US Codex
Bill
Notes

Title II — Incentivizing Innovation for Truly Innovative New Drugs, Bi­o­log­i­cals, Devices, and Other Technologies

S. 1676 · 116th Congress · May 23, 2019 · Lineage

II Incentivizing Innovation for Truly Innovative New Drugs, Bi­o­log­i­cals, Devices, and Other Technologies

Sec. 201 Maintaining an economically stable dialysis infrastructure

(a)
In general— Section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended—
(1)
in subparagraph (D), in the matter preceding clause (i), by striking “Such system” and inserting “Subject to subparagraph (J), such system”; and
(2)
by adding at the end the following new subparagraph:

“(J) For payment for renal dialysis services furnished on or after January 1, 2020, under the system under this paragraph—

“(i) the payment adjustment described in clause (i) of subparagraph (D)—

“(I) shall not take into account comorbidities; and

“(II) shall only take into account age for purposes of distinguishing between individuals who are under 18 years of age and those who are 18 years of age and older but shall not include any other adjustment for age;

“(ii) the Secretary shall reassess any adjustments related to patient weight under such clause;

“(iii) the payment adjustment described in clause (ii) of such subparagraph shall not be included;

“(iv) the standardization factor described in the final rule published in the Federal Register on November 8, 2012 (77 Fed. Reg. 67470), shall be established using the most currently available data (and not historical data) and adjusted on an annual basis, based on such available data, to account for any change in utilization of drugs and any modification in adjustors applied under this paragraph; and

“(v) take into account reasonable costs for determining the payment rate consistent with paragraph (2)(B).”

(b)
Inclusion of network fee as an allowable cost— Section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)), as amended by subsection (a), is amended by adding at the end the following new subparagraph:

“(K) Not later than January 1, 2020, the Secretary shall amend the ESRD facility cost report to include the per treatment network fee (as described in paragraph (7)) as an allowable cost or offset to revenue.”

(c)
Determination of productivity adjustment— Section 1886(b)(3)(B)(xi) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(B)(xi)) is amended—
(1)
in subclause (I), by striking “For 2012” and inserting “Subject to subclause (IV), for 2012”; and
(2)
by adding at the end, the following new subclause:

“(IV) For each of 2020 through 2024, the productivity adjustment described in subclause (II) shall be zero for a payment system in any year in which the Medicare Payment Advisory Commission estimates that payments under this title pursuant to such payment system, on an aggregate national basis, exceed costs, on an aggregate national basis, by 3.0 percent or less.”

(d)
Payment for new and innovative drugs and biologicals that are renal dialysis services— Section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395ww(b)(14)), as amended by subsections (a) and (b), is amended by adding the following new subparagraph—

“(L) Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services

“(i) In general—For drugs or biologicals determined to be within a functional category, the Secretary, in consultation with stakeholders, shall ensure that the single payment amount is adequate to cover the cost of new innovative drugs or biologicals and increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. In carrying out the preceding sentence, the Secretary shall use the cost and utilization data collected during the two-year transitional payment period, as described in the final regulation published on November 14, 2018 (83 Fed. Reg. 56922 et seq.).

“(ii) Money to follow the patient—The Secretary, through notice and comment rulemaking, shall implement a policy for any drug or biological that is not provided to the “average” patient that results in the amount by which the single payment amount is increased pursuant to this subparagraph shall be paid only when a provider or renal dialysis facility has demonstrated that it has administered the drug or biological to a patient.”

(e)
New devices and other technologies— As part of the promulgation of the annual rule for the Medicare end stage renal disease prospective payment system under section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2021, and in consultation with stakeholders, the Secretary shall establish a process for identifying and determining appropriate payment amounts for incorporating new devices and technologies into the bundled payment under such system.