[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3821 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  2d Session
                                S. 3821

To amend title XVIII of the Social Security Act to improve the payment 
method for oxygen and oxygen related equipment, supplies, and services, 
to increase beneficiary access to oxygen and oxygen related equipment, 
            supplies, and services, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 28, 2024

Mr. Cassidy (for himself, Mr. Warner, and Ms. Klobuchar) introduced the 
 following bill; which was read twice and referred to the Committee on 
                                Finance

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to improve the payment 
method for oxygen and oxygen related equipment, supplies, and services, 
to increase beneficiary access to oxygen and oxygen related equipment, 
            supplies, and services, 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 ``Supplemental 
Oxygen Access Reform Act of 2024'' or the ``SOAR Act of 2024''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
 TITLE I--PROTECT BENEFICIARY ACCESS TO SUPPLEMENTAL OXYGEN THERAPY IN 
                         THE HOME AND COMMUNITY

Sec. 101. Reform of the Medicare supplemental oxygen benefit.
Sec. 102. Establishment of supplemental oxygen responsibilities 
                            criteria.
Sec. 103. Technical corrections.
   TITLE II--PROTECTING BENEFICIARY ACCESS TO RESPIRATORY THERAPISTS

Sec. 201. Reimbursement for respiratory therapists.
              TITLE III--ADOPTION OF ELECTRONIC TEMPLATES

Sec. 301. Use of electronic templates to document medical necessity and 
                            restoring clinical inference for oxygen and 
                            oxygen related equipment, supplies, and 
                            services.
             TITLE IV--ESTABLISHMENT OF BENEFICIARY RIGHTS

Sec. 401. Establishing protections for individuals receiving oxygen or 
                            oxygen related equipment, supplies, or 
                            services.

 TITLE I--PROTECT BENEFICIARY ACCESS TO SUPPLEMENTAL OXYGEN THERAPY IN 
                         THE HOME AND COMMUNITY

SEC. 101. REFORM OF THE MEDICARE SUPPLEMENTAL OXYGEN BENEFIT.

    (a) Removing Oxygen and Oxygen Related Equipment, Supplies, and 
Services From Competitive Acquisition Program To Improve Patient Access 
to Supplemental Oxygen Therapy.--Section 1847(a)(3) of the Social 
Security Act (42 U.S.C. 1395w-3(a)(3)) is amended by--
            (1) inserting ``and exclusion'' after ``Exception 
        authority'';
            (2) by redesignating subparagraphs (A) and (B) as clauses 
        (i) and (ii), respectively, and moving such clauses as so 
        redesignated 2 ems to the right;
            (3) by striking ``In carrying out'' and inserting the 
        following:
                    ``(A) In general.--In carrying out''; and
            (4) by adding at the end the following new subparagraph:
                    ``(B) Exclusion of oxygen, and oxygen related 
                equipment, supplies, and services.--Beginning on or 
                after January 1, 2025, the Secretary shall exclude 
                oxygen and oxygen related equipment, supplies, and 
                services from the competitive acquisition program under 
                this section and payment for oxygen and oxygen related 
                equipment, supplies, and services shall be made as 
                prescribed under subparagraphs (E), (F), and (H) of 
                section 1834(a)(9).''.
    (b) Establishing Adequate Payment for Oxygen and Oxygen Related 
Equipment, Supplies, and Services.--Section 1834(a)(9) of the Social 
Security Act (42 U.S.C. 1395m(a)(9)) is amended--
            (1) in the first sentence of the matter preceding 
        subparagraph (A), by inserting the following before the period: 
        ``(for oxygen and oxygen equipment furnished before January 1, 
        2025) or the amount determined under subparagraph (E), subject 
        to subparagraphs (F), (G), and (H) (for oxygen and oxygen 
        related equipment, supplies, and services furnished on or after 
        January 1, 2025);''; and
            (2) by adding at the end the following:
                    ``(E) Payment for oxygen and oxygen related 
                equipment, supplies, and services excluded from 
                competitive acquisition program.--Subject to 
                subparagraphs (F), (G), and (H) in the case of oxygen 
                and oxygen related equipment, supplies, and services 
                furnished on or after January 1, 2025--
                            ``(i) in areas that are competitive bidding 
                        areas in which a competitive bidding program is 
                        implemented for other covered items, the 
                        payment amount is equal to--
                                    ``(I) for 2025, the fee schedule 
                                amounts for the area for items and 
                                services in effect on December 31, 
                                2024; and
                                    ``(II) for each subsequent year, 
                                the amount determined under this clause 
                                for the preceding year, increased by 
                                the percentage increase in the consumer 
                                price index for all urban consumers 
                                (United States city average) for the 
                                12-month period ending on December 31 
                                of the previous year;
                            ``(ii) in rural areas and non-contiguous 
                        areas (Alaska, Hawaii, and U.S. territories), 
                        the payment amount is equal to--
                                    ``(I) 50 percent of 110 percent of 
                                the national average price for the item 
                                or service determined under section 
                                414.210 (g)(1)(ii) of title 42, Code of 
                                Federal Regulations; and
                                    ``(II) 50 percent of--
                                            ``(aa) for 2025, the fee 
                                        schedule amount for the area in 
                                        effect on December 31, 2024; 
                                        and
                                            ``(bb) for each subsequent 
                                        year, the amount determined 
                                        under this subclause for the 
                                        preceding year, increased by 
                                        the percentage increase in the 
                                        consumer price index for all 
                                        urban consumers (United States 
                                        city average) for the 12-month 
                                        period ending on December 31 of 
                                        the previous year; and
                            ``(iii) in areas other than those described 
                        in clauses (i) and (ii), the payment amount is 
                        equal to the sum of 75 percent of the adjusted 
                        payment amount established under clause (i) and 
                        25 percent of the unadjusted fee schedule 
                        amount otherwise determined without taking into 
                        account this subparagraph.
                    ``(F) Special rule for liquid oxygen.--
                            ``(i) Payment.--
                                    ``(I) In general.--In lieu of the 
                                volume adjustment established under 
                                paragraph (5)(C), not later than 
                                January 1, 2025, the Secretary in 
                                consultation with suppliers, 
                                manufacturers, patients and patient 
                                advocates, and physicians, and through 
                                notice-and-comment rulemaking, shall 
                                establish a separate payment amount 
                                that meets the requirements of this 
                                subparagraph made to a supplier for the 
                                provision of liquid oxygen and liquid 
                                oxygen related equipment, supplies, and 
                                services that meets the requirements 
                                described in subparagraph (G).
                                    ``(II) Payment floor.--The payment 
                                amount established under subclause (I) 
                                may not be less than an amount equal to 
                                200 percent of the 2015 Durable Medical 
                                Equipment, Prosthetics/Orthotics & 
                                Supplies Fee Schedule updated by the 
                                consumer price index for all urban 
                                consumers (United States city average) 
                                for years 2016 through 2024.
                                    ``(III) Update mechanism.--
                                Beginning on January 1, 2026, the 
                                payment amount described in subclause 
                                (I) shall be increased annually by the 
                                projected percentage increase in the 
                                consumer price index for all urban 
                                consumers (United States city average) 
                                for the 12-month period ending December 
                                31 of the previous year.
                            ``(ii) Considerations.--In implementing the 
                        payment amount under this subparagraph, the 
                        Secretary shall take into account the cost of 
                        liquid oxygen on a per pound basis, the cost of 
                        liquid oxygen equipment, the infrastructure 
                        costs associated with providing liquid oxygen 
                        equipment and supplies (including labor, 
                        storage, transportation, maintenance, and 
                        similar costs), the cost of complying with 
                        Federal and State regulations specific to the 
                        delivery and transportation of liquid oxygen, 
                        and any other cost factors the Secretary deems 
                        appropriate after consulting with stakeholders 
                        such as suppliers, providers, patients and 
                        patient advocates, and manufacturers.
                            ``(iii) Monthly add-on for high-flow 
                        patients.--
                                    ``(I) In general.--Subject to 
                                subclause (II), the Secretary shall 
                                establish a non-budget neutral add-on 
                                to the payment amount under clause (i) 
                                when the prescribing practitioner 
                                orders an oxygen flow rate equal to or 
                                greater than 6 liters per minute.
                                    ``(II) Add-on amount.--The add-on 
                                amount shall equal the per pound cost 
                                of the oxygen exceeding the amount 
                                required to provide a liter flow that 
                                is equal to or greater than 6 liters 
                                per minute.
                            ``(iv) Periodic assessment of the base 
                        rate.--The Secretary shall assess at least once 
                        every 3 years the adequacy of the payment 
                        amounts under this subparagraph on a cost-
                        related basis or other economical and equitable 
                        basis.
                            ``(v) Transitional interim payment.--
                                    ``(I) In general.--For items and 
                                services furnished on or after the date 
                                of the enactment of the SOAR Act of 
                                2024 and prior to the implementation of 
                                the payment amount established under 
                                this subparagraph, the Secretary shall 
                                adopt a transitional interim payment 
                                amount for liquid oxygen, and liquid 
                                oxygen equipment, supplies, and 
                                services in an amount equal to 200 
                                percent of the 2015 Durable Medical 
                                Equipment, Prosthetics/Orthotics & 
                                Supplies Fee Schedule updated by the 
                                consumer price index for all urban 
                                consumers (United States city average) 
                                for years 2016 through 2024.
                                    ``(II) Update.--This amount shall 
                                be updated annually by the projected 
                                percentage change in the consumer price 
                                index for all urban consumers (United 
                                States city average) for the 12-month 
                                period ending on December 31 of the 
                                previous year, until the Secretary 
                                implements the payment amount under 
                                this subparagraph.
                            ``(vi) Coverage criteria.--
                                    ``(I) In general.--Not later than 
                                January 1, 2025, the Secretary, in 
                                consultation with stakeholders, shall 
                                establish objective clinical criteria 
                                for the coverage of liquid oxygen, and 
                                liquid oxygen equipment, supplies, and 
                                services under this title.
                                    ``(II) Update of criteria.--The 
                                Secretary shall review and update the 
                                coverage standards under this clause 
                                every 5 years to ensure the standards 
                                take into consideration current medical 
                                and clinical guidelines and take into 
                                effect modality in order to maximize 
                                beneficiary independence.''.

SEC. 102. ESTABLISHMENT OF SUPPLEMENTAL OXYGEN RESPONSIBILITIES 
              CRITERIA.

    (a) In General.--1834(a)(9) of the Social Security Act (42 U.S.C. 
1395m(a)(9)), as amended by section 101(b), is further amended by 
inserting the following new subparagraph:
                    ``(G) Oxygen and oxygen related equipment, 
                supplies, and services.--In consultation with 
                stakeholders, the Secretary shall define the scope of 
                services a supplier of oxygen and oxygen related 
                equipment, supplies, and services must provide to 
                receive payment under this part, to include--
                            ``(i) conducting an initial evaluation of 
                        the beneficiary using the uniform oxygen 
                        patient evaluation form described in paragraph 
                        (5)(G) to determine the appropriate use of 
                        oxygen and oxygen related equipment, supplies, 
                        and services by the beneficiary, including the 
                        use of portable equipment;
                            ``(ii) ensuring the beneficiary has 
                        appropriate access to portable oxygen, and 
                        portable oxygen equipment, supplies, and 
                        services based on the mobility needs of the 
                        beneficiary, including the needs of the 
                        beneficiary outside the home of the 
                        beneficiary;
                            ``(iii) providing written and verbal 
                        beneficiary and caregiver education regarding 
                        oxygen and oxygen related equipment, supplies, 
                        and services, stationary and portable options, 
                        and oxygen safety, which includes evaluating 
                        the environment of the beneficiary for safety 
                        risks or hazards, such as fire and fall 
                        hazards;
                            ``(iv) providing appropriate delivery, set-
                        up, and coordination of oxygen services 
                        (including the delivery of any oxygen equipment 
                        or supplies to a beneficiary prior to such 
                        beneficiary being discharged, delivering such 
                        equipment, and setting up the equipment), as 
                        needed, in a timely manner as agreed upon by 
                        the beneficiary or caregiver, supplier, and 
                        prescribing practitioner;
                            ``(v) evaluating the ability of the 
                        beneficiary to operate the equipment safely and 
                        effectively;
                            ``(vi) providing infection control 
                        information and instructions about all 
                        equipment and supplies;
                            ``(vii) providing equipment-related 
                        services, including checking oxygen system 
                        purity levels and flow rates, changing and 
                        cleaning filters, and assuring the integrity of 
                        alarms and back-up systems, consistent with the 
                        manufacturer specifications and in accordance 
                        with all Federal, State, and local laws and 
                        regulations;
                            ``(viii) monitoring visits when necessary 
                        by appropriate personnel, including a 
                        respiratory therapist to evaluate all aspects 
                        of the services being provided to the 
                        beneficiary by the provider;
                            ``(ix) documenting exception reporting by 
                        the supplier to the prescribing physician when 
                        changes occur in the compliance of the 
                        beneficiary with the beneficiary's plan of 
                        care;
                            ``(x) providing, as needed, continued 
                        education to the beneficiary or caregiver 
                        regarding appropriate oxygen equipment 
                        maintenance practices and performance;
                            ``(xi) providing, as prescribed by the plan 
                        of care of the prescribing practitioner, 
                        appropriate oxygen and oxygen related 
                        equipment, supplies, and services (including 
                        supplemental supplies and emergency oxygen 
                        back-ups as appropriate);
                            ``(xii) ensuring oxygen and oxygen 
                        equipment can be used appropriately outside the 
                        home of a beneficiary based on necessity;
                            ``(xiii) providing 24-hour on-call coverage 
                        to respond to beneficiary needs relating to 
                        oxygen and oxygen related equipment, supplies, 
                        and services; and
                            ``(xiv) assisting the beneficiary with the 
                        coordination of oxygen and oxygen related 
                        equipment, supplies, and services, including by 
                        assisting the beneficiary find a different 
                        supplier if the beneficiary temporarily travels 
                        outside of the service area of the supplier. If 
                        the beneficiary relocates permanently, the new 
                        supplier caring for the beneficiary will assume 
                        responsibility for billing the Medicare program 
                        directly.''.
    (b) Effective Date.--The amendment made by this section shall take 
effect on the date that is 1 year after the date of enactment of this 
Act.

SEC. 103. TECHNICAL CORRECTIONS.

    Section 1861(n) is amended by striking ``iron lungs, oxygen tents'' 
and inserting ``oxygen and oxygen related equipment, supplies, and 
services''.

   TITLE II--PROTECTING BENEFICIARY ACCESS TO RESPIRATORY THERAPISTS

SEC. 201. REIMBURSEMENT FOR RESPIRATORY THERAPISTS.

    (a) Protecting Access to Respiratory Therapist Services.--
            (1) Adding respiratory therapist services to the definition 
        of medical and other health services.--Section 1861(s)(2) of 
        the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended--
                    (A) in subparagraph (JJ), by inserting ``and'' 
                after the semicolon; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(KK) respiratory therapist services (as defined 
                in subsection (nnn)) furnished on or after January 1, 
                2025.''.
            (2) Definition of respiratory therapist services.--Section 
        1861 of the Social Security Act (42 U.S.C. 1395x) is amended by 
        adding at the end the following new subsection:
    ``(nnn) Respiratory Therapist Services.--The term `respiratory 
therapist services' means services performed by a respiratory therapist 
within the scope of practice of a respiratory therapist as defined by 
State law, regulations, and applicable accreditation standards for the 
assessment, treatment, and monitoring of patients requiring oxygen and 
oxygen related equipment, supplies, or services.''.
    (b) Add-On Payment Adjustment.--Section 1834(a)(9) of the Social 
Security Act (42 U.S.C. 1395m(a)(9)), as amended by sections 101(b) and 
102(a), is further amended by adding at the end the following new 
subparagraph:
                    ``(H) Monthly payment add-on adjustment for 
                respiratory therapist services.--For respiratory 
                therapist services furnished on or after January 1, 
                2025, the Secretary shall implement through notice and 
                comment rulemaking and in consultation with 
                stakeholders a non-budget neutral add-on payment 
                adjustment to the payment amount established under this 
                paragraph that reflects the cost of providing 
                respiratory therapist services as clinically 
                appropriate under State law.''.

              TITLE III--ADOPTION OF ELECTRONIC TEMPLATES

SEC. 301. USE OF ELECTRONIC TEMPLATES TO DOCUMENT MEDICAL NECESSITY AND 
              RESTORING CLINICAL INFERENCE FOR OXYGEN AND OXYGEN 
              RELATED EQUIPMENT, SUPPLIES, AND SERVICES.

    (a) Adopting Electronic Templates for Determining Medical 
Necessity.--Section 1834(a)(5) of the Social Security Act (42 U.S.C. 
1395m(a)(5)) is amended by adding at the end the following:
                    ``(G) Adoption of electronic templates to document 
                medical necessity.--
                            ``(i) In general.--For any oxygen and 
                        oxygen related equipment, supplies or service, 
                        including liquid oxygen, furnished on or after 
                        January 1, 2025, the Secretary shall adopt a 
                        template in an electronic format that meets the 
                        requirements of clause (ii) to be completed by 
                        the prescribing practitioner (as defined by the 
                        Secretary) that shall constitute the complete 
                        request for information to determine whether 
                        payment for such service, equipment, or 
                        supplies is covered by this title and is 
                        reasonable and necessary for the diagnosis or 
                        treatment of illness or injury (under section 
                        1862(a)(1)(A)).
                            ``(ii) Template requirements.--The template 
                        shall require the prescribing practitioner to 
                        provide each of the following:
                                    ``(I) Documentation that the 
                                beneficiary was seen by a prescribing 
                                practitioner within the appropriate 
                                timeframes for certification of the 
                                need for the services, equipment, or 
                                supplies.
                                    ``(II) Documentation of the 
                                qualifying blood gas or saturation test 
                                results.
                                    ``(III) Documentation indicating 
                                that the beneficiary needs or is using 
                                the appropriate equipment, supplies, 
                                and services.
                                    ``(IV) Any other documentation 
                                determined appropriate by the 
                                Secretary, except the Secretary shall 
                                not require the prescribing 
                                practitioner to provide medical record 
                                notes regarding the beneficiary.
                            ``(iii) Contractor adjudication.--The 
                        Secretary shall require Medicare administrative 
                        contractors to adjudicate claims for payment 
                        for oxygen and oxygen related equipment, 
                        supplies, and services using electronic 
                        transactions.
                    ``(H) Restoration of clinical inference and 
                judgment.--For claims submitted on or after the date of 
                enactment of this subparagraph with respect to the 
                conduct of payment audits of suppliers of oxygen and 
                oxygen related equipment, supplies, and services under 
                this part the Secretary shall use clinical inference 
                and clinical judgment in the evaluation of templates, 
                medical records, and orders when conducting such audits 
                in the same manner as the Secretary interpreted and 
                applied such clinical judgment to claim reviews before 
                2009 pursuant to the Secretary's instruction to 
                contractors.''.

             TITLE IV--ESTABLISHMENT OF BENEFICIARY RIGHTS

SEC. 401. ESTABLISHING PROTECTIONS FOR INDIVIDUALS RECEIVING OXYGEN OR 
              OXYGEN RELATED EQUIPMENT, SUPPLIES, OR SERVICES.

    Section 1834(a)(5) of the Social Security Act (42 U.S.C. 
1395m(a)(5)), as amended by section 301, is further amended by adding 
at the end the following new subparagraph:
                    ``(I) Establishing protections for individuals 
                receiving oxygen or oxygen related equipment, supplies, 
                or services.--The Secretary shall establish through 
                regulation protections for any individual receiving 
                oxygen or oxygen related equipment, supplies, or 
                services under this part where such individual shall 
                have the right to--
                            ``(i) choose the local supplier of such 
                        services from among qualified suppliers and to 
                        change such supplier;
                            ``(ii) receive communications from the 
                        supplier in a clear and understandable manner;
                            ``(iii) ensure privacy and confidentiality 
                        in all aspects of treatment and the personal 
                        health information of such individual 
                        consistent with Federal and State laws;
                            ``(iv) be informed by the supplier of such 
                        services about all aspects of the services 
                        being furnished by such supplier and be 
                        informed of the right to refuse treatment, to 
                        discontinue treatment, and to refuse to 
                        participate in experimental research;
                            ``(v) be informed by the supplier of 
                        policies and expectations of the supplier 
                        regarding patient conduct and responsibilities;
                            ``(vi) be informed by the supplier about 
                        treatment modalities and categories of 
                        equipment relating to oxygen services for use 
                        by the individual and offered by the supplier;
                            ``(vii) be informed by the supplier of the 
                        policies of such supplier regarding 24-hour on-
                        call coverage;
                            ``(viii) be informed by the supplier of the 
                        financial responsibilities of the individual 
                        with regard to such services;
                            ``(ix) be provided with the appropriate 
                        gaseous or liquid oxygen equipment, supplies, 
                        and services to ensure the mobility of the 
                        beneficiary, as well as the clinically 
                        appropriate amount of oxygen and oxygen related 
                        equipment, supplies, and services as agreed 
                        upon by the individual (or the individual's 
                        representative), the supplier, and the 
                        prescribing practitioner;
                            ``(x) receive equipment that is maintained 
                        to the guidelines of the manufacturer;
                            ``(xi) have broken or faulty equipment 
                        repaired or replaced in a timely manner;
                            ``(xii) have oxygen or oxygen related 
                        equipment or supplies delivered by the supplier 
                        and to be contacted consistent with the 
                        requirements of section 410.38 of title 42, 
                        Code of Federal Regulations;
                            ``(xiii) be informed by the supplier of any 
                        potential changes to the equipment, supplies, 
                        or services of the individual and the right to 
                        consult with the prescribing practitioner of 
                        the individual regarding such changes to ensure 
                        they are appropriate and necessary and to be 
                        informed of the exceptions, as specified by the 
                        Secretary, when a supplemental oxygen services 
                        supplier may change the oxygen equipment of the 
                        individual;
                            ``(xiv) be informed by the supplier of the 
                        internal and external grievance processes of 
                        the supplier (as well as how to contact 
                        Medicare through a hotline or beneficiary 
                        ombudsman), which shall include the right of an 
                        individual to file, personally or through a 
                        representative of the individual's choosing, an 
                        internal or external grievance without 
                        retaliation or denial of services;
                            ``(xv) in the case of a supplier 
                        involuntary discharging an individual--
                                    ``(I) receive from such supplier a 
                                written notice that is provided to the 
                                individual no later than 30 days in 
                                advance of the involuntary discharge of 
                                the individual; and
                                    ``(II) have such supplier--
                                            ``(aa) follow established 
                                        involuntary discharge 
                                        procedures; or
                                            ``(bb) in the case of an 
                                        immediate threat to the health 
                                        and safety of others, follow an 
                                        abbreviated involuntary 
                                        discharge procedure;
                            ``(xvi) be assisted by the supplier in 
                        obtaining the oxygen equipment and supplies 
                        prescribed by the treating physician of the 
                        individual when the individual is traveling;
                            ``(xvii) receive from the supplier oxygen 
                        supplies, refills, and emergency back-up 
                        equipment, as appropriate; and
                            ``(xviii) be informed of a plan by the 
                        supplier in case of a power outage or other 
                        natural emergency, so that the individual will 
                        continue to receive the necessary oxygen 
                        supplies and equipment.''.
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