Bringing Enhanced Treatments and Therapies to ESRD Recipients Kidney Care Act or the BETTER Kidney Care Act
This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish a demonstration program for Medicare beneficiaries with end-stage renal disease (ESRD).
Under the program, renal dialysis facilities, kidney disease specialists, physician practices, and other health care practitioners may form an organization that partners with certain health care entities to provide integrated care to beneficiaries with ESRD. Such care must include all covered Medicare benefits as well as transition services for transplantations, palliative care, and hospice. Each organization must have a minimum number or percentage of participating beneficiaries (350 or 60% of beneficiaries served at the organization's facilities) and must also comply with certain fiscal, governance, and quality of care requirements.
Additionally, the Government Accountability Office must study certain data that is reported to the CMS regarding pediatric dialysis care, as well as the effects of race-based corrections to a specified kidney function test on referrals of ESRD patients for transplant evaluations.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8254 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 8254
To establish a demonstration program to provide integrated care for
Medicare beneficiaries with end-stage renal disease, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 15, 2020
Mr. Blumenauer (for himself, Mr. Smith of Missouri, Mr. Cardenas, Mrs.
Rodgers of Washington, Mr. Butterfield, Mr. Wenstrup, and Ms. Shalala)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on Ways and
Means, 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 establish a demonstration program to provide integrated care for
Medicare beneficiaries with end-stage renal disease, 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.
This Act may be cited as the ``Bringing Enhanced Treatments and
Therapies to ESRD Recipients Kidney Care Act'' or the ``BETTER Kidney
Care Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Although the relative rate of end-stage renal disease
(referred to in this section as ``ESRD'') among the Nation's
minority populations has declined, significant disparities
remain. Compared to Whites, Black Americans are 2.6 times more
likely to have kidney failure, while Native Americans and
Alaska Natives are 1.2 times more likely. Hispanics are 1.3
times more likely to have kidney failure compared to non-
Hispanics.
(2) Disparities also exist with respect to treatment
modalities. Specifically, although home dialysis can offer
advantages, Black, Hispanic, and Native American and Alaska
Native ESRD patients are less likely to initiate home treatment
than White ESRD patients.
(3) Numerous studies show that individuals with low incomes
and in low-income communities are at greater risk for ESRD.
(4) In addition to their kidney disease, ESRD patients
across all races and ethnicities often suffer from one or more
comorbidities. Eighty-eight percent of ESRD patients have a
history of hypertension, 42 percent have diabetes, and nearly
30 percent have congestive heart failure.
(5) Each month, ESRD patients see multiple providers and
take several medications to manage their kidney disease and
comorbid conditions. Of all patients, those with ESRD stand to
benefit greatly from better coordinated care.
(6) The Executive Order on Advancing American Kidney Health
recognizes the need to develop and implement new ESRD care
delivery models to improve quality and value for ESRD patients
and the Medicare program.
(7) In alignment with that goal, it is imperative that
Medicare test new models that have at their core an
interdisciplinary care team, among other structural
requirements, to--
(A) help ESRD patients better navigate the health
care system;
(B) empower such patients to manage their plan of
care and medication regimen;
(C) support such patients in receiving the
treatment modality, including a kidney transplant, as
prescribed by their nephrologist;
(D) access services to meet the nonclinical needs
of such patients that can affect care outcomes; and
(E) receive additional services, such as transplant
evaluation, palliative care, evaluation for hospice
eligibility, and vascular access care.
SEC. 3. DEMONSTRATION PROGRAM TO PROVIDE INTEGRATED CARE FOR MEDICARE
BENEFICIARIES WITH END-STAGE RENAL DISEASE.
(a) In General.--Title XVIII of the Social Security Act is amended
by inserting after section 1866F the following new section:
``demonstration program to provide integrated care for medicare
beneficiaries with end-stage renal disease
``Sec. 1866G. (a) Establishment.--
``(1) In general.--The Secretary shall conduct under this
section the ESRD Fee-For-Service Integrated Care Demonstration
Program (in this section referred to as the `Program'), which
is voluntary for Program-eligible beneficiaries and eligible
participating providers, to assess the effects of alternative
care delivery models and payment methodologies on patient care
improvements under this title for such beneficiaries. Under the
Program--
``(A) Program-eligible beneficiaries shall be
considered original Medicare Fee-For-Service
beneficiaries (as defined in section 1899(h)(3)) for
the duration of the participation of such beneficiaries
under the Program;
``(B) eligible participating providers may form an
ESRD Fee-For-Service Integrated Care Organization (in
this section referred to as an `Organization'); and
``(C) an Organization shall integrate care under
the original Medicare Fee-For-Service program under
parts A and B for Program-eligible beneficiaries.
``(2) Definitions.--In this section:
``(A) Eligible participating provider.--The term
`eligible participating provider' means any of the
following:
``(i) A facility certified as a renal
dialysis facility under this title.
``(ii) An entity that owns one or more of
such facilities described in clause (i).
``(iii) A nephrologist (including a
pediatric nephrologist) or nephrology practice.
``(iv) Any other physician or physician
group practice.
``(v) A nurse practitioner, physician
assistant, or clinical nurse specialist (as
such terms are defined in section 1861(aa)(5))
or a clinical social worker (as defined in
section 1861(hh)(1)) working in conjunction
with such a nurse practitioner, physician
assistant, or clinical nurse specialist.
``(B) Eligible participating partner.--The term
`eligible participating partner' means, with respect to
an Organization, any of the following:
``(i) A Medicare Advantage plan described
in section 1851(a)(2) or a Medicare Advantage
organization offering such a plan.
``(ii) A medicaid managed care organization
(as defined in section 1903(m)).
``(iii) A hospital or an academic medical
center experienced in the care of patients
receiving dialysis.
``(iv) Any other entity determined
appropriate by the Secretary.
``(C) Program-eligible beneficiary.--
``(i) In general.--The term `Program-
eligible beneficiary' means, with respect to an
Organization offering an ESRD Fee-For-Service
Integrated Care Model, an individual entitled
to benefits under part A and enrolled under
part B (including such an individual entitled
to medical assistance under a State plan under
title XIX) who--
``(I) is identified by the
Secretary as having end-stage renal
disease and who is receiving renal
dialysis services under the original
Medicare Fee-For-Service program under
parts A and B, and is not enrolled in a
Medicare Advantage plan under part C or
group health insurance coverage or
individual health insurance coverage
(as defined in section 2791(b) of the
Public Health Service Act (42 U.S.C.
300gg-91(b))) that is primary to
coverage under this title;
``(II) receives renal dialysis
services primarily from an eligible
participating provider of such
Organization, including such renal
dialysis services received after being
identified as a suitable candidate for
transplantation; and
``(III) has attained the age of 18
years.
``(ii) Affirmation of program eligibility
upon hospice election or kidney transplant.--A
Program-eligible beneficiary who was assigned
to or elected an ESRD Fee-For-Service
Integrated Care Model offered by an
Organization and who--
``(I) elects to receive hospice
benefits under section 1852(d)(1); or
``(II) receives a kidney transplant
as covered under this title and
maintains entitlement to benefits under
part A and enrollment in part B on the
basis of end stage renal disease,
shall continue to meet the definition of
Program-eligible beneficiary established under
this subparagraph.
``(b) ESRD Fee-For-Service Integrated Care Organization Eligibility
Requirements.--
``(1) Organizations.--
``(A) In general.--One or more eligible
participating providers may establish an Organization
and may enter into, subject to subparagraph (B), one or
more partnership, ownership, or co-ownership agreements
with one or more eligible participating partners to
establish an Organization or to offer one or more ESRD
Fee-For-Service Integrated Care Models in accordance
with paragraph (2).
``(B) Limitation on number of agreements.--The
Secretary may specify a limitation on the number of
Organizations in which an eligible participating
partner may participate for purposes of offering one or
more ESRD Fee-For-Service Integrated Care Models under
partnership, ownership, or co-ownership agreements
described in subparagraph (A).
``(C) Minimum program eligible beneficiary
participation requirement.--
``(i) In general.--Subject to clause (ii),
the Secretary may not enter into or continue an
agreement with an Organization unless the
Organization has at least 350 Program-eligible
beneficiaries, or at least 60 percent of
Program-eligible beneficiaries receiving care
from the Organization's facilities, who are
assigned to or elect an ESRD Fee-For-Service
Integrated Model offered by the Organization
and who continue their assignment to or
election of the Organization.
``(ii) Allowing transition.--The Secretary
may waive the requirement under clause (i) for
an Organization during the first agreement year
with respect to the Organization.
``(D) Fiscal soundness requirements.--
``(i) In general.--The Secretary shall
enter into appropriate agreements under this
section only with Organizations that
demonstrate sufficient capital reserves,
measured as a percentage of monthly prospective
payments described in subsection (e) and
consistent with capital reserve requirements
established by each State in which the
Organization operates, subject to clause (ii).
``(ii) Alternative mechanism to demonstrate
risk-bearing capacity.--An Organization shall
be considered to meet the requirement in clause
(i) if the Organization includes at least one
eligible participating provider or eligible
participating partner that--
``(I)(aa) is licensed under State
law as a risk-bearing entity eligible
to offer health insurance or health
benefits coverage in each State in
which the Organization participates in
the demonstration under this section;
or
``(bb) is otherwise authorized by
each state in which the Organization
participates in the demonstration under
this section to bear risk for offering
health insurance or health benefits;
``(II) agrees to bear risk under
the Organization; and
``(III) has the capacity to bear
risk commensurate with the
Organization's expected expenditures
under an agreement under this section.
``(iii) Disclosure.--Each Organization with
an agreement under this section shall, in
accordance with current regulations of the
Secretary that govern similar disclosures,
report to the Secretary financial information
consistent with such information required to be
reported by a Medicare Advantage organization
under part C to demonstrate that the
Organization has a fiscally sound operation.
``(E) Governance requirements.--Each Organization
with an agreement under this section shall establish a
governing body with oversight responsibility for the
Organization's compliance with Program requirements
that includes--
``(i) representation from each eligible
participating provider of such Organization;
``(ii) at least two nephrologists, one of
which may be affiliated with an eligible
participating provider; and
``(iii) at least one beneficiary advocate.
``(2) ESRD fee-for-service integrated care model.--
``(A) Benefit requirements.--
``(i) In general.--Subject to clause (iii),
an Organization shall offer an ESRD Fee-For-
Service Integrated Care Model that shall--
``(I) cover all benefits under
parts A and B (subject to payment rules
regarding the treatment of and payment
for kidney organ acquisitions and
hospice described in subsections (e)(3)
and (4)); and
``(II) include services for
transition (particularly including
education) into transplantation,
palliative care, and hospice.
``(ii) Determination and treatment of
savings.--
``(I) In general.--The Secretary
shall require any Organization offering
an ESRD Fee-For-Service Integrated Care
Model to provide for the return under
subclause (VI) to a Program-eligible
beneficiary assigned to or who elects
an Organization savings equal to the
amount, if any, by which the payment
amount described in subclause (V) with
respect to the Program-eligible
beneficiary for a year exceeds the
average revenue amount described in
subclause (IV) with respect to the
Program-eligible beneficiary for the
year.
``(II) Savings determination
process.--The Secretary shall determine
the savings described in subclause (I)
in the same manner as the rebate
calculation for individuals with end-
stage renal disease enrolled in
Medicare Advantage organizations under
section 1859(b)(6)(B)(iii).
``(III) Application of medical loss
ratio requirements.--Nothing shall
preclude the Secretary from applying
medical loss ratio requirements
described in section 1857(e)(4) under
this section.
``(IV) Average revenue amount
described.--The revenue amount
described in this subclause, with
respect to an Organization offering an
ESRD Fee-For-Service Integrated Care
Model and a Program-eligible
beneficiary assigned to or who elects
such Organization, is the
Organization's estimated average
revenue requirements, including
administrative costs and return on
investment, for the Organization to
provide the benefits described in
clause (i) under the Model for the
Program-eligible beneficiary for the
year.
``(V) Payment amount described.--
The payment amount described in this
subclause, with respect to an
Organization offering an ESRD Fee-For-
Service Integrated Care Model and a
Program-eligible beneficiary assigned
to or who elects such Organization, is
the payment amount to the Organization
under subsection (e)(1) (adjusted
pursuant to subsection (e)(2) and
subject to the treatment of payments
for kidney acquisitions and hospice
care described in paragraphs (3) and
(4) of subsection (e), respectively)
made with respect to the Program-
eligible beneficiary for the year.
``(VI) Returning savings to
program-eligible beneficiaries.--An
Organization shall, in a manner
specified by the Secretary and
consistent with returning Medicare
Advantage rebates to individuals under
part C, return the amount under
subclause (I) to a Program-eligible
beneficiary through offering benefits
not covered under the original Medicare
Fee-For-Service program consistent with
the types of benefits, including non-
health related benefits, that Medicare
Advantage organizations may offer.
``(iii) Benefit requirements for dual
eligibles.--In the case of a Program-eligible
beneficiary who is entitled to medical
assistance under a State plan under title XIX,
an Organization, in accordance with a mutual
agreement entered into between the State and
Organization under subsection (e)(7)--
``(I) shall provide, or arrange for
the provision of, all benefits (other
than long-term services and supports)
for which the Program-eligible
beneficiary is entitled to under a
State plan under title XIX; and
``(II) may elect to provide, or
arrange for the provision of, long-term
services and supports for which the
Program-eligible beneficiary is
entitled under a State plan under title
XIX, including services related to the
transition into palliative care or
hospice.
``(iv) Application of medicare ffs provider
choice and cost-sharing requirements.--Under an
ESRD Fee-For-Service Integrated Care Model
offered by an Organization, the Organization
shall--
``(I) allow Program-eligible
beneficiaries to receive benefits as
described in subsection (b)(2)(A)(i)(I)
from any provider of services or
supplier enrolled under this title and
who otherwise meets all applicable
requirements under this title;
``(II) not apply any cost-sharing
requirements for benefits described in
subsection (b)(2)(A)(i)(I) in addition
to premium and cost-sharing
requirements, respectively, that would
be applicable under part A or part B
for such benefits.
``(v) Promoting access to high-quality
providers.--An Organization offering an ESRD
Fee-For-Service Integrated Care Model shall
develop and implement performance-based
incentives, including financial incentives
funded through payments made to an Organization
under subsection (e), for providers of services
and suppliers to promote delivery of high
quality and efficient care. Such incentives
shall comply with section 1852(j)(4) and
section 422.208 of title 42, Code of Federal
regulations (as in effect on the date of
enactment of this section) and be based on
clinical measures or non-clinical measures,
such as with respect to notification of patient
discharge from a hospital, patient education
(such as with respect to treatment options,
including disease maintenance, and nutrition),
rates of completion of patient education
categorized by race, rates of completion of
transplant evaluation for patients who are
clinically eligible for transplant, rates of
completion of transplant evaluation categorized
by race, and the interoperability of electronic
health records developed by an Organization
according to requirements and standards
specified by the Secretary pursuant to
subparagraph (B).
``(B) Quality and reporting requirements.--
``(i) Clinical measures.--Under the
Program, the Secretary shall--
``(I) require each participating
Organization to submit to the Secretary
data on clinical measures developed
using, as a reference, measures
submitted by organizations
participating in the Comprehensive ESRD
Care Initiative operated by the Center
for Medicare and Medicaid Innovation to
assess the quality of care provided;
``(II) establish requirements for
participating Organizations to submit
to the Secretary, in a form and manner
specified by the Secretary, information
on such measures; and
``(III) establish standards for
making information on quality under the
Program established under this section
as assessed using clinical measures
described in subclause (I) available to
the public.
As part of the standards described in subclause
(III) the Secretary shall, in consultation with
relevant stakeholders, develop standards that
would establish a minimum threshold for the
volume of individual patients to be listed for
transplant in an Organ Procurement and
Transplant Network under contract with the
Secretary and that would measure the number of
individuals that an Organization moved on to,
kept on, or removed from the transplant list
and the number of individuals that receive a
transplant after participating in the
Organization. The number of Program-eligible
beneficiaries assigned to an Organization on
the transplant list that have not opted out at
the time of the agreement between the Secretary
and an Organization shall be noted as part of
such agreement. Organizations shall submit such
measures as a condition of payment and Program-
eligible beneficiary assignment under this
subsection.
``(ii) Requirement for stakeholder input.--
In developing measures and requirements under
subclauses (I) and (II) of clause (i), the
Secretary shall request and consider input from
a stakeholder board that includes at least one
nephrologist, a pediatric nephrologist, other
suppliers and providers of services as
determined appropriate by the Secretary, renal
dialysis facilities, beneficiary advocates, a
health equity expert, a mental health provider,
a transplant surgeon, and Medicare-approved
transplant programs. Section 14 of the Federal
Advisory Committee Act shall not apply to the
stakeholder board.
``(iii) Additional assessments and
reporting requirements.--The Secretary shall
assess the extent to which an Organization
offers integrated and patient-centered care
through analysis of information obtained from
Program-eligible beneficiaries assigned to or
who elect the Organization through surveys,
such as the In-Center Hemodialysis Consumer
Assessment of Healthcare Providers and Systems.
``(iv) No effect on other renal dialysis
facility quality requirements.--Nothing in this
section shall be construed as affecting the
requirements established under section 1881(h).
``(C) Requirements for esrd fee-for-service
integrated care strategy.--
``(i) In general.--An Organization seeking
a contract under this section to offer one or
more ESRD Fee-For-Service Integrated Care
Models shall develop and submit for the
Secretary's approval as part of the application
of the Organization to participate in the
Program under this section, subject to clauses
(ii) and (iii), an ESRD Fee-For-Service
Integrated Care Strategy.
``(ii) ESRD fee-for-service integrated care
strategy.--In assessing an ESRD Fee-For-Service
Integrated Care Strategy under clause (i), the
Secretary shall consider the extent to which
the Strategy includes elements such as the
following:
``(I) Use of interdisciplinary care
teams led by at least one nephrologist,
and comprised of registered nurses,
social workers, renal dialysis facility
managers, and as appropriate other
representatives from alternative
settings described in subclause (VIII).
``(II) Use of a decision process
for care plans and care management that
includes the nephrologist, a member of
the transplant evaluation team, and
other practitioners responsible for
direct delivery of care to Program-
eligible beneficiaries assigned to or
who elect the Organization involved.
``(III) Use of health risk and
other assessments to determine the
physical, psychosocial, nutrition,
language, cultural, and other needs of
Program-eligible beneficiaries assigned
to or who elect the Organization
involved.
``(IV) Development and at least
annual updating of individualized care
plans that incorporate at least the
medical, social, and functional needs,
preferences, and care goals of Program-
eligible beneficiaries assigned to or
who elect the Organization, including a
discussion on reconsideration of the
method and location of dialysis.
``(V) Coordination and furnishing
of non-clinical coordination benefits,
such as transportation, aimed at
improving the adherence of Program-
eligible beneficiaries assigned to or
who elect the Organization with care
recommendations.
``(VI) As appropriate, coordination
services, such as transplant
evaluation, palliative care, evaluation
for hospice eligibility, and vascular
access care.
``(VII) In the case of an
individual who, during an assignment
to, or an election of an ESRD Fee-For-
Service Integrated Care model offered
by an Organization, receives
confirmation that a kidney transplant
is imminent, the provision of
counseling services by an
interdisciplinary care team described
in subclause (I) to such individual on
preparation for and potential benefits
and risks associated with such
transplant.
``(VIII) Delivery of benefits and
services in settings alternative to
traditional clinical settings, such as
the home of the Program-eligible
beneficiary.
``(IX) Use of patient reminder
systems.
``(X) Education programs for
patients, families, and caregivers.
``(XI) Use of health care advice
resources, such as nurse advice lines.
``(XII) Use of team-based health
care delivery models that provide
comprehensive and continuous medical
care, such as medical homes.
``(XIII) Co-location of providers
and services.
``(XIV) Use of a demonstrated
capacity to share electronic health
record information across sites of
care.
``(XV) Use of programs to promote
better adherence to recommended
treatment regimens, including
prescription drug, by individuals,
including by addressing barriers to
access to care by such individuals,
including strategies to coordinate any
prescription drug benefits under any
prescription drug plan under part D in
which a Program-eligible beneficiary is
enrolled.
``(XVI) Use of defined protocols,
developed in conjunction with the
pediatric nephrology community, to
facilitate the transition of pediatric
individuals into adult end-stage renal
disease care.
``(XVII) Use of health equity
experts to implement programs and
protocols which seek to decrease
gender, racial, ethnic, and language
inequities.
``(XVIII) Other services,
strategies, and approaches identified
by the Organization to improve care
coordination and delivery.
``(3) Beneficiary protections.--
``(A) Seamless access to care.--The Secretary shall
ensure that the Organization establishes processes and
takes steps necessary, including educating relevant
providers of services and suppliers about the Program,
to ensure that Program-eligible beneficiaries assigned
to or who elected an ESRD Fee-For-Service Integrated
Care Model offered by an Organization do not experience
any disruption in access to providers of services and
suppliers furnishing benefits under this title due to
such assignment or election. Assignment to or an
election of an ESRD Fee-For-Service Integrated Care
Model offered by an Organization shall not be construed
as affecting a Program-eligible beneficiary's ability
to receive benefits described in subsection
(b)(2)(A)(i)(I) from any provider of services or
suppliers enrolled and who otherwise meets requirements
under this title, as described in subsection
(b)(2)(A)(iv).
``(B) Anti-discrimination.--Each agreement between
the Secretary and an Organization under this section
shall--
``(i) provide that each eligible
participating provider of such Organization may
not deny, limit, or condition the furnishing of
services, or affect the quality of services
furnished, under this title to Program-eligible
beneficiaries on whether or not such a
beneficiary is assigned to or elects the
Organization; and
``(ii) prohibit the Organization from
engaging in any activity that could reasonably
be expected to have the effect of denying or
discouraging assignment to or an election of an
ESRD Fee-For-Service Integrated Care Model
offered by an Organization by a Program-
eligible beneficiary whose medical condition or
history indicates a need for substantial future
medical services.
``(C) Quality assurance; patient safeguards.--Each
agreement between the Secretary and an Organization
under this section shall require that such Organization
have in effect at a minimum--
``(i) a written plan of quality assurance
and improvement, and procedures implementing
such plan, in accordance with regulations; and
``(ii) written safeguards of the rights of
Program-eligible beneficiaries assigned to or
who elect the Organization (including a patient
bill of rights and procedures for grievances
and appeals) in accordance with regulations and
with other requirements of this title and
applicable Federal and State laws designed to
protect Program-eligible beneficiaries
(including those who are entitled to medical
assistance under a State plan under title XIX).
``(D) Oversight.--The Secretary shall develop and
implement an oversight program to monitor an
Organization's compliance with Program requirements
under an agreement under this section.
``(4) Treatment as alternative payment model and eligible
alternative payment entity.--
``(A) Treatment of program.--The ESRD Fee-For-
Service Integrated Care Demonstration Program
established under this section shall meet the
definition of an alternative payment model described in
section 1833(z)(3)(C)(iv).
``(B) Treatment of organization.--An Organization
offering one or more ESRD Fee-For-Service Integrated
Care Models shall be treated under this section as an
eligible alternative payment entity as described in
clauses (i) and (ii)(I) of section 1833(z)(3)(D).
``(c) Program Operation and Scope.--
``(1) In general.--The Secretary shall develop a process
such that an Organization can apply to offer one or more ESRD
Fee-For-Service Integrated Care Models. Such application shall
include information on at least the following:
``(A) The estimated average revenue amount
described in subsection (b)(2)(A)(ii)(II) for the
Organization to cover benefits described in subsection
(b)(2)(A)(i)(I).
``(B) Any benefits offered by the Organization
beyond those described in such subsection.
``(C) A description of the Organization's ESRD Fee-
For-Service Integrated Care strategy specified in
subsection (b)(2)(D), including a detailed explanation
of the Organization's approach to fulfill the
requirement to coordinate the delivery of
multidisciplinary health and social services that,
pursuant to a mutual agreement between a State and
Organization, integrates acute and long-term care
services and supports.
``(2) Program initiation.--The Secretary shall initiate the
Program such that Organizations begin serving Program-eligible
beneficiaries not later than January 1, 2024.
``(3) Initial agreement period.--The Secretary shall enter
into agreements for an initial period of not less than 5 years
with all Organizations that meet all Program requirements
established under this section, as determined by the Secretary
through the application process described in paragraph (1).
``(4) Allowance for service area expansions.--During each
year of the Program's operation, the Secretary shall allow an
Organization with an agreement under this section to expand its
service area during the initial agreement period upon the
Secretary's determination, through the application process
described in paragraph (1), that the Organization meets all
Program requirements established under this section.
``(5) Contract suspension and termination process.--
``(A) In general.--Subject to subparagraph (B)(ii),
the Secretary may suspend assignment to or an election
of an ESRD Fee-For-Service Integrated Care Model
offered by an Organization if the Organization fails to
comply with any Program requirements specified in an
agreement under this section. An Organization also
shall be considered not in compliance if, for any
calendar month during an agreement year, more than 50
percent of the total number of Program-eligible
beneficiaries assigned to or who elect an ESRD Fee-For-
Service Integrated Care Model offered by the
Organization opt out of the Program.
``(B) Opportunity for corrective action plan and
appeal.--
``(i) In general.--Prior to suspending
assignment to or an election of an ESRD Fee-
For-Service Integrated Care Model offered by an
Organization or terminating an agreement under
this section, the Secretary shall afford an
Organization sufficient opportunity to remedy
any deficiencies in complying with any Program
requirements under this section by implementing
a corrective action plan. Any corrective action
plan implemented under this subparagraph shall
specify a date by which the Organization shall
resolve such deficiencies and shall remain in
effect until such time that the Secretary
confirms that the Organization has achieved
compliance.
``(ii) Imposition of agreement suspension
or termination.--In the case of an Organization
that fails to achieve compliance by the date
specified in corrective action plan, subject to
clause (iii) and depending on the severity of a
compliance deficiency, the Secretary in a
manner consistent with processes established
under part C of this title may--
``(I) suspend Program-eligible
beneficiaries' assignments to or an
election of an ESRD Fee-For-Service
Integrated Care Model offered by an
Organization; or
``(II) terminate an agreement with
an Organization under this section.
``(iii) Immediate agreement termination for
violating the prohibition on discrimination.--
Notwithstanding the corrective action plan
process established under clause (i), the
Secretary may, in addition to the circumstances
under which a contract under part C may be
immediately terminated, immediately terminate
an agreement under this section with an
Organization if the Secretary--
``(I) notifies the Organization of
the intent to investigate allegations
of systematic activities with the
intent of violating the prohibition on
discrimination established under
subsection (b)(3)(B)(ii);
``(II) determines, after conducting
a rigorous analysis of all available
data based on a sufficient sample size,
that the Organization engaged in
systematic activities with the intent
of violating the prohibition on
discrimination established in
subsection (b)(3)(B)(ii); and
``(III) discloses credible evidence
to the Organization regarding a
determination made under subclause
(II).
``(iv) Recovery of monthly prospective
payments.--The Secretary may recover the
prorated share of any monthly prospective
payments described in subsection (e) covering
the period of the month following an agreement
termination if such agreement termination is
effective in the middle of a calendar month.
``(v) Notification of program-eligible
beneficiary upon agreement termination.--Each
agreement under this section between the
Secretary and an Organization shall require the
Organization to provide and pay for written
notice in advance of an agreement's
termination, as well as a description of
alternatives for obtaining benefits under this
title, in a manner consistent with beneficiary
notification requirements in the event of a
contract termination under part C.
``(6) Program evaluation.--The Secretary shall conduct an
evaluation of the Program under this section to inform a
determination regarding a Program expansion under paragraph
(7). Such evaluation shall include an analysis of--
``(A) the quality of care furnished under the
Program, including the measurement of patient-level
outcomes and patient experience and patient-reported
outcome measures determined appropriate by the
Secretary; and
``(B) the changes in spending under parts A and B
by reason of the Program.
``(7) Program expansion.--
``(A) In general.--The Secretary may, through
rulemaking, expand the duration and scope of the
Program under this section, to the extent determined
appropriate by the Secretary, if--
``(i) the Secretary determines that such
expansion is expected to--
``(I) reduce spending under this
title without reducing the quality of
patient care; or
``(II) improve the quality of
patient care without increasing
spending under this title;
``(ii) the Chief Actuary of the Centers for
Medicare & Medicaid Services certifies that
such expansion would reduce (or would not
result in any increase in) net program spending
under this title; and
``(iii) the Secretary determines that such
expansion would not deny or limit the coverage
or provision of benefits under this title for
applicable individuals.
``(B) Ensuring program continuity.--The Secretary
shall implement any Program expansion made in
accordance with this paragraph in a manner that ensures
that Program-eligible beneficiaries and Organizations
with an agreement under this section do not experience
any disruptions in the Program.
``(8) Part d data sharing arrangement.--The Secretary on a
monthly basis shall, in accordance with the regulations
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996, provide access to
Organizations to part D data claims that include part D data on
Program-eligible beneficiaries assigned to or an election of an
ESRD Fee-For-Service Integrated Care Model offered by an
Organization unless a Program-eligible beneficiary opts out of
such data sharing.
``(9) Funding.--The Secretary shall allocate funds made
available under section 1115A(f)(1) to implement and evaluate
the demonstration program established under this section.
``(d) Identification and Assignment of Program-Eligible
Beneficiaries.--
``(1) In general.--The Secretary shall establish a process
for the initial and ongoing identification of Program-eligible
beneficiaries.
``(2) Assignment of program-eligible beneficiaries to an
organization's esrd fee-for-service integrated care model.--
``(A) In general.--Under the Program, the Secretary
shall assign all Program-eligible beneficiaries to an
ESRD Fee-For-Service Integrated Care Model offered by
an Organization that includes the dialysis facility at
which the Program-eligible beneficiary primarily
receives renal dialysis services.
``(B) Opt-out period and changes upon initial
assignment or election.--The Secretary shall provide
for a 90-day period beginning on the date on which the
assignment of or election made by a Program-eligible
beneficiary into an ESRD Fee-For-Service Integrated
Care Model offered by an Organization becomes effective
during which a Program-eligible beneficiary may--
``(i) opt out of the Program; or
``(ii) make a one-time change of assignment
or election into an ESRD Fee-For-Service
Integrated Care Model offered by a different
Organization.
``(C) Deemed re-assignment and re-election.--The
Secretary shall establish a process through which a
Program-eligible beneficiary assigned to or who elects
an ESRD Fee-For-Service Integrated Care Model offered
by an Organization with respect to a year is deemed,
unless the Program-eligible beneficiary otherwise
changes such assignment or election under this
paragraph, to have elected to continue such assignment
or election with respect to the subsequent year.
``(D) Annual opportunity to opt out or elect an
esrd fee-for-service integrated care model offered by a
different organization.--
``(i) In general.--Annually, a Program-
eligible beneficiary shall be given a 90-day
period to--
``(I) opt out of the Program; or
``(II) make a one-time change of
assignment or election into an ESRD
Fee-For-Service Integrated Care Model
offered by a different Organization.
``(ii) Alignment with medicare advantage
open enrollment period.--To the extent
practicable, the Secretary shall align the
annual 90-day period described in clause (i)
with the Medicare Advantage open enrollment
period.
``(E) Opt out for change in principal diagnosis or
entering home dialysis treatment.--In addition to any
other period during which a Program-eligible
beneficiary may, pursuant to this paragraph, opt out of
the Program, in the case of a Program-eligible
beneficiary who, after assignment under this paragraph,
is diagnosed with a principal diagnosis (as defined by
the Secretary) other than end-stage renal disease or
enters into home dialysis treatment, such individual
shall be given the opportunity to opt out of the
Program during such period as specified by the
Secretary.
``(3) Program-eligible beneficiary notification.--
``(A) In general.--The Secretary shall ensure that
an Organization notifies Program-eligible beneficiaries
about the Program under this section and provides them
with materials explaining the Program, including--
``(i) information about receiving benefits
under this title through such Organization; and
``(ii) an explanation that they retain the
right to receive care from any Medicare
provider.
``(B) Timing of notification.--Upon assignment to
or election of an ESRD Fee-For-Service Integrated Care
Model offered by an Organization, the Secretary shall
provide the Organization written notification
confirming the beneficiary's assignment or election and
not later than 15 business days after the date of
receipt of such notification, the Organization shall
provide written notice to the Program-eligible
beneficiary of such assignment or election.
``(C) Content of written notice.--Subject to
subparagraph (D), such notification shall--
``(i) inform Program-eligible beneficiaries
about the Program using an information guide
developed by the Organization and approved by
the Secretary;
``(ii) include the distribution of other
Program materials developed by the Organization
and approved by the Secretary;
``(iii) inform Program-eligible
beneficiaries about the importance of
transplantation as the best outcome, as well as
minimum requirements for transplant eligibility
before and during dialysis treatment; and
``(iv) provide contact information for
representatives of the Organization to respond
to Program-eligible beneficiaries' questions.
``(D) Limitation on unsolicited notification.--
``(i) In general.--Under the Program, no
person or entity (other than the Secretary, an
employee of the Secretary, or an employee or
volunteer of a federally authorized State
Health Insurance Assistance Program (SHIP)),
subject to clause (ii), may provide any
information about the Program, including
information, materials, and assistance
described in subparagraph (B), to a Program-
eligible beneficiary unless such Program-
eligible beneficiary requests such information,
materials, or assistance.
``(ii) Exception for providers treating
beneficiaries.--An eligible participating
provider that is part of an Organization may
provide information, materials, and assistance
described in subparagraph (B) to a Program-
eligible beneficiary, without prior request of
such beneficiary, if such beneficiary is
receiving renal dialysis services from a
facility that participates in such
Organization.
``(iii) Parity in notification.--In the
case that an eligible participating provider
that is part of an Organization participates in
notifying Program-eligible beneficiaries about
the Program under this subparagraph, such
notification shall be provided in the same
manner to all Program-eligible beneficiaries to
which, pursuant to clause (ii), such eligible
participating provider may provide information,
materials, and assistance described in such
clause.
``(E) Program-eligible beneficiary grievance and
appeal rights.--Program-eligible beneficiaries
participating in the Program under this section shall
have grievance and appeal rights and procedures
consistent with those rights and procedures established
under subsections (f) and (g) of section 1852.
``(e) ESRD Fee-For-Service Integrated Care Program Monthly Payment
and Claims Processing Mechanism.--
``(1) In general.--For each Program-eligible beneficiary
receiving care through an Organization, the Secretary shall
make a monthly prospective payment in accordance with payment
rates that would be determined under section 1853(a)(1)(H).
``(2) Application of health status risk adjustment
methodology.--The Secretary shall adjust the monthly
prospective payment to an Organization under this subsection in
the same manner in which the payment amount to a Medicare
Advantage plan is adjusted under section 1853(a)(1)(C).
``(3) Treatment of and payment for kidney acquisition
costs.--
``(A) Excluding costs for kidney acquisitions from
ma benchmark.--The Secretary shall adjust the payment
amount to an Organization to exclude from such payment
amount the Secretary's estimate of the standardized
costs for payments for organ acquisitions for kidney
transplants in the area involved for the year.
``(B) FFS treatment of and payment for kidney
acquisitions.--An Organization shall provide all
benefits described in subsection (b)(2)(A)(i), except
for kidney acquisition costs. Payment for kidney
acquisition costs covered under this title furnished to
a Program-eligible beneficiary shall be made in
accordance with this title and in such amounts as would
otherwise be made and determined for such items and
services provided to such a beneficiary not
participating in the Program under this section.
``(4) Treatment of and payment for hospice care.--
``(A) In general.--An agreement under this section
shall require an Organization to inform each Program-
eligible beneficiary who is assigned to or elects an
ESRD Fee-For-Service Integrated Care Model offered by
the Organization about the availability of hospice care
if--
``(i) a hospice program participating under
this title is located within the Organization's
service area; or
``(ii) it is common practice to refer
patients to hospice programs outside such
service area.
``(B) Payment.--If a Program-eligible beneficiary
who is assigned to or elects an ESRD Fee-For-Service
Integrated Care Model offered by an Organization with
an agreement under this section makes an election under
section 1812(d)(1) to receive hospice care from a
particular hospice program--
``(i) payment for the care furnished to the
Program-eligible beneficiary shall be made by
the Secretary to the hospice program elected by
the Program-eligible beneficiary;
``(ii) payment for other services for which
the Program-eligible beneficiary individual is
eligible notwithstanding the Program-eligible
beneficiary's election of hospice care under
section 1812(d)(1), including services not
related to the Program-eligible beneficiary's
terminal illness, shall be made by the
Secretary to the Organization or the provider
or supplier of the service instead of the
monthly prospective payment determined under
subsection (f); and
``(iii) the Secretary shall continue to
make monthly payments to the Organization in an
amount equal to the value of benefits and
services determined under subsection
(b)(2)(A)(ii)(IV).
``(5) Application of cmi claims processing framework.--
``(A) In general.--Under the Program, the Secretary
shall apply a claims processing framework based on
those that the Center for Medicare and Medicaid
Innovation applies under various direct contracting
models under section 1115A such that--
``(i) providers of services and suppliers
serving Program-eligible beneficiaries continue
to submit claims to a medicare administrative
contractor;
``(ii) the Secretary forwards claims to the
Organization for payment; and
``(iii) the Organization pays providers of
services and suppliers an amount equal to the
amount that they would otherwise receive under
the original Medicare Fee-For-Service program
plus any additional amount to which the
provider may be eligible under subsection
(b)(2)(A)(v) of this section.
``(B) Application of balance billing limitations.--
Section 1852(a)(2)(A) (relating to payments made by an
MA organization to a non-contract provider of
services), section 1852(k)(1) (relating to limitations
on balance billing), and section 1866(a)(1)(o)
(relating to payments made by an MA organization to a
non-contract supplier) shall apply to the Program.
``(C) Payments for graduate medical education.--
Section 1886(d)(11) and section 1886(h)(3)(D) (relating
to payments for graduate medical education) shall apply
to Organizations and providers of services under the
Program.
``(6) No effect on ma esrd rate setting or risk adjustment
model.--To ensure the integrity of the Medicare Advantage end
stage renal disease rate setting process and risk adjustment
factors applied to Medicare Advantage end stage renal disease
rates, claims paid on behalf of Program-eligible beneficiaries
shall not be included in neither the determination of such
rates nor the development of such risk adjustment factors.
``(7) Agreement between a state and organization for
medicaid benefits.--In the case that a State and Organization
enter into a mutual agreement under which the Organization
coordinates benefits under title XIX for Program-eligible
beneficiaries eligible for benefits under this title and title
XIX such mutual agreement shall specify the payment from the
State for providing or arranging for the provision of such
benefits.
``(8) Affirmation of state obligations to pay premium and
cost-sharing amounts.--A State shall continue to make medical
assistance under the State plan under title XIX available for
the duration of the Program for Medicare cost-sharing (as
defined in section 1905(p)(3)) under this title for qualified
Medicare beneficiaries described in section 1905(p)(1) and
other individuals who are Program-eligible beneficiaries
assigned to or who elect an Organization and entitled to
medical assistance for premiums and such cost-sharing under the
State plan under title XIX in an amount equal to the amount of
medical assistance that would be made available by such State
if such Program-eligible beneficiaries were not participating
in the Program under this section.
``(f) Waiver Authority.--
``(1) In general.--The Secretary shall waive those
requirements waived under section 1899 determined by the
Secretary to be relevant and necessary for the operation of the
Program under this section and may waive, as necessary, such
additional requirements that have been or may be waived based
on authority established under section 1115A for purposes of
models tested by the Centers for Medicare and Medicaid
Innovation in order to carry out the Program under this
section.
``(2) Notice of waivers.--Not later than 3 months after the
date of enactment of this section, the Secretary shall publish
a notice of waivers that will apply in connection with the
Program. The notice shall include the specific conditions that
an Organization must meet to qualify for each waiver, and
commentary explaining the waiver requirements.
``(g) Report.--Not later than December 31, 2025, the Medicare
Payment Advisory Commission shall submit to Congress an interim report
on the Program.''.
(b) Rules of Construction.--
(1) Use of medicare supplemental policy under an esrd fee-
for-service integrated care model.--Nothing in the provisions
of, or amendments made by, this Act shall be construed to
prevent a Program-eligible beneficiary assigned to, or who
elects, an ESRD Fee-For-Service Integrated Care Model offered
by an Organization with an agreement under this section from
enrolling in or continuing enrollment in a medicare
supplemental policy available to such Program-eligible
beneficiary or receiving benefits under such medicare
supplemental policy throughout the duration of the Program-
eligible beneficiary's participation in an ESRD Fee-For-Service
Integrated Care model offered by an Organizations with an
agreement under this section.
(2) Application of state rules regarding issuance of
medicare supplemental policies to individual under age 65.--
Nothing in the provisions of, or amendments made by, this Act
shall be construed to establish a Federal requirement on an
issuer of a medicare supplemental policy to offer such medicare
supplemental policy to individuals under age 65.
(3) Continued availability of medicare supplemental
policies to individuals under age 65.--Nothing in the
provisions of, or amendments made by, this Act shall be
construed to affect a State's authority to require an issuer of
a medicare supplemental policy to offer such medicare
supplemental policy to individual.
(c) GAO Study and Report on Payment Adequacy for Pediatric ESRD
Services.--
(1) Study on payment for pediatric esrd services.--The
Comptroller General of the United States shall conduct a study
to examine the accuracy of pediatric data reported to the
Centers for Medicare & Medicaid Services as part of the ESRD
prospective payment system. The study shall evaluate whether
the organizations described in section 1866G of the Social
Security Act, as added by subsection (a), and the existing
prospective payment system accurately capture and reimburse
costs of pediatric dialysis care and include an analysis of the
following factors that influence such costs:
(A) Increased acuity of nursing care compared to
adult dialysis patients, especially for smaller and
younger pediatric hemodialysis patients.
(B) Need for developmental and behavioral
specialists, including child life specialists.
(C) Need for more frequent assessment by pediatric
dieticians to adjust formulas and diet for the
specialized growth and nutrition requirements of
children treated with dialysis.
(D) Need for social workers, school liaisons, and
other trained individuals designated to help families
navigate challenging psychosocial situations and to
coordinate with schools to ensure school attendance and
optimize school performance among pediatric dialysis
patients.
(E) Need for a broader array of dialysis supplies,
including different-sized dialyzers, tubing, and
peritoneal fluid bags to accommodate care provided
infants through young adults.
(2) Report.--Not later than 18 months after the date of the
enactment of this Act, the Comptroller General shall submit to
Congress a report containing the results of the study conducted
under paragraph (1), together with recommendations for such
legislation and administrative action as the Comptroller
General determines appropriate.
(d) GAO Study and Report on the Impact of Race-Based Correction of
EGFR on Referral of ESRD Patients for Transplant Evaluation.--
(1) Study on impact of race-based correction of egfr on
referral of esrd patients for transplant evaluation.--The
Comptroller General of the United States shall conduct a study
to examine the impact of race-based correction of the estimated
glomerular filtration rate (referred to in this subsection as
``eGFR'') on the referral of ESRD patients for transplant
evaluation.
(2) Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General shall submit to
Congress a report containing the results of the study conducted
under paragraph (1), together with recommendations for such
legislation and administrative action as the Comptroller
General determines appropriate.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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.
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