H.R. 1691 — what changed

changed This Act may be cited as the “Ensuring Patient Access to Critical Breakthrough Products Act of 2023”.2024”.

added “(Q) in the case of a breakthrough device (as defined in section 1861(nnn)) furnished during the transitional coverage period (as so defined) with respect to such device, which is not furnished in accordance with the Food and Drug Administration-approved labeling for such device or that the Secretary determines, based on a review of clinical data, presents an undue risk of harm that outweighs the potential clinical benefits for individuals entitled to benefits under part A or enrolled under part B;”

added “(nnn) Breakthrough device

added “(1) In general—The term “breakthrough device” means a device so designated by the Secretary under section 1899C.

added “(2) Transitional coverage period—The term “transitional coverage period” means, with respect to a breakthrough device, the 4-year period that begins on the date that such device is so designated by the Secretary under section 1899C.”

added “1899C. Designation of breakthrough devices

added “(a) In general—Beginning 18 months after the date of the enactment of this section, upon application of a manufacturer of a device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) that is cleared, classified, or approved under section 510(k), 513(f)(2), or 515 of such Act on or after the date of the enactment of this section, the Secretary shall designate such device as a breakthrough device if the Secretary determines that such device meets the criteria specified in subsection (b).

added “(b) Criteria—For purposes of subsection (a), the criteria specified in this subsection are, with respect to a device, the following:

added “(1) The device is provided with priority review pursuant to section 515B of the Federal Food, Drug, and Cosmetic Act.

added “(2) In the case such device is cleared under section 510(k) of such Act, such device is so cleared based on clinical trial information from an applicable device clinical trial (as such terms are defined in section 402(j) of such Act) that enrolled individuals entitled to benefits under part A or enrolled under part B.

added “(3) The device is not a clinical diagnostic laboratory test.

added “(c) Determination process

added “(1) In general—The Secretary shall make a determination with respect to a device that is the subject of an application described in subsection (a) not later than 6 months after such application is submitted to the Secretary.

added “(2) Explanation required in case of determination that device does not meet criteria for designation—In the case that the Secretary determines that a device that is the subject of an application described in subsection (a) does not meet the criteria specified in subsection (b), the Secretary shall notify the manufacturer of such device of such determination and include in such notification an explanation identifying the specific criterion or criteria that such device failed to meet.

added “(d) Reports—The Secretary shall submit to Congress on an annual basis a report specifying—

added “(1) the number of applications received under this section during such year;

added “(2) the number of devices designated as breakthrough devices under this section during such year; and

added “(3) the number of applications for a designation for a device under this section with respect to which the Secretary determined that such device did not meet the criteria specified in subsection (b) during such year.”

removed “1899C. Coverage of breakthrough devices

removed “(a) Breakthrough devices—For purposes of this section, the term breakthrough device means a medical device that is a device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) and that is—

removed “(1) provided with review priority by the Secretary under subsection (d)(5) of section 515 of such Act; and

removed “(2) approved or cleared pursuant to section 510(k), 513(f), or 515 of such Act for use in treating an indication on or after March 15, 2021.

removed “(b) Coverage

removed “(1) Transitional coverage

removed “(A) In general—During the transitional coverage period (as defined in subparagraph (B)) a breakthrough device shall be—

removed “(i) deemed to be reasonable and necessary for purposes of section 1862(a)(1)(A);

removed “(ii) deemed to be approved for an additional payment under section 1886(d)(5)(K) (other than with respect to the cost criterion under clause (ii)(I) of such section);

removed “(iii) deemed to be approved for pass-through payment under section 1833(t)(6) and section 1833(i) (other than with respect to the cost criterion under section 1833(t)(6)(A)(iv)); and

removed “(iv) insofar as such breakthrough device may be furnished in a setting for which payment is made under an applicable payment system described in subparagraphs (D) through (I) of subsection (c)(4), deemed eligible for an additional payment or payment adjustment, as the case may be, pursuant to subsection (d)(3) when furnished in a setting for which payment is made under such an applicable payment system during such transitional coverage period.

removed “(B) Transitional coverage period defined—As used in this section, the term transitional coverage period means, with respect to a breakthrough device, the period that—

removed “(i) begins on the date of the approval under section 515 of the Federal Food, Drug, and Cosmetic Act or of the clearance under section 510(k) of such Act, as applicable, of such device by the Secretary for the indication described in subsection (a)(1); and

removed “(ii) ends on the last day of the 4-year period that begins on the date that the Secretary, pursuant to subsection (c)(2), updates the relevant applicable payment system (as defined in subsection (c)(4)) to recognize the unique temporary or permanent code or codes assigned under subsection (c)(1) to such breakthrough device, except as provided in subsections (d)(1)(B) and (d)(2)(B).

removed “(C) Data used to meet the NTAP and pass-through cost criteria—In determining whether a breakthrough device qualifies for an additional payment under section 1886(d)(5)(K) or for pass-through payment under section 1833(t)(6) or section 1833(i), the Secretary shall use the most recently available data and information on the costs of such breakthrough device, which may include list prices and invoice prices charged for such breakthrough device.

removed “(2) Process for regular coverage—For purposes of the application of section 1862(a)(1)(A) to a breakthrough device furnished after the transitional coverage period (as defined in paragraph (1)(B)) for such device, the Secretary shall establish a process for the coverage of such breakthrough devices under this title after such period as follows:

removed “(A) Identification of additional evidence

removed “(i) In general—With respect to a breakthrough device, not later than 1 year after the date of the approval of such device under section 515 of the Federal Food, Drug, and Cosmetic Act or of the clearance of such device under section 510(k) of such Act, as applicable, the Secretary shall identify whether any additional data or evidence is required with respect to any indications for such device for purposes of the application of such section 1862(a)(1)(A) to such device for such indications.

removed “(ii) Non-duplication of data requests—In carrying out clause (i) with respect to a breakthrough device, the Secretary shall ensure that data or evidence identified—

removed “(I) does not duplicate data required to be collected by the Food and Drug Administration with respect to such breakthrough device;

removed “(II) minimizes the administrative burdens of data collection and reporting on providers of services, suppliers, and manufacturers of breakthrough devices; and

removed “(III) is not otherwise unnecessary or redundant.

removed “(B) Proposal for coverage after the transitional coverage period—Not later than 2 years after the date of the approval or clearance of a breakthrough device by the Food and Drug Administration, the Secretary shall develop a proposal for coverage under this title of such breakthrough device for such indications as the Secretary determines to be appropriate, based on the data and evidence collected under subparagraph (A), for such devices furnished after the transitional coverage period under paragraph (1) for such device. If the Secretary does not, on a date that is before the end of such two-year period, take action to modify the indications for which coverage of a breakthrough device may be provided under this title after such period, for purposes of section 1862(a)(1)(A) coverage under this title of such breakthrough device shall be made for all indications for which such device is approved under section 515 of the Federal Food, Drug, and Cosmetic Act or cleared under section 510(k) of such Act.

removed “(3) Rules of construction—Nothing in this section shall be construed to—

removed “(A) affect the ability of the manufacturer of a breakthrough device to seek approval for pass-through payment status under section 1833(t)(6) or to seek approval for an additional payment under section 1886(d)(5)(K) insofar as such breakthrough device does not qualify for transitional coverage under paragraph (1);

removed “(B) affect the application and approval process for pass-through payment status under section 1833(t)(6) or for an additional payment under section 1886(d)(5)(K) in the case of a medical device that is not approved by the Food and Drug Administration as a breakthrough device; or

removed “(C) prohibit the Secretary from using existing authority under this title to suspend or terminate coverage of a breakthrough device if the Secretary, based on clinical evidence, determines that—

removed “(i) such breakthrough device offers no clinical benefit to Medicare beneficiaries; or

removed “(ii) furnishing such breakthrough device to Medicare beneficiaries causes, or may cause, serious harm to Medicare beneficiaries.

removed “(c) Coding

removed “(1) Prompt assignment—Not later than three months after the date of approval or clearance of a breakthrough device by the Food and Drug Administration, the Secretary shall assign a unique temporary or permanent code or codes for purposes of coverage and payment for such breakthrough device under the applicable payment systems (described in paragraph (4)).

removed “(2) Updates

removed “(A) IPPS—The Secretary shall provide for semiannual updates under the applicable payment system described in paragraph (4)(A) (relating to the inpatient hospital prospective payment system) to recognize the code or codes assigned under paragraph (1).

removed “(B) OPPS—The Secretary shall provide for quarterly updates under the applicable payment system described in paragraph (4)(B) (relating to the outpatient hospital prospective payment system) to recognize the code or codes assigned under paragraph (1).

removed “(C) Other payment systems—The Secretary shall provide for semiannual or quarterly updates, as the case may be, under the applicable payment systems described in subparagraphs (C) through (L) of paragraph (4) to recognize the code or codes assigned under paragraph (1).

removed “(3) Transparency—The process for the assignment of a code or codes under this subsection shall provide for public notice and a meaningful opportunity for public comment from affected parties.

removed “(4) Applicable payment systems described—For purposes of this subsection, the term applicable payment systems means—

removed “(A) with respect to inpatient hospital services, the prospective payment system for inpatient hospital services established under section 1886(d);

removed “(B) with respect to outpatient hospital services, the prospective payment system for covered OPD services established under section 1833(t);

removed “(C) with respect to ambulatory surgical center services, the fee schedule for such services established under 1833(i);

removed “(D) with respect to physicians’ services, the physician fee schedules established under section 1848;

removed “(E) with respect to covered items of durable medical equipment, the applicable fee schedules established under section 1834;

removed “(F) with respect to diagnostic laboratory tests, the payment amounts under section 1834A and the fee schedules establish under section 1848, as the case may be;

removed “(G) with respect to inpatient hospital services furnished by rehabilitation facilities, the prospective payment system established under section 1886(j);

removed “(H) with respect to inpatient hospital services furnished by long-term care hospitals, the prospective payment system under section 1886(m);

removed “(I) with respect to inpatient hospital services furnished by psychiatric hospitals and psychiatric units, the prospective payment system under section 1886(s);

removed “(J) with respect to home health services, the prospective payment system under section 1895; and

removed “(K) with respect to items and services, or a provider of services or supplier, not described in subparagraphs (A) through (I), the payment system established under this title for such items and services when furnished by such provider of services or supplier.

removed “(d) Payment

removed “(1) Inpatient hospital prospective payment system: deemed eligibility for breakthrough payment—The Secretary shall deem each breakthrough device as approved for an additional payment under section 1886(d)(5)(K) for the 4-year period that begins—

removed “(A) except as provided in subparagraph (B), on the date that the Secretary, pursuant to subsection (c)(2)(A), updates the payment system under section 1886(d) to recognize the unique temporary or permanent code or codes assigned under subsection (c)(1) to such breakthrough device; or

removed “(B) in the case of a device that has not received approval or clearance as a breakthrough device by the Food and Drug Administration before such payment system is updated under subsection (c)(2)(A) to recognize the unique temporary or permanent code or codes assigned under subsection (c)(1) to such device, on the date of such approval or clearance.

removed “(2) Outpatient prospective payment system: deemed eligibility for pass-through payment—The Secretary shall deem each breakthrough device as approved for pass-through payment under section 1833(t)(6) (including for purposes of section 1833(i)(2)(D)) during the 4-year period that begins—

removed “(A) except as provided in subparagraph (B), on the date that the Secretary, pursuant to subsection (c)(2)(B), updates the payment system under section 1833(t) to recognize the unique temporary or permanent code or codes assigned under subsection (c)(1) to such breakthrough device; or

removed “(B) in the case of a device that has not received approval or clearance as a breakthrough device by the Food and Drug Administration before such payment system is updated under subsection (c)(2)(B) to recognize the unique temporary or permanent code or codes assigned under subsection (c)(1) to such device, on the date of such approval or clearance.

removed “(3) Other payment systems

removed “(A) In general—In the case of a breakthrough device that is furnished and for which payment may be made under the payment system established under section 1834, 1834A, 1848, 1886(j), 1886(m), 1886(s), or 1895 or any other provision of this title (other than sections 1833(i), 1833(t), and 1886(d)), the Secretary shall provide for an additional payment for such breakthrough device under such applicable payment system or an adjustment to such applicable payment system, as the case may be. The payment basis for such additional payment or adjustment, as the case may be, shall equal an amount that the Secretary determines covers the costs of such breakthrough device.

removed “(B) Cost information—In determining the costs of a breakthrough device for purposes of determining an additional payment or payment adjustment under subparagraph (A), the Secretary shall use the most recently available data and information on the costs of such breakthrough device, which may include list prices and invoice prices charged for such breakthrough device.

removed “(C) Rule of construction—Nothing in this paragraph shall be construed to affect the authority of the Secretary to use claims data to establish new or modify existing ambulatory payment classification groups, diagnosis-related groups, level II HCPCS codes or such other groups or codes as the Secretary may establish under the annual rulemaking authority under the provisions referred to in subparagraph (A).

removed “(D) Clinical diagnostic laboratory tests—An additional payment or payment adjustment under subparagraph (A) for a breakthrough device under the applicable payment system established in section 1834A may be in the form of an increase to the amount determined for the breakthrough device using cross-walking under section 1834A(c)(1)(A), an extension of the initial period of payment applicable to advance diagnostic laboratory tests under section 1834A(d)(1)(A), and in such other form or manner as the Secretary determines reflects the costs for such breakthrough device under the relevant provisions of section 1834A.

removed “(4) Payment for breakthrough devices after the transitional coverage period—Payment for a breakthrough device that is furnished after the conclusion of the transitional coverage period under subsection (b)(1) for such device shall be made pursuant to the applicable payment system involved, taking into account the additional evidence and data collected under subsection (b)(2).

removed “(e) Special rules for certain breakthrough devices

removed “(1) Coverage of specified breakthrough devices

removed “(A) In general—Subject to the succeeding provisions of this subsection and notwithstanding any other provision of law, the Secretary shall provide for coverage and payment pursuant to this section of a specified breakthrough device (as defined in subparagraph (B)).

removed “(B) Specified breakthrough device defined—In this section, the term specified breakthrough device means a breakthrough device with respect to which no Medicare benefit category exists.

removed “(2) Period of transitional coverage

removed “(A) In general—Subject to subparagraph (C), the provisions of subsection (b)(1) (relating to the transitional coverage period and payment for breakthrough devices, including the use of the most recently available data and information on costs) shall apply to a specified breakthrough device in the same manner as such provisions apply to a breakthrough device. The Secretary may use methodologies under existing payment systems established under this title, may provide for appropriate adjustments to such methodologies, or may establish a new payment methodology under this title, to provide for payment for a specified breakthrough device to ensure the payment basis for such payment covers costs of the specified breakthrough device are covered by such payment.

removed “(B) Report

removed “(i) In general—With respect to each specified breakthrough device, the Secretary shall submit to Congress a report on the coverage of and payment for such specified breakthrough device under this section that includes the following information:

removed “(I) The manner in which coverage is provided and payment is made for the specified breakthrough device, including how such device was classified (such as an item of durable medical equipment or otherwise) and the payment methodology the Secretary applied with respect to such device.

removed “(II) The impact of the availability of the specified breakthrough device to Medicare beneficiaries, including impacts on the quality of patient care, patient outcomes, and patient experience.

removed “(III) The impact of the availability of the specified breakthrough device to Medicare beneficiaries on program expenditures under this title.

removed “(IV) Such other information as the Secretary determines to be appropriate.

removed “(ii) Deadline

removed “(I) In general—Except as provided in subclause (II), the Secretary shall submit a report required under this subparagraph no later than the end of the transitional period of coverage and payment applicable to such specified breakthrough device.

removed “(II) Extension to generate additional data—If the Secretary determines that additional data or evidence is required to complete a report required under this subparagraph with respect to a specified breakthrough device, the deadline under this clause may be extended for an additional two years.

removed “(C) Additional period of transitional coverage to develop additional data—Insofar as the Secretary determines that additional data or evidence is required to complete a report required under subparagraph (B) with respect to a specified breakthrough device, the transitional coverage period of coverage and payment for such device shall be extended by the lesser of—

removed “(i) two years; or

removed “(ii) the amount of additional time required for the submission of the report with respect to such device.

removed “(3) Coverage and payment after the transitional period—The Secretary may continue to provide for coverage of and payment for a specified breakthrough device after the end of the transitional period of coverage and payment for breakthrough devices through the national coverage determination process if the Secretary determines that the specified breakthrough device—

removed “(A) improves the quality of care and patient outcomes;

removed “(B) improves the delivery of care; or

removed “(C) reduces spending under this title without reducing the quality of care.”

removed “(x) Effective for discharges occurring on or after October 1, 2019, in the case of a new medical service or technology that is a breakthrough device (as defined in section 1899C(a)), the additional payment established for such breakthrough device under this subparagraph shall be made for the 4-year period applicable to such breakthrough device under section 1899C(d)(1). In determining the amount of the additional payment for a breakthrough device under this subparagraph during such 4-year period, the Secretary shall apply section 412.88(b) of title 42, Code of Federal Regulations, as in effect on the date of the enactment of this clause, except as if the reference in such section to “65 percent” were a reference to “65 percent (or such greater percent specified by the Secretary)”.”

removed “(iii) Special rule for breakthrough devices—Notwithstanding clause (i) or (ii), or any other provision of this paragraph to the contrary, in the case of a breakthrough device (as defined in section 1899C(a)) that is furnished on or after January 1, 2020, payment under this paragraph for such breakthrough device shall be made for the 4-year period applicable to such breakthrough device under section 1899C(d)(2). The provisions of this clause shall also apply for purposes of transitional pass-through payment under section 1833(i)(2)(D).”