,i #aahth ,,congress #ast ,session ,h4 ,r4 #bjg ,,in ,,the ,,house ,,of ,,representatives ,january #i1 #bjbc,mr4 ,schweikert introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 and ,veterans' ,affairs1 for a period to be subsequently determined by the ,speaker1 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 consultations1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,advanced ,safe ,testing at ,residence ,telehealth ,act of #bjbc4 7b7 ,table of contents ,the table of contents is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,coverage and payment for certain tests and assistive telehealth consultations2 demonstration program under certain ,state ,medicaid programs4 ,sec4 #ahei;,a4 ,tests and assistive telehealth consultations demonstration4 ,sec4 #c4 ,pilot program on improved access to certain tests and assistive telehealth consultations for veterans4 #b4 ,coverage and payment for certain tests and assistive telehealth consultations2 demonstration program under certain ,state ,medicaid programs 7a7 ,tests and assistive telehealth consultations demonstration ,part ,c of title ,,xviii of the ,social ,security ,act is amended by inserting after section #ahei 7#db ,u4,s4,c4 #aciew-#bh7 the following new subsection3 #ahei;,a4 ,tests and assistive telehealth consultations demonstration 7a7 ,establishment 7#a7 ,in general ,the ,secretary shall establish a ,value-,based ,insurance ,design ,model demonstration program 7in this section referred to as the ,,vbid demonstration program7 to provide to eligible ,medicare beneficiaries-- 7,a7 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 beneficiary2 and 7,b7 home and community-based care4 7#b7 ,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 beneficiaries4 7#c7 ,limitations on number of plans for ,,vbid demonstration program ,the ,,vbid demonstration program shall be carried out with respect to not greater than #be ,,ma plans1 with a minimum of #aj ,,ma plans that serve rural or underserved areas4 7#d7 ,eligible ,,ma plans defined ,for purposes of this section1 the term eligible ,,ma plan means a plan that1 in addition to items and services for which coverage is otherwise provided under this part 7including benefits under section #aheb7;a77#c7 and notwithstanding any waivers under section #aiae7;c771 provides for coverage of-- 7,a7 tests that are medical devices 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or wearable patient monitoring device1 including adaptive artificial intelligence1 machine learning1 and software as a medical device 7,sa,m,d7 technologies that operate to the full scope of medical purpose defined by the ,administrator of the ,food and ,drug ,administration7 and are identified by the ,secretary as having appropriate at home use that is approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and are either-- 7i7 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-#ai for an individual when such test is ordered by a physician or practitioner in conjunction with a ,,covid-#ai diagnostic test or screening for purposes of discounting a diagnosis of influenza or a related diagnosis for such individual2 7ii7 a serology test for ,,covid-#ai2 7iii7 a diagnostic test or screening for the diagnosis of prostate cancer1 ovarian cancer1 breast cancer1 hypothyroidism1 rheumatoid arthritis1 celiac disease1 vascular inflammation1 cardiovascular health1 strep throat1 or lipoprotein 7,a72 7iv7 a haptoglobin genetic test2 7v7 a prediabetes and diabetes screening2 7vi7 an ,ig,e allergy test2 7vii7 a screening or diagnostic capsule endoscopy2 or 7viii7 any other test identified by the ,secretary1 including those proposed by the ,,ma organization1 as having appropriate for at-home use that is approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,b7 assistive telehealth consultations2 7,c7 telehealth services2 7,d7 fitness benefits2 7,e7 meal benefits 7beyond limited basis72 7,f7 transportation services2 7,g7 safety and other equipment not otherwise covered under this title2 and 7,h7 care in rural or highly rural areas 7as determined in consultation with the ,secretary of ,agriculture using the ,rural-,urban ,commuting ,areas coding system74 7#e7 ,other matters relating to documentation and claims review ,the requirements of paragraphs 7#b7 and 7#c7 of section #daj4cb7;d7 of title #db1 ,code of ,federal ,regulations 7as in effect on the date of the enactment of this paragraph71 relating to documentation and claims review1 respectively1 shall apply to a test described in paragraph 7#d77;,a7 and an assistive telehealth consultation4 7#f7 ,demographic data ,to be eligible for reimbursement under this paragraph1 each claim for reimbursement shall include1 with respect to each eligible ,medicare beneficiary1 the following demographic data3 7,a7 ,age4 7,b7 ,race and ethnicity4 7,c7 ,gender4 7,d7 ,an affirmative or negative statement of the existence of any chronic condition4 7,e7 ,any other information the ,secretary determines appropriate4 7#g7 ,assistive telehealth consultation ,in this subsection1 the term assistive telehealth consultation means a telehealth service 7as defined in section #ahcd7m77#d77;,f77 that is-- 7,a7 an evaluation and management service2 7,b7 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 individual2 7,c7 the ordering of a diagnostic test or screening2 7,d7 an assessment of an individual succeeding the delivery of a diagnostic test or screening2 7,e7 any assistance in the collection 7or transmission7 of images or data necessary for a diagnostic test or screening and securing the sample for shipping2 7,f7 the referral of an eligible telehealth individual to a physician or practitioner for in-person treatment2 or 7,g7 the review of a diagnostic test or screening by a physician or practitioner4 7b7 ,eligible ,,ma organizations ,for purposes of this section1 the term eligible ,,ma organization means an ,,ma organization that-- 7#a7 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 7h72 and 7#b7 meets such other criteria as the ,secretary may require4 7c7 ,eligible ,medicare beneficiary defined ,in this section1 the term eligible ,medicare beneficiary means a ,medicare beneficiary who-- 7#a7 is eligible for benefits under this title and-- 7,a7 is eligible to enroll in an eligible ,,ma plan under the ,,vbid demonstration program2 7,b7 is a subsidy-eligible individual 7as defined in section #ahfj;,d-#ad7;a77#c77;,a772 and 7,c7 is age #fe or older2 or 7#b7 is a dual eligible individual 7as defined in section #aiae7;h77#b77;,b77 or qualified medicare beneficiary 7as defined in section #aije7p77#a77 who is eligible for medical assistance under a ,state plan under title ,,xix4 7d7 ,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 7and not otherwise covered under part ,c7 and provided to eligible ,medicare beneficiaries under such plans4 ,such payment rates shall-- 7#a7 be based upon payment rates established for purposes of payment under section #ahec2 7#b7 be in addition to payments otherwise made to such organization with respect to such plans under part ,c2 7#c7 be adjusted to reflect the costs of treating eligible ,medicare beneficiaries under this section2 and 7#d7 not be made for a test via a telecommunications system described in subsection 7a77#d71 unless the physician or practitioner determines such a test is medically necessary and appropriate 7as determined by the ,secretary74 7e7 ,special election period ,notwithstanding sections #aheb7;e77#b77;,c7 and #ahfj;,d-#a7;b77#a77;,b77iii71 an eligible ,medicare beneficiary may1 other than during the annual1 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 program4 7f7 ,beneficiary education ,the ,secretary shall help to educate1 through ,state ,health ,insurance ,assistance ,programs and other organizations that assist seniors with respect to benefits and enrollment under this title1 eligible ,medicare beneficiaries on the availability of the ,,vbid demonstration program4 7g7 ,implementation 7#a7 ,deadline ,the ,,vbid demonstration program shall be implemented not later than ,january #a of the second year beginning after the date of the enactment of this section4 7#b7 ,duration ,subject to paragraph 7#c71 the ,,vbid demonstration program shall be conducted for a period of five years4 7#c7 ,extension or expansion ,taking into account the report under subsection 7h77#b71 the ,secretary may1 through notice and comment rulemaking1 expand the duration1 scope1 or both the duration and scope of the ,,vbid demonstration program 7including implementation on a nationwide or permanent basis or both71 other than under the original ,medicare fee-for-service program under parts ,a and ,b of such title1 to the extent determined appropriate by the ,secretary1 unless the ,secretary determines that such expansion is expected to-- 7,a7 increase aggregate expenditures under this title and title ,,xix with respect to eligible ,medicare beneficiaries participating in the ,,vbid demonstration program2 or 7,b7 decrease the quality of health care services furnished to eligible ,medicare beneficiaries participating in the ,,vbid demonstration program4 7h7 ,independent evaluation and reports 7#a7 ,independent evaluation 7,a7 ,in general ,the ,secretary shall provide for the evaluation of the ,,vbid demonstration program by an independent third party4 7,b7 ,evaluation objectives ,such evaluation shall determine the extent to which the ,,vbid demonstration program has resulted in-- 7i7 improved patient care2 7ii7 reduced hospitalizations or rehospitalizations2 7iii7 reduced or delayed nursing facility admissions and lengths of stay under title ,,xix2 7iv7 reduced spend down of income and assets for purposes of becoming eligible for medical assistance under a ,state plan under title ,,xix2 7v7 improved quality of life for the eligible ,medicare beneficiaries enrolled in an eligible ,,ma plan participating in the ,,vbid demonstration program2 7vi7 improved caregiver satisfaction2 and 7vii7 addressing disparities and access for underserved populations4 7,c7 ,evaluation process ,such evaluation shall be completed in accordance with the following process3 7i7 ,the ,secretary shall1 prior to the implementation of such program1 establish goals for such program with respect to the evaluation objectives described in subparagraph 7,b7 and criteria for measuring the extent to which an eligible ,,ma plan participating in the ,,vbid demonstration program meets such goals4 7ii7 ,the ,secretary shall implement clear data collection and reporting requirements for such eligible ,,ma plans in order to carry out such evaluation4 ,in carrying out such process1 the ,secretary shall recognize that definitions1 benefits1 and program requirements for long-term care services and supports vary across ,states4 7#b7 ,reports ,not later than four years after the implementation of the ,,vbid demonstration program1 the ,secretary shall submit to ,congress a report containing the results of the evaluation conducted under paragraph 7#a71 together with such recommendations for legislative or administrative action as the ,secretary determines appropriate4 ,in preparing such report1 the ,secretary shall use at least three years worth of data under the ,,vbid demonstration program4 7i7 ,budget neutrality ,for any year after the third year of the ,,vbid demonstration program1 the ,secretary shall ensure that the aggregate payments made under this title and title ,,xix1 including under the ,,vbid demonstration program1 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 implemented4 7j7 ,paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the testing and evaluation of the ,,vbid demonstration program4 4 7b7 ,demonstration program under certain ,state ,medicaid programs 7#a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 subject to paragraph 7#c71 the ,secretary of ,health and ,human ,services1 acting through the ,deputy ,administrator and ,director of the ,center for ,medicare and ,medicaid ,innovation of the ,centers for ,medicare ,medicaid ,services1 shall administer a program that awards grants to at least #e1 but not more than #aj ,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 7#db ,u4,s4,c4 #acif et seq47 for tests described in section #ahei;,a7a77#d7 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 individuals4 7#b7 ,applications ,to be eligible to receive a grant under this subsection1 a ,state shall submit an application to the ,secretary in such manner1 and containing such information as the ,secretary may require4 7#c7 ,duration2 amount 7,a7 ,duration ,a grant under this subsection shall be for a #d-year period4 7,b7 ,amount ,a ,state that is awarded a grant under this subsection shall be for an amount not to exceed #ab1jjj1jjj4 7#d7 ,funding ,the ,secretary1 acting through the ,deputy ,administrator and ,director1 shall provide for not more than #ajj1jjj1jjj to carry out the program described in paragraph 7#a7 from amounts otherwise appropriated pursuant to section #aaae;,a7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7f774 #c4 ,pilot program on improved access to certain tests and assistive telehealth consultations for veterans 7a7 ,pilot program 7#a7 ,establishment ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,veterans shall establish a pilot program on improved access to certain telehealth services for veterans 7in this section referred to as the pilot program74 ,under the pilot program1 the ,secretary shall furnish covered services to participants1 at no cost to the participants1 in accordance with this section4 7#b7 ,provision of covered services 7,a7 ,health care providers ,the ,secretary shall select not fewer than five facilities of the ,department of ,veterans ,affairs through which to carry out the program1 of which not fewer than three shall serve veterans in rural or highly rural areas 7as determined through the use of the ,rural-,urban ,commuting ,areas coding system of the ,department of ,agriculture74 7,b7 ,covered services ,under the pilot program1 and notwithstanding that the provider ordering or providing the service is not at the same location as the participant receiving the service1 health care providers at each facility selected under subparagraph 7,a7 shall furnish to program participants the following services3 7i7 ,tests described in subparagraph 7,c7 that are ordered by the health care provider via a telecommunications system4 7ii7 ,assistive telehealth consultations that are provided by the health care provider via a telecommunications system4 7,c7 ,tests described ,a test described in this subparagraph is a test that-- 7i7 is a medical device 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 or wearable patient monitoring device1 and 7ii7 is for a condition determined relevant by the ,secretary for purposes of the pilot program4 7#c7 ,participation in program 7,a7 ,application ,to participate in the pilot program1 veterans eligible to apply under subparagraph 7,b7 shall submit an application for such participation in such form1 at such time1 and containing such information as the ,secretary determines appropriate4 7,b7 ,eligibility ,a veteran is eligible to submit an application for participation in the pilot program if the veteran-- 7i7 is enrolled in the system of patient enrollment of the ,department under section #agje7;a7 of title #ch1 ,united ,states ,code2 and 7ii7 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 program4 7#d7 ,no payment 7,a7 ,pilot program ,the ,secretary may not charge a program participant for any cost of services furnished under the pilot program4 7,b7 ,effect on certain in person tests ,while a veteran is a program participant in the pilot program1 the ,secretary may not make payment for a test described in paragraph 7#b77;,c7 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 system1 unless the physician or practitioner determines such a test is medically necessary and appropriate 7as determined by the ,secretary74 7#e7 ,termination 7,a7 ,in general ,subject to subparagraph 7,b71 the pilot program shall terminate on the date that is three years after the date on which the pilot program commences4 7,b7 ,extension ,if the ,secretary determines1 based on the results of the interim report under subsection 7b77#a71 that it is appropriate to extend the pilot program1 the ,secretary may extend the termination of such program for a period of not more than two years4 7b7 ,reports 7#a7 ,interim report ,not later than one year after the date on which the pilot program commences1 the ,secretary shall submit to the appropriate congressional committees an interim report4 ,such report shall include the following information3 7,a7 ,the number of veterans who have participated in the pilot program4 7,b7 ,the types of at-home diagnostics furnished under the pilot program4 7,c7 ,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 program4 7,d7 ,an assessment of the quality of life of veterans who have participated in the pilot program1 including the results of a satisfaction survey provided to each such veteran4 7#b7 ,final report ,not later than #ij days after the date of termination of the pilot program under subsection 7a77#d77;,a7 7or1 if the pilot program is extended under subsection 7a77#d77;,b71 the date on which such extension terminates71 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 7#a74 7c7 ,definitions ,in this section3 7#a7 ,the term appropriate congressional committees means-- 7,a7 the ,committee on ,energy and ,commerce1 the ,committee on ,veterans' ,affairs1 and the ,committee on ,ways and ,means of the ,house of ,representatives2 and 7,b7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,veterans' ,affairs of the ,senate4 7#b7 ,the term assistive telehealth consultation has the meaning given such term in section #ahei;,a7a77#g7 of the ,social ,security ,act1 as added by section #a of this ,act4