II 112th CONGRESS 1st Session S. 1407 IN THE SENATE OF THE UNITED STATES July 22, 2011 Ms. Snowe (for herself and Ms. Cantwell) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to establish accreditation requirements for suppliers and providers of air ambulance services, and for other purposes.

1.

Short title

This Act may be cited as the Air Ambulance Medicare Accreditation and Accountability Act.

2.

Accreditation requirement

(a)

In general

Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection: (p)

Accreditation requirement for air ambulance services

(1)

In general

Beginning with the date that is 2 years after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act, with respect to air ambulance services for which payment is made under the fee schedule established under subsection (l) and that are furnished by a supplier or provider (directly or under an arrangement described in subsection (l)(1)), payment may only be made for such services provided by an air ambulance if— (A)the supplier or provider provides for appropriate medical oversight by a physician (as determined by the Secretary); and (B)except as provided in paragraph (5), the air ambulance is accredited by an accreditation organization designated by the Secretary under paragraph (3)(B) as a level III or higher air ambulance. (2)

Accreditation levels

The Secretary shall establish a process for accrediting the air ambulances of suppliers and providers of air ambulance services. Under such process, an accreditation organization designated by the Secretary under paragraph (3)(B) may accredit an air ambulance of a supplier or provider of air ambulance services at any of the following levels (listed from lowest to highest level of accreditation): (A)

Level III

The air ambulance— (i)has the capability and scope of practice to provide advanced resuscitation during transport, including the criteria described in paragraph (4)(B); and (ii)meets such other criteria as the Secretary determines appropriate for such accreditation. (B)

Level II

The air ambulance— (i)meets the criteria for being accredited as a level III air ambulance (as described in subparagraph (A)); (ii)has the capability to provide care during transport at the level of care and scope of practice of a hospital emergency department, including the criteria described in paragraph (4)(C); and (iii)meets such other criteria as the Secretary determines appropriate for such accreditation. (C)

Level I

The air ambulance— (i)meets the criteria for being accredited as a level II air ambulance (as described in subparagraph (B)); (ii)has the capability to provide care during transport at the level of care and scope of practice of a tertiary level intensive care unit, including the criteria described in paragraph (4)(D); and (iii)meets such other criteria as the Secretary determines appropriate for such accreditation. (3)

Accreditation organizations

(A)

Factors for designation of accreditation organizations

The Secretary shall consider the following factors in designating accreditation organizations under subparagraph (B) and in reviewing and updating the list of accreditation organizations designated pursuant to subparagraph (C): (i)The ability of the organization to provide timely reviews of applications for such accreditation. (ii)Whether the organization uses random site visits, audits, or other strategies to ensure adherence to the accreditation criteria described in paragraph (2). (iii)The ability of the organization to take into account the capacities of and special circumstances applicable to air ambulances of suppliers or providers of air ambulance services located in a rural area (as defined in section 1886(d)(2)(D)). (iv)The ability of the organization to take into account the capacities of and special circumstances applicable to air ambulances owned and operated by units of State or local government. (v)Whether the organization has established reasonable fees for such accreditation. (vi)Whether the organization has applicable accreditation experience. (vii)Whether the organization has developed an accreditation program that is adequate and appropriate to the goal of ensuring high-caliber air ambulance services. (viii)The ability of the organization to effectively enforce the accreditation criteria described in paragraph (2). (ix)Such additional factors specified by the Secretary regarding quality, medical services, and emergency medical services integration. (x)Such other factors as the Secretary determines appropriate. (B)

Designation

The Secretary shall designate organizations to accredit air ambulances of suppliers and providers of air ambulance services under this subsection. The list of accreditation organizations so designated may be modified pursuant to subparagraph (C). (C)

Review and modification of list of accreditation organizations

(i)

In general

The Secretary shall review the list of accreditation organizations designated under subparagraph (B) taking into account the factors under subparagraph (A). Taking into account the results of such review, the Secretary may, by regulation, modify the list of accreditation organizations designated under subparagraph (B). (ii)

Special rule for accreditations done prior to removal from list of designated accreditation organizations

In the case where the Secretary removes an organization from the list of accreditation organizations designated under subparagraph (B), any air ambulance of a supplier or provider that is accredited by the organization during the period beginning on the date on which the organization is designated as an accreditation organization under subparagraph (B) and ending on the date on which the organization is removed from such list shall be considered to have been accredited by an organization designated by the Secretary under subparagraph (B) for the remaining period such accreditation is in effect. (4)

Criteria for accreditation

(A)

In general

Not later than 1 year after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act, the Secretary shall establish criteria for use by an accreditation organization designated under paragraph (3)(B) to evaluate an air ambulance of a supplier or provider of air ambulance services for the purpose of accreditation of such air ambulance. Such criteria shall be specific to each accreditation level described in paragraph (2) and include, at a minimum, the criteria applicable to such level under such paragraph. (B)

Level III criteria described

In the case of accreditation of an air ambulance of a supplier or provider as a level III air ambulance, the criteria described in subparagraph (A) shall include the following: (i)

Provision of patient care

Minimum accreditation criteria related to the provision of patient care, including— (I)standards that require the air ambulance to have available during transport, medical equipment for the proper provision of patient care consistent with the provision of advanced resuscitation and life support, including communications necessary for the coordination of patient care, patient monitoring systems, on-board suction, oxygen, and electrical systems to maintain medical devices; (II)standards for maintaining a medically suitable patient care environment (including sanitation and infection control and permanently installed climate control); (III)standards for the design of aircraft medical bays to ensure access to medical equipment and patients in a manner that enables the medical crew to perform basic and advanced resuscitation and life support medical interventions while secure; (IV)standards for the medical training and qualifications of the medical crew of the air ambulance; (V)standards for medical oversight; (VI)standards for the makeup of the medical crew of the air ambulance and for the equipment and aircraft attributes needed for specific medical missions; and (VII)standards and reporting requirements related to quality assurance, peer review, and outcomes and proficiency measures. (ii)

Service requirements

In the case of air ambulance services furnished in a State that does not impose minimum service requirements related to appropriate utilization and transport, such minimum service requirements, including— (I)standards for licensing by the State; (II)standards for transport from emergency scene calls of all individuals regardless of ability to pay; (III)standards for minimum availability for scene response (weather permitting); (IV)standards for response to emergency scene calls within a specified flight time; (V)standards for adherence to established criteria for the appropriate medical institution to receive a patient from emergency scene responses (including such criteria published by appropriate professional medical associations); and (VI)standards for appropriate utilization and transport. (C)

Level II criteria described

In the case of accreditation of an air ambulance of a supplier or provider as a level II air ambulance, the criteria described in subparagraph (A) shall include the capability to provide care during transport at the level of care and scope of practice of a hospital emergency department, including— (i)standards that require the air ambulance to— (I)be equipped with a ventilator fully capable of volume or pressure modes of ventilation; and (II)be equipped with multiple infusion pumps and use a pharmaceutical formulary; (ii)standards that require the air ambulance and, as needed, medical personnel to have the capability to conduct invasive patient monitoring; and (iii)standards for advanced qualifications, capability, and training of medical personnel of the air ambulance (such as standards for monitoring high-risk patients, managing critical care pharmaceuticals and blood, and point of care blood testing). (D)

Level I criteria described

In the case of accreditation of an air ambulance of a supplier or provider as a level I air ambulance, the criteria described in subparagraph (A) shall include the capability to provide care during transport at the level of care and scope of practice of a tertiary level intensive care unit, including— (i)standards that require the air ambulance and, as needed, medical personnel— (I)to have the capability to transport specialty care patients (including those on intra-aortic balloon pumps, extracorporeal membrane oxygenation, ventrical assist devices, or isolettes and high-risk obstetric patients); (II)to have the capability to provide critical care transport for an adult patient for not less than 100 miles without refueling; and (III)to have within the medical bay of the air ambulance sufficient space and the capability to provide, as needed, either 3 person teams (such as in the case of patients with a ventrical assist device or patients needing critical care services) or to provide care for 2 patients needing critical care services simultaneously; (ii)standards for sufficient power, configuration, and design of the medical bay of the air ambulance to provide critical care services during transport without delaying transport or compromising electrical systems supporting medical devices; and (iii)standards that require the air ambulance to be equipped with multiple infusion pumps and use a pharmaceutical formulary consistent with critical care provided in a tertiary level intensive care unit. (E)

Requirements

The Secretary shall consider the following in establishing criteria under subparagraph (A): (i)Ensuring that the criteria described in such subparagraph does not adversely impact access to air ambulances for individuals, particularly in rural areas. (ii)The needs of— (I)suppliers and providers of air ambulance services located in a rural area (as defined in section 1886(d)(2)(D)); and (II)air ambulances owned and operated by units of State or local government. (iii)The extent to which each of the criteria is economically feasible, particularly in rural areas (as so defined). (iv)The extent to which each of the criteria is technically feasible, as well as market availability and future development of equipment and products that can be installed on or carried aboard existing aircraft. (v)The incorporation of appropriate implementation timeframes for the criteria in a manner that does not impede access, particularly in rural areas (as so defined). (vi)Ensuring that the criteria is developed and established through a transparent process with the input of stakeholders. (vii)Ensuring that the criteria includes a requirement that the supplier or provider of air ambulance services follows an internal policy that provides clear direction on the distribution to and receipt of gifts from referring individuals or entities, including clear limitations on the provision of such gifts beyond those of nominal value. (viii)Ensuring regular updating of the criteria. (5)

Exception

During the 3-year period beginning on the effective date of the accreditation requirement under paragraph (1)(B), the Secretary shall exempt an air ambulance of a supplier or provider from such accreditation requirement if the application of such requirement to the air ambulance would require the supplier or provider to replace its air ambulance or would impose on the supplier or provider an undue economic burden with respect to compliance costs. (6)

Data collection requirements

The Secretary shall establish the following requirements for the collection of data related to the utilization of such services: (A)The establishment of protocols for the collection and reporting of data by the supplier or provider of air ambulance services regarding patient transport provided from the scene of an incident and during an inter-hospital transfer, including information regarding— (i)patient on-board mileage for ground and air transport; and (ii)the involvement of ground ambulance transportation in any portions or segments of the transportation of the patient. (B)The collection and reporting of information obtained via data use agreements with receiving institutions regarding the rates of discharge from the hospital emergency department of patients after transport by air ambulance, including assessment of injury and illness to describe utilization appropriateness. (C)The collection and reporting of information regarding the extent to which air ambulance transports, other than those by specialized pediatric and newborn transport teams, are to receiving institutions with whom the supplier or provider of air ambulance services is affiliated or has a contractual arrangement for receiving hospital destination. (7)

Definition of air ambulance service

For purposes of this subsection, the term air ambulance service means a fixed wing or a rotary wing air ambulance service. . (b)

Conforming amendments

Section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)) is amended— (1)in paragraph (24), by striking or at the end; (2)in paragraph (25), by striking the period at the end and inserting ; or; and (3)by adding at the end the following new paragraph: (26)beginning with the date that is 2 years after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act, which are air ambulance services (as defined in section 1834(p)(7)) for which payment is made under the fee schedule established under section 1834(l) and that are furnished by a supplier or provider (directly or under an arrangement described in section 1834(l)(1)), if the requirements described in section 1834(p)(1) are not met. . (c)

Relationship to State licensure requirements

(1)

In general

Nothing in this Act or the amendments made by this Act shall affect any requirement that a supplier or provider of air ambulance services comply with State or local laws governing the licensing and certification of such supplier or provider, an air ambulance, or the medical personnel of an air ambulance. (2)

Preemption

Nothing in this Act or the Amendments made by this Act shall preempt a State or local government from establishing licensure or other requirements for suppliers or providers of air ambulance services that exceed the criteria established by the Secretary of Health and Human Services for purposes of accreditation of air ambulances under section 1834(p) of the Social Security Act, as added by subsection (a), except to the extent that the requirement directly conflicts with a requirement under such subsection or other applicable Federal law.

3.

Reimbursement for air ambulance services under Medicaid

Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)), as amended by section 2001(a)(2)(B) of the Patient Protection and Affordable Care Act (Public Law 111–148), is amended— (1)in paragraph (25), by striking or at the end; (2)in paragraph (26), by striking the period at the end and inserting ; or; and (3)by inserting after paragraph (26) the following new paragraph: (27)with respect to amounts expended for the transport by an air ambulance of a patient, in an emergency or nonemergency situation (in this paragraph referred to as air ambulance services), or for any medical services provided to the patient in the course of such transport, unless— (A)not later than 180 days after the date of enactment of this paragraph, the State submits a State plan amendment to the Secretary that describes the State's licensing and regulatory requirements for the provision of air ambulance services within the State, including— (i)such requirements relating to the provision of medical services in the course of transport by air ambulance; (ii)the State's medically-related use and dispatch protocols for air ambulance services; (iii)whether the State imposes minimum service requirements described under section 1834(p)(4)(B)(ii); and (iv)any other relevant information, as determined appropriate by the Secretary; and (B)not later than January 1, 2015, the State certifies to the Secretary that the State's licensing and regulatory requirements for the provision of air ambulance services within the State comply with national guidelines published by the Federal Interagency Committee on Emergency Medical Services for the use and dispatch of air ambulance services. .

4.

Reimbursement for air ambulance services under medicare

(a)

In general

Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) is amended by adding at the end the following new paragraph: (15)

Payment for air ambulance services

(A)

In general

In the case of air ambulance services furnished on or after the date that is 2 years after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act (or, if the Secretary determines additional time is necessary, such other date (but not later than 3 years after such date of enactment) as the Secretary specifies) the Secretary shall establish a revised air ambulance rate structure under the fee schedule under this subsection in accordance with the succeeding provisions of this paragraph. (B)

Objectives

Revisions to the fee schedule under this subsection pursuant to this paragraph shall be limited to changes intended to accomplish the following objectives: (i)Better reflect relative cost differences for providing air ambulance services at higher levels of accreditation under subsection (p). (ii)Promote quality care. (iii)Preserve timely access to air ambulance services in those geographic areas that receive air ambulance services as of such date of enactment and incentivize the provision of such services in geographic areas that are unserved or underserved. (C)

Consideration of relative cost of services

(i)

In general

Subject to clause (ii) and subparagraph (D), revisions to the fee schedule under this subsection pursuant to this paragraph shall provide for higher levels of reimbursement for the transport of an individual as follows: (I)Air ambulance services provided by an air ambulance that is accredited under subsection (p) as a level II air ambulance shall be reimbursed at a higher rate than such services provided by an air ambulance that is accredited under such subsection as a level III air ambulance. (II)Air ambulance services provided by an air ambulance that is accredited under subsection (p) as a level I air ambulance shall be reimbursed at a higher rate than such services provided by an air ambulance that is accredited under such subsection as a level II air ambulance. (ii)

Requirements

The Secretary shall ensure that the revisions under clause (i)— (I)reflect an assessment of the relative differential in the cost of care provided by air ambulances with differing levels of accreditation under subsection (p); and (II)do not alter any adjustments related to providing services in rural areas or accounting for geographic differences in cost as provided under the fee schedule under this subsection as of the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act, including any increase in payments under paragraph (12) or (13). (D)

Sole community air ambulance services

(i)

In general

Under such revised air ambulance rate structure, air ambulance services provided by a sole community air ambulance for which the transport originates in a rural area (as defined in section 1886(d)(2)(D)) with a Rural-Urban Commuting Area code of level 7 or higher shall be reimbursed at a higher rate than such services provided by an air ambulance that is accredited under subsection (p) at the same level as the sole community air ambulance but which is not a sole community air ambulance. (ii)

Definition of sole community air ambulance

In this paragraph, the term sole community air ambulance means an air ambulance that serves a rural area (as defined in section 1886(d)(2)(D)) with a low population density and is a distance of not less than 100 air statute miles from the base of operation of any other air ambulance. (E)

Mitigation of potential impacts on access to services

The Secretary shall, prior to the implementation of the revised air ambulance rate structure under this paragraph, modify any potential revisions in payment rates under such revised air ambulance rate structure as necessary to ensure that such revisions do not adversely impact current access to air ambulance services, particularly in rural and underserved areas, including by— (i)providing for a reasonable transition period to the revised air ambulance rate structure, including through the use of payment floors for each year of the transition period; (ii)limiting changes in such payment rates based on the assessment of relative costs; and (iii)taking into consideration the capacities, volume, and special circumstances of— (I)suppliers or providers of air ambulance services located in a rural area (as defined in section 1886(d)(2)(D)); and (II)air ambulances owned and operated by units of State or local government. (F)

Consultation

The Secretary shall consult with all relevant stakeholders in establishing the revised air ambulance rate structure under this paragraph. (G)

Independent cost study

In establishing such revised air ambulance rate structure, the Secretary shall use a cost analysis conducted by an independent organization under a contract with the Secretary. (H)

Budget neutrality

Revisions in payment implemented pursuant to this paragraph shall result in the same estimated amount of aggregate expenditures under this title for air ambulance services furnished in the fiscal year in which such revisions in payment are implemented and each subsequent year as would have been made under this title for such care in such fiscal year and each such subsequent year if such revisions had not been implemented. For purposes of applying the preceding sentence, the Secretary shall take into account any updates or other adjustments applicable to payments for such services or increases in utilization of such services expected as of the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act. (I)

Noncoverage event

Not later than 180 days after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act, the Secretary shall establish noncoverage events for which reimbursement for air ambulance services will not be provided under this subsection. Such noncoverage events shall include the following: (i)Patient death or serious disability caused by loss of oxygen supply. (ii)Patient or passenger death or serious disability caused by emergency medical transportation vehicle failure or crash. (iii)Patient death or serious disability caused by transport to an unintended destination. (iv)Responding without a formal request by emergency medical services or hospital personnel. (v)Patient death or serious disability caused by dropping a patient or allowing a fall. (vi)Death or serious disability to emergency medical services personnel or a patient caused by the failure of the emergency medical transportation vehicle to communicate an initial estimated time of arrival or delays. (J)

Definition of air ambulance service

In this paragraph, the term air ambulance service has the meaning given that term in subsection (p)(7). . (b)

Conforming amendment

Section 1862(a)(26) of the Social Security Act, as added by section 2(b), is amended by inserting , or (beginning with the date that is 180 days after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act) in the case where the Secretary determines that a noncoverage event established under section 1834(l)(15)(I) has occurred in the furnishing of such service before the period at the end.

5.

Air Ambulance Quality Data Reporting Program

Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)), as amended by section 4, is amended— (1)in paragraph (3)(B), by striking subparagraph (C) and inserting subparagraph (C) and paragraph (16); and (2)by adding at the end the following new paragraph: (16)

Air Ambulance Quality Data Reporting Program

(A)

Reduction in update for failure to report

(i)

In general

For each year (beginning with January 1 following the date that is 3 years after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act), in the case of a supplier or provider of air ambulance services that does not submit data to the Secretary in accordance with subparagraph (C) with respect to such year, after determining the percentage increase under paragraph (3)(B), and after application of paragraph (3)(C), the Secretary shall reduce such percentage increase for payments under the fee schedule under this subsection during such year by 0.4 percentage points (or, beginning with January 1 following the date that is 5 years after such date of enactment, 2.0 percentage points). (ii)

Special rule

The application of this subparagraph may result in such percentage increase being less than 0.0 for a year, and may result in payment rates under the fee schedule under this subsection for a year being less than such payment rates for the preceding year. (B)

Noncumulative application

Any reduction under subparagraph (A) shall apply only with respect to the year involved and the Secretary shall not take into account such reduction in computing the payment amount under the fee schedule under this subsection for a subsequent year. (C)

Submission of quality data

For each year (beginning with January 1 following the date that is 3 years after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act), each supplier or provider of air ambulance services shall submit to the Secretary data on quality measures specified under subparagraph (D). Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this subparagraph. (D)

Quality measures

(i)

In general

The Secretary shall specify quality measures for each accreditation level for air ambulances under subsection (p) that reflect the capability of the air ambulance to deliver such services equal to each such accreditation level. Subject to clause (ii), any measure specified by the Secretary under this subparagraph must have been endorsed by the entity with a contract under section 1890(a). (ii)

Exception

In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a), the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. (iii)

Time frame

Not later than 2 years after the date of enactment of the Air Ambulance Medicare Accreditation and Accountability Act, the Secretary shall publish the measures selected under this subparagraph that will be applicable with respect to the year beginning on January 1 following the date that is 3 years after such date of enactment. (iv)

Updating measures specified

(I)

In general

The Secretary may, by regulation, revise quality measures specified under this subparagraph on an annual basis. (II)

Consultation

The Secretary shall consult with relevant stakeholders in revising quality measures under subclause (I). (E)

Public availability of data submitted

The Secretary shall establish procedures for making data submitted under subparagraph (C) available to the public. Such procedures shall ensure that a supplier or provider of air ambulance services has the opportunity to review the data that is to be made public with respect to the supplier or provider prior to such data being made public. The Secretary shall report quality measures that relate to air ambulance services on the Internet website of the Centers for Medicare & Medicaid Services. (F)

Implementation

(i)

In general

The Secretary shall promulgate regulations to carry out this paragraph. (ii)

Consultation

The Secretary shall consult with relevant stakeholders in promulgating regulations under clause (i). .

6.

Study and report by the Institute of Medicine on ground critical care transport

(a)

In general

The Secretary of Health and Human Services is authorized to enter into an agreement with the Institute of Medicine of the National Academies to conduct a study on ground critical care transport that identifies the following: (1)Any barriers to effective use of ground critical care transport. (2)Any design issues with respect to emergency medical transportation vehicles that may affect patient and crew safety. (3)Any issues with respect to reimbursement for such services under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) that may affect the high quality of care and expeditious transport provided by ground critical care ambulances. (b)

Report

An agreement entered into under subsection (a) shall provide for the Institute of Medicine to submit to the Secretary of Health and Human Services and to Congress a report containing the results of the study conducted under such subsection.