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Friday, March 18, 2016
Tuesday, March 15, 2016
Section 3021 of Affordable Care Act: CMMI Center for Medicare & Medicaid Innovation
http://www.hhs.gov/sites/default/files/ppacacon.pdf
[5500 words]
(a) IN GENERAL.—Title XI of the Social Security Act is amended by inserting after section 1115 the following new section: ‘‘CENTER FOR MEDICARE AND MEDICAID INNOVATION ‘‘SEC. 1115A ø42 U.S.C. 1315a¿.
(a) CENTER FOR MEDICARE AND MEDICAID INNOVATION ESTABLISHED.—
‘‘(1) IN GENERAL.—There is created within the Centers for Medicare & Medicaid Services a Center for Medicare and Medicaid Innovation (in this section referred to as the ‘CMI’) to carry out the duties described in this section. The purpose of the CMI is to test innovative payment and service delivery models to reduce program expenditures under the applicable titles while preserving or enhancing the quality of care furnished to individuals under such titles. In selecting such models, the Secretary shall give preference to models that also improve the coordination, quality, and efficiency of health care services furnished to applicable individuals defined in paragraph (4)(A). ‘
(2) DEADLINE.—The Secretary shall ensure that the CMI is carrying out the duties described in this section by not later than January 1, 2011.
‘‘(3) CONSULTATION.—In carrying out the duties under this section, the CMI shall consult representatives of relevant Federal agencies, and clinical and analytical experts with expertise in medicine and health care management. The CMI shall use open door forums or other mechanisms to seek input from interested parties. ‘‘
(4) DEFINITIONS.—In this section: ‘‘(A) APPLICABLE INDIVIDUAL.—The term ‘applicable individual’ means— ‘‘(i) an individual who is entitled to, or enrolled for, benefits under part A of title XVIII or enrolled for benefits under part B of such title; ‘‘(ii) an individual who is eligible for medical assistance under title XIX, under a State plan or waiver; or
‘‘(iii) an individual who meets the criteria of both clauses (i) and (ii). ‘‘(B) APPLICABLE TITLE.—The term ‘applicable title’ means title XVIII, title XIX, or both.
‘‘(5) TESTING WITHIN CERTAIN GEOGRAPHIC AREAS.—For purposes of testing payment and service delivery models under this section, the Secretary may elect to limit testing of a model to certain geographic areas. øAs added by section 10306(1)¿
‘‘(b) TESTING OF MODELS (PHASE I).—
‘‘(1) IN GENERAL.—The CMI shall test payment and service delivery models in accordance with selection criteria under paragraph (2) to determine the effect of applying such models under the applicable title (as defined in subsection (a)(4)(B)) on program expenditures under such titles and the quality of care received by individuals receiving benefits under such title. ‘‘
(2) SELECTION OF MODELS TO BE TESTED.— ‘‘(A) IN GENERAL.—øAs revised by section 10306(a)(2)(A)¿ The Secretary shall select models to be tested from models where the Secretary determines that there is evidence that the model addresses a defined population for which there are deficits in care leading to poor clinical outcomes or potentially avoidable expenditures. The Secretary shall focus on models expected to reduce program costs under the applicable title while preserving or enhancing the quality of care received by individuals receiving benefits under such title. The models selected under this subparagraph may include, but are not limited to, the models described in subparagraph (B). ‘‘(B) OPPORTUNITIES.—The models described in this subparagraph are the following models: ‘‘(i) Promoting broad payment and practice reform in primary care, including patient-centered medical home models for high-need applicable individuals, medical homes that address women’s unique health care needs, and models that transition primary care practices away from fee-for-service based reimbursement and toward comprehensive payment or salarybased payment. ‘‘(ii) Contracting directly with groups of providers of services and suppliers to promote innovative care delivery models, such as through risk-based comprehensive payment or salary-based payment. ‘‘(iii) Utilizing geriatric assessments and comprehensive care plans to coordinate the care (including through interdisciplinary teams) of applicable individuals with multiple chronic conditions and at least one of the following: ‘‘(I) An inability to perform 2 or more activities of daily living. ‘‘(II) Cognitive impairment, including dementia. ‘‘(iv) Promote care coordination between providers of services and suppliers that transition health care
providers away from fee-for-service based reimbursement and toward salary-based payment. ‘‘(v) Supporting care coordination for chronically-ill applicable individuals at high risk of hospitalization through a health information technology-enabled provider network that includes care coordinators, a chronic disease registry, and home tele-health technology. ‘‘(vi) Varying payment to physicians who order advanced diagnostic imaging services (as defined in section 1834(e)(1)(B)) according to the physician’s adherence to appropriateness criteria for the ordering of such services, as determined in consultation with physician specialty groups and other relevant stakeholders. ‘‘(vii) Utilizing medication therapy management services, such as those described in section 935 of the Public Health Service Act. ‘‘(viii) Establishing community-based health teams to support small-practice medical homes by assisting the primary care practitioner in chronic care management, including patient self-management, activities. ‘‘(ix) Assisting applicable individuals in making informed health care choices by paying providers of services and suppliers for using patient decision-support tools, including tools that meet the standards developed and identified under section 936(c)(2)(A) of the Public Health Service Act, that improve applicable individual and caregiver understanding of medical treatment options. ‘‘(x) Allowing States to test and evaluate fully integrating care for dual eligible individuals in the State, including the management and oversight of all funds under the applicable titles with respect to such individuals. ‘‘(xi) Allowing States to test and evaluate systems of all-payer payment reform for the medical care of residents of the State, including dual eligible individuals. ‘‘(xii) Aligning nationally recognized, evidencebased guidelines of cancer care with payment incentives under title XVIII in the areas of treatment planning and follow-up care planning for applicable individuals described in clause (i) or (iii) of subsection (a)(4)(A) with cancer, including the identification of gaps in applicable quality measures. ‘‘(xiii) Improving post-acute care through continuing care hospitals that offer inpatient rehabilitation, long-term care hospitals, and home health or skilled nursing care during an inpatient stay and the 30 days immediately following discharge. ‘‘(xiv) Funding home health providers who offer chronic care management services to applicable individuals in cooperation with interdisciplinary teams.
‘‘(xv) Promoting improved quality and reduced cost by developing a collaborative of high-quality, low-cost health care institutions that is responsible for— ‘‘(I) developing, documenting, and disseminating best practices and proven care methods; ‘‘(II) implementing such best practices and proven care methods within such institutions to demonstrate further improvements in quality and efficiency; and ‘‘(III) providing assistance to other health care institutions on how best to employ such best practices and proven care methods to improve health care quality and lower costs. ‘‘(xvi) Facilitate inpatient care, including intensive care, of hospitalized applicable individuals at their local hospital through the use of electronic monitoring by specialists, including intensivists and critical care specialists, based at integrated health systems. ‘‘(xvii) Promoting greater efficiencies and timely access to outpatient services (such as outpatient physical therapy services) through models that do not require a physician or other health professional to refer the service or be involved in establishing the plan of care for the service, when such service is furnished by a health professional who has the authority to furnish the service under existing State law. ‘‘(xviii) Establishing comprehensive payments to Healthcare Innovation Zones, consisting of groups of providers that include a teaching hospital, physicians, and other clinical entities, that, through their structure, operations, and joint-activity deliver a full spectrum of integrated and comprehensive health care services to applicable individuals while also incorporating innovative methods for the clinical training of future health care professionals.
øClauses (xix) and (xx) added by section 10306(2)(B)¿
‘‘(xix) Utilizing, in particular in entities located in medically underserved areas and facilities of the Indian Health Service (whether operated by such Service or by an Indian tribe or tribal organization (as those terms are defined in section 4 of the Indian Health Care Improvement Act)), telehealth services— ‘‘(I) in treating behavioral health issues (such as post-traumatic stress disorder) and stroke; and ‘‘(II) to improve the capacity of non-medical providers and non-specialized medical providers to provide health services for patients with chronic complex conditions. ‘‘(xx) Utilizing a diverse network of providers of services and suppliers to improve care coordination for applicable individuals described in subsection (a)(4)(A)(i) with 2 or more chronic conditions and a history of prior-year hospitalization through interventions developed under the Medicare Coordinated Care
Demonstration Project under section 4016 of the Balanced Budget Act of 1997 (42 U.S.C. 1395b–1 note).
‘‘(C) ADDITIONAL FACTORS FOR CONSIDERATION.—In selecting models for testing under subparagraph (A), the CMI may consider the following additional factors: ‘‘(i) Whether the model includes a regular process for monitoring and updating patient care plans in a manner that is consistent with the needs and preferences of applicable individuals. ‘‘(ii) Whether the model places the applicable individual, including family members and other informal caregivers of the applicable individual, at the center of the care team of the applicable individual. ‘‘(iii) Whether the model provides for in-person contact with applicable individuals. ‘‘(iv) Whether the model utilizes technology, such as electronic health records and patient-based remote monitoring systems, to coordinate care over time and across settings. ‘‘(v) Whether the model provides for the maintenance of a close relationship between care coordinators, primary care practitioners, specialist physicians, community-based organizations, and other providers of services and suppliers. ‘‘(vi) Whether the model relies on a team-based approach to interventions, such as comprehensive care assessments, care planning, and self-management coaching. ‘‘(vii) Whether, under the model, providers of services and suppliers are able to share information with patients, caregivers, and other providers of services and suppliers on a real time basis. ‘‘(viii) øAs added by section 10306(2)(C)¿ Whether the model demonstrates effective linkage with other public sector or private sector payers. ‘‘
(3) BUDGET NEUTRALITY.— ‘‘(A) INITIAL PERIOD.—The Secretary shall not require, as a condition for testing a model under paragraph (1), that the design of such model ensure that such model is budget neutral initially with respect to expenditures under the applicable title. ‘‘
(B) TERMINATION OR MODIFICATION.
—The Secretary shall terminate or modify the design and implementation of a model unless the Secretary determines (and the Chief Actuary of the Centers for Medicare & Medicaid Services, with respect to program spending under the applicable title, certifies), after testing has begun, that the model is expected to— ‘‘(i) improve the quality of care (as determined by the Administrator of the Centers for Medicare & Medicaid Services) without increasing spending under the applicable title; ‘‘(ii) reduce spending under the applicable title without reducing the quality of care; or
spending. Such termination may occur at any time after such testing has begun and before completion of the testing. ‘‘
(4) EVALUATION.— ‘‘(A) IN GENERAL.—The Secretary shall conduct an evaluation of each model tested under this subsection. Such evaluation shall include an analysis of— ‘‘(i) the quality of care furnished under the model, including the measurement of patient-level outcomes and patient-centeredness criteria determined appropriate by the Secretary; and ‘‘(ii) the changes in spending under the applicable titles by reason of the model. ‘‘(B) INFORMATION.—The Secretary shall make the results of each evaluation under this paragraph available to the public in a timely fashion and may establish requirements for States and other entities participating in the testing of models under this section to collect and report information that the Secretary determines is necessary to monitor and evaluate such models. ‘‘(C) MEASURE SELECTION.—øAs added by section 10306(3)¿ To the extent feasible, the Secretary shall select measures under this paragraph that reflect national priorities for quality improvement and patient-centered care consistent with the measures described in 1890(b)(7)(B). ‘‘
(c) EXPANSION OF MODELS (PHASE II).'
—Taking into account the evaluation under subsection (b)(4), the Secretary may, through rulemaking, expand (including implementation on a nationwide basis) the duration and the scope of a model that is being tested under subsection (b) or a demonstration project under section 1866C, to the extent determined appropriate by the Secretary, if— øAs revised by section 10306(4)¿ ‘‘(1) the Secretary determines that such expansion is expected to— ‘‘(A) reduce spending under applicable title without reducing the quality of care; or ‘‘(B) improve the quality of patient care without increasing spending; ‘‘(2) 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 applicable titles; and øParagraph (3) and succeeding sentence added by section 10306(4)¿ ‘‘(3) the Secretary determines that such expansion would not deny or limit the coverage or provision of benefits under the applicable title for applicable individuals. In determining which models or demonstration projects to expand under the preceding sentence, the Secretary shall focus on models and demonstration projects that improve the quality of patient care and reduce spending. ‘‘
(d) IMPLEMENTATION.—
‘‘(1) WAIVER AUTHORITY.—The Secretary may waive such requirements of titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), and 1903(m)(2)(A)(iii) as may be necessary solely for purposes of carrying out this section with respect to testing models described in subsection (b).
‘‘(2) LIMITATIONS ON REVIEW.—There shall be no administrative or judicial review under section 1869, section 1878, or otherwise of— ‘‘(A) the selection of models for testing or expansion under this section; ‘‘(B) the selection of organizations, sites, or participants to test those models selected; ‘‘(C) the elements, parameters, scope, and duration of such models for testing or dissemination; ‘‘(D) determinations regarding budget neutrality under subsection (b)(3); ‘‘(E) the termination or modification of the design and implementation of a model under subsection (b)(3)(B); and ‘‘(F) determinations about expansion of the duration and scope of a model under subsection (c), including the determination that a model is not expected to meet criteria described in paragraph (1) or (2) of such subsection.
‘‘(3) ADMINISTRATION.—Chapter 35 of title 44, United States Code, shall not apply to the testing and evaluation of models or expansion of such models under this section. ‘‘
(e) APPLICATION TO CHIP.—
The Center may carry out activities under this section with respect to title XXI in the same manner as provided under this section with respect to the program under the applicable titles. ‘‘
(f) FUNDING.—
‘‘(1) IN GENERAL.—There are appropriated, from amounts in the Treasury not otherwise appropriated— ‘‘(A) $5,000,000 for the design, implementation, and evaluation of models under subsection (b) for fiscal year 2010; ‘‘(B) $10,000,000,000 for the activities initiated under this section for the period of fiscal years 2011 through 2019; and ‘‘(C) the amount described in subparagraph (B) for the activities initiated under this section for each subsequent 10-year fiscal period (beginning with the 10-year fiscal period beginning with fiscal year 2020). Amounts appropriated under the preceding sentence shall remain available until expended. ‘‘(2) USE OF CERTAIN FUNDS.—Out of amounts appropriated under subparagraphs (B) and (C) of paragraph (1), not less than $25,000,000 shall be made available each such fiscal year to design, implement, and evaluate models under subsection (b).
‘‘(g) REPORT TO CONGRESS.—
Beginning in 2012, and not less than once every other year thereafter, the Secretary shall submit to Congress a report on activities under this section. Each such report shall describe the models tested under subsection (b), including the number of individuals described in subsection (a)(4)(A)(i)
and of individuals described in subsection (a)(4)(A)(ii) participating in such models and payments made under applicable titles for services on behalf of such individuals, any models chosen for expansion under subsection (c), and the results from evaluations under subsection (b)(4).
In addition, each such report shall provide such recommendations as the Secretary determines are appropriate for legislative action to facilitate the development and expansion of successful payment models.’’.
(b) MEDICAID CONFORMING AMENDMENT.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by section 8002(b), is amended— (1) in paragraph (81), by striking ‘‘and’’ at the end; (2) in paragraph (82), by striking the period at the end and inserting ‘‘; and’’; and (3) by inserting after paragraph (82) the following new paragraph: ‘‘(83) provide for implementation of the payment models specified by the Secretary under section 1115A(c) for implementation on a nationwide basis unless the State demonstrates to the satisfaction of the Secretary that implementation would not be administratively feasible or appropriate to the health care delivery system of the State.’’.
(c) REVISIONS TO HEALTH CARE QUALITY DEMONSTRATION PROGRAM.—Subsections (b) and (f) of section 1866C of the Social Security Act (42 U.S.C. 1395cc–3) are amended by striking ‘‘5-year’’ each place it appears.
.....SEC. 3022. MEDICARE SHARED SAVINGS PROGRAM.
[5500 words]
PART 3—ENCOURAGING DEVELOPMENT OF
NEW PATIENT CARE MODELS
SEC. 3021. ESTABLISHMENT OF CENTER FOR
MEDICARE AND MEDICAID
INNOVATION
WITHIN CMS.
(a) IN GENERAL.—Title XI of the Social Security Act is amended by inserting after section 1115 the following new section: ‘‘CENTER FOR MEDICARE AND MEDICAID INNOVATION ‘‘SEC. 1115A ø42 U.S.C. 1315a¿.
(a) CENTER FOR MEDICARE AND MEDICAID INNOVATION ESTABLISHED.—
‘‘(1) IN GENERAL.—There is created within the Centers for Medicare & Medicaid Services a Center for Medicare and Medicaid Innovation (in this section referred to as the ‘CMI’) to carry out the duties described in this section. The purpose of the CMI is to test innovative payment and service delivery models to reduce program expenditures under the applicable titles while preserving or enhancing the quality of care furnished to individuals under such titles. In selecting such models, the Secretary shall give preference to models that also improve the coordination, quality, and efficiency of health care services furnished to applicable individuals defined in paragraph (4)(A). ‘
(2) DEADLINE.—The Secretary shall ensure that the CMI is carrying out the duties described in this section by not later than January 1, 2011.
‘‘(3) CONSULTATION.—In carrying out the duties under this section, the CMI shall consult representatives of relevant Federal agencies, and clinical and analytical experts with expertise in medicine and health care management. The CMI shall use open door forums or other mechanisms to seek input from interested parties. ‘‘
(4) DEFINITIONS.—In this section: ‘‘(A) APPLICABLE INDIVIDUAL.—The term ‘applicable individual’ means— ‘‘(i) an individual who is entitled to, or enrolled for, benefits under part A of title XVIII or enrolled for benefits under part B of such title; ‘‘(ii) an individual who is eligible for medical assistance under title XIX, under a State plan or waiver; or
‘‘(iii) an individual who meets the criteria of both clauses (i) and (ii). ‘‘(B) APPLICABLE TITLE.—The term ‘applicable title’ means title XVIII, title XIX, or both.
‘‘(5) TESTING WITHIN CERTAIN GEOGRAPHIC AREAS.—For purposes of testing payment and service delivery models under this section, the Secretary may elect to limit testing of a model to certain geographic areas. øAs added by section 10306(1)¿
‘‘(b) TESTING OF MODELS (PHASE I).—
‘‘(1) IN GENERAL.—The CMI shall test payment and service delivery models in accordance with selection criteria under paragraph (2) to determine the effect of applying such models under the applicable title (as defined in subsection (a)(4)(B)) on program expenditures under such titles and the quality of care received by individuals receiving benefits under such title. ‘‘
(2) SELECTION OF MODELS TO BE TESTED.— ‘‘(A) IN GENERAL.—øAs revised by section 10306(a)(2)(A)¿ The Secretary shall select models to be tested from models where the Secretary determines that there is evidence that the model addresses a defined population for which there are deficits in care leading to poor clinical outcomes or potentially avoidable expenditures. The Secretary shall focus on models expected to reduce program costs under the applicable title while preserving or enhancing the quality of care received by individuals receiving benefits under such title. The models selected under this subparagraph may include, but are not limited to, the models described in subparagraph (B). ‘‘(B) OPPORTUNITIES.—The models described in this subparagraph are the following models: ‘‘(i) Promoting broad payment and practice reform in primary care, including patient-centered medical home models for high-need applicable individuals, medical homes that address women’s unique health care needs, and models that transition primary care practices away from fee-for-service based reimbursement and toward comprehensive payment or salarybased payment. ‘‘(ii) Contracting directly with groups of providers of services and suppliers to promote innovative care delivery models, such as through risk-based comprehensive payment or salary-based payment. ‘‘(iii) Utilizing geriatric assessments and comprehensive care plans to coordinate the care (including through interdisciplinary teams) of applicable individuals with multiple chronic conditions and at least one of the following: ‘‘(I) An inability to perform 2 or more activities of daily living. ‘‘(II) Cognitive impairment, including dementia. ‘‘(iv) Promote care coordination between providers of services and suppliers that transition health care
providers away from fee-for-service based reimbursement and toward salary-based payment. ‘‘(v) Supporting care coordination for chronically-ill applicable individuals at high risk of hospitalization through a health information technology-enabled provider network that includes care coordinators, a chronic disease registry, and home tele-health technology. ‘‘(vi) Varying payment to physicians who order advanced diagnostic imaging services (as defined in section 1834(e)(1)(B)) according to the physician’s adherence to appropriateness criteria for the ordering of such services, as determined in consultation with physician specialty groups and other relevant stakeholders. ‘‘(vii) Utilizing medication therapy management services, such as those described in section 935 of the Public Health Service Act. ‘‘(viii) Establishing community-based health teams to support small-practice medical homes by assisting the primary care practitioner in chronic care management, including patient self-management, activities. ‘‘(ix) Assisting applicable individuals in making informed health care choices by paying providers of services and suppliers for using patient decision-support tools, including tools that meet the standards developed and identified under section 936(c)(2)(A) of the Public Health Service Act, that improve applicable individual and caregiver understanding of medical treatment options. ‘‘(x) Allowing States to test and evaluate fully integrating care for dual eligible individuals in the State, including the management and oversight of all funds under the applicable titles with respect to such individuals. ‘‘(xi) Allowing States to test and evaluate systems of all-payer payment reform for the medical care of residents of the State, including dual eligible individuals. ‘‘(xii) Aligning nationally recognized, evidencebased guidelines of cancer care with payment incentives under title XVIII in the areas of treatment planning and follow-up care planning for applicable individuals described in clause (i) or (iii) of subsection (a)(4)(A) with cancer, including the identification of gaps in applicable quality measures. ‘‘(xiii) Improving post-acute care through continuing care hospitals that offer inpatient rehabilitation, long-term care hospitals, and home health or skilled nursing care during an inpatient stay and the 30 days immediately following discharge. ‘‘(xiv) Funding home health providers who offer chronic care management services to applicable individuals in cooperation with interdisciplinary teams.
‘‘(xv) Promoting improved quality and reduced cost by developing a collaborative of high-quality, low-cost health care institutions that is responsible for— ‘‘(I) developing, documenting, and disseminating best practices and proven care methods; ‘‘(II) implementing such best practices and proven care methods within such institutions to demonstrate further improvements in quality and efficiency; and ‘‘(III) providing assistance to other health care institutions on how best to employ such best practices and proven care methods to improve health care quality and lower costs. ‘‘(xvi) Facilitate inpatient care, including intensive care, of hospitalized applicable individuals at their local hospital through the use of electronic monitoring by specialists, including intensivists and critical care specialists, based at integrated health systems. ‘‘(xvii) Promoting greater efficiencies and timely access to outpatient services (such as outpatient physical therapy services) through models that do not require a physician or other health professional to refer the service or be involved in establishing the plan of care for the service, when such service is furnished by a health professional who has the authority to furnish the service under existing State law. ‘‘(xviii) Establishing comprehensive payments to Healthcare Innovation Zones, consisting of groups of providers that include a teaching hospital, physicians, and other clinical entities, that, through their structure, operations, and joint-activity deliver a full spectrum of integrated and comprehensive health care services to applicable individuals while also incorporating innovative methods for the clinical training of future health care professionals.
øClauses (xix) and (xx) added by section 10306(2)(B)¿
‘‘(xix) Utilizing, in particular in entities located in medically underserved areas and facilities of the Indian Health Service (whether operated by such Service or by an Indian tribe or tribal organization (as those terms are defined in section 4 of the Indian Health Care Improvement Act)), telehealth services— ‘‘(I) in treating behavioral health issues (such as post-traumatic stress disorder) and stroke; and ‘‘(II) to improve the capacity of non-medical providers and non-specialized medical providers to provide health services for patients with chronic complex conditions. ‘‘(xx) Utilizing a diverse network of providers of services and suppliers to improve care coordination for applicable individuals described in subsection (a)(4)(A)(i) with 2 or more chronic conditions and a history of prior-year hospitalization through interventions developed under the Medicare Coordinated Care
Demonstration Project under section 4016 of the Balanced Budget Act of 1997 (42 U.S.C. 1395b–1 note).
‘‘(C) ADDITIONAL FACTORS FOR CONSIDERATION.—In selecting models for testing under subparagraph (A), the CMI may consider the following additional factors: ‘‘(i) Whether the model includes a regular process for monitoring and updating patient care plans in a manner that is consistent with the needs and preferences of applicable individuals. ‘‘(ii) Whether the model places the applicable individual, including family members and other informal caregivers of the applicable individual, at the center of the care team of the applicable individual. ‘‘(iii) Whether the model provides for in-person contact with applicable individuals. ‘‘(iv) Whether the model utilizes technology, such as electronic health records and patient-based remote monitoring systems, to coordinate care over time and across settings. ‘‘(v) Whether the model provides for the maintenance of a close relationship between care coordinators, primary care practitioners, specialist physicians, community-based organizations, and other providers of services and suppliers. ‘‘(vi) Whether the model relies on a team-based approach to interventions, such as comprehensive care assessments, care planning, and self-management coaching. ‘‘(vii) Whether, under the model, providers of services and suppliers are able to share information with patients, caregivers, and other providers of services and suppliers on a real time basis. ‘‘(viii) øAs added by section 10306(2)(C)¿ Whether the model demonstrates effective linkage with other public sector or private sector payers. ‘‘
(3) BUDGET NEUTRALITY.— ‘‘(A) INITIAL PERIOD.—The Secretary shall not require, as a condition for testing a model under paragraph (1), that the design of such model ensure that such model is budget neutral initially with respect to expenditures under the applicable title. ‘‘
(B) TERMINATION OR MODIFICATION.
—The Secretary shall terminate or modify the design and implementation of a model unless the Secretary determines (and the Chief Actuary of the Centers for Medicare & Medicaid Services, with respect to program spending under the applicable title, certifies), after testing has begun, that the model is expected to— ‘‘(i) improve the quality of care (as determined by the Administrator of the Centers for Medicare & Medicaid Services) without increasing spending under the applicable title; ‘‘(ii) reduce spending under the applicable title without reducing the quality of care; or
spending. Such termination may occur at any time after such testing has begun and before completion of the testing. ‘‘
(4) EVALUATION.— ‘‘(A) IN GENERAL.—The Secretary shall conduct an evaluation of each model tested under this subsection. Such evaluation shall include an analysis of— ‘‘(i) the quality of care furnished under the model, including the measurement of patient-level outcomes and patient-centeredness criteria determined appropriate by the Secretary; and ‘‘(ii) the changes in spending under the applicable titles by reason of the model. ‘‘(B) INFORMATION.—The Secretary shall make the results of each evaluation under this paragraph available to the public in a timely fashion and may establish requirements for States and other entities participating in the testing of models under this section to collect and report information that the Secretary determines is necessary to monitor and evaluate such models. ‘‘(C) MEASURE SELECTION.—øAs added by section 10306(3)¿ To the extent feasible, the Secretary shall select measures under this paragraph that reflect national priorities for quality improvement and patient-centered care consistent with the measures described in 1890(b)(7)(B). ‘‘
(c) EXPANSION OF MODELS (PHASE II).'
—Taking into account the evaluation under subsection (b)(4), the Secretary may, through rulemaking, expand (including implementation on a nationwide basis) the duration and the scope of a model that is being tested under subsection (b) or a demonstration project under section 1866C, to the extent determined appropriate by the Secretary, if— øAs revised by section 10306(4)¿ ‘‘(1) the Secretary determines that such expansion is expected to— ‘‘(A) reduce spending under applicable title without reducing the quality of care; or ‘‘(B) improve the quality of patient care without increasing spending; ‘‘(2) 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 applicable titles; and øParagraph (3) and succeeding sentence added by section 10306(4)¿ ‘‘(3) the Secretary determines that such expansion would not deny or limit the coverage or provision of benefits under the applicable title for applicable individuals. In determining which models or demonstration projects to expand under the preceding sentence, the Secretary shall focus on models and demonstration projects that improve the quality of patient care and reduce spending. ‘‘
(d) IMPLEMENTATION.—
‘‘(1) WAIVER AUTHORITY.—The Secretary may waive such requirements of titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), and 1903(m)(2)(A)(iii) as may be necessary solely for purposes of carrying out this section with respect to testing models described in subsection (b).
‘‘(2) LIMITATIONS ON REVIEW.—There shall be no administrative or judicial review under section 1869, section 1878, or otherwise of— ‘‘(A) the selection of models for testing or expansion under this section; ‘‘(B) the selection of organizations, sites, or participants to test those models selected; ‘‘(C) the elements, parameters, scope, and duration of such models for testing or dissemination; ‘‘(D) determinations regarding budget neutrality under subsection (b)(3); ‘‘(E) the termination or modification of the design and implementation of a model under subsection (b)(3)(B); and ‘‘(F) determinations about expansion of the duration and scope of a model under subsection (c), including the determination that a model is not expected to meet criteria described in paragraph (1) or (2) of such subsection.
‘‘(3) ADMINISTRATION.—Chapter 35 of title 44, United States Code, shall not apply to the testing and evaluation of models or expansion of such models under this section. ‘‘
(e) APPLICATION TO CHIP.—
The Center may carry out activities under this section with respect to title XXI in the same manner as provided under this section with respect to the program under the applicable titles. ‘‘
(f) FUNDING.—
‘‘(1) IN GENERAL.—There are appropriated, from amounts in the Treasury not otherwise appropriated— ‘‘(A) $5,000,000 for the design, implementation, and evaluation of models under subsection (b) for fiscal year 2010; ‘‘(B) $10,000,000,000 for the activities initiated under this section for the period of fiscal years 2011 through 2019; and ‘‘(C) the amount described in subparagraph (B) for the activities initiated under this section for each subsequent 10-year fiscal period (beginning with the 10-year fiscal period beginning with fiscal year 2020). Amounts appropriated under the preceding sentence shall remain available until expended. ‘‘(2) USE OF CERTAIN FUNDS.—Out of amounts appropriated under subparagraphs (B) and (C) of paragraph (1), not less than $25,000,000 shall be made available each such fiscal year to design, implement, and evaluate models under subsection (b).
‘‘(g) REPORT TO CONGRESS.—
Beginning in 2012, and not less than once every other year thereafter, the Secretary shall submit to Congress a report on activities under this section. Each such report shall describe the models tested under subsection (b), including the number of individuals described in subsection (a)(4)(A)(i)
and of individuals described in subsection (a)(4)(A)(ii) participating in such models and payments made under applicable titles for services on behalf of such individuals, any models chosen for expansion under subsection (c), and the results from evaluations under subsection (b)(4).
In addition, each such report shall provide such recommendations as the Secretary determines are appropriate for legislative action to facilitate the development and expansion of successful payment models.’’.
(b) MEDICAID CONFORMING AMENDMENT.—Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)), as amended by section 8002(b), is amended— (1) in paragraph (81), by striking ‘‘and’’ at the end; (2) in paragraph (82), by striking the period at the end and inserting ‘‘; and’’; and (3) by inserting after paragraph (82) the following new paragraph: ‘‘(83) provide for implementation of the payment models specified by the Secretary under section 1115A(c) for implementation on a nationwide basis unless the State demonstrates to the satisfaction of the Secretary that implementation would not be administratively feasible or appropriate to the health care delivery system of the State.’’.
(c) REVISIONS TO HEALTH CARE QUALITY DEMONSTRATION PROGRAM.—Subsections (b) and (f) of section 1866C of the Social Security Act (42 U.S.C. 1395cc–3) are amended by striking ‘‘5-year’’ each place it appears.
.....SEC. 3022. MEDICARE SHARED SAVINGS PROGRAM.
Sunday, March 6, 2016
Yale Inaugural Health Industry Conference (11/2015)
https://www.law.yale.edu/solomon-center/events/inaugural-conference
Wednesday, February 24, 2016
MolDX NGS/CGP Article V2 2016/02/16
Next Generation Sequencing Coding and Billing Guidelines
(M00127, V2)
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCat/MolDx%20Website~MolDx~Browse%20By%20Topic~Covered%20Tests~A59HL70436?open&navmenu=Browse^By^Topic||||
Next Generation Sequencing (NGS)
NGS testing platforms allow identification of somatic and/or germline alterations in multiple genes at the same time. This guideline focuses on two main types of somatic, tumor tissue-based, testing panels. Germline panels will be addressed in another article as needed.
NGS testing platforms allow identification of somatic and/or germline alterations in multiple genes at the same time. This guideline focuses on two main types of somatic, tumor tissue-based, testing panels. Germline panels will be addressed in another article as needed.
Targeted (aka Hot Spot) Tumor Panels
Targeted NGS panels identify somatic alterations known to occur in certain areas (i.e., 'hotspots') in specific genes of interest. Generally, these NGS panels can detect single nucleotide variants (SNVs or point mutations) and small (typically ≤10 bp) insertions or deletions. These alterations typically represent genomic targets with corresponding targeted cancer therapies. Identification of a genomic target guides use of the corresponding targeted therapy.
Targeted NGS panels identify somatic alterations known to occur in certain areas (i.e., 'hotspots') in specific genes of interest. Generally, these NGS panels can detect single nucleotide variants (SNVs or point mutations) and small (typically ≤10 bp) insertions or deletions. These alterations typically represent genomic targets with corresponding targeted cancer therapies. Identification of a genomic target guides use of the corresponding targeted therapy.
To bill for targeted NGS services, review CPT codes 81445, 81450 and 81455. Base the selected code on the number of genes in your laboratory’s NGS panel and the test indication for solid organ and hematolymphoid neoplasms. The UOS for the NGS panel is one.
Note: Individual gene tests performed in the NGS panel should NOT be registered and reported with multiple CPT Tier 1 and/or Tier II codes.
Comprehensive Genomic Profile (CGP) TestingCGP refers to NGS-based testing that has been optimized to identify all types of molecular alterations (i.e., SNVs, small and large insertions and deletions, CNVs, and rearrangements/translocations/fusions) in cancer-related genes in a single test using complex proprietary bioinformatics.
Because CGP includes SNVs, small (≤ 10 bp) and large (> 10 bp) insertions and deletions, CNVs, AND rearrangements (i.e., translocations/fusions), CPT codes 81445, 81450, and 81455 do NOT describe a CGP service. Therefore, to report a CGP service, test providers should use CPT code 81479 - Unlisted molecular pathology procedure.
Thursday, February 11, 2016
CMS CR 9501 (Feb 5 2016; Withdrawn)
This is the text of the temporarily posted and withdrawn CMS TRANSMITTAL about drug pricing demonstration projects.
EFFECTIVE DATE: July 1, 2016
*Unless otherwise specified, the effective date is the date of service.
IMPLEMENTATION DATE: July 5, 2016 I.
GENERAL INFORMATION
A. Background:
The purpose of the Change Request (CR) is to instruct CMS shared system maintainers to implement a mechanism that will allow the use and testing of different Average Sales Price (ASP) payment limit values in certain defined geographic areas based on ZIP code. The replacement values would be used in Part B settings such as hospital outpatient departments, physician offices, and pharmacies that currently submit claims for Part B drugs. The information in the background document of this implementation CR is to be construed as final, but this information may be modified as details regarding the implementation of this payment model are finalized.
Medicare pays for most drugs that are administered in a physician’s office or the hospital outpatient department at ASP plus 6 percent by statute regardless of the price a provider pays to acquire the drug. Medicare makes an additional separate payment for administration of the drug under the physician fee schedule or the hospital outpatient prospective payment system (OPPS). The ASP is calculated quarterly using manufacturer-submitted data on sales to all purchasers; rebates, discounts and price concessions are reflected in the ASP. The statute does not identify a reason for setting the payment limit at an additional 6 percent above ASP, although physicians and others have asserted that it is needed for handling and overhead costs.
The ASP methodology does not take into account the effectiveness of a particular drug, or the cost of comparable drugs, when determining the Medicare payment amount. The ASP methodology has been criticized for encouraging the use of more expensive products because the add-on to the drug’s cost is a percentage of the sales price while handling and overhead costs may not vary with the drug’s price.
Medicare is developing methods to test the impact of changes to Part B drug payments. One approach that is being considered would focus on the 6 percent add-on to the ASP. This approach would be implemented via a grouping of five digit ZIP codes, grouped into MSAs or similar units. In this approach, ZIP codes not assigned to an alternative payment would continue to receive payment as ASP+6 percent; these ZIP codes may be grouped together to capture an MSA or similar units. The ZIP code groupings would be done by CMS and the pricing flag field that would be added in existing filler on the ZIP code file sent to the contractors would indicate which ASP pricing methodology applies to any specific ZIP code. Medicare could test the impacts on changes to the ASP add-on percentage for their effects on spending and prescribing patterns to determine, for example, if the changes affect the financial incentive for physicians or hospitals to choose higher cost drugs that do not offer additional clinical value.
Medicare is also developing methods to test the impact of targeted pricing changes to payments for individual Part B drugs beyond changes to the ASP-based payment. These targeted drug payments could vary across a different set of ZIP codes than those assigned to the different ASP methodologies. CMS is targeting a July 5, 2016 implementation for the system changes to support these new pricing methods discussed above, but additional approaches that test other methods of targeted pricing would likely be phased in later. Also, since this model is going through notice and comment rulemaking, there is a possibility that the new ASP and Zip 5 and Zip 9 files that contain the new pricing values developed under rule making will be available and effective sometime between August 1 and September 15, 2016 rather than on August 1, 2016 exactly.
B. Policy:
Section 1115A of the Social Security Act (the Act) (added by Section 3021 of the Affordable Care Act) (42 U.S.C. 1315a) authorizes CMS’s Center for Medicare & Medicaid Innovation to test innovative health care payment and service delivery models that have the potential to lower Medicare, Medicaid, and Children's Health Insurance Program spending while maintaining or improving the quality of beneficiaries’ care.
Contractors shall implement necessary changes to their respective systems in order to accommodate a new Part B Drug Payment Model to test different approaches for the payment of Part B drugs.
Contractors shall refer to the attachment(s) to this CR for a more detailed outline of the programmatic requirements of the Model. Contractors shall also refer to the attached proposed revised layouts for the ZIP code files and ASP file that CMS will create for this model.
Please note that the new payment indicator will appear on both the Zip 5 and the Zip 9 files; the indicator is the same on both files based on the first five digits of the Zip. CMS is providing the indicator on both files in case that will help to simplify implementation logic changes. *
*NOTE** - The CMS supplied payment indicator that will be included on the revised ZIP 5 and ZIP 9 files is only based on the first 5 digits of the particular ZIP code. However, CMS is replicating the ZIP 5 payment indicator on the ZIP 9 file per FISS request. **NOTE** - Once the new drug pricing payment model is in effect (that is, once the one-time off-cycle ASP and ZIP Code files are installed per instructions below), there is no need for MACs to adjust (either when brought to their attention or by searching their own files) any previously adjudicated claims in order to ensure they are priced using the new model. Any claim adjustments necessitated by the normal course of claims processing shall be adjudicated and priced based on the “FROM” date of service on the claim.
(X).
Pub. 100-19 Transmittal: 137 Date: February 5, 2016 Change Request: 9501
SUBJECT: Implementation of the Part B Drug Payment Model (Phase 1)
EFFECTIVE DATE: July 1, 2016
*Unless otherwise specified, the effective date is the date of service.
IMPLEMENTATION DATE: July 5, 2016 I.
GENERAL INFORMATION
A. Background:
The purpose of the Change Request (CR) is to instruct CMS shared system maintainers to implement a mechanism that will allow the use and testing of different Average Sales Price (ASP) payment limit values in certain defined geographic areas based on ZIP code. The replacement values would be used in Part B settings such as hospital outpatient departments, physician offices, and pharmacies that currently submit claims for Part B drugs. The information in the background document of this implementation CR is to be construed as final, but this information may be modified as details regarding the implementation of this payment model are finalized.
Medicare pays for most drugs that are administered in a physician’s office or the hospital outpatient department at ASP plus 6 percent by statute regardless of the price a provider pays to acquire the drug. Medicare makes an additional separate payment for administration of the drug under the physician fee schedule or the hospital outpatient prospective payment system (OPPS). The ASP is calculated quarterly using manufacturer-submitted data on sales to all purchasers; rebates, discounts and price concessions are reflected in the ASP. The statute does not identify a reason for setting the payment limit at an additional 6 percent above ASP, although physicians and others have asserted that it is needed for handling and overhead costs.
The ASP methodology does not take into account the effectiveness of a particular drug, or the cost of comparable drugs, when determining the Medicare payment amount. The ASP methodology has been criticized for encouraging the use of more expensive products because the add-on to the drug’s cost is a percentage of the sales price while handling and overhead costs may not vary with the drug’s price.
Medicare is developing methods to test the impact of changes to Part B drug payments. One approach that is being considered would focus on the 6 percent add-on to the ASP. This approach would be implemented via a grouping of five digit ZIP codes, grouped into MSAs or similar units. In this approach, ZIP codes not assigned to an alternative payment would continue to receive payment as ASP+6 percent; these ZIP codes may be grouped together to capture an MSA or similar units. The ZIP code groupings would be done by CMS and the pricing flag field that would be added in existing filler on the ZIP code file sent to the contractors would indicate which ASP pricing methodology applies to any specific ZIP code. Medicare could test the impacts on changes to the ASP add-on percentage for their effects on spending and prescribing patterns to determine, for example, if the changes affect the financial incentive for physicians or hospitals to choose higher cost drugs that do not offer additional clinical value.
Medicare is also developing methods to test the impact of targeted pricing changes to payments for individual Part B drugs beyond changes to the ASP-based payment. These targeted drug payments could vary across a different set of ZIP codes than those assigned to the different ASP methodologies. CMS is targeting a July 5, 2016 implementation for the system changes to support these new pricing methods discussed above, but additional approaches that test other methods of targeted pricing would likely be phased in later. Also, since this model is going through notice and comment rulemaking, there is a possibility that the new ASP and Zip 5 and Zip 9 files that contain the new pricing values developed under rule making will be available and effective sometime between August 1 and September 15, 2016 rather than on August 1, 2016 exactly.
B. Policy:
Section 1115A of the Social Security Act (the Act) (added by Section 3021 of the Affordable Care Act) (42 U.S.C. 1315a) authorizes CMS’s Center for Medicare & Medicaid Innovation to test innovative health care payment and service delivery models that have the potential to lower Medicare, Medicaid, and Children's Health Insurance Program spending while maintaining or improving the quality of beneficiaries’ care.
Contractors shall implement necessary changes to their respective systems in order to accommodate a new Part B Drug Payment Model to test different approaches for the payment of Part B drugs.
Contractors shall refer to the attachment(s) to this CR for a more detailed outline of the programmatic requirements of the Model. Contractors shall also refer to the attached proposed revised layouts for the ZIP code files and ASP file that CMS will create for this model.
Please note that the new payment indicator will appear on both the Zip 5 and the Zip 9 files; the indicator is the same on both files based on the first five digits of the Zip. CMS is providing the indicator on both files in case that will help to simplify implementation logic changes. *
*NOTE** - The CMS supplied payment indicator that will be included on the revised ZIP 5 and ZIP 9 files is only based on the first 5 digits of the particular ZIP code. However, CMS is replicating the ZIP 5 payment indicator on the ZIP 9 file per FISS request. **NOTE** - Once the new drug pricing payment model is in effect (that is, once the one-time off-cycle ASP and ZIP Code files are installed per instructions below), there is no need for MACs to adjust (either when brought to their attention or by searching their own files) any previously adjudicated claims in order to ensure they are priced using the new model. Any claim adjustments necessitated by the normal course of claims processing shall be adjudicated and priced based on the “FROM” date of service on the claim.
(X).
Thursday, February 4, 2016
Brief Excerpt: St Jude Earnings Call re NCDs and LCDs
St Jude Earnings Call re Q4 2015 (brief excerpt, 1/27/2016)
So a quick update here on where we are and what our plan is around the CardioMEMS product line. As you know we got off to a quick start last year, and about mid-year we had a negative determination at First Coast, which then spiraled in to several articles resulting in [Novitas] beginning a process to make a determination.
All of that has caused a lot of unrest in the customer base on two levels, and it really is around the fear of reimbursement. The physician feedback and patient outcomes have been outstanding, and the performance of the product actually in the field is better than we had expected and better that what we had seen in the champion trial.
So the product line itself is on track. The business dynamics and the market dynamics and this is also feedback directly from our customers. This is the product that they’ve been looking for in trying to get at not only the expense but the quality of life issues of managing this disease. So we think CardioMEMS is an important clinical advancement and will in fact change the way heart failure is managed.
The process that we’re going through is first, we continue to work with the local MACs. We are making sure that they have all of the most current data, the latest data from [Lansing] was very encouraging from a real world perspective, 31 months of follow-up with a 48% reduction in hospitalization. This is significant data, and again bringing the real world perspective in the play.
At the same time, we’ve had ongoing discussion with CMS, and so the strategy is really to make sure that our customer base in informed, make sure the local MACs are informed and up-to-date with the latest data and that we’re going through the process which we will update on February 5 with CMS to apply for national coverage to make sure that we can begin to plan and begin to work with heart failure centers around the country in getting their programs up and going without a concern that they would make both time and cost commitment to find out that they could end up in a negative reimbursement situation.
So we have short term strategy, again education of the heart failure community and the MACs as well as the work that we’re doing with CMS. We think the timeline for these things will be first quarter, working its way with a submission will take anywhere from 9 to 12 months with CMS.
So a quick update here on where we are and what our plan is around the CardioMEMS product line. As you know we got off to a quick start last year, and about mid-year we had a negative determination at First Coast, which then spiraled in to several articles resulting in [Novitas] beginning a process to make a determination.
All of that has caused a lot of unrest in the customer base on two levels, and it really is around the fear of reimbursement. The physician feedback and patient outcomes have been outstanding, and the performance of the product actually in the field is better than we had expected and better that what we had seen in the champion trial.
So the product line itself is on track. The business dynamics and the market dynamics and this is also feedback directly from our customers. This is the product that they’ve been looking for in trying to get at not only the expense but the quality of life issues of managing this disease. So we think CardioMEMS is an important clinical advancement and will in fact change the way heart failure is managed.
The process that we’re going through is first, we continue to work with the local MACs. We are making sure that they have all of the most current data, the latest data from [Lansing] was very encouraging from a real world perspective, 31 months of follow-up with a 48% reduction in hospitalization. This is significant data, and again bringing the real world perspective in the play.
At the same time, we’ve had ongoing discussion with CMS, and so the strategy is really to make sure that our customer base in informed, make sure the local MACs are informed and up-to-date with the latest data and that we’re going through the process which we will update on February 5 with CMS to apply for national coverage to make sure that we can begin to plan and begin to work with heart failure centers around the country in getting their programs up and going without a concern that they would make both time and cost commitment to find out that they could end up in a negative reimbursement situation.
So we have short term strategy, again education of the heart failure community and the MACs as well as the work that we’re doing with CMS. We think the timeline for these things will be first quarter, working its way with a submission will take anywhere from 9 to 12 months with CMS.
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