42 U.S.C. § 1395aaa

Current through P.L. 118-106 (published on www.congress.gov on 10/04/2024)

Section 1395aaa - Contract with a consensus-based entity regarding performance measurement

(a) Contract

(1) In general

For purposes of activities conducted under this chapter, the Secretary shall identify and have in effect a contract with a consensus-based entity, such as the National Quality Forum, that meets the requirements described in subsection (c). Such contract shall provide that the entity will perform the duties described in subsection (b).

(2) Timing for first contract

As soon as practicable after July 15, 2008, the Secretary shall enter into the first contract under paragraph (1).

(3) Period of contract

A contract under paragraph (1) shall be for a period of 4 years (except as may be renewed after a subsequent bidding process).

(4) Competitive procedures

Competitive procedures (as defined in section 132 of title 41) shall be used to enter into a contract under paragraph (1).

(b) Duties

The duties described in this subsection are the following:

(1) Priority setting process

The entity shall synthesize evidence and convene key stakeholders to make recommendations, with respect to activities conducted under this chapter, on an integrated national strategy and priorities for health care performance measurement in all applicable settings. In making such recommendations, the entity shall-

(A) ensure that priority is given to measures-

(i) that address the health care provided to patients with prevalent, high-cost chronic diseases;

(ii) with the greatest potential for improving the quality, efficiency, and patient-centeredness of health care; and

(iii) that may be implemented rapidly due to existing evidence, standards of care, or other reasons; and

(B) take into account measures that-

(i) may assist consumers and patients in making informed health care decisions;

(ii) address health disparities across groups and areas; and

(iii) address the continuum of care a patient receives, including services furnished by multiple health care providers or practitioners and across multiple settings.

(2) Endorsement of measures

The entity shall provide for the endorsement of standardized health care performance measures. The endorsement process under the preceding sentence shall consider whether a measure-

(A) is evidence-based, reliable, valid, verifiable, relevant to enhanced health outcomes, actionable at the caregiver level, feasible to collect and report, and responsive to variations in patient characteristics, such as health status, language capabilities, race or ethnicity, and income level; and

(B) is consistent across types of health care providers, including hospitals and physicians.

(3) Maintenance of measures

The entity shall establish and implement a process to ensure that measures endorsed under paragraph (2) are updated (or retired if obsolete) as new evidence is developed.

(4) Removal of measures

The entity may provide input to the Secretary on quality and efficiency measures described in paragraph (7)(B) that could be considered for removal.

(5) Annual report to Congress and the Secretary; secretarial publication and comment

(A)¹ Annual report

By not later than March 1 of each year (beginning with 2009), the entity shall submit to Congress and the Secretary a report containing the following:

(i) A description of-

(I) the implementation of quality measurement initiatives under this chapter and the coordination of such initiatives with quality initiatives implemented by other payers;

(II) the recommendations made under paragraph (1);

(III) the performance by the entity of the duties required under the contract entered into with the Secretary under subsection (a);

(IV) gaps in endorsed quality measures, which shall include measures that are within priority areas identified by the Secretary under the national strategy established under section 280j of this title, and where quality measures are unavailable or inadequate to identify or address such gaps;

(V) areas in which evidence is insufficient to support endorsement of quality measures in priority areas identified by the Secretary under the national strategy established under section 280j of this title and where targeted research may address such gaps; and

(VI) the matters described in clauses (i) and (ii) of paragraph (7)(A).

(ii) An itemization of financial information for the fiscal year ending September 30 of the preceding year, including-

(I) annual revenues of the entity (including any government funding, private sector contributions, grants, membership revenues, and investment revenue);

(II) annual expenses of the entity (including grants paid, benefits paid, salaries or other compensation, fundraising expenses, and overhead costs); and

(III) a breakdown of the amount awarded per contracted task order and the specific projects funded in each task order assigned to the entity.

(iii) Any updates or modifications of internal policies and procedures of the entity as they relate to the duties of the entity under this section, including-

(I) specifically identifying any modifications to the disclosure of interests and conflicts of interests for committees, work groups, task forces, and advisory panels of the entity; and

(II) information on external stakeholder participation in the duties of the entity under this section (including complete rosters for all committees, work groups, task forces, and advisory panels funded through government contracts, descriptions of relevant interests and any conflicts of interest for members of all committees, work groups, task forces, and advisory panels, and the total percentage by health care sector of all convened committees, work groups, task forces, and advisory panels.²

(B) Secretarial review and publication of annual report

Not later than 6 months after receiving a report under subparagraph (A) for a year, the Secretary shall-

(i) review such report; and

(ii) publish such report in the Federal Register, together with any comments of the Secretary on such report.

(6) Review and endorsement of episode grouper under the physician feedback program

The entity shall provide for the review and, as appropriate, the endorsement of the episode grouper developed by the Secretary under section 1395w-4(n)(9)(A) of this title. Such review shall be conducted on an expedited basis.

(7) Convening multi-stakeholder groups

(A) In general

The entity shall convene multi-stakeholder groups to provide input on-

(i) the selection of quality and efficiency measures described in subparagraph (B), from among-

(I) such measures that have been endorsed by the entity; and

(II) such measures that have not been considered for endorsement by such entity but are used or proposed to be used by the Secretary for the collection or reporting of quality and efficiency measures; and

(ii) national priorities (as identified under section 280j of this title) for improvement in population health and in the delivery of health care services for consideration under the national strategy established under section 280j of this title.

(B) Quality and efficiency measures

(i) In general

Subject to clause (ii), the quality and efficiency measures described in this subparagraph are quality and efficiency measures-

(I) for use pursuant to sections 1395f(i)(5)(D), 1395l(i)(7), 1395l(t)(17), 1395w-4(k)(2)(C), 1395cc(k)(3), 1395rr(h)(2)(A)(iii),³ 1395ww(b)(3)(B)(viii), 1395ww(j)(7)(D), 1395ww(m)(5)(D), 1395ww(o)(2), 1395ww(s)(4)(D), and 1395fff(b)(3)(B)(v) of this title;

(II) for use in reporting performance information to the public; and

(III) for use in health care programs other than for use under this chapter.

(ii) Exclusion

Data sets (such as the outcome and assessment information set for home health services and the minimum data set for skilled nursing facility services) that are used for purposes of classification systems used in establishing payment rates under this subchapter shall not be quality and efficiency measures described in this subparagraph.

(C) Requirement for transparency in process

(i) In general

In convening multi-stakeholder groups under subparagraph (A) with respect to the selection of quality and efficiency measures, the entity shall provide for an open and transparent process for the activities conducted pursuant to such convening.

(ii) Selection of organizations participating in multi-stakeholder groups

The process described in clause (i) shall ensure that the selection of representatives comprising such groups provides for public nominations for, and the opportunity for public comment on, such selection.

(D) Multi-stakeholder group defined

In this paragraph, the term "multi-stakeholder group" means, with respect to a quality and efficiency measure, a voluntary collaborative of organizations representing a broad group of stakeholders interested in or affected by the use of such quality and efficiency measure.

(8) Transmission of multi-stakeholder input

Not later than February 1 of each year (beginning with 2012), the entity shall transmit to the Secretary the input of multi-stakeholder groups provided under paragraph (7).

(9) Prioritization of measure endorsement

The Secretary-

(A) during the period beginning on December 27, 2020, and ending on December 31, 2023, shall prioritize the endorsement of measures relating to maternal morbidity and mortality by the entity with a contract under subsection (a) in connection with endorsement of measures described in paragraph (2); and

(B) on and after January 1, 2024, may prioritize the endorsement of such measures by such entity.

(c) Requirements described

The requirements described in this subsection are the following:

(1) Private nonprofit

The entity is a private nonprofit entity governed by a board.

(2) Board membership

The members of the board of the entity include-

(A) representatives of health plans and health care providers and practitioners or representatives of groups representing such health plans and health care providers and practitioners;

(B) health care consumers or representatives of groups representing health care consumers; and

(C) representatives of purchasers and employers or representatives of groups representing purchasers or employers.

(3) Entity membership

The membership of the entity includes persons who have experience with-

(A) urban health care issues;

(B) safety net health care issues;

(C) rural and frontier health care issues; and

(D) health care quality and safety issues.

(4) Open and transparent

With respect to matters related to the contract with the Secretary under subsection (a), the entity conducts its business in an open and transparent manner and provides the opportunity for public comment on its activities.

(5) Voluntary consensus standards setting organization

The entity operates as a voluntary consensus standards setting organization as defined for purposes of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (Public Law 104-113) and Office of Management and Budget Revised Circular A-119 (published in the Federal Register on February 10, 1998).

(6) Experience

The entity has at least 4 years of experience in establishing national consensus standards.

(7) Membership fees

If the entity requires a membership fee for participation in the functions of the entity, such fees shall be reasonable and adjusted based on the capacity of the potential member to pay the fee. In no case shall membership fees pose a barrier to the participation of individuals or groups with low or nominal resources to participate in the functions of the entity.

(d) Funding

(1) For purposes of carrying out this section, the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1395i of this title and the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title (in such proportion as the Secretary determines appropriate), of $10,000,000 to the Centers for Medicare & Medicaid Services Program Management Account for each of fiscal years 2009 through 2013. Amounts transferred under the preceding sentence shall remain available until expended.

(2) For purposes of carrying out this section and section 1395aaa-1 of this title (other than subsections (e) and (f)), the Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1395i of this title and the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, in such proportion as the Secretary determines appropriate, to the Centers for Medicare & Medicaid Services Program Management Account of $5,000,000 for fiscal year 2014, $30,000,000 for each of fiscal years 2015 through 2017, $7,500,000 for each of fiscal years 2018 and 2019, $20,000,000 for fiscal year 2020, $26,000,000 for fiscal year 2021, $20,000,000 for fiscal year 2022, $20,000,000 for fiscal year 2023, and $9,000,000 for the period beginning on October 1, 2023, and ending on December 31, 2024. Amounts transferred under the preceding sentence shall remain available until expended. Amounts transferred for each of fiscal years 2018, 2019, 2020, 2021, 2022, 2023, and 2024 and the period beginning on October 1, 2024, and ending on December 31, 2024, shall be in addition to any unobligated funds transferred for a preceding fiscal year that are available under the preceding sentence.

(e) Annual report by Secretary to Congress

(1) In general

By not later than March 1 of each year (beginning with 2019), the Secretary shall submit to Congress a report containing the following:

(A) A comprehensive plan that identifies the quality measurement needs of programs and initiatives of the Secretary and provides a strategy for using the entity with a contract under subsection (a) and any other entity the Secretary has contracted with or may contract with to perform work associated with section 1395aaa-1 of this title to help meet those needs, specifically with respect to the programs under this subchapter and subchapter XIX.

(B) The amount of funding provided under subsection (d) for purposes of carrying out this section and section 1395aaa-1 of this title that has been obligated by the Secretary, the amount of funding provided that has been expended, and the amount of funding provided that remains unobligated.

(C) With respect to the activities described under this section or section 1395aaa-1 of this title, a description of how the funds described in paragraph (2) have been obligated or expended, including how much of that funding has been obligated or expended for work performed by the Secretary, the entity with a contract under subsection (a), and any other entity the Secretary has contracted with to perform work.

(D) Subject to paragraph (2)(B), a description of the activities for which the funds described in paragraph (2) were used, including task orders and activities assigned to the entity with a contract under subsection (a), activities performed by the Secretary, and task orders and activities assigned to any other entity the Secretary has contracted with to perform work related to carrying out section 1395aaa-1 of this title.

(E) Subject to paragraph (2)(B), the amount of funding described in paragraph (2) that has been obligated or expended for each of the activities described in paragraph (4).

(F) Subject to paragraph (2)(B), estimates for, and descriptions of, obligations and expenditures that the Secretary anticipates will be needed in the succeeding two year period to carry out each of the quality measurement activities required under this section and section 1395aaa-1 of this title, including any obligations that will require funds to be expended in a future year.

(2) Additional requirements for reports

(A) Addressing GAO report

Each of the annual reports submitted in 2021 and 2022 pursuant to paragraph (1) shall also include the following:

(i) A comprehensive analysis detailing the ways in which the Centers for Medicare & Medicaid Services has addressed each of the recommendations set forth in the report by the Government Accountability Office (GAO-19-628) issued on September 19, 2019, and titled "Health Care Quality: CMS Could More Effectively Ensure Its Quality Measurement Activities Promote Its Objectives".

(ii) A detailed description of-

(I) any additional steps that the Centers for Medicare & Medicaid Services expects to take to address the findings and recommendations set forth in such report; and

(II) the anticipated timing for such steps.

(B) Ensuring detailed information

(i) In general

In the case of an annual report submitted in 2021 or a subsequent year pursuant to paragraph (1), the information required under-

(I) paragraph (1)(D) shall also include detailed information on each of the activities described in clause (ii);

(II) paragraph (1)(E) shall also include detailed information on the specific amounts obligated or expended on each of the activities described in clause (ii); and

(III) paragraph (1)(F) shall also include detailed information on the specific quality measurement activities required and future funding needed for each of the activities described in clause (ii).

(ii) Activities described

The activities described in this clause are the following:

(I) Measure selection activities.

(II) Measure development activities.

(III) Public reporting activities.

(IV) Education and outreach activities.

(f) Additional reporting by the Secretary to Congress

(1) In general

By not later than September 30 of each year (beginning with 2021), the Secretary shall submit to Congress a report on the amount of unobligated balances for appropriations relating to quality measurement. Such report shall include detailed plans on how the Secretary expects to expend such unobligated balances in the upcoming fiscal years.

(2) Separate report

The annual report required under paragraph (1) shall be separate from the annual report required under subsection (e).

¹See 2018 Amendment note below.

²So in original. Probably should be "panels)."

³See References in Text note below.

42 U.S.C. § 1395aaa

Aug. 14, 1935, ch. 531, title XVIII, §1890, as added Pub. L. 110-275, title I, §183(a)(1), July 15, 2008, 122 Stat. 2583; amended Pub. L. 111-148, title III, §§3003(b), 3014, title X, §§10304, 10322(b), Mar. 23, 2010, 124 Stat. 367, 384, 938, 954; Pub. L. 112-240, title VI, §609(a), Jan. 2, 2013, 126 Stat. 2349; Pub. L. 113-67, div. B, title I, §11091109,, 127 Stat. 1197; Pub. L. 113-93, title I, §109, Apr. 1, 2014, 128 Stat. 1043; Pub. L. 114-10, title II, §207, Apr. 16, 2015, 129 Stat. 145; Pub. L. 115-123, div. E, title II, §50206(a)-(c) (1), Feb. 9, 2018, 132 Stat. 183-185; Pub. L. 116-59, div. B, title IV, §14011401,, 133 Stat. 1105; Pub. L. 116-69, div. B, title IV, §1401(a), Nov. 21, 2019, 133 Stat. 1138; Pub. L. 116-94, div. N, title I, §102(a), Dec. 20, 2019, 133 Stat. 3096; Pub. L. 116-136, div. A, title III, §3802(a), Mar. 27, 2020, 134 Stat. 427; Pub. L. 116-159, div. C, title II, §22022202,, 134 Stat. 730; Pub. L. 116-215, div. B, title I, §11031103,, 134 Stat. 1042; Pub. L. 116-260 div. CC, title I, §102, Dec. 27, 2020, 134 Stat. 2940; Pub. L. 118-42, div. G, title I, §301, Mar. 9, 2024, 138 Stat. 414.

EDITORIAL NOTES

REFERENCES IN TEXTClause (iii) of section 1395rr(h)(2)(A) of this title, referred to in subsec. (b)(7)(B)(i)(I), was redesignated clause (iv) by Pub. L. 113-93, title II, §217(d)(1)(B), Apr. 1, 2014, 128 Stat. 1062.Section 12(d) of the National Technology Transfer and Advancement Act of 1995, referred to in subsec. (c)(5), is section 12(d) of Pub. L. 104-113 which is set out as a note under section 272 of Title 15, Commerce and Trade.

CODIFICATIONIn subsec. (a)(4), "section 132 of title 41" substituted for "section 4(5) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(5))" on authority of Pub. L. 111-350, §6(c), Jan. 4, 2011, 124 Stat. 3854, which Act enacted Title 41, Public Contracts.

PRIOR PROVISIONSA prior section 1395aaa, act Aug. 14, 1935, ch. 531, title XVIII, §1890, as added Aug. 18, 1987, Pub. L. 100-93, §10, 101 Stat . 696, which related to limitation of liability of beneficiaries with respect to services furnished by excluded individuals and entities, was amended and transferred to section 1862(e)(2) of act Aug. 14, 1935, by Pub. L. 100-360, title IV, §411(i)(4)(D) (ii), July 1, 1988, 102 Stat. 790, as amended by Pub. L. 100-485, title VI, §608(d) (24)(C)(ii), Oct. 13, 1988, 102 Stat. 2421, and is classified to section 1395y(e)(2) of this title.

AMENDMENTS2024-Subsec. (d)(2). Pub. L. 118-42 substituted "$20,000,000" for "and $20,000,000" and inserted ",and $9,000,000 for the period beginning on October 1, 2023, and ending on December 31, 2024" before period at end in first sentence and substituted "2023, and 2024 and the period beginning on October 1, 2024, and ending on December 31, 2024" for "and 2023" in last sentence.2020-Subsec. (b)(4). Pub. L. 116-260, §102(c), added par. (4).Subsec. (b)(9). Pub. L. 116-260, §102(d), added par. (9). Subsec. (d)(2). Pub. L. 116-260, §102(a), substituted "$26,000,000 for fiscal year 2021, $20,000,000 for fiscal year 2022, and $20,000,000 for fiscal year 2023" for "and for the period beginning on October 1, 2020, and ending on December 18, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020" in first sentence and "2020, 2021, 2022, and 2023" for "and 2020, and for the period beginning on October 1, 2020, and ending on December 18, 2020" in last sentence. Pub. L. 116-215 substituted "December 18, 2020" for "December 11, 2020" in two places. Pub. L. 116-159 substituted "December 11, 2020" for "November 30, 2020" in two places. Pub. L. 116-136, §3802, substituted "$20,000,000 for fiscal year 2020, and for the period beginning on October 1, 2020, and ending on November 30, 2020, the amount equal to the pro rata portion of the amount appropriated for such period for fiscal year 2020" for "and $4,830,000 for the period beginning on October 1, 2019, and ending on May 22, 2020" in first sentence and ",2019, and 2020, and for the period beginning on October 1, 2020, and ending on November 30, 2020," for "and 2019 and for the period beginning on October 1, 2019, and ending on May 22, 2020" in last sentence.Subsec. (e). Pub. L. 116-260, §102(b)(1)(A), (B), (G), designated existing provisions as par. (1), inserted heading, redesignated former pars. (1) to (6) as subpars. (A) to (F), respectively, of par. (1), and added par. (2).Subsec. (e)(1)(A). Pub. L. 116-260, §102(b)(1)(C), struck out at end "In years after the first plan under this paragraph is submitted, the requirements of this paragraph may be met by providing an update to the plan."Subsec. (e)(1)(D). Pub. L. 116-260, §102(b)(1)(D), substituted "Subject to paragraph (2)(B), a description" for "A description".Subsec. (e)(1)(E). Pub. L. 116-260, §102(b)(1)(E), substituted "Subject to paragraph (2)(B), the amount" for "The amount".Subsec. (e)(1)(F). Pub. L. 116-260, §102(b)(1)(F), substituted "Subject to paragraph (2)(B), estimates" for "Estimates".Subsec. (f). Pub. L. 116-260, §102(b)(2), added subsec. (f).2019-Subsec. (d)(2). Pub. L. 116-94 substituted "$4,830,000 for the period beginning on October 1, 2019, and ending on May 22, 2020" for "$1,665,000 for the period beginning on October 1, 2019, and ending on December 20, 2019" in first sentence and "May 22, 2020" for "December 20, 2019," in last sentence. Pub. L. 116-69 substituted "$1,665,000 for the period beginning on October 1, 2019, and ending on December 20, 2019" for "$1,069,000 for the period beginning on October 1, 2019, and ending on November 21, 2019" in first sentence and "December 20, 2019" for "November 21, 2019" in last sentence. Pub. L. 116-59 substituted "$7,500,000 for each of fiscal years 2018 and 2019, and $1,069,000 for the period beginning on October 1, 2019, and ending on November 21, 2019" for "and $7,500,000 for each of fiscal years 2018 and 2019" in first sentence and inserted "and for the period beginning on October 1, 2019, and ending on November 21, 2019," after "2018 and 2019" in last sentence. 2018-Subsec. (b)(5)(A). Pub. L. 115-123, §50206(c)(1), substituted "containing the following:" for "containing a description of-" in introductory provisions, inserted "(i) A description of-", redesignated former cls. (i) to (vi) as subcls. (I) to (VI), respectively, of cl. (i), realigned margins, and added cls. (ii) and (iii). Subsec. (d)(2). Pub. L. 115-123, §50206(a), substituted "2014," for "2014 and" and inserted ",and $7,500,000 for each of fiscal years 2018 and 2019" after "through 2017" and "Amounts transferred for each of fiscal years 2018 and 2019 shall be in addition to any unobligated funds transferred for a preceding fiscal year that are available under the preceding sentence." after "until expended." Subsec. (e). Pub. L. 115-123, §50206(b), added subsec. (e). 2015-Subsec. (d)(2). Pub. L. 114-10 substituted "and $30,000,000 for each of fiscal years 2015 through 2017" for "and $15,000,000 for the first 6 months of fiscal year 2015". 2014-Subsec. (d). Pub. L. 113-93 designated existing provisions as par. (1) and added par. (2). 2013-Subsec. (b)(4). Pub. L. 112-240, §609(a)(2), struck out par. (4). Text read as follows: "The entity shall promote the development and use of electronic health records that contain the functionality for automated collection, aggregation, and transmission of performance measurement information."Subsec. (d). Pub. L. 113-67 inserted at end "Amounts transferred under the preceding sentence shall remain available until expended." Pub. L. 112-240, §609(a)(1), substituted "fiscal years 2009 through 2013" for "fiscal years 2009 through 2012". 2010-Subsec. (b)(5)(A)(iv) to (vi). Pub. L. 111-148, §3014(a)(2), added cls. (iv) to (vi). Subsec. (b)(6). Pub. L. 111-148, §3003(b), added par. (6).Subsec. (b)(7). Pub. L. 111-148, §10304, substituted "quality and efficiency" for "quality" wherever appearing in text. Pub. L. 111-148, §3014(a)(1), added par. (7).Subsec. (b)(7)(B). Pub. L. 111-148, §10304, which directed substitution of "quality and efficiency" for "quality" wherever appearing, was executed by substituting "Quality and efficiency" for "Quality" in subpar. heading to reflect the probable intent of Congress. Subsec. (b)(7)(B)(i)(I). Pub. L. 111-148, §10322(b), inserted "1395ww(s)(4)(D)," after "1395ww(o)(2),".Subsec. (b)(8). Pub. L. 111-148, §3014(a)(1), added par. (8).

STATUTORY NOTES AND RELATED SUBSIDIARIES

EFFECTIVE DATE OF 2020 AMENDMENT Pub. L. 116-136, div. A, title III, §3802(b), Mar. 27, 2020, 134 Stat. 427, provided that: "The amendments made by subsection (a) [amending this section] shall take effect as if included in the enactment of the Further Consolidated Appropriations Act, 2020 (Public Law 116-94)."

EFFECTIVE DATE OF 2019 AMENDMENT Pub. L. 116-94, div. N, title I, §102(b), Dec. 20, 2019, 133 Stat. 3096, provided that: "The amendments made by subsection (a) [amending this section] shall take effect as if included in the enactment of the Further Continuing Appropriations Act, 2020, and Further Health Extenders Act of 2019 (Public Law 116-69)." Pub. L. 116-69, div. B, title IV, §1401(b), Nov. 21, 2019, 133 Stat. 1138, provided that: "The amendments made by subsection (a) [amending this section] shall take effect as if included in the enactment of the Continuing Appropriations Act, 2020, and Health Extenders Act of 2019 (Public Law 116-59)."

EFFECTIVE DATE OF 2018 AMENDMENT Pub. L. 115-123, div. E, title II, §50206(c)(2), Feb. 9, 2018, 132 Stat. 185, provided that: "The amendments made by this subsection [amending this section] shall apply to reports submitted for years beginning with 2019."

Secretary

The term "Secretary" means the Secretary of Housing and Urban Development.1 See References in Text note below.