[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4670 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                H. R. 4670

To amend title XVIII of the Social Security Act to provide coverage and 
 payment for certain tests and assistive telehealth consultations, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 22, 2021

Mr. Schweikert introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
Ways and Means, and Veterans' Affairs, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to provide coverage and 
 payment for certain tests and assistive telehealth consultations, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Advanced Safe 
Testing at Residence Telehealth Act of 2021''.
    (b) Table of Contents.--The table of contents is as follows:

Sec. 1. Short title.
Sec. 2. Coverage and payment for certain tests and assistive telehealth 
                            consultations; demonstration program under 
                            certain State Medicaid programs.
        ``Sec. 1859A. Tests and assistive telehealth consultations 
                            demonstration.
Sec. 3. Pilot program on improved access to certain tests and assistive 
                            telehealth consultations for veterans.

SEC. 2. COVERAGE AND PAYMENT FOR CERTAIN TESTS AND ASSISTIVE TELEHEALTH 
              CONSULTATIONS; DEMONSTRATION PROGRAM UNDER CERTAIN STATE 
              MEDICAID PROGRAMS.

    (a) Tests and Assistive Telehealth Consultations Demonstration.--
Part C of title XVIII of the Social Security Act is amended by 
inserting after section 1859 (42 U.S.C. 1395w-28) the following new 
subsection:

``SEC. 1859A. TESTS AND ASSISTIVE TELEHEALTH CONSULTATIONS 
              DEMONSTRATION.

    ``(a) Establishment.--
            ``(1) In general.--The Secretary shall establish a Value-
        Based Insurance Design Model demonstration program (in this 
        section referred to as the `VBID demonstration program') to 
        provide to eligible Medicare beneficiaries--
                    ``(A) an assistive telehealth consultation that is 
                furnished via a telecommunications system by a 
                physician or practitioner to an eligible telehealth 
                individual enrolled under part B notwithstanding that 
                the individual physician or practitioner ordering the 
                test did not furnish the test or that the individual 
                physician or practitioner providing the assistive 
                telehealth consultation is not at the same location as 
                the beneficiary; and
                    ``(B) home and community-based care.
            ``(2) Agreements.--The Secretary shall enter into 
        agreements with eligible MA organizations under which such 
        organizations shall offer eligible MA plans under the VBID 
        demonstration program to eligible Medicare beneficiaries.
            ``(3) Limitations on number of plans for vbid demonstration 
        program.--The VBID demonstration program shall be carried out 
        with respect to not greater than 25 MA plans, with a minimum of 
        10 MA plans that serve rural or underserved areas.
            ``(4) Eligible ma plans defined.--For purposes of this 
        section, the term `eligible MA plan' means a plan that, in 
        addition to items and services for which coverage is otherwise 
        provided under this part (including benefits under section 
        1852(a)(3) and notwithstanding any waivers under section 
        1915(c)), provides for coverage of--
                    ``(A) tests that are medical devices (as defined in 
                section 201(h) of the Federal Food, Drug, and Cosmetic 
                Act or wearable patient monitoring device, including 
                adaptive artificial intelligence, machine learning, and 
                software as a medical device (SaMD) technologies that 
                operate to the full scope of medical purpose defined by 
                the Administrator of the Food and Drug Administration) 
                and are identified by the Secretary as having 
                appropriate at home use that is approved under section 
                505 of the Federal Food, Drug, and Cosmetic Act, and 
                are either--
                            ``(i) a diagnostic test or screening for 
                        the diagnosis of influenza or a similar 
                        respiratory condition that is required to 
                        obtain a final diagnosis of COVID-19 for an 
                        individual when such test is ordered by a 
                        physician or practitioner in conjunction with a 
                        COVID-19 diagnostic test or screening for 
                        purposes of discounting a diagnosis of 
                        influenza or a related diagnosis for such 
                        individual;
                            ``(ii) a serology test for COVID-19;
                            ``(iii) a diagnostic test or screening for 
                        the diagnosis of prostate cancer, ovarian 
                        cancer, breast cancer, hypothyroidism, 
                        rheumatoid arthritis, celiac disease, vascular 
                        inflammation, cardiovascular health, strep 
                        throat, or lipoprotein (A);
                            ``(iv) a haptoglobin genetic test;
                            ``(v) a prediabetes and diabetes screening;
                            ``(vi) an IgE allergy test;
                            ``(vii) a screening or diagnostic capsule 
                        endoscopy; or
                            ``(viii) any other test identified by the 
                        Secretary, including those proposed by the MA 
                        organization, as having appropriate for at-home 
                        use that is approved under section 505 of the 
                        Federal Food, Drug, and Cosmetic Act;
                    ``(B) assistive telehealth consultations;
                    ``(C) telehealth services;
                    ``(D) fitness benefits;
                    ``(E) meal benefits (beyond limited basis);
                    ``(F) transportation services;
                    ``(G) safety and other equipment not otherwise 
                covered under this title; and
                    ``(H) care in rural or highly rural areas (as 
                determined in consultation with the Secretary of 
                Agriculture using the Rural-Urban Commuting Areas 
                coding system).
            ``(5) Other matters relating to documentation and claims 
        review.--The requirements of paragraphs (2) and (3) of section 
        410.32(d) of title 42, Code of Federal Regulations (as in 
        effect on the date of the enactment of this paragraph), 
        relating to documentation and claims review, respectively, 
        shall apply to a test described in paragraph (4)(A) and an 
        assistive telehealth consultation.
            ``(6) Demographic data.--To be eligible for reimbursement 
        under this paragraph, each claim for reimbursement shall 
        include, with respect to each eligible Medicare beneficiary, 
        the following demographic data:
                    ``(A) Age.
                    ``(B) Race and ethnicity.
                    ``(C) Gender.
                    ``(D) An affirmative or negative statement of the 
                existence of any chronic condition.
                    ``(E) Any other information the Secretary 
                determines appropriate.
            ``(7) Assistive telehealth consultation.--In this 
        subsection, the term `assistive telehealth consultation' means 
        a telehealth service (as defined in section 1834(m)(4)(F)) that 
        is--
                    ``(A) an evaluation and management service;
                    ``(B) an assessment of any evidence of systems 
                which would make a diagnostic test or screening 
                necessary to be furnished in the home of an eligible 
                telehealth individual;
                    ``(C) the ordering of a diagnostic test or 
                screening;
                    ``(D) an assessment of an individual succeeding the 
                delivery of a diagnostic test or screening;
                    ``(E) any assistance in the collection (or 
                transmission) of images or data necessary for a 
                diagnostic test or screening and securing the sample 
                for shipping;
                    ``(F) the referral of an eligible telehealth 
                individual to a physician or practitioner for in-person 
                treatment; or
                    ``(G) the review of a diagnostic test or screening 
                by a physician or practitioner.
    ``(b) Eligible MA Organizations.--For purposes of this section, the 
term `eligible MA organization' means an MA organization that--
            ``(1) is located in a State that the Secretary has 
        determined is able to participate in the VBID demonstration 
        program by agreeing to make available data necessary for 
        purposes of conducting the independent evaluation required 
        under subsection (h); and
            ``(2) meets such other criteria as the Secretary may 
        require.
    ``(c) Eligible Medicare Beneficiary Defined.--In this section, the 
term `eligible Medicare beneficiary' means a Medicare beneficiary who--
            ``(1) is eligible for benefits under this title and--
                    ``(A) is eligible to enroll in an eligible MA plan 
                under the VBID demonstration program;
                    ``(B) is a subsidy-eligible individual (as defined 
                in section 1860D-14(a)(3)(A)); and
                    ``(C) is age 65 or older; or
            ``(2) is a dual eligible individual (as defined in section 
        1915(h)(2)(B)) or qualified medicare beneficiary (as defined in 
        section 1905(p)(1)) who is eligible for medical assistance 
        under a State plan under title XIX.
    ``(d) Payments.--The Secretary shall establish payment rates for 
eligible MA organizations offering eligible MA plans under the VBID 
demonstration program for benefits covered under such program (and not 
otherwise covered under part C) and provided to eligible Medicare 
beneficiaries under such plans. Such payment rates shall--
            ``(1) be based upon payment rates established for purposes 
        of payment under section 1853;
            ``(2) be in addition to payments otherwise made to such 
        organization with respect to such plans under part C;
            ``(3) be adjusted to reflect the costs of treating eligible 
        Medicare beneficiaries under this section; and
            ``(4) not be made for a test via a telecommunications 
        system described in subsection (a)(4), unless the physician or 
        practitioner determines such a test is medically necessary and 
        appropriate (as determined by the Secretary).
    ``(e) Special Election Period.--Notwithstanding sections 
1852(e)(2)(C) and 1860D-1(b)(1)(B)(iii), an eligible Medicare 
beneficiary may, other than during the annual, coordinated election 
periods under such sections discontinue enrollment in an MA plan not 
participating in the VBID demonstration program and enroll in an MA 
plan participating in such program.
    ``(f) Beneficiary Education.--The Secretary shall help to educate, 
through State Health Insurance Assistance Programs and other 
organizations that assist seniors with respect to benefits and 
enrollment under this title, eligible Medicare beneficiaries on the 
availability of the VBID demonstration program.
    ``(g) Implementation.--
            ``(1) Deadline.--The VBID demonstration program shall be 
        implemented not later than January 1 of the second year 
        beginning after the date of the enactment of this section.
            ``(2) Duration.--Subject to paragraph (3), the VBID 
        demonstration program shall be conducted for a period of five 
        years.
            ``(3) Extension or expansion.--Taking into account the 
        report under subsection (h)(2), the Secretary may, through 
        notice and comment rulemaking, expand the duration, scope, or 
        both the duration and scope of the VBID demonstration program 
        (including implementation on a nationwide or permanent basis or 
        both), other than under the original Medicare fee-for-service 
        program under parts A and B of such title, to the extent 
        determined appropriate by the Secretary, unless the Secretary 
        determines that such expansion is expected to--
                    ``(A) increase aggregate expenditures under this 
                title and title XIX with respect to eligible Medicare 
                beneficiaries participating in the VBID demonstration 
                program; or
                    ``(B) decrease the quality of health care services 
                furnished to eligible Medicare beneficiaries 
                participating in the VBID demonstration program.
    ``(h) Independent Evaluation and Reports.--
            ``(1) Independent evaluation.--
                    ``(A) In general.--The Secretary shall provide for 
                the evaluation of the VBID demonstration program by an 
                independent third party.
                    ``(B) Evaluation objectives.--Such evaluation shall 
                determine the extent to which the VBID demonstration 
                program has resulted in--
                            ``(i) improved patient care;
                            ``(ii) reduced hospitalizations or 
                        rehospitalizations;
                            ``(iii) reduced or delayed nursing facility 
                        admissions and lengths of stay under title XIX;
                            ``(iv) reduced spend down of income and 
                        assets for purposes of becoming eligible for 
                        medical assistance under a State plan under 
                        title XIX;
                            ``(v) improved quality of life for the 
                        eligible Medicare beneficiaries enrolled in an 
                        eligible MA plan participating in the VBID 
                        demonstration program;
                            ``(vi) improved caregiver satisfaction; and
                            ``(vii) addressing disparities and access 
                        for underserved populations.
                    ``(C) Evaluation process.--Such evaluation shall be 
                completed in accordance with the following process:
                            ``(i) The Secretary shall, prior to the 
                        implementation of such program, establish goals 
                        for such program with respect to the evaluation 
                        objectives described in subparagraph (B) and 
                        criteria for measuring the extent to which an 
                        eligible MA plan participating in the VBID 
                        demonstration program meets such goals.
                            ``(ii) The Secretary shall implement clear 
                        data collection and reporting requirements for 
                        such eligible MA plans in order to carry out 
                        such evaluation.
                In carrying out such process, the Secretary shall 
                recognize that definitions, benefits, and program 
                requirements for long-term care services and supports 
                vary across States.
            ``(2) Reports.--Not later than four years after the 
        implementation of the VBID demonstration program, the Secretary 
        shall submit to Congress a report containing the results of the 
        evaluation conducted under paragraph (1), together with such 
        recommendations for legislative or administrative action as the 
        Secretary determines appropriate. In preparing such report, the 
        Secretary shall use at least three years worth of data under 
        the VBID demonstration program.
    ``(i) Budget Neutrality.--For any year after the third year of the 
VBID demonstration program, the Secretary shall ensure that the 
aggregate payments made under this title and title XIX, including under 
the VBID demonstration program, do not exceed the amount which the 
Secretary estimates would have been expended under such titles during 
such year if the VBID demonstration program had not been implemented.
    ``(j) Paperwork Reduction Act.--Chapter 35 of title 44, United 
States Code, shall not apply to the testing and evaluation of the VBID 
demonstration program.''.
    (b) Demonstration Program Under Certain State Medicaid Programs.--
            (1) In general.--Not later than 1 year after the date of 
        the enactment of this Act, subject to paragraph (3), the 
        Secretary of Health and Human Services, acting through the 
        Deputy Administrator and Director of the Center for Medicare 
        and Medicaid Innovation of the Centers for Medicare & Medicaid 
        Services, shall administer a program that awards grants to at 
        least 5, but not more than 10 States or territories for 
        purposes of the State Medicaid program to provide coverage to 
        individuals entitled to benefits under the State plan under 
        title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) 
        for tests described in section 1859A(a)(4) of such Act that are 
        ordered and assistive telehealth consultations that are 
        furnished via a telecommunications system by a physician or 
        practitioner to such individuals notwithstanding that the 
        individual physician or practitioner ordering the test did not 
        furnish the test or that the individual physician or 
        practitioner providing the assistive telehealth consultation is 
        not at the same location as the individuals.
            (2) Applications.--To be eligible to receive a grant under 
        this subsection, a State shall submit an application to the 
        Secretary in such manner, and containing such information as 
        the Secretary may require.
            (3) Duration; amount.--
                    (A) Duration.--A grant under this subsection shall 
                be for a 4-year period.
                    (B) Amount.--A State that is awarded a grant under 
                this subsection shall be for an amount not to exceed 
                $12,000,000.
            (4) Funding.--The Secretary, acting through the Deputy 
        Administrator and Director, shall provide for not more than 
        $100,000,000 to carry out the program described in paragraph 
        (1) from amounts otherwise appropriated pursuant to section 
        1115A(f) of the Social Security Act (42 U.S.C. 1315a(f)).

SEC. 3. PILOT PROGRAM ON IMPROVED ACCESS TO CERTAIN TESTS AND ASSISTIVE 
              TELEHEALTH CONSULTATIONS FOR VETERANS.

    (a) Pilot Program.--
            (1) Establishment.--Not later than 180 days after the date 
        of the enactment of this Act, the Secretary of Veterans shall 
        establish a pilot program on improved access to certain 
        telehealth services for veterans (in this section referred to 
        as the ``pilot program''). Under the pilot program, the 
        Secretary shall furnish covered services to participants, at no 
        cost to the participants, in accordance with this section.
            (2) Provision of covered services.--
                    (A) Health care providers.--The Secretary shall 
                select not fewer than five facilities of the Department 
                of Veterans Affairs through which to carry out the 
                program, of which not fewer than three shall serve 
                veterans in rural or highly rural areas (as determined 
                through the use of the Rural-Urban Commuting Areas 
                coding system of the Department of Agriculture).
                    (B) Covered services.--Under the pilot program, and 
                notwithstanding that the provider ordering or providing 
                the service is not at the same location as the 
                participant receiving the service, health care 
                providers at each facility selected under subparagraph 
                (A) shall furnish to program participants the following 
                services:
                            (i) Tests described in subparagraph (C) 
                        that are ordered by the health care provider 
                        via a telecommunications system.
                            (ii) Assistive telehealth consultations 
                        that are provided by the health care provider 
                        via a telecommunications system.
                    (C) Tests described.--A test described in this 
                subparagraph is a test that--
                            (i) is a medical device (as defined in 
                        section 201(h) of the Federal Food, Drug, and 
                        Cosmetic Act) or wearable patient monitoring 
                        device, and
                            (ii) is for a condition determined relevant 
                        by the Secretary for purposes of the pilot 
                        program.
            (3) Participation in program.--
                    (A) Application.--To participate in the pilot 
                program, veterans eligible to apply under subparagraph 
                (B) shall submit an application for such participation 
                in such form, at such time, and containing such 
                information as the Secretary determines appropriate.
                    (B) Eligibility.--A veteran is eligible to submit 
                an application for participation in the pilot program 
                if the veteran--
                            (i) is enrolled in the system of patient 
                        enrollment of the Department under section 
                        1705(a) of title 38, United States Code; and
                            (ii) has received health care under the 
                        laws administered by the Secretary during the 
                        two-year period preceding the date on which the 
                        veteran is first selected by the Secretary for 
                        participation in the pilot program.
            (4) No payment.--
                    (A) Pilot program.--The Secretary may not charge a 
                program participant for any cost of services furnished 
                under the pilot program.
                    (B) Effect on certain in person tests.--While a 
                veteran is a program participant in the pilot program, 
                the Secretary may not make payment for a test described 
                in paragraph (2)(C) that is furnished in-person by a 
                physician or practitioner to the veteran if a physician 
                or practitioner has previously ordered such a test for 
                the veteran under the pilot program via a 
                telecommunications system, unless the physician or 
                practitioner determines such a test is medically 
                necessary and appropriate (as determined by the 
                Secretary).
            (5) Termination.--
                    (A) In general.--Subject to subparagraph (B), the 
                pilot program shall terminate on the date that is three 
                years after the date on which the pilot program 
                commences.
                    (B) Extension.--If the Secretary determines, based 
                on the results of the interim report under subsection 
                (b)(1), that it is appropriate to extend the pilot 
                program, the Secretary may extend the termination of 
                such program for a period of not more than two years.
    (b) Reports.--
            (1) Interim report.--Not later than one year after the date 
        on which the pilot program commences, the Secretary shall 
        submit to the appropriate congressional committees an interim 
        report. Such report shall include the following information:
                    (A) The number of veterans who have participated in 
                the pilot program.
                    (B) The types of at-home diagnostics furnished 
                under the pilot program.
                    (C) An assessment of whether participation in the 
                pilot program resulted in any changes in clinically 
                relevant endpoints for the participant with respect to 
                the conditions identified during an assistive 
                telehealth consultation or through a covered test under 
                the pilot program.
                    (D) An assessment of the quality of life of 
                veterans who have participated in the pilot program, 
                including the results of a satisfaction survey provided 
                to each such veteran.
            (2) Final report.--Not later than 90 days after the date of 
        termination of the pilot program under subsection (a)(4)(A) 
        (or, if the pilot program is extended under subsection 
        (a)(4)(B), the date on which such extension terminates), the 
        Secretary shall submit to the appropriate congressional 
        committees a final report on the pilot program that contains 
        any relevant updates to the information specified in paragraph 
        (1).
    (c) Definitions.--In this section:
            (1) The term ``appropriate congressional committees'' 
        means--
                    (A) the Committee on Energy and Commerce, the 
                Committee on Veterans' Affairs, and the Committee on 
                Ways and Means of the House of Representatives; and
                    (B) the Committee on Health, Education, Labor, and 
                Pensions and the Committee on Veterans' Affairs of the 
                Senate.
            (2) The term ``assistive telehealth consultation'' has the 
        meaning given such term in section 1859A(a)(7) of the Social 
        Security Act, as added by section 1 of this Act.
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