GIP days as a percent of total hospice days decreased from 2.1 percent in FY 2009 to 1.3 percent in FY 2018. Finally, the percent of IRC days remained relatively constant from FY 2009-FY 2018 at 0.3 percent of total hospice days in FY 2018. The results were similar for the percent of payments by level of care. RHC payments as a percent of total hospice payments increased from 89.2 percent in FY 2009 to 93.4 percent in FY 2018. CHC payments as a percent of total payments decreased from 1.9 percent of payments in FY 2009 to 1.0 percent in FY 2018. GIP payments decreased from 8.7 percent of total hospice payments in FY 2009 to 5.3 percent in FY 2018. Finally, IRC payments as a percent of total hospice payments increased slightly to 0.3 percent in 2018 from 0.2 percent in 2009.
As discussed previously in this proposed rule, section 1814(i)(6) of the Act, as amended by section 3132(a)(1)(B) of the Affordable Care Act, authorizes the Secretary to collect additional data and information determined appropriate to revise payments for hospice care and for other purposes. The data collected may be used to revise the methodology for determining the payment rates for RHC and other hospice services (in a budget-neutral manner in the first year), no earlier than October 1, 2013, as described in section 1814(i)(6)(D) of the Act. Furthermore, section 3132(a)(1)(C) of the Affordable Care Act specifies that the Secretary may collect additional data and information on cost reports, claims, or other mechanisms as the Secretary determines to be appropriate.
The Secretary is required to consult with hospice programs and the MedPAC regarding additional data collection and payment reform options. We have transparently conducted payment reform analysis and have released research findings to the public in our 2013 and 2014 Technical Reports,
Based on stakeholder suggestions, we began collecting additional information on the hospice claims form as of April 1, 2014.
Effective for cost reporting periods beginning on or after October 1, 2014, freestanding hospices are required to file the revised hospice cost report (Form CMS-1984-14).
In the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47142) we stated that we received many suggestions for ways to improve data collection to support larger payment reform efforts in the future and that we expected to analyze additional claims and cost report data reported by hospices to determine whether additional regulatory proposals to reform and strengthen the Medicare hospice benefit would be warranted (80 FR 47161). Likewise, MedPAC, the Government Accountability Office (GAO), and the Office of the Inspector General (OIG) have all recommended that CMS collect more comprehensive data to better evaluate trends in utilization of the Medicare hospice benefit.
We continued to analyze hospice claims and cost report data to determine whether additional changes need to be made to more accurately align hospice payment with the costs of providing care. Specifically, we have continued to examine whether there is a misalignment between payment and costs for CHC, IRC, and GIP. In its March 2018 Report to the Congress, MedPAC stated Medicare's payment rates for the CHC, IRC and GIP levels of care appear to be lower than the average and median costs per day for freestanding providers and suggested that rebalancing the payment rates may be warranted.
Additionally, we received public comments on past rules that indicated the payment rates for CHC, IRC and GIP are much different from the average costs of providing those levels of care. Specifically, several commenters expressed concerns regarding the rates for these levels of care being insufficient to acquire and maintain contracts for inpatient levels of care. In response to the FY 2015 Hospice Wage Index and Payment Rate Update proposed rule (79 FR 26538), a commenter suggested that hospices have difficulty contracting for respite care in many areas because the hospice respite rate may be $5 to $50 less per day than the facility's Medicaid rate. This commenter also stated that nursing facilities in many states do not want to accept less than their Medicaid
Using information collected from the revised hospice cost report, for the first time, we are able to estimate hospices' average costs per day by level of care. As required by section 1814(i)(1)(A) of the Act, payment for hospice services must be an amount equal to the costs which are reasonable and related to providing hospice care, or which are based on such other tests of reasonableness as the Secretary may prescribe in regulations. Therefore, given that we now have several years' worth of cost report data from the revised hospice cost report, we calculated the average costs per day by level of care and compared such costs to the per diem payment rates by level of care to determine if there is a misalignment between payment and costs and whether the per diem payment rates for CHC, IRC, and GIP should be rebased. To conduct this analysis, we used a variety of different data sources, including cost reports and hospice claims data. We also used additional sources such as prior hospice final rules that detail wage indices and payment rate updates, as well as the CMS Provider of Services (POS) file. The methodology of this analysis is described below.
Our analysis was based on information obtained from the Healthcare Cost Report Information System (HCRIS). The Hospice Cost Report Data contains cost and statistical data for freestanding and provider-based hospice providers. The dataset is normally updated quarterly and is available on the last day of the month following the quarter's end. To determine the average per-day costs of providing hospice services, we conducted initial analysis of both freestanding and provider-based Medicare hospice cost reports. We used the following HCRIS data files as of December 31, 2018, for cost reports from FY 2017 to support our analyses:
a. Sometimes within a provider-based cost report, the same CCN was listed multiple times (that is, there might be two separate reports of RHC costs for the same CCN within a provider-based cost report). In order to limit each hospice to one single cost report, we selected the cost report with the highest RHC cost.
b. Sometimes a CCN appeared in a freestanding cost report as well as appeared in a provider-based cost report.
Table 2 below shows the starting sample and the number of hospice cost reports after applying the exclusions listed above.
Next, we constructed a series of flags to identify cost reports that did not fill out fields that we would expect hospices to report (for example, nursing services).
Next, to remove outliers from this analysis, we applied another set of exclusions as described in the FY 2019 Hospice Wage Index and Payment Rate Update proposed rule (83 FR 20948). Specifically, we described how a trimming methodology is applied to cost reports so that statistical anomalies were minimized. For each calculated outcome (for example, average RHC costs per day), we excluded those values that are above the 99th percentile and those values that are below the 1st percentile. We refer to this trim as the “1% Trim”. The data we exclude vary for each level of care. For example, we may exclude a hospice's data when calculating RHC costs per day, but not exclude it when calculating GIP costs per day. After all the described exclusions were applied, table 3 below shows how many freestanding cost reports were used for this analysis.
Primarily, due to the small sample size of provider-based hospices after these exclusions (see explanation below), we ultimately decided to only use freestanding hospice cost reports. As shown in table 2, there were 918 provider-based cost reports (that is, 26 SNF, 473 HHA, and 419 hospital) before applying the new Level I edits to the provider-based hospice cost reports. After applying the new Level I edits there were 96 provider-based cost reports remaining. Likewise, in MedPAC's March 2017 Report to Congress, they stated that included in the costs of provider-based hospices are overhead costs allocated from the parent provider, which contribute to provider-based hospices having higher costs than freestanding hospices. The Commission believes payment policy should focus on the efficient delivery of services to Medicare beneficiaries. If freestanding hospices are able to provide high-quality care at a lower cost than provider-based hospices, payment rates should be set accordingly, and the higher costs of provider-based hospices should not be a reason for increasing Medicare payment rates.
However, we did consider using both freestanding and provider-based cost reports, with all cost report adjustments, including Level I edits, to rebase the payment rates for CHC, IRC, and GIP. We also considered not applying the Level I edits to the freestanding cost reports for this rebasing analysis. Both of these alternative approaches are described in section V.E. of this proposed rule. The remaining discussion in this section will focus on our analysis of freestanding hospice cost reports for FY 2017. This analysis focused on the costs per day by level of care found within the hospice cost reports and reported on Worksheet C, column 3, Lines 3, 8, 13 and 18.
We created an analytic data set based on Medicare hospice claims downloaded from the Chronic Condition Data Warehouse—Virtual Research Data Center (CCW VRDC) to examine hospice utilization on specific days during FY 2017. We assigned a wage index (using the FY 2017 hospice wage indices) to each day of hospice service based on the core-based
In order to compute the average cost per day for each level of care using information from the freestanding hospice cost reports, after applying the exclusions, we made several adjustments to the average cost calculations, as described below.
Costs reported on Medicare cost reports vary due to many factors, including variation in costs driven by geographic location. For example, all else equal, hospices in high wage areas (for example, New York City) may have higher costs compared to hospices in low wage areas. Daily payment rates for hospice are adjusted to account for geographic differences in wage rates. However, this geographic wage adjustment is only applied to the labor share of the base payment rate. The labor share for RHC and CHC is 68.71 percent, for GIP it is 64.01 percent and for IRC, it is 54.13 percent. Medicare adjusts for these wage differences by first multiplying the base payment rate paid to hospices by the labor share of the base payment rate. That value is then multiplied by the wage index assigned to the CBSA where the hospice provided services to the patient. Therefore, it is important to calculate average costs after removing any regional differences that may be driven by wages, otherwise we would over-adjust for wage differences across regions. For example, we remove the wage differences in RHC costs by calculating the following value for each hospice:
We perform a similar calculation for the other levels of care using the corresponding cost per day from FY 2017 cost reports and the appropriate labor share for CHC, IRC, and GIP. For example, the adjusted GIP cost per day uses the same formula, but instead includes GIP cost per day from FY 2017 cost reports, the hospice's average wage index for all GIP days in the formula, and the GIP labor share of 64.01 percent.
Due to exclusions mentioned previously, not all hospices that submitted claims during FY 2017 have a corresponding cost report in our final sample. As a result, the characteristics of the sample of cost reports used to calculate average cost per day for each level of care do not necessarily match up with the characteristics of all hospices that submitted claims during FY 2017. If not accounted for, our sample of cost reports may over-represent certain types of hospices. To correct for this, we categorize each hospice in our sample by facility type,
1. Using claims, we compute the total number of days provided in FY 2017 by all hospices within a particular category;
2. We compute the total number of days, as reported on the claims provided in FY 2017, using only the hospices in our trimmed sample of cost reports within a particular category (Table 3); and
3. For each level of care and each category of hospices, we construct a ratio using the value in Step 1 over the value in Step 2.
For each cost report in our sample, we multiply each provider's days (as reported on claims) by level of care by the ratio in order to make the sample cost reports more representative of the overall population of hospices. We then multiply the provider's average per diem cost as reported on the cost report times the number of adjusted days from the prior step to yield total costs by level of care for that provider. We then compute the weighted average for each level of care by summing across hospices the total costs by level of care divided by the sum of the adjusted days across the cost reports in our sample.
We compute the weighted average equation for each level of care. For example, we use a separate equation to calculate the average GIP cost per day that uses GIP costs and GIP days. The equation as described above is an approach to calculate the average per day cost for each level of care. However, Medicare pays for the CHC level of care using a per hour rate instead of a per day rate. We calculated each hospice's hourly cost of CHC by taking their CHC cost per day from the hospice cost report and dividing it by their average number of hours of CHC provided on CHC days occurring in FY 2017 as reported on each hospice's claims. Each hospice's CHC cost per hour (adjusted by average number of hours of CHC) is then averaged (using the weighted average formula discussed above) across all hospices in our sample to create the overall average of CHC cost per hour. To convert the CHC cost per hour into a CHC cost per day we multiply the average CHC cost per hour by 24 hours. It is important to note that each hospice's hourly CHC cost is based on their average number of CHC minutes per day, which is less than 24 hours. That means a full CHC per day payment (which covers 24 hours) will be larger than the average CHC cost per day (which covers a time period less than 24 hours).
Applying all of the steps as described above, average costs per day by level of care in FY 2017 are listed in Table 4 below:
• Days 1 through 60: The ratio of average resource use for RHC days in days 1 through 60 to average resource use across all RHC days was 1.2603 to 1.
• Days 61 and beyond: The ratio of average resource use for RHC days after day 60 to the average resource use across all RHC days was 0.8722 to 1.
We multiplied the average cost per day for RHC in FY 2017 by the corresponding resource use ratio to calculate the average cost per day for the first 60 days and any RHC days after 60 days. The resulting average cost per day for RHC is shown in Table 5.
To determine if there is any misalignment between the average costs of providing CHC, IRC and GIP and the per diem payment rates for these levels of care, we inflated the average costs in FY 2017 to FY 2019 dollars. We did this by multiplying the average FY 2017 costs by level of care by the hospice market basket update payment update for FY 2018 (82 FR 36649) and FY 2019 (83 FR 38630) less the multifactor productivity adjustments (MFP). Table 6 below shows the estimated average costs for CHC, IRC and GIP for FY 2019 (that is, taking the average FY 2017 cost per day by each level of care inflated to 2019 dollars).
We also analyzed the average costs of the RHC for the first 60 days and any RHC days after day 60 inflated from FY 2017 dollars to FY 2019 dollars by applying the hospice market basket update less the MFP adjustments. The results in Table 7 show the estimated average costs for RHC by days for FY 2019.
We then compared the FY 2019 average costs for CHC, IRC and GIP to the FY 2019 payment rates for these three levels of care. Our analysis shows that there is a misalignment between average costs and payment for these three levels of care. Table 8 below shows: The percent of total hospice days by level of care; the estimated average FY 2019 costs by level of care; the current FY 2019 per diem payment rates; and the estimated percent increase to the payment rates to more accurately align the per diem payments for CHC, IRC and GIP with the costs of providing these levels of
The payment rates for CHC, IRC, and GIP are significantly less than the average costs of providing care. We also compared the FY 2019 average costs for RHC for the first 60 days and any RHC days after day 60 to the FY 2019 payment rates for RHC and the percentage difference between payment and average costs and the results are shown in Table 9 below.
For RHC, the payment rates significantly exceed the average costs of providing care for this level of care for the first 60 days and any RHC days after day 60.
As mentioned above, section 1814(i)(1)(A) of the Act requires that payment for hospice services must be an amount equal to the costs which are reasonable and related to the cost of providing hospice care. As described above, the average costs of providing CHC, IRC and GIP are significantly higher than the payment amounts for these three levels of care. Using the hospice payment reform authority under section 1814(i)(6) of the Act, we are proposing to rebase the payment rates for CHC, IRC, and GIP by setting these payment amounts equal to the FY 2019 estimated average costs per day, as described in the methodology above, before application of the hospice payment update percentage outlined in section III.C of this proposed rule. We are proposing to rebase the payment rates for CHC, IRC, and GIP as follows:
Although there is no coinsurance amount for RHC, CHC or GIP, the
Section 1814(i)(6)(D)(ii) of the Act requires that any revisions to the methodology for determining the payment rates for other services included in hospice care to be done in a budget-neutral manner in the fiscal year in which such revisions in payment are implemented as would have been made for care in the fiscal year if such revisions had not been implemented. Therefore, in order to offset the proposed increases in payment rates to the CHC, IRC, and GIP levels of care, we are proposing to reduce the RHC payment rates by 2.71 percent in order to implement rebasing in a budget-neutral manner in FY 2020. Reducing the RHC payment rate to a level equal to the estimated RHC costs would require a reduction in the RHC payment rate that exceeds the proposed 2.71 percent. While we are rebasing the per diem payment rates for CHC, GIP, and IRC to more accurately align the payment with costs, the reduction to the RHC payment rates is not considered rebasing as the 2.71 percent reduction does not bring the RHC payment in alignment with the costs of providing this level of care. The purpose of the 2.71 percent reduction to the RHC payment rates is to ensure that the revisions to the payment rates for CHC, GIP and IRC are made in a budget-neutral manner, in accordance with the law.
To calculate the proposed 2.71 percent reduction to the RHC payment rates, we first calculate two sets of payments using different payment parameters.
1. Total payments for hospice days provided during FY 2018 under the existing FY 2019 payment rates and FY 2019 wage indices.
2. Total payments for hospice days provided during FY 2018 under a new RHC payment rate and the rebased payment rates for CHC, IRC, and GIP.
We set the RHC payment rate in step (2) equal to the value that makes total payments between step (1) and step (2) equivalent. We calculate that rate using the following steps:
1. We calculate the difference in Medicare payments when using the rebased CHC, IRC, and GIP payment rates instead of the payment rates in place during FY 2019.
2. We calculate one minus the value from Step (1) over the RHC payments made under the payment rates in place during FY 2019.
3. We multiply the value in Step (2) by each RHC payment rate (the first 60 days and any RHC days after day 60) in place during FY 2019 to establish the budget- neutral RHC payment rates (the first 60 days and any RHC days after day 60).
The calculated payment rates in Step (3) will make the total payments made under the rebased FY 2019 payment rates equal to the total payments made under the existing FY 2019 payment rates.
The results of this calculation demonstrate that in order to rebase CHC, IRC, and GIP levels of care in a budget-neutral manner, the RHC payment rates would need to be reduced by 2.71 percent. The proposed 2.71 percent reduction would be applied to the RHC payment rates for the first 60 days and RHC days after day 60 (that is we would take each of the RHC payment rates and multiply by the 0.9729 to determine the FY 2019 RHC payment rates).
To summarize, we are proposing: To rebase the payment rates for CHC and GIP and set these rates equal to their estimated FY 2019 average costs per day (see Table 10 above); we are proposing to rebase the payment rate for IRC and set this rate equal to the estimated FY 2019 average cost per day, with a reduction of 5 percent to the estimated FY 2019 average cost per day to account for coinsurance (see Table 10 above); and we are proposing a 2.71 percent reduction to the RHC payment rates to offset the proposed increases to the CHC, IRC, and GIP payment rates as the proposed increases in the payment rates for these three levels of care must be implemented in a budget-neutral manner in accordance with section 1814(i)(6)(D)(ii) of the Act. While the per diem payments were a reasonable way to pay hospices, we think the proposal to rebase the per diem payments for CHC, GIP, and IRC better reflects the costs of providing care. This proposal is in accordance with section 1814(i)(A) of the Act that provides the authority to set such payments reasonable to the cost of providing hospice care.
It is our intent to ensure that payment rates under the hospice benefit align as closely as possible with the average costs hospices incur when efficiently providing covered services to beneficiaries. This proposal is not intended to place an arbitrary limit on hospice services and we believe the rebased rates for CHC, IRC, and GIP may help appropriately increase access to these levels of care. We continue to expect hospices to adhere to the long-standing policy to provide “virtually all” care during a hospice election as articulated in the 1983 Hospice Care proposed and final rules as well as most recently in FY 2019 Hospice Wage Index and Payment Rate Update final rule. We also believe this proposal is responsive to industry concerns regarding the challenges in securing needed contracts with facilities to provide inpatient levels of care by more accurately aligning Medicare payments for hospice services for higher cost levels of care. We are soliciting comments on our proposal to rebase the payment rates for CHC, IRC, and GIP, which results in an increase in the payment rates to those three levels of care, and to maintain overall budget neutrality through a proposed reduction to the RHC payment rates.
We believe that rebasing the per diem payment amounts for CHC, GIP, and IRC is appropriate in order to better align payments with the costs of providing care and that potential, subsequent increases in utilization of those levels of care would not necessarily be inappropriate. However, we are also soliciting comment on whether rebasing the payment amounts for CHC, GIP, and
Historically we have calculated the hospice wage index values by using the prior fiscal year's pre-floor, pre-reclassified hospital wage index. In an effort to align with the Inpatient Prospective Payment System (IPPS) and other payment systems, we are proposing to change the hospice wage index methodology. Specifically, we are proposing to change from our established policy of using the pre-floor, pre-reclassified acute care hospital wage index from the prior fiscal year as the basis for the hospice wage index, and instead to align with the same timeframe used by the IPPS and other payment systems. In other words, we are proposing to use the pre-floor, pre-reclassified hospital wage index from the current fiscal year as the basis for the hospice wage index. Under this proposal, the FY 2020 hospice wage index would be based on the FY 2020 pre-floor, pre-reclassified IPPS hospital wage index rather than on the FY 2019 pre-floor, pre-reclassified IPPS hospital wage index.
Using the concurrent pre-floor, pre-reclassified hospital wage index would result in the most up-to-date wage data being the basis for the hospice wage index, increasing payment accuracy. It would also result in more consistency and parity in the wage index methodology used by Medicare. Medicare's skilled nursing facility (SNF), home health and acute care hospital prospective payment systems already use the most current wage index data as the basis for their wage indices. Thus, if our proposal is finalized, the wage-adjusted Medicare payments of various provider types would be based upon wage index data from the same timeframe. We are considering similar policies to use the concurrent pre-floor, pre-reclassified hospital wage index data in other Medicare payment systems, such as inpatient psychiatric facilities and inpatient rehabilitation facilities.
Overall, the impact between the FY 2020 wage index with the 1-year lag and the proposed FY 2020 wage index removing the 1-year lag is 0.0 percent due to the wage index standardization factor, which ensures that wage index updates and revisions are implemented in a budget-neutral manner. The anticipated impact on Medicare hospice payments due to the change in the wage index methodology can be found in table 11 below.
We invite comments on this proposal to align the hospice wage index with that of the SNF PPS and Home Health PPS, by using the most current pre-floor, pre-reclassified IPPS hospital wage index as the basis for the hospice wage index.
The hospice wage index is used to adjust payment rates for hospice agencies under the Medicare program to reflect local differences in area wage levels, based on the location where services are furnished. The hospice wage index utilizes the wage adjustment factors used by the Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital wage adjustments. Our regulations at § 418.306(c) require each labor market to be established using the most current hospital wage data available, including any changes made by Office of Management and Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions.
In section III.B.1 above, we proposed to use the current FY's hospital wage index data to calculate the hospice wage index values. For FY 2020, the proposed hospice wage index would be based on the FY 2020 hospital pre-floor, pre-reclassified wage index. This means that the hospital wage data used for the hospice wage index are not adjusted to take into account any geographic reclassification of hospitals including those in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act. The appropriate wage index value is applied to the labor portion of the hospice payment rate based on the geographic area in which the beneficiary resides when receiving RHC or CHC. The appropriate wage index value is applied to the labor portion of the payment rate based on the geographic location of the facility for beneficiaries receiving GIP or IRC.
In the FY 2006 Hospice Wage Index final rule (70 FR 45135), we adopted the policy that, for urban labor markets without a hospital from which hospital wage index data could be derived, all of the Core-Based Statistical Areas (CBSAs) within the state would be used to calculate a statewide urban average pre-floor, pre-reclassified hospital wage index value to use as a reasonable proxy for these areas. For FY 2020, there are two CBSAs without a hospital from which hospital wage data can be derived: 25980, Hinesville-Fort Stewart, Georgia and 16180, Carson City, NV. The FY 2020 wage index value for Carson City, NV is 1.0518 and the wage index value for Hinesville-Fort Stewart, Georgia is 0.8237.
There exist some geographic areas where there were no hospitals, and thus, no hospital wage data on which to base the calculation of the hospice wage index. In the FY 2008 Hospice Wage Index final rule (72 FR 50217 through 50218), we implemented a methodology to update the hospice wage index for rural areas without hospital wage data. In cases where there was a rural area without rural hospital wage data, we use the average pre-floor, pre-reclassified hospital wage index data from all contiguous CBSAs, to represent a reasonable proxy for the rural area. The term “contiguous” means sharing a border (72 FR 50217). Currently, the only rural area without a hospital from which hospital wage data could be derived is Puerto Rico. However, for rural Puerto Rico, we would not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity to one another of almost all of Puerto Rico's various urban and non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas); instead, we would continue to use the most recent wage index previously available for that area. For
As described in the August 8, 1997 Hospice Wage Index final rule (62 FR 42860), the pre-floor and pre-reclassified hospital wage index is used as the raw wage index for the hospice benefit. These raw wage index values are subject to application of the hospice floor to compute the hospice wage index used to determine payments to hospices. Pre-floor, pre-reclassified hospital wage index values below 0.8 are adjusted by a 15 percent increase subject to a maximum wage index value of 0.8. For example, if County A has a pre-floor, pre-reclassified hospital wage index value of 0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593. Since 0.4593 is not greater than 0.8, then County A's hospice wage index would be 0.4593. In another example, if County B has a pre-floor, pre-reclassified hospital wage index value of 0.7440, we would multiply 0.7440 by 1.15 which equals 0.8556. Because 0.8556 is greater than 0.8, County B's hospice wage index would be 0.8.
The proposed hospice wage index applicable for FY 2020 (October 1, 2019 through September 30, 2020) is available on our website at:
As we stated above, historically, we have calculated the hospice wage index values using unadjusted wage index values from another provider setting. Stakeholders have frequently commented on certain aspects of the hospice wage index values and their impact on payments. We are soliciting comments on concerns stakeholders may have regarding the wage index used to adjust hospice payments and suggestions for possible updates and improvements to the geographic adjustment of hospice payments.
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were to be updated by a factor equal to the inpatient hospital market basket percentage increase set out under section 1886(b)(3)(B)(iii) of the Act, minus 1 percentage point. Payment rates for FYs since 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs must be the inpatient market basket percentage increase for that FY.
Section 3401(g) of the Affordable Care Act mandated that, starting with FY 2013 (and in subsequent FYs), the hospice payment update percentage would be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP).
The proposed hospice payment update percentage for FY 2020 is based on the estimated inpatient hospital market basket update of 3.2 percent (based on IHS Global Inc.'s fourth-quarter 2018 forecast with historical data through the third quarter 2018). Due to the requirements at sections 1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of the Act, the estimated inpatient hospital market basket update for FY 2020 of 3.2 percent must be reduced by a MFP adjustment as mandated by Affordable Care Act (currently estimated to be 0.5 percentage point for FY 2020). In effect, the proposed hospice payment update percentage for FY 2020 would be 2.7 percent.
Currently, the labor portion of the hospice payment rates is as follows: For RHC, 68.71 percent; for CHC, 68.71 percent; for General Inpatient Care, 64.01 percent; and for Respite Care, 54.13 percent. The non-labor portion is equal to 100 percent minus the labor portion for each level of care. Therefore, the non-labor portion of the payment rates is as follows: For RHC, 31.29 percent; for CHC, 31.29 percent; for General Inpatient Care, 35.99 percent; and for Respite Care, 45.87 percent. Beginning with cost reporting periods starting on or after October 1, 2014, freestanding hospice providers are required to submit cost data using CMS Form 1984-14 (
There are four hospice payment categories, all of which are distinguished by the location and intensity of the services provided. The base payments are adjusted for geographic differences in wages by multiplying the labor share, which varies by category, of each base rate by the applicable hospice wage index. A hospice is paid the RHC rate for each day the beneficiary is enrolled in hospice, unless the hospice provides CHC, IRC, or GIP. CHC is provided during a period of patient crisis to maintain the patient at home; IRC is short-term care to allow the usual caregiver to rest and be relieved from caregiving; and GIP is provided to treat symptoms that cannot be managed in another setting.
As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47172), we implemented two different RHC payment rates, one RHC rate for the first 60 days and a second RHC rate for days 61 and beyond. In addition, in that final rule, we implemented a Service Intensity Add-on (SIA) payment for RHC when direct patient care is provided by a RN or social worker during the last 7 days of the beneficiary's life. The SIA payment is equal to the CHC hourly rate multiplied by the hours of nursing or social work provided (up to 4 hours total) that occurred on the day of service, if certain criteria are met. In order to maintain budget neutrality, as required under section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted by a SIA budget neutrality factor.
As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47177), we will continue to make the SIA payments budget neutral through an annual determination of the SIA budget neutrality factor (SBNF), which will then be applied to the RHC payment rates. The SBNF will be calculated for each FY using the most current and complete utilization data available at the time of rulemaking. For FY 2020, this calculation would also reflect the proposed increase in the hourly rate for CHC as a result of rebasing, discussed in section III.A.2.c of this proposed rule.
In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52156), we initiated a policy of applying a wage index standardization factor to hospice payments in order to eliminate the aggregate effect of annual variations in hospital wage data. In order to calculate the wage index
As discussed in section III.A.3 of this proposed rule, we are proposing to rebase the per diem payment rates for the CHC, IRC, and GIP levels of care. Section 1814(i)(6) of the Act, as amended by section 3132(a)(1)(B) of the Affordable Care Act, authorizes the Secretary to collect additional data and information determined appropriate to revise payments for hospice care and for other purposes. The data collected may be used to revise the methodology for determining the payment rates for RHC and other hospice services (in a budget-neutral manner in the first year), no earlier than October 1, 2013, as described in section 1814(i)(6)(D) of the Act. As mentioned above and outlined in the Affordable Care Act, hospice payment reform must be done in a budget-neutral manner. In other words, total estimated hospice expenditures under these rebased payment rates must equal total estimated hospice expenditures absent rebasing (we are assuming no change in utilization). In order to rebase the per diem payment amounts for CHC, IRC, and GIP in a budget-neutral manner, in section III.A.2.c we proposed that increases to the CHC, IRC, and GIP per diem payment amounts would be offset by corresponding decreases to the RHC per diem payment amounts to maintain overall budget neutrality.
The proposed FY 2020 payment rates for RHC would be the proposed FY 2019 payment rates, reduced by a budget neutrality factor as a result of the proposed rebasing of the CHC, IRC, and GIP payment amounts, adjusted by the SIA budget neutrality factor, adjusted by the wage index standardization factor, and increased by the 2.7 hospice payment update percentage as shown in table 12. The proposed FY 2020 rebased payment rates for CHC, IRC, and GIP would be the proposed rebased FY 2019 payment rates, adjusted by the wage index standardization factor and increased by the 2.7 market basket update percent as shown in table 13.
Sections 1814(i)(5)(A) through (C) of the Act require that hospices submit quality data, based on measures to be specified by the Secretary. In the FY 2012 Hospice Wage Index final rule (76 FR 47320 through 47324), we implemented a Hospice Quality Reporting Program as required by section 3004 of the Affordable Care Act. Hospices were required to begin collecting quality data in October 2012, and submit that quality data in 2013. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to that FY. The proposed FY 2020 rates for hospices that do not submit the required quality data would be updated by the proposed FY 2020 hospice payment update percentage of 2.7 percent minus 2 percentage points. These rates are shown in tables 14 and 15.
As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47183), we implemented changes mandated by the IMPACT Act of 2014 (Pub. L. 113-185). Specifically, for accounting years that end after September 30, 2016, and before October 1, 2025, the hospice cap is updated by the hospice payment update percentage rather than using the CPI-U. The proposed hospice cap amount for the FY 2020 cap year will be $29,993.99, which is equal to the FY 2019 cap amount ($29,205.44) updated by the proposed FY 2020 hospice payment update percentage of 2.7 percent.
Hospice care is a comprehensive, holistic approach to treatment that recognizes the impending death of an individual may necessitate a transition from curative to palliative care if the individual so chooses. Medicare hospice care services are virtually all-inclusive, and are focused on meeting the physical, emotional, psychosocial and spiritual needs of the terminally ill individual and his or her family. In order to make an informed choice about whether to receive hospice care, the patient, family, and caregiver must have an understanding of what services are going to be provided by the hospice and that, because there is no longer a reasonable expectation for a cure, care should now focus on comfort and quality of life. The services covered under the Medicare hospice benefit are comprehensive such that, upon election, the individual waives all rights to Medicare payment for services related to the treatment of the individual's condition with respect to which a diagnosis of terminal illness has been made, except when provided by the designated hospice or attending physician. Because of the significance of this decision, the terminally ill individual must elect hospice care in order to receive services under the Medicare hospice benefit. Since we first implemented the Medicare hospice benefit in 1983, it has been our general view that the waiver required by law requires hospices to provide virtually all the care that is needed by terminally ill patients (48 FR 56010).
In order to be eligible to elect the Medicare hospice benefit, a beneficiary must be certified as terminally ill, meaning that the beneficiary has a medical prognosis of a life expectancy of 6 months or less if the illness runs its normal course (42 CFR 418.3). For the initial certification, the patient-designated attending physician (if any) and the hospice medical director (or hospice physician member of the interdisciplinary group (IDG)) must each certify in writing, at the beginning of the period, that the individual is terminally ill based on the physician's or medical director's clinical judgment regarding the normal course of the individual's illness. The regulations § 418.25 require that the hospice admit a patient only on the recommendation of the medical director in consultation with, or with input from, the patient's attending physician (if any).
In reaching a decision to certify that the patient is terminally ill, the hospice medical director must consider the principal diagnosis of the patient, all other health conditions, whether related or unrelated to the terminal condition, and all clinically relevant information
Because the receipt of hospice services under the Medicare hospice benefit is dependent upon the eligible beneficiary electing to receive hospice care, the regulations at § 418.24 provide the requirements of the hospice election statement. The election statement must include the identification of the designated hospice and attending physician (if any); the individual's or representative's acknowledgement that he or she has been given a full understanding of the palliative rather than curative nature of hospice care; and the individual's or representative's acknowledgement that the individual waives the right to Medicare payment for services related to the terminal illness and related conditions, except when provided by the designated hospice or attending physician. Services unrelated to the terminal illness and related conditions remain eligible for Medicare coverage and payment outside of the hospice benefit.
Once the beneficiary has elected hospice care, the hospice conducts an initial assessment visit in advance of furnishing care. During this visit, the hospice must provide the patient or representative with a spoken and written notice of the patient's rights and responsibilities as required by the CoPs at § 418.52. Our rules state that the beneficiary has the right to be involved in developing his or her hospice plan of care; receive information about the services covered under the hospice benefit; and receive information about the scope of services that the hospice will provide and specific limitations on those services. The hospice program must assure the patient that its staff will protect patients' rights and will involve patients in decisions about their care, treatment and services.
• Improving quality of care for beneficiaries;
• Protecting the integrity of the Medicare Trust Fund by ensuring that Medicare pays only for services and goods that are reasonable and necessary and that are provided in the most appropriate setting; and
• Protecting beneficiaries by expeditiously addressing individual complaints.
Changes to the QIO Program were made to ensure that Medicare beneficiary needs are better met by designating a special type of organization, a Medicare Beneficiary and Family—Centered Care—Quality Improvement Organization (BFCC-QIO), to address quality of care concerns and appeals. When Medicare beneficiaries have a complaint that is not related to the clinical quality of healthcare, they and their healthcare provider can agree to participate in a flexible, dialogue-based resolution process, called “immediate advocacy,” which is coordinated by the BFCC-QIO (§ 476.110).
The patient rights are provided to the beneficiary at the beginning of a hospice election. Likewise, the hospice CoPs at § 418.54 require that the hospice registered nurse must complete the initial assessment within 48 hours after the election of hospice care, unless the physician, patient, or representative requests that the initial assessment be completed in less than 48 hours. The initial assessment is to gather critical information necessary to treat the patient/family's immediate care needs. The hospice IDG, in consultation with the individual's attending physician (if any), must complete a comprehensive assessment no later than 5 calendar days after the election of hospice care. Additionally, the hospice CoPs at § 418.54(c) provide the content requirements for the initial and comprehensive assessments used to identify patient, family, and caregiver needs for physical, emotional, psychosocial, and spiritual care. As part of the comprehensive assessment, the hospice is required to assess the patient for complications and risk factors, which can affect care planning. The needs identified in these assessments drive the development and revisions of an individualized written plan of care for each patient as required by the CoPs at § 418.56. Collectively, the IDG, in consultation with the patient's attending physician (if any), makes care plan decisions for each patient to ensure that each care plan is individualized to meet the unique needs of each hospice beneficiary. The plan of care also must reflect patient, family, and caregiver preferences, goals, and interventions based on the problems identified in the initial, comprehensive, and updated comprehensive assessments. The plan of care must include all services necessary for the palliation and management of the terminal illness and related conditions and the CoPs at § 418.56(c) detail the plan of care content requirements, including the following:
(1) Interventions to manage pain and symptoms.
(2) A detailed statement of the scope and frequency of services necessary to meet the specific patient and family needs.
(3) Measurable outcomes anticipated from implementing and coordinating the plan of care.
(4) Drugs and treatment necessary to meet the needs of the patient.
(5) Medical supplies and appliances necessary to meet the needs of the patient.
(6) The interdisciplinary group's documentation of the patient's or representative's level of understanding, involvement, and agreement with the plan of care, in accordance with the hospice's own policies, in the clinical record. Furthermore, as a condition for payment, the services provided must be consistent with the plan of care (§ 418.200).
Though hospices are responsible for providing all services needed for palliation and management of the terminal illness and related conditions, the 2008 Hospice Conditions of Participation final rule (73 FR 32088, June 5, 2008) states that while needs unrelated to the terminal illness and related conditions are not the responsibility of the hospice, the hospice may choose to furnish services for those needs regardless of responsibility (73 FR 32114). If a hospice does not choose to furnish services for those needs unrelated to the terminal illness and related conditions,
To ensure comprehensive and coordinated care, at § 418.56(e) we require hospices to have a communication system that allows for the exchange of information with other non-hospice health care providers who are furnishing care unrelated to the terminal illness and related conditions. We also require hospices to designate a registered nurse (RN) who is a member of the IDG to coordinate implementation of the comprehensive plan of care. The designated RN must assure that coordination of care and continuous assessment of patient, family, and caregiver needs occur among staff providing services to the patient, family, and caregiver so that all IDG members are kept informed of the patient/family's status.
As discussed in section III.C.2., the hospice medical director, the attending physician (if any), and the hospice IDG determine, for each patient, what items and services are related and unrelated to the palliation and management of the terminal illness and related conditions during the admission process, the initial and comprehensive assessments, and in the development of the hospice plan of care. To the extent that individuals receive services outside of the Medicare hospice benefit during a hospice election, Medicare coverage is determined by whether or not the services are for the treatment of a condition completely unrelated to the individual's terminal illness and related conditions (48 FR 38146, 38148, August 22, 1983). As such, it is our long-standing position that services unrelated to the terminal illness and related conditions should be exceptional, unusual and rare given the comprehensive nature of the services covered under the Medicare hospice benefit (48 FR 56008, 56010, December 16, 1983). The Medicare claims processing system has edits in place to prevent other non-hospice claims from being processed while a patient is under a hospice election. For claims unrelated to the terminal illness and related conditions to be processed for Medicare payment while a patient is under a hospice election, the non-hospice provider or supplier must use a modifier or condition code on the claim to indicate that the service billed is unrelated to the patient's terminal condition. This is to help ensure that payment is made from the appropriate Medicare trust fund, and that duplicate payments are avoided.
In accordance with the hospice CoPs at § 418.56(e)(5), and in alignment with continuity of care principles,
While hospices are required by the CoPs to have a system of communication with non-hospice providers to furnish such information, we have heard anecdotally from non-hospice providers stating that they are unable to reach or do not receive return calls from the hospice to discuss the hospice beneficiary's coordination of services that the hospice has determined unrelated to his or her terminal illness and related condition(s). Likewise, we have also received anecdotal reports from hospices who state they were unaware that patients had received care from non-hospice providers. In these reports, the hospice would first learn of this outside care when non-hospice providers would contact the hospice seeking reimbursement. If this care was related to the terminal illness and related conditions and the hospice did not make arrangements for such care, the beneficiary would be liable for the costs of receiving that care. Additionally, if non-hospice providers bill Medicare for services that potentially should have been the coverage responsibility of hospice, Medicare could be making duplicative payments for care related to the terminal illness and related conditions.
The OIG released a report in June of 2012 identifying situations where Medicare may have been paying twice for prescription drugs for hospice beneficiaries. This report also suggests that Medicare hospice beneficiaries themselves could also be paying unnecessary co-payments or coinsurance for prescription drugs.
After a hospice election, many maintenance drugs or drugs used to treat or cure a condition are typically discontinued as the focus of care shifts to palliation and comfort measures. However, there are maintenance drugs that are appropriate to continue as they may offer symptom relief for the palliation and management of the terminal illness and related conditions. Some examples of maintenance drugs include those to manage conditions such as heart disease, COPD, and diabetes. We continue to receive complaints from Part D plan sponsors and pharmacies that some hospice providers fail to respond to frequent outreach efforts from Part D sponsors seeking recovery for claims in the four categories or to clarify payment responsibility for medications for hospice beneficiaries. We believe that this represents a lack of coordination between hospices and Part D pharmacies and sponsors, which ultimately affects the quality of care furnished to an especially vulnerable population and results in additional costs to beneficiaries, as well as Part D plan sponsors.
In previous years' hospice proposed rules, we have included data on non-hospice expenditures for beneficiaries under a hospice election. These total non-hospice expenditures include beneficiary cost-sharing amounts. For Parts A and B, the beneficiary cost-sharing amounts in FY 2017 totaled approximately $138 million and for Part D, the beneficiary cost-sharing totaled approximately $68.6 million (83 FR 20946 through 20947). We believe that this is a substantial financial burden being placed on terminally ill individuals for services that potentially should have been covered by hospice. In previous years' rules, we have provided data and case studies on the most frequently reported principal diagnoses on hospice claims and their associated non-hospice expenditures for what were determined to be services for unrelated conditions (80 FR 47154 and 81 FR 25510). These diagnoses included lung cancer, cerebral degeneration of the brain (that is, conditions that cause dementia), chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF). We also discussed the recommended evidence-based clinical practice guidelines for those diagnoses, including the use of certain types of DME, supplies and drugs. Our analysis revealed that items such as oxygen, respiratory agents, hospital beds, wheelchairs, common palliative drugs, and disease-specific drugs were not being furnished or covered by hospice even though we would expect such items to be clinically indicated and provided for the palliation and management of the terminal illness and related conditions (80 FR 47154). This suggests that hospice beneficiaries may be incurring unnecessary financial burden as they are having to seek out and pay for items and services for pain and symptom relief—services that hospice should be furnishing and covering.
We have received numerous anecdotal reports from beneficiaries, families, and non-hospice providers that hospice patients are obtaining needed drugs and other services outside of the hospice benefit because they have been told that hospice would not cover the drugs as the hospice determined that they were unrelated to the terminal illness and related conditions. Many of these anecdotal reports state that the beneficiaries and families believe that these items, services, and drugs were related to the terminal illness and related conditions and believed that they should have been provided by the hospice. The beneficiaries and/or the families stated that they did not know they would have to seek care outside of the hospice benefit for these conditions because the hospice did not tell them these items, services, and drugs would not be furnished by the hospice until the patient needed them. The Medicare Beneficiary Ombudsman Office also has received similar reports. The Medicare Ombudsman helps beneficiaries with Medicare-related complaints, grievances, and information requests, regarding what beneficiaries need to know to make appropriate health care decisions; beneficiary rights and protections under Medicare; and how to get issues resolved.
The Medicare Ombudsman also shares information with the Secretary of Health and Human Services, Congress, and other organizations about what does and doesn't work well to improve the quality of the services and care beneficiaries get through Medicare. Examples of recent Medicare Ombudsman reports of patients being told only after electing the benefit and the commencement of hospice care that certain items, services or drugs were not covered by the hospice include:
• An incident was reported to the Medicare Beneficiary Ombudsman Office by a hospice beneficiary who stated that when she ran out of her
• A family member contacted CMS on behalf of his mother and stated that the hospice refused to furnish a seated walker because the hospice had determined the need for a seated walker was unrelated to the beneficiary's terminal illness and related conditions. This beneficiary was unable to ambulate without having to stop and sit down because of shortness of breath due to her end-stage lung cancer. The family member mentioned that his father was going to purchase the walker out of pocket, but he wanted to check with Medicare before doing so. The beneficiary was very distressed because being able to ambulate in her own home lessened the pain of lying in bed for prolonged periods of time and improved the quality of her life. The family member stated he did not know whom to call because he was under the impression that hospice was to cover everything his mother needed.
• During a CMS field office site visit, one hospice beneficiary reported that the hospice would not cover the cost of his benign prostatic hypertrophy (BPH) medication as the hospice stated the medication was unrelated to his terminal illness and related conditions. This medication helped alleviate urinary retention which caused him significant discomfort. This beneficiary had a hospice-reported principal diagnosis of sepsis due to a urinary tract infection. The beneficiary obtained his BPH medication through his pharmacy benefit but he stated he thought hospice was to provide him with all of his medications because that was the impression the hospice had given him when he elected hospice. He said he was never told by the hospice what medications or services he would have to obtain on his own.
• CMS has received multiple reports of hospice beneficiaries requiring palliative chemotherapy or palliative radiation for pain and symptom management, but these beneficiaries are told by hospices that these services are not covered under the hospice benefit because these treatments are curative in nature and therefore not in alignment with the hospice philosophy of care. These beneficiaries report that they were not told this when they elected hospice and they revoked the hospice benefit in order to receive needed treatments to alleviate pain.
• Similarly, CMS has met with physician associations to discuss the Medicare hospice benefit and physicians report that when they try to refer patients to hospice who require palliative blood transfusions for symptom management, the physicians and their patients are being told by hospices that the Medicare hospice benefit does not cover palliative blood transfusions. The physicians reported that they either do not refer these patients to hospice to ensure that the patients can continue their palliative blood transfusions, or for those patients that do elect the hospice benefit, those patients revoke hospice care to receive their palliative blood transfusions and then re-elect hospice care after they have received these services. We note that the Medicare hospice benefit does cover services for pain and symptom management, including palliative chemotherapy, radiation and blood transfusions. The per diem payment amounts paid to hospices account for such services and hospices are required to cover those items, services, and drugs for the palliation and management of the terminal illness and related conditions.
The continued anecdotal reports we receive from various stakeholders may suggest that some hospices are not adequately informing hospice patients at hospice election about the scope of services covered under the hospice benefit and thus hospice patients may not have complete benefit coverage information when electing the hospice benefit. This lack of coverage transparency may result in hospice patients having to seek out needed items, services and drugs outside of the Medicare hospice benefit and incur unexpected financial liability as a result. This also may suggest that hospices could be making care plan decisions based on cost or convenience rather than based on the needs, preferences and goals of the patient. This is not in alignment with the Medicare hospice benefit regulations and CoPs. We expect that services received outside of the hospice benefit to be rare.
Since the implementation of the Medicare hospice benefit, we have received frequent requests, via informal means and through the formal rulemaking process to provide additional guidance about determining what are considered “related conditions” as these are the coverage responsibility of hospice. Our position has been the same since the implementation of the Medicare hospice benefit in 1983. We believe that hospices are required to provide virtually all of the care needed by the terminally ill individual (48 FR 56010). Any services needed outside of the hospice benefit (that is, “unrelated”) should be exceptional and unusual. We reiterate that the terminally ill individual's unique clinical condition makes it necessary for these determinations of related versus unrelated conditions to be made for each patient. To be responsive to the numerous requests for more guidance, in recent years' rules we have provided additional guidance regarding eligibility requirements for hospice admission (79 FR 50470 and 80 FR 25878); assessment of other conditions and comorbidities (80 FR 25878 through 25879); and, reporting of related and unrelated conditions on hospice claims (80 FR 25880). However, in spite of the guidance provided, we continue to have concerns that these decisions are based on a more narrow view of the overall condition of the individual, as is evidenced by the non-trivial amount of items, services, and drugs for potentially related conditions provided by non-hospice providers to beneficiaries under a hospice election.
As mentioned previously, the CoPs at § 418.56 require that the hospice include all services needed for the palliation and management of the terminal illness and related conditions on the individualized hospice plan of care. Similarly, the hospice interpretative guidelines for § 418.56 state that the plan of care should also identify the conditions or symptoms that the hospice determines to be “unrelated” so hospices can provide ongoing sharing of information with
The Medicare hospice regulations and CoPs are designed to ensure comprehensive coverage of hospice services and to help educate patients and their families regarding the scope of hospice services. Patient protection, empowerment, and advocacy are of such utmost importance that the CoPs at § 418.52 explicitly require that the hospice inform the patient of his or her rights and promote the exercise of these rights. However, as described in section III.C.3 above, we have concerns about whether patients are being adequately informed about the scope of services covered under the Medicare hospice benefit and whether patient rights are being fully promoted and protected. Furthermore, we continue to be concerned about the currently reported poor or absent communication between hospice and non-hospice providers needed to ensure coordination of all reasonable and necessary services for Medicare hospice beneficiaries. This may result in a lack of coverage transparency and where beneficiaries are unaware of their financial liability while under a hospice election for those items, services, and drugs the hospice has determined to be unrelated to their terminal prognosis.
Patients and their families must be provided complete and accurate information regarding their hospice benefit under Medicare, as well as their rights, responsibilities, and financial liability to ensure that they are empowered to make informed treatment decisions that align with their personal needs, preferences, and goals. In order to receive services under the Medicare hospice benefit, the beneficiary must make a choice to elect the benefit. As with all medical choices, this would mean that the beneficiary (or representative) has given informed consent for services. Stated simply, informed consent in medical care, which includes hospice care, is a process of communication between a clinician and a patient that results in the patient's authorization or agreement to undergo a specific medical intervention or mode of care.
Therefore, we are proposing to modify the hospice election statement content requirements at § 418.24(b) to increase coverage transparency for patients under a hospice election. In addition to the existing election statement content requirements at § 418.24(b), we are proposing that hospices also would be required to include the following on the election statement:
• Information about the holistic, comprehensive nature of the Medicare hospice benefit;
• A statement that, although it would be rare, there could be some necessary items, drugs, or services that will not be covered by the hospice because the hospice has determined that these items, drugs, or services are to treat a condition that is unrelated to the terminal illness and related conditions.
• Information about beneficiary cost-sharing for hospice services.
• Notification of the beneficiary's (or representative's) right to request an election statement addendum that includes a written list and a rationale for the conditions, items, drugs, or services that the hospice has determined to be unrelated to the terminal illness and related conditions and that immediate advocacy is available through the BFCC-QIO if the beneficiary (or representative) disagrees with the hospice's determination.
Likewise, we are proposing to make the corresponding regulations text changes at § 418.24(b).
Additionally, we are proposing that hospices would be required, upon request, to provide to the beneficiary (or representative) an election statement addendum with a list and rationale for the conditions, items, services, and drugs that the hospice has determined as unrelated to the terminal illness and related conditions. Similarly, we are proposing that hospices would be required to provide the election statement addendum upon request to other non-hospice providers that are treating such conditions, and Medicare contractors who request such information. We are proposing that if the election statement addendum is requested at the time of hospice election, the hospice must provide this information, in writing, to the individual (or representative) within 48 hours of the request. Furthermore, we are proposing that if this addendum is requested during the course of hospice care, the hospice must provide this information, in writing, immediately to the requesting individual (or representative), non-hospice provider, or Medicare contractor, as this information should be readily available in the beneficiary's hospice medical record. While we believe that hospices should be able to immediately provide this information, in writing, to the requesting beneficiary (or representative), non-hospice provider or Medicare contractor, we are soliciting comment on the appropriate timeframe to provide this information to the requesting party if such information is requested after the election of hospice care. During the course of hospice care, if there are changes to the plan of care that result in a determination that a new illness or condition has arisen, we are proposing that hospices would be required to issue an updated addendum to the patient (or representative) reflecting whether or not items, services and supplies related to the new illness or condition will be provided by the hospice.
The purpose of the proposed addendum is to inform beneficiaries and their families of non-covered conditions, items, services, and drugs to provide full coverage transparency to hospice patients and their families to assist in making treatment decisions. Likewise, the addendum will help facilitate communication and benefit coordination between hospices and non-hospice providers. We propose that if there is a request for the addendum, the presence of the signed addendum (and updated, signed addenda) in the beneficiary's hospice medical record would be a new condition for payment for Medicare hospice services.
Hospices can develop and design the addendum to meet their needs, similar to how hospices develop their own hospice election statement. We propose the addendum would be titled “Patient Notification of Hospice Non-Covered Items, Services, and Drugs.” We propose that the addendum would include the following information:
1. Name of the hospice;
2. Beneficiary's name and hospice medical record identifier;
3. Identification of the beneficiary's terminal illness and related conditions;
4. A list of the beneficiary's current diagnoses/conditions present on hospice admission (or upon plan of care update, as applicable) and the associated items, services, and drugs, not covered by the hospice because they have been determined by the hospice to be unrelated to the terminal illness and related conditions;
5. A written clinical explanation, in language the beneficiary and his or her representative can understand, as to why the identified conditions, items, services, and drugs are considered unrelated to the terminal illness and related conditions and not needed for pain or symptom management. This clinical explanation would be accompanied by a general statement that the decision as to whether or not conditions, items, services, and drugs is related is made for each patient and that the beneficiary should share this clinical explanation with other health care providers from which they seek services unrelated to their terminal illness and related conditions;
6. References to any relevant clinical practice, policy, or coverage guidelines.
7. Information on the following domains:
i. The purpose of the addendum is to notify the hospice beneficiary (or representative) of those conditions, items, services, and drugs the hospice will not be covering because the hospice has determined they are unrelated to the beneficiary's terminal illness and related conditions.
ii. The addendum is subject to review and shall be updated, as needed, when the plan of care is updated in accordance with § 418.56. The hospice will provide these updates, in writing, to the beneficiary (or representative).
The addendum must include language that immediate advocacy is available through the BFCC-QIO if the beneficiary (or representative) disagrees with the hospice's determination. Specifically, the language must include contact information for the BFCC-QIO, as well as, the following statement: “
8. Name and signature of Medicare hospice beneficiary (or representative) and date signed, along with a statement that signing this addendum (or its updates) is only acknowledgement of receipt of the addendum (or its updates) and not necessarily the beneficiary's agreement with the hospice's determinations.
Finally, we are proposing to add the election statement addendum content requirements to the regulations at § 418.24.
As discussed and proposed above, the signed addendum (and any signed updates) would be a new condition for payment. This does not mean that in order to meet this condition for payment that the beneficiary (or representative), or non-hospice provider must agree with the hospice's determination. For purposes of this condition for payment, the signed addendum is only acknowledgement of the beneficiary's (or representative's) receipt of the addendum (or its updates) and this payment requirement would be met if there was a signed addendum (and any signed updates) in the requesting beneficiary's medical record with the hospice. This addendum would not be required to be submitted with any hospice claims. Likewise, the hospice beneficiary (or representative) would not have to separately consent to the release of this information to non-hospice providers furnishing services for unrelated conditions as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule allows those doctors, nurses, hospitals, laboratory technicians, and other health care providers that are covered entities to use or disclose protected health information, such as X-rays, laboratory and pathology reports, diagnoses, and other medical information for treatment purposes without the patient's express authorization. This includes sharing the information to consult with other providers, including providers who are not covered entities, to treat a different patient, or to refer the patient (45 CFR 164.506).
This hospice election statement addendum would only be required for Medicare hospice beneficiaries who request such information, though hospices may choose to provide this addendum to all of their hospice patients, regardless of payer source (after making appropriate adjustments for the specific payer). Hospices can determine which member of the IDG would be responsible for completing this addendum, but we would expect that this typically would be the function of the hospice registered nurse responsible for the patient's plan of care. As mentioned previously, hospices must designate a registered nurse (RN), who is a member of the IDG, to coordinate implementation of the comprehensive plan of care. The designated RN must assure that coordination of care and continuous assessment of patient, family, and caregiver needs occur among staff providing services to the patient, family, and caregiver so that all IDG members are kept informed of the patient/family/caregiver's status (§ 418.56(a)).
While ideally this addendum would be provided to the requesting beneficiary (or representative) at the time of hospice election, we recognize that hospices may need some leeway to have discussion amongst the members of the IDG to finish developing the hospice plan of care. Therefore, we are proposing that the addendum would be required to be provided to the requesting beneficiary (or representative) within 48 hours of the hospice election date; and the beneficiary would sign the addendum and receive a completed, signed copy at that time for his/her records. This is in alignment with the current CoP requirements at § 418.54(a) stating that the hospice registered nurse must complete an initial assessment within 48 hours after the election of hospice care. Hospices would be exempt from completing this addendum if the beneficiary died within 48 hours of the election date of hospice care. The original beneficiary or representative-signed election statement and addendum would be included in the patient's hospice medical record as already required by the hospice CoPs at § 418.104(a)(2).
If the beneficiary (or representative) requests this addendum after admission to hospice, we are proposing that the hospice would provide the addendum immediately to the beneficiary (or representative), as this information should already be readily available in the beneficiary's hospice medical
While the proposed election statement addendum outlines the content requirements for the addendum, it does not mandate the use of a specific form. Hospices are able to design the addendum in the form or format that best meets their needs, assuming all content requirements are met. As there is currently a model election statement available in a MLN Matters® article, SE1631,
Furthermore, Part D plan sponsors currently have a prior authorization process in place for their member enrolled in hospice for the four categories of drugs (analgesics, anti-nausea, anti-anxiety, and laxatives) and a voluntary, standardized form was developed with industry input for hospices to submit to Part D plans in order to assist in: (1) Proactively avoiding a drug claim from rejecting at point-of-sale; (2) overriding a reject edit at point-of-sale; and (3) communicating a change in the a patient's hospice status.
While the CoPs already require that information on unrelated conditions should be documented and communicated to beneficiaries and non-hospice providers (§ 418.56), we believe that making this a condition for payment will help to ensure that hospices are diligent in providing this information to Medicare hospice beneficiaries. It is important to note that the proposed modifications to the hospice election statement and the election statement addendum, “Patient Notification of Hospice Non-Covered Items, Services, and Drugs,” leverages existing hospice regulations, CoPs, and QIO requirements for hospices to:
• Identify those conditions and services present on hospice admission (and at plan of care update, as necessary) that the hospice has determined to be unrelated to the terminal illness and related conditions (§§ 418.22, 418.54(c)(2), 418.102), as outlined in element 4 of the addendum as noted above;
• Inform the beneficiary and family about what is covered and not covered by the hospice on the plan of care (§§ 418.52 and 418.56(b)), as outlined in the proposed additional election statement content requirements and elements 3, 4, 5, and 6 of the addendum as noted above;
• Coordinate with providers that are providing care unrelated to the terminal illness and related conditions (§ 418.56(e)(5)), as outlined in the proposed, additional election statement content requirements and elements 4, 5, and 6 of the addendum as noted above; Educate beneficiaries about their patient rights (§§ 418.52(a) and 476.78(b)(3)), as outlined in the proposed, additional election statement content requirements and element 7 of the addendum as noted above.
We believe that the election statement addendum will promote greater transparency regarding coverage under the Medicare hospice benefit, as well as informing the beneficiary as to those services they might need to seek outside of the hospice benefit. This would help in beneficiary decision-making regarding needed items, services, and drugs, and to determine the model of care that best meets their treatment preferences and goals of care. Likewise, we believe the addendum would provide information that would allow hospice beneficiaries to anticipate potential financial liability for health care services outside of the hospice benefit. Because hospices would have to provide a list and clinical rationale for those items, services, and drugs that they will not be covering because the hospice has determined them to be unrelated to the terminal illness and related conditions, to requesting hospice beneficiaries (or representatives), non-hospice providers rendering services to hospice beneficiaries, and/or Medicare contractors, we believe this accountability may mitigate unnecessary financial burden for hospice beneficiaries. A primary goal of the election statement addendum is to hold hospices more accountable to hospice beneficiaries through benefit coverage transparency. Hospices should already be holistic and comprehensive in their approach to the provision of hospice services. We believe this proposal would be an incremental step in ensuring beneficiaries are receiving information regarding the full scope of Medicare hospice benefits. Subsequently, if the proposed addendum is finalized, we would continue to monitor hospice utilization trends, including non-hospice spending, to determine whether any additional changes may be warranted.
As the hospice regulations and the CoPs already require the assessment and documentation of unrelated conditions as described throughout this section, we believe there is no increase in hospice burden resulting from this addendum requirement to communicate with non-hospice providers. Similarly, we believe the collection of information for the election statement and the addendum is already accounted for in the hospice CoP burden estimates in its information collection request (OMB control number: 0938-1067) that was re-
Furthermore, this addendum, if filled out completely, updated regularly, and shared proactively and in a timely manner with non-hospice providers and pharmacies, would minimize multiple calls from non-hospice providers and pharmacies to the hospice requesting information on a patient's unrelated conditions, items, services, and drugs since the addendum would provide this comprehensive information in a practical, consistent, and useful format. In effect, this addendum would reduce burden for non-hospice providers because this addendum could assist in making treatment decisions and support the coding of an appropriate modifier or condition code on non-hospice claims for services unrelated to the terminal illness and related conditions. Non-hospice providers providing services to hospice beneficiaries are required to report the following on Medicare claims to identify that the items or services were for the treatment of conditions unrelated to the terminal illness and related conditions:
• Institutional providers would submit a claim with condition code 07.
• Physicians would submit a claim with modifier GW.
The election statement addendum may allow the non-hospice provider to be “without fault” if there is any question regarding an overpayment. In accordance with section 1870 of the Act, a provider is responsible for an overpayment if the provider knew or had reason to know that service(s) were not reasonable and necessary, and/or the provider did not follow correct procedures or use care in billing or receiving payment. If non-hospice providers have the addendum, this potentially could satisfy section 1870 of the Act in providing that the non-hospice provider did not have reason to know that the services were not reasonable and necessary (considering the service itself is reasonable and necessary and satisfies all other requirements for payment). Moreover, if a non-hospice provider submits a claim to Medicare for services provided to a beneficiary that are unrelated to the terminal illness and related conditions but does not have the supporting documentation that the services are unrelated, this could be considered a false claim under the False Claims Act.
We note that this addendum is not to be used by hospices as a vehicle in which to exercise unlimited ability to determine services as unrelated to the terminal illness and related conditions. It has always been CMS' expectation that hospice would be providing virtually all of the care needed by terminally ill individuals (48 FR 56010). Similarly, in a 1993 HCFA (now CMS) ruling, “Weight To Be Given To a Treating Physician's Opinion In Determining Medicare Coverage Of Inpatient Care In a Hospital Or Skilled Nursing Facility,” we stated that even though a physician's opinion is very important in making treatment determinations, no presumptive weight should be assigned to the treating physician's medical opinion alone, as coverage decisions are not made solely on this opinion.
We believe that the proposed election statement addendum, as a condition for payment, will achieve the goal of increasing comprehensive patient education, awareness, empowerment, and coverage transparency by:
• Providing information to the beneficiary (or representative), upon request, regarding those conditions, items, services, and drugs not covered by the hospice in an uncomplicated written format;
• Promoting informed consent;
• Encouraging discussion between the hospice and the terminally ill individual and their family regarding hospice covered and non-covered conditions, items, services, and drugs;
• Safeguarding patient rights and protecting the integrity of the hospice benefit by informing beneficiaries of an already established process through
• Providing a communication mechanism between hospice and non-hospice providers to help ensure benefit coordination for terminally ill patients.
This proposal outlines the modifications to the election statement content requirements and the required elements of the election statement addendum that we would require; we expect that hospices should already be complying with the existing, underlying coverage requirements. We are soliciting public comment on all aspects of the proposed modifications to the election statement content requirements, and the proposed election statement addendum, “Patient Notification of Hospice Non-Covered Items, Services, and Drugs,” as described in this section as well as the corresponding proposed revision to the regulations at § 418.24(b) in section VI of this proposed rule.
The Medicare hospice benefit is currently only available as part of traditional, fee-for-service (FFS) Medicare as hospice care is excluded from the scope of what Medicare Advantage (MA) plans must offer under section 1852(a)(1)(B)(i) of the Act. MA enrollees that are eligible for and elect the hospice benefit remain in their MA plan, but receive hospice care through traditional FFS Medicare. In turn, CMS pays hospice organizations directly for hospice services based on the FFS payment system. Generally, following the month the enrollee elects hospice, CMS pays the MA plan the rebate amount, but not the risk-adjusted capitated amount for Part A and Part B services. The MA plan remains responsible for the provision of supplemental benefits, and in the case of an MA-PD, Part D drugs that the hospice has determined are unrelated to the enrollee's terminal illness and related conditions. However, if the beneficiary requires items, services, or non-Part D drugs that the hospice has determined to be unrelated to the beneficiary's terminal illness and related conditions, then the costs for any treatment are borne by Medicare FFS rather than the MA plan in accordance with the MA program's special rules for hospice care at §§ 422.320(c)(3) and 417.585. Incorporating hospice into other kinds of care delivery models may be a way of alleviating the payment fragmentation described above.
As outlined above, the Medicare hospice benefit is currently only available as part of traditional FFS Medicare. As part of delivery system transformation, we seek information on the interaction of the hospice benefit and various alternative care delivery models, including MA, Accountable Care Organizations (ACOs), and other future models designed to change the incentives in providing care under traditional FFS Medicare. Finally, we seek information on the impact of alternative delivery and payment models implemented outside of the Medicare program on the provision of hospice care and any lessons learned that we should consider for the future design of the Medicare hospice benefit. The questions and complexities around incorporating hospice into MA are indicative of the operational considerations that would need to be addressed around any long-term programmatic change, especially with regards to other contexts, such as ACOs or other models or changes within the Medicare hospice benefit to adapt to a changing payor mix and environment. For example, with respect to MA, unless an alternative approach to building hospice into the current bid for Part A and B services were followed, county benchmarks and the risk adjustment model would need to be revised to incorporate the cost of these beneficiaries. Additionally, although alternative network approaches might be considered, incorporating hospice into MA could result in MA plans only contracting with a subset of local hospices, thereby potentially limiting patient access and choice, and network adequacy standards would need to be developed by CMS. Additionally, given that CMS cannot and should not interfere in the contracting process between MA plans and their contracted providers, if hospice providers agree to payment rates that are lower than what Medicare currently pays that may result in changes in the quantity and types of services provided. One way managed care or value-based arrangements could address these issues may be to construct payments for hospice care such that they align closely with how hospices are paid under traditional FFS Medicare.
We note that we are testing ways to incorporate hospice into other kinds of care delivery models to alleviate payment fragmentation. One approach is to test incorporating hospice into MA under the CMS Innovation Center's authority (section 1115A of the Social Security Act). Under this voluntary model, beginning in 2021, MA enrollees in participating plans will have hospice care provided through their chosen MA plan. Through this RFI, we are seeking public comments on other broader approaches, beyond the model noted above, regarding the appropriate role of hospice as part of the care options available. Specifically, we are seeking public comments on how hospice under Medicare FFS relates to other treatment options, how it impacts the provision of a spectrum of care for those that need supportive and palliative care before becoming hospice eligible and after, and whether rates of live discharge are a reflection of the current structure of Medicare FFS. We are also seeking comment on any care coordination differences for hospice patients that received Medicare through traditional FFS prior to hospice election, were enrolled in an MA plan prior to hospice election, or received care from providers that participate in an Accountable Care Organization (ACO) prior to hospice election. Finally, we are soliciting public comments on the pros and cons of including hospice services as the part of the benefits provided in value-based or capitated payment arrangements given that some hospices likely have experience with ACOs and experience with Medicaid managed care when providing hospice care through the Medicaid program, as well as experience in providing hospice care to patients enrolled in “commercial coverage” (non-Medicare/Medicaid managed care plans). We believe the information gathered under this RFI will help to inform: (1) Future CMS payment models; (2) the role hospice with respect to ACOs; and (3) our general understanding of the traditional FFS hospice environment in relation to the increasing penetration of managed care through the MA program.
The Hospice Quality Reporting Program includes meeting the reporting requirements for both the Hospice Item Set (HIS) and Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey. Section 3004(c) of the Affordable Care Act amended section 1814(i)(5) of the Act to authorize a quality reporting program for hospices. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements for that FY. Depending on the amount
As stated in the FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements (83 FR 38622), we launched the Meaningful Measures initiative (which identifies high priority areas for quality measurement and improvement) to improve outcomes for patients, their families, and providers while also reducing burden on clinicians and providers. Meaningful Measures initiative is not intended to replace any existing programs, but will help programs identify and select individual measures. Meaningful Measure Initiative areas are intended to increase measure alignment across our programs and other public and private initiatives. Additionally, it will point to high priority areas where there may be gaps in available quality measures while helping guide our efforts to develop and implement quality measures to fill those gaps. More information about the Meaningful Measures initiative can be found at:
The Meaningful Measures initiative fits well with the HQRP since it has changed little since we began with FY 2014 Hospice Wage Index and Payment Rate Update final rule, (76 FR 26806). The Meaningful Measures initiative enables us to review HQRP to close the gaps in quality measures to reflect the hospice industry as it has progressed to meet hospice care, including symptom management for its patients regardless of where hospice care is provided.
In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48257), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of data items that support the following 7 National Quality Forum (NQF)-endorsed measures for hospice:
• NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen,
• NQF #1634 Pain Screening,
• NQF #1637 Pain Assessment,
• NQF #1638 Dyspnea Treatment,
• NQF #1639 Dyspnea Screening,
• NQF #1641 Treatment Preferences,
• NQF #1647 Beliefs/Values Addressed (if desired by the patient).
We finalized the following two additional measures in the FY 2017 Hospice Wage Index and Payment Rate Update final rule, effective April 1, 2017. Data collected will, if not reported, affect payments for FY 2019 and subsequent years. (81 FR 52163 through 52173):
• Hospice Visits when Death is Imminent,
• Hospice and Palliative Care
Composite Process Measure—Comprehensive Assessment at Admission. The Hospice and Palliative Care Composite Process Measure—Comprehensive Assessment at Admission measure (hereafter referred to as “the Hospice Comprehensive Assessment Measure”) underwent an off-cycle review by the NQF Palliative and End-of-Life Standing Committee and successfully received NQF endorsement in July 2017.
Data for the “Hospice Visits when Death is Imminent” measure pair is being collected using new items added to the HIS V2.00.0, effective April 1, 2017.
Our goal is to identify measures that provide a window into hospice care throughout the dying process, fit well with the hospice business model, and meet the objectives of the Meaningful Measures initiative. Quality measures should provide timely, understandable, comprehensive, clinically valid, and meaningful feedback to hospice leadership, all of its staff, and their different teams regardless of the hospice setting where care is provided. We seek public input on measure concepts and/or actual quality measures along with public comment on the discussions presented below.
As part of Meaningful Measures initiative, we seek to develop claims-based and outcome measures as part of the future for the HQRP. While we acknowledge that there are limitations of using claims data as a source for measure development, there are several advantages to using claims data as part of a robust hospice quality reporting program. Claims-based measures place minimal burden on providers as they do not require additional data collection and data submission. Furthermore, in contrast to self-reported data that are dependent on hospice, patient, or caregiver participation, claims data has the benefit of following a relatively consistent format and of using a standard set of pre-established codes that describe specific diagnoses, procedures, and drugs. Additionally, nearly every encounter that a patient has with the healthcare system leads to the generation of a claim, creating an abundant and standardized source of patient information. This makes claims data widely available, relatively inexpensive, and amenable to analysis because they are readily available in an electronic format.
Medicare is the largest payer of hospice services and Medicare-certified providers predominate in hospice so it makes good sense to use claims data to reflect hospice care. Further, other settings, such as the Inpatient Quality Reporting Program (QRP) and the post-acute care (PAC) QRPs, have adopted claims-based measures, and the NQF has endorsed claims-based measures and believes they can capture quality even when not directly assessing clinical care. Although claims data have some limitations, such as incomplete reflection of care processes and patient outcomes, they will continue to be a valuable and important source of data for quality reporting for a selected set of metrics and as part of a hospice quality reporting program that includes other measures, such as HIS and CAHPS® Hospice Survey.
While not mutually exclusive of claims-based measures, we also seek to develop outcome measures as part of the Meaningful Measures initiative. Outcome measures could help with improving pain and symptom management, which is core to hospice care. They could also help identify the value of different staff providing care at different times in hospice. For these reasons, we plan to explore the development of other claims-based and outcome measures for the HQRP to work toward the high priority areas of reducing regulatory burden and identifying gaps in care. In identifying high priority areas for future measure enhancement and development, CMS takes into consideration input from all stakeholders including; Measures Application Partnership (MAP); the Office of the Inspector General (OIG); the Medicare Payment Advisory Commission (MedPAC); Technical
The FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements, (82 FR 36638), noted that, based on input from stakeholders, CMS has identified two “high priority” areas that will be addressed by claims-based measure development: Potentially avoidable hospice care transitions and access to levels of hospice care. The potentially avoidable hospice care transitions concept was developed as a measure under consideration called Transitions from Hospice Care, Followed by Death or Acute Care. The goal of this measure is to identify hospices that have notably higher rates of live discharges followed shortly by death or acute care utilization, when compared to their peers. Details about this measure can be found in the FY 2017 Hospice Wage Index and Payment Rate Update and the NQF website,
The access to levels of hospice care measure concept is also detailed in the FY 2018 Hospice Wage Index and Payment Rate Update. After further analyses, it was determined that this measure concept as currently specified could result in hospices providing higher levels of care when it is not required by the plan of care or expected by CMS. We remain committed to developing claims-based measures that meet high priority areas and are rethinking both measures based on feedback from the MAP and our analyses. We are seeking public comment on ways to further develop these two measure concepts and different measure concepts that fall under these high priority areas.
We discussed the plan to develop a hospice assessment tool in the FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements, (82 FR 36638). A technical expert panel on development of such an assessment tool was held in October 2017 followed by a pilot study that began with training 9 hospice sites in December 2017. We are sincerely thankful for and appreciative of the 9 Medicare hospices that participated in the pilot study. We learned much from them during the pilot study and afterwards in lessons learned interviews. Information from that pilot study, referred to as Pilot A, can be found on the HQRP website at:
One of the requests raised at the September 2018 SODF was to change the name of the hospice assessment tool from Hospice Evaluation Assessment Reporting Tool (HEART) to a name that is not as easily confused with other HQRP related tools like the Hospice Abstraction Reporting Tool (HART). We agree with this feedback since people refer to both by their same sounding acronyms and seek public comment on the name for the hospice assessment tool.
We will keep providers informed about future measure and assessment tool development efforts and solicit key stakeholder input through regular sub-regulatory channels. Additionally, future measure concepts under development, including details regarding measure definitions, data sources, data collection approaches, and timeline for implementation will be communicated in future rulemaking.
Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. Such data must be submitted in a form and manner, and at a time specified by the Secretary. Section 1814(i)(5)(A)(i) of the Act requires that beginning with the FY 2014 and for each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements for that FY.
Hospices are currently required to submit HIS data to CMS using the Quality Improvement and Evaluation System (QIES) Assessment and the Submission Processing (ASAP) system. We will be migrating to a new internet Quality Improvement and Evaluation System (iQIES) as soon as FY 2020 that will enable us to make real-time upgrades, and we are designating that system as the data submission system for the Hospice QRP. Effective October 1, 2019, we are proposing to notify the public of any changes to the CMS-designated system in the future using sub-regulatory mechanisms such as web page postings, listserv messaging, and webinars. We are inviting public comment on this proposal.
The CAHPS® Hospice Survey is a component of the CMS HQRP which is used to collect data on the experiences of hospice patients and the primary caregivers listed in their hospice records. Readers who want more information about the development of the survey, originally called the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 FR 48261. National implementation of the CAHPS® Hospice Survey commenced January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452).
The CAHPS® Hospice Survey measures received NQF endorsement on October 26th, 2016 (NQF #2651). We adopted these 8 survey based measures for the CY 2018 data collection period and for subsequent years. These 8 measures are reported on Hospice Compare.
We previously finalized the participation requirements for the FY 2020, FY 2021, and FY 2022 APUs (see 82 FR 36673). We propose to extend the same participation requirements for the HQRP for FY 2023 and all future years. As part of the Patients Over Paperwork initiative, we solicit comments about the CAHPS Hospice Survey questionnaire. We seek comments regarding suggested changes, additions or deletions to the instrument that would improve its value to hospices for quality improvement and consumers for selecting a hospice.
We began public reporting of the results of the CAHPS® Hospice Survey on Hospice Compare as of February 2018. We report the most recent 8 quarters of data on the basis of a rolling average, with the most recent quarter of data being added and the oldest quarter of data removed from the averages for each data refresh. We refresh the data 4 times a year in the months of February, May, August, and November.
We previously finalized a volume-based exemption for CAHPS® Hospice Survey Data Collection and Reporting requirements in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (82 FR 36671). We propose to continue our policy for a volume-based exemption for CAHPS® Hospice Survey Data Collection for FY 2021 and every year thereafter. For example, for the FY 2021 APU, hospices that have fewer than 50 survey eligible decedents/caregivers in the period from January 1, 2018 through December 31, 2018 (reference year) are eligible to apply for an exemption from CAHPS® Hospice Survey data collection and reporting requirements (corresponds to the CY 2019 data collection period). To qualify, hospices must submit an exemption request form for the FY 2021 APU. The exemption request form is available on the official CAHPS® Hospice Survey website:
Starting with FY 2022 we propose to provide an automatic exemption to any hospice that (1) is an active agency and (2) according to CMS data sources has served less than a total of 50 unique decedents/caregivers in the reference year. The automatic exemption is good for 1 year and will be reassessed in subsequent years. Hospices with fewer than 50 unique decedents/caregivers in the reference year would not be required to submit an exemption request form.
Hospices that have a total patient count of more than 50 unique decedents/caregivers in the reference year, but who have a total of fewer than 50 survey-eligible decedents/caregivers will not be granted an automatic exemption. For example, hospices may have more than 50 unique decedents/caregivers, but have some decedents/caregivers who are not eligible to be sampled for the CAHPS Hospice Survey, which would therefore lead to fewer than 50 survey-eligible decedents/caregivers. Such hospices may qualify for a size exemption. To do so, they must apply for a size exemption by submitting the size exemption request form as outlined above. This exemption is valid for 1 year only. If the hospice remains eligible for the size exemption, it must request the exemption annually for every applicable FY APU period. We solicit feedback on these proposals.
We previously finalized a one-time newness exemption for hospices that meet the criteria as stated in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52181). In the FY 2019 Hospice Wage Index and Payment Rate Update final rule (83 FR 38642), we continued the newness exemption for FY 2023, FY 2024, FY 2025, and all future years. We encourage hospices to keep the letter they receive providing them with their CCN. The letter can be used to show when you received your number.
We previously finalized survey participation requirements for FY 2022 through FY 2025 as stated in the FY 2018 and FY 2019 Hospice Wage Index and Payment Rate Update final rules (82 FR 36670 and 83 FR 38642 through 38643). We propose to continue those requirements in all subsequent years. Below we reprint the Hospice Survey data submission dates finalized in the FY 2019 Hospice Wage Index and Payment Rate Update final rule (83 FR 38643).
For further information about the CAHPS® Hospice Survey, we encourage hospices and other entities to visit:
Under section 1814(i)(5)(E) of the Act, the Secretary is required to establish procedures for making any quality data submitted by hospices available to the public. These procedures shall ensure that a hospice has the opportunity to review the data that is to be made public prior to such data being made public; the data will be available on our public website.
To meet the Act's requirement for making quality measure data public, we launched the Hospice Compare website in August 2017. This website allows consumers, providers, and other stakeholders to search for all Medicare-certified hospice providers and view their information and quality measure scores. Since its release, the CMS Hospice Compare website has reported 7 HIS Measures (NQF #1641, NQF #1647, NQF #1634, NQF #1637, NQF #1639, NQF #1638, and NQF #1617). In February 2018, CAHPS® Hospice Survey measures (NQF #2651) were added to the website, and in November 2018, the Hospice and Palliative Care Composite Process Measure—Comprehensive Assessment at Admission (NQF #3235) was added to the website.
In the FY 2017 Hospice Wage Index and Payment Rate Update (81 FR 52163 to 52169, August 6, 2016), we finalized the “Hospice Visits when Death is Imminent” measure pair for
As stated in the FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements (83 FR 38643 to 38645, August 6, 2018), quality measures are added to Hospice Compare once they meet the readiness standards for public reporting, which is determined through rigorous testing for reliability, validity, and reportability. Since the proposal of the “Hospice Visits when Death is Imminent” measure pair, CMS has conducted further measure testing activities according to National Quality Forum (NQF) guidelines and the Blueprint for the CMS Measures Management System Version 14.0 available at
As we assessed the scientific acceptability of “Hospice Visits when Death is Imminent” measure pair, we determined that Measure 1 meets established standards for reliability, validity, and reportability. Therefore, the measure will be publicly reported in FY 2019 as stated in the FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements (83 FR 38645 to 38648). Our testing of Measure 2 of the “Hospice Visits when Death is Imminent” measure pair (referred to as Measure 2) revealed that the measure does not meet readiness standards for public reporting at this time and additional testing is needed before we are able to make a decision on the public reporting of Measure 2. Therefore, we have decided not to publish Measure 2 of the “Hospice Visits when Death is Imminent” measure pair at this time. See our discussion on our website:
Although Measure 2 will not be publicly reported at this time, we believe that Measure 2 focuses on an important aspect of quality care for imminently dying patients. Therefore, we will include quality performance data on the measure in each hospice's confidential Quality Measure Reports and the Review and Correct Report available on the Certification and Survey Provider Enhanced Reporting (CASPER) system. Hospices will also still receive credit for reporting on Measure 2 as part of the HQRP requirements. Furthermore, Measure 2 aligns with our Meaningful Measures initiative and its quality priorities, particularly “Strengthen Person and Family Engagement as Partners in Their Care—End of Life Care according to Preferences.” While Measure 1 of the “Hospice Visits when Death is Imminent” measure pair (referred to as Measure 1) addresses case management and clinical care, Measure 2, which includes visits from social workers, chaplains or spiritual counselors, licensed practical nurses, and aides, recognizes providers' flexibility to provide individualized care from a variety of disciplines that is in line with the patient, family, and caregiver's preferences and goals for care and contributes to the overall well-being of the individual and others important to them at the end of life. As such, we believe that Measure 2 addresses a high-priority measure area where there is significant opportunity for improvement, as well as is meaningful to patients, clinicians, and providers alike.
We will conduct additional testing on Measure 2 to determine if and how the measure specifications may be modified or re-specified, and/or if the method for displaying the measure may be adjusted, so that this measure meets the highest standards of scientific acceptability and reportability. Additional testing will also ensure that Measure 2 is thoroughly evaluated to determine that it meets the criteria for display on Hospice Compare.
The results of the additional testing will inform the next steps regarding the public reporting of Measure 2 of “Hospice Visits when Death is Imminent” measure pair. As stated in the FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements (83 FR 38643), we will inform providers of updates to testing and public reporting of quality measures, including Measure 2 of the “Hospice Visits when Death is Imminent” measure pair, through sub-regulatory channels and regular HQRP communication strategies, such as Open Door Forums, Medicare Learning Network, CMS.gov website announcements, listserv messaging, and other opportunities.
While we have decided not to publicly report Measure 2 of the “Hospice Visits when Death is Imminent” measure pair on the Provider Preview Reports and Hospice Compare at this time, the measure will remain on provider's CASPER Quality Measure (QM) Reports. CASPER QM Reports are intended for providers' internal use and are meant to aid hospices in quality improvement efforts. Although the measure will not be publicly reported at this time, we believe that it is important for providers to internally review and be informed by these data, to ensure that they are providing their patients and caregivers the individualized support they need in the patients' last days of life. Our decision not to publicly report Measure 2 of the “Hospice Visits when Death is Imminent” measure pair at this time is distinct from our interest in continuing collecting these data. Specifically, these data are needed to determine whether a measure meets all the criteria for public reporting. Continued data collection will enable us to test and modify or re-specify a measure so that these criteria are satisfied. We seek to balance these data collection effort with the section 1814(i)(5)(E) of the Act, which states, “The Secretary shall report quality measures that relate to hospice care provided by hospice programs on the internet website of the Centers for Medicare & Medicaid Services.” We believe that information required for the robust analyses to further develop this measure, modify or re-specify it to allow for public reporting justifies continuing data collection.
The data collection and submission requirements for the “Hospice Visits When Death is Imminent” measure pair will not change in order to collect the data for measure 1, which will be publicly reported beginning with FY 2019. Measure 2, which will not be publicly reported at this time, needs to be further evaluated for modification or re-specification. Measure 2 of “Hospice Visits when Death is Imminent” measure pair is calculated using items
We are cognizant and respectful of the time and effort that hospices take to complete the HIS V2.00.0 items used to calculate and test Measure 2. We will continually evaluate the volume and robustness of the resulting data to determine when data collection is no longer required.
In the FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements (83 FR 38649), we finalized plans to publicly post information from the Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (PUF) and/or other publicly available CMS data to the Hospice Compare website. This PUF data, along with clear text explaining the purpose and uses of this information and suggesting consumers discuss this information with their healthcare provider, will be displayed under a new “General information” section on Hospice Compare in summer 2019. This new section will precede the existing “Family Experience of Care” section on the Hospice Compare website. Tables 17 through 19 show how these data will displayed on Hospice Compare.
As part of our ongoing efforts to make the Hospice Compare website more meaningful and informative to our beneficiaries, their caregivers, and families, we propose to post information from other publicly available government data, in addition to the data from the PUF or other CMS sources, to the Hospice Compare website at some time in the future. We are proposing to be able to use informative data from other government sources on Hospice Compare in the future and as soon as FY 2020. Examples, provided for illustration, from where CMS could pull publicly available government data include the United States Census Bureau, Centers for Disease Control and Prevention, and National Institutes of Health.
We may use information available in these public government files to augment the “General Information” section described above. This “General Information” section including PUF data and, if this proposal is finalized, information from other public government data will provide additional information along with the HIS and CAHPS® quality measures that are already displayed.
Any future reporting of public government data on the Hospice Compare website will be displayed in a consumer-friendly format. This means we may display the data as shown in these publicly available government files or present the data after additional calculations. For example, the data could be averaged over multiple years, displayed as a percentage rather than the raw number, or other calculations could be based on a given year or over multiple years, so the data has meaning to end-users. Furthermore, by performing these calculations, we can make the data apply to hospices broadly regardless of size, location, or other factors.
Also, we would like to note that data used from these publicly available sources are not quality measures. Rather, they present supplementary information that many consumers seek during the provider selection process and, therefore, will help them to make an informed decision. This is similar to other useful information we already display on Hospice Compare under the Spotlight, Tools and Tips, and Additional Information sections on the Hospice Compare homepage. Data from publicly available data sources can serve as one more piece of information, along with quality of care metrics from the HIS and CAHPS® Hospice Survey and other useful information, to help consumers effectively and efficiently compare hospice providers and make an informed decision about their care in a stressful time. We also believe such information may be useful to providers. For example, adding information from the United States Census Bureau may help consumers better understand the service area in which they are looking for services (for example, if there is a large population of people from a similar race/ethnicity in the area). This information may also help providers better understand their service area to see if there are any business development opportunities (for example, if there is a large population of a similar race/ethnicity, the provider may consider investing resources in better serving patients from this background).
To ensure that end-users understand that these data provide information about hospice characteristics and are not a reflection of the quality of care a hospice provides, we will, with consultation from key stakeholders, carefully craft explanatory language to ensure that consumers understand the information and how the data are meant for informational purposes only.
As we determine which publicly available government data sources we will use and how we will be using and presenting information from these sources, we will inform the public and engage with stakeholders via sub-regulatory processes, including regular HQRP communication strategies such as Open Door Forums, Medicare Learning Network, Spotlight Announcements, and other opportunities.
We are soliciting public comment on our proposal to post information from publicly available government sources to the Hospice Compare website in the future.
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• 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.
Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. This data must be submitted in a form and manner, and at a time specified by the Secretary.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
To calculate this burden estimate, we use salary information from the Bureau of Labor Statistics (BLS) website at
Section 1814(a)(7) of the Act requires for the first 90-day period of a hospice election the individual's attending physician (as defined in section 1861(dd)(3)(B) of the Act) (which for purposes of this subparagraph does not include a nurse practitioner), and the medical director (or physician member of the interdisciplinary group described in section 1861(dd)(2)(B) of the Act) of the hospice program providing (or arranging for) the care, each certify in writing, at the beginning of the period, that the individual is terminally ill (as defined in section 1861(dd)(3)(A) of the Act). The regulations codified at §§ 418.22 and 418.25 provide the requirements regarding the certification of terminal illness and admission to hospice care. The hospice medical director must specify that the individual's prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course. Additionally, clinical information and other documentation that support the medical prognosis must accompany the certification and must be filed in the medical record with the written certification. The physician must include a brief narrative explanation of the clinical findings that supports a life expectancy of 6 months or less as part of the certification. The aforementioned regulations also require that the hospice medical director must consider both related and unrelated conditions and current clinically relevant information when making the decision to certify the individual as terminally ill. Likewise, the hospice CoPs at § 418.102(b) provide the requirements regarding the certification responsibility of the hospice medical director or hospice physician designee which includes a review of the clinical information, including both related and unrelated conditions, for each hospice patient.
In order to receive hospice services under the Medicare hospice benefit, eligible beneficiaries must elect to receive hospice care by completing an election statement. By signing this election statement, the individual acknowledges that he/she waives all rights to Medicare payments for treatment related to the terminal illness and related conditions. The content requirements for the hospice election statement are listed at § 418.24(b) and each hospice election statement must include the following information:
• Identification of the particular hospice and of the attending physician that will provide care to the individual. The individual or representative must acknowledge that the identified attending physician was his or her choice.
• The individual's or representative's acknowledgement that he or she has been given a full understanding of the palliative rather than curative nature of hospice care, as it relates to the individual's terminal illness.
• Acknowledgement that certain Medicare services, as set forth in § 418.24(d), are waived by the election.
• The effective date of the election, which may be the first day of hospice care or a later date, but may be no earlier than the date of the election statement.
• The signature of the individual or representative.
Once a beneficiary is certified as terminally ill and elects the Medicare hospice benefit, the hospice conducts an initial assessment visit in advance of furnishing care. During this visit, the hospice must provide the patient or representative with verbal and written notice of the patient's rights and responsibilities as required by the CoPs at § 418.52. Likewise, the regulations at § 476.78 state that providers must inform Medicare beneficiaries at the time of admission, in writing, that the care for which Medicare payment is sought will be subject to Quality Improvement Organization (QIO) review.
The beneficiary needs identified in the initial and comprehensive assessments drive the development and revisions of an individualized written plan of care for each patient as required by the hospice CoPs at § 418.56. The hospice plan of care is established, reviewed and updated by the hospice IDG and must include all services necessary for the palliation and management of the terminal illness and related conditions. While needs unrelated to the terminal illness and related conditions are not the responsibility of the hospice, the hospice may choose to furnish services for those needs regardless of responsibility. However, if a hospice does not choose to furnish services for those needs unrelated to the terminal illness and related conditions, the hospice is to communicate and coordinate with those health care providers who are caring for the unrelated needs, as described in § 418.56(e). In accordance with the CoPs, the hospice must document the services and treatments that address how they will meet the patient and family-specific needs related to the terminal illness and related conditions in the plan of care, and those needs unrelated to the terminal illness and related conditions that are present when the patient elects hospice should also be documented. This documentation ensures that the hospice is aware of those unrelated needs and who is addressing them. This documentation provides the support for the hospices' financial responsibility for the hospice services they will be providing. There is limited beneficiary financial liability for hospice services upon election of the Medicare hospice benefit. However, for any services received that are unrelated to the terminal illness and related conditions, the beneficiary would incur any associated copayments and coinsurance.
Hospices already are required to review, determine, and document information on unrelated conditions per the hospice regulations and CoPs. However, to ensure Medicare beneficiaries are provided disclosure of those conditions, items, services, and drugs the hospice has determined to be unrelated to the terminal illness and related conditions at the time of admission, we propose to add to the regulations at § 418.24(b) and (c), the requirement of an election statement addendum titled “Patient Notification of Hospice Non-Covered Items, Services, and Drugs” that would be issued to the patient (or representative) within 48 hours of the hospice election date to ensure that Medicare beneficiaries are fully informed whether or not all items, services, and drugs identified on the hospice plan of care will be furnished by the hospice. The addendum statement would not be required if the beneficiary died within 48 hours of the hospice election date. This addendum would accompany the hospice election statement and each hospice would use the required proposed elements to develop and design their own addendum to best meet their needs and the requirement. This requirement for payment would be added to the regulations at § 418.24(b) and (c).
The burden associated with the documentation requirement for the addendum includes the time for each hospice to develop the addendum that the hospice provides to the beneficiary (or their representative) within 48 hours of election of the Medicare hospice benefit. The addendum must include the name of the issuing hospice, beneficiary's name, and hospice medical record identifier. The addendum must also allow the hospice registered nurse to document a list of non-covered conditions, items, services, and drugs, as well as provide a clinical explanation as to why these conditions, items, services, and drugs have been determined to be unrelated to the terminal illness and related conditions. This documentation would include references to any relevant clinical practice, policy, or coverage guidelines. The addendum must include statements informing the patient as to the purpose of the addendum and information on BFCC-QIO Immediate Advocacy rights and contact information. The addendum would be signed by the beneficiary as an acknowledgement that he or she has received this information, but signing it does not mean the beneficiary agrees with the determination. We believe that the burden for the hospice associated with the election statements addendum would be the cost of developing the form and the cost of filling out the form. There is no associated burden for hospices to communicate/coordinate with non-hospice providers regarding the content of the addendum statement because the hospice CoPs, as described above, have always required hospices to have a system of communication with non-hospice providers in place. However, we believe that the election statement addendum would reduce burden for non-hospice providers through a consistent and streamlined process by which non-hospice providers can make informed treatment decisions and accurately submit claims with the appropriate condition code or modifier.
We estimate a one-time burden for the development of the election statement addendum. We estimate that it would take a hospice administrative assistant 15 minutes (15/60 = 0.25 hours) to develop the addendum with the required elements, and the hospice administrator 15 minutes (15/60 = 0.25 hours) to review the addendum. The clerical time plus administrator time equals a one-time burden of 30 minutes or (30/60 = 0.50 hours) per hospice. For all 4,465 hospices, the total time required would be (0.50 × 4,465) = 2,232.5 hours. At $57.12 per hour for an executive administrative assistant, the cost per hospice would be (0.25 × $57.12) = $14.28. At $118.70 per hour for the administrator's time, the cost per hospice would be (0.25 × $118.70) = $29.68. Therefore, the one-time cost, per hospice, for the development of the form would be ($14.28+29.68) = $43.96, and the total one-time cost for all hospices would be ($43.96 × 4,465) = $196,281.
Per the hospice CoPs at § 418.56(a), the hospice must designate a registered nurse that is a member of the interdisciplinary group to provide coordination of care and to ensure continuous assessment of each patient's and family's needs and implementation of the interdisciplinary plan of care. The hospice CoPs at § 418.54 require that a registered nurse conduct the initial assessment, therefore, the registered nurse would be responsible for completing the addendum for each hospice election as part of the routine admission paperwork. We estimate that there would be 1,268,497 hospice elections in a year based on FY 2017 claims data. Approximately 16 percent of hospice beneficiaries die within the first 48 hours after the hospice election date. Hospices would not be required to complete the election statement addendum for those hospice beneficiaries that die within 48 hours of hospice election. Therefore, the estimated total number of hospice elections in FY 2020 that would require the hospice election statement addendum would be (1,268,497 × 0.84) = 1,065,537. There are 4,465 Medicare-certified hospices, so on average there would be (1,065,537/4,465) = 239 hospice elections per hospice. The estimated burden for the hospice registered nurse to extrapolate this information from the existing documentation in the patient's hospice medical record and complete this addendum would be 10 minutes (10/60 = 0.1667). At $70.72 per hour for a registered nurse over 10 minutes (0.1667 × $70.72 = $11.79), we estimate the total cost of RN time to complete the addendum per hospice in FY 2020 to be ($11.79 × 239) = $2,818, and the total cost of RN time to complete the addendum for all hospices in FY 2020 would be ($2,818 × 4,465) = $12,582,370. The estimated total per hospice and total annual hospice cost associated with the proposed addendum (including one-time form development and total RN costs) in FY 2020 are shown in table 21 below. These total costs would include the one-time development of the addendum, so subsequent years' costs would only include the cost for the RN to complete the addendum statement. Providing this information to the beneficiary would be part of the routine admissions process and, as such, incurs no additional burden to that process.
To ensure comprehensive and coordinated care, the CoPs at § 418.56(e) require hospices to have a communication system that allows for the exchange of information with other non-hospice health care providers who are furnishing care unrelated to the terminal illness and related conditions. Therefore, it is our expectation that hospices are already determining what is related and unrelated to the terminal illness and related conditions. The election statement addendum would add no additional burden for communicating with non-hospice providers, as this decision-making process has been a long-standing CoP requirement, as described above and in the preamble of this proposed rule. However, burden would be reduced for non-hospice providers, including institutional, non-institutional and pharmacy providers because less time would be spent trying to obtain needed information for treatment decisions and accurate claims submissions.
To estimate the cost burden reduction, we first calculated the estimated current burden, in the absence of the addendum, for communicating and coordinating information regarding unrelated conditions between hospice and non-hospice providers. Next, we calculated the estimated burden, using the addendum for communicating and coordinating information regarding unrelated conditions between hospice and non-hospice providers. Finally, we analyzed the difference between the burden estimates to see if there is any overall reduction. To do this, we analyzed all Medicare Parts A and B non-hospice claims for beneficiaries under a hospice election in FY 2017. We also examined the Part D claims for drugs provided to hospice beneficiaries under a hospice election. Specifically, we analyzed the following:
• The total number of non-hospice, institutional claims with condition code 07 (to indicate the services were unrelated to the terminal illness and related conditions).
• The total number of non-hospice, non-institutional claims with “GW” modifier (to indicate the services were unrelated to the terminal illness and related conditions).
• The total number of Part D claims for beneficiaries under a hospice election.
• The average number of hospice beneficiaries per non-hospice provider with institutional claims with condition code 07.
• The average number of hospice beneficiaries per non-hospice provider with non-institutional claims with “GW” modifier.
• The average number of hospice beneficiaries per non-hospice provider with Part D claims.
To calculate the average number of hospice beneficiaries per non-hospice provider, we count the number of unique beneficiaries associated with each non-hospice provider as beneficiaries may receive services by more than one non-hospice provider. This means that some beneficiaries are double-counted. However, given this estimate is calculated based on the number of expected communication encounters between hospices and non-hospice providers, this is the appropriate approach. Because we double-counted beneficiaries, we expect that average to be larger than the ratio of unique beneficiaries to unique non-hospice providers. Table 22 below summarizes Part A, B and D claims that overlap with hospice episodes in FY 2017.
In order for non-hospice providers to make treatment decisions regarding services, items and medications for hospice beneficiaries and to submit the appropriate modifier or condition code on Medicare claims, they need supporting information from the hospice regarding related and unrelated conditions. As such, we first estimate the current burden associated with this communication and coordination in the absence of the election statement addendum. We believe this would require the non-hospice providers to contact the hospice and have a detailed phone call to obtain and document the information on unrelated conditions, items, services, and medications. For non-hospice providers submitting institutional claims (including inpatient acute care hospitals, SNFs, HHAs, and institutional outpatient providers), typically nurse case managers provide coordination of care for those beneficiaries in these settings who are receiving inpatient services or who are preparing to transition to a post-acute care setting or home. The estimated burden for the registered nurse to contact the hospice to obtain the needed information would be 15 minutes (15/60 = 0.25). The average number of hospice beneficiaries receiving services per institutional, non-hospice provider is 11 per year, which would mean each institutional, non-hospice provider would have an average of 11 communication encounters with hospice. The total number of institutional, non-hospice providers servicing hospice beneficiaries in FY 2017 was 19,354. At $70.72 per hour for a registered nurse (0.25 × $70.72) = $17.68, we estimate the total cost per institutional, non-hospice provider furnishing services to hospice beneficiaries in FY 2020 to be ($17.68 × 11) = $194.48 and the annual total cost for all institutional, non-hospice providers in FY 2018 would be ($194.48 × 19,354) = $3,763,966.
For non-institutional, non-hospice providers (including physicians), we also expect that a nurse would contact the hospice to obtain the needed clinical information on unrelated conditions, items, services and drugs. The estimated burden for the registered nurse to contact the hospice to obtain the needed information would be 15 minutes (15/60 = 0.25). The average number of hospice beneficiaries receiving services per non-institutional, non-hospice provider is 12 per year, which would mean each provider would have an average of 12 communication encounters with a hospice. The total number of non-institutional, non-hospice providers servicing hospice beneficiaries in FY 2017 was 75,181. At $70.72 per hour for a registered nurse (0.25 × $70.72) = $17.68, we estimate the total cost per non-institutional, non-hospice provider furnishing services to hospice beneficiaries in FY 2020 to be ($17.68 × 12) = $212.16 and the annual total cost for all non-institutional, non-hospice providers in FY 2018 would be ($212.16 × 75,181) = $15,950,401.
For Part D providers furnishing drugs to hospice beneficiaries, the estimated burden for the pharmacy technician at the point of service to contact the hospice to obtain the needed clinical information regarding the drugs deemed by the hospice as unrelated to the terminal illness and related conditions would be 15 minutes (15/60 = 0.25). The average number of hospice beneficiaries receiving services per Part D pharmacy providing maintenance drugs is 12 per year, which would mean each pharmacy would have an average of 12 communication encounters with hospice. The total number of Part D pharmacies providing maintenance drugs to hospice beneficiaries in FY 2017 was 60,632. At $31.80 per hour for a pharmacy technician (0.25 × $31.80) = $7.95, we estimate the total cost per Part D pharmacy providing maintenance drugs to be ($7.95 × 12) = $95.40 and the annual total cost for all Part D pharmacies providing maintenance drugs to be ($95.40 × 60,632) = $5,784,293. The estimated total annual burden for all non-hospice providers furnishing services, items and medications to hospice beneficiaries in FY 2020 without the availability of the hospice election statement addendum identifying unrelated conditions, items, services and drugs would be $25,498,660 ($3,763,966 + $15,950,401 + $5,784,293).
However, with the availability of the “Patient Notification of Hospice Covered/Non-Covered Items, Services, and Drugs” election statement addendum, we believe this estimated burden would be reduced for non-hospice providers through a streamlining of the communication and coordination process. For institutional, non-hospice providers (those who would submit claims for unrelated services with condition code 07), the estimated burden for the registered nurse to contact the hospice to obtain the needed information would be reduced to 5 minutes (5/60 = 0.0833). The average number of hospice beneficiaries receiving services per institutional non-hospice provider is 11 per year. The total number of institutional non-hospice providers servicing hospice beneficiaries in FY 2017 was 19,354. At $70.72 per hour for a registered nurse (0.0833 × $70.72) = $5.89, we estimate the total cost per institutional non-hospice provider in FY 2020 to be ($5.89 × 11) = $64.79 and the annual total cost for all institutional non-hospice providers in FY 2020 would be ($64.79 × 19,354) = $1,253,945.66 an annual decrease in burden by ($3,763,966−$1,253,945.66) = $2,510,020.34.
For non-institutional, non-hospice providers (those who would submit claims for unrelated services with modifier GW), the estimated burden for the registered nurse to contact the hospice to obtain the needed information would be reduced to 5 minutes (5/60 = 0.0833). The average number of hospice beneficiaries receiving services per non-institutional, non-hospice provider is 12 per year. The total number of non-institutional, non-hospice providers servicing hospice
For Part D pharmacies providing drugs to hospice beneficiaries, the estimated burden for the pharmacy technician at the point of service to contact the hospice to obtain the needed clinical information regarding the drugs deemed by the hospice as unrelated to the terminal illness and related conditions would be reduce to 5 minutes (5/60 = 0.0833). The average number of hospice beneficiaries receiving services per Part D pharmacy providing maintenance drugs is 12 per year. The total number of Part D pharmacies providing maintenance drugs to hospice beneficiaries in FY 2017 was 60,632. At $31.80 per hour for a pharmacy technicians (0.0833 × $31.80) = $2.65, we estimate the total cost per Part D pharmacy providing maintenance drugs to be ($2.65 × 12) = $31.80 and the annual total cost for all Part D pharmacies providing maintenance drugs to be ($31.80 × 60,632) = $1,928,097.60, an annual decrease in burden by ($5,784,293 − $1,928,097.60) = $3,856,195.40. The estimated total annual burden for all non-hospice providers furnishing services, items and drugs to hospice beneficiaries in FY 2020 with the availability of the hospice election statement addendum identifying unrelated conditions, items, services and medication would be $8,495,836.66 for an overall burden reduction of ($25,498,660 − $8,495,836.66) = $17,002,823.34. The total reduction in burden for all institutional, non-institutional, and Part D pharmacy non-hospice providers is summarized in table 23 below.
The use of the “Patient Notification of Hospice Non-Covered Items, Services, and Drugs” election statement addendum would result in an estimated, total overall provider burden reduction of −$4,224,173 ($12,778,651 − $17,002,824) in FY 2020. Table 24 below summarizes the FY 2020 estimated total burden reduction.
We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements. The requirements are not effective until they have been approved by OMB.
To obtain copies of the supporting statement and any related forms for the proposed collections previously discussed, visit our website at:
We invite public comments on these information collection requirements. If you wish to comment, submit your comments electronically as specified in the
Because of the large number of public comments we normally receive on
This proposed rule meets the requirements of our regulations at § 418.306(c) and (d), which require annual issuance, in the
We estimate that the aggregate impact of the payment provisions in this proposed rule would result in an estimated increase of $540 million in payments to hospices, resulting from the hospice payment update percentage of 2.7 percent for FY 2020. Section 1814(i)(6)(D)(ii) of the Act requires the proposed rebasing of the per diem payment rates for CHC, GIP, and IRC to be done in a budget-neutral manner in the first year of implementation. Therefore, the proposed rebased rates for CHC, GIP, and IRC would not result in an overall payment impact for the Medicare program as we are proposing to reduce the RHC payment rates to ensure that total estimated payments to hospices are budget-neutral given the proposed increases to the CHC, GIP, and IRC payment rates. In addition, the proposed change in the hospice wage index to use the FY 2020 pre-floor, pre-reclassified hospital wage index (rather than the FY 2019 pre-floor, pre-reclassified hospital wage index) as the basis for the FY 2020 hospice wage index would not result in an overall payment impact for the Medicare program as annual wage index updates are now similarly implemented in a budget-neutral manner. Certain events may limit the scope or accuracy of our impact analysis, because such an analysis is susceptible to forecasting errors due to other changes in the forecasted impact time period. The nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon hospices.
We have examined the impacts of this 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), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (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)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
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) 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 (also referred to as “economically significant”); (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.
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability presents the costs and benefits of the rulemaking.
The Regulatory Flexibility Act (RFA) 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. The great majority of hospitals and most other health care providers and suppliers are small entities by meeting the Small Business Administration (SBA) definition of a small business (in the service sector, having revenues of less than $7.5 million to $38.5 million in any 1 year), or being nonprofit organizations. For purposes of the RFA, we consider all hospices as small entities as that term is used in the RFA. HHS's practice in interpreting the RFA is to consider effects economically “significant” only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. The effect of the FY 2020 hospice payment update percentage results in an overall increase in estimated hospice payments of 2.7 percent, or $540 million. The distributional effects of the proposed FY 2020 hospice wage index do not result in a greater than 5 percent of hospices experiencing decreases in payments of 3 percent or more of total revenue. Finally, the distributional effects of the proposed FY 2020 increases to the CHC, IRC, and GIP per diem payment rates as a result of rebasing, offset by a proposed decrease to the FY 2020 RHC payment rates of less than 3 percent to maintain budget neutrality in the first year of implementation, do not result in a greater than 5 percent of hospices experiencing decreases in payments of 3 percent or more of total revenue. Therefore, the Secretary has determined that this rule will not create a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This rule will only affect hospices. Therefore, the Secretary has determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (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. The 2019 UMRA threshold is $154 million. This rule is not anticipated to have an effect on state, local, or tribal governments, in the aggregate, or on the private sector of $154 million or more.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have reviewed this rule under these criteria of Executive Order 13132, and have determined that it will not impose substantial direct costs on state or local governments.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the
Using the wage information from the Bureau of Labor Statistics (BLS) for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $107.38 per hour, including overhead and fringe benefits (
The FY 2020 hospice payment impacts appear in table 24. We tabulate the resulting payments according to the classifications (for example, provider type, geographic region, facility size), and compare the difference between current and future payments to determine the overall impact. The first column shows the breakdown of all hospices by provider type and control (non-profit, for-profit, government, other), facility location, facility size. The second column shows the number of hospices in each of the categories in the first column. The third column shows our estimate of applying the proposed rebased payment rates of CHC, IRC, and GIP (and the decreased RHC rate used to achieve budget neutrality). The fourth column shows the hospice payments using FY 2018 Hospice Claims, FY 2020 rebased Payments, and FY 2020 Wage Index without the 1-Year lag. The fifth column show the proposed FY 2020 hospice payment update percentage of 2.7 percent as mandated by section 1814(i)(1)(C) of the Act, and is consistent for all providers. The 2.7 percent hospice payment update percentage is based on an estimated 3.2 percent inpatient hospital market basket update, reduced by a 0.5 percentage point productivity adjustment. It is projected that aggregate payments would increase by 2.7 percent, assuming hospices do not change their service and billing practices. The sixth column shows the estimated total impact for FY 2020. We have set the rates so the overall impact is zero percent due to the requirement that any revisions in payment are implemented in a budget-neutral manner in accordance with section 1814(i)(6)(D)(ii) of the Act (accomplished for the proposed rebasing of the CHC, GIP, and IRC payment rates by a corresponding proposed decrease to the RHC payment rates).
In addition, to assist providers in understanding the potential impacts of the proposed wage index with and without the lag and the proposed rebasing of CHC, IRC, and GIP, we are providing a provider-specific impact analysis file, which is available on our website at
As illustrated in table 25, the combined effects of all the proposals vary by specific types of providers and by location.
This proposed rule includes proposals related to the election statement addendum that would be provided, upon request, to hospice beneficiaries (or representative), non-hospice providers, and Medicare contractors. If finalized, this change would become effective for hospice elections on and after October 1, 2019. The election statement addendum would add no additional burden for communicating with non-hospice providers, as this decision-making process has been a long-standing CoP requirement, as described in the preamble of this proposed rule. However, burden would be reduced for non-hospice providers, including institutional, non-institutional and pharmacy providers because less time would be spent trying to obtain needed information for treatment decisions and accurate claims submissions. As a result of this election statement addendum, we estimate that this rule generates $4.2 million in annualized cost savings, or $3 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon beginning in FY 2020. The burden reduction for this proposal is detailed in section IV of this proposed rule and the total annual reduction is included in table 24.
For the FY 2020 Hospice Wage Index and Rate Update proposed rule, we considered alternatives to the proposals articulated in section III.A. First, we considered not applying the Level I edits to the freestanding cost reports to estimate the FY 2017 costs per day by level of care. Our analysis showed that the differences in costs for each level of care between these two approaches were minimal. As described in the FY 2019 hospice proposed rule (89 FR 20949), industry representatives have suggested using these Level I edits to force adherence to certain cost reporting principles that could lead to the reporting of higher-quality hospice cost data and therefore, we believe it is most technically appropriate to apply the Level I edits. Table 26 describes the FY 2017 estimated, average per day costs by level of care applying all cost report adjustments, and those same estimated costs applying all cost report adjustments except the Level I edits.
We also considered proposing to use freestanding and provider-based cost reports to rebase CHC, IRC, and GIP per diem rates, rather than using only freestanding hospice cost reports. When we analyzed both freestanding and provider-based cost reports, the results from these two samples tend to be similar, however, on average, incorporating provider-based cost reports results in higher costs than the cost reports for freestanding hospices only as shown in table 27.
Since the costs are higher, the FY 2019 rebased payment rates for CHC, GIP, and IRC when using cost reports for both freestanding and provider-based hospices would also be higher and we would need to reduce the RHC payment more in order to maintain budget neutrality as shown in table 28. If we utilized freestanding and provider-based cost reports, RHC would need to be reduced by 2.92 percent to offset the increases to the per diem payment amounts for CHC, GIP, and IRC.
In MedPAC's March 2018 Report to Congress, MedPAC stated that included in the costs of provider-based hospices are overhead costs allocated from the parent provider, which contributes to provider-based hospices having higher costs than freestanding providers. The Commission believes payment policy should focus on the efficient delivery of services to Medicare's beneficiaries. If freestanding hospices are able to provide high-quality care at a lower cost than provider-based hospices, payment rates should be set accordingly, and the higher costs of provider-based hospices should not be a reason for increasing Medicare payment rates.
As required by OMB Circular A-4 (available at:
Executive Order 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017 (82 FR 9339, February 3, 2017) and requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This proposed rule is expected to be an E.O. 13771 deregulatory action with $4.2 million in annualized cost savings, or $3 million per year on an ongoing basis discounted at 7 percent relative to year 2016, over a perpetual time horizon beginning in FY 2020. The burden reduction for this proposal is detailed in section IV of this proposed rule and the total annual reduction is included in Table 24. Details on the estimated cost savings of this rule with comment period can be found in the rule's collection of information and economic analysis.
We estimate that aggregate payments to hospices in FY 2020 will increase by $540 million, or 2.7 percent, compared to payments in FY 2019. We estimate that in FY 2020, hospices in urban and rural areas will experience, on average, 2.8 percent and 2.1 percent increases, respectively, in estimated payments compared to FY 2019. Hospices providing services in the South Atlantic, Middle Atlantic and East North Central regions would experience the largest estimated increases in payments of 4.7 percent and 2.8 percent, respectively. Hospices serving patients in the Pacific and outlying regions would experience, on average, the lowest estimated increase of 1.0 and −0.3 percent, respectively in FY 2020 payments. We also estimate an overall reduction in burden of $4.2 million as a result of the proposed election statement addendum. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
42 U.S.C. 1302 and 1395hh.
The revisions and additions read as follows:
(b) * * *
(2) The individual's or representative's acknowledgement that he or she has been given a full understanding of the palliative rather than curative nature of hospice care, as it relates to the individual's terminal illness and related conditions.
(3) Acknowledgement that the individual has been provided information on the hospice's coverage responsibility and that certain Medicare services, as set forth in paragraph (e) of this section, are waived by the election. This includes providing the individual with information indicating that services unrelated to the terminal illness and related conditions are exceptional and unusual and hospice should be providing virtually all care needed by the individual who has elected hospice.
(5) Information on individual cost-sharing for hospice services.
(6) Notification of the individual's (or representative's) right to receive an election statement addendum, as set forth in paragraph (c) of this section, if there are conditions, items, services, and drugs the hospice has determined to be unrelated to the individual's terminal illness and related conditions and would not be covered by the hospice.
(7) Information on BFCC-QIO, including the right to immediate advocacy and BFCC-QIO contact information.
(c)
(1) The addendum must be titled “Patient Notification of Hospice Non-Covered Items, Services, and Drugs.”
(2) Name of the hospice.
(3) Individual's name and hospice medical record identifier.
(4) Identification of the individual's terminal illness and related conditions.
(5) A list of the individual's conditions present on hospice admission (or upon plan of care update) and the associated items, services, and drugs not covered by the hospice because they have been determined by the hospice to be unrelated to the terminal illness and related conditions.
(6) A written clinical explanation, in language the individual (or representative) can understand, as to why the identified conditions, items, services, and drugs are considered unrelated to the individual's terminal illness and related conditions and not needed for pain or symptom management. This clinical explanation must be accompanied by a general statement that the decision as to whether or not conditions, items, services, and drugs are related is made for each patient and that the individual should share this clinical explanation with other health care providers from which they seek items, services, or drugs unrelated to their terminal illness and related conditions.
(7) References to any relevant clinical practice, policy, or coverage guidelines.
(8) Information on the following—
(i)
(ii)
(9) Name and signature of the individual (or representative) and date signed, along with a statement that signing this addendum (or its updates) is only acknowledgement of receipt of the addendum (or its updates) and not necessarily the individual's (or representative's) agreement with the hospice's determinations.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020. We also propose minor revisions to the regulation text to reflect the revised assessment schedule under Patient Driven Payment Model (PDPM). Additionally, we propose to revise the definition of group therapy under the SNF PPS, and to implement a subregulatory process for updating the code lists (International Classification of Diseases, Tenth Version (ICD-10) codes) used under PDPM. We are also soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust SNF payments. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 18, 2019.
In commenting, please refer to file code CMS-1718-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Penny Gershman, (410) 786-6643, for information related to SNF PPS clinical issues.
Anthony Hodge, (410) 786-6645, for information related to payment for SNF-level swing-bed services.
John Kane, (410) 786-0557, for information related to the development of the payment rates and case-mix indexes, and general information.
Kia Sidbury, (410) 786-7816, for information related to the wage index.
Bill Ullman, (410) 786-5667, for information related to level of care determinations and consolidated billing.
Casey Freeman, (410) 786-4354, for information related to skilled nursing facility quality reporting program.
James Poyer, (410) 786-2261, for information related to the skilled nursing facility value-based purchasing program.
As discussed in the FY 2014 SNF PPS final rule (78 FR 47936), tables setting forth the Wage Index for Urban Areas Based on CBSA Labor Market Areas and the Wage Index Based on CBSA Labor Market Areas for Rural Areas are no longer published in the
Readers who experience any problems accessing any of these online SNF PPS wage index tables should contact Kia Sidbury at (410) 786-7816.
To assist readers in referencing sections contained in this document, we are providing the following Table of Contents.
This proposed rule would update the SNF prospective payment rates for fiscal year (FY) 2020 as required under section 1888(e)(4)(E) of the Social Security Act (the Act). It would also respond to section 1888(e)(4)(H) of the Act, which requires the Secretary to provide for publication in the
In accordance with sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5) of the Act, the federal rates in this proposed rule would reflect an update to the rates that we published in the SNF PPS final rule for FY 2019 (83 FR 39162), as corrected in the FY 2019 SNF PPS correction notice (83 FR 49832), which reflects the SNF market basket update, as adjusted by the multifactor productivity (MFP) adjustment, for FY 2020. In addition, we are proposing to revise the definition of group therapy under the SNF PPS and to implement a subregulatory process for updating ICD-10 code lists used under the PDPM.
This proposed rule proposes to update requirements for the SNF QRP, including the proposal of two Transfer of Health Information quality measures as well as standardized patient assessment data elements to begin collection on October 1, 2020 in satisfaction of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185, enacted October 6, 2014). We are also proposing to exclude baseline nursing home residents from the Discharge to Community Measure. In addition, we are proposing to expand data collection for SNF QRP quality measures to all skilled nursing facility residents, regardless of their payer. Further, we are also proposing the public display of the quality measure, Drug Regimen Review Conducted With Follow-Up for Identified Issues- Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality Reporting Program (QRP). We are also proposing to revise references in regulation text to reflect enhancements to the system used for the submission of data. Finally, we are requesting information on quality measures and standardized resident assessment data elements under consideration for future years.
In accordance with section 1888(h) of the Act, this proposed rule would update certain policies for the SNF VBP.
The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care. The Office of the National Coordinator for Health Information Technology (ONC) and CMS work collaboratively to advance interoperability across settings of care, including post-acute care.
To further interoperability in post-acute care, we developed a Data Element Library (DEL) to serve as a publicly available centralized, authoritative resource for standardized data elements and their associated mappings to health IT standards. The DEL furthers CMS' goal of data standardization and interoperability, which is also a goal of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act). These interoperable data elements can reduce provider burden by allowing the use and exchange of healthcare data, support provider exchange of electronic health information for care coordination, person-centered care, and support real-time, data driven, clinical decision making. Standards in the Data Element Library (
The 21st Century Cures Act (the Cures Act) (Pub. L. 114-255, enacted December 13, 2016) requires HHS to take new steps to enable the electronic sharing of health information ensuring interoperability for providers and settings across the care continuum. In another important provision, Congress defined “information blocking” as practices likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information, and established new authority for HHS to discourage these practices. In March 2019, ONC and CMS published the proposed rules, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program,” (84 FR 7424) and “Interoperability and Patient Access” (84 FR 7610) to promote secure and more immediate access to health information for patients and healthcare providers through the implementation of information blocking provisions of the Cures Act and the use of standardized application programming interfaces (APIs) that enable easier access to electronic health information. These two proposed rules are open for public comment at
As amended by section 4432 of the Balanced Budget Act of 1997 (BBA 1997) (Pub. L. 105-33, enacted on August 5, 1997), section 1888(e) of the Act provides for the implementation of a PPS for SNFs. This methodology uses prospective, case-mix adjusted per diem payment rates applicable to all covered SNF services defined in section 1888(e)(2)(A) of the Act. The SNF PPS is effective for cost reporting periods beginning on or after July 1, 1998, and covers all costs of furnishing covered SNF services (routine, ancillary, and capital-related costs) other than costs associated with approved educational activities and bad debts. Under section 1888(e)(2)(A)(i) of the Act, covered SNF services include post-hospital extended care services for which benefits are provided under Part A, as well as those items and services (other than a small number of excluded services, such as physicians' services) for which payment may otherwise be made under Part B and which are furnished to Medicare beneficiaries who are residents in a SNF during a covered Part A stay. A comprehensive discussion of these provisions appears in the May 12, 1998
Section 215(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added section 1888(g) to the Act requiring the Secretary to specify an all-cause all-condition hospital readmission measure and an all-condition risk-adjusted potentially preventable hospital readmission measure for the SNF setting. Additionally, section 215(b) of PAMA added section 1888(h) to the Act requiring the Secretary to implement a VBP program for SNFs. Finally, section 2(c)(4) of the IMPACT Act amended section 1888(e)(6) to the Act, which requires the Secretary to implement a quality reporting program for SNFs under which SNFs report data on measures and resident assessment data.
Under sections 1888(e)(1)(A) and 1888(e)(11) of the Act, the SNF PPS included an initial, three-phase transition that blended a facility-specific rate (reflecting the individual facility's historical cost experience) with the federal case-mix adjusted rate. The transition extended through the facility's first 3 cost reporting periods under the PPS, up to and including the one that began in FY 2001. Thus, the SNF PPS is no longer operating under the transition, as all facilities have been paid at the full federal rate effective with cost reporting periods beginning in FY 2002. As we now base payments for SNFs entirely on the adjusted federal per diem rates, we no longer include adjustment factors under the transition related to facility-specific rates for the upcoming FY.
Section 1888(e)(4)(E) of the Act requires the SNF PPS payment rates to be updated annually. The most recent annual update occurred in a final rule that set forth updates to the SNF PPS payment rates for FY 2019 (83 FR 39162), as corrected in the FY 2019 SNF PPS correction notice (83 FR 49832).
Section 1888(e)(4)(H) of the Act specifies that we provide for publication annually in the
• The unadjusted federal per diem rates to be applied to days of covered SNF services furnished during the upcoming FY.
• The case-mix classification system to be applied for these services during the upcoming FY.
• The factors to be applied in making the area wage adjustment for these services.
Along with other revisions discussed later in this preamble, this proposed rule will provide the required annual updates to the per diem payment rates for SNFs for FY 2020.
Under section 1888(e)(4) of the Act, the SNF PPS uses per diem federal payment rates based on mean SNF costs in a base year (FY 1995) updated for inflation to the first effective period of the PPS. We developed the federal payment rates using allowable costs from hospital-based and freestanding SNF cost reports for reporting periods beginning in FY 1995. The data used in developing the federal rates also incorporated a Part B add-on, which is an estimate of the amounts that, prior to the SNF PPS, would be payable under Part B for covered SNF services furnished to individuals during the course of a covered Part A stay in a SNF.
In developing the rates for the initial period, we updated costs to the first effective year of the PPS (the 15-month period beginning July 1, 1998) using a SNF market basket index, and then standardized for geographic variations in wages and for the costs of facility differences in case mix. In compiling the database used to compute the federal payment rates, we excluded those providers that received new provider exemptions from the routine cost limits, as well as costs related to payments for exceptions to the routine cost limits. Using the formula that the BBA 1997 prescribed, we set the federal rates at a level equal to the weighted mean of freestanding costs plus 50 percent of the difference between the freestanding mean and weighted mean of all SNF costs (hospital-based and freestanding) combined. We computed and applied separately the payment rates for facilities located in urban and rural areas, and adjusted the portion of the federal rate attributable to wage-related costs by a wage index to reflect geographic variations in wages.
Section 1888(e)(5)(A) of the Act requires us to establish a SNF market basket index that reflects changes over time in the prices of an appropriate mix of goods and services included in covered SNF services. Accordingly, we have developed a SNF market basket index that encompasses the most commonly used cost categories for SNF routine services, ancillary services, and capital-related expenses. In the SNF PPS final rule for FY 2018 (82 FR 36548 through 36566), we revised and rebased the market basket index, which included updating the base year from FY 2010 to 2014.
The SNF market basket index is used to compute the market basket percentage change that is used to update the SNF federal rates on an annual basis, as required by section 1888(e)(4)(E)(ii)(IV) of the Act. This market basket percentage update is adjusted by a forecast error correction, if applicable, and then further adjusted by the application of a productivity adjustment as required by section 1888(e)(5)(B)(ii) of the Act and described in section III.B.4. of this proposed rule. For FY 2020, the growth rate of the 2014-based SNF market basket is estimated to be 3.0 percent, based on the IHS Global Insight, Inc. (IGI) first quarter 2019 forecast with historical data through fourth quarter 2018, before the multifactor productivity adjustment is applied.
In section III.B.5. of this proposed rule, we discuss the 2 percent reduction applied to the market basket update for those SNFs that fail to submit measures data as required by section 1888(e)(6)(A) of the Act.
Section 1888(e)(5)(B) of the Act defines the SNF market basket percentage as the percentage change in the SNF market basket index from the midpoint of the previous FY to the midpoint of the current FY. For the federal rates set forth in this proposed rule, we use the percentage change in the SNF market basket index to compute the update factor for FY 2020. This factor is based on the FY 2020 percentage increase in the 2014-based SNF market basket index reflecting routine, ancillary, and capital-related expenses. In this proposed rule, the SNF market basket percentage is estimated to be 3.0 percent for FY 2020 based on IGI's first quarter 2019 forecast (with historical data through fourth quarter 2018). Finally, as discussed in section II.B. of this proposed rule, we no longer compute update factors to adjust a facility-specific portion of the SNF PPS rates, because the initial three-phase transition period from facility-specific to full federal rates that started with cost reporting periods beginning in July 1998 has expired.
As discussed in the June 10, 2003 supplemental proposed rule (68 FR 34768) and finalized in the August 4, 2003 final rule (68 FR 46057 through 46059), § 413.337(d)(2) provides for an adjustment to account for market basket forecast error. The initial adjustment for market basket forecast error applied to the update of the FY 2003 rate for FY 2004, and took into account the cumulative forecast error for the period from FY 2000 through FY 2002, resulting in an increase of 3.26 percent to the FY 2004 update. Subsequent adjustments in succeeding FYs take into account the forecast error from the most recently available FY for which there is final data, and apply the difference between the forecasted and actual change in the market basket when the difference exceeds a specified threshold. We originally used a 0.25 percentage point threshold for this purpose; however, for the reasons specified in the FY 2008 SNF PPS final rule (72 FR 43425, August 3, 2007), we adopted a 0.5 percentage point threshold effective for FY 2008 and subsequent FYs. As we stated in the final rule for FY 2004 that first issued the market basket forecast error adjustment (68 FR 46058, August 4, 2003), the adjustment will reflect both upward and downward adjustments, as appropriate.
For FY 2018 (the most recently available FY for which there is final data), the estimated increase in the market basket index was 2.6 percentage points, and the actual increase for FY 2018 is 2.6 percentage points, resulting in the actual increase being the same as the estimated increase. Accordingly, as the difference between the estimated and actual amount of change in the market basket index does not exceed the 0.5 percentage point threshold, the FY 2020 market basket percentage change of 3.0 percent would not be adjusted to account for the forecast error correction. Table 2 shows the forecasted and actual market basket amounts for FY 2018.
Section 1888(e)(5)(B)(ii) of the Act, as added by section 3401(b) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148, enacted on March 23, 2010) requires that, in FY 2012 and in subsequent FYs, the market basket percentage under the SNF payment system (as described in section 1888(e)(5)(B)(i) of the Act) is to be reduced annually by the multifactor productivity (MFP) adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. Section 1886(b)(3)(B)(xi)(II) of the Act, in turn, defines the MFP adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multi-factor productivity (as projected by the Secretary for the 10-year period ending with the applicable FY, year, cost-reporting period, or other annual period). The Bureau of Labor Statistics (BLS) is the agency that publishes the official measure of private nonfarm business MFP. We refer readers to the BLS website at
MFP is derived by subtracting the contribution of labor and capital inputs growth from output growth. The projections of the components of MFP are currently produced by IGI, a nationally recognized economic forecasting firm with which CMS contracts to forecast the components of the market baskets and MFP. To generate a forecast of MFP, IGI replicates the MFP measure calculated by the BLS, using a series of proxy variables derived from IGI's U.S. macroeconomic models. For a discussion of the MFP projection methodology, we refer readers to the FY 2012 SNF PPS final rule (76 FR 48527 through 48529) and the FY 2016 SNF PPS final rule (80 FR 46395). A complete description of the MFP projection methodology is available on our website at
Per section 1888(e)(5)(A) of the Act, the Secretary shall establish a SNF market basket index that reflects changes over time in the prices of an appropriate mix of goods and services included in covered SNF services. Section 1888(e)(5)(B)(ii) of the Act, added by section 3401(b) of the Affordable Care Act, requires that for FY 2012 and each subsequent FY, after determining the market basket percentage described in section 1888(e)(5)(B)(i) of the Act, the Secretary shall reduce such percentage by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act (which we refer to as the MFP adjustment). Section 1888(e)(5)(B)(ii) of the Act further states that the reduction of the market basket percentage by the MFP adjustment may result in the market basket percentage being less than zero for a FY, and may result in payment rates under section 1888(e) of the Act being less than such payment rates for the preceding fiscal year. Thus, if the application of the MFP adjustment to the market basket percentage calculated under section 1888(e)(5)(B)(i) of the Act results in an MFP-adjusted market basket percentage that is less than zero, then the annual update to the unadjusted federal per diem rates under section 1888(e)(4)(E)(ii) of the Act would be negative, and such rates would decrease relative to the prior FY.
The MFP adjustment, calculated as the 10-year moving average of changes in MFP for the period ending September 30, 2020, is estimated to be 0.5 percent based on IGI's first quarter 2019 forecast. Also, consistent with section 1888(e)(5)(B)(i) of the Act and § 413.337(d)(2), the market basket percentage for FY 2020 for the SNF PPS is based on IGI's first quarter 2019 forecast of the SNF market basket percentage, which is estimated to be 3.0 percent. In accordance with section 1888(e)(5)(B)(ii) of the Act and § 413.337(d)(3), this market basket percentage is then reduced by the MFP adjustment of 0.5 percent. The resulting MFP-adjusted SNF market basket update would be equal to 2.5 percent, or 3.0 percent less 0.5 percentage point.
Sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5)(i) of the Act require that the update factor used to establish the FY 2020 unadjusted federal rates be at a level equal to the market basket index percentage change. Accordingly, we determined the total growth from the average market basket level for the period of October 1, 2018, through September 30, 2019 to the average market basket level for the period of October 1, 2019, through September 30, 2020. This process yields a percentage change in the 2014-based SNF market basket of 3.0 percent. As further explained in section III.B.3. of this proposed rule, as applicable, we adjust the market basket percentage change by the forecast error from the most recently available FY for which there is final data and apply this adjustment whenever the difference between the forecasted and actual percentage change in the market basket exceeds a 0.5 percentage point threshold. Since the difference between the forecasted FY 2018 SNF market basket percentage change and the actual FY 2018 SNF market basket percentage change (FY 2018 is the most recently available FY for which there is historical data) did not exceed the 0.5 percentage point threshold, the FY 2020 market basket percentage change of 3.0 percent would not be adjusted by the forecast error correction.
Section 1888(e)(5)(B)(ii) of the Act requires us to reduce the market basket percentage change by the MFP adjustment (10-year moving average of changes in MFP for the period ending September 30, 2020) of 0.5 percent, as described in section III.B.4 of this proposed rule. The resulting net SNF market basket update would equal 2.5 percent, or 3.0 percent less the 0.5 percentage point MFP adjustment. We note that our policy has been that, if more recent data become available (for example, a more recent estimate of the SNF market basket and/or MFP adjustment), we would use such data, if appropriate, to determine the SNF market basket percentage change, labor-related share relative importance, forecast error adjustment, and MFP adjustment in the SNF PPS final rule.
We also note that section 1888(e)(6)(A)(i) of the Act provides that, beginning with FY 2018, SNFs that fail to submit data, as applicable, in accordance with sections 1888(e)(6)(B)(i)(II) and (III) of the Act for a fiscal year will receive a 2.0 percentage point reduction to their market basket update for the fiscal year involved, after application of section 1888(e)(5)(B)(ii) of the Act (the MFP adjustment) and section 1888(e)(5)(B)(iii) of the Act (the 1 percent market basket increase for FY 2018). In addition, section 1888(e)(6)(A)(ii) of the Act states that application of the 2.0 percentage point reduction (after application of section 1888(e)(5)(B)(ii) and (iii) of the Act) may result in the market basket index percentage change being less than 0.0 for a fiscal year, and may result in payment rates for a fiscal year being less than such payment rates for the preceding fiscal year. Section 1888(e)(6)(A)(iii) of the Act further specifies that the 2.0 percentage point reduction is applied in a noncumulative manner, so that any reduction made under section 1888(e)(6)(A)(i) of the Act applies only with respect to the fiscal year involved, and that the reduction cannot be taken into account in computing the payment amount for a subsequent fiscal year.
Accordingly, for the reasons specified in this proposed rule, we are proposing to apply the FY 2020 SNF market basket increase factor of 2.5 percent in our determination of the FY 2020 SNF PPS unadjusted federal per diem rates, which reflects a market basket increase factor of 3.0 percent, less the 0.5 percentage point MFP-adjustment.
As discussed in the FY 2019 SNF PPS final rule (83 FR 39162), we are implementing a new case-mix classification system to classify SNF patients under the SNF PPS, beginning in FY 2020, called the Patient Driven Payment Model (PDPM). As discussed in section V.B of that final rule, under PDPM, the unadjusted Federal per diem rates are divided into six components, five of which are case-mix adjusted components (Physical Therapy (PT), Occupational Therapy (OT), Speech-Language Pathology (SLP), Nursing, and Non-Therapy Ancillaries (NTA)), and one of which is a non-case-mix component, as exists under RUG-IV. In calculating the FY 2020 unadjusted Federal per diem rates that would be used under PDPM in FY 2020, we applied the FY 2020 MFP-adjusted market basket increase factor to the unadjusted Federal per diem rates provided in Tables 4 and 5 of the FY 2019 SNF PPS final rule (83 FR 39169) and then applied the methodology for separating the RUG-IV base rates into the PDPM base rates, as discussed and finalized in section V.B.3 of the FY 2019 SNF PPS final rule (83 FR 39191 through 39194).
Tables 3 and 4 reflect the proposed updated unadjusted federal rates for FY 2020, prior to adjustment for case-mix.
Under section 1888(e)(4)(G)(i) of the Act, the federal rate also incorporates an adjustment to account for facility case-mix, using a classification system that accounts for the relative resource utilization of different patient types. The statute specifies that the adjustment is to reflect both a resident classification system that the Secretary establishes to account for the relative resource use of different patient types, as well as resident assessment data and other data that the Secretary considers appropriate. In the FY 2019 final rule (83 FR 39162, August 8, 2018), we finalized a new case-mix classification model, the PDPM, to take effect beginning October 1, 2019. The RUG-IV model classifies most patients into a therapy payment group and primarily uses the volume of therapy services provided to the patient as the basis for payment classification, thus inadvertently creating an incentive for SNFs to furnish therapy regardless of the individual patient's unique characteristics, goals, or needs. PDPM eliminates this incentive and improves the overall accuracy and appropriateness of SNF payments by classifying patients into payment groups based on specific, data-driven patient characteristics, while simultaneously reducing the administrative burden on SNFs.
The PDPM (like the RUG-IV) uses clinical data from the MDS to assign case-mix classifiers to each patient that are then used to calculate a per diem payment under the SNF PPS. As discussed in section IV.A. of this proposed rule, the clinical orientation of the case-mix classification system supports the SNF PPS's use of an administrative presumption that considers a beneficiary's initial case-mix classification to assist in making certain SNF level of care determinations. Further, because the MDS is used as a basis for payment, as well as a clinical assessment, we have provided extensive training on proper coding and the timeframes for MDS completion in our Resident Assessment Instrument (RAI) Manual. For an MDS to be considered valid for use in determining payment, the MDS assessment must be completed in compliance with the instructions in the RAI Manual in effect at the time the assessment is completed. For payment and quality monitoring purposes, the RAI Manual consists of both the Manual instructions and the interpretive guidance and policy clarifications posted on the appropriate MDS website at
Under section 1888(e)(4)(H), each update of the payment rates must include the case-mix classification methodology applicable for the upcoming FY. The FY 2020 payment rates set forth in this proposed rule reflect the use of the PDPM case-mix classification system from October 1, 2019, through September 30, 2020. We list the proposed case-mix adjusted PDPM payment rates for FY 2020, provided separately for urban and rural SNFs, in Tables 6 and 7 with corresponding case-mix values.
As discussed in the FY 2019 SNF PPS final rule (83 FR 39255 through 39256), we finalized the implementation of PDPM in a budget neutral manner. To accomplish this, as discussed in the FY 2019 SNF PPS final rule (83 FR 39256), the unadjusted PDPM case mix indexes (CMIs) were multiplied by 1.46 so that the total estimated payments under the PDPM would be equal to the total actual payments under RUG-IV. Further, section 3.11.2 of the PDPM technical report, available at
In this proposed rule, we propose to update the payment year used as the basis for the calculation of the standardization multiplier and budget neutrality multiplier, in order to best ensure that PDPM will be implemented in a budget neutral manner, as finalized in the FY 2019 SNF PPS final rule. The only difference in methodology between that used to calculate these multipliers and CMIs in the FY 2019 SNF PPS final rule and that used to calculate the multipliers and CMIs in this proposed rule is that, in this proposed rule, we are updating the data used from FY 2017 data to FY 2018 data. The impact of using the updated FY 2018 data and the proposed updated adjustment multipliers for standardization and budget neutrality, is provided in Table 5. We would note that while the multipliers discussed in the FY 2019 SNF PPS final rule and in the PDPM Technical Report are given to the hundredths place, in order to make clear the effect of this change in data, the multipliers in Table 5 are shown to the thousandths place. The CMIs provided in Tables 6 and 7 reflect the use of the proposed multipliers in Table 5, based on the update to FY 2018 data.
Given the differences between RUG-IV and PDPM in terms of patient classification and billing, it is important that the format of Tables 6 and 7 reflect these differences. More specifically, under both RUG-IV and PDPM, providers use a Health Insurance Prospective Payment System (HIPPS) code on a claim in order to bill for covered SNF services. Under RUG-IV, the HIPPS code includes the three character RUG-IV group into which the patient classifies as well as a two character assessment indicator code that represents the assessment used to generate this code. Under PDPM, while providers would still use a HIPPS code, the characters in that code represent different things. For example, the first character represents the PT and OT group into which the patient classifies. If the patient is classified into the PT and OT group “TA”, then the first character in the patient's HIPPS code would be an A. Similarly, if the patient is classified into the SLP group “SB”, then the second character in the patient's HIPPS code would be a B. The third character represents the Nursing group into which the patient classifies. The fourth character represents the NTA group into which the patient classifies. Finally, the fifth character represents the assessment used to generate the HIPPS code.
Therefore, we have modified the format of Tables 6 and 7 from what we have used for similar tables in prior SNF PPS rulemaking, such as Tables 6 and 7 of the FY 2019 SNF PPS final rule (83 FR 39170 through 39172). Column 1 of Tables 6 and 7 represents the character in the HIPPS code associated with a given PDPM component. Columns 2 and 3 provide the case-mix index and associated case-mix adjusted component rate, respectively, for the relevant PT group. Columns 4 and 5 provide the case-mix index and associated case-mix adjusted component rate, respectively, for the relevant OT group. Columns 6 and 7 provide the case-mix index and associated case-mix adjusted component rate, respectively, for the relevant SLP group. Column 8 provides the nursing case-mix group (CMG) that is connected with a given PDPM HIPPS character. For example, if the patient qualified for the nursing group CBC1, then the third character in the patient's HIPPS code would be a “P.” Columns 9 and 10 provide the case-mix index and associated case-mix adjusted component rate, respectively, for the relevant nursing group. Finally, columns 11 and 12 provide the case-mix index and associated case-mix adjusted component rate, respectively, for the relevant NTA group. Tables 6 and 7 do not reflect adjustments which may be made to the SNF PPS rates as a result of either the SNF QRP, discussed in section VI.B. of this proposed rule, or the SNF VBP program, discussed in sections III.B.5. and VI.C. of this proposed rule, or other adjustments, such as the variable per diem adjustment. Further, we use the revised OMB delineations adopted in the FY 2015 SNF PPS final rule (79 FR 45632, 45634), with updates as reflected in OMB Bulletin Nos, 15-01 and 17-01, to identify a facility's urban or rural status for the purpose of determining which set of rate tables would apply to the facility.
Section 1888(e)(4)(G)(ii) of the Act requires that we adjust the federal rates to account for differences in area wage levels, using a wage index that the Secretary determines appropriate. Since the inception of the SNF PPS, we have used hospital inpatient wage data in developing a wage index to be applied to SNFs. We propose to continue this practice for FY 2020, as we continue to believe that in the absence of SNF-specific wage data, using the hospital inpatient wage index data is appropriate and reasonable for the SNF PPS. As explained in the update notice for FY 2005 (69 FR 45786), the SNF PPS does not use the hospital area wage index's occupational mix adjustment, as this adjustment serves specifically to define the occupational categories more clearly in a hospital setting; moreover, the collection of the occupational wage data also excludes any wage data related to SNFs. Therefore, we believe that using the updated wage data exclusive of the occupational mix adjustment continues to be appropriate for SNF payments. As in previous years, we would continue to use the pre-reclassified IPPS hospital wage data, unadjusted for occupational mix and the rural floor, as the basis for the SNF PPS wage index. For FY 2020, the updated wage data are for hospital cost reporting periods beginning on or after October 1, 2015 and before October 1, 2016 (FY 2016 cost report data).
We note that section 315 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554, enacted on December 21, 2000) authorized us to establish a geographic reclassification procedure that is specific to SNFs, but only after collecting the data necessary to establish a SNF PPS wage index that is based on wage data from nursing homes. However, to date, this has proven to be unfeasible due to the volatility of existing SNF wage data and the significant amount of resources that would be required to improve the quality of that data. More specifically, auditing all SNF cost reports, similar to the process used to audit inpatient hospital cost reports for purposes of the Inpatient Prospective Payment System (IPPS) wage index, would place a burden on providers in terms of recordkeeping and completion of the cost report worksheet. As discussed in greater detail later in this section, adopting such an approach would require a significant commitment of resources by CMS and the Medicare Administrative Contractors, potentially far in excess of those required under the IPPS given that there are nearly five times as many SNFs as there are inpatient hospitals. Therefore, while we continue to believe that the development of such an audit process could improve SNF cost reports in such a manner as to permit us to establish a SNF-specific wage index, we do not regard an undertaking of this magnitude as being feasible within the current level of programmatic resources.
In addition, we propose to continue to use the same methodology discussed in the SNF PPS final rule for FY 2008 (72 FR 43423) to address those geographic areas in which there are no hospitals, and thus, no hospital wage index data on which to base the calculation of the
In the SNF PPS final rule for FY 2006 (70 FR 45026, August 4, 2005), we adopted the changes discussed in OMB Bulletin No. 03-04 (June 6, 2003), which announced revised definitions for MSAs and the creation of micropolitan statistical areas and combined statistical areas. In adopting the CBSA geographic designations, we provided for a 1-year transition in FY 2006 with a blended wage index for all providers. For FY 2006, the wage index for each provider consisted of a blend of 50 percent of the FY 2006 MSA-based wage index and 50 percent of the FY 2006 CBSA-based wage index (both using FY 2002 hospital data). We referred to the blended wage index as the FY 2006 SNF PPS transition wage index. As discussed in the SNF PPS final rule for FY 2006 (70 FR 45041), since the expiration of this 1-year transition on September 30, 2006, we have used the full CBSA-based wage index values.
In the FY 2015 SNF PPS final rule (79 FR 45644 through 45646), we finalized changes to the SNF PPS wage index based on the newest OMB delineations, as described in OMB Bulletin No. 13-01, beginning in FY 2015, including a 1-year transition with a blended wage index for FY 2015. OMB Bulletin No. 13-01 established revised delineations for Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas in the United States and Puerto Rico based on the 2010 Census, and provided guidance on the use of the delineations of these statistical areas using standards published on June 28, 2010 in the
Once calculated, we would apply the wage index adjustment to the labor-related portion of the federal rate. Each year, we calculate a revised labor-related share, based on the relative importance of labor-related cost categories (that is, those cost categories that are labor-intensive and vary with the local labor market) in the input price index. In the SNF PPS final rule for FY 2018 (82 FR 36548 through 36566), we finalized a proposal to revise the labor-related share to reflect the relative importance of the 2014-based SNF market basket cost weights for the following cost categories: Wages and Salaries; Employee Benefits; Professional Fees: Labor-Related; Administrative and Facilities Support Services; Installation, Maintenance, and Repair Services; All Other: Labor-Related Services; and a proportion of Capital-Related expenses.
We calculate the labor-related relative importance from the SNF market basket, and it approximates the labor-related portion of the total costs after taking into account historical and projected price changes between the base year and FY 2020. The price proxies that move the different cost categories in the market basket do not necessarily change at the same rate, and the relative importance captures these changes. Accordingly, the relative importance figure more closely reflects the cost share weights for FY 2020 than the base year weights from the SNF market basket.
We calculate the labor-related relative importance for FY 2020 in four steps. First, we compute the FY 2020 price index level for the total market basket and each cost category of the market basket. Second, we calculate a ratio for each cost category by dividing the FY 2020 price index level for that cost category by the total market basket price index level. Third, we determine the FY 2020 relative importance for each cost category by multiplying this ratio by the base year (2014) weight. Finally, we add the FY 2020 relative importance for each of the labor-related cost categories (Wages and Salaries, Employee Benefits, Professional Fees: Labor-Related, Administrative and Facilities Support Services, Installation, Maintenance, and Repair Services, All Other: Labor-related services, and a portion of Capital-Related expenses) to produce the FY 2020 labor-related relative importance. Table 8 summarizes the proposed labor-related share for FY 2020, based on IGI's first quarter 2019 forecast with historical data through fourth quarter 2018, compared to the labor-related share that was used for the FY 2019 SNF PPS final rule.
In order to calculate the labor portion of the case-mix adjusted per diem rate, one would multiply the total case-mix adjusted per diem rate, which is the sum of all five case-mix adjusted components into which a patient classifies, and the non-case-mix component rate, by the FY 2020 labor-related share percentage provided in Table 8. The remaining portion of the rate would be the non-labor portion. In prior years, we have included tables which provide the case-mix adjusted RUG-IV rates, by RUG-IV group, broken out by total rate, labor portion and non-labor portion, such as Table 9 of the FY 2019 SNF PPS final rule (83 FR 39175). However, under PDPM, as the total rate is calculated as a combination of six different component rates, five of which are case-mix adjusted, and given the sheer volume of possible combinations of these five case-mix adjusted components, it is not feasible to provide tables similar to those that have existed in prior rulemaking.
Therefore, to aid stakeholders in understanding the effect of the wage index on the calculation of the SNF per diem rate, we have included a revised hypothetical rate calculation in Table 9.
Section 1888(e)(4)(G)(ii) of the Act also requires that we apply this wage index in a manner that does not result in aggregate payments under the SNF PPS that are greater or less than would otherwise be made if the wage adjustment had not been made. For FY 2020 (federal rates effective October 1, 2019), we would apply an adjustment to fulfill the budget neutrality requirement. We would meet this requirement by multiplying each of the components of the unadjusted federal rates by a budget neutrality factor equal to the ratio of the weighted average wage adjustment factor for FY 2019 to the weighted average wage adjustment factor for FY 2020. For this calculation, we would use the same FY 2018 claims utilization data for both the numerator and denominator of this ratio. We define the wage adjustment factor used in this calculation as the labor share of the rate component multiplied by the wage index plus the non-labor share of the rate component. The proposed budget neutrality factor for FY 2020 would be 1.0060.
As discussed above, historically, we have calculated the SNF PPS wage index values using unadjusted wage index values from another provider setting. Stakeholders have frequently commented on certain aspects of the SNF PPS wage index values and their impact on payments. We are soliciting comments on concerns stakeholders may have regarding the wage index used to adjust SNF PPS payments and suggestions for possible updates and improvements to the geographic adjustment of SNF PPS payments.
Beginning with payment for services furnished on October 1, 2018, section 1888(h) of the Act requires the Secretary to reduce the adjusted Federal per diem rate determined under section 1888(e)(4)(G) of the Act otherwise applicable to a SNF for services furnished during a fiscal year by 2 percent, and to adjust the resulting rate for a SNF by the value-based incentive payment amount earned by the SNF based on the SNF's performance score for that fiscal year under the SNF VBP Program. To implement these requirements, we finalized in the FY 2019 SNF PPS final rule the addition of § 413.337(f) to our regulations (83 FR 39178).
Please see section VI.B. of this proposed rule for a discussion of our proposals for the SNF VBP Program.
The following series of tables provides an example of how payment would be calculated during FY 2020 under PDPM for a hypothetical 30 day SNF stay, involving the hypothetical SNF XYZ, located in Frederick, MD (Urban CBSA 43524), for a hypothetical patient who is classified into such groups that the patient's HIPPS code is NHNC1. Table 9 shows the adjustments made to the federal per diem rates (prior to application of any adjustments under the SNF QRP and SNF VBP programs as discussed above) to compute the provider's case-mix adjusted per diem rate for FY 2020, based on the patient's PDPM classification, as well as how the VPD adjustment factor affects calculation of the per diem rate for a given day of the stay. Table 10 shows the adjustments made to the case-mix adjusted per diem rate from Table 9 to account for the provider's wage index. The wage index used in this example is based on the FY 2020 SNF PPS wage index that appears in Table A available on the CMS website at
The establishment of the SNF PPS did not change Medicare's fundamental requirements for SNF coverage. However, because the case-mix classification is based, in part, on the beneficiary's need for skilled nursing care and therapy, we have attempted, where possible, to coordinate claims review procedures with the existing resident assessment process and case-mix classification system discussed in section III.C. of this proposed rule. This
In accordance with the regulations at § 413.345, we include in each update of the federal payment rates in the
A beneficiary who does not qualify for the presumption is not automatically classified as either meeting or not meeting the level of care definition, but instead receives an individual determination on this point using the existing administrative criteria. This presumption recognizes the strong likelihood that those beneficiaries who are assigned one of the designated case-mix classifiers during the immediate post-hospital period would require a covered level of care, which would be less likely for other beneficiaries.
In the July 30, 1999 final rule (64 FR 41670), we indicated that we would announce any changes to the guidelines for Medicare level of care determinations related to modifications in the case-mix classification structure. The FY 2018 final rule (82 FR 36544) further specified that we would henceforth disseminate the standard description of the administrative presumption's designated groups via the SNF PPS website at
However, we note that this administrative presumption policy does not supersede the SNF's responsibility to ensure that its decisions relating to level of care are appropriate and timely, including a review to confirm that any services prompting the assignment of one of the designated case-mix classifiers (which, in turn, serves to trigger the administrative presumption) are themselves medically necessary. As we explained in the FY 2000 SNF PPS final rule (64 FR 41667), the administrative presumption is itself rebuttable in those individual cases in which the services actually received by the resident do not meet the basic statutory criterion of being reasonable and necessary to diagnose or treat a beneficiary's condition (according to section 1862(a)(1) of the Act). Accordingly, the presumption would not apply, for example, in those situations where the sole classifier that triggers the presumption is itself assigned through the receipt of services that are subsequently determined to be not reasonable and necessary. Moreover, we want to stress the importance of careful monitoring for changes in each patient's condition to determine the continuing need for Part A SNF benefits after the ARD of the 5-day assessment. Finally, regarding the new set of case-mix classifiers designated under the PDPM for this purpose, we noted in the FY 2019 SNF PPS final rule (83 FR 39253, August 8, 2018) our intent “. . . to review the new designations going forward and make further adjustments over time as we gain actual operating experience under the new classification model.” Accordingly, to the extent that it may become evident in actual practice that these new criteria are not accurately performing their intended role (for example, by capturing cases that do not actually require an SNF level of care), we would propose appropriate adjustments to correct them.
Sections 1842(b)(6)(E) and 1862(a)(18) of the Act (as added by section 4432(b) of the BBA 1997) require a SNF to submit consolidated Medicare bills to its Medicare Administrative Contractor (MAC) for almost all of the services that its residents receive during the course of a covered Part A stay. In addition, section 1862(a)(18) of the Act places the responsibility with the SNF for billing Medicare for physical therapy, occupational therapy, and speech-language pathology services that the resident receives during a noncovered stay. Section 1888(e)(2)(A) of the Act excludes a small list of services from the consolidated billing provision (primarily those services furnished by physicians and certain other types of practitioners), which remain separately billable under Part B when furnished to a SNF's Part A resident. These excluded service categories are discussed in greater detail in section V.B.2. of the May 12, 1998 interim final rule (63 FR 26295 through 26297).
A detailed discussion of the legislative history of the consolidated billing provision is available on the SNF PPS website at
As explained in the FY 2001 proposed rule (65 FR 19232), the amendments enacted in section 103 of the BBRA not only identified for exclusion from this provision a number of particular service codes within four specified categories (that is, chemotherapy items, chemotherapy administration services, radioisotope services, and customized prosthetic devices), but also gave the Secretary the authority to designate additional, individual services for exclusion within each of the specified service categories. In the proposed rule for FY 2001, we also noted that the BBRA Conference report (H.R. Rep. No. 106-479 at 854 (1999) (Conf. Rep.)) characterizes the individual services that this legislation targets for exclusion as high-cost, low probability events that could have devastating financial impacts because their costs far exceed the payment SNFs receive under the PPS. According to the conferees, section 103(a) of the BBRA is an attempt to exclude from the PPS certain services
As we further explained in the final rule for FY 2001 (65 FR 46790), and as is consistent with our longstanding policy, any additional service codes that we might designate for exclusion under our discretionary authority must meet the same statutory criteria used in identifying the original codes excluded from consolidated billing under section 103(a) of the BBRA: they must fall within one of the four service categories specified in the BBRA; and they also must meet the same standards of high cost and low probability in the SNF setting, as discussed in the BBRA Conference report. Accordingly, we characterized this statutory authority to identify additional service codes for exclusion as essentially affording the flexibility to revise the list of excluded codes in response to changes of major significance that may occur over time (for example, the development of new medical technologies or other advances in the state of medical practice) (65 FR 46791). In this proposed rule, we specifically invite public comments identifying HCPCS codes in any of these four service categories (chemotherapy items, chemotherapy administration services, radioisotope services, and customized prosthetic devices) representing recent medical advances that might meet our criteria for exclusion from SNF consolidated billing. We may consider excluding a particular service if it meets our criteria for exclusion as specified above. Commenters should identify in their comments the specific HCPCS code that is associated with the service in question, as well as their rationale for requesting that the identified HCPCS code(s) be excluded.
We note that the original BBRA amendment (as well as the implementing regulations) identified a set of excluded services by means of specifying HCPCS codes that were in effect as of a particular date (in that case, as of July 1, 1999). Identifying the excluded services in this manner made it possible for us to utilize program issuances as the vehicle for accomplishing routine updates of the excluded codes, to reflect any minor revisions that might subsequently occur in the coding system itself (for example, the assignment of a different code number to the same service). Accordingly, in the event that we identify through the current rulemaking cycle any new services that would actually represent a substantive change in the scope of the exclusions from SNF consolidated billing, we would identify these additional excluded services by means of the HCPCS codes that are in effect as of a specific date (in this case, as of October 1, 2019). By making any new exclusions in this manner, we could similarly accomplish routine future updates of these additional codes through the issuance of program instructions.
Section 1883 of the Act permits certain small, rural hospitals to enter into a Medicare swing-bed agreement, under which the hospital can use its beds to provide either acute- or SNF-level care, as needed. For critical access hospitals (CAHs), Part A pays on a reasonable cost basis for SNF-level services furnished under a swing-bed agreement. However, in accordance with section 1888(e)(7) of the Act, SNF-level services furnished by non-CAH rural hospitals are paid under the SNF PPS, effective with cost reporting periods beginning on or after July 1, 2002. As explained in the FY 2002 final rule (66 FR 39562), this effective date is consistent with the statutory provision to integrate swing-bed rural hospitals into the SNF PPS by the end of the transition period, June 30, 2002.
Accordingly, all non-CAH swing-bed rural hospitals have now come under the SNF PPS. Therefore, all rates and wage indexes outlined in earlier sections of this final rule for the SNF PPS also apply to all non-CAH swing-bed rural hospitals. As finalized in the FY 2010 SNF PPS final rule (74 FR 40356 through 40357), effective October 1, 2010, non-CAH swing-bed rural hospitals are required to complete an MDS 3.0 swing-bed assessment which is limited to the required demographic, payment, and quality items. As discussed in the FY 2019 SNF PPS final rule (83 FR 39235), revisions were made to the swing bed assessment in order to support implementation of PDPM, effective October 1, 2019. A discussion of the assessment schedule and the MDS effective beginning FY 2020 appears in the FY 2019 SNF PPS final rule (83 FR 39229 through 39237). The latest changes in the MDS for swing-bed rural hospitals appear on the SNF PPS website at
As set forth in the FY 2019 SNF PPS final rule (83 FR 39162), effective October 1, 2019 under the PDPM, patients will be classified into case-mix groups under each therapy component based on patient characteristics rather than using the volume of therapy services furnished to the patient as the basis for classification. Additionally, as discussed in the FY 2019 SNF PPS final rule (83 FR 39237 through 39243), we finalized a combined limit on concurrent and group therapy furnished to a patient, specifically that, for each therapy discipline, no more than 25 percent of the therapy services furnished to a patient in a covered Medicare Part A stay may be in a group or concurrent setting. Given these policy changes relating to therapy classification and therapy provision under the PDPM, as well as recent efforts to increase standardization across PAC settings, we believed it was appropriate to evaluate other policies associated with therapy under PDPM to determine if other policies should be revised as well.
In the FY 2012 SNF PPS final rule (76 FR 48511 through 48517), we finalized changes relating to the definition of group therapy and payment of group therapy services, specifically to define group therapy as the practice of one therapist or therapy assistant treating four patients at the same time while the patients are performing either the same or similar activities. In the FY 2012 SNF PPS final rule (76 FR 48511), we noted that, using our STRIVE data as a baseline, we identified under RUG-IV two significant changes in provider behavior related to the provision of therapy services to Medicare beneficiaries in SNFs. First, we saw a major decrease in the amount of concurrent therapy (that is therapy provided to two patients by one therapist or therapy assistant doing
As we stated in the FY 2012 SNF PPS final rule (76 FR 48511), because in group therapy, patients are performing similar activities, in contrast to concurrent therapy, group therapy gives patients the opportunity to benefit from each other's therapy regimen by observing and interacting with one another and applying the lessons learned from others to one's own therapy program in order to progress. At that time, we stated that large groups, such as those of five or more participants, can make it difficult for the participants to engage with one another over the course of the session. In addition, we have long believed that individual therapists could not adequately supervise large groups, and since the inception of the SNF PPS in July 1998, we have capped the number of residents at four. Furthermore, we believed that groups of fewer than four participants did not maximize the group therapy benefit for the participants. As we stated in the FY 2012 final rule (76 FR 48511), we believed that in groups of two or three participants, the opportunities for patients in the group to interact and learn from each other are significantly diminished given the small size of the group. Thus, we revised the definition of group therapy to require a group size for the SNF setting of exactly four patients, which we believed was the size that permits the therapy participants to derive the maximum benefit from the group therapy setting.
Since that time, we have monitored group therapy utilization and found that, as discussed in the FY 2019 SNF PPS final rule (83 FR 39237 through 39238), group therapy represents a very small proportion of therapy provided to SNF patients. Further, as discussed in the FY 2019 SNF PPS final rule (83 FR 39240 through 39241), some commenters suggested that we revise the definition of group therapy to include two to six participants doing the same or similar activities, as this would better align with the Inpatient Rehabilitation Facility (IRF) setting and allow increased flexibility so that patients in smaller SNFs, presumably where a group of exactly four patients may be difficult to attain, could utilize and benefit from group therapy. In our response to these comments, in the FY 2019 SNF PPS final rule (83 FR 39241), we stated that we may consider changing the definition of group therapy in future rulemaking. In the past we stated our concern that a group that consisted of more than 4 participants would not allow for adequate supervision of each participant as well as cause difficulty for participants to engage with one another in the most effective way. Conversely, we maintained that a group of fewer than 4 participants would not allow for effective interaction to best achieve the goals of a group. For these reasons, we defined group therapy as exactly 4 participants. However, based on our review of the use of group therapy in the IRF and outpatient settings where the definition of group therapy is less restrictive than the current definition under the SNF PPS, we have found that therapists do seem capable of managing groups of various sizes. Based on this review, we believe therapists have the clinical judgment to determine whether groups of different sizes would clinically benefit their patients, which they should be able to demonstrate with adequate documentation. Patients can often benefit from the psycho-social aspect of groups, and in some situations, a group of six participants is not too large to provide that benefit to participants. For example, a cooking activity which will provide very functional therapy for patients planning to return home can be done in a group of six that will enhance the patient's psycho-social experience in the SNF. Alternatively, a group of 2-3 patients can be clinically useful for certain patients as well. For example, a group of 2-3 patients who have pragmatic language difficulties following a stroke or head injury could very well benefit from a small communication group to work on the social aspects of language together without the concern of distraction that a larger group might cause. Thus, while we continue to maintain minimal concerns that some groups may be either too small or too large to allow for effective interaction, we believe that the potential clinical benefits of various size groups outweigh our concerns, and that it would be appropriate to allow therapists greater flexibility to perform therapy in groups of different sizes.
In light of our discussion above and the comments in the FY 2019 SNF PPS final rule, and to align the SNF PPS more closely with other settings, in this proposed rule, we propose to adopt a new definition of group therapy for use under PDPM, effective October 1, 2019, as further discussed below.
In an effort to support CMS' cross-setting initiatives under the IMPACT Act and Meaningful Measures Initiative, we have looked at ways to align the definition of group therapy used under the SNF PPS more closely with the definitions used within the outpatient setting covered under Medicare Part B and under the IRF PPS, as this type of standardization would reduce administrative burden on providers by utilizing the same or similar definitions across settings. For group therapy in the outpatient setting, the Medicare Benefit Policy Manual, Chapter 15, Section 230 states that contractors pay for outpatient physical therapy services (which includes outpatient speech-language pathology services) and outpatient occupational therapy services provided simultaneously to two or more individuals by a practitioner as group therapy services (CPT code 97150). This manual section further states that the individuals can be, but need not be, performing the same activity. In addition, this section states that the physician or therapist involved in group therapy services must be in constant attendance, but one-on-one patient contact is not required. Under the IRF PPS, the definition of group therapy (found in Section 2 of the IRF PAI Training Manual,
We considered using the same definition as used in the outpatient setting covered under Medicare Part B, which is two or more patients performing either the same or different activity, as opposed to the IRF definition of two to six patients performing the same or similar activities. However, given the greater degree of similarity between the IRF and SNF settings in terms of the intensity of therapy and patient acuity, we believe that the IRF PPS definition would be more appropriate in the SNF setting.
Accordingly, for the reasons discussed previously, we are proposing to define group therapy in the SNF Part A setting as a qualified rehabilitation therapist or therapy assistant treating two to six patients at the same time who are performing the same or similar activities. We believe this definition would offer therapists more clinical flexibility when determining the appropriate number for a group, without compromising the therapist's ability to manage the group and the patient's ability to interact effectively and benefit from group therapy.
We continue to believe that individual therapy is the preferred mode of therapy provision and offers the most tailored service for patients. As we stated in the FY 2012 proposed rule (76 FR 26387), while group therapy can play an important role in SNF patient care, group therapy is not appropriate for either all patients or for all conditions, and is primarily effective as a supplement to individual therapy, which we maintain should be considered the primary therapy mode and standard of care in therapy services provided to SNF residents.
Additionally, we continue to maintain that when group therapy is used in a SNF, therapists must document its use in order to demonstrate why it is the most appropriate mode of therapy for the patient who is receiving it. As stated in the FY 2012 proposed rule (76 FR 26388) regarding group therapy documentation, because group therapy is not appropriate for either all patients or all conditions, and in order to verify that group therapy is medically necessary and appropriate to the needs of each beneficiary, SNFs should include in the patient's plan of care an explicit justification for the use of group, rather than individual or concurrent, therapy. This description should include, but need not be limited to, the specific benefits to that particular patient of including the documented type and amount of group therapy; that is, how the prescribed type and amount of group therapy will meet the patient's needs and assist the patient in reaching the documented goals. In addition, we believe that the above documentation is necessary to demonstrate that the SNF is providing services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident in accordance with section 1819(b)(2) of the Act.
In the FY 2019 SNF PPS final rule (83 FR 39162), we finalized the implementation of PDPM, effective October 1, 2019. The PDPM utilizes ICD-10 codes in several ways, including to assign patients to clinical categories used for categorization in the PT, OT, and SLP components, as well as identifying certain comorbidities relevant for classification under the SLP and NTA components. The ICD-10 mappings and lists that would be used under PDPM, once implemented, are available on the PDPM website at
Each year, the ICD-10 Coordination and Maintenance Committee, a federal interdepartmental committee that is chaired by representatives from the National Center for Health Statistics (NCHS) and by representatives from CMS, meets biannually and publishes updates to the ICD-10 medical code data sets in June of each year. These changes become effective October 1 of the year in which these updates are issued by the committee. The ICD-10 Coordination and Maintenance Committee also has the ability to make changes to the ICD-10 medical code data sets effective on April 1, but has not yet done so.
As providers are required to follow the most up to date coding guidance issued by this committee in accordance with 45 CFR part 162, subpart J, it is essential that we be able to update our code mappings and lists consistent with the latest coding guidance. Therefore, to ensure that the ICD-10 mappings and lists used under PDPM reflect the most up to date codes possible, we propose to update any ICD-10 code mappings and lists used under PDPM, as well as the SNF GROUPER software and other such products related to patient classification and billing, through a subregulatory process which would consist of posting updated code mappings and lists on the PDPM website at
Nonsubstantive changes would be limited to those specific changes that are necessary to maintain consistency with the most current ICD-10 medical code data set, which Medicare providers are generally required to use. Our intent in applying these nonsubstantive changes through the proposed subregulatory process would be to keep the same conditions in the PDPM clinical categories and comorbidities lists, but ensure that the codes used to identify those conditions are synchronized with the most current ICD-10 medical code data set. For example, to the extent that the ICD-10-CM Coordination and Maintenance Committee changes an ICD-10 code for a comorbid condition on our comorbidities lists into one or more codes that provide additional detail, we would update the SNF GROUPER software and ICD-10 mappings and lists on the CMS website to reflect the new codes through the subregulatory process proposed above. By contrast, we would use notice and comment rulemaking to make substantive changes to the ICD-10 code mappings and lists under the PDPM. For the purposes of this policy, a substantive change would be defined simply as any change that does not fall within the definition of a nonsubstantive change—that is, changes that go beyond the intention of maintaining consistency with the most current ICD-10 medical code data set. For instance, changes to the assignment of a code to a comorbidity list or other changes that amount to changes in policy would be substantive changes. Taking the example above, there may be situations in which the addition of one or more of these new codes to the list of comorbidities may not be appropriate. For example, the ICD-10 code for a particular condition is divided into two more detailed codes, one of which represents a condition that generally is predictive of the costs of care in a SNF and one of which is not. We would propose through notice and comment rulemaking to delete the code that does not reflect increased costs of care in a SNF from the list of comorbidities in the SNF GROUPER software because removing the code would constitute a substantive change. We propose to indicate all changes to codes in the GROUPER software by posting a complete ICD-10 mapping table, including new, discontinued, and modified codes, on the PDPM website at
We believe that the proposed subregulatory update process (by which nonsubstantive changes to the ICD-10 code mappings and lists used under PDPM as well as the SNF GROUPER software and other such products related to patient classification and billing would be posted on the CMS websites specified above), is the best way for us to convey information about changes to the ICD-10 medical code
Additionally, the proposed subregulatory process is in alignment with similar policies in the SNF PPS and the IRF PPS settings. For example, the SNF PPS already uses a subregulatory process to make nonsubstantive updates to the list of Healthcare Common Procedure Coding System (HCPCS) codes that are subject to the consolidated billing (CB) provision of the SNF PPS. We post routine annual updates to the lists of codes that are included or excluded from CB on the SNF CB website at
Likewise, the IRF PPS also utilizes processes similar to that proposed here. In the FY 2007 IRF PPS final rule (71 FR 48360 through 48361), we implemented a similar subregulatory updating process for the IRF tier comorbidities list, and the FY 2018 IRF PPS final rule (82 FR 36267 through 36269) established a similar process for updating the ICD-10 code lists used for the IRF presumptive compliance methodology. Both the IRF tier comorbidities list and the IRF presumptive compliance methodology also use ICD-10 codes. Therefore, we believe the subregulatory process proposed in this rule is appropriate because it is also consistent with processes used in another Medicare setting.
We are proposing that this subregulatory process for updating the ICD-10 codes used under the PDPM would take effect beginning with the updates for FY 2020. The proposed ICD-10 code mappings and lists for use under the PDPM are available for download from the SNF PPS website (
Along with our proposed revisions as discussed elsewhere in this proposed rule, we are also proposing to make certain revisions to the regulations text itself to reflect the revised assessment schedule under the PDPM, as finalized in the FY 2019 SNF PPS final rule (83 FR 39229). Specifically, we propose to revise the prescribed PPS assessment schedule as set forth in § 413.343(b), to reflect the elimination, upon the conversion from RUG-IV to PDPM on October 1, 2019, of all scheduled assessments after the initial 5-day, Medicare-required assessment. We note that even though this assessment is commonly referred to as the “5-day” assessment (reflecting its original 5-day assessment window), an additional 3 grace days have always been available beyond that window for its actual completion. Further, because those additional 3 grace days will be directly incorporated into the assessment window itself effective October 1, 2019 (as finalized in the FY 2019 SNF PPS final rule (83 FR 39231, 39232, and 39234)), thus resulting in an overall 8-day assessment window, we additionally propose to include a conforming revision in § 413.343(b) to make clear that the actual deadline for completing this assessment is no later than the 8th day of posthospital SNF care. In addition, because under the PDPM, there is only one scheduled patient assessment, we also propose to replace the phrase “patient assessments” in § 413.343(b) with the phrase “an initial patient assessment.” Accordingly, we propose to revise § 413.343(b) to state that the assessment schedule must include performance of an initial patient assessment no later than the 8th day of posthospital SNF care.
We further propose to revise the existing language in § 413.343(b) that additionally requires the completion of “such other assessments that are necessary to account for changes in patient care needs,” to state “such other interim payment assessments as the SNF determines are necessary to account for changes in patient care needs.” As we finalized in the FY 2019 SNF PPS final rule (83 FR 39230 through 39234), the optional Interim Payment Assessment (IPA) will serve as the instrument for conducting assessments under the PDPM that the SNF determines are necessary after the completion of the 5-day, Medicare-required assessment to address clinical changes throughout a SNF stay. We believe that our proposed language is consistent with the expectation expressed in the FY 2019 SNF PPS final rule for SNFs “. . . to provide excellent skilled nursing and rehabilitative care and continually monitor and document patient status” (83 FR 39233), and makes clear that the SNF's responsibility in this context would include recognizing those situations that warrant a decision to complete an IPA in order to account appropriately for a change in patient status. Finally, to ensure consistency, we also propose to make a conforming revision to the regulations text in the introductory paragraph of § 409.30, so that it would use the same terminology of “initial patient assessment” as would appear in revised § 413.343(b). Specifically, in the introductory paragraph of § 409.30, we would replace the phrase “the 5-day assessment” with “the initial patient assessment.” We note that the regulations text in the introductory paragraph of § 409.30 would continue to specify that the assessment reference date (ARD) for this assessment must occur no later than the 8th day of posthospital SNF care, consistent with the instructions set forth in sections 2.8 and 2.9 of the RAI Version 3.0 Manual.
The Skilled Nursing Facility Quality Reporting Program (SNF QRP) is authorized by section 1888(e)(6) of the Act and it applies to freestanding SNFs, SNFs affiliated with acute care facilities, and all non-CAH swing-bed rural hospitals. Under the SNF QRP, the Secretary must reduce by 2 percentage points the annual market basket percentage update described in section 1888(e)(5)(B)(i) of the Act applicable to a SNF for a fiscal year, after application of section 1888(e)(5)(B)(ii) of the Act (the MFP adjustment) and section 1888(e)(5)(B)(iii) of the Act, in the case of a SNF that does not submit data in accordance with sections 1888(e)(6)(B)(i) of the Act for that fiscal year. For more information on the
For a detailed discussion of the considerations we historically used for the selection of SNF QRP quality, resource use, and other measures, we refer readers to the FY 2016 SNF PPS final rule (80 FR 46429 through 46431).
The SNF QRP currently has 11 measures for the FY 2021 SNF QRP, which are set out in Table 12.
In this proposed rule, we are proposing to adopt two process measures for the SNF QRP that, as required by section 1888(e)(6)(B)(i)(II) of the Act, would satisfy section 1899B(c)(1)(E)(ii) of the Act, which requires that the quality measures specified by the Secretary include measures with respect to the quality measure domain titled “Accurately communicating the existence of and providing for the transfer of health information and care preferences of an individual to the individual, family caregiver of the individual, and providers of services furnishing items and services to the individual when the individual transitions from a post-acute care (PAC) provider to another applicable setting, including a different PAC provider, a hospital, a critical access hospital, or the home of the individual.” Given the length of this domain title, hereafter, we will refer to this quality measure domain as “Transfer of Health Information.”
The two measures we are proposing to adopt are: (1) Transfer of Health Information to the Provider-Post-Acute Care (PAC); and (2) Transfer of Health Information to the Patient-Post-Acute Care (PAC). Both of these proposed measures support our Meaningful Measures priority of promoting effective communication and coordination of care, specifically the Meaningful Measure area of the transfer of health information and interoperability.
In addition to the two measure proposals, we are proposing to update the specifications for the Discharge to Community—PAC SNF QRP measure to exclude baseline nursing facility (NF) residents from the measure.
We are seeking public comment on each of these proposals.
The proposed Transfer of Health Information to the Provider-Post-Acute Care (PAC) Measure is a process-based measure that assesses whether or not a current reconciled medication list is given to the subsequent provider when a patient is discharged or transferred from his or her current PAC setting.
In 2013, 22.3 percent of all acute hospital discharges were discharged to PAC settings, including 11 percent who were discharged to home under the care of a home health agency, and nine percent who were discharged to SNFs.
The transfer and/or exchange of health information from one provider to another can be done verbally (for example, clinician-to-clinician communication in-person or by telephone), paper-based (for example, faxed or printed copies of records), and via electronic communication (for example, through a health information exchange network using an electronic health/medical record, and/or secure messaging). Health information, such as medication information, that is incomplete or missing increases the likelihood of a patient or resident safety risk, and is often life-threatening.
Care transitions across health care settings have been characterized as complex, costly, and potentially hazardous, and may increase the risk for multiple adverse outcomes.
Patients in PAC settings often have complicated medication regimens and require efficient and effective communication and coordination of care between settings, including detailed transfer of medication information.
Patients in PAC settings are often taking multiple medications. Consequently, PAC providers regularly are in the position of starting complex new medication regimens with little knowledge of the patients or their medication history upon admission. Furthermore, inter-facility communication barriers delay resolving medication discrepancies during transitions of care.
Transfer of a medication list between providers is necessary for medication reconciliation interventions, which have been shown to be a cost-effective way to avoid ADEs by reducing errors,
The proposed measure was developed after consideration of feedback we received from stakeholders and four TEPs convened by our contractors. Further, the proposed measure was developed after evaluation of data collected during two pilot tests we conducted in accordance with the CMS Measures Management System Blueprint.
Our measure development contractors constituted a TEP which met on September 27, 2016,
Our measure development contractors solicited stakeholder feedback on the proposed measure by requesting comment on the CMS Measures Management System Blueprint website, and accepted comments that were submitted from March 19, 2018 to May 3, 2018. The comments received expressed overall support for the measure. Several commenters suggested ways to improve the measure, primarily related to what types of information should be included at transfer. We incorporated this input into development of the proposed measure. The summary report for the March 19 to May 3, 2018 public comment period titled “IMPACT Medication-Profile-Transferred-Public-Comment-Summary-Report” is available at
The proposed measure was tested between June and August 2018 in a pilot test that involved 24 PAC facilities/agencies, including five IRFs, six SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted a total of 801 records. Analysis of agreement between coders within each participating facility (266 qualifying pairs) indicated a 93-percent agreement for this measure. Overall, pilot testing enabled us to verify its reliability, components of face validity, and feasibility of being implemented across PAC settings. Further, more than half of the sites that participated in the pilot test stated during the debriefing interviews that the measure could distinguish facilities or agencies with higher quality medication information transfer from those with lower quality medication information transfer at discharge. The pilot test summary report titled “Transfer of Health Information 2018 Pilot Test Summary Report” is available at
We included the proposed measure in the SNF QRP section of the 2018 Measures Under Consideration (MUC) list. The MAP conditionally supported this measure pending NQF endorsement, noting that the measure can promote the transfer of important medication information. The MAP also suggested that CMS consider a measure that can be adapted to capture bi-directional information exchange, and recommended that the medication information transferred include important information about supplements and opioids. More information about the MAP's recommendations for this measure is available at
As part of the measure development and selection process, we also identified one NQF-endorsed quality measure similar to the proposed measure, titled Documentation of Current Medications in the Medical Record (NQF #0419, CMS eCQM ID: CMS68v8). This measure was adopted as one of the recommended adult core clinical quality measures for eligible professionals for the EHR Incentive Program beginning in 2014, and was also adopted under the Merit-based Incentive Payment System (MIPS) quality performance category beginning in 2017. The measure is calculated based on the percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attests to documenting a list of current medications using all resources immediately available on the date of the encounter.
The proposed Transfer of Health Information to the Provider-Post-Acute Care (PAC) measure addresses the transfer of information whereas the NQF-endorsed measure #0419 assesses the documentation of medications, but not the transfer of such information. This is important as the proposed measure assesses for the transfer of medication information for the proposed measure calculation. Further, the proposed measure utilizes standardized patient assessment data elements (SPADEs), which is a requirement for measures specified under the Transfer of Health Information measure domain under section 1899B(c)(1)(E) of the Act, whereas NQF #0419 does not.
After review of the NQF-endorsed measure, we determined that the proposed Transfer of Health Information to the Provider-Post-Acute Care (PAC) measure better addresses the Transfer of Health Information measure domain, which requires that at least some of the data used to calculate the measure be collected as standardized patient assessment data through the post-acute care assessment instruments. Section 1899B(e)(2)(A) of the Act requires that any measure specified by the Secretary be endorsed by the entity with a contract under section 1890(a) of the Act, which is currently the National Quality Form (NQF). However, when a feasible and practical measure has not been NQF endorsed for a specified area or medical topic determined appropriate by the Secretary, section 1899B(e)(2)(B) of the Act allows the Secretary to specify a measure that is not NQF endorsed as long as due consideration is given to the measures that have been endorsed or adopted by a consensus organization identified by the Secretary. For the reasons discussed above, we believe that there is currently no feasible NQF-endorsed measure that we could adopt under section 1899B(c)(1)(E) of the Act. However, we note that we intend to submit the proposed measure to the NQF for consideration of endorsement when feasible.
The proposed Transfer of Health Information to the Provider-Post-Acute Care (PAC) quality measure is calculated as the proportion of resident stays with a discharge assessment indicating that a current reconciled medication list was provided to the subsequent provider at the time of discharge. The proposed measure denominator is the total number of SNF resident stays, ending in discharge to a “subsequent provider,” which is defined as a short-term general acute-care hospital, a skilled nursing facility (SNF), intermediate care (intellectual and developmental disabilities providers), home under care of an organized home health service organization or hospice, hospice in an institutional facility, an inpatient rehabilitation facility (IRF), an LTCH, a Medicaid nursing facility, an inpatient psychiatric facility, or a critical access hospital (CAH). These health care providers were selected for inclusion in the denominator because they are identified as subsequent providers on the discharge destination item that is currently included on the resident assessment instrument minimum data set (MDS), the current version being MDS 3.0. The proposed measure numerator is the number of SNF resident stays with an MDS discharge assessment indicating a current reconciled medication list was provided to the subsequent provider at the time of discharge. For additional technical information about this proposed
For more information about the data submission requirements we are proposing for this measure, we refer readers to section VI.A.8.c. of this proposed rule.
Beginning with the FY 2022 SNF QRP, we are proposing to adopt the Transfer of Health Information to the Patient-Post-Acute Care (PAC) measure, a measure that satisfies the IMPACT Act domain of Transfer of Health Information, with data collection for discharges beginning October 1, 2020. This process-based measure assesses whether or not a current reconciled medication list was provided to the patient, family, or caregiver when the patient was discharged from a PAC setting to a private home/apartment, a board and care home, assisted living, a group home, transitional living or home under care of an organized home health service organization, or a hospice.
In 2013, 22.3 percent of all acute hospital discharges were discharged to PAC settings, including 11 percent who were discharged to home under the care of a home health agency.
The communication of health information, such as a reconciled medication list, is critical to ensuring safe and effective patient transitions from health care settings to home and/or other community settings. Incomplete or missing health information, such as medication information, increases the likelihood of a patient safety risk, often life-threatening.
Finally, the transfer of a patient's discharge medication information to the patient, family, or caregiver is common practice and supported by discharge planning requirements for participation in Medicare and Medicaid programs.
The proposed measure was developed after consideration of feedback we received from stakeholders and four TEPs convened by our contractors. Further, the proposed measure was developed after evaluation of data collected during two pilot tests we conducted in accordance with the CMS MMS Blueprint.
Our measure development contractors constituted a TEP which met on September 27, 2016,
Our measure development contractors solicited stakeholder feedback on the proposed measure by requesting comment on the CMS Measures Management System Blueprint website, and accepted comments that were submitted from March 19, 2018 to May 3, 2018. Several commenters noted the importance of ensuring that the instruction provided to patients and caregivers is clear and understandable to promote transparent access to medical record information and meet the goals of the IMPACT Act. The summary report for the March 19 to May 3, 2018 public comment period titled “IMPACT- Medication Profile Transferred Public Comment Summary Report” is available at
Between June and August 2018, we held a pilot test involving 24 PAC facilities/agencies, including five IRFs, six SNFs, six LTCHs, and seven HHAs. The 24 pilot sites submitted a total of 801 assessments. Analysis of agreement between coders within each participating facility (241 qualifying pairs) indicated an 87 percent agreement for this measure. Overall, pilot testing enabled us to verify its reliability, components of face validity, and feasibility of being implemented across PAC settings. Further, more than half of the sites that participated in the pilot test stated, during debriefing interviews, that the measure could distinguish facilities or agencies with higher quality medication information transfer from those with lower quality medication information transfer at discharge. The pilot test summary report titled “Transfer of Health Information 2018 Pilot Test Summary Report” is available at
We included the proposed measure in the SNF QRP section of the 2018 MUC list. The MAP conditionally supported this measure pending NQF endorsement, noting that the measure can promote the transfer of important medication information to the patient. The MAP recommended that providers transmit medication information to patients that is easy to understand because health literacy can impact a person's ability to take medication as directed. More information about the MAP's recommendations for this measure is available at
Section 1899B(e)(2)(A) of the Act, requires that any measure specified by the Secretary be endorsed by the entity with a contract under section 1890(a) of the Act, which is currently the NQF. However, when a feasible and practical measure has not been NQF-endorsed for a specified area or medical topic determined appropriate by the Secretary, section 1899B(e)(2)(B) of the Act allows the Secretary to specify a measure that is not NQF-endorsed as long as due consideration is given to the measures that have been endorsed or adopted by a consensus organization identified by the Secretary. Therefore, in the absence of any NQF-endorsed measures that address the proposed Transfer of Health Information to the Patient-Post-Acute Care (PAC), which requires that at least some of the data used to calculate the measure be collected as standardized patient assessment data through the post-acute care assessment instruments, we believe that there is currently no feasible NQF-endorsed measure that we could adopt under section 1899B(c)(1)(E) of the Act. However, we note that we intend to submit the proposed measure to the NQF for consideration of endorsement when feasible.
The calculation of the proposed Transfer of Health Information to the Patient-Post-Acute Care (PAC) measure would be based on the proportion of resident stays with a discharge assessment indicating that a current reconciled medication list was provided to the resident, family, or caregiver at the time of discharge.
The proposed measure denominator is the total number of SNF resident stays ending in discharge to a private home/apartment, a board and care home, assisted living, a group home, transitional living or home under care of an organized home health service organization, or a hospice. These locations were selected for inclusion in the denominator because they are identified as home locations on the discharge destination item that is currently included on the MDS. The proposed measure numerator is the number of SNF resident stays with an MDS discharge assessment indicating a current reconciled medication list was provided to the resident, family, or caregiver at the time of discharge. For technical information about this proposed measure we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
For more information about the data submission requirements we are
We are proposing to update the specifications for the Discharge to Community—PAC SNF QRP measure to exclude baseline nursing facility (NF) residents from the measure. This measure reports a SNF's risk-standardized rate of Medicare FFS residents who are discharged to the community following a SNF stay, do not have an unplanned readmission to an acute care hospital or LTCH in the 31 days following discharge to community, and who remain alive during the 31 days following discharge to community. We adopted this measure in the FY 2017 SNF PPS final rule (81 FR 52021 through 52029).
In the FY 2017 SNF PPS final rule (81 FR 52025), we addressed public comments recommending exclusion of SNF residents who were baseline NF residents, as these residents lived in a NF prior to their SNF stay and may not be expected to return to the community following their SNF stay. In the FY 2018 SNF PPS final rule (82 FR 36596), we addressed public comments expressing support for a potential future modification of the measure that would exclude baseline NF residents; commenters stated that the exclusion would result in the measure more accurately portraying quality of care provided by SNFs, while controlling for factors outside of SNF control.
We assessed the impact of excluding baseline NF residents from the measure using CY 2015 and CY 2016 data, and found that this exclusion impacted both patient- and facility-level discharge to community rates. We defined baseline NF residents as SNF residents who had a long-term NF stay in the 180 days preceding their hospitalization and SNF stay, with no intervening community discharge between the NF stay and qualifying hospitalization for measure inclusion. Baseline NF residents represented 10.4 percent of the measure population after all measure exclusions were applied. Observed resident-level discharge to community rates were significantly lower for baseline NF residents (2.37 percent) compared with non-NF residents (53.32 percent). The national observed resident-level discharge to community rate was 48.01 percent when baseline NF residents were included in the measure, increasing to 53.32 percent when they were excluded from the measure. After excluding baseline NF residents, 38.5 percent of SNFs had an increase in their risk-standardized discharge to community rate that exceeded the increase in the national observed resident-level discharge to community rate.
Based on public comments received and our impact analysis, we are proposing to exclude baseline NF residents from the Discharge to Community—PAC SNF QRP measure beginning with the FY 2020 SNF QRP, with baseline NF residents defined as SNF residents who had a long-term NF stay in the 180 days preceding their hospitalization and SNF stay, with no intervening community discharge between the NF stay and hospitalization.
For additional technical information regarding the Discharge to Community—PAC SNF QRP measure, including technical information about the proposed exclusion, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Resident Assessment Data Elements,” available at
We are inviting public comment on this proposal.
We are seeking input on the importance, relevance, appropriateness, and applicability of each of the measures, standardized patient assessment data elements (SPADEs), and concepts under consideration listed in the Table 13 for future years in the SNF QRP.
While we will not be responding to specific comments submitted in response to this Request for Information in the FY 2020 SNF PPS final rule, we intend to use this input to inform our future measure and SPADE development efforts
Section 1888(e)(6)(B)(i)(III) of the Act requires that, for fiscal years 2019 and each subsequent year, SNFs must report standardized patient
In the FY 2018 SNF PPS proposed rule (82 FR 21059 through 21076), we proposed to adopt SPADEs that would satisfy the first five categories. In the FY 2018 SNF PPS final rule, commenters expressed support for our adoption of SPADEs in general, including support for our broader standardization goal and support for the clinical usefulness of specific proposed SPADEs. However, we did not finalize the majority of our SPADE proposals in recognition of the concern raised by many commenters that we were moving too fast to adopt the SPADEs and modify our assessment instruments in light of all of the other requirements we were also adopting under the IMPACT Act at that time (82 FR 36598 through 36600). In addition, we noted our intention to conduct extensive testing to ensure that the standardized patient assessment data elements we select are reliable, valid, and appropriate for their intended use (82 FR 36599).
We did, however, finalize the adoption of SPADEs for two of the categories described in section 1899B(b)(1)(B) of the Act: (1) Functional status: Data elements currently reported by SNFs to calculate the measure Application of Percent of Long-Term Care Hospital Patients with an Admission and Discharge Functional Assessment and a Care Plan That Addresses Function (NQF #2631); and (2) Medical conditions and comorbidities: The data elements used to calculate the pressure ulcer measures, Percent of Residents or Patients with Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678) and the replacement measure, Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury. We stated that these data elements were important for care planning, known to be valid and reliable, and already being reported by SNFs for the calculation of quality measures.
Since we issued the FY 2018 SNF PPS final rule, SNFs have had an opportunity to familiarize themselves with other new reporting requirements that we have adopted under the IMPACT Act. We have also conducted further testing of the SPADEs, as described more fully below, and believe that this testing supports the use of the SPADEs in our PAC assessment instruments. Therefore, we are now proposing to adopt many of the same SPADEs that we previously proposed to adopt, along with other SPADEs.
We are proposing that SNFs would be required to report these SPADEs beginning with the FY 2022 SNF QRP. If finalized as proposed, SNFs would be required to report these data with respect to SNF admissions and discharges that occur between October 1, 2020 and December 31, 2020 for the FY 2022 SNF QRP. Beginning with the FY 2023 SNF QRP, we propose that SNFs must report data with respect to admissions and discharges that occur during the subsequent calendar year (for example, CY 2021 for the FY 2023 SNF QRP, CY 2022 for the FY 2024 SNF QRP).
We are also proposing that SNFs that submit the Hearing, Vision, Race, and Ethnicity SPADEs with respect to admission only will be deemed to have submitted those SPADEs with respect to both admission and discharge, because it is unlikely that the assessment of those SPADEs at admission will differ from the assessment of the same SPADEs at discharge.
In selecting the proposed SPADEs below, we considered the burden of assessment-based data collection and aimed to minimize additional burden by evaluating whether any data that is currently collected through one or more PAC assessment instruments could be collected as SPADE. In selecting the proposed SPADEs below, we also took into consideration the following factors with respect to each data element:
(1) Overall clinical relevance;
(2) Interoperable exchange to facilitate care coordination during transitions in care;
(3) Ability to capture medical complexity and risk factors that can inform both payment and quality; and
(4) Scientific reliability and validity, general consensus agreement for its usability.
In identifying the SPADEs proposed below, we additionally drew on input from several sources, including TEPs held by our data element contractor, public input, and the results of a recent National Beta Test of candidate data elements conducted by our data element contractor (hereafter “National Beta Test”).
The National Beta Test collected data from 3,121 patients and residents across 143 LTCHs, SNFs, IRFs, and HHAs from November 2017 to August 2018 to evaluate the feasibility, reliability, and validity of candidate data elements across PAC settings. The National Beta Test also gathered feedback on the candidate data elements from staff who administered the test protocol in order to understand usability and workflow of the candidate data elements. More information on the methods, analysis plan, and results for the National Beta Test are available in the document titled, “Development and Evaluation of Candidate Standardized Patient Assessment Data Elements: Findings from the National Beta Test (Volume 2),” available at
Further, to inform the proposed SPADEs, we took into account feedback from stakeholders, as well as from technical and clinical experts, including feedback on whether the candidate data elements would support the factors described above. Where relevant, we also took into account the results of the Post-Acute Care Payment Reform Demonstration (PAC PRD) that took place from 2006 to 2012.
A number of underlying conditions, including dementia, stroke, traumatic brain injury, side effects of medication, metabolic and/or endocrine imbalances, delirium, and depression, can affect cognitive function and mental status in
Symptoms of dementia may improve with pharmacotherapy, occupational therapy, or physical activity,
In alignment with our Meaningful Measures Initiative, accurate assessment of cognitive function and mental status of patients and residents in PAC is expected to make care safer by reducing harm caused in the delivery of care; promote effective prevention and treatment of chronic disease; strengthen person and family engagement as partners in their care; and promote effective communication and coordination of care. For example, standardized assessment of cognitive function and mental status of patients and residents in PAC will support establishing a baseline for identifying changes in cognitive function and mental status (for example, delirium), anticipating the patient's or resident's ability to understand and participate in treatments during a PAC stay, ensuring patient and resident safety (for example, risk of falls), and identifying appropriate support needs at the time of discharge or transfer. Standardized patient assessment data elements will enable or support clinical decision-making and early clinical intervention; person-centered, high quality care through facilitating better care continuity and coordination; better data exchange and interoperability between settings; and longitudinal outcome analysis. Therefore, reliable standardized patient assessment data elements assessing cognitive function and mental status are needed in order to initiate a management program that can optimize a patient's or resident's prognosis and reduce the possibility of adverse events.
The data elements related to cognitive function and mental status were first proposed as standardized patient assessment data elements in the FY 2018 SNF PPS proposed rule (82 FR 21060 through 21063). In response to our proposals, a few commenters noted that the proposed data elements did not capture some dimensions of cognitive function and mental status, such as functional cognition, communication, attention, concentration, and agitation. One commenter also suggested that other cognitive assessments should be considered for standardization. Another commenter stated support for the standardized assessment of cognitive function and mental status, because it could support appropriate use of skilled therapy for beneficiaries with degenerative conditions, such as dementia, and appropriate use of medications for behavioral and psychological symptoms of dementia.
We are inviting comment on our proposals to collect as standardized patient assessment data the following data with respect to cognitive function and mental status.
We are proposing that the data elements that comprise the BIMS meet the definition of standardized patient assessment data with respect to cognitive function and mental status under section 1899B(b)(1)(B)(ii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21060 through 21061), dementia and cognitive impairment are associated with long-term functional dependence and, consequently, poor quality of life and increased health care costs and mortality.
The BIMS is a performance-based cognitive assessment screening tool that assesses repetition, recall with and without prompting, and temporal orientation. The data elements that make up the BIMS are seven questions on the repetition of three words, temporal orientation, and recall that result in a cognitive function score. The BIMS was developed to be a brief, objective screening tool, with a focus on learning and memory. As a brief screener, the BIMS was not designed to diagnose dementia or cognitive impairment, but rather to be a relatively quick and easy to score assessment that could identify cognitively impaired patients as well as those who may be at risk for cognitive decline and require further assessment. It is currently in use in two of the PAC assessments: The MDS used by SNFs and the IRF-PAI used by IRFs. For more information on the BIMS, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The data elements that comprise the BIMS were first proposed as standardized patient assessment data elements in the FY 2018 SNF PPS proposed rule (82 FR 21060 through 21061). In that proposed rule, we stated that the proposal was informed by input we received through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 expressed support for use of the BIMS, noting that it is reliable, feasible to use across settings, and will provide useful information about patients and residents. We also stated that the data collected through the BIMS will provide a clearer picture of patient or resident complexity, help with the care planning process, and be useful during care transitions and when coordinating across providers. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, a few commenters supported the use of the BIMS as standardized patient assessment data elements. Other commenters were critical of the BIMS, noting its limitations for assessing mild cognitive impairment and functional cognition. Another stated that the BIMS should be administered with respect to discharge, as well as admission to capture changes during the stay. One expressed concern that the BIMS cannot be completed by patients and residents who are unable to communicate.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the BIMS was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the BIMS to be feasible and reliable for use with PAC patients and residents. More information about the performance of the BIMS in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements and the TEP supported the assessment of patient or resident cognitive status at both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. Some commenters also expressed concern that the BIMS, if used alone, may not be sensitive enough to capture the range of cognitive impairments, including mild cognitive impairment (MCI). A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
We understand the concerns raised by stakeholders that BIMS, if used alone, may not be sensitive enough to capture the range of cognitive impairments, including functional cognition and MCI, but note that the purpose of the BIMS data elements as SPADEs is to screen for cognitive impairment in a broad population. We also acknowledge that further cognitive tests may be required based on a patient's condition and will take this feedback into consideration in the development of future standardized assessment data elements. However, taking together the importance of assessing for cognitive status, stakeholder input, and strong test results, we are proposing that the BIMS data elements meet the definition of standardized patient assessment data with respect to cognitive function and mental status under section 1899B(b)(1)(B)(ii) of the Act and to adopt the BIMS as standardized patient assessment data for use in the SNF QRP.
We are proposing that the data elements that comprise the Confusion Assessment Method (CAM) meet the definition of standardized patient assessment data with respect to cognitive function and mental status under section 1899B(b)(1)(B)(ii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21061), the CAM was developed to identify the signs and symptoms of delirium. It results in a score that suggests whether a patient or resident should be assigned a diagnosis of delirium. Because patients and residents with multiple comorbidities receive services from PAC providers, it is important to assess delirium, which is associated with a high mortality rate and prolonged duration of stay in hospitalized older adults.
The CAM is a patient assessment that screens for overall cognitive impairment, as well as distinguishes delirium or reversible confusion from other types of cognitive impairment. The CAM is currently in use in two of the PAC assessments: A four-item version of the CAM is used in the MDS in SNFs and a six-item version of the CAM is used in the LTCH CARE Data Set (LCDS) in LTCHs. We are proposing the four-item version of the CAM that assesses acute change in mental status, inattention, disorganized thinking, and altered level of consciousness. For more information on the CAM, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The data elements that comprise the CAM were first proposed as standardized patient assessment data
In response to our proposal in the FY 2018 SNF PPS proposed rule, a few commenters supported the use of the CAM as standardized patient assessment data elements, with one noting that it distinguishes delirium or reversible confusion from other types of cognitive impairments to share across settings for care coordination.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the CAM was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the CAM to be feasible and reliable for use with PAC patients and residents. More information about the performance of the CAM in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although they did not specifically discuss the CAM data elements, the TEP supported the assessment of patient or resident cognitive status with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for delirium, stakeholder input, and strong test results, we are proposing that the CAM data elements meet the definition of standardized patient assessment data with respect to cognitive function and mental status under section 1899B(b)(1)(B)(ii) of the Act and to adopt the CAM as standardized patient assessment data elements for use in the SNF QRP.
We are proposing that the Patient Health Questionnaire—2 to 9 (PHQ-2 to 9) data elements meet the definition of standardized patient assessment data with respect to cognitive function and mental status under section 1899B(b)(1)(B)(ii) of the Act. The proposed data elements are based on the PHQ-2 mood interview, which focuses on only the two cardinal symptoms of depression, and the longer PHQ-9 mood interview, which assesses presence and frequency of nine signs and symptoms of depression. The name of the data element, the PHQ-2 to 9, refers to an embedded a skip pattern that transitions residents with a threshold level of symptoms in the PHQ-2 to the longer assessment of the PHQ-9. The skip pattern is described further below.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21062 through 21063), depression is a common and under-recognized mental health condition. Assessments of depression help PAC providers better understand the needs of their patients and residents by: Prompting further evaluation after establishing a diagnosis of depression; elucidating the patient's or resident's ability to participate in therapies for conditions other than depression during their stay; and identifying appropriate ongoing treatment and support needs at the time of discharge.
The proposed PHQ-2 to 9 is based on the PHQ-9 mood interview. The PHQ-2 consists of questions about only the first two symptoms addressed in the PHQ-9: Depressed mood and anhedonia (inability to feel pleasure), which are the cardinal symptoms of depression. The PHQ-2 has performed well as both a screening tool for identifying depression, to assess depression severity, and to monitor patient mood over time.
Components of the proposed data elements are currently used in the OASIS for HHAs (PHQ-2) and the MDS for SNFs (PHQ-9). We are proposing altering the administration instructions for the existing data elements to adopt the PHQ-2 to 9 gateway logic, meaning that administration of the full PHQ-9 is contingent on resident responses to questions about the cardinal symptoms of depression. For more information on the PHQ-2 to 9, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The PHQ-2 data elements were first proposed as SPADEs in the FY 2018 SNF PPS proposed rule (82 FR 21062 through 21063). In that proposed rule we stated that the proposal was informed by input we received from the TEP convened by our data element contractor on April 6 and 7, 2016. The TEP members particularly noted that the brevity of the PHQ-2 made it feasible to administer with low burden for both assessors and PAC patients or residents. A summary of the April 6 and 7, 2016 TEP meeting titled “SPADE Technical Expert Panel Summary (First Convening)” is available at
In response to our proposal to use the PHQ-2 in the FY 2018 SNF PPS proposed rule, a few commenters supported screening residents for depression with the PHQ-2. One commenter opposed the replacement of the PHQ-9 on the MDS with PHQ-2 because of the clinical significance of depression on quality of care and resident outcomes in the SNF population. Another expressed concern about the use of multi-step “gateway” questions, because use of the PHQ-2 and PHQ-9 may result in data not being standardized across settings and providers gathering data unrelated to the appropriateness of care.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the PHQ-2 to 9 was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the PHQ-2 to 9 to be feasible and reliable for use with PAC patients and residents. More information about the performance of the PHQ-2 to 9 in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the PHQ-2 to 9. The TEP was supportive of the PHQ-2 to 9 data element set as a screener for signs and symptoms of depression. The TEP's discussion noted that symptoms evaluated by the full PHQ-9 (for example, concentration, sleep, appetite) had relevance to care planning and the overall well-being of the patient or resident, but that the gateway approach of the PHQ-2 to 9 would be appropriate as a depression screening assessment, as it depends on the well-validated PHQ-2 and focuses on the cardinal symptoms of depression. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for depression, stakeholder input, and strong test results, we are proposing that the PHQ-2 to 9 data elements meet the definition of standardized patient assessment data with respect to cognitive function and mental status under section 1899B(b)(1)(B)(ii) of the Act and to adopt the PHQ-2 to 9 data elements as standardized patient assessment data elements for use in the SNF QRP.
Special services, treatments, and interventions performed in PAC can have a major effect on an individual's health status, self-image, and quality of life. The assessment of these special services, treatments, and interventions in PAC is important to ensure the continuing appropriateness of care for the patients and residents receiving them, and to support care transitions from one PAC provider to another, an acute care hospital, or discharge. In alignment with our Meaningful Measures Initiative, accurate assessment of special services, treatments, and interventions of patients and residents served by PAC providers is expected to make care safer by reducing harm caused in the delivery of care; promote effective prevention and treatment of chronic disease; strengthen person and family engagement as partners in their care; and promote effective communication and coordination of care.
For example, standardized assessment of special services, treatments, and
A TEP convened by our data element contractor provided input on all of the proposed data elements for special services, treatments, and interventions. In a meeting held on January 5 and 6, 2017, this TEP found that these data elements are appropriate for standardization because they would provide useful clinical information to inform care planning and care coordination. The TEP affirmed that assessment of these services and interventions is standard clinical practice, and that the collection of these data by means of a list and checkbox format would conform with common workflow for PAC providers. A summary of the January 5 and 6, 2017 TEP meeting titled “SPADE Technical Expert Panel Summary (Second Convening)” is available at
Comments on the category of special services, treatments, and interventions were also submitted by stakeholders during the FY 2018 SNF PPS proposed rule (82 FR 21063 through 21073) public comment period. A comment across all special services, treatments, and interventions data elements requested that the additional reporting burden of the special services, treatments, and interventions data elements be addressed in payment calculations. Another comment submitted for several special services, treatments, and interventions data elements requested additional time be allowed before the providers are required to submit these data. One commenter expressed concern about increased reporting burden of the data elements proposed in FY 2018 because they would require an additional look-back time frame. Several commenters supported the inclusion of nutritional data elements as standardized data elements noting their importance in capturing information on care coordination and safe care transitions. One commenter noted the limitations of the nutritional data elements, namely that they do not capture information on swallowing or the clinical rationale for feeding/nutrition needs.
Information on data element performance in the National Beta Test, which collected data between November 2017 and August 2018, is reported within each data element proposal below. Clinical staff who participated in the National Beta Test supported these data elements because of their importance in conveying patient or resident significant health care needs, complexity, and progress. However, clinical staff also noted that, despite the simple “check box” format of these data element, they sometimes needed to consult multiple information sources to determine a patient's or resident's treatments.
We are inviting comment on our proposals to collect as standardized patient assessment data the following data with respect to special services, treatments, and interventions.
We are proposing that the Chemotherapy (IV, Oral, Other) data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21063 through 21064), chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. It is sometimes used when a patient has a malignancy (cancer), which is a serious, often life-threatening or life-limiting condition. Both intravenous (IV) and oral chemotherapy have serious side effects, including nausea/vomiting, extreme fatigue, risk of infection due to a suppressed immune system, anemia, and an increased risk of bleeding due to low platelet counts. Oral chemotherapy can be as potent as chemotherapy given by IV, and can be significantly more convenient and less resource-intensive to administer. Because of the toxicity of these agents, special care must be exercised in handling and transporting chemotherapy drugs. IV chemotherapy is administered either peripherally, or more commonly, given via an indwelling central line, which raises the risk of bloodstream infections. Given the significant burden of malignancy, the resource intensity of administering chemotherapy, and the side effects and potential complications of these highly-toxic medications, assessing the receipt of chemotherapy is important in the PAC setting for care planning and determining resource use. The need for chemotherapy predicts resource intensity, both because of the complexity of administering these potent, toxic drug combinations under specific protocols, and because of what the need for chemotherapy signals about the patient's underlying medical condition. Furthermore, the resource intensity of IV chemotherapy is higher than for oral chemotherapy, as the protocols for administration and the care of the central line (if present) for IV chemotherapy require significant resources.
The Chemotherapy (IV, Oral, Other) data element consists of a principal data element (Chemotherapy) and three response option sub-elements: IV chemotherapy, which is generally resource-intensive; Oral chemotherapy, which is less invasive and generally requires less intensive administration protocols; and a third category, Other, provided to enable the capture of other less common chemotherapeutic approaches. This third category is potentially associated with higher risks and is more resource intensive due to chemotherapy delivery by other routes (for example, intraventricular or intrathecal). If the assessor indicates that the resident is receiving chemotherapy on the principal Chemotherapy data element, the assessor would then indicate by which route or routes (for example, IV, Oral, Other) the chemotherapy is administered.
A single Chemotherapy data element that does not include the proposed three sub-elements is currently in use in the MDS in SNFs. We are proposing to expand the existing Chemotherapy data element in the MDS to include sub-elements for IV, Oral, and Other. For more information on the Chemotherapy (IV, Oral, Other) data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Chemotherapy data element was first proposed as a standardized patient assessment data element in the FY 2018 SNF PPS proposed rule (82 FR 21063 through 21064). In that proposed rule, we stated that the proposal was informed by input we received through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 expressed support for the IV Chemotherapy data element and suggested it be included as standardized patient assessment data. We also stated that those commenters had noted that assessing the use of chemotherapy services is relevant to share across the care continuum to facilitate care coordination and care transitions and noted the validity of the data element. Commenters also noted the importance of capturing all types of chemotherapy, regardless of route, and stated that collecting data only on patients and residents who received chemotherapy by IV would limit the usefulness of this standardized data element. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of Chemotherapy (IV, Oral, Other) as standardized patient assessment data elements.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Chemotherapy data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Chemotherapy data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Chemotherapy data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP members did not specifically discuss the Chemotherapy data element, the TEP members supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for chemotherapy, stakeholder input, and strong test results, we are proposing, we are proposing that the Chemotherapy (IV, Oral, Other) data element with a principal data element and three sub-elements meet the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Chemotherapy (IV, Oral, Other) data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Radiation data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21064 through 21065), radiation is a type of cancer treatment that uses high-energy radioactivity to stop cancer by damaging cancer cell DNA, but it can also damage normal cells. Radiation is an important therapy for particular types of cancer, and the resource utilization is high, with frequent radiation sessions required, often daily for a period of several weeks. Assessing whether a patient or resident is receiving radiation therapy is important to determine resource utilization because PAC patients and residents will need to be transported to and from radiation treatments, and monitored and treated for side effects after receiving this intervention. Therefore, assessing the receipt of radiation therapy, which would compete with other care processes given the time burden, would be important for care planning and care coordination by PAC providers.
The proposed data element consists of the single Radiation data element. The Radiation data element is currently in use in the MDS in SNFs. For more information on the Radiation data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Radiation data element was first proposed as a SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21064 through 21065). In that proposed rule, we stated that the proposal was informed by input we received through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016, expressed support for the Radiation data element, noting its importance and clinical usefulness for patients and residents in PAC settings, due to the side effects and consequences of radiation treatment on patients and residents that need to be considered in care planning and care transitions, the feasibility of the item, and the potential for it to improve quality. A summary
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of Radiation as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Radiation data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Radiation data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Radiation data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP members did not specifically discuss the Radiation data element, the TEP members supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for radiation, stakeholder input, and strong test results, we are proposing that the Radiation data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Radiation data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Oxygen Therapy (Intermittent, Continuous, High-Concentration Oxygen Delivery System) data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21065), oxygen therapy provides a patient or resident with extra oxygen when medical conditions such as chronic obstructive pulmonary disease, pneumonia, or severe asthma prevent the patient or resident from getting enough oxygen from breathing. Oxygen administration is a resource-intensive intervention, as it requires specialized equipment such as a source of oxygen, delivery systems (for example, oxygen concentrator, liquid oxygen containers, and high-pressure systems), the patient interface (for example, nasal cannula or mask), and other accessories (for example, regulators, filters, tubing). The data element proposed here captures patient or resident use of three types of oxygen therapy (intermittent, continuous, and high-concentration oxygen delivery system), which reflects the intensity of care needed, including the level of monitoring and bedside care required. Assessing the receipt of this service is important for care planning and resource use for PAC providers.
The proposed data element, Oxygen Therapy, consists of the principal Oxygen Therapy data element and three response option sub-elements: Continuous (whether the oxygen was delivered continuously, typically defined as >=14 hours per day); Intermittent; or High-concentration oxygen delivery system. Based on public comments and input from expert advisors about the importance and clinical usefulness of documenting the extent of oxygen use, we added a third sub-element, high-concentration oxygen delivery system, to the sub-elements, which previously included only intermittent and continuous. If the assessor indicates that the resident is receiving oxygen therapy on the principal oxygen therapy data element, the assessor then would indicate the type of oxygen the patient receives (for example, Continuous, Intermittent, High-concentration oxygen delivery system).
These three proposed sub-elements were developed based on similar data elements that assess oxygen therapy, currently in use in the MDS in SNFs (“Oxygen Therapy”), previously used in the OASIS (“Oxygen (intermittent or continuous)”), and a data element tested in the PAC PRD that focused on intensive oxygen therapy (“High O2 Concentration Delivery System with FiO2 >40 percent”). For more information on the proposed Oxygen Therapy (Continuous, Intermittent, High-concentration oxygen delivery system) data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Oxygen Therapy (Continuous, Intermittent) data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21065). In that proposed rule, we stated that the proposal was informed by input we received on the single data element, Oxygen (inclusive of intermittent and continuous oxygen use), through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 expressed the importance of the Oxygen data element, noting feasibility of this item in PAC, and the relevance of it to
In response to our proposal in the FY 2018 SNF PPS proposed rule, a few commenters supported the adoption of Oxygen Therapy (Continuous, Intermittent) as a standardized patient assessment data element. Another commenter recommended that an option for high-concentration oxygen be added. In response to public comments, we added a third sub-element for “High-Concentration Oxygen Delivery System” to the Oxygen Therapy data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Oxygen Therapy data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Oxygen Therapy data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Oxygen Therapy data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Oxygen Therapy data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing oxygen therapy, stakeholder input, and strong test results, we are proposing that the Oxygen Therapy (Continuous, Intermittent, High-concentration Oxygen Delivery System) data element with a principal data element and three sub-elements meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Oxygen Therapy (Continuous, Intermittent, High-concentration Oxygen Delivery System) data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Suctioning (Scheduled, As needed) data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21065 through 21066), suctioning is a process used to clear secretions from the airway when a person cannot clear those secretions on his or her own. It is done by aspirating secretions through a catheter connected to a suction source. Types of suctioning include oropharyngeal and nasopharyngeal suctioning, nasotracheal suctioning, and suctioning through an artificial airway such as a tracheostomy tube. Oropharyngeal and nasopharyngeal suctioning are a key part of many patients' care plans, both to prevent the accumulation of secretions than can lead to aspiration pneumonias (a common condition in patients and residents with inadequate gag reflexes), and to relieve obstructions from mucus plugging during an acute or chronic respiratory infection, which often lead to desaturations and increased respiratory effort. Suctioning can be done on a scheduled basis if the patient is judged to clinically benefit from regular interventions, or can be done as needed when secretions become so prominent that gurgling or choking is noted, or a sudden desaturation occurs from a mucus plug. As suctioning is generally performed by a care provider rather than independently, this intervention can be quite resource intensive if it occurs every hour, for example, rather than once a shift. It also signifies an underlying medical condition that prevents the patient from clearing his/her secretions effectively (such as after a stroke, or during an acute respiratory infection). Generally, suctioning is necessary to ensure that the airway is clear of secretions which can inhibit successful oxygenation of the individual. The intent of suctioning is to maintain a patent airway, the loss of which can lead to death or complications associated with hypoxia.
The Suctioning (Scheduled, As needed) data element consists of a principal data element, and two sub-elements: Scheduled; and As needed. These sub-elements capture two types of suctioning. Scheduled indicates suctioning based on a specific frequency, such as every hour; As needed means suctioning only when indicated. If the assessor indicates that the resident is receiving suctioning on the principal Suctioning data element, the assessor would then indicate the frequency (for example, Scheduled, As needed). The proposed data element is based on an item currently in use in the MDS in SNFs which does not include our proposed two sub-elements, as well as data elements tested in the PAC PRD that focused on the frequency of suctioning required for patients with tracheostomies (“Trach Tube with Suctioning: Specify most intensive frequency of suctioning during stay [Every __hours]”). We are proposing to expand the existing Suctioning data element on the MDS to include sub-elements for Scheduled and As Needed. For more information on the Suctioning data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient
The Suctioning data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21065 through 21066). In that proposed rule, we stated that the proposal was informed by input we received on the Suctioning data element currently included in the MDS in SNFs through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 expressed support for this data element. The input noted the feasibility of this item in PAC, and the relevance of this data element to facilitating care coordination and supporting care transitions. We also stated that those commenters had suggested that we examine the frequency of suctioning to better understand the use of staff time, the impact on a patient or resident's capacity to speak and swallow, and intensity of care required. Based on these comments, we decided to add two sub-elements (Scheduled and As needed) to the suctioning element. The proposed Suctioning data element includes both the principal Suctioning data element that is included on the MDS in SNFs and two sub-elements, Scheduled and As needed. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of Suctioning (Scheduled, As needed) as a standardized patient assessment data element. One commenter objected to “scheduled” suctioning as a response option due to a clinical practice guideline recommendation that suctioning should only be performed when clinically indicated and not on a scheduled basis.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Suctioning data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Suctioning data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Suctioning data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Suctioning data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicited additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for suctioning, stakeholder input, and strong test results, we are proposing that the Suctioning (Scheduled, As needed) data element with a principal data element and two sub-elements meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Suctioning (Scheduled, As needed) data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Tracheostomy Care data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21066 through 21067), a tracheostomy provides an air passage to help a patient or resident breathe when the usual route for breathing is obstructed or impaired. Generally, in all of these cases, suctioning is necessary to ensure that the tracheostomy is clear of secretions, which can inhibit successful oxygenation of the individual. Often, individuals with tracheostomies are also receiving supplemental oxygenation. The presence of a tracheostomy, albeit permanent or temporary, warrants careful monitoring and immediate intervention if the tracheostomy becomes occluded or if the device used becomes dislodged. While in rare cases the presence of a tracheostomy is not associated with increased care demands (and in some of those instances, the care of the ostomy is performed by the patient) in general the presence of such as device is associated with increased patient risk, and clinical care services will necessarily include close monitoring to ensure that no life-threatening events occur as a result of the tracheostomy. In addition, tracheostomy care, which primarily consists of cleansing, dressing changes, and replacement of the tracheostomy cannula (tube), is a critical part of the care plan. Regular cleansing is important to prevent infection such as pneumonia, and to prevent any occlusions with which there are risks for inadequate oxygenation.
The proposed data element consists of the single Tracheostomy Care data element. The proposed data element is currently in use in the MDS in SNFs (“Tracheostomy care”). For more information on the Tracheostomy Care data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality
The Tracheostomy Care data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21066 through 21067). In that proposed rule, we stated that the proposal was informed by input we received on the Tracheostomy Care data element through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016, supported this data element, noting the feasibility of this item in PAC, and the relevance of this data element to facilitating care coordination and supporting care transitions. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, we received a few comments in support of the adoption of Tracheostomy Care as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Tracheostomy Care data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Tracheostomy Care data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Tracheostomy Care data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Tracheostomy Care data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for tracheostomy care, stakeholder input, and strong test results, we are proposing that the Tracheostomy Care data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Tracheostomy Care data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Non-invasive Mechanical Ventilator (Bilevel Positive Airway Pressure [BiPAP], Continuous Positive Airway Pressure [CPAP]) data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21067), BiPAP and CPAP are respiratory support devices that prevent the airways from closing by delivering slightly pressurized air via electronic cycling throughout the breathing cycle (BiPAP) or through a mask continuously (CPAP). Assessment of non-invasive mechanical ventilation is important in care planning, as both CPAP and BiPAP are resource-intensive (although less so than invasive mechanical ventilation) and signify underlying medical conditions about the patient or resident who requires the use of this intervention. Particularly when used in settings of acute illness or progressive respiratory decline, additional staff (for example, respiratory therapists) are required to monitor and adjust the CPAP and BiPAP settings and the patient or resident may require more nursing resources.
The proposed data element, Non-invasive Mechanical Ventilator (BIPAP, CPAP), consists of the principal Non-invasive Mechanical Ventilator data element and two response option sub-elements: BiPAP and CPAP. If the assessor indicates that the resident is receiving non-invasive mechanical ventilation on the principal Non-invasive Mechanical Ventilator data element, the assessor would then indicate which type (for example, BIPAP, CPAP). Data elements that assess non-invasive mechanical ventilation are currently included on LCDS for the LTCH setting (“Non-invasive Ventilator (BIPAP, CPAP)”), and the MDS for the SNF setting (“Non-invasive Mechanical Ventilator (BiPAP/CPAP)”). We are proposing to expand the existing BiPAP/CPAP data element on the MDS, retaining and relabeling the BiPAP/CPAP data element to be Non-invasive Mechanical Ventilator (BiPAP, CPAP), and adding two sub-elements for BiPAP and CPAP. For more information on the Non-invasive Mechanical Ventilator (BIPAP, CPAP) data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Non-invasive Mechanical Ventilator data element was first proposed as standardized patient assessment data elements in the FY 2018 SNF PPS proposed rule (82 FR 21067). In that proposed rule, we stated that the proposal was informed by input we received through a call for input
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of Non-Invasive Mechanical Ventilator (BiPAP, CPAP) as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Non-invasive Mechanical Ventilator data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Non-invasive Mechanical Ventilator data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Non-invasive Mechanical Ventilator data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Non-invasive Mechanical Ventilator data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for non-invasive mechanical ventilation, stakeholder input, and strong test results, we are proposing that the Non-invasive Mechanical Ventilator (BiPAP, CPAP) data element with a principal data element and two sub-elements meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Non-invasive Mechanical Ventilator (BiPAP, CPAP) data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Invasive Mechanical Ventilator data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21067 through 21068), invasive mechanical ventilation includes ventilators and respirators that ventilate the patient through a tube that extends via the oral airway into the pulmonary region or through a surgical opening directly into the trachea. Thus, assessment of invasive mechanical ventilation is important in care planning and risk mitigation. Ventilation in this manner is a resource-intensive therapy associated with life-threatening conditions without which the patient or resident would not survive. However, ventilator use has inherent risks requiring close monitoring. Failure to adequately care for the patient or resident who is ventilator dependent can lead to iatrogenic events such as death, pneumonia, and sepsis. Mechanical ventilation further signifies the complexity of the patient's underlying medical or surgical condition. Of note, invasive mechanical ventilation is associated with high daily and aggregate costs.
The proposed data element, Invasive Mechanical Ventilator, consists of a single data element. Data elements that capture invasive mechanical ventilation are currently in use in the MDS in SNFs and LCDS in LTCHs. The MDS currently assesses invasive mechanical ventilation with the Ventilator or Respirator data element. We are proposing to rename this data element in the MDS to be Invasive Mechanical Ventilator. For more information on the Invasive Mechanical Ventilator data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Invasive Mechanical Ventilator data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21067 through 21068). In that proposed rule, we stated that the proposal was informed by input we received through a call for input published on the CMS Measures Management System Blueprint website on data elements that assess invasive ventilator use and weaning status that were tested in the PAC PRD (“Ventilator—Weaning” and “Ventilator—Non-Weaning”). Input submitted from August 12 to September 12, 2016 expressed support for this data
In response to our proposal in the FY 2018 SNF PPS proposed rule, a few commenters supported the adoption of Invasive Mechanical Ventilator as a standardized patient assessment data element. One commenter stated that a data element to indicate “weaning” is important because it indicates higher resource utilization.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Invasive Mechanical Ventilator data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Invasive Mechanical Ventilator data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Invasive Mechanical Ventilator data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Invasive Mechanical Ventilator data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for invasive mechanical ventilation, stakeholder input, and strong test results, we are proposing that the Invasive Mechanical Ventilator data element that assesses the use of an invasive mechanical ventilator meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Invasive Mechanical Ventilator data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the IV Medications (Antibiotics, Anticoagulants, Vasoactive Medications, Other) data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21068 through 21069), when we proposed a similar data element related to IV medications, IV medications are solutions of a specific medication (for example, antibiotics, anticoagulants) administered directly into the venous circulation via a syringe or intravenous catheter. IV medications are administered via intravenous push, single, intermittent, or continuous infusion through a catheter placed into the vein. Further, IV medications are more resource intensive to administer than oral medications, and signify a higher patient complexity (and often higher severity of illness).
The clinical indications for each of the sub-elements of the IV Medications data element (Antibiotics, Anticoagulants, Vasoactive Medications, and Other) are very different. IV antibiotics are used for severe infections when the bioavailability of the oral form of the medication would be inadequate to kill the pathogen or an oral form of the medication does not exist. IV anticoagulants refer to anti-clotting medications (that is, “blood thinners”). IV anticoagulants are commonly used for hospitalized patients who have deep venous thrombosis, pulmonary embolism, or myocardial infarction, as well as those undergoing interventional cardiac procedures. Vasoactive medications refer to the IV administration of vasoactive drugs, including vasopressors, vasodilators, and continuous medication for pulmonary edema, which increase or decrease blood pressure or heart rate. The indications, risks, and benefits of each of these classes of IV medications are distinct, making it important to assess each separately in PAC. Knowing whether or not patients and residents are receiving IV medication and the type of medication provided by each PAC provider will improve quality of care.
The IV Medications (Antibiotics, Anticoagulants, Vasoactive Medications, and Other) data element we are proposing consists of a principal data element (IV Medications) and four response option sub-elements: Antibiotics, Anticoagulants, Vasoactive Medications, and Other. The Vasoactive Medications sub-element was not proposed in the FY 2018 SNF PPS proposed rule. We added the Vasoactive Medications sub-element to our proposal in order to harmonize the proposed IV Medications element with the data currently collected in the LCDS.
If the assessor indicates that the resident is receiving IV medications on the principal IV Medications data element, the assessor would then indicate which types of medications (for
An IV Medications data element was first proposed as SPADEs in the FY 2018 SNF PPS proposed rule (82 FR 21068 through 21069). In that proposed rule, we stated that the proposal was informed by input we received on Vasoactive Medications through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 supported this data element with one noting the importance of this data element in supporting care transitions. We also stated that those commenters had criticized the need for collecting specifically Vasoactive Medications, giving feedback that the data element was too narrowly focused. In addition, public comment received indicated that the clinical significance of vasoactive medications administration alone was not high enough in PAC to merit mandated assessment, noting that related and more useful information could be captured in an item that assessed all IV medication use. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of Intravenous (IV) Medications (Antibiotics, Anticoagulation, Other) as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the IV Medications data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the IV Medications data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the IV Medications data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the IV Medications data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for IV medications, stakeholder input, and strong test results, we are proposing that the IV Medications (Antibiotics, Anticoagulants, Vasoactive Medications, Other) data element with a principal data element and four sub-elements meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Medications (Antibiotics, Anticoagulants, Vasoactive Medications, Other) data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Transfusions data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21069), transfusion refers to introducing blood or blood products into the circulatory system of a person. Blood transfusions are based on specific protocols, with multiple safety checks and monitoring required during and after the infusion in case of adverse events. Coordination with the provider's blood bank is necessary, as well as documentation by clinical staff to ensure compliance with regulatory requirements. In addition, the need for transfusions signifies underlying patient complexity that is likely to require care coordination and patient monitoring, and impacts planning for transitions of care, as transfusions are not performed by all PAC providers.
The proposed data element consists of the single Transfusions data element. A data element on transfusion is currently in use in the MDS in SNFs (“Transfusions”) and a data element tested in the PAC PRD (“Blood Transfusions”) was found feasible for use in each of the four PAC settings. For more information on the Transfusions data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of Transfusions as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Transfusions data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Transfusions data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Transfusions data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Transfusions data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for transfusions, stakeholder input, and strong test results, we are proposing that the Transfusions data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Transfusions data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Dialysis (Hemodialysis, Peritoneal dialysis) data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21070), dialysis is a treatment primarily used to provide replacement for lost kidney function. Both forms of dialysis (hemodialysis and peritoneal dialysis) are resource intensive, not only during the actual dialysis process but before, during, and following. Patients and residents who need and undergo dialysis procedures are at high risk for physiologic and hemodynamic instability from fluid shifts and electrolyte disturbances, as well as infections that can lead to sepsis. Further, patients or residents receiving hemodialysis are often transported to a different facility, or at a minimum, to a different location in the same facility for treatment. Close monitoring for fluid shifts, blood pressure abnormalities, and other adverse effects is required prior to, during, and following each dialysis session. Nursing staff typically perform peritoneal dialysis at the bedside, and as with hemodialysis, close monitoring is required.
The proposed data element, Dialysis (Hemodialysis, Peritoneal dialysis) consists of the principal Dialysis data element and two response option sub-elements: Hemodialysis and Peritoneal dialysis. If the assessor indicates that the resident is receiving dialysis on the principal Dialysis data element, the assessor would then indicate which type (Hemodialysis or Peritoneal dialysis). Dialysis data elements are currently included on the MDS in SNFs and the LCDS in LTCHs and assess the overall use of dialysis. We are proposing to expand the existing Dialysis data element in the MDS to include sub-elements for Hemodialysis and Peritoneal dialysis.
As the result of public feedback described below, in this proposed rule, we are proposing a data element that includes the principal Dialysis data element and two sub-elements (Hemodialysis and Peritoneal dialysis). For more information on the Dialysis data elements, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Dialysis data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21070). In that proposed rule, we stated that the proposal was informed by input we received on a singular Hemodialysis data element through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 supported the assessment of hemodialysis and recommended that the data element be expanded to include peritoneal dialysis. We also stated that those commenters had supported the singular Hemodialysis data element, noting the relevance of this information for sharing across the care continuum to facilitate care coordination and care transitions, the potential for this data element to be used to improve quality, and the feasibility for use in PAC. In addition, we received comment that the item would be useful in improving patient and resident transitions of care. We also noted that several commenters had stated that peritoneal dialysis should be included in a standardized data element on dialysis and recommended collecting information on peritoneal dialysis in addition to hemodialysis. The rationale for including peritoneal dialysis from commenters included the fact that patients and residents receiving peritoneal dialysis will have different needs at post-acute discharge compared to those receiving hemodialysis or not having any dialysis. Based on these comments, the Hemodialysis data element was expanded to include a principal Dialysis data element and two sub-elements, Hemodialysis and Peritoneal dialysis. We are proposing the version of the Dialysis element that
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of Dialysis (Hemodialysis, Peritoneal dialysis) as a standardized patient assessment data element.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Dialysis data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Dialysis data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Dialysis data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although they did not specifically discuss the Dialysis data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for dialysis, stakeholder input, and strong test results, we are proposing that the Dialysis (Hemodialysis, Peritoneal dialysis) data element with a principal data element and two sub-elements meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Dialysis (Hemodialysis, Peritoneal dialysis) data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the IV Access (Peripheral IV, Midline, Central line) data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21070 through 21071), patients or residents with central lines, including those peripherally inserted or who have subcutaneous central line “port” access, always require vigilant nursing care to keep patency of the lines and ensure that such invasive lines remain free from any potentially life-threatening events such as infection, air embolism, or bleeding from an open lumen. Clinically complex patients and residents are likely to be receiving medications or nutrition intravenously. The sub-elements included in the IV Access data elements distinguish between peripheral access and different types of central access. The rationale for distinguishing between a peripheral IV and central IV access is that central lines confer higher risks associated with life-threatening events such as pulmonary embolism, infection, and bleeding.
The proposed data element, IV Access (Peripheral IV, Midline, Central line), consists of the principal IV Access data element and three response option sub-elements: Peripheral IV, Midline, and Central line. The proposed IV Access data element is not currently included on any of the PAC assessment instruments. For more information on the IV Access (Peripheral IV, Midline, Central line) data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The IV Access data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21070 through 21071). In that proposed rule, we stated that the proposal was informed by input we received on one of the PAC PRD data elements, Central Line Management, a type of IV access, through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 supported the assessment of central line management and recommended that the data element be broadened to also include other types of IV access. Several commenters noted feasibility and importance of facilitating care coordination and care transitions. However, a few commenters recommended that the definition of this data element be broadened to include peripherally inserted central catheters (“PICC lines”) and midline IVs. Based on public comment feedback and in consultation with expert input, described below, we created an overarching IV Access data element with sub-elements for other types of IV access in addition to central lines (that is, peripheral IV and midline). This expanded version of IV Access is the data element being proposed. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of the IV Access (Peripheral IV, Midline,
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the IV Access data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the IV Access data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the IV Access data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the IV Access data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for IV access, stakeholder input, and strong test results, we are proposing that the IV access (Peripheral IV, Midline, Central line) data element with a principal data element and three sub-elements meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the IV Access (Peripheral IV, Midline, Central line) data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Parenteral/IV Feeding data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21071 through 21072), parenteral nutrition/IV feeding refers to a patient or resident being fed intravenously using an infusion pump, bypassing the usual process of eating and digestion. The need for IV/parenteral feeding indicates a clinical complexity that prevents the patient or resident from meeting his or her nutritional needs enterally, and is more resource intensive than other forms of nutrition, as it often requires monitoring of blood chemistries and the maintenance of a central line. Therefore, assessing a patient's or resident's need for parenteral feeding is important for care planning and resource use. In addition to the risks associated with central and peripheral intravenous access, total parenteral nutrition is associated with significant risks such as air embolism and sepsis.
The proposed data element consists of the single Parenteral/IV Feeding data element. The proposed Parenteral/IV Feeding data element is currently in use in the MDS in SNFs, and equivalent or related data elements are in use in the LCDS, IRF-PAI, and OASIS. For more information on the Parenteral/IV Feeding data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Parenteral/IV Feeding data element was first proposed as a SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21071 through 21072). In that proposed rule, we stated that the proposal was informed by input we received on Total Parenteral Nutrition (an item with nearly the same meaning as the proposed data element, but with the label used in the PAC PRD) through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 supported this data element, noting its relevance to facilitating care coordination and supporting care transitions. After the public comment period, the Total Parenteral Nutrition data element was renamed Parenteral/IV Feeding, to be consistent with how this data element is referred to in the MDS in SNFs. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of the Parenteral/IV Feeding as a standardized patient assessment data element, with one requesting “universal” guidance for coding, which would be clearly defined and more broadly applicable to patients and residents in all PAC settings.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Parenteral/IV Feeding data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Parenteral/IV Feeding data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Parenteral/IV Feeding data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Parenteral/IV Feeding data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for parenteral/IV feeding, stakeholder input, and strong test results, we are proposing that the Parenteral/IV Feeding data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Parenteral/IV Feeding data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Feeding Tube data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21072), the majority of patients admitted to acute care hospitals experience deterioration of their nutritional status during their hospital stay, making assessment of nutritional status and method of feeding if unable to eat orally very important in PAC. A feeding tube can be inserted through the nose or the skin on the abdomen to deliver liquid nutrition into the stomach or small intestine. Feeding tubes are resource intensive and, therefore, are important to assess for care planning and resource use. Patients with severe malnutrition are at higher risk for a variety of complications.
The proposed data element consists of the single Feeding Tube data element. The Feeding Tube data element is currently included in the MDS for SNFs, and in the OASIS for HHAs, where it is labeled Enteral Nutrition. A related data element, collected in the IRF-PAI for IRFs (“Tube/Parenteral Feeding”), assesses use of both feeding tubes and parenteral nutrition. For more information on the Feeding Tube data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Feeding Tube data element was first proposed as a SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21072). In that proposed rule, we stated that the proposal was informed by input we received through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 on an Enteral Nutrition data element (the Enteral Nutrition data item is the same as the data element we are proposing in this proposed rule, but is used in the OASIS under a different name) supported the data element, noting the importance of assessing enteral nutrition status for facilitating care coordination and care transitions. After the public comment period, the Enteral Nutrition data element used in public comment was renamed Feeding Tube, indicating the presence of an assistive device. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of the Feeding Tube as a standardized patient assessment data element. Another commenter recommended that the term “enteral feeding” be used instead of “feeding tube.”
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Feeding Tube data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Feeding Tube data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Feeding Tube data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Feeding Tube data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for feeding tubes, stakeholder input, and strong test results, we are proposing that the Feeding Tube data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Feeding Tube data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Mechanically Altered Diet data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21072 through 21073), the Mechanically Altered Diet data element refers to food that has been altered to make it easier for the patient or resident to chew and swallow, and this type of diet is used for patients and residents who have difficulty performing these functions. Patients with severe malnutrition are at higher risk for a variety of complications.
In PAC settings, there are a variety of reasons that patients and residents may have impairments related to oral feedings, including clinical or cognitive status. The provision of a mechanically altered diet may be resource intensive, and can signal difficulties associated with swallowing/eating safety, including dysphagia. In other cases, it signifies the type of altered food source, such as ground or puree that will enable the safe and thorough ingestion of nutritional substances and ensure safe and adequate delivery of nourishment to the patient. Often, patients and residents on mechanically altered diets also require additional nursing supports, such as individual feeding or direct observation, to ensure the safe consumption of the food product. Assessing whether a patient or resident requires a mechanically altered diet is therefore important for care planning and resource identification.
The proposed data element consists of the single Mechanically Altered Diet data element. The proposed data element is currently included on the MDS for SNFs. A related data element (“Modified food consistency/supervision”) is currently included on the IRF-PAI for IRFs. Another related data element is included in the OASIS for HHAs that collects information about independent eating that requires “a liquid, pureed or ground meat diet.” For more information on the Mechanically Altered Diet data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Mechanically Altered Diet data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21072 through 21073).
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported the adoption of the Mechanically Altered Diet as a standardized patient assessment data element, with one requesting “universal” guidance for coding, which would be clearly defined and more broadly applicable to patients and residents in all PAC settings.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Mechanically Altered Diet data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Mechanically Altered Diet data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Mechanically Altered Diet data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Mechanically Altered Diet data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for mechanically altered diet, stakeholder input, and strong test results, we are proposing that the Mechanically Altered Diet data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Mechanically Altered Diet data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Therapeutic Diet data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21073), a therapeutic diet refers to meals planned to increase, decrease, or eliminate specific foods or nutrients in a patient's or resident's diet, such as a low-salt diet, for the purpose of treating a medical condition. The use of therapeutic diets among patients and residents in PAC provides insight on the clinical complexity of these patients and residents and their multiple comorbidities. Therapeutic diets are less resource intensive from the bedside nursing perspective, but do signify one or more underlying clinical conditions that preclude the patient from eating a regular diet. The communication among PAC providers about whether a patient is receiving a particular therapeutic diet is critical to ensure safe transitions of care.
The proposed data element consists of the single Therapeutic Diet data element. This data element is currently in use in the MDS in SNFs. For more information on the Therapeutic Diet data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Therapeutic Diet data element was first proposed as standardized patient assessment data in the FY 2018 SNF PPS proposed rule (82 FR 21073). In response to our proposal in the FY 2018 SNF PPS proposed rule, commenters supported the adoption of the Therapeutic Diet as a standardized patient assessment data element. Two commenters stated that the coding instructions should be clear and more broadly applicable to patients and residents in all PAC settings. Another two commenters suggested that the definition of Therapeutic Diet should be aligned with the Academy of Nutrition and Dietetics' definition, with one stating that “medically altered diet” should be added to the nutritional data elements.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Therapeutic Diet data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Therapeutic Diet data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Therapeutic Diet data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on September 17, 2018, for the purpose of soliciting input on the proposed standardized patient assessment data elements. Although the TEP did not specifically discuss the Therapeutic Diet data element, the TEP supported the assessment of the special services, treatments, and interventions included in the National Beta Test with respect to both admission and discharge. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for therapeutic diet, stakeholder input, and strong test results, we are proposing that the Therapeutic Diet data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the Therapeutic data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the High-Risk Drug Classes: Use and Indication data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act.
Most patients and residents receiving PAC services depend on short- and long-term medications to manage their medical conditions. However, as a treatment, medications are not without risk; medications are in fact a leading cause of adverse events. A study by the
ADEs are known to occur across different types of healthcare settings. For example, the incidence of ADEs in the outpatient setting has been estimated at 1.15 ADEs per 100 person-months,
Understanding the types of medication a patient is taking and the reason for its use are key facets of a patient's treatment with respect to medication. Some classes of drugs are associated with more risk than others.
We sought public input on the relevance of conducting assessments on medication reconciliation and specifically on the proposed High-Risk Drug Classes: Use and Indication data element. Our data element contractor presented data elements related to medication reconciliation to the TEP convened on April 6 and 7, 2016. The TEP supported a focus on high-risk drugs, because of higher potential for harm to patients and residents, and were in favor of a data element to capture whether or not indications for medications were recorded in the medical record. A summary of the April 6 and 7, 2016 TEP meeting titled “SPADE Technical Expert Panel Summary (First Convening)” is available at:
We also solicited public input on data elements related to medication reconciliation during a public input period from April 26 to June 26, 2017. Several commenters expressed support for the medication reconciliation data elements that were put on display, noting the importance of medication reconciliation in preventing medication errors and stated that the items seemed feasible and clinically useful. A few commenters were critical of the choice of 10 drug classes posted during that comment period, arguing that ADEs are not limited to high-risk drugs, and raised issues related to training assessors to correctly complete a valid assessment of medication reconciliation. A summary report for the April 26 to June 26, 2017 public comment period titled “SPADE May-June 2017 Public Comment Summary Report” is available at:
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the proposed standardized patient assessment data elements. The TEP acknowledged the challenges of assessing medication safety, but were supportive of some of the data elements focused on medication reconciliation that were tested in the National Beta Test. The TEP was especially supportive of the focus on the six high-risk drug classes and using these classes to assess whether the indication for a drug is recorded. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. These activities provided updates on the field-testing work and solicited feedback on data elements considered for standardization, including the High-Risk Drug Classes: Use and Indication data element. One stakeholder group was critical of the six drug classes included as response options in the High-Risk Drug Classes: Use and Indication data element, noting that potentially risky medications (for example, muscle relaxants) are not included in this list; that there may be important differences between drugs within classes (for example, more recent versus older style antidepressants); and that drug allergy information is not captured. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. Additionally, one commenter questioned whether the time to complete this SPADE would differ across settings. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing high-risk drugs and for whether or not indications are noted for high-risk drugs, stakeholder input, and strong test results, we are proposing that the High-Risk Drug Classes: Use and Indication data element meets the definition of standardized patient assessment data with respect to special services, treatments, and interventions under section 1899B(b)(1)(B)(iii) of the Act and to adopt the High-Risk Drug Classes: Use and Indication data element as standardized patient assessment data for use in the SNF QRP.
Assessing medical conditions and comorbidities is critically important for care planning and safety for patients and residents receiving PAC services, and the standardized assessment of selected medical conditions and comorbidities across PAC providers is important for managing care transitions and understanding medical complexity.
Below we discuss our proposals for data elements related to the medical
In alignment with our Meaningful Measures Initiative, accurate assessment of medical conditions and comorbidities of patients and residents in PAC is expected to make care safer by reducing harm caused in the delivery of care; promote effective prevention and treatment of chronic disease; strengthen person and family engagement as partners in their care; and promote effective communication and coordination of care. The SPADEs will enable or support: Clinical decision-making and early clinical intervention; person-centered, high quality care through: facilitating better care continuity and coordination; better data exchange and interoperability between settings; and longitudinal outcome analysis. Therefore, reliable data elements assessing medical conditions and comorbidities are needed in order to initiate a management program that can optimize a patient's or resident's prognosis and reduce the possibility of adverse events.
We are inviting comment that apply specifically to the standardized patient assessment data for the category of medical conditions and co-morbidities, specifically on:
In acknowledgement of the opioid crisis, we specifically are seeking comment on whether or not we should add these pain items in light of those concerns. Commenters should address to what extent collection of the data below through patient queries might encourage providers to prescribe opioids.
We are proposing that a set of three data elements on the topic of Pain Interference (Pain Effect on Sleep, Pain Interference with Therapy Activities, and Pain Interference with Day-to-Day Activities) meet the definition of standardized patient assessment data with respect to medical condition and comorbidity data under section 1899B(b)(1)(B)(iv) of the Act.
The practice of pain management began to undergo significant changes in the 1990s because the inadequate, non-standardized, non-evidence-based assessment and treatment of pain became a public health issue.
We appreciate the important concerns related to the misuse and overuse of opioids in the treatment of pain and to that end we note that in this proposed rule we have also proposed a SPADE that assess for the use of, as well as importantly the indication for that use of, high risk drugs, including opioids. Further, in the FY 2017 SNF PPS final rule (81 FR 52039) we adopted the Drug Regimen Review Conducted With Follow-Up for Identified Issues—Post Acute Care (PAC) SNF QRP measure which assesses whether PAC providers were responsive to potential or actual clinically significant medication issue(s), which includes issues associated with use and misuse of opioids for pain management, when such issues were identified.
We also note that the proposed SPADE related to pain assessment are not associated with any particular approach to management. Since the use of opioids is associated with serious complications, particularly in the elderly,
We believe that standardized assessment of pain interference will support PAC clinicians in applying best-practices in pain management for chronic and acute pain, consistent with current clinical guidelines. For example, the standardized assessment of both opioids and pain interference would support providers in successfully tapering patients/residents who arrive in the PAC setting with long-term opioid use off of opioids onto non-pharmacologic treatments and non-opioid medications, as recommended by the Society for Post-Acute and Long-Term Care Medicine,
The Pain Interference data elements consist of three data elements: Pain Effect on Sleep, Pain Interference with Therapy Activities, and Pain Interference with Day-to-Day Activities. Pain Effect on Sleep assesses the frequency with which pain effects a resident's sleep. Pain Interference with Therapy Activities assesses the frequency with which pain interferes with a resident's ability to participate in therapies. The Pain Interference with Day-to-Day Activities assesses the extent to which pain interferes with a resident's ability to participate in day-to-day activities excluding therapy.
A similar data element on the effect of pain on activities is currently included in the OASIS. A similar data element on the effect on sleep is currently included in the MDS instrument. We are proposing to expand and modify the existing Pain data elements in the MDS to include the Pain Effect on Sleep; Pain Interference with Therapy Activities; and Pain Interference with Day to Day Activities data elements. For more information on the Pain Interference data elements, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
We sought public input on the relevance of conducting assessments on pain and specifically on the larger set of Pain Interview data elements included in the National Beta Test. The proposed data elements were supported by comments from the TEP meeting held by our data element contractor on April 7 to 8, 2016. The TEP affirmed the feasibility and clinical utility of pain as a concept in a standardized assessment. The TEP agreed that data elements on pain interference with ability to participate in therapies versus other activities should be addressed. Further, during a more recent convening of the same TEP on September 17, 2018, the TEP supported the interview-based pain data elements included in the National Beta Test. The TEP members were particularly supportive of the items that focused on how pain interferes with activities (that is, Pain Interference data elements), because understanding the extent to which pain interferes with function would enable clinicians to determine the need for appropriate pain treatment. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We held a public input period in 2016 to solicit feedback on the standardization of pain and several other items that were under development in prior efforts. From the prior public comment period, we included several pain data elements (Pain Effect on Sleep; Pain Interference—Therapy Activities; Pain Interference—Other Activities) in a second call for public input, open from April 26 to June 26, 2017. The items we sought comment on were modified from all stakeholder and test efforts. Commenters provided general comments about pain assessment in general in addition to feedback on the specific pain items. A few commenters shared their support for assessing pain, the potential for pain assessment to improve the quality of care, and for the validity and reliability of the data elements. Commenters affirmed that the item of pain and the effect on sleep would be suitable for PAC settings. Commenters' main concerns included redundancy with existing data elements, feasibility and utility for cross-setting use, and the applicability of interview-based items to patients and residents with cognitive or communication impairments, and deficits. A summary report for the April 26 to June 26, 2017 public comment period titled “SPADE May-June 2017 Public Comment Summary Report” is available at
The Pain Interference data elements were included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Pain Interference data elements to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Pain Interference data elements in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,”
In addition, our data element contractor convened a TEP on September 17, 2018 for the purpose of soliciting input on the standardized patient assessment data elements. The TEP supported the interview-based pain data elements included in the National Beta Test. The TEP members were particularly supportive of the items that focused on how pain interferes with activities (that is, Pain Interference data elements), because understanding the extent to which pain interferes with function would enable clinicians to determine the need for pain treatment. A summary of the September 17, 2018 TEP meeting titled “SPADE Technical Expert Panel Summary (Third Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. Additionally, one commenter expressed strong support for the Pain data elements and was encouraged by the fact that this portion of the assessment goes beyond merely measuring the presence of pain. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for the effect of pain on function, stakeholder input, and strong test results, we are proposing that the three Pain Interference data elements (Pain Effect on Sleep, Pain Interference with Therapy Activities, and Pain Interference with Day-to-Day Activities) meet the definition of standardized patient assessment data with respect to medical conditions and comorbidities under section 1899B(b)(1)(B)(iv) of the Act and to adopt the Pain Interference data elements (Pain Effect on Sleep, Pain Interference with Therapy Activities, and Pain Interference with Day-to-Day Activities) data elements as standardized patient assessment data for use in the SNF QRP.
Hearing and vision impairments are conditions that, if unaddressed, affect activities of daily living, communication, physical functioning, rehabilitation outcomes, and overall quality of life. Sensory limitations can lead to confusion in new settings, increase isolation, contribute to mood disorders, and impede accurate assessment of other medical conditions. Failure to appropriately assess, accommodate, and treat these conditions increases the likelihood that patients and residents will require more intensive and prolonged treatment. Onset of these conditions can be gradual, so individualized assessment with accurate screening tools and follow-up evaluations are essential to determining which patients and residents need hearing- or vision-specific medical attention or assistive devices and accommodations, including auxiliary aids and/or services, and to ensure that person-directed care plans are developed to accommodate a patient's or resident's needs. Accurate diagnosis and management of hearing or vision impairment would likely improve rehabilitation outcomes and care transitions, including transition from institutional-based care to the community. Accurate assessment of hearing and vision impairment would be expected to lead to appropriate treatment, accommodations, including the provision of auxiliary aids and services during the stay, and ensure that patients and residents continue to have their vision and hearing needs met when they leave the facility.
In alignment with our Meaningful Measures Initiative, we expect accurate and individualized assessment, treatment, and accommodation of hearing and vision impairments of patients and residents in PAC to make care safer by reducing harm caused in the delivery of care; promote effective prevention and treatment of chronic disease; strengthen person and family engagement as partners in their care; and promote effective communication and coordination of care. For example, standardized assessment of hearing and vision impairments used in PAC will support ensuring patient safety (for example, risk of falls), identifying accommodations needed during the stay, and appropriate support needs at the time of discharge or transfer. Standardized assessment of these data elements will: Enable or support clinical decision-making and early clinical intervention; person-centered, high quality care (for example, facilitating better care continuity and coordination); better data exchange and interoperability between settings; and longitudinal outcome analysis. Therefore, reliable data elements assessing hearing and vision impairments are needed to initiate a management program that can optimize a patient's or resident's prognosis and reduce the possibility of adverse events.
Comments on the category of impairments were also submitted by stakeholders during the FY 2018 SNF PPS proposed rule (82 FR 21074 through 21076) public comment period. A commenter stated hearing, vision, and communication assessments should be administered at the beginning of assessment process, to provide evidence about any sensory deficits that may affect the patient's or resident's ability to participate in the assessment and to allow the assessor to offer an assistive device. Another commenter supported the decision to assess hearing and vision with respect to admission only and not discharge, and to use existing MDS items for hearing and vision, thereby not creating additional burden.
We are inviting comment on our proposals to collect as standardized patient assessment data the following data with respect to impairments.
We are proposing that the Hearing data element meets the definition of standardized patient assessment data with respect to impairments under section 1899B(b)(1)(B)(v) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21074 through 21075), accurate assessment of hearing impairment is important in the PAC setting for care planning and resource use. Hearing impairment has been associated with lower quality of life, including poorer physical, mental, social functioning, and emotional health.
The proposed data element consists of the single Hearing data element. This data consists of one question that assesses level of hearing impairment. This data element is currently in use in the MDS in SNFs. For more information on the Hearing data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Hearing data element was first proposed as a SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21074 through 21075). In that proposed rule, we stated that the proposal was informed by input we received on the PAC PRD form of the data element (“Ability to Hear”) through a call for input published on the CMS Measures Management System Blueprint website. Input submitted from August 12 to September 12, 2016 recommended that hearing, vision, and communication assessments be administered at the beginning of patient assessment process. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported Hearing as a standardized patient assessment data element to facilitate care coordination. One stated that coding instructions about use of a hearing device by the resident should be more clearly defined. Commenters were supportive of adopting the Hearing data element for standardized cross-setting use, noting that it would help address the needs of patient and residents with disabilities and that failing to identify impairments during the initial assessment can result in inaccurate diagnoses of impaired language or cognition and can validate other information obtained from patient assessment.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Hearing data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Hearing data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Hearing data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on January 5 and 6, 2017 for the purpose of soliciting input on all the SPADEs, including the Hearing data element. The TEP affirmed the importance of standardized assessment of hearing impairment in PAC patients and residents. A summary of the January 5 and 6, 2017 TEP meeting titled “SPADE Technical Expert Panel Summary (Second Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. Additionally, a commenter expressed support for the Hearing data element and suggested administration at the beginning of the patient assessment to maximize utility. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for hearing, stakeholder input, and strong test results, we are proposing that the Hearing data element meets the definition of standardized patient assessment data with respect to impairments under section 1899B(b)(1)(B)(v) of the Act and to adopt the Hearing data element as standardized patient assessment data for use in the SNF QRP.
We are proposing that the Vision data element meets the definition of SPADE with respect to impairments under section 1899B(b)(1)(B)(v) of the Act.
As described in the FY 2018 SNF PPS proposed rule (82 FR 21075 through 21076), evaluation of an individual's ability to see is important for assessing for risks such as falls and provides opportunities for improvement through treatment and the provision of accommodations, including auxiliary aids and services, which can safeguard patients and residents and improve their overall quality of life. Further, vision impairment is often a treatable risk factor associated with adverse events and poor quality of life. For example, individuals with visual impairment are more likely to experience falls and hip fracture, have less mobility, and report depressive
The proposed data element consists of the single Vision data element (Ability To See in Adequate Light) that consists of one question with five response categories. The Vision data element that we are proposing for standardization was tested as part of the development of the MDS in SNFs and is currently in use in that assessment. Similar data elements, but with different wording and fewer response option categories, are in use in the OASIS. For more information on the Vision data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
The Vision data element was first proposed as a SPADE in the FY 2018 SNF PPS proposed rule (82 FR 21075 through 21076). In that proposed rule, we stated that the proposal was informed by input we received on the Ability to See in Adequate Light data element (version tested in the PAC PRD with three response categories) through a call for input published on the CMS Measures Management System Blueprint website. Although the data element in public comment differed from the proposed data element, input submitted from August 12 to September 12, 2016 supported assessing vision in PAC settings and the useful information a vision data element would provide. We also stated that commenters had noted that the Ability to See item would provide important information that would facilitate care coordination and care planning, and consequently improve the quality of care. Other commenters suggested it would be helpful as an indicator of resource use and noted that the item would provide useful information about the abilities of patients and residents to care for themselves. Additional commenters noted that the item could feasibly be implemented across PAC providers and that its kappa scores from the PAC PRD support its validity. Some commenters noted a preference for MDS version of the Vision data element in SNFs over the form put forward in public comment, citing the widespread use of this data element. A summary report for the August 12 to September 12, 2016 public comment period titled “SPADE August 2016 Public Comment Summary Report” is available at
In response to our proposal in the FY 2018 SNF PPS proposed rule, two commenters supported Vision as a standardized patient assessment data element to facilitate care coordination. One stated that coding instructions for use of a vision device by the resident should be more clearly defined. Commenters recommended that hearing, vision, and communication assessments be administered at the beginning of patient assessment process. One commenter supported having a SPADE for vision across PAC settings, but stated it captures only basic information for risk adjustment, and more detailed information would need to be collected to use it as an outcome measure.
Subsequent to receiving comments on the FY 2018 SNF PPS rule, the Vision data element was included in the National Beta Test of candidate data elements conducted by our data element contractor from November 2017 to August 2018. Results of this test found the Vision data element to be feasible and reliable for use with PAC patients and residents. More information about the performance of the Vision data element in the National Beta Test can be found in the document titled “Proposed Specifications for SNF QRP Quality Measures and Standardized Patient Assessment Data Elements,” available at
In addition, our data element contractor convened a TEP on January 5 and 6, 2017 for the purpose of soliciting input on all the SPADEs including the Vision data element. The TEP affirmed the importance of standardized assessment of vision impairment in PAC patients and residents. A summary of the January 5 and 6, 2017 TEP meeting titled “SPADE Technical Expert Panel Summary (Second Convening)” is available at
We also held Special Open Door Forums and small-group discussions with PAC providers and other stakeholders in 2018 for the purpose of updating the public about our on-going SPADE development efforts. Finally, on November 27, 2018, our data element contractor hosted a public meeting of stakeholders to present the results of the National Beta Test and solicit additional comments. General input on the testing and item development process and concerns about burden were received from stakeholders during this meeting and via email through February 1, 2019. Additionally, a commenter expressed support for the Vision data element and suggested administration at the beginning of the patient assessment to maximize utility. A summary of the public input received from the November 27, 2018 stakeholder meeting titled “Input on Standardized Patient Assessment Data Elements (SPADEs) Received After November 27, 2018 Stakeholder Meeting” is available at
Taking together the importance of assessing for vision, stakeholder input, and strong test results, we are proposing that the Vision data element meets the definition of standardized patient assessment data with respect to
Subparagraph (A) of section 2(d)(2) of the IMPACT Act requires CMS to assess appropriate adjustments to quality measures, resource measures, and other measures, and to assess and implement appropriate adjustments to payment under Medicare based on those measures, after taking into account studies conducted by ASPE on social risk factors (described below) and other information, and based on an individual's health status and other factors. Subparagraph (C) of section 2(d)(2) of the IMPACT Act further requires the Secretary to carry out periodic analyses, at least every three years, based on the factors referred to subparagraph (A) so as to monitor changes in possible relationships. Subparagraph (B) of section 2(d)(2) of the IMPACT Act requires CMS to collect or otherwise obtain access to data necessary to carry out the requirement of the paragraph (both assessing adjustments described above in such subparagraph (A) and for periodic analyses in such subparagraph (C)). Accordingly we are proposing to use our authority under subparagraph (B) of section 2(d)(2) of the IMPACT Act to establish a new data source for information to meet the requirements of subparagraphs (A) and (C) of section 2(d)(2) of the IMPACT Act. In this rule, we are proposing to collect and access data about social determinants of health (SDOH) to perform CMS' responsibilities under subparagraphs (A) and (C) of section 2(d)(2) of the IMPACT Act, as explained in more detail below. Social determinants of health, also known as social risk factors, or health-related social needs, are the socioeconomic, cultural and environmental circumstances in which individuals live that impact their health. We are proposing to collect information on seven proposed SDOH SPADE data elements relating to race, ethnicity, preferred language, interpreter services, health literacy, transportation, and social isolation; a detailed discussion of each of the proposed SDOH data elements is found in section VI.A.7.f.(2) of this proposed rule.
We are also proposing to use the resident assessment instrument minimum data set (MDS), the current version being MDS 3.0, described as a PAC assessment instrument under section 1899B(a)(2)(B) of the Act, to collect these data via an existing data collection mechanism. We believe this approach will provide CMS with access to data with respect to the requirements of section 2(d)(2) of the IMPACT Act, while minimizing the reporting burden on PAC health care providers by relying on a data reporting mechanism already used and an existing system to which PAC health care providers are already accustomed.
The IMPACT Act includes several requirements applicable to the Secretary, in addition to those imposing new data reporting obligations on certain PAC providers as discussed in section VI.A.7.f.(2) of this proposed rule. Subparagraphs (A) and (B) of section 2(d)(1) of the IMPACT Act require the Secretary, acting through the Office of the Assistant Secretary for Planning and Evaluation (ASPE), to conduct two studies that examine the effect of risk factors, including individuals' socioeconomic status, on quality, resource use and other measures under the Medicare program. The first ASPE study was completed in December 2016 and is discussed below, and the second study is to be completed in the fall of 2019. We recognize that ASPE, in its studies, is considering a broader range of social risk factors than the SDOH data elements in this proposal, and address both PAC and non-PAC settings. We acknowledge that other data elements may be useful to understand, and that some of those elements may be of particular interest in non-PAC settings. For example, for beneficiaries receiving care in the community, as opposed to an in-patient facility, housing stability and food insecurity may be more relevant. We will continue to take into account the findings from both of ASPE's reports in future policy making.
One of the ASPE's first actions under the IMPACT Act was to commission the National Academies of Sciences, Engineering, and Medicine (NASEM) to define and conceptualize socioeconomic status for the purposes of ASPE's two studies under section 2(d)(1) of the IMPACT Act. The NASEM convened a panel of experts in the field and conducted an extensive literature review. Based on the information collected, the 2016 NASEM panel report titled, “Accounting for Social Risk Factors in Medicare Payment: Identifying Social Risk Factors,” concluded that the best way to assess how social processes and social relationships influence key health-related outcomes in Medicare beneficiaries is through a framework of social risk factors instead of socioeconomic status. Social risk factors discussed in the NASEM report include socioeconomic position, race, ethnicity, gender, social context, and community context. These factors are discussed at length in chapter 2 of the NASEM report, titled “Social Risk Factors.”
Each of the data elements we are proposing to collect and access pursuant to our authority under section 2(d)(2)(B) of the IMPACT Act is identified in the 2016 NASEM report as a social risk factor that has been shown to impact care use, cost and outcomes for Medicare beneficiaries. CMS uses the term social determinants of health (SDOH) to denote social risk factors, which is consistent with the objectives of Healthy People 2020.
ASPE issued its first Report to Congress, titled “Social Risk Factors and Performance Under Medicare's Value-Based Purchasing Programs,” pursuant to section 2(d)(1)(A) of the IMPACT Act on December 21, 2016.
Section 2(d)(2) of the IMPACT Act relates to CMS activities and imposes several responsibilities on the Secretary relating to quality, resource use, and other measures under Medicare. As mentioned previously, under subparagraph (A) of section 2(d)(2) of the IMPACT Act, the Secretary is required, on an ongoing basis, taking into account the ASPE studies and other information, and based on an individual's health status and other factors, to assess appropriate adjustments to quality, resource use, and other measures, and to assess and implement appropriate adjustments to Medicare payments based on those measures. Section 2(d)(2)(A)(i) of the IMPACT Act applies to measures adopted under subsections (c) and (d) of section 1899B of the Act and to other measures under Medicare. However, CMS' ability to perform these analyses, and assess and make appropriate adjustments is hindered by limits of existing data collections on SDOH data elements for Medicare beneficiaries. In its first study in 2016, in discussing the second study, ASPE noted that information relating to many of the specific factors listed in the IMPACT Act, such as health literacy, limited English proficiency, and Medicare beneficiary activation, are not available in Medicare data.
Subparagraph 2(d)(2)(A) of the IMPACT Act specifically requires the Secretary to take the studies and considerations from ASPE's reports to Congress, as well as other information as appropriate, into account in assessing and implementing adjustments to measures and related payments based on measures in Medicare. The results of the ASPE's first study demonstrated that Medicare beneficiaries with social risk factors tended to have worse outcomes on many quality measures, and providers who treated a disproportionate share of beneficiaries with social risk factors tended to have worse performance on quality measures. As a result of these findings, ASPE suggested a three-pronged strategy to guide the development of value-based payment programs under which all Medicare beneficiaries receive the highest quality healthcare services possible. The three components of this strategy are to: (1) Measure and report quality of care for beneficiaries with social risk factors; (2) set high, fair quality standards for care provided to all beneficiaries; and (3) reward and support better outcomes for beneficiaries with social risk factors. In discussing how measuring and reporting quality for beneficiaries with social risk factors can be applied to Medicare quality payment programs, the report offered nine considerations across the three-pronged strategy, including enhancing data collection and developing statistical techniques to allow measurement and reporting of performance for beneficiaries with social risk factors on key quality and resource use measures.
Congress, in section 2(d)(2)(B) of the IMPACT Act, required the Secretary to collect or otherwise obtain access to the data necessary to carry out the provisions of paragraph (2) of section 2(d) of the IMPACT Act through both new and existing data sources. Taking into consideration NASEM's conceptual framework for social risk factors discussed above, ASPE's study, considerations under section 2(d)(1)(A) of the IMPACT Act, as well as the current data constraints of ASPE's first study and its suggested considerations, we are proposing to collect and access data about SDOH under section 2(d)(2) of the IMPACT Act. Our collection and use of the SDOH data described in section VI.A.7.f.(1) of this proposed rule, under section 2(d)(2) of the IMPACT Act, would be independent of our proposal below (in section VI.A.7.f.(2) of this proposed rule and our authority to require submission of that data for use as SPADE under section 1899B(a)(1)(B) of the Act.
Accessing standardized data relating to the SDOH data elements on a national level is necessary to permit CMS to conduct periodic analyses, to assess appropriate adjustments to quality measures, resource use measures, and other measures, and to assess and implement appropriate adjustments to Medicare payments based on those measures. We agree with ASPE's observations, in the value-based purchasing context, that the ability to measure and track quality, outcomes, and costs for beneficiaries with social risk factors over time is critical as policymakers and providers seek to reduce disparities and improve care for these groups. Collecting the data as proposed will provide the basis for our periodic analyses of the relationship between an individual's health status and other factors and quality, resource use, and other measures, as required by section 2(d)(2) of the IMPACT Act, and to assess appropriate adjustments. These data will also permit us to develop the statistical tools necessary to maximize the value of Medicare data, reduce costs and improve the quality of care for all beneficiaries. Collecting and accessing SDOH data in this way also supports the three-part strategy put forth in the first ASPE report, specifically ASPE's consideration to enhance data collection and develop statistical techniques to allow measurement and reporting of performance for beneficiaries with social risk factors on key quality and resource use measures.
For the reasons discussed above, we are proposing under section 2(d)(2) of the IMPACT Act, to collect the data on the following SDOH: (1) Race, as described in section VI.A.7.f.(2)(a) of this proposed rule; (2) Ethnicity, as described in section VI.A.7.f.(2)(a) of this proposed rule; (3) Preferred Language, as described in section VI.A.7.f.(2)(b) of this proposed rule; (4) Interpreter Services as described in section VI.A.7.f.(2)(b) of this proposed rule; (5) Health Literacy, as described in section VI.A.7.f.(2)(c) of this proposed rule; (6) Transportation, as described in section VI.A.7.f.(2)(d) of this proposed rule; and (5) Social Isolation, as described in section VI.A.7.f.(2)(e) of this proposed rule. These data elements are discussed in more detail below in section VI.A.7.f.(2) of this proposed rule. We welcome comment on this proposal.
Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to collect SPADEs with respect to other categories deemed necessary and appropriate. Below we are proposing to create a Social Determinants of Health SPADE category under section 1899B(b)(1)(B)(vi) of the Act. In addition to collecting SDOH data for the purposes outlined above under section 2(d)(2)(B) of the IMPACT Act, we are also proposing to collect as SPADE these same data elements (race, ethnicity, preferred language, interpreter services, health literacy, transportation, and social isolation) under section 1899B(b)(1)(B)(vi) of the Act. We believe that this proposed new category of Social Determinants of Health will inform provider understanding of individual patient risk factors and treatment preferences, facilitate coordinated care and care planning, and improve patient outcomes. We are proposing to deem this category necessary and appropriate, for the purposes of SPADE, because using common standards and definitions for
All of the Social Determinants of Health data elements we are proposing under section 1899B(b)(1)(B)(vi) of the Act have the capacity to take into account treatment preferences and care goals of residents and patients, and to inform our understanding of resident and patient complexity and risk factors that may affect care outcomes. While acknowledging the existence and importance of additional SDOH, we are proposing to assess some of the factors relevant for patients and residents receiving post-acute care that PAC settings are in a position to impact through the provision of services and supports, such as connecting patients and residents with identified needs with transportation programs, certified interpreters, or social support programs.
As previously mentioned and described in more detail below we are proposing to adopt the following seven data elements as SPADE under the proposed Social Determinants of Health category: Race, ethnicity, preferred language, interpreter services, health literacy, transportation, and social isolation. To select these data elements, we reviewed the research literature, a number of validated assessment tools and frameworks for addressing SDOH currently in use (for example, Health Leads, NASEM, Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), and ICD-10), and we engaged in discussions with stakeholders. We also prioritized balancing the reporting burden for PAC providers with our policy objective to collect SPADEs that will inform care planning and coordination and quality improvement across care settings. Furthermore, incorporating SDOH data elements into care planning has the potential to reduce readmissions and help beneficiaries achieve and maintain their health goals.
We also considered feedback received during a listening session that we held on December 13, 2018. The purpose of the listening session was to solicit feedback from health systems, research organizations, advocacy organizations and state agencies, and other members of the public on collecting patient-level data on SDOH across care settings, including consideration of race, ethnicity, spoken language, health literacy, social isolation, transportation, sex, gender identity, and sexual orientation. We also gave participants an option to submit written comments. A full summary of the listening session, titled “Listening Session on Social Determinants of Health Data Elements: Summary of Findings,” includes a list of participating stakeholders and their affiliations, and is available at
The persistence of racial and ethnic disparities in health and health care is widely documented, including in PAC settings.
The ability to improve understanding of and address racial and ethnic disparities in PAC outcomes requires the availability of better data. There is currently a Race and Ethnicity data element, collected in the MDS, LCDS, IRF-PAI, and OASIS, that consists of a single question, which aligns with the 1997 Office of Management and Budget (OMB) minimum data standards for federal data collection efforts.
We are proposing to revise the current Race and Ethnicity data element for purposes of this proposal to conform to the 2011 HHS Data Standards for person-level data collection, while also meeting the 1997 OMB minimum data
The proposed Race data element asks, “What is your race?” We are proposing to include fourteen response options under the race data element: (1) White; (2) Black or African American; (3) American Indian or Alaska Native; (4) Asian Indian; (5) Chinese; (6) Filipino; (7) Japanese; (8) Korean; (9) Vietnamese; (10) Other Asian; (11) Native Hawaiian; (12) Guamanian or Chamorro; (13) Samoan; and, (14) Other Pacific Islander.
The proposed Ethnicity data element asks, “Are you Hispanic, Latino/a, or Spanish origin?” We are proposing to include five response options under the ethnicity data element: (1) Not of Hispanic, Latino/a, or Spanish origin; (2) Mexican, Mexican American, Chicano/a; (3) Puerto Rican; (4) Cuban; and, (5) Another Hispanic, Latino, or Spanish Origin.
We believe that the two proposed data elements for race and ethnicity conform to the 2011 HHS Data Standards for person-level data collection, while also meeting the 1997 OMB minimum data standards for race and ethnicity, because under those standards, more detailed information on population groups can be collected if those additional categories can be aggregated into the OMB minimum standard set of categories.
In addition, we received stakeholder feedback during the December 13, 2018 SDOH listening session on the importance of improving response options for race and ethnicity as a component of health care assessments and for monitoring disparities. Some stakeholders emphasized the importance of allowing for self-identification of race and ethnicity for more categories than are included in the 2011 HHS Standard to better reflect state and local diversity, while acknowledging the burden of coding an open-ended health care assessment question across different settings.
We believe that the proposed modified race and ethnicity data elements more accurately reflect the diversity of the U.S. population than the current race/ethnicity data element included in MDS, LCDS, IRF-PAI and, OASIS.
In an effort to standardize the submission of race and ethnicity data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we are proposing to adopt the Race and Ethnicity data elements described above as SPADEs with respect to the proposed Social Determinants of Health category.
Specifically, we are proposing to replace the current Race/Ethnicity data element with the proposed Race and Ethnicity data elements on the MDS. We are also proposing that SNFs that submit the Race and Ethnicity data elements with respect to admission will be considered to have submitted with respect to discharge as well, because it is unlikely that the results of these assessment findings will change between the start and end of the SNF stay, making the information submitted with respect to a resident's admission the same with respect to a resident's discharge.
More than 64 million Americans speak a language other than English at home, and nearly 40 million of those individuals have limited English proficiency (LEP).
Presently, the preferred language of residents and patients and need for interpreter services are assessed in two PAC assessment tools. The LCDS and the MDS use the same two data elements to assess preferred language and whether a patient or resident needs or wants an interpreter to communicate with health care staff. The MDS initially implemented preferred language and interpreter services data elements to assess the needs of SNF residents and patients and inform care planning. For alignment purposes, the LCDS later adopted the same data elements for LTCHs. The 2009 NASEM (formerly Institute of Medicine) report on standardizing data for health care quality improvement emphasizes that language and communication needs should be assessed as a standard part of health care delivery and quality improvement strategies.
In developing our proposal for a standardized language data element across PAC settings, we considered the current preferred language and interpreter services data elements that are in LCDS and MDS. We also considered the 2011 HHS Primary Language Data Standard and peer-reviewed research. The current preferred language data element in LCDS and MDS asks, “What is your preferred language?” Because the preferred language data element is open-ended, the patient or resident is able to identify their preferred language, including American Sign Language (ASL). Finally, we considered the recommendations from the 2009 NASEM (formerly Institute of Medicine) report, “Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement.” In it, the committee recommended that organizations evaluating a patient's language and communication needs for health care purposes, should collect data on the preferred spoken language and on an individual's assessment of his/her level of English proficiency.
A second language data element in LCDS and MDS asks, “Do you want or need an interpreter to communicate with a doctor or health care staff?” and includes yes or no response options. In contrast, the 2011 HHS Primary Language Data Standard recommends either a single question to assess how well someone speaks English or, if more granular information is needed, a two-part question to assess whether a language other than English is spoken at home and if so, identify that language. However, neither option allows for a direct assessment of a patient's or resident's preferred spoken or written language nor whether they want or need interpreter services for communication with a doctor or care team, both of which are an important part of assessing resident and patient needs and the care planning process. More information about the HHS Data Standard for Primary Language is available on the website at
Research consistently recommends collecting information about an individual's preferred spoken language and evaluating those responses for purposes of determining language access needs in health care.
In addition, we received feedback during the December 13, 2018 listening session on the importance of evaluating and acting on language preferences early to facilitate communication and allowing for patient self-identification of preferred language. Although the discussion about language was focused on preferred spoken language, there was general consensus among participants that stated language preferences may or may not accurately indicate the need for interpreter services, which supports collecting and evaluating data to determine language preference, as well as the need for interpreter services. An alternate suggestion was made to inquire about preferred language specifically for discussing health or health care needs. While this suggestion does allow for ASL as a response option, we do not have data indicating how useful this question might be for assessing the desired information and thus we are not including this question in our proposal.
Improving how preferred language and need for interpreter services data are collected is an important component of improving quality by helping PAC providers and other providers understand patient needs and develop plans to address them. For more information on the Preferred Language and Interpreter Services data elements, we refer readers to the document titled “Proposed Specifications for SNF QRP Measures and Standardized Patient Assessment Data Elements,” available on the website at
In an effort to standardize the submission of language data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we are proposing to adopt the Preferred Language and Interpreter Services data elements currently used on the MDS, and describe above, as SPADEs with respect to the Social Determinants of Health category.
The Department of Health and Human Services defines health literacy as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”
Health literacy is prioritized by Healthy People 2020 as an SDOH.
The Single Item Literacy Screener (SILS) question asks, “How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?” Possible response options are: (1) Never; (2) Rarely; (3) Sometimes; (4) Often; and (5) Always. The SILS question, which assesses reading ability, (a primary component of health literacy), tested reasonably well against the 36 item Short Test of Functional Health Literacy in Adults (S-TOFHLA), a thoroughly vetted and widely adopted health literacy test, in assessing the likelihood of low health literacy in an adult sample from primary care practices participating in the Vermont Diabetes Information System.
In addition, we received feedback during the December 13, 2018 SDOH listening session on the importance of recognizing health literacy as more than understanding written materials and filling out forms, as it is also important to evaluate whether patients and residents understand their conditions. However, the NASEM recently recommended that health care providers implement health literacy universal precautions instead of taking steps to ensure care is provided at an appropriate literacy level based on individualized assessment of health literacy.
The proposed Health Literacy data element is consistent with considerations raised by NASEM and other stakeholders and research on health literacy, which demonstrates an impact on health care use, cost, and outcomes.
In an effort to standardize the submission of health literacy data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we are proposing to adopt the SILS question, described above for the Health Literacy data element, as SPADE under the Social Determinants of Health Category. We are proposing to add the Health Literacy data element to the MDS.
Transportation barriers commonly affect access to necessary health care, causing missed appointments, delayed care, and unfilled prescriptions, all of which can have a negative impact on health outcomes.
The proposed Transportation data element from the PRAPARE tool asks, “Has lack of transportation kept you from medical appointments, meetings, work, or from getting things needed for daily living?” The three response options are: (1) Yes, it has kept me from medical appointments or from getting my medications; (2) Yes, it has kept me
The proposed data element is responsive to research on the importance of addressing transportation needs as a critical SDOH and would adopt the Transportation item from the PRAPARE tool.
In addition, we received stakeholder feedback during the December 13, 2018 SDOH listening session on the impact of transportation barriers on unmet care needs. While recognizing that there is no consensus in the field about whether providers should have responsibility for resolving patient transportation needs, discussion focused on the importance of assessing transportation barriers to facilitate connections with available community resources.
Adding a Transportation data element to the collection of SPADE would be an important step to identifying and addressing SDOH that impact health outcomes and patient experience for Medicare beneficiaries. For more information on the Transportation data element, we refer readers to the document titled “Proposed Specifications for SNF QRP Measures and Standardized Patient Assessment Data Elements,” available on the website at
In an effort to standardize the submission of transportation data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we are proposing to adopt the Transportation data element described above as SPADE with respect to the Social Determinants of Health category. If finalized as proposed, we would add the Transportation data element to the MDS.
Distinct from loneliness, social isolation refers to an actual or perceived lack of contact with other people, such as living alone or residing in a remote area.
We are proposing to adopt as SPADE a single social isolation data element that is currently part of the AHC Screening Tool. The AHC item was selected from the Patient-Reported Outcomes Measurement Information System (PROMIS®) Item Bank on Emotional Distress and asks, “How often do you feel lonely or isolated from those around you?” The five response options are: (1) Never; (2) Rarely; (3) Sometimes; (4) Often; and (5) Always.
In addition, we received stakeholder feedback during the December 13, 2018 SDOH listening session on the value of receiving information on social isolation for purposes of care planning. Some stakeholders also recommended assessing social isolation as an SDOH as opposed to social support.
The proposed Social Isolation data element is consistent with NASEM considerations about social isolation as a function of social relationships that impacts health outcomes and increases mortality risk, as well as the current work of a NASEM committee examining how social isolation and loneliness impact health outcomes in adults 50
In an effort to standardize the submission of social isolation data among IRFs, HHAs, SNFs and LTCHs, for the purposes outlined in section 1899B(a)(1)(B) of the Act, while minimizing the reporting burden, we are proposing to adopt the Social Isolation data element described above as SPADE with respect to the proposed Social Determinants of Health category. We are proposing to add the Social Isolation data element to the MDS.
We are soliciting comment on these proposals.
We refer readers to the regulatory text at § 413.360(b) for information regarding the current policies for reporting SNF QRP data.
SNFs are currently required to submit MDS data to CMS using the Quality Improvement and Evaluation System (QIES) Assessment and Submission Processing (ASAP) system. We will be migrating to a new internet Quality Improvement and Evaluation System (iQIES) that will enable real-time upgrades over the next few years, and we are proposing to designate that system as the data submission system for the SNF QRP once it becomes available, but no later than October 1, 2021.
We are proposing to revise our regulatory text at § 413.360(a) by replacing “Certification and Survey Provider Enhanced Reports (CASPER)” with “CMS designated data submission”. We are proposing to revise our regulatory text at § 413.360(d)(1) by replacing the reference to the “Quality Improvement Evaluation System (QIES) Assessment Submission and Processing (ASAP)” with “CMS designated data submission” and § 413.360(d)(4) by replacing the reference to “QIES ASAP” with “CMS designated data submission system” effective October 1, 2019. In addition we are proposing to notify the public of any future changes to the CMS designated system using subregulatory mechanisms, such as website postings, listserv messaging, and webinars.
We invite public comments on this proposal.
As discussed in section VI.A.4. of this proposed rule, we are proposing to adopt the Transfer of Health Information to Provider-Post-Acute Care (PAC) and Transfer of Health Information to Patient-Post-Acute Care (PAC) quality measures beginning with the FY 2022 SNF QRP. We also are proposing that SNFs would report the data on those measures using the MDS. SNFs would be required to collect data on both measures for residents beginning with October 1, 2020 discharges.
We refer readers to the FY 2018 SNF PPS final rule (82 FR 36601 through 36603) for the data collection and submission time frames that we finalized for the SNF QRP.
We invite public comment on this proposal.
As discussed in section VI.A.6. of this proposed rule, we are proposing to adopt SPADEs beginning with the FY 2022 SNF QRP. We are proposing that SNFs would report the data using the MDS. Similar to the proposed schedule for reporting the Transfer of Health Information to the Provider-Post-Acute Care (PAC) and Transfer of Health Information to the Patient-Post-Acute Care (PAC) quality measures, SNFs would be required to collect the SPADEs for residents beginning with October 1, 2020 admissions and discharges. SNFs that submit data with respect to admission for the Hearing, Vision, Race, and Ethnicity SPADEs would be considered to have submitted data with respect to discharges. We refer readers to the FY 2018 SNF PPS final rule (82 FR 36601 through 36603) for the data collection and submission time frames that we finalized for the SNF QRP.
We have received public input suggesting that the quality measures used in the SNF QRP should be calculated using data collected from all residents receiving SNF services, regardless of the residents' payer. This input was provided to us via comments requested about quality measure development on the CMS Measures Management System Blueprint website,
In response to that request for public input, several commenters, including MedPAC, submitted comments stating that they would be supportive of an effort to collect data specified under the SNF QRP from all SNF residents regardless of their payer. Benefits highlighted by commenters included that such data would serve to better inform beneficiaries on the broader quality of the entire SNF, as well as more comprehensive quality improvement efforts across payers. MedPAC also highlighted that while the data collection activity incurs some
Further, we believe that the most accurate representation of the quality provided in SNFs to Medicare residents would be best conveyed using data collected via the MDS on all SNF residents, regardless of payer.
Accordingly, we are proposing that for purposes of meeting the requirements of the SNF QRP, SNF would be required to collect and submit MDS data on all SNF residents regardless of their payer. We believe that this proposal will ensure that Medicare residents are receiving the same quality of SNF care as other residents.
While we appreciate that collecting quality data on all residents regardless of payer may create additional burden, we are aware that many SNFs currently collect MDS data on all residents, regardless of their payer, and that some SNFs may consider it burdensome to separate out Medicare beneficiaries from other residents for purposes of submitting the assessments to CMS.
We also note that collecting data on all SNF residents, regardless of their payer, would align our data collection requirements under the SNF QRP with the data collection requirements we have adopted for the LTCH QRP and Hospice QRP.
This proposal, if finalized, would be effective beginning with the FY 2022 program year.
We invite public comment on this proposal.
Section 1899B(g) of the Act requires the Secretary to establish procedures for making the SNF QRP data available to the public after ensuring that SNFs have the opportunity to review their data prior to public display. Measure data are currently displayed on the Nursing Home Compare website, an interactive web tool that assists individuals by providing information on SNF quality of care. For more information on Nursing Home Compare, we refer readers to the website at
In this proposed rule, we are proposing to begin publicly displaying data for the Drug Regimen Review Conducted With Follow-Up for Identified Issues—Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) measure beginning CY 2020 or as soon as technically feasible. We finalized the Drug Regimen Review Conducted With Follow-Up for Identified Issues—Post Acute Care (PAC) Skilled Nursing Facility (SNF) Quality Reporting Program (QRP) measure in the FY 2017 SNF PPS final rule (81 FR 52034 through 52039).
Data collection for this assessment-based measure began with patients admitted and discharged on or after October 1, 2018. We are proposing to display data based on four rolling quarters, initially using discharges from January 1, 2019 through December 31, 2019 (Quarter 1 2019 through Quarter 4 2019). To ensure the statistical reliability of the data, we are proposing that we would not publicly report a SNF's performance on the measure if the SNF had fewer than 20 eligible cases in any four consecutive rolling quarters. SNFs that have fewer than 20 eligible cases would be distinguished with a footnote that states, “The number of cases/resident stays is too small to publicly report”. We invite public comment on our proposal.
Section 215(b) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) authorized the SNF VBP Program (the “Program”) by adding section 1888(h) to the Act. As a prerequisite to implementing the SNF VBP Program, in the FY 2016 SNF PPS final rule (80 FR 46409 through 46426), we adopted an all-cause, all-condition hospital readmission measure, as required by section 1888(g)(1) of the Act and discussed other policies to implement the Program such as performance standards, the performance period and baseline period, and scoring. In the FY 2017 SNF PPS final rule (81 FR 51986 through 52009), we adopted an all-condition, risk-adjusted potentially preventable hospital readmission measure for SNFs, as required by section 1888(g)(2) of the Act, and adopted policies on performance standards, performance scoring, and sought comment on an exchange function methodology to translate SNF performance scores into value-based incentive payments, among other topics. In the FY 2018 SNF PPS final rule (82 FR 36608 through 36623), we adopted additional policies for the Program, including an exchange function methodology for disbursing value-based incentive payments. Additionally, in the FY 2019 SNF PPS final rule (83 FR 39272 through 39282), we adopted more policies for the Program, including a scoring adjustment for low-volume facilities.
The SNF VBP Program applies to freestanding SNFs, SNFs affiliated with acute care facilities, and all non-CAH swing-bed rural hospitals. Section 1888(h)(1)(B) of the Act requires that the SNF VBP Program apply to payments for services furnished on or after October 1, 2018. We believe the implementation of the SNF VBP Program is an important step towards transforming how care is paid for, moving increasingly towards rewarding better value, outcomes, and innovations instead of merely rewarding volume.
For additional background information on the SNF VBP Program, including an overview of the SNF VBP Report to Congress and a summary of the Program's statutory requirements, we refer readers to the FY 2016 SNF PPS final rule (80 FR 46409 through 46410). We also refer readers to the FY 2017 SNF PPS final rule (81 FR 51986 through 52009) for discussion of the policies that we adopted related to the potentially preventable hospital readmission measure, scoring, and other topics. We refer readers to the FY 2018 SNF PPS final rule (82 FR 36608 through 36623) for discussions of the policies that we adopted related to value-based incentive payments, the exchange function, and other topics. Finally, we refer readers to the FY 2019 SNF PPS final rule (83 FR 39272 through 39282), where we adopted a corrections policy for numerical values of performance standards, a scoring adjustment for low-volume facilities, and addressed other topics.
For background on the measures we have adopted for the SNF VBP Program, we refer readers to the FY 2016 SNF PPS final rule (80 FR 46419), where we finalized the Skilled Nursing Facility 30-Day All-Cause Readmission Measure (SNFRM) (NQF #2510) that we are currently using for the SNF VBP Program. We also refer readers to the FY 2017 SNF PPS final rule (81 FR 51987 through 51995), where we finalized the Skilled Nursing Facility 30-Day Potentially Preventable Readmission Measure (SNFPPR) that we will use for the SNF VBP Program instead of the
In the FY 2017 SNF PPS final rule (81 FR 51987 to 51995), we adopted the SNFPPR as the SNF all-condition risk-adjusted potentially preventable hospital readmission measure for the SNF VBP Program to meet the requirements in section 1888(g)(2) of the Act. This claims-based measure assesses the facility-level risk-standardized rate of unplanned, potentially preventable hospital readmissions for SNF patients within 30 days of discharge from a prior admission to an Inpatient Prospective Payment System (IPPS) hospital, CAH, or psychiatric hospital. However, we have not yet transitioned the SNF VBP Program to using the SNFPPR.
The SNFPPR is one of two potentially preventable readmission measures specified for use in the SNF setting. The SNFPPR is specified for use for the SNF VBP Program and a second measure, the Potentially Preventable 30-Day Post-Discharge Readmission Measure for Skilled Nursing Facility Quality Reporting Program, is specified for use in the SNF QRP. While these two measures are aligned in terms of exclusion criteria and risk adjustment approach, they differ in their readmission windows. The SNFPPR utilizes a 30-day post-hospital discharge readmission window whereas the SNF QRP potentially preventable readmission measure utilizes a 30-day post-SNF discharge readmission window, consistent with the discharge readmission window specified in other measures we have developed with respect to domains described in section 1899B of the Act, such as the Potentially Preventable 30-Day Post-Discharge Readmission Measure for Inpatient Rehabilitation Facility QRP and the Potentially Preventable 30-Day Post-Discharge Readmission Measure for Home Health QRP.
As described in the FY 2017 SNF PPS final rule (81 FR 51992), our rationale for having two different measures was that the readmission window associated with each measure assesses different aspects of SNF care. The readmission window for the SNFPPR measure was developed to align with the SNFRM which was previously adopted for the SNF VBP Program. Both the SNFRM and SNFPPR measure specifications, including the readmission window, were designed to harmonize with CMS's Hospital Wide All-Cause Unplanned Readmission (HWR) measure used in the Hospital IQR Program. The advantage of this window is that it assesses readmissions both during the SNF stay and post-SNF discharge for most SNF patients, depending on the SNF length of stay (LOS).
The readmission window used for the SNF QRP measure aligns with the readmission window used in other readmission measures for post-acute care (PAC) providers. The focus of this post-PAC only discharge readmission window is on assessing potentially preventable hospital readmissions during the 30 days after discharge from the PAC provider.
While the SNFPPR and the SNF QRP potentially preventable readmission measures assess different aspects of SNF care, we have received stakeholder feedback that having two SNF potentially preventable readmission measures has caused confusion. To minimize the confusion surrounding these two different measures, we are changing the name of the SNFPPR to Skilled Nursing Facility Potentially Preventable Readmissions after Hospital Discharge. We believe this new measure name will clearly differentiate the SNF VBP potentially preventable readmission measure from the SNF QRP potentially preventable readmission measure, thereby reducing stakeholder confusion. We intend to submit the SNFPPR measure, hereafter referred to as the Skilled Nursing Facility Potentially Preventable Readmissions after Hospital Discharge measure, to the National Quality Forum (NQF) for endorsement review as soon as that is feasible.
We refer readers to the FY 2016 SNF PPS final rule (80 FR 46422) for a discussion of our considerations for determining performance periods under the SNF VBP Program. Based on those considerations, as well as public comment, we adopted CY 2017 as the performance period for the FY 2019 SNF VBP Program, with a corresponding baseline period of CY 2015.
Additionally, in the FY 2018 SNF PPS final rule (82 FR 36613 through 36614), we adopted FY 2018 as the performance period for the FY 2020 SNF VBP Program, with a corresponding baseline period of FY 2016. We refer readers to that rule for a discussion of the need to shift the Program's measurement periods from the calendar year to the fiscal year. Finally, we refer readers to the FY 2019 SNF PPS final rule (83 FR 39277 through 39278), where we adopted FY 2019 as the performance period for the FY 2021 program year, with a corresponding baseline period of FY 2017. In that final rule, we also adopted a policy where we would adopt for each program year a performance period that is the 1-year period following the performance period for the previous program year. We adopted a similar policy for the baseline period, where we stated that we would adopt for each program year a baseline period that is the 1-year period following the baseline period for the previous year.
Under this policy, the performance period for the FY 2022 program year will be FY 2020, and the baseline period will be FY 2018.
We refer readers to the FY 2017 SNF PPS final rule (81 FR 51995 through 51998) for a summary of the statutory provisions governing performance standards under the SNF VBP Program and our finalized performance standards policy, as well as the numerical values for the achievement threshold and benchmark for the FY 2019 program year. We also responded to public comments on these policies in that final rule.
We published the final numerical values for the FY 2020 performance standards in the FY 2018 SNF PPS final rule (82 FR 36613) and published the final numerical values for the FY 2021 performance standards in the FY 2019 SNF PPS final rule (83 FR 39276). We also adopted a policy allowing us to correct the numerical values of the performance standards in the FY 2019 SNF PPS final rule (83 FR 39276 through 39277).
As we discuss in this proposed rule, we will adopt FY 2018 as the baseline period for the FY 2022 program year under our previously-adopted policy of advancing the performance and baseline period for each program year automatically.
Based on the baseline period for the FY 2022 program year, we are estimating that the performance standards would have the numerical values noted in Table 14. We note that these values represent estimates based on the most recently-available data, and we will update the numerical values in the FY 2020 SNF PPS final rule.
We refer readers to the FY 2017 SNF PPS final rule (81 FR 52000 through 52005) for a detailed discussion of the scoring methodology that we have finalized for the Program, along with responses to public comments on our policies and examples of scoring calculations. We also refer readers to the FY 2018 SNF PPS final rule (82 FR 36614 through 36616) for discussion of the rounding policy we adopted, our request for comments on SNFs with zero readmissions, and our request for comments on a potential extraordinary circumstances exception policy.
We also refer readers to the FY 2019 SNF PPS final rule (83 FR 39278 through 39281), where we adopted (1) A scoring policy for SNFs without sufficient baseline period data, (2) a scoring adjustment for low-volume SNFs, and (3) an extraordinary circumstances exception policy.
We are not proposing any updates to SNF VBP scoring policies in this proposed rule.
We refer readers to the FY 2018 SNF PPS final rule (82 FR 36616 through 36621) for discussion of the exchange function methodology that we have adopted for the Program, as well as the specific form of the exchange function (logistic, or S-shaped curve) that we finalized, and the payback percentage of 60 percent. We adopted these policies for FY 2019 and subsequent fiscal years.
We also discussed the process that we undertake for reducing SNFs' adjusted Federal per diem rates under the Medicare SNF PPS and awarding value-based incentive payments in the FY 2019 SNF PPS final rule (83 FR 39281 through 39282).
For estimates of FY 2020 SNF VBP Program incentive payment multipliers, we encourage SNFs to refer to FY 2019 SNF VBP Program performance information, available at:
We are not proposing any updates to SNF VBP payment policies in this proposed rule. However, for the reader's information, we modeled the estimated impacts of the low-volume adjustment policy that we established in the FY 2019 SNF PPS final rule for FY 2020 and estimate that the application of the low-volume adjustment policy to the FY 2020 program year would redistribute an additional $8.1 million to these low-volume SNFs for that program year. This would increase the 60 percent payback percentage for FY 2020 by approximately 1.51 percent, resulting in a payback percentage for FY 2020 that is 61.51 percent of the estimated $534.1 million in withheld funds for that fiscal year.
Section 1888(g)(6) of the Act requires the Secretary to establish procedures to make SNFs' performance information on SNF VBP Program measures available to the public on the Nursing Home Compare website or a successor, and to provide SNFs an opportunity to review and submit corrections to that information prior to its publication. We began publishing SNFs' performance information on the SNFRM in accordance with this directive and the statutory deadline of October 1, 2017.
Additionally, section 1888(h)(9)(A) of the Act requires the Secretary to make available to the public certain information on SNFs' performance under the SNF VBP Program, including SNF Performance Scores and their ranking. Section 1888(h)(9)(B) of the Act requires the Secretary to post aggregate information on the Program, including the range of SNF Performance Scores and the number of SNFs receiving value-based incentive payments, and the range and total amount of those payments.
In the FY 2017 SNF PPS final rule (81 FR 52009), we discussed the statutory requirements governing public reporting of SNFs' performance information under the SNF VBP Program. We also sought and responded to public comments on issues that we should consider when posting performance information on Nursing Home Compare or a successor website. In the FY 2018 SNF PPS final rule (82 FR 36622 through 36623), we finalized our policy to publish SNF measure performance information under the SNF VBP Program on Nursing Home Compare after SNFs have had an opportunity to review and submit corrections to that information under the two-phase Review and Corrections process that we adopted in the FY 2017 SNF PPS final rule (81 FR 52007 through 52009) and for which we adopted additional requirements in the FY 2018 SNF PPS final rule. In the FY 2018 SNF PPS final rule, we also adopted requirements to rank SNFs and adopted data elements that we will include in the ranking to provide consumers and stakeholders with the necessary information to evaluate SNFs' performance under the Program.
As we have considered issues associated with public reporting of SNFs' performance information on the Nursing Home Compare website, we have identified an issue that we believe warrants additional discussion. Specifically, we are concerned that the performance information available for display for a specific SNF may, as a result of the application of two policies we have finalized for the Program, be confusing to the public. Specifically, SNFs with fewer than 25 eligible stays during the baseline period for a fiscal year will only be scored on achievement and will not have improvement information available for display. In addition, a SNF with fewer than 25 eligible stays during a performance period will receive an assigned SNF performance score for that Program year that results in a value-based incentive payment amount equal to the adjusted federal per diem rate that the SNF would have received for the fiscal year in the absence of the Program.
In these cases, we do not believe it would be appropriate to suppress the SNF's information entirely given the statutory requirements in section 1888(h)(9)(A) of the Act to publicly report SNF-specific information, but we are concerned about publishing performance information that is not
Based on these considerations, we propose to suppress the SNF information available to display as follows: (1) If a SNF has fewer than 25 eligible stays during the baseline period for a Program year, we would not display the baseline RSRR or improvement score, though we would still display the performance period RSRR, achievement score and total performance score if the SNF had sufficient data during the performance period; (2) if a SNF has fewer than 25 eligible stays during the performance period for a Program year and receives an assigned SNF performance score as a result, we would report the assigned SNF performance score and we would not display the performance period RSRR, the achievement score or improvement score; and (3) if a SNF has zero eligible cases during the performance period for a Program year, we would not display any information for that SNF. Based on historical data, we estimate that approximately 16 percent of SNFs will have fewer than 25 eligible stays during the performance period and similarly approximately 16 percent of SNFs will have fewer than 25 stays in the baseline period for FY 2020.
We believe that this policy will ensure that we publish as much information as possible about the SNF VBP Program's performance assessments while ensuring that the published information is reliable and based on a sufficient quantity of information. We further believe that this policy will provide stakeholders with meaningful information about SNFs' performance under the Program.
We welcome public comment on this proposal.
In the FY 2017 SNF PPS final rule (81 FR 52007 through 52009), we adopted a two-phase review and corrections process for SNFs' quality measure data that will be made public under section 1888(g)(6) of the Act and SNF performance information that will be made public under section 1888(h)(9) of the Act. We explained that we would accept corrections to the quality measure data used to calculate the measure rates that are included in any SNF's quarterly confidential feedback report, and that we would provide SNFs with an annual confidential feedback report containing the performance information that will be made public. We detailed the process for requesting Phase One corrections and finalized a policy whereby we would accept Phase One corrections to any quarterly report provided during a calendar year until the following March 31.
However, as we have continued implementation of the SNF VBP Program, we have reconsidered what deadline would be appropriate for the Phase One correction process. Our experience managing the 2019 SNF VBP Program has shown that fewer than 10 facilities submitted sufficient correction information under the Phase One correction process after October 1, 2018 and before March 31, 2019. Additionally, we are concerned about the effects of the March 31 deadline on value-based incentive payment calculations since the deadline is currently 6 months after payment incentives begin. For example, performance score reports for the FY 2019 SNF VBP Program were provided in August 2018 and incentive payments for that FY were made beginning with services provided on October 1, 2018, but SNFs still had until March 31, 2019 to make a correction. We believe that the March 31 deadline also creates uncertainty for SNFs because, as shown above in the timeline that applied to the FY 2019 Program, their payment incentives could potentially change 6 months after they take effect. If we approve a correction request, we then need to reprocess several months of claims for the SNF in question and potentially need to adjust the exchange function for the fiscal year depending on the scope of the correction and its effects on the payback percentage pool for the fiscal year. We do not believe these outcomes are beneficial to the Program or to SNFs that would have less predictability about their incentive payment percentages for the fiscal year. We believe that the lack of predictability for SNF payment percentages might adversely impact SNF financial planning because payment amounts would not be set for all SNFs until after the March 31 deadline.
We believe that we can mitigate this uncertainty by adopting a 30-day deadline for Phase One correction requests, and note that this proposal would align the Phase One review and correction process with the Phase Two process. Under current operations, we issue a report in June that contains all of the underlying claim information used to calculate the measure rate for the program year, as well as the measure rate itself. We are proposing that SNFs would have 30 days from the date that we issue that report to review the claims and measure rate information and to submit to us a correction request if the SNF believes that any of that information is inaccurate. We note that this proposal would not preclude a SNF from submitting a correction request for any claims for which it discovers an error prior to receiving the June report. However, the 30 day review and correction period would commence on the day that we issue the June report, and a SNF would not be able to request that we correct any underlying claims or its measure rate after the conclusion of that 30 day period.
We are proposing this deadline in lieu of the current March 31 deadline for Phase One corrections. We note that we initially proposed to adopt a 30-day deadline for Phase One corrections in the FY 2017 SNF PPS proposed rule (81 FR 24255), though we finalized a deadline of March 31 following the calendar year in which we provide the report. We adopted that extended deadline to balance our desire to ensure that measure data are sufficiently accurate with SNFs' need for sufficient information with which to evaluate those reports, as well as to provide SNFs with more time to review each quarter's data. In addition, we encouraged SNFs to review the quarterly reports provided with stay-level information and make any corrections to claims before the proposed deadline. However, for the reasons discussed above, we now believe that a 30-day timeframe is sufficient for SNFs to determine if there were errors in its measure calculation by CMS or its contractor.
We believe that this policy will ensure that the underlying claims data that we use to calculate quality measure performance for the SNF VBP Program will be finalized prior to their use in scoring and payment calculations. We believe that this policy will also ensure that any corrections submitted under Phase One do not result in changes to quality measure data months after incentive payment calculations, which will also avoid changes to the exchange function, and as a result, changes to other SNFs' value-based incentive payment percentages for a fiscal year because of data errors for any SNFs. Our experience managing the 2019 SNF VBP Program indicates that very few SNFs would be adversely impacted by the earlier deadline. We also seek to provide SNFs with earlier final annual payment percentage information for their financial planning purposes.
We welcome public comments on this proposal.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
To fairly evaluate whether an information collection should be approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit comment on the following issues:
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our burden estimates.
• The quality, utility, and clarity of the information to be collected.
• Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques.
We are soliciting public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs).
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2017 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, 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 overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, we believe that doubling the mean hourly wage to help estimate the total cost is a reasonably accurate estimation method.
The following proposed changes will be submitted to OMB for approval under control number 0938-1140 (CMS-10387). The changes would not impose any new or revised burden. Subject to renewal, the control number is currently set to expire on February 28, 2022. It was last approved on February 12, 2019, and remains active.
The Minimum Data Set (MDS) is part of the process for the clinical assessment of all SNF residents and serves multiple purposes. It is used as a data collection tool for SNFs in the PPS to inform the Patient Driven Payment Model (PDPM) for the purpose of reimbursement, for the SNF QRP for the purpose of monitoring the quality of care in SNFs, and under the requirements of Omnibus Budget Reconciliation Act (OBRA) 1987 for the collection of data for the purposes of comprehensive resident assessment, quality and care planning for SNF residents.
Under sections 4204(b) and 4214(d) of OBRA 1987, requirements related to the submission and retention of resident assessment data are not subject to the PRA. The MDS assessments that are used to inform payment consist of the PPS 5-day assessment, the PPS discharge assessment, and the optional Interim Payment Assessment (IPA). The requirements necessary to administer the payment rate methodology described in 42 CFR 413.337 are subject to the PRA. Thus, the PPS 5-day, PPS discharge, and IPA assessments are subject to the PRA and are active under OMB control number 0938-1140.
Section 2(a) of the IMPACT Act amended the statute by adding section 1899B to the Act, which requires, among other things, SNFs to report standardized patient assessment data, data on quality measures, and data on resource use and other measures. Under section 1899B(m) of the Act, modifications to the SNF assessment instrument, the MDS, required to achieve standardization of patient assessment data are exempt from PRA requirements. However, if the data elements for quality measures and standardized patient assessment data are finalized as proposed, then we believe that we will have met the requirements for standardization of patient assessment data. Therefore, the exemption of the SNF QRP from the PRA is no longer applicable such that the SNF QRP requirements and burden will be submitted to OMB for review and approval. The active ICR serves as the basis for which we now address the previously exempt requirements and burden.
Under our active information collection, only the PPS 5-day and PPS discharge assessments used in the PDPM are also used as the assessments for collecting quality measure and standardized patient assessment data under the SNF QRP. Our active burden sets out 51 minutes (0.85 hours) per PPS 5-day assessment and 51 minutes per PPS discharge assessment. Consistent with the FY 2019 SNF PPS final rule (August 8, 2018; 83 FR 39283) we continue to use the OMRA assessment (with 272 items) to estimate the amount of time to complete a PPS assessment. This is also consistent with our active information collection. In sections VI.A.4 and VI.A.7 of this rule, we propose to add 60.5 items across the PPS 5-day and PPS discharge assessments. Given that the PPS OMRA item set has 272 items (as compared to the PPS discharge assessment with 143 items) that are approved under our active collection, the added items, while increasing burden for each of the assessments, have no impact on our currently approved burden estimates since the active collection uses the PPS
When calculating the burden for each assessment, we estimate it will take 40 minutes (0.6667 hours) at $70.72/hr for an RN to collect the information necessary for preparing the assessment, 10 minutes (0.1667 hours) at $55.95/hr (the average hourly wage for RN ($70.72/hr) and health information technician ($41.18/hr)) for staff to code the responses, and 1 minute (0.0167 hours) at $41.18/hr for a health information technician to transmit the results. In total, we estimate that it will take 51 minutes (0.85 hours) to complete a single PPS assessment. Based on the adjusted hourly wages for the noted staff, we estimate that it will cost $57.17 [($70.72/hr × 0.6667 hr) + ($55.95/hr × 0.1667 hr) + ($41.18/hr × 0.0167 hr)] to prepare, code, and transmit each PPS assessment.
Based on our most current data, there are 15,471 Medicare Part A SNFs. Based on FY 2017 data, we estimate that 2,406,401 5-day PPS assessments will be completed and submitted by Part A SNFs each year under the PDPM and SNF QRP. We used the same number of assessments (2,406,401) as a proxy for the number of PPS discharge assessments that would be completed and submitted each year, since all residents who require a 5-day PPS assessment will also require a discharge assessment under the PDPM and SNF QRP. We use the Significant Change in Status Assessment (SCSA) as a proxy to estimate the number of IPAs as the criteria for completing an SCSA is similar to that for the IPA. Based on FY 2017 data, 92,240 IPAs would be completed per year under the PDPM.
The total number of PPS 5-day assessments, PPS discharge assessments, and IPAs that would be completed across all facilities is 4,905,042 assessments (2,406,401 + 2,406,401 + 92,240, respectively). The total estimated time for all assessments across all facilities is 4,169,286 hours per year (4,905,042 assessments × 0.85 hours/assessment). For all assessments across all facilities, we estimate a burden of $280,421,251 (4,905,042 assessments × $57.17/assessment).
Given that our proposal to add 60.5 items across the PPS 5-day and PPS discharge assessments is accounted for by using the OMRA assessment as a proxy for all assessments, and given that our estimate for the number of Medicare Part A SNFs and for the number PPS 5-day and PPS discharge assessments completed and submitted by Part A SNFs each year remains unchanged, we are not proposing to revise or adjust any of our active burden estimates. In this regard, we will be submitting a revised information collection request to OMB to account for the added items.
In section VI.A.8.b. of this proposed rule, there are no burden implications associated with updating the data submission system to the iQIES for the SNF QRP once it becomes available, but no later than October 1, 2021. This designation is a replacement of the existing QIES ASAP data submission system and imposes no additional requirements or burden on the part of SNFs.
We are not proposing to remove, add, or revise any of our SNF VBP measure-related requirements or burden. Because this proposed rule would not impose any new or revised SNF VBP collection of information requirements or burden, the rule contains no SNF-VBP related collections of information that would be subject to OMB approval under the authority of the PRA.
We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements. The requirements are not effective until they have been approved by OMB.
We invite public comments on our proposed information collection requirements/burden. If you wish to comment, please identify the rule (CMS-1718-P) along with the information collection's CMS ID number (CMS-10387) and OMB control number (0938-1140).
To obtain copies of the supporting statement and any applicable supplementary materials, you may make your request using one of following:
1. Access CMS' website address at
2. Email your request, including your address, phone number, OMB control number, and CMS document identifier to
3. Call the Reports Clearance Office at 410-786-1326.
See this rule's
Because of the large number of public comments we normally receive on
This proposed rule would update the FY 2019 SNF prospective payment rates as required under section 1888(e)(4)(E) of the Act. It also responds to section 1888(e)(4)(H) of the Act, which requires the Secretary to provide for publication
We have examined the impacts of this proposed 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), 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)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated an economically significant rule, under section 3(f)(1) of Executive Order 12866. Accordingly, we have prepared a regulatory impact analysis (RIA) as further discussed below. Also, the rule has been reviewed by OMB.
This proposed rule sets forth updates of the SNF PPS rates contained in the SNF PPS final rule for FY 2019 (83 FR 39162). We estimate that the aggregate impact will be an increase of approximately $887 million in payments to SNFs in FY 2020, resulting from the SNF market basket update to the payment rates. We note that these impact numbers do not incorporate the SNF VBP reductions that we estimate will total $527.4 million in FY 2020. We would note that events may occur to limit the scope or accuracy of our impact analysis, as this analysis is future-oriented, and thus, very susceptible to forecasting errors due to events that may occur within the assessed impact time period.
In accordance with sections 1888(e)(4)(E) and 1888(e)(5) of the Act, we update the FY 2019 payment rates by a factor equal to the market basket index percentage change adjusted by the MFP adjustment to determine the payment rates for FY 2020. The impact to Medicare is included in the total column of Table 17. In updating the SNF PPS rates for FY 2020, we made a number of standard annual revisions and clarifications mentioned elsewhere in this proposed rule (for example, the update to the wage and market basket indexes used for adjusting the federal rates).
The annual update set forth in this proposed rule applies to SNF PPS payments in FY 2020. Accordingly, the analysis of the impact of the annual update that follows only describes the impact of this single year. Furthermore, in accordance with the requirements of the Act, we will publish a rule or notice for each subsequent FY that will provide for an update to the payment rates and include an associated impact analysis.
The FY 2020 SNF PPS payment impacts appear in Table 17. Using the most recently available data, in this case FY 2018, we apply the current FY 2019 wage index and labor-related share value to the number of payment days to simulate FY 2019 payments. Then, using the same FY 2018 data, we apply the proposed FY 2020 wage index and labor-related share value to simulate FY 2020 payments. We tabulate the resulting payments according to the classifications in Table 17 (for example, facility type, geographic region, facility ownership), and compare the simulated FY 2019 payments to the simulated FY 2020 payments to determine the overall impact. The breakdown of the various categories of data Table 17 follows:
• The first column shows the breakdown of all SNFs by urban or rural status, hospital-based or freestanding status, census region, and ownership.
• The first row of figures describes the estimated effects of the various changes on all facilities. The next six rows show the effects on facilities split by hospital-based, freestanding, urban, and rural categories. The next nineteen rows show the effects on facilities by urban versus rural status by census region. The last three rows show the effects on facilities by ownership (that is, government, profit, and non-profit status).
• The second column shows the number of facilities in the impact database.
• The third column shows the effect of the transition to PDPM. This represents the effect on providers, assuming no changes in behavior or case-mix, from changing the case-mix classification model used to classify patients in a Medicare Part A SNF stay. The total impact of this change is 0.0 percent; however, there are distributional effects of this change.
• The fourth column shows the effect of the annual update to the wage index. This represents the effect of using the most recent wage data available. The total impact of this change is 0.0 percent; however, there are distributional effects of the change.
• The fifth column shows the effect of all of the changes on the FY 2020 payments. The update of 2.5 percent is constant for all providers and, though not shown individually, is included in the total column. It is projected that aggregate payments will increase by 2.5 percent, assuming facilities do not change their care delivery and billing practices in response.
As illustrated in Table 17, the combined effects of all of the changes vary by specific types of providers and by location. For example, due to changes in this proposed rule, providers in the urban Pacific region would experience a 1.7 percent increase in FY 2020 total payments.
Estimated impacts for the SNF QRP are based on analysis discussed in section VII.B.1. of this proposed rule. The proposed SNF QRP requirements add no additional burden to the active OMB #0938-1140 (CMS-10387).
Estimated impacts of the FY 2020 SNF VBP Program are based on historical data and appear in Table 18. We modeled SNF performance in the Program using SNFRM data from CY 2015 as the baseline period and CY 2017 as the performance period. Additionally, we modeled a logistic exchange function with a payback percentage of 60 percent, as we finalized in the FY 2018 SNF PPS final rule (82 FR 36619 through 36621), though we note that the 60 percent payback percentage for FY 2020 will adjust to account for the low-volume scoring adjustment that we adopted in the FY 2019 SNF PPS final rule (83 FR 39278 through 39280). Based on the 60 percent payback percentage (as modified by the low-income scoring adjustment), we estimate that we will redistribute approximately $320.4 million in value-based incentive payments to SNFs in FY 2020, which means that the SNF VBP Program is estimated to result in approximately $213.6 million in savings to the Medicare Program in FY 2020. We refer readers to the FY 2019 SNF PPS final rule (83 FR 39278 through 39280) for additional information about payment adjustments for low-volume SNFs in the SNF VBP Program.
Our detailed analysis of the impacts of the FY 2020 SNF VBP Program follows in Table 18.
As described in this section, we estimated that the aggregate impact for FY 2020 under the SNF PPS will be an increase of approximately $887 million in payments to SNFs, resulting from the SNF market basket update to the payment rates.
Section 1888(e) of the Act establishes the SNF PPS for the payment of Medicare SNF services for cost reporting periods beginning on or after July 1, 1998. This section of the statute prescribes a detailed formula for calculating base payment rates under the SNF PPS, and does not provide for the use of any alternative methodology. It specifies that the base year cost data to be used for computing the SNF PPS payment rates must be from FY 1995 (October 1, 1994, through September 30, 1995). In accordance with the statute, we also incorporated a number of elements into the SNF PPS (for example, case-mix classification methodology, a market basket index, a wage index, and the urban and rural distinction used in the development or adjustment of the federal rates). Further, section 1888(e)(4)(H) of the Act specifically requires us to disseminate the payment rates for each new FY through the
As required by OMB Circular A-4 (available online at
This proposed rule sets forth updates of the SNF PPS rates contained in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on the above, we estimate that the overall payments for SNFs under the SNF PPS in FY 2020 are projected to increase by approximately $887 million, or 2.5 percent, compared with those in FY 2019. We estimate that in FY 2020 under PDPM, SNFs in urban and rural areas will experience, on average, a 1.8 percent increase and 6.4 percent increase, respectively, in estimated payments compared with FY 2019. Providers in the urban Outlying region will experience the largest estimated increase in payments of approximately 61.3 percent. Providers in the urban Middle Atlantic region will experience the largest estimated decrease in payments of 0.8 percent.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, non-profit organizations, and small governmental jurisdictions. Most SNFs and most other providers and suppliers are small entities, either by reason of their non-profit status or by having revenues of $27.5 million or less in any 1 year. We utilized the revenues of individual SNF providers (from recent Medicare Cost Reports) to classify a small business, and not the revenue of a larger firm with which they may be affiliated. As a result, for the purposes of the RFA, we estimate that almost all SNFs are small entities as that term is used in the RFA, according to the Small Business Administration's latest size standards (NAICS 623110), with total revenues of $27.5 million or less in any 1 year. (For details, see the Small Business Administration's website at
This proposed rule sets forth updates of the SNF PPS rates contained in the SNF PPS final rule for FY 2019 (83 FR 39162). Based on the above, we estimate that the aggregate impact for FY 2020 will be an increase of $887 million in payments to SNFs, resulting from the SNF market basket update to the payment rates. While it is projected in Table 18 that most providers would experience a net increase in payments, we note that some individual providers within the same region or group may experience different impacts on payments than others due to the distributional impact of the FY 2020 wage indexes, PDPM transition and the degree of Medicare utilization.
Guidance issued by the Department of Health and Human Services on the proper assessment of the impact on small entities in rulemakings, utilizes a cost or revenue impact of 3 to 5 percent as a significance threshold under the RFA. In their March 2019 Report to Congress (available at
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of an MSA and has fewer than 100 beds. This proposed rule will affect small rural hospitals that (1) furnish SNF services under a swing-bed agreement or (2) have a hospital-based SNF. We anticipate that the impact on small rural hospitals will be a positive impact. Moreover, as noted in previous SNF PPS final rules (most recently, the one for FY 2019 (83 FR 39288)), the category of small rural hospitals is included within the analysis of the impact of this proposed rule on small entities in general. As indicated in Table 18, the effect on facilities for FY 2020 is projected to be an aggregate positive impact of 2.5 percent. As the overall
Section 202 of the Unfunded Mandates Reform Act of 1995 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 2019, that threshold is approximately $154 million. This proposed rule will impose no mandates on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. This proposed rule would have no substantial direct effect on state and local governments, preempt state law, or otherwise have federalism implications.
Executive Order 13771 (January 30, 2017) requires that the costs associated with significant new regulations “to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This proposed rule is not subject to the requirements of E.O. 13771 because it is expected to result in no more than de minimis costs.
This proposed regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this year's proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons, we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcome any comments on the approach in estimating the number of entities which will review the proposed rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore, for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We seek comments on this assumption.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $107.38 per hour, including overhead and fringe benefits
In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.
Health facilities, Medicare.
Diseases, Health facilities, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
42 U.S.C. 1302 and 1395hh.
42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww; and sec. 124 of Public Law 106-113, 113 Stat. 1501A-332; sec. 3201 of Public Law 112-96, 126 Stat. 156; sec. 632 of Public Law 112-240, 126 Stat. 2354; sec. 217 of Public Law 113-93, 129 Stat. 1040; and sec. 204 of Public Law 113-295, 128 Stat. 4010; and sec. 808 of Public Law 114-27, 129 Stat. 362.
(b)
(a)
(d) * * *
(1) SNFs that do not meet the requirements in paragraph (b) of this section for a program year will receive a notification of non-compliance sent through at least one of the following methods: The CMS designated data submission system, the United States Postal Service, or via an email from the Medicare Administrative Contractor (MAC). A SNF may request reconsideration no later than 30 calendar days after the date identified on the letter of non-compliance.
(4) CMS will notify SNFs, in writing, of its final decision regarding any reconsideration request through at least one of the following methods: CMS designated data submission system, the United States Postal Service, or via email from the CMS Medicare Administrative Contractor (MAC).
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to amend the Toxic Substances Control Act (TSCA) section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every 4 years. EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce burden for certain CDR reporters. Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA section 8(a) rules, including CDR. The definitions may reduce burden on chemical manufacturers by increasing the number of manufacturers considered small. Overall, these regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner.
Comments must be received on or before June 24, 2019.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0321, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
You may be potentially affected by this action if you manufacture (defined by statute at 15 U.S.C. 2602(9) to include import) chemical substances, including chemical users or processors who may manufacture byproduct chemical substances, and are therefore subject to either of the following: (1) Reporting under the TSCA Chemical Data Reporting (CDR) requirements at 40 CFR part 711 or (2) TSCA reporting and recordkeeping requirements at 40 CFR part 704 or other TSCA reporting requirements which reference the small manufacturer standards at 40 CFR 704.3. Any use of the term “manufacture” in this document will encompass “import,” the term “manufacturer” will encompass “importer,” and the term “chemical substance” will encompass “byproduct chemical substance,” unless otherwise stated.
The regulated community consists of entities that produce domestically or import into the United States chemical substances listed on the TSCA Inventory. The Agency's previous experience with TSCA section 8(a) collections has shown that most respondents affected by this collection activity are from the following North American Industrial Classification System (NAICS) code categories:
• NAICS 325—Chemical Manufacturing; and
• NAICS 324—Petroleum and Coal Product Manufacturing.
In addition to the anticipated respondents from the NAICS listed previously, the regulated community consists of manufacturers of byproducts that are required to report under certain TSCA section 8(a) rules, including CDR. Byproduct manufacturers may be listed under a different primary activity for a site, such as NAICS codes 22, 322, 327310, 331, and 3344 representing, utilities, paper manufacturing, cement manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing, respectively.
The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicable provisions at 40 CFR 711.8. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under
Section 8(a)(1) of TSCA authorizes the EPA Administrator to promulgate rules under which manufacturers and processors of chemical substances must maintain such records and submit such information as the EPA Administrator may reasonably require (15 U.S.C. 2607). TSCA section 8(a) generally excludes small manufacturers and processors of chemical substances from the reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3)(A)(ii) to require TSCA section 8(a) reporting from small manufacturers and processors with respect to any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6; that is the subject of an order in effect under TSCA sections 4 or 5(e); that is subject to a consent agreement under TSCA section 4; or that is the subject of relief granted pursuant to a civil action under TSCA section 5 or 7.
TSCA section 8(a)(3)(B) authorizes the EPA Administrator, after consultation with the Administrator of the Small Business Administration (SBA), to prescribe by rule the standards for determining the manufacturers and processors which qualify as small manufacturers and processors. Pursuant
TSCA section 8(a)(5) requires the EPA Administrator, to the extent feasible, to not require unnecessary or duplicative reporting and minimize the cost of compliance for small manufacturers.
TSCA section 14 imposes requirements for the assertion, substantiation and review of confidential business information (CBI) claims.
In this action, EPA is proposing several amendments to the current CDR rule requirements. These amendments, described in more detail in Unit III., include:
• Changing requirements for making confidentiality claims, including to identify when upfront substantiation is required, update the substantiation questions, and identify data elements that cannot be claimed as confidential to align with the Lautenberg Chemical Safety for the 21st Century Act (2016 Amendments);
• Replacing certain processing and use codes (industrial function and commercial/consumer product use) with codes based on the Organisation for Economic Co-operation and Development's (OECD) functional use and product and article use codes, including adding reporting of the OECD-based functional use codes for consumer and commercial use information;
• Adding the requirement to report the NAICS code(s) for the site of manufacture;
• Modifying the requirement to indicate whether a chemical is removed from the waste stream and recycled, remanufactured, reprocessed, or reused with the requirement to indicate whether a chemical is removed from the waste stream and recycled;
• Adding a requirement to identify the percent total production volume of a chemical substance that is a byproduct;
• Requiring that the secondary submitter of a joint submission report the chemical specific function along with the percentage of the chemical in the imported product;
• Adding a voluntary data element to provide a public contact;
• Modifying the definition of “parent company” to clarify the definition, add the requirement to report a foreign parent company, when applicable, and codify reporting scenarios;
• Simplifying the reporting process for co-manufacturers by enabling a multi-reporter process for reporters to separately report directly to EPA within the e-CDRweb reporting tool;
• Allowing reporting in specified metal categories for inorganic byproducts;
• Adding exemptions for specifically identified byproducts that are recycled in a site-limited, enclosed system and for byproducts that are manufactured as part of non-integral pollution control and boiler equipment; and
• Clarifying regulatory text by removing outdated text, consolidating exemptions, and making other improvements.
Additionally, EPA is proposing an amendment to update the size standards definition for small manufacturers for reporting and recordkeeping requirements under TSCA section 8(a). Further details of this amendment are in Unit IV.
EPA is also giving notice of some aspects of the amendments to TSCA from the Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016 Amendments) that may impact, more broadly, TSCA submitters. For example, under TSCA section 14(e)(1)(B), the Agency is charged with implementing a ten year “sunset” provision for confidentiality claims.
Because the small manufacturer size standard under TSCA section 8(a) impacts the CDR rule more than other TSCA section 8(a) reporting rules at this time, EPA included these two actions as one proposed rule. However, EPA recognizes that the changes made to the small business definition will impact current and future TSCA section 8(a) reporting rules and intends to finalize these amendments as two separate actions.
EPA is taking other, non-regulatory steps to minimize the burden on all reporters, including small entities, by improving the reporting application and database to be user-friendly and dynamic, consisting of straightforward questions that include fill-in-the-blank (number) fields, check boxes, and drop-down menus. In addition, EPA is replacing the current pre-formatted Form U with a customized report based on the actual information submitted by a site through e-CDRweb, the electronic reporting tool. Although these changes are not discussed further in this proposal, they are an important component of the effort to reduce burden and modernize the data collection system. EPA is adding an addendum to the current CDR rule ICR (OMB Control Number 2070-0162) for the regulatory changes proposed in this document. In addition to the changes outlined in this proposed rule, if needed, EPA will provide a second addendum to this ICR to address non-regulatory changes. As was done for previous CDR collections, EPA will provide industry with the opportunity to test and comment on the updated e-CDRweb prior to the 2020 CDR submission period. EPA anticipates holding a webinar to introduce the revised e-CDRweb to the regulated community directly following the finalization of the CDR Revisions rule. During the webinar, EPA will issue a general invitation to interested parties to participate in a short testing period of the revised e-CDRweb. EPA will open the testing period within 4 months after this proposal is finalized, and currently anticipates that testing will occur in the February to March 2020 timeframe. Because of resource constraints, the testing period will be limited to 25 participants. For additional information, contact the person under
EPA is proposing revisions to the CDR rule for three primary reasons: Align with amendments to TSCA from the Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016 Amendments), improve the CDR data collected as necessary to support the implementation of TSCA, and reduce burden for CDR reporters pursuant to TSCA section 8(a)(5).
The 2016 Amendments to TSCA changed requirements associated with confidentiality claims, including identifying the data elements eligible for confidentiality claims and when substantiation of claims is required. EPA is proposing revisions to the CDR rule to address these changes.
EPA is proposing to modify the definition for small manufacturers, as a result of the 2016 Amendments revision of TSCA section 8(a)(3)(C), which requires EPA, after consultation with the Administrator of the SBA, to review the adequacy of the standards for determining which manufacturers and processors qualify as small manufacturers and processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). EPA published a determination that revision of the TSCA section 8(a) size standards for small manufacturers as warranted in a
EPA is also proposing to make some changes to the CDR data reporting so the information collected is tailored to better meet the Agency's overall information needs and aligned with specific needs for prioritization and risk evaluation under TSCA section 6. TSCA section 2 specifies that “adequate information should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such information should be the responsibility of those who manufacture and those who process such chemical substances and mixtures” (TSCA section 2(b)(1)). These proposed changes include the addition of data elements, such as a site-specific NAICS code and how much of a chemical is a byproduct; modification to multi-reporter submission requirements, including adding a process for jointly reporting co-manufactured chemicals; and changes to current data elements, such as codes used for reporting processing and use information. In addition, proposed changes to the parent company reporting requirements would increase EPA's ability to protect confidential information while better enabling EPA to make information publicly available and the addition of a voluntary public contact would direct inquiries from the public to a designated individual rather than to the technical contact. These changes would help to meet the Agency's requirement under TSCA section 26(h), in carrying out TSCA sections 4, 5, and 6, to make scientific decisions consistent with the best available science, improve the CDR data collected as necessary to support the implementation of TSCA, and improve EPA's ability to effectively provide public access to the information. Furthermore, these changes would meet the Agency's objective to obtain new and updated information relating to potential exposures to a major subset of chemical substances listed on the TSCA Inventory.
At the same time, EPA is interested in reducing burden on industry while maintaining the Agency's ability to receive the information it needs to understand exposure to these chemicals (TSCA section 8(a)(5)). EPA used experiences from the 2016 CDR submission period, concerns identified by users of CDR information, and burden-reduction suggestions made as part of public comment opportunities, including public comments solicited in conjunction with Executive Order 13777,
Additionally, EPA has received comments that modernizing the CDR data collection and public access to the database would reduce reporting burden and facilitate ease of use by reporters and the public (81 FR 90843; EPA-HQ-OPPT-2016-0597 and Refs. 1, 2, and 3). These comments were used to develop this proposal and to inform other, non-regulatory changes that EPA plans to make to the reporting process.
EPA has evaluated the potential costs and benefits of revising CDR reporting requirements and modifying standards for small manufacturers in CDR and other TSCA section 8(a) reporting. Some aspects of the proposal increase burden and cost while other aspects decrease burden and result in cost savings. Overall, EPA estimates that the combined impact of all the proposed amendments would decrease the total burden and result in a cost savings to industry and government reporters. These analyses, which are available in the docket (Refs. 4 and 5), are discussed in Units III. and IV. and are briefly summarized here.
1.
• For changes to modify or add reportable data elements (
• For changes to claiming confidentiality (discussed in Unit III.A.), the incremental burden is expected to decrease by 340 hours with an associated cost savings of $0.03 million.
• For changes to add byproducts exemptions (discussed in Unit III.D.), the incremental burden is expected to decrease by 68,000 hours with an associated cost savings of $5.2 million.
• For changes to implement consolidated category reporting for certain inorganic metals (discussed in Unit III.D.), the incremental burden is expected to decrease by 13,000 hours with an associated cost savings of $1.0 million.
• For changes that affect CDR reporting eligibility (targeted to certain sites with varying reductions to the number of chemicals reported per site), the incremental burden is expected to result in a net decrease by 81,000 hours with associated cost savings at $6.3 million. There are increases in burden and costs for several requirements, such as the need to assess whether exemptions apply (compliance determination) and the need to familiarize oneself with modifications to the rule (rule familiarization), estimated at 3,000 hours with an associated cost of $0.24 million. However, the changes to form completion in the aggregate are estimated to result in an overall net decrease in burden and cost savings due to decreases in the number of sites reporting and or the number of chemical reports from a site. These decreases are due to the proposed byproduct exemptions (discussed in Units III.D.2. and III.D.3.) and consolidated category reporting (discussed in Unit III.D.1.).
In sum, the overall incremental impacts to industry and government reporters result in a net decrease in burden and cost savings. Estimates include rule familiarization, compliance determination, and CDR form completion (Ref. 4). Note that estimated changes to recordkeeping burden and cost are negligible and estimated at zero. An estimated 5,660 sites are expected to report during the next CDR submission period in 2020. The total incremental burden reduction and cost savings are estimated at a 36,000 hour reduction and $2.79 million cost savings. On an annualized basis using a 3 percent and
2.
a.
Under this proposed definition, incremental future cycle burden reductions and cost savings are estimated at 64,000 hours and $5.0 million, respectively, over a four-year CDR reporting cycle (Ref. 5). On an annualized basis, using a 3 percent and 7 percent discount rate over a 10-year period yields net annualized incremental cost savings of $1.2 million and $1.2 million per year, respectively (Ref. 5). This proposal also includes a small government exemption (described in this unit).
b.
3.
1.
2.
The CDR rule requires U.S. manufacturers of certain chemicals listed on the TSCA Inventory to report to EPA every four years the identity of chemical substances manufactured for all years since the last principal reporting year. For example, for the 2020 submission period, the principal reporting year is 2019 and the last principal reporting year for the 2016 submission period was 2015. Reporting during the 2020 submission period covers the manufacture of chemicals in 2016, 2017, 2018, and 2019. To help minimize reporting burden, detailed information is required only for the principal reporting year (
Persons domestically manufacturing or importing chemical substances are required to report information such as company name, site location and other identifying information, production volume of the reportable chemical substance, and exposure-related information associated with the manufacture of each reportable chemical substance, including the physical form and maximum concentration of the chemical substance, the number of potentially exposed workers at the reporting site and certain processing and use information (40 CFR 711.15). The processing and use information that is currently required includes: Process or use category; NAICS code; industrial function category; percent production volume associated with each process or use category; number of sites; number of potentially exposed industrial or commercial workers; and consumer/commercial information such as use category, use in or on products intended for use by children, and maximum concentration. Under CDR, submitters report information to the extent that it is “known to or reasonably ascertainable” (40 CFR 711.15), which means “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know” (40 CFR 711.3, referencing 40 CFR 704.3). Reported information can be claimed as confidential (40 CFR 711.30).
EPA uses the data reported pursuant to the CDR rule to support health, safety, and environmental protection activities related to chemical manufacturing and use. Manufacturing, processing and use information about chemicals in commerce helps EPA understand exposure to these chemicals and screen and prioritize chemicals to identify potential human health and environmental effects. EPA uses the data reported under the CDR rule to support many activities under TSCA and to provide overall support for EPA and other federal, state, local, and tribal health, safety, and environmental protection activities (Ref. 6 and 83 FR 36928, July 31, 2018 (EPA-HQ-OPPT-2017-0648)).
CDR provides basic exposure-related data which EPA uses in a wide variety of its activities, from choosing the chemicals EPA will focus on for prioritization and assessment activities to informing response actions, such as to hurricanes and other disasters. For example, in accordance with TSCA section 6(b)(1)(A), EPA is required to consider “the conditions of use or significant changes in conditions of use of the chemical substance, and the
For another example, to help prepare EPA and others to respond to hurricane disasters that occurred in 2018, EPA prepared information about chemicals expected to be in the affected areas from data sources such as CDR.
In 2012, EPA published its TSCA Work Plan for Chemical Assessments. CDR data were used extensively in the development of this Work Plan. Using CDR data collected during the 2012 CDR submission period, EPA updated the exposure rankings for the chemicals initially screened as part of the original Work Plan and, in 2014, published a revised Work Plan (2014 Work Plan). TSCA requires that at least 50 percent of all chemical substances undergoing risk evaluation (High-Priority designations) come from the 2014 Work Plan, until the Work Plan chemical list is exhausted.
The Interagency Testing Committee (ITC), an independent advisory committee to the EPA Administrator, uses CDR data when updating the Priority Testing List (PTL). The ITC designates or recommends chemicals to the PTL that the Agency may prioritize when requiring testing under TSCA section 4 or collecting information under TSCA sections 8(a) or 8(d). In making those determinations, production volumes reported to CDR are used to identify the opportunity for exposure to a particular chemical.
OECD member countries develop Emission Scenario Documents (ESD). EPA is an active participant of the OECD Task Force and regularly works on the development of ESDs that are reviewed by the Task Force and added to the published series of ESDs. ESDs developed by EPA cover both occupational exposures and environmental releases due to EPA's review responsibilities under TSCA. In a separate and related effort, EPA has regularly developed industry-specific generic scenarios which are similar to an OECD ESD, as tools to assist in the assessment of the many types of uses for new chemicals reviewed under TSCA. CDR data are used to identify the chemicals commonly used in specific industries, estimate the number of potentially exposed workers, and develop estimates of exposure and releases that support the development of these documents and scenarios.
Additional examples of how EPA uses CDR data include use by the Office of Research and Development to characterize the life cycle of chemicals for life cycle inventories, to develop conceptual models, and to develop standardized emission and release estimates from chemical production. The Office of Water uses CDR data to identify facilities in specific industry sectors while developing effluent guidelines and to identify chemicals of interest and their associated processing and use activities for Effluent Guidelines Annual Review Reports.
In 1988, EPA established the general TSCA section 8(a) small manufacturer definition for use in other rules issued under TSCA section 8(a), which are codified at 40 CFR 704.3. These are the current standards that apply to CDR:
Small manufacturer or importer means a manufacturer or importer that meets either of the following standards:
1.
2.
3.
Pursuant to authority under TSCA section 8(a)(3)(B), certain TSCA section 8(a) rules codify slight variations of the general TSCA section 8(a) small manufacturer definition at 40 CFR 704.3 (see,
EPA is proposing changes to requirements related to claiming CDR data as confidential to be consistent with the new statutory requirements in TSCA section 14. TSCA requires the Agency to review and make determinations regarding the validity of confidential claims for information submitted to EPA. EPA estimates that this proposed change would result in a decrease in burden, which is explained in detail in Table 4-14 in the Economic Analysis (Ref. 4).
New statutory provisions that are pertinent to reporting under CDR include the following:
• Under TSCA section 14(c)(3), all claims of confidentiality must be substantiated at the time the information is submitted to EPA, except for those types of information exempt under TSCA section 14(c)(2).
• The submitter must provide a statement supporting the claim, as described in TSCA section 14(c)(1)(B) and must certify that the statement is true and correct, as described in TSCA section 14(c)(5).
• TSCA section 14(b)(3)(B) limits confidentiality claims for reported use information that customarily would be shared with the general public or within an industry or industry sector.
• Under TSCA section 14(e)(1)(B), confidentiality claims on information not described in TSCA section 14(c)(2) expire after ten years, unless a request for extension is submitted and granted.
The proposed amendments to the CDR rule address these new provisions, with the exception of the TSCA section 14(e)(1)(B) CBI expiration provision which while it will impact all TSCA submissions filed after June 22, 2016 does not distinctively impact the CDR data collections.
This preamble discussion also includes information about other provisions of TSCA relating to actions EPA must take, but that do not impact the regulatory text or require specific submitter actions.
1.
EPA is proposing revisions to the current substantiation questions in 40 CFR 711.30 and the addition of new substantiation questions to address data elements which, prior to amended TSCA, did not require substantiation at the time of submission. The questions are in the proposed regulatory text at the end of this notice. In addition, Appendix B of the CDR Revisions EA (Ref. 4) provides a summary of the questions prior to the 2016 TSCA Amendments and those that are being proposed in this action (Ref. 4). These questions would facilitate the Agency's implementation of TSCA section 14 and the requirement to review and approve, approve in part, deny in part, or fully deny requests for confidentiality. These CDR-specific questions are designed to encourage thoughtful consideration of the need for confidential treatment, improve the consistency of EPA's review of the responses, and reduce the need for multiple discussions between EPA and the submitter regarding the substantiations that may otherwise hinder the Agency's ability to timely fulfill its review obligations under TSCA.
The questions have been carefully drafted to elicit the required information to allow for a CBI review and determination, without imposing an unnecessary burden. A set of standard questions, set forth in proposed 40 CFR 711.30(b), would apply to all non-exempt CBI claims. These questions generally ask about the impact of disclosure on the submitter's competitive position, whether the information has been made available to others, and the controls used to protect the confidential information. These are similar in concept to questions under the current CDR at 40 CFR 711.30. Additional questions are targeted to specific data elements. For chemical substance identity confidentiality claims, the additional substantiation questions, set forth in proposed 40 CFR 711.30(c), are substantively the same as exist under the current CDR at 40 CFR 711.30(b). An additional question for company, site, and technical contact identity is set forth in proposed 40 CFR 711.30(d). Although substantively the same as exists for site identity substantiations in the current CDR at 40 CFR 711.30(c), it is newly applied to company name and technical contact confidentiality claims. Additional questions for processing and use information are set forth in proposed 40 CFR 711.30(e) and are substantively the same as exist in the current CDR at 40 CFR 711.30(d).
• Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article;
• Marketing and sales information;
• Information identifying a supplier or customer;
• In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents;
• Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article;
• Specific production or import volumes of the manufacturer or processor; and
• Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under TSCA section 5.
EPA believes that the only data elements collected under CDR that may be subject to the TSCA section 14(c)(2) limit on substantiation requirements are: (1) Production volume and (2) supplier information associated with joint submissions, such as supplier identity and details of the full composition of a mixture. However, these two data elements may still be subject to substantiation and CBI review under the circumstances described in TSCA section 14(f).
A joint submission is a submission started by a primary submitter, typically an importer. The primary submitter provides the trade name of the subject chemical substance or mixture, the name and address of the supplier, and other information as appropriate. Given the requirements of amended TSCA, EPA proposes to require that the primary submitter identify whether the supplier information, including the supplier identity and chemical substance name (trade name) is confidential. Substantiation of the confidentiality claims for this information is not required at the time of submission under the proposed rule because EPA believes it is exempt from substantiation as “[i]nformation identifying a supplier” under TSCA section 14(c)(2)(C).
The secondary submitter of the joint submission provides their company name and location, a technical contact, trade name, and chemical identity(ies) and percentage of each chemical substance in the composition of the substance or mixture represented by the trade name. In addition, as explained in Unit III.B.5., EPA proposes to collect the function of each chemical in the mixture. Given the requirements of amended TSCA, EPA is proposing to provide the ability for the secondary submitter to specifically identify whether this information is claimed as confidential. Except for the percentage composition information, which is generally exempt from substantiation pursuant to TSCA section 14(c)(2)(D), all other reported data elements are subject to substantiation at the time the information is submitted.
2.
3.
This statutory provision directly impacts and limits confidentiality claims for certain CDR processing and use data. Thus, EPA proposes to codify in the regulatory text that the following data elements cannot be claimed as confidential because they constitute general descriptions of processes and uses that customarily would be shared with the general public or within an industry or industry sector:
•
•
For the purposes of this proposal, EPA believes that other CDR processing and use data elements do not offer a “general description” and therefore do not fall within the limits of TSCA section 14(b)(3)(B). Under this proposal, submitters may continue to assert claims of confidentiality for the following processing and use data elements:
•
• Certain Consumer and Commercial use data elements. Percent production volume, maximum concentration, and number of commercial workers (§ 711.15(b)(4)(ii)(D), (E), and (F)).
4.
1.
EPA did not develop burden estimates associated with replacing the current CDR codes with ones based on the OECD codes because such an estimate heavily relies on the e-CDRweb user interface which will feature burden-reducing guided data entry. The addition of the function categories for commercial/consumer products is a new data element whose addition could potentially result in an increase in burden (not estimated at this time). For additional information, see section 4.1.3.2 in the Economic Analysis (Ref. 4).
The OECD Internationally Harmonized Functional, Product, and Article Use Categories were developed through the OECD Working Party on Exposure Assessment (Task Force on Exposure Assessment) under the leadership of the EPA, based on a review of current functional use and product categories from the United States, Canada, and the European Union; bilateral discussions with the European Chemicals Agency (ECHA); and multiple reviews from task force members. The OECD categories are described in the document “Internationally Harmonised Functional, Product and Article Use Categories” (referred to herein as the OECD Category Document) (Ref. 8).
Harmonizing CDR use codes with the OECD codes would expand the utilization of applicable use and exposure-related information from international sources to support EPA risk evaluation and risk assessment activities for new and existing chemicals. Additionally, this harmonization would provide industry with international uniformity in use and exposure information reporting, enabling industry to better streamline their different country-specific reporting requirements.
EPA has received requests to harmonize CDR data categories and descriptions with other countries to the extent possible. In particular, industry stakeholder groups such as the American Chemistry Council have expressed a desire to harmonize with Canadian and OECD data collections in order to provide common global terminology and preciseness in risk evaluation (Ref. 9). EPA worked closely with Canada in the development of the current CDR processing and use codes, and both EPA and Canada were involved in the development of the OECD Harmonized codes.
Under CDR, there are two main categories of use codes: Function use codes and product use codes. The function of a chemical combined with the type of product that the chemical is used in provides an exposure scenario with unique characteristics. These exposure scenarios are necessary for implementation of TSCA for the prioritization of the chemical and for further consideration for the development of exposure and risk evaluations.
a.
Function codes are based on the intended physical or chemical characteristic for when a chemical substance or mixture is consumed as a reactant; incorporated into a formulation, mixture, reaction product, or article; repackaged; or used (
During screening and risk evaluation activities, EPA evaluates how the chemical substance is manufactured, processed, distributed in commerce, used, and disposed of. Currently, CDR requires the reporting of consumer and commercial product categories but does not require the reporting of chemical function within the product category. The lack of functional use information for consumer and commercial applications has restricted EPA's ability to provide more complete evaluations or more realistic characterizations of exposure for consumer and commercial applications; instead, EPA relies in many cases on scenarios using potentially conservative assumptions. (Ref. 10) The addition of information on the function of the chemical in combination with the consumer or commercial product category would improve EPA's ability to consider exposures to consumers and in commercial applications, providing a more accurate and real-world understanding of the uses of chemical substances throughout their life cycle.
As explained in the OECD Category Document, the OECD product and article use categories are intended to focus on the end-use application of chemicals within products and articles, rather than upstream manufacturing and processing. However, the functional use categories cover the life cycle and describe the specific function that a chemical provides when used in the formulation of a product or article, or when used within an industrial process. While the function of a chemical may be the same across its life cycle, certain functions may only be appropriate for consideration in an industrial setting,
Adopting the OECD functional use codes would provide greater detail by expanding the function categories from the 35 codes currently used by CDR to 117 codes. For example, the broad current CDR category
EPA is listing these codes in the CDR instructions discussed in Unit III.B.1. Additional details about the proposed function categories, how they are related to the OECD functional use categories, and a crosswalk with the current CDR function codes are in the supplemental document
CDR product categories are broader than the OECD categories. Using the OECD categories would provide a specificity that would be more helpful to EPA in carrying out its responsibilities under TSCA. For example, a broad CDR category is
2.
EPA would use the NAICS code information in its analysis of the reported manufacturing-related information to better analyze the data by industry sector. EPA's insight into particular industry sectors has been limited without this particular data element. For example, during the 2017 negotiated rulemaking, participants asked EPA to analyze specific industries to determine if there was overlap in reporting among different Agency programs and to determine if EPA could trace the life cycle of some chemical substances from their manufacture through their use and to their disposal (Refs. 13 and 14). NAICS codes would have better enabled EPA to fulfill the requests because many other EPA programs, such as the Toxics Release Inventory (TRI), require the reporting of NAICS codes. By adding the site's NAICS code as a required data element for CDR, EPA would be better able to use information from CDR in conjunction with TRI data to support implementation of TSCA.
Because reporting under CDR is done by the site that is conducting the manufacturing activity, the site is expected to be sufficiently knowledgeable to be able to determine the appropriate NAICS code. EPA believes sites would be able to identify a single NAICS code per site; however, the Agency is interested in comments on whether the CDR reporting tool should enable the reporting of multiple NAICS codes based on each chemical substance, similar to how the technical contact is reported.
EPA believes that the manufacturing of chemicals incorporates a narrower range of NAICS codes than the processing and use of chemicals. Therefore, identifying the more specific NAICS code for the manufacturing site is not expected to result in the large number of combinations experienced in 2006 for the processing and use information.
3.
EPA is soliciting comment on whether submitters should identify the percentage of total production volume of their chemical substance that is recycled instead of only designating whether recycling occurred, the burden associated with providing such an estimate, and any difficulties industry might encounter in estimating such a percentage (either to the nearest 10 percent or more accurately). EPA believes that the percent production volume for a chemical substance that is being recycled or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream would be information relevant to the exposure profile of a chemical substance and indicates efficiencies within the chemical manufacturing industry. EPA is interested in the exposures from these activities. In addition, information about whether certain types of industries recycle or whether certain types of chemicals are recycled and if such recycling is increasing or decreasing provides information about changes in the manufacturing environment that inform EPA's TSCA activities. Collecting specific percentages about recycling could give EPA a better understanding of the recycling reporting universe and provide EPA the opportunity to grant more targeted reporting exemptions and burden reduction activities in future reporting cycles.
4.
Information about byproduct reporting has been of particular interest due to requirements of the 2016 amendments to TSCA to conduct a negotiated rulemaking for manufacturers of inorganic byproducts. During the deliberations of the negotiated rulemaking committee, EPA was unable to specifically identify, from the CDR data, chemical substances manufactured as byproducts or byproduct manufacturers who would be impacted by changes to the reporting requirements. With the addition of this data element, EPA will be able to identify those manufacturers that recycle portions of their substances or only report to CDR due to their byproduct production. EPA would consequently be better able to understand a larger spectrum of potential exposure scenarios, by improving understanding of the connection between manufacturing and downstream activities for the purposes of substance life cycle assessments and risk evaluation. In addition, EPA would use this information to inform future decisions about potential changes to CDR requirements.
There are situations where the same chemical substance is manufactured both as a primary chemical substance and a byproduct. While this is rare, it is a known occurrence. For example, when commercial stearic acid is manufactured, it is known to contain significant amounts of palmitic acid and oleic acid as byproducts. Such a producer would also be likely to separately manufacture palmitic acid and/or oleic acid as primary chemical products. In this situation, if the palmitic acid that is manufactured as a byproduct is used for a reportable commercial purpose, its volume would be reported along with the volume of palmitic acid that is separately manufactured at the same site and its volume would be counted as the byproduct portion when calculating the percent manufactured as a byproduct. It is important to recognize that an overproduction of the primary manufactured substance does not meet the regulatory definition of a byproduct, and thus is not considered a byproduct for the purposes of CDR, and should not be counted as such when calculating the percent manufactured for this data element.
5.
6.
7.
Currently, sites required to report to CDR must report their U.S. parent company, which is defined to mean the highest-level company located in the United States that directly owns at least 50 percent of the voting stock of the manufacturer (see 40 CFR 711.3). The site must report its U.S. parent company name, address, and Dun and Bradstreet D-U-N-S® (D&B) number (see 40 CFR 711.15(b)(2)(i)).
Including the foreign parent company would increase the ability of EPA to protect information claimed as confidential. Currently, some confidential information may be inadvertently disclosed due to challenges in identifying connections between sites when the parent companies are outside of the United States. EPA takes such relationships into account when aggregating confidential information. By reporting the foreign parent company, EPA would be able to better identify company groupings for data aggregation and, ultimately, protection of information claimed as confidential.
This modification would be responsive to industry concerns expressed during the 2016 CDR submission period with not being able to report their “true” parent company when that company is outside of the United States. In many cases, sites know the foreign corporation's name more readily than the U.S. parent company's name.
As opposed to relying exclusively on the foreign parent company (where applicable), EPA is retaining the U.S. parent company reporting requirement to allow EPA to align future CDR collections with historical data; inclusion of the U.S. parent company for 2020 reporting would enable EPA to correlate with past reporting cycles and potentially to increase consistency in reporting among sites associated with the same parent company. Including both the U.S. and the foreign parent companies would provide data users greater flexibility when combining CDR data with data from other sources, some of which are limited to only U.S. information.
(1) If the site is entirely owned by a single U.S. company that is not owned by another company, then that single company is the U.S. parent company and there is no foreign parent company.
(2) If the site is entirely owned by a single U.S. company that is, itself, owned by another U.S.-based company (
(3) If the site is owned by more than one company (
(4) If the site is ultimately owned by a 50:50 joint venture or a cooperative, the joint venture or cooperative is its own U.S. parent company. If the site is owned by a U.S. joint venture or cooperative, the highest level of the joint venture or cooperative is the U.S. parent company. If the site is owned by a joint venture or cooperative outside the United States, the highest level of the joint venture or cooperative outside the United States is the foreign parent company.
(5) If the site is entirely owned by a foreign company (
(6) If the site is a federally owned, the highest-level federal agency or department is the U.S. parent company.
(7) If the site is owned by a non-federal public entity, that entity (such as a municipality, State, or tribe) is the U.S. parent company.
EPA is proposing to change the method manufacturers use to report co-manufactured chemicals. A co-manufacturing relationship occurs when a chemical substance, manufactured other than by import, is produced exclusively for another person who contracts for such production. To be considered a co-manufacture situation, the producing company produces the chemical substance exclusively for another person (the contracting company) under contract for that production. If the chemical substance is produced for other purposes, then the situation fails this first test of “co-manufacturing.” For example, if a company manufactures a chemical for speculative purposes based on expectations of the market, the company is not operating in a co-manufacturing situation. In addition, the other person contracting the manufacture (
EPA is avoiding the use of the term toll manufacturer for this proposal and future guidance to add clarity for the co-manufacturing situation. In instructions, guidance, and other communication with submitters, EPA may previously have referred to co-manufacturing as toll manufacturing, and more specifically to the two parties as the contracting manufacturer and the toll manufacturer. Because EPA does not specifically define the term “toll manufacturer,” EPA now believes the use of this term may be open to mis-interpretation and it would be clearer to use terms associated with the CDR definition of manufacturer in 40 CFR 711.3. Additionally, EPA believes the chemical industry often refers to toll manufacturing in a more general manner, where both of the tests included in the CDR definition for manufacture are not met. These tests are: (1) The chemical substance is produced exclusively for another person who contracts for such production, and (2) that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technology for the plant process.
Pursuant to the CDR definition of “site” at 40 CFR 711.3, the site reported is the site of physical manufacture (
The companies must designate a single technical contact for the specified chemical(s), who can be an employee of either the contracting company or the producing company (or a consultant). This technical contact should be knowledgeable about the specific chemical and should be the best equipped to answer questions about the certain chemical.
Submitters have identified multiple concerns with the current reporting process for co-manufacturers. Current issues associated with using this method for reporting include:
• The contracting company and producing company are unsure who should be primarily or solely responsible for CDR reporting and are concerned regarding the shared liability.
• The producing company has information (such as the number of workers likely to be exposed) that the contracting company does not have, and the contracting company has information (such as information about the processing and use of the chemical substance) that the producing company does not have. However, when currently completing the CDR chemical report, one company may not be willing to share information it considers confidential with the other company.
• In situations where the producing company is reporting for additional chemical substances, the current co-reporting requirement may result in the need to submit multiple CDR reports for the producing company's site. This created a complicated situation that required special handling and increased confusion and burden for the submitter.
In response, EPA is proposing a new methodology for the 2020 and future reporting cycles. Under this new reporting methodology, the contracting company (as the primary submitter) would have the responsibility to initiate a co-manufacture report that would prompt the reporting requirements for the producing company (as the secondary submitter). The contracting company would start the chemical report for the co-manufactured chemical, identifying the chemical substance and the producing company. The contracting company would then initiate the co-manufacture report using e-CDRweb to send a notification to the producing company. Additionally, the contracting company is responsible for completing the volume manufactured (40 CFR 711.15(b)(3)) and the processing and use-related section (40 CFR 711.15(b)(4)). Upon receipt of the email, the producing company will have the information needed to begin its portion of the co-manufacture report, which would include the manufacturing-related data elements from 40 CFR 711.15(b)(3), including the production volume.
Although the manufacturing information section includes the chemical identity field, it is EPA's belief, based on the two tests for a co-manufacturing situation in which the contracting company specifies the
This improved reporting mechanism would protect the confidentiality of both the producing company and contracting company by ensuring that the contracting company would not require any potentially confidential information from the part of the producing company. This method also would eliminate confusion between the two involved parties by designating the contracting company as the primary submitter responsible for initiating the reporting process. As with current reporting, both parties would remain liable for reporting the co-manufactured chemical because each party has a portion of the information required under CDR. In addition, this co-manufacture reporting procedure enables the use of one Form U per site, because the contracting company indicates the producing company's site without starting a separate Form U and the producing company completes an independent report for any other, non-co-manufactured chemicals in its own site report.
The second alternative would be to retain the current reporting mechanism (described in
EPA requests comments on the proposed reporting methodology where the contracting company is the primary submitter and on the two alternative reporting scenarios (where the producing company is the primary submitter or retaining the current reporting mechanism without a primary or secondary submitter) for improving the reporting process for co-manufacturing situations. In addition to comments on the general approaches, EPA is interested in comments on the information that should be included on each portion of the co-manufacturing report (for the proposed and first alternative).
EPA is proposing three changes that directly impact manufacturers of byproduct substances, including inorganic byproducts, to: (1) Allow reporting in metal categories for inorganic byproducts; (2) exempt specifically listed byproducts that are recycled in a site-limited manner; and (3) exempt byproducts manufactured in pollution control and boiler equipment when that equipment is non-integral to the primary manufacturing process. Byproducts are defined at 40 CFR 704.3 to mean a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s). In developing these proposals, EPA relied on information gathered during the negotiated rulemaking process (EPA-HQ-OPPT-2016-0597 and 81 FR 90843, December 15, 2016) and from other public comments (EPA-HQ-OA-2017-0190 and 82 FR 17793, April 13, 2017), with the intent to develop proposals for addressing burden for these byproduct manufacturers while maintaining the information needed by EPA, as described in Unit I.C.
1.
If the manufacturer has multiple inorganic byproduct chemical substances to report, they would be able to choose to report some byproduct substances in categories and other different byproduct substances as specific substances. However, the manufacturer would not be able to bifurcate the production volume of the same byproduct chemical substance and report a portion in a category and another portion as a specific chemical substance unless the bifurcation is due to having different metal elements present in the byproduct. Some substances would be required to be reported as listed on the TSCA Inventory and not as part of these metal compound categories, because they are of particular interest to EPA. They are described later in this unit.
EPA believes this proposed method of reporting in categories would simplify reporting and ease reporting burden for manufacturers whose inorganic byproduct metal-containing substances have chemical compositions that are non-specific and difficult to identify, while also providing information that meets EPA's needs. Additionally, because manufacturers would retain the ability to report to CDR by specific substances contained on the TSCA Inventory (as is currently required), manufacturers of these byproduct
Inorganic metal substances that are manufactured as products and not as byproducts would be ineligible to report within a metal category because these non-byproduct substances are intended products and should be more easily identifiable by their manufacturers.
EPA has the explicit authority under TSCA section 26(c) to take any actions authorized or required by TSCA with respect to categories of chemical substances, and the Agency has experience assessing chemicals in categories under TSCA. For an example of how EPA could use information reported in metal compound categories, see the Antimony Trioxide (ATO) Risk Assessment conducted in 2014 (Ref. 19). Because ATO is not specifically listed on the TRI, releases reported under the broader category of antimony compounds were used as a surrogate to evaluate the potential for aquatic exposures.
The proposed defined inorganic metal compound categories are designed in part to allow CDR reporting to align more closely with those chemical substances and compound categories on the 2014 Update to the TSCA Work Plan for Chemical Assessments.
TRI also uses a similar option of reporting under compound categories, many of which are metals. EPA recognizes that many companies report to both statutory programs and is interested in aligning TRI and CDR to the extent possible and reasonable given the differing purposes of the two rules.
The proposed CDR metal categories list is comprised of the following categories from the 2014 Update to the TSCA Work Plan for Chemical Assessments and from TRI (Refs. 20 and 21). In the future, EPA may modify, by rulemaking, the metal categories list as more chemicals are evaluated as part of the existing chemical program:
To better characterize which substances would be reportable within these metal compound categories, EPA is proposing to use the definition of inorganic chemical substances that was originally part of the IUR (51 FR 113, June 12, 1986). For the purposes of this rule, inorganic substances would be defined to mean those substances that do not contain carbon or contain carbon only in the form of carbonato [=CO3], cyano [-CN], cyanato [-OCN], isocyano [-NC], or isocyanato [-NCO] groups, or the chalcogen analogues of such groups (
As an example of how to use this inorganic metal compound category reporting method, a manufacturer who is domestically producing Copper chloride, Copper hydroxide, and Copper sulfide as byproduct substances would have the option to report all of these inorganic byproducts under a single report of Copper and Copper compounds, aggregating their volumes. If reporting by category, the manufacturer in this example would first assess if it meets the threshold for reporting by combining the production volumes for all three substances (Copper chloride, Copper hydroxide, and Copper sulfide). If the combined threshold for
In terms of reporting, however, EPA is proposing that only the
EPA is interested in obtaining comment on the proposal to allow reporting of inorganic substances in metal compound categories, including the methodology for how to report using categories. Specifically, EPA is interested in receiving comments on deviating from the standard approach used for CDR of reporting the volume of substance manufactured and instead using the approach of reporting the weight of the metal in the compounds when reporting by the metal category. Would it be more appropriate to report the full weight of the chemical substance instead of the metal weight? Are submitters likely to report using this approach?
• Substances that have been individually identified on the 2014 Update to the TSCA Work Plan for Chemical Assessments (Ref. 20): specifically,
• Substances that are the subject of certain TSCA actions as listed in 40 CFR 711.6, including TSCA section 5(a)(2) Significant New Use Rules (SNURs), TSCA section 5(b)(4) rules, TSCA sections 4, 5(e) and 5(f) orders, TSCA section 6 rules, TSCA section 4 test rules, Enforceable Consent Agreements (ECAs) developed under the procedures of 40 CFR part 790, and TSCA section 5 or 7 civil actions. Note that lists of subject chemicals can be identified using the eCDRweb reporting tool or separately from EPA's Substance Registry Services (SRS) website (
• Chemical substances undergoing prioritization or risk evaluation under TSCA section 6. While the current list
For example, consider reporting within the chromium category. There is a TSCA section 6 action (40 CFR 749.68) that covers several hexavalent chromium-based water treatment chemicals. Those covered substances (
2.
Based on information provided by these two industries, these byproduct substances are directly recycled in physically enclosed systems in a site-limited manner (see definition of “Site-limited” at 40 CFR 711.3). For the purposes of CDR, EPA considers an enclosed system to be a system of equipment directly connected to the production process that is designed, constructed, and operated in a manner which prevents emissions, or the release of any chemical substance into the facility or environment during the production process. Such emissions, including fugitive emissions, could lead to exposures to workers, the public, or the environment. For an enclosed system, exposure and release could only occur due to loss of integrity or failure of the manufacturing process equipment or control systems.
To meet the EPA enclosed system scenario, any equipment that the byproduct is present in at any point during the process sequence, such as tanks, reaction vessels, reactors, processing units (
EPA recognizes that there may be some potential for exposures and releases (
Based on 2016 CDR data, the sites reporting under CDR within these two industries have reported chemicals that are related to these byproducts because they are subsequently manufactured from the byproducts or from other substances via the same overall manufacturing process. EPA therefore would collect exposure-related information about the manufacturing site for these two industries.
This proposed exemption is only for the volumes of the byproduct substance, listed at 40 CFR 711.10(c)(2)(i) (as proposed), that are recycled in a site-limited manner in physically enclosed systems of the same overall manufacturing process. Volumes that are used for a commercial purpose distinct from their manufacture as a byproduct remain reportable. Also, volumes that are removed from the enclosed systems, such as those that are stored in an open tank or pit, or stored in any non-connected tank or vessel, are excluded from this exemption and remain reportable.
There are circumstances where the cement kiln dust is stored for a period of time in a tank that is connected in an enclosed system with the other operating equipment. Because the cement kiln dust is stored, it cannot meet the requirements of the non-isolated intermediate exemption and therefore would need to be considered for reporting under CDR (Refs. 25 and 26).
EPA agrees that, based on the information provided by PCA, relevant portions of CKD processing meet the definition of enclosed as described for this proposed exemption; however it does not meet the non-isolated intermediate exemption. In addition, the recycling operation uses the CKD to manufacture clinker (which consists of Portland cement), which is reported under CDR by its component substances and therefore would supply the Agency with exposure information from a similar production process. Based on
AF&PA identified that the Kraft pulping cycle begins with the production of black liquor as a byproduct of pulping in the production of paper, and the black liquor is subsequently used to manufacture green liquor. Calcium oxide and green liquor are used to manufacture white liquor, which results in the production of calcium carbonate as a byproduct. The calcium carbonate is recycled to produce calcium oxide. From the information provided, EPA believes that both black liquor and calcium carbonate are byproducts that are recycled in site-limited, enclosed systems. Based on CDR data submitted for the most recent principal reporting year (2015), EPA estimates that approximately 382 billion lbs of black liquor and calcium carbonate together might meet the criteria established in this exemption. This is the amount of black liquor and calcium carbonate that was reported as recycled and used on-site (out of the approximately 386 billion lbs total manufactured domestically in 2015). The other substances in the cycle are intentionally manufactured substances and would therefore continue to be reportable under CDR. Because the sites would be reporting these other substances, their production of black liquor and calcium carbonate would meet the requirements for this proposed exemption.
Any person would be able to request that EPA amend the manufacturing process and related byproduct substance exempted list. EPA is proposing to model the procedure to request amendments after the one described in 40 CFR 711.6(b)(2)(iii) to amend the list of partially exempted chemical substances for which the processing and use information is of low current interest. The proposed procedure would require a written request that identifies the process and byproduct chemical substance in question, including a written rationale for the request that provides sufficient specific information, including cites and relevant documents, to demonstrate to EPA that the byproduct substance(s) and manufacturing process(es) in question either would or would not meet the criteria for this exemption.
EPA is proposing to consider the following factors when evaluating a request to amend the list of exempted manufacturing processes and related byproduct substances: (1) Whether the byproduct substance is recycled or otherwise used to manufacture another chemical substance within an enclosed system, within the same overall manufacturing process, and on the same site as that byproduct was originally manufactured; (2) whether the site is reporting under CDR other chemical substances, in particular a chemical substance other than the byproduct substance that was manufactured from the byproduct or manufactured in the same overall manufacturing process; (3) whether EPA has a current interest in the byproduct substance; and (4) whether the byproduct substance must have already been reported under CDR or would be expected to be reported if not exempted by this exemption.
Regarding the second consideration, EPA expects to be able to ascertain typical exposure scenarios for the process based on information for other substances that are reported at the facility in the same or similar manufacturing process. If no other substances are reported, EPA would not have any exposure-related information about the manufacturing site.
Regarding the third consideration, EPA may have a current interest in a byproduct substance that is the subject of a rule proposed or promulgated under TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or is the subject of an ECA developed under the procedures of 40 CFR part 790, or is the subject of an order issued under TSCA sections 4, 5(e) or 5(f), or is the subject of relief that has been granted under a civil action under TSCA section 5 or 7. As noted earlier, lists of subject chemicals can be identified using the eCDRweb reporting tool or separately in EPA's Substance Registry Services (SRS). Instructions for determining subject chemicals are provided on the CDR website and in CDR guidance. EPA may also have a current interest in a byproduct substance that is undergoing risk evaluation, is being considered for prioritization, or that has particular uses or attributes that are of interest. This list is not exhaustive. For example, EPA may have a current interest for other reasons, including activities under other statutes, such as the Resource Conservation and Recovery Act (RCRA).
If a request related to a particular byproduct substance and process is resubmitted, any subsequent request would need to clearly identify new information contained in the request. EPA may request other information that it believes necessary to evaluate the request. EPA would issue a written response to each request within 120 days of receipt of the request. As needed, the Agency would initiate rulemaking to revise the list of exempted byproduct substances. To assist EPA in reaching a decision regarding a particular request prior to a given principal reporting year, requests would be required to be submitted to EPA no later than 12 months prior to the start of the next principal reporting year. EPA is interested in comments that may improve the proposed process for requesting amendments to the manufacturing process and related byproduct substance exempted list.
3.
The site must continue to report chemical substances that are subsequently manufactured from these byproducts. The production of byproducts in equipment that is integral to the production processes remain subject to reporting as well, unless otherwise exempted. For example, utilities that produce electricity as a product may be using boilers as part of their production of electricity, and therefore those boilers are considered equipment integral to the production process. Thus, byproducts produced by these electric utility boilers would continue to be subject to reporting. Another example, reverberatory furnaces, which may function similarly to some boilers, can have a chemical processing function such as smelting. This and similar equipment, when used in such scenarios, would be considered integral to the main production process and any resultant manufactured byproduct substances would continue to be subject to reporting.
Examples of non-integral pollution control equipment include flue gas desulfurization and selective catalytic reduction systems. Under this proposed exemption, if a byproduct substance produced from this equipment is recycled for a non-exempted commercial purpose, the byproduct would be exempted from reporting under CDR. However, any chemical substance manufactured from the otherwise exempted byproduct would be subject to reporting unless otherwise exempted or the manufactured volumes are below the reporting threshold. EPA is interested in receiving comments on other examples of non-integral pollution control equipment, including descriptions of potential byproducts that could be produced in such equipment.
In reviewing how the CDR information is used, EPA believes the information about byproducts produced from the identified non-integral equipment is generally less critical to be obtained via CDR than information about byproducts produced from integral equipment for risk evaluations conducted under TSCA. Release from pollution control equipment can often be obtained through national inventories such as TRI. Among other tools, EPA uses generic scenarios, including OECD-approved Emission Scenario Documents, to develop environmental release assessments. The generic scenarios can be used in combination with information from CDR to develop estimates of facility releases. These Emission Scenario Documents do not include emissions from non-integral equipment; thus, CDR data from such equipment are generally not needed to support these environmental release assessments. EPA is interested in comments that may improve the approach proposed for this exemption.
EPA is also proposing to make other general updates to the regulatory text in 40 CFR part 711 that have been identified subsequent to the CDR rule's original promulgation in 2011. The general updates to the regulatory text include removing outdated text, consolidating byproduct-related exemption text, and simplifying and clarifying language throughout the regulatory text.
1.
2.
3.
• 40 CFR 711.1(a) to remove the discussion about compiling and keeping current the TSCA Inventory, including the discussion about adding new chemicals to the Inventory. This discussion is unnecessary for an understanding of the scope of the CDR rule.
• 40 CFR 711.1(c) to include a statement about TSCA section 11 subpoena authority, as a reminder that EPA has this authority for compliance purposes.
• 40 CFR 711.3 definitions for
• 40 CFR 711.6(a)(4) to reverse the order of “certain forms of natural gas” and “water” for clarification purposes.
• 40 CFR 711.10 to remove duplicative wording and add clarity to the requirements.
• 40 CFR 711.15(a) to add clarity to the reporting requirements.
• 40 CFR 711.35(c)(1) to update references.
EPA is proposing modifications to the TSCA section 8(a) small manufacturer size standards, as required, following EPA's determination on November 30, 2017 that revision to the current size standards is warranted (82 FR 56824). The proposed standards would apply to small manufacturers for TSCA section 8(a) rules, including CDR, unless a different standard is identified in the regulatory text of a particular rule. EPA
Initially, when TSCA was implemented in the 1970's, EPA took a case-by-case approach to the definition of small manufacturers and processors and established individual size standards for each TSCA section 8(a) rule. EPA then developed a general 8(a) small manufacturer definition and size standards. These standards, finalized in the
For the TSCA section 8(a) small manufacturer definition update, EPA is proposing to update the current definition based on inflation. EPA is interested in public consideration of this approach and is soliciting comments regarding the extent to which this approach would reduce the reporting burden for those small manufacturers with fewer available resources, while ensuring Agency information needs are still met.
The proposed modification to the TSCA section 8(a) small manufacturer size standards are based on a number of factors, including: (1) Information gathered during meetings with the Small Business Administration, including the Office of Advocacy, regarding its definition of small business (Ref. 31); (2) preliminary comments and suggestions from representatives of the chemical industry, nongovernmental organizations, and state, local, and tribal governments submitted when EPA published its final determination that a revision to the standards is warranted (82 FR 56824, November 30, 2017); (3) review of various alternative exemption criteria; and (4) comments received on EPA's User Fees for the Administration of the Toxic Substances Control Act proposed rule (TSCA Fees Rule) (83 FR 8212, February 26, 2018). Documentation of these meetings, comments, and the analysis can be found in the dockets for the determination (EPA-HQ-OPPT-2016-0675), the proposed TSCA Fees Rule (EPA-HQ-OPPT-2016-0401), and this proposal (EPA-HQ-OPPT-2018-0321).
The proposed definition would be applicable to chemical manufacturers (including importers), but not to chemical processors. Because the scope of EPA's analysis of the proposed definition is focused on impacts to the CDR, in which reporting is required by manufacturers and not processors, EPA believes it is best to continue the past practice to develop definitions, as applicable, for small processors on a rule-by-rule basis. In addition, EPA has reviewed the existing TSCA section 8(a) rules that contain definitions for small processors. Because EPA has not received any reports under those rules for at least ten years, EPA believes that applying this proposed definition to processors would have no impact (Ref. 32). EPA welcomes comment on whether the proposed definition should be expanded to include processors.
All data in this preamble represent impacts to the manufacturing portion of the chemical industry, as evaluated for the CDR. The proposed definition is as follows:
(1)
(2)
Under CDR, sites that meet the small manufacturer requirements are exempted from the need to report either for the full site (based on the second standard) or for particular chemical substances (based on the first standard), unless the chemical substance the site is manufacturing (including importing) is the subject of one of certain TSCA actions: A rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 5(e), or is the subject of relief that has been granted under a civil action under TSCA sections 5 or 7. As part of this proposal, EPA is proposing to add TSCA section 4 orders to the list of certain TSCA actions. The authority to issue section 4 orders was added to TSCA when the statute was amended in 2016.
The current small manufacturer definition at 40 CFR 704.3 includes an inflation index to provide direction for determining the need to update the two standards comprising the definition (see Unit II.C.). For future inflation adjustments, EPA is proposing to use the Gross Domestic Product (GDP) deflator, or implicit price deflator, instead of the Produce Price Index (PPI) for Chemical and Allied Products when determining the need to adjust the total annual sales values. EPA is making this proposal because the types of small manufacturers subject to TSCA section 8(a) reporting requirements are broader than those defined by the PPI for Chemicals and Allied Products, which covers only Chemicals and Allied Products. The GDP deflator is less volatile and is broader than the PPI for Chemicals and Allied Products, and therefore EPA believes it is a better measure for considering an update to the revenue size standards in the proposed definition.
EPA estimates that the proposed definition would eliminate reporting entirely for 93 industry sites and would reduce reporting by eliminating the need to report at least one chemical for an additional 129 industry sites (Ref. 5). Overall, 888 chemical reports from industry sites would no longer be submitted to CDR. In sum, the use of the inflation adjustment definition results in a reduction of 2 percent of sites, an overall reduction of 2 percent of chemical reports, and a reduction of 0.07 percent of total volume reported (Ref. 5).
EPA estimates 33 government sites report under CDR in a four-year cycle. Under the proposed definition of small governments, reporting would be eliminated entirely for four government sites with an associated six chemical reports.
In the process of making this determination, EPA evaluated the effect of adjusting the small manufacturer size standard for nanoscale materials for inflation and found that it would cause no measurable impact on the number of reports received. Furthermore, since the first reports for nanoscale materials, which would make up a large portion of reported information, are due within one year after the final effective date of the rule and before any newly proposed small manufacturer definition would take effect, EPA does not want to complicate the process or potentially confuse regulated entities who are in the process of compiling the required information.
Two of the chemical-specific rules, namely 40 CFR 704.43 (Chlorinated Napthalenes) and 40 CFR 704.102 (Hexachloronorbornadiene) have their own rule-specific small manufacturer definitions. EPA is not proposing to change the definitions for these two rules because it has been over ten years since EPA has received any reports under these rules. EPA therefore believes a change to the small manufacturer definitions for these rules would have no impact. However, EPA is interested in comment on whether the small manufacturer definitions for these two rules should be changed.
Industry compliance with TSCA reporting and recordkeeping requirements involves the expenditure of time, money, and personnel resources. These costs have particular impact on companies that have limited financial and personnel resources, such as smaller firms. Such manufacturers tend to have fewer administrative personnel and less capability for data compilation and recordkeeping than larger firms.
However, while recognizing the burdens on smaller firms, EPA is required to make risk management decisions based on reasonably available information, such as that collected through CDR. The information collection authority of TSCA section 8(a) reflects congressional recognition of EPA's need for sufficient data from the chemical industry. EPA has concluded that if a firm produces a subject chemical in substantial quantities, it is inappropriate to exempt that company from TSCA section 8(a) reporting requirements. Production data is valuable to EPA as an indicator of chemical exposure and high volume chemical production reflects a greater potential for environmental release. For this reason, EPA is maintaining the annual production or importation
EPA also has the authority to develop new size standards separate from the general 8(a) small manufacturer definition in this proposed rule. Such development would be done in appropriate cases when the Agency finds that the general TSCA section 8(a) small manufacturer definition is not suitable for a new specific TSCA section 8(a) rule. However, when changing the definition for a specific rule, EPA must follow full notice and comment rulemaking procedures with regard to the amended definition and size standards.
EPA has an additional objective for the general TSCA section 8(a) small manufacturer definition and size standards. The standards should not prevent TSCA section 8(a) rules from providing information that is representative of firms of different sizes. Large and small firms have varying amounts of capital available, and therefore may utilize different production processes, techniques, and equipment. Different methods of production may cause the potential for chemical exposure to vary among large and small firms. It is important for the Agency to be able to monitor these differences. To ensure that EPA would receive information from a representative portion of manufacturers regulated under TSCA section 8(a), the structure of the definitions and levels of the size standards have been designed to allow the Agency to obtain production, use, and exposure data from a variety of firms.
A final objective for the standards is that they be easily analyzed and applied by both industry and the Agency. EPA is proposing exemption criteria that represent readily available data. These data enable identification of companies which would be likely to qualify for a small manufacturer exemption. The standards could also be easily enforced because the selected criteria would enable EPA to monitor compliance with the exemption.
In developing the size standards proposed in this rule, EPA examined the utility of several possible criteria for “small” as possible measures of chemical exposure potential and the resources available to manufacturers.
EPA looked at criteria for “small” used by other agencies, reviewed other “small” manufacturer definitions used by EPA, and reexamined criteria used for past rules under TSCA section 8(a), with specific focus on the recently finalized TSCA section 8(a) nanoscale materials rule (82 FR 3641, January 12, 2017). EPA considered the possible utility of parameters that have not been used previously, such as market share and net profit. EPA also relied on the input of industry representatives documented in the docket for the final determination that a revision to the standards is warranted and from SBA in meetings with EPA staff (82 FR 56824/EPA-HQ-OPPT-2016-0675-0022 and Ref. 31).
No parameter or set of parameters can meet EPA objectives and requirements perfectly. The various types of parameters considered, and their possible levels, are only approximations of company resources or EPA's information needs. EPA reviewed industry comments from the determination, as well as considerations factored into the development and evaluation of the original definitions, in selecting standards which best meet the Agency's requirements. EPA also took into consideration the comments on the TSCA Fees Rule (83 FR 8212, February 26, 2018), regarding the definition of small manufacturer. The following unit describes EPA's evaluation of possible alternative definitions.
In the definitions used in the past by other Federal agencies, as well as at EPA under TSCA, there is no single definition of a “small” business. The definitions and size standards differ according to context and purpose. Identified broad categories include (1) benefits distribution, (2) data analysis and reporting, and (3) regulation and information collection (where flexibility is sought in balance with program objectives) (Ref. 5).
When establishing its size standards, SBA examines various industry characteristics such as average firm size, degree of competition within an industry, start-up costs and entry barriers, and distribution of firms by size. SBA also evaluates federal market factors including a small business's share in total industry's receipts. For more details, please see the “SBA's Standards Methodology” white paper, available at
The size standards are intended to reflect the degree of competition within individual industries. SBA size standards vary by industry type to reflect the unique competitive characteristics of different industries. In some cases, SBA uses a revenue standard, or defines a business size in terms of assets. In other cases, the size standard is based on the number of employees. Within the chemical industry, the values assigned to the employment standards vary considerably among different industry groupings, which are represented using NAICS codes (Ref. 5).
For purposes of data analysis and reporting, Bureau of the Census (Census) uses a size standard of employee number at 500 to separate small businesses into their own subgroup for data reporting. Similarly, the U.S. Department of Agriculture's (USDA) Economic Research Service (ERS) identifies small farms at less than $350,000 farm income for reporting and research purposes. The purpose of these small business definitions is to identify companies whose paperwork burden can be lessened without substantial impact on the agencies' information bases (Ref. 5). Similarly, but to a much greater extent, small business definitions developed in regulatory contexts involve detailed program-specific balancing considerations. For example, the Occupational Safety and Health Administration (OSHA) defines a small business as having 10 employees or fewer for their Fire Protection in Shipyards regulations (Ref. 5).
Not unlike other federal agencies with similar purposes, EPA has separate definitions for “small” manufacturers, producers, processors, waste generators, and facilities under different statutes or regulations, including the National Primary Drinking Water Regulations, National Pollutant Discharge Elimination System Permit Regulations, RCRA laws, and the TRI. Each definition was created to meet individual programmatic needs or statutory requirements; it is therefore difficult to draw comparisons across the different definitions. For more information on the different “small” entity definitions used by other federal agencies and EPA, see Tables B-2 and B-3 in the Economic Analysis (Ref. 5).
When EPA first established the general TSCA section 8(a) small manufacturer definition at 40 CFR 704.3 (49 FR 45425, November 16, 1984), EPA considered a number of possible parameters for the size standards, including: (1) Total annual company profit, (2) total company assets, (3) total annual company sales, (4) annual chemical sales, (5) number of company employees, (6) annual production volume per chemical, and (7) market share. When EPA reevaluated the size standards (82 FR 56824, November 30, 2017), the Agency considered the initial parameters again and additionally considered (8) barriers to entry, (9) start-up or expansion costs, (10) average firm size as a factor of employment and sales, (11) industry competition and concentration, (12) growth trends, and (13) technological changes, which were suggested by SBA's Office of Advocacy during the comment period and SBA consultation as part of EPA's determination process for reviewing whether revision to the current size standards for small manufacturers and processors was warranted (82 FR 56824, November 30, 2017).
To consider these parameters for this proposed rule, EPA explored SBA's approach to defining small businesses: A manufacturer (including importer) is defined as small in accordance with the size standards identified by NAICS codes at 13 CFR 121.201. EPA considered adopting an SBA-based size-standard in combination with various production volume modifiers such as 25,000; 50,000; and 100,000 pounds. For example, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer (including importer) is greater than 50,000 pounds, the manufacturer (including importer) would not qualify as small for purposes of reporting on the production or importation of that substance at that site.
EPA examined the impact of the various SBA-related definitions and the inflation adjusted definition on the number of reports, including by subcategories of particular interest to EPA such as TSCA Work Plan chemicals and by overall production volume. Details are in Table 2-1 of the Economic Analysis (Ref. 5). Any of the revised small manufacturing definitions considered resulted in fewer retained reports. Some of the definitions resulted in the addition of reports that are currently exempted. Details are in Tables 5-15 and 5-16 of the Economic Analysis (Ref. 5).
Comparing the options by the amount of overall production volume reported provides another insight into the impacts. Under the SBA-based size standards with production volume modifiers of 50,000 and 100,000 pounds, 38 million and 96 million pounds would be exempted, respectively. In comparison, under the inflation adjusted option, 13.7 billion pounds would be exempted. When compared to the baseline production volume, these would result in the retention of reporting on 99.93 percent (inflation adjusted), 99.9998 percent (SBA-based size-standard with a production-volume modifier of 50,000 pounds) and 99.9995 percent (SBA- based size-standard with a production-volume modifier of 100,000 pounds). In addition, under the inflation adjusted option the average report exempted 15.5 million pounds, whereas under the SBA-based size standards with production volume modifiers of 50,000 and 100,000 pounds, the average report exempted 23,000 pounds and 37,000 pounds, respectively. More details are in Tables 5-15 and 5-16 of the Economic Analysis (Ref. 5).
After analyses, the agency determined that adopting SBA's definition with the various production volume modifiers would likely result in loss of information for TSCA implementation, such as information on TSCA Work Plan chemicals. Given the impacts on losses to the CDR information necessary for the TSCA program coupled with the inherently higher complexity of an SBA-based definition (system involving a mix of revenue and employment bases with levels of size standards varying according to NAICS), EPA chose to propose the inflation adjustment option. EPA is, however, interested in comments on adopting the SBA standard (or an SBA-like standard) for small manufacturers, with an alternative production volume modifier, instead of the proposed definition. Details of SBA's standard can be found at 13 CFR 121.201 and on their website (Ref. 33). Details of EPA's analysis, options considered, and conclusions are summarized in detail in the Economic Analysis (Ref. 5).
EPA's full analysis of the costs, cost savings, and benefits of this proposed definition is presented in detail in the Economic Analysis (Ref. 5). EPA welcomes comments on this proposal and on the other options and size standards EPA considered for evaluating the revised definition. In particular, EPA is seeking comments on an alternative definition for a small manufacturer (
EPA requests comment on all changes and other topics described in this proposed rule, and the Economic Analyses prepared in support of this proposed rule (Refs. 4 and 5). EPA encourages all interested persons to submit comments on the issues identified in this Notice and to identify any other relevant issues as well. This input will assist the Agency in developing final rules that successfully addresses information needs while minimizing potential reporting burdens associated with the rule. EPA requests that commenters making specific recommendations include supporting documentation where appropriate.
EPA is also interested in receiving comment on whether reporting production volumes in ranges instead of to two significant figures would reduce burden for submitters while continuing to provide the information needed by EPA for implementation of TSCA. The current requirement to report to two
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to the Office of Management and Budget for review under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket for this action as required by section 6(a)(3)(E) of Executive Order 12866.
The EPA prepared two economic analyses of the potential costs, cost savings, and benefits associated with this action. A copy of these economic analyses, entitled
The CDR revisions and TSCA section 8(a) small manufacturer definition update are part of an action that is expected overall to be a deregulatory action under Executive Order 13771 (82 FR 9339, February 3, 2017).
For CDR, the information collection requirements in 40 CFR part 711 related to the submission of Form U's are already approved by OMB under the PRA, 44 U.S.C. 3501
The ICR addendum quantifies the burdens associated with the proposed CDR revisions and TSCA section 8(a) small manufacturer definition update (RIN 2070-AK33). EPA is proposing revisions to the CDR rule for three primary reasons: Align with amended TSCA, increase the usefulness of the CDR data collected, and reduce burden for CDR reporters pursuant to TSCA section 8(a)(5). The CDR data collection provides chemical manufacture, processing, and use information that helps EPA identify what chemicals the public may be exposed to as consumers or in commercial and industrial settings. The data also help EPA assess routes of potential exposure to those chemicals.
The PRA mandates that federal agencies estimate the recordkeeping and reporting burden of a rule. In this context, the term “burden” is interpreted as the total time, effort, or financial resources expended by individuals to generate, maintain, retain, disclose, or provide information to or for a federal agency. It includes the time regulated entities need to review instructions and to develop, acquire, install, and use technology and systems to collect, validate, verify, and disclose information. It also includes time taken to adjust existing ways to comply with any previously applicable instructions and requirements and to train personnel to respond to the information collection task.
For CDR, users submit data to EPA using a Form U on a four-year reporting cycle for the “principal year” and for the years since the previous principal reporting year (currently three years). Completion of the Form U involves reporting on a per-site basis for each of the reportable chemicals at that site. Therefore, each site subject to CDR requirements is considered a respondent that will submit one Form U (response) on one or more chemicals. Sites are subject to CDR reporting requirements when annual chemical production volume is at or above reporting thresholds (typically 25,000 lbs, but 2,500 lb for certain reporters) in any calendar year in the principal reporting year and the previous three years. There is one response per respondent, as one Form U per site accommodates multiple chemical reports in the same submission. Activities for preparing and submitting a CDR reporting form include rule familiarization, compliance determination, form completion, and recordkeeping.
The changes covered by the proposed CDR revisions fall in to the following categories:
• Co-manufacturer reporting;
• Modifications and additions to reportable data elements;
• Changes to claiming confidentiality; and
• Byproduct provisions.
The changes proposed for the TSCA section 8(a) small manufacturer definition update are as follows:
•
•
These changes are described in further detail in the CDR ICR Addendum (Ref. 34). Table 2 summarizes the changes to reporting under this proposed definition.
For TSCA section 8(a) reporting outside of CDR, including the TSCA section 8(a) Preliminary Assessment Information Rule (PAIR) or any of the chemical specific TSCA section 8(a) rules, EPA does not estimate incremental burden and cost either because EPA has not received any chemical reports under the rule for an extended period of time, or because the rule uses a different definition that is not being changed by this proposal.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601
Under RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined as:
1. A small business, as defined by the SBA's regulations at 13 CFR 121.201;
2. A small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and
3. A small organization that is any not-for-profit enterprise which is independently owned and operated and not dominant in its field.
The regulated community does not include small not-for-profit organizations. Additionally, no small governments are expected to be adversely affected by the proposed rule; in fact, the proposal creates an exemption for small governments. Therefore, the focus of the RFA analysis is on small businesses.
The existing CDR rule, at 40 CFR 711.9, generally exempts from reporting small businesses, defined at 40 CFR 704.3 as entities with annual sales of less than $40 million and less than 100,000-pound production of any given chemical substance at a site; or annual sales of less than $4 million. Note that under the proposed rule, as under current regulations, a small business would be ineligible for the exemption if it produces any chemical substance that is the subject of a regulation proposed or promulgated under TSCA sections 4, 5(b)(4), or 6; that is the subject of an order in effect under TSCA sections 4 or 5(e); that is subject to a consent agreement under TSCA section 4; or that is the subject of relief that has been granted pursuant to a civil action under TSCA sections 5 or 7. A small business may also report voluntarily.
For purposes of the economic analysis covering the CDR revisions portion of the proposed rule (Ref. 4), this small manufacturer exemption is assumed to be unchanged. Conversely, for the TSCA section 8(a) small manufacturer definition update portion of the rule (Ref. 5), reporting requirements on the Form U are assumed to be unchanged with changes to the exemption as the focus of the Economic Analysis (Ref. 5). Further discussions in this unit summarize results from each economic analysis, and then provide the synthesized overall conclusion.
1.
2.
• First standard, A manufacturer (including importer) of a substance is small if its total annual sales, when combined with those of its parent company (if any) are less than $110 million. However, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer (including importer) is greater than 100,000 pounds, the manufacturer or importer will not qualify as small for purposes of reporting on the production or importation of that substance at that site, unless the manufacturer (including importer) qualifies as small under the second standard of this definition.
• Second Standard. A manufacturer (including importer) of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $11 million, regardless of the quantity of substances produced or imported by that manufacturer (including importer).
Under the proposed definition, the only change from the current TSCA section 8(a) small manufacturer definition is to increase levels for revenue size standards. As a result, EPA expects that no currently exempt small manufacturers would become newly subject to any current TSCA section 8(a) rules under this proposed definition, because all manufacturers that are currently exempt would remain exempt under this proposal. Moreover, the proposed rule would allow exemptions for certain current reporters, thereby eliminating their reporting burden. However, a small amount of incremental burden is incurred for rule familiarization.
As done for the CDR revisions portion of the proposed rule, EPA analyzed potential small business impacts for purposes of the small entity analysis using the SBA size standards which are either revenue or employment based, depending on the industry sector. For the small manufacturer definition update, EPA estimates that 732 small parent entities would potentially be affected by the proposed rule. Based on estimated compliance costs annualized over a 10-year period and average
3.
EPA continues to be interested in the potential impacts of this proposed rule on small entities and welcomes comments on issues related to such impacts.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and would not significantly or uniquely affect small governments. According to the information derived using the 2016 CDR, there are government entities that report to CDR, including: seven municipalities, one county-level public utility district, and one tribal entity. However, under the proposed changes, four of the municipalities would be exempt, with the remaining entities incurring a minimal average incremental burden and cost per site at about 3 hours and $262 per year, respectively. Consequently, impacts would not exceed $100 million for all governments. Additionally, under the proposed small government definition, four government entities would be exempt from TSCA section 8(a) reporting requirements (Ref. 5).
In sum, the proposed rule is not expected to result in expenditures by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (when adjusted annually for inflation) in any one year. Accordingly, this proposed rule is not subject to the requirements of sections 202, 203, or 205 of UMRA.
This action would not have federalism implications. It would 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 Executive Order 13132 (64 FR 43255, August 10, 1999).
This action would not have tribal implications because it is not expected to have substantial direct effects on tribal governments, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). According to the information presented in the economic analysis for the TSCA section 8(a) small manufacturer definition update (Ref. 5), there is one tribal entity that reported during the 2016 CDR collection. Under the proposed rule, this entity is estimated to incur a minimal average incremental burden and cost per site at about 1 hour and $103 per year, respectively. Consequently, EPA has concluded that the impacts of the proposed rule would not significantly nor uniquely affect the communities of tribal governments. Thus, Executive Order 13175 does not apply to this proposed rule.
Executive Order 13045 (62 FR 19885, April 23, 1997), requires that federal agencies examine the impacts of each regulatory action on children for any economically significant regulation (as defined by Executive Order 12866) that the Agency has reason to believe may disproportionately affect children. EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks, such that the analysis required under section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it would not establish an environmental standard intended to mitigate health or safety risks. Nevertheless, the information obtained by the reporting required by this proposed rule would be used to inform the Agency's decision-making process regarding chemical substances to which children may be disproportionately exposed. This information would also assist the Agency and others in determining whether the chemical substances covered in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
Because this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
This action will not have high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The Agency believes that the rule would improve the information collected under CDR and better assist EPA and others in determining the potential hazards and risks associated with the chemical substances covered by the CDR. Because the CDR is an information collection requirement, the information that would be improved through the proposed rule would enable the Agency to target educational, regulatory, or enforcement activities towards industries or chemical substances that pose the greatest risks and/or to target programs for geographic areas that are at the highest risk. Thus, the information to be gathered under the proposed rule would help EPA make decisions that would benefit potentially at-risk communities, some of which may be disadvantaged.
The proposed rule is directed at manufacturers (including importers) of chemical substances. All consumers of these chemical products and all workers who come into contact with these chemical substances could benefit if data regarding the chemical substances' health and environmental effects were developed. Therefore, it would not appear that the costs and the benefits of the proposed rule would be disproportionately distributed across different geographic regions or among different categories of individuals.
Environmental protection, Toxic substances control act, Reporting and recordkeeping requirements.
Environmental protection, Toxic substances control act, TSCA chemical data reporting and recordkeeping requirements.
Environmental protection, Toxic substances control act, Chemical information rules.
Therefore, EPA proposes to amend 40 CFR parts 704, 711 and 712 as follows:
15 U.S.C. 2607(a).
The additions and revisions read as follows:
(1)
(2)
(3)
(c) * * *
(2) Persons described in § 704.5 (a) through (f).
15 U.S.C. 2607(a).
(a) This part specifies reporting and recordkeeping procedures under section 8(a) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2607(a)) for certain manufacturers (including importers) of chemical substances. TSCA section 8(a) authorizes the EPA Administrator to require reporting of information necessary for the administration of TSCA.
(c) TSCA section 15(3) makes it unlawful for any person to fail or refuse to submit information required under this part. In addition, TSCA section 15(3) makes it unlawful for any person to fail to keep, and permit access to, records required by this part. Section 16 of TSCA provides that any person who violates a provision of TSCA section 15 is liable to the United States for a civil penalty and may be criminally prosecuted. Pursuant to TSCA section 17, the Federal Government may seek judicial relief to compel submission of TSCA section 8(a) information and to otherwise restrain any violation of TSCA section 15. (EPA does not intend to concentrate its enforcement efforts on insignificant clerical errors in reporting.) TSCA section 11 allows for inspections to assure compliance and the Administrator may by subpoena require the attendance and testimony of witnesses and the production of reports, papers, documents, answers to questions, and other information that the Administrator deems necessary.
The additions and revisions read as follows:
(1) Produced exclusively for another person who contracts for such production, and
(2) That other person dictates the specific chemical identity of the chemical substance and controls the total amount produced and the basic technology for the manufacturing process.
(1) If the site is entirely owned by a single U.S. company that is not owned by another company, that single company is the U.S. parent company.
(2) If the site is entirely owned by a single U.S. company that is, itself, owned by another U.S.-based company (
(3) If the site is owned by more than one company (
(4) If the site is owned by a 50:50 joint venture or a cooperative, the joint venture or cooperative is its own parent company. If the site is owned by a U.S. joint venture or cooperative, the highest level of the joint venture or cooperative is the U.S. parent company. If the site is owned by a joint venture or cooperative outside the United States, the highest level of the joint venture or cooperative outside the United States is the foreign parent company.
(5) If the site is entirely owned by a foreign company (
(6) If the site is federally owned, the highest-level federal agency or department is the U.S. parent company.
(7) If the site is owned by a non-federal public entity, that entity (such as a municipality, State, or tribe) is the U.S. parent company.
(1) For chemical substances manufactured under contract,
The following groups or categories of chemical substances are exempted from some or all of the reporting requirements of this part, with the following exception: A chemical substance described in paragraph (a)(1), (a)(2), or (a)(4), or (b) of this section is not exempted from any of the reporting requirements of this part if that chemical substance is the subject of a rule proposed or promulgated under TSCA sections 4, 5(a)(2), 5(b)(4), or 6, or is the subject of an enforceable consent agreement (ECA) developed under the procedures of 40 CFR part 790, or is the subject of an order issued under TSCA sections 4, 5(e), or 5(f), or is the subject of relief that has been granted under a civil action under TSCA sections 5 or 7.
(a) * * *
(4).
(a)
(b)
A person described in § 711.8 is not subject to the requirements of this part if that person qualifies as a small manufacturer or small government as those terms are defined in 40 CFR 704.3. Notwithstanding this exclusion, a person who qualifies as a small manufacturer or small government is subject to this part with respect to any chemical substance that is the subject of a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA sections 4 or 5(e), or is the subject of relief that has been granted under a civil action under TSCA sections 5 or 7.
A person described in § 711.8 is not subject to the requirements of this part with respect to any chemical substance described in § 711.5, when:
(a) The person manufactured or imported the chemical substance solely in small quantities for research and development.
(b) The person imported the chemical substance as part of an article.
(c) The person manufactured the chemical substance in any of the following manners:
(1) Any byproduct if its only commercial purpose is for use by public or private organizations that (i) burn it as a fuel, (ii) dispose of it as a waste, including in a landfill or for enriching soil, or (iii) extract component chemical substances from it for commercial purposes. (This exclusion only applies to the byproduct; it does not apply to the component substances extracted from the byproduct.)
(2) Byproduct substances listed in subparagraph (i) for the following manufacturing processes, when recycled or otherwise used within a site-limited, physically enclosed system that is part of the same overall manufacturing process from which the byproduct substance was generated, and when the site is reporting the byproduct or a different chemical substance that was manufactured from the recycled
(i)
(A) Portland Cement Manufacturing (
(B) Kraft Pulping Process (
(ii)
(A) Any person may request that EPA amend the chemical substance list in paragraph (c)(2)(i) of this section. Your request must be in writing and must be submitted to the address provided in 40 CFR 700.17(a). Please label your request as follows: Attention: TSCA Chemical Data Reporting—Byproduct Exemption Request. Requests must identify the manufacturing process and byproduct chemical substance in question, as well as its CASRN or other chemical identification number as identified in § 711.15(b)(3)(i), and must contain a written rationale for the request that provides sufficient specific information, addressing the considerations listed in (c)(2)(ii)(B) of this section, including cites and relevant documents, to demonstrate to EPA that the byproduct substance and process in question either does or does not meet the criteria explained in paragraph (c)(2) of this section. If a request related to a particular byproduct substance and process is resubmitted, any subsequent request must clearly identify new information contained in the request. EPA may request other information that it believes necessary to evaluate the request. EPA will issue a written response to each request within 120 days of receipt of the request and will maintain copies of these responses in a docket that will be established for each reporting cycle.
(B)
(
(
(
(
(C) As needed, the Agency will initiate rulemaking to make revisions to the list of substances in paragraph (c)(2)(i) of this section.
(D) To assist EPA in reaching a decision regarding a particular request prior to a given principal reporting year, requests must be submitted to EPA no later than 12 months prior to the start of the next principal reporting year.
(3) A quantity of the byproduct that is manufactured solely in the following equipment when it is not integral to the chemical manufacturing processes of the site:
(i) Pollution control equipment.
(ii) Boilers used to generate heat or electricity for that site.
(4) The chemical substances described in this section: (Although they are manufactured for commercial purposes under TSCA, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part.)
(i) Any impurity.
(ii) Any byproduct which is not used for commercial purposes.
(iii) Any chemical substance which results from a chemical reaction that occurs incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight.
(iv) Any chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of another chemical substance, mixture, or article.
(v) Any chemical substance which results from a chemical reaction that occurs upon end use of another chemical substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping product, fuel additive, water softening and treatment agent, photographic film, battery, match, or safety flare, and which is not itself manufactured or imported for distribution in commerce or for use as an intermediate.
(vi) Any chemical substance which results from a chemical reaction that occurs upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or any other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that occur as described elsewhere in this paragraph.
(vii) Any chemical substance which results from a chemical reaction that occurs when (A) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutralizer, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or (B) a chemical substance, which is intended solely to impart a specific physiochemical characteristic, functions as intended.
(viii) Any nonisolated intermediate.
Any person who must report under this part, as described in § 711.8, must submit the information described in this section for each chemical substance described in § 711.5 that the person manufactured (including imported) for commercial purposes in an amount of 25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134 kg) or more for chemical substances subject to the rules, orders, or actions described in § 711.8(b)) at any one site during any calendar year since the last principal reporting year (
(a)
(b)
(1)
(2)
(i) The legal name, address, and Dun and Bradstreet D-U-N-S® (D&B) number for the highest-level parent company located in the United States and, if one exists, the highest-level foreign-based parent company. A submitter under this part must obtain a D&B number for the parent company if none exists and must report using the standardized conventions for the naming of a parent company as provided in the CDR Instructions for Reporting identified in § 711.35.
(ii) The name of a person who will serve as technical contact for the submitter company who will be able to answer questions about the information submitted by the company to EPA, and that technical contact person's full mailing address, telephone number, and email address.
(iii) The legal name and full street address of each site. A submitter under this part must include the appropriate D&B number for each site reported, and the county or parish (or other jurisdictional indicator) in which the site is located. A submitter under this part must obtain a D&B number for the site reported if none exists. For a co-manufacturing situation, the contracting company must report both the site controlling the contract and the producing company's site information.
(iv) The six-digit NAICS code for the site. A submitter under this part must include the appropriate six-digit NAICS code for each site reported.
(3)
(i) The specific, currently correct CA Index name as used to list the chemical substance on the TSCA Inventory and the correct corresponding CASRN for each reportable chemical substance at each site. Submitters who wish to report chemical substances listed on the confidential portion of the TSCA Inventory will need to report the chemical substance using the corresponding TSCA Accession Number that is listed on the public portion of the Inventory. In addition to reporting the chemical identifying number itself, submitters must specify the type of number they are reporting by selecting from among the codes in Table 3 of this paragraph.
(A)
(B)
(
(
(ii) For the principal reporting year only, a statement indicating, for each reportable chemical substance at each site, whether the chemical substance is manufactured in the United States, imported into the United States, or both manufactured in the United States and imported into the United States.
(iii) For the principal reporting year, the total annual volume (in pounds) of each reportable chemical substance domestically manufactured or imported at each site. The total annual domestically manufactured volume (not including imported volume) and the total annual imported volume must be separately reported. These amounts must be reported to two significant figures of accuracy. In addition, the total annual volume (domestically manufactured plus imported volumes in pounds) of each reportable chemical substance at each site for each complete calendar year since the last principal reporting year.
(iv) For the principal reporting year only, the volume used on site and the volume directly exported of each reportable chemical substance domestically manufactured or imported at each site. These amounts must be reported to two significant figures of accuracy.
(v) For the principal reporting year only, a designation indicating, for each imported reportable chemical substance at each site, whether the imported chemical substance is physically present at the reporting site.
(vi) For the principal reporting year only, the percentage, rounded off to the closest 10 percent, of total production volume of the reportable chemical substance, for each reportable chemical substance at each site, that is manufactured as a byproduct at the site. Where this percentage accounts for less than 5 percent of the total production volume of the reportable chemical substance, submitters instead must report the percentage, rounded off to the closest 1 percent.
(vii) For the principal reporting year only, a designation indicating, for each reportable chemical substance at each site, whether the chemical substance is being recycled or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream.
(viii) For the principal reporting year only, the total number of workers reasonably likely to be exposed to each reportable chemical substance at each site. For each reportable chemical substance at each site, the submitter must select from among the ranges of workers listed in Table 5 of this paragraph and report the corresponding code (
(ix) For the principal reporting year only, the maximum concentration, measured by percentage of weight, of each reportable chemical substance at the time it is sent off-site from each site. If the chemical substance is site-limited, you must report the maximum concentration, measured by percentage of weight of the reportable chemical substance at the time it is reacted on-site to produce a different chemical substance. This information must be reported regardless of the physical form(s) in which the chemical substance is sent off-site/reacted on-site. For each chemical substance at each site, select the maximum concentration of the chemical substance from among the ranges listed in Table 6 of this paragraph and report the corresponding code (
(x) For the principal reporting year only, the physical form(s) of the reportable chemical substance as it is sent off-site from each site. If the chemical substance is site-limited, you must report the physical form(s) of the reportable chemical substance at the time it is reacted on-site to produce a
(A) Dry powder.
(B) Pellets or large crystals.
(C) Water- or solvent-wet solid.
(D) Other solid.
(E) Gas or vapor.
(F) Liquid.
(xi) For the principal reporting year only, submitters must report the percentage, rounded off to the closest 10 percent, of total production volume of the reportable chemical substance, reported in response to paragraph (b)(3)(iv) of this section, that is associated with each physical form reported under paragraph (b)(3)(x) of this section.
(4)
(i)
(B) A code indicating the sector(s) that best describe the industrial activities associated with each industrial processing or use operation reported under paragraph (b)(4)(i)(A) of this section. For each chemical substance, report the code that corresponds to the appropriate sector(s) listed in Table 8 of this paragraph. A particular sector code may need to be reported more than once, to the extent that a submitter reports more than one function code (under paragraph (b)(4)(i)(C) of this section) that applies to a given sector code under this paragraph.
(C) For each sector reported under paragraph (b)(4)(i)(B) of this section, function category code(s) as provided in the CDR Instructions for Reporting identified in § 711.35 must be selected to designate the function category(ies) that best represents the specific manner in which the chemical substance is used. A particular function category may need to be reported more than once, to the extent that a submitter reports more than one industrial processing or use operation/sector combination (under paragraphs (b)(4)(i)(A) and (b)(4)(i)(B) of this section) that applies to a given function category under this paragraph. If more than 10 unique combinations of industrial processing or use operations/sector/function categories apply to a chemical substance, submitters need only report the 10 unique combinations for the chemical substance that cumulatively represent the largest percentage of the submitter's production volume for that chemical substance, measured by weight. If none of the listed function categories accurately describes a use of a chemical substance, the category “Other” may be used, and must include a description of the use.
(D) The estimated percentage, rounded off to the closest 10 percent, of total production volume of the reportable chemical substance associated with each combination of industrial processing or use operation, sector, and function category. Where a
(E) For each combination of industrial processing or use operation, sector, and function category, the submitter must estimate the number of sites at which each reportable chemical substance is processed or used. For each combination associated with each chemical substance, the submitter must select from among the ranges of sites listed in Table 9 of this paragraph and report the corresponding code (
(F) For each combination of industrial processing or use operation, sector, and function category, the submitter must estimate the number of workers reasonably likely to be exposed to each reportable chemical substance. For each combination associated with each chemical substance, the submitter must select from among the worker ranges listed in paragraph (b)(3)(viii) of this section and report the corresponding code (
(ii)
(B) for each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section, code(s) described in paragraph (b)(4)(i)(C) of this section must be selected to designate the function category(ies) that best represents the specific manner in which the chemical substance is used. A particular function category may need to be reported more than once, to the extent that a submitter reports more than one consumer or commercial product category (under paragraphs (b)(4)(ii)(A) of this section) that applies to a given function category under this paragraph. If none of the listed function categories accurately describes a use of a chemical substance, the category “Other” may be used, and must include a description of the use.
(C) An indication, within each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section, whether the use is a consumer or a commercial use.
(D) Submitters must determine, within each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section, whether any amount of each reportable chemical substance manufactured (including imported) by the submitter is present in (for example, a plasticizer chemical substance used to make pacifiers) or on (for example, as a component in the paint on a toy) any consumer products intended for use by children age 14 or younger, regardless of the concentration of the chemical substance remaining in or on the product. Submitters must select from the following options: The chemical substance is used in or on any consumer products intended for use by children, the chemical substance is not used in or on any consumer products intended for use by children, or information as to whether the chemical substance is used in or on any consumer products intended for use by children is not known to or reasonably ascertainable by the submitter.
(E) The estimated percentage, rounded off to the closest 10 percent, of the submitter's site's total production volume of the reportable chemical substance associated with each consumer and commercial product category. Where a particular consumer and commercial product category accounts for less than 5 percent of the total production volume of a reportable chemical substance, the percentage must not be rounded off to 0 percent if the production volume attributable to that commercial and consumer product category is 25,000 lb (11,340 kg) or more during the reporting year. Instead, in such a case, submitters must report the percentage, rounded off to the closest 1 percent, of the submitter's site's total production volume of the reportable chemical substance associated with the particular consumer and commercial product category.
(F) Where the reportable chemical substance is used in consumer or commercial products, the estimated typical maximum concentration, measured by weight, of the chemical substance in each consumer and commercial product category reported under paragraph (b)(4)(ii)(A) of this section. For each chemical substance in each commercial and consumer product category reported under paragraph (b)(4)(ii)(A) of this section, submitters must select from among the ranges of concentrations listed in Table 6 in paragraph (b)(3)(ix) of this section and report the corresponding code (
(G) Where the reportable chemical substance is used in a commercial product, the submitter must estimate the number of commercial workers reasonably likely to be exposed to each reportable chemical substance. For each combination associated with each substance, the submitter must select from among the worker ranges listed in Table 5 in paragraph (b)(3)(viii) of this section and report the corresponding code (
All information reported to EPA in response to the requirements of this part must be submitted during an applicable submission period, which runs from June 1 to September 30 at 4-year intervals, beginning in 2020. In each submission period, any person described in § 711.8 must report as described in this part.
(c)
Any such confidentiality claims must be asserted at the time the information is submitted. These claims will apply only to the information submitted with the claim. Instructions for asserting confidentiality claims are provided in the document identified in § 711.35. Information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2.
(2)
(i) For public contact information if voluntarily provided;
(ii) For chemical identities listed on the public portion of the TSCA Inventory or for chemical category identification when reporting pursuant to § 711.15(b)(3)(i);
(iii) For processing and use data elements required by § 711.15(b)(4)(i)(A), (B), and (C) and § 711.15(b)(4)(ii)(A), (B), and (C), or
(iv) When a response is left blank or designated as not known or reasonably ascertainable.
(3) All confidentiality claims must be substantiated at time of submission, in accordance with the requirements in subsections (b) through (f) of this section. Confidentiality claims for the following data elements are exempt from this substantiation requirement:
(i) Production volume information required pursuant to § 711.15(b)(3)(iii).
(ii) Joint submission information from the primary submitter including trade name and supplier identification required pursuant to § 711.15(b)(3)(i)(A), (B), and (C).
(iii) Joint submission information from the secondary submitter including the percentage of formulation required pursuant to § 711.15(b)(3)(i)(A), (B), and (C).
(4) All confidentiality claims require certification in accordance with subsection (g) of this section. All asserted confidentiality claims, whether subject to substantiation and review or not, may only be asserted consistent with the representations set forth in the certification described in subsection (h) of this section.
(b)
(1) Will disclosure of the information claimed as confidential likely cause substantial harm to your business's competitive position? If you answered yes, explain the substantial harm.
(2) To the extent your business has disclosed the information to others (both internally and externally), has your business taken precautions to protect the disclosed information? If yes, please explain and identify the specific measures or internal controls your business has taken to protect the information claimed as confidential.
(3) Does any of the information claimed as confidential appear in any public documents, including (but not limited to) safety data sheets, advertising or promotional material, professional or trade publications, or any other media or publications available to the general public? If you answered yes, explain why the information should be treated as confidential.
(4) Does any of the information you are claiming as confidential constitute a trade secret?
(5) Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B))? If so, indicate the number of years (between 1-10 years) or the specific date after which the claim is withdrawn.
(6) Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If yes, provide the circumstances associated with the prior determination, whether the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination.
(c)
(1) Is this chemical substance publicly known to be in U.S. commerce by a specific chemical identity or name that is consistent with its listing on the confidential portion of the TSCA Inventory? If yes, explain why the chemical identity should still be afforded confidential status (
I certify that on the date referenced, I searched the internet for the chemical substance identity (
(2) Does this particular chemical substance leave the site of manufacture (including import) in any form,
(3) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product?
(4) Would disclosure of the specific chemical name release confidential process information? If yes, please explain?
(d)
(1) Has company, site, or technical contact identity information been linked with a reportable chemical substance in any public document or in any other Federal, State, or local reporting scheme? For example, is the chemical identity linked to a facility in a filing under the Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through a Safety Data Sheet (SDS)? If yes, explain why the information should be treated as confidential.
(e)
(1) Is the information claimed as confidential publicly known? For example, is the information available in advertisements or other marketing materials, professional journals or other similar materials, or in non-confidential mandatory or voluntary government filings or publications? Has your company ever publicly released this information? If yes, explain why the information should be treated as confidential.
(2) Has your company ever provided this information on the chemical substance to any person and not asked that it be treated as confidential? If yes, explain why the information should be treated as confidential.
(f)
(g)
(h)
I certify that all claims for confidentiality asserted with this submission are true and correct, and all information submitted herein to substantiate such claims is true and correct. Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken reasonable measures to protect the confidentiality of the information; (2) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (3) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and (4) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.
(i)
(c) * * *
(1)
15 U.S.C. 2607(a).
(c) Persons who qualify as small manufacturers (including importers) in respect to a specific chemical substance listed in § 712.30 are exempt. However, this exemption does not apply with respect to any chemical in § 712.30 designated by an asterisk. A manufacturer is qualified as small and is exempt from submitting a report under this subpart for a chemical substance manufactured at a particular plant site if it meets the definition for small manufacturer in § 704.3.