Source: https://www.law.cornell.edu/uscode/text/42/1395m-1
Timestamp: 2020-02-18 14:10:05
Document Index: 372743455

Matched Legal Cases: ['§ 1395', '§\u202f1395', 'art 426', '§\u202f1834', '§\u202f216', '§\u202f216']

42 U.S. Code § 1395m–1 - Improving policies for clinical diagnostic laboratory tests | U.S. Code | US Law | LII / Legal Information Institute
Section 1395m–1. Improving policies for clinical diagnostic laboratory tests
42 U.S. Code § 1395m–1. Improving policies for clinical diagnostic laboratory tests
(a) Reporting of private sector payment rates for establishment of medicare payment rates
(2) Definition of applicable laboratory
In this section, the term “applicable laboratory” means a laboratory that, with respect to its revenues under this subchapter, a majority of such revenues are from this section, section 1395l(h) of this title, or section 1395w–4 of this title. The Secretary may establish a low volume or low expenditure threshold for excluding a laboratory from the definition of applicable laboratory under this paragraph, as the Secretary determines appropriate.
(3) Applicable information defined
(A) In generalIn this section, subject to subparagraph (B), the term “applicable information” means, with respect to a laboratory test for a data collection period, the following:
(B) Exception for certain contractual arrangements
(4) Data collection period defined
In this section, the term “data collection period” means a period of time, such as a previous 12 month period, specified by the Secretary.
(5) Treatment of discounts
The payment rate reported by a laboratory under this subsection shall reflect all discounts, rebates, coupons, and other price concessions, including those described in section 1395w–3a(c)(3) of this title.
(6) Ensuring complete reporting
(8) Private payor definedIn this section, the term “private payor” means the following:
A health insurance issuer and a group health plan (as such terms are defined in section 300gg–91 of this title).
A medicaid managed care organization (as defined in section 1396b(m) of this title).
(9) Civil money penalty
The provisions of section 1320a–7a of this title (other than subsections (a) and (b)) shall apply to a civil money penalty under this paragraph in the same manner as they apply to a civil money penalty or proceeding under section 1320a–7a(a) of this title.
(10) Confidentiality of informationNotwithstanding any other provision of law, information disclosed by a laboratory under this subsection is confidential and shall not be disclosed by the Secretary or a Medicare contractor in a form that discloses the identity of a specific payor or laboratory, or prices charged or payments made to any such laboratory, except—
(11) Protection from public disclosure
A payor shall not be identified on information reported under this subsection. The name of an applicable laboratory under this subsection shall be exempt from disclosure under section 552(b)(3) of title 5.
(12) Regulations
(b) Payment for clinical diagnostic laboratory tests
(1) Use of private payor rate information to determine medicare payment rates
(B) Application of payment amounts to hospital laboratories
The payment amounts established under this section shall apply to a clinical diagnostic laboratory test furnished by a hospital laboratory if such test is paid for separately, and not as part of a bundled payment under section 1395l(t) of this title.
(2) Calculation of weighted median
(3) Phase-in of reductions from private payor rate implementation
(B) Applicable percent definedIn this paragraph, the term “applicable percent” means—
(C) No application to new testsThis paragraph shall not apply to payment amounts determined under this section for either of the following.
A new advanced diagnostic test [1] (as defined in subsection (d)(5)) under subsection (d).
(4) Application of market rates
(B) Other adjustments not applicable
(5) Sample collection fee
In the case of a sample collected from an individual in a skilled nursing facility or by a laboratory on behalf of a home health agency, the nominal fee that would otherwise apply under section 1395l(h)(3)(A) of this title shall be increased by $2.
(c) Payment for new tests that are not advanced diagnostic laboratory tests
(1) Payment during initial periodIn the case of a clinical diagnostic laboratory test that is assigned a new or substantially revised HCPCS code on or after April 1, 2014, and which is not an advanced diagnostic laboratory test (as defined in subsection (d)(5)), during an initial period until payment rates under subsection (b) are established for the test, payment for the test shall be determined—
(2) Gapfilling process describedThe gapfilling process described in this paragraph shall take into account the following sources of information to determine gapfill amounts, if available:
(3) Additional consideration
(4) Explanation of payment rates
(d) Payment for new advanced diagnostic laboratory tests
(1) Payment during initial period
In the case of an advanced diagnostic laboratory test for which payment has not been made under the fee schedule under section 1395l(h) of this title prior to April 1, 2014, during an initial period of three quarters, the payment amount for the test for such period shall be based on the actual list charge for the laboratory test.
(B) Actual list charge
For purposes of subparagraph (A), the term “actual list charge”, with respect to a laboratory test furnished during such period, means the publicly available rate on the first day at which the test is available for purchase by a private payor.
(2) Special rule for timing of initial reporting
(3) Application of market rates after initial period
(4) Recoupment if actual list charge exceeds market rate
(5) Advanced diagnostic laboratory test definedIn this subsection, the term “advanced diagnostic laboratory test” means a clinical diagnostic laboratory test covered under this part that is offered and furnished only by a single laboratory and not sold for use by a laboratory other than the original developing laboratory (or a successor owner) and meets one of the following criteria:
(1) Temporary codes for certain new tests
(2) Existing testsNot later than January 1, 2016, for each existing advanced diagnostic laboratory test (as so defined) and each existing clinical diagnostic laboratory test that is cleared or approved by the Food and Drug Administration for which payment is made under this part as of April 1, 2014, if such test has not already been assigned a unique HCPCS code, the Secretary shall—
(3) Establishment of unique identifier for certain tests
(f) Input from clinicians and technical experts
(1) In generalThe Secretary shall consult with an expert outside advisory panel, established by the Secretary not later than July 1, 2015, composed of an appropriate selection of individuals with expertise, which may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics, in issues related to clinical diagnostic laboratory tests, which may include the development, validation, performance, and application of such tests, to provide—
(A) input on—
(2) Compliance with FACA
(3) Continuation of annual meeting
The Secretary shall continue to convene the annual meeting described in section 1395l(h)(8)(B)(iii) of this title after the implementation of this section for purposes of receiving comments and recommendations (and data on which the recommendations are based) as described in such section on the establishment of payment amounts under this section.
(1) Issuance of coverage policies
A medicare administrative contractor shall only issue a coverage policy with respect to a clinical diagnostic laboratory test in accordance with the process for making a local coverage determination (as defined in section 1395ff(f)(2)(B) of this title), including the appeals and review process for local coverage determinations under part 426 of title 42, Code of Federal Regulations (or successor regulations).
(B) No effect on national coverage determination process
This paragraph shall not apply to the national coverage determination process (as defined in section 1395ff(f)(1)(B) of this title).
(2) Designation of one or more medicare administrative contractors for clinical diagnostic laboratory tests
There shall be no administrative or judicial review under section 1395ff of this title, section 1395oo of this title, or otherwise, of the establishment of payment amounts under this section.
Chapter 35 of title 44 shall not apply to information collected under this section.
For purposes of implementing this section, the Secretary shall provide for the transfer, from the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, to the Centers for Medicare & Medicaid Services Program Management Account, for each of fiscal years 2014 through 2018, $4,000,000, and for each of fiscal years 2019 through 2023, $3,000,000. Amounts transferred under the preceding sentence shall remain available until expended.
(i) Transitional rule
During the period beginning on April 1, 2014, and ending on December 31, 2016, with respect to advanced diagnostic laboratory tests under this part, the Secretary shall use the methodologies for pricing, coding, and coverage in effect on the day before April 1, 2014, which may include cross-walking or gapfilling methods.
(Aug. 14, 1935, ch. 531, title XVIII, § 1834A, as added Pub. L. 113–93, title II, § 216(a), Apr. 1, 2014, 128 Stat. 1053.)
The Federal Advisory Committee Act, referred to in subsec. (f)(2), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, which is set out in the Appendix to Title 5, Government Organization and Employees.
Pub. L. 113–93, title II, § 216(c)(2), Apr. 1, 2014, 128 Stat. 1061, provided that:
“The Inspector General of the Department of Health and Human Services shall—
publicly release an annual analysis of the top 25 laboratory tests by expenditures under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]; and
conduct analyses the Inspector General determines appropriate with respect to the implementation and effect of the new payment system for laboratory tests under section 1834A of the Social Security Act [42 U.S.C. 1395m–1], as added by subsection (a).”
[1]  So in original. Probably should be preceded by “laboratory”.