82 FR 45590 - Medicare Program; Request for Nominations to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 188 (September 29, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45590-45592 | |
| FR Document | 2017-20923 |
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)] [Notices] [Pages 45590-45592] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20923] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1698-N] Medicare Program; Request for Nominations to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice requests nominations to fill vacancies on the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel). The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on issues related to clinical diagnostic laboratory tests (CDLTs). As announced in the notice published in the Federal Register on June 16, 2017, entitled ``Medicare Program; Rechartering, Membership, and Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on August 1, 2017'' (82 FR 27705), the Secretary approved the rechartering of the Panel on April 25, 2017 for a 2-year period effective through April 25, 2019. DATES: The agency will receive nominations on a continuous basis. ADDRESSES: All nominations should be sent electronically to the following email address: [email protected]. Web site: For additional information on the Panel and updates to the Panel's activities, we refer readers to our Web site at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. FOR FURTHER INFORMATION CONTACT: Persons wishing to nominate individuals to serve on the Panel or to [[Page 45591]] obtain further information may submit an email to the following email address: [email protected]. News Media: Representatives should contact the CMS Press Office at (202) 690-6145. SUPPLEMENTARY INFORMATION: I. Background The Advisory Panel on Clinical Diagnostic Laboratory Tests is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (Pub. L. 113-93, enacted on April 1, 2014) (PAMA). The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests. Such individuals may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics. The Panel will provide input and recommendations to the Secretary and the Administrator of CMS, on the following:The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test; and The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests. Other aspects of the new payment system under section 1834A of the Act. A notice announcing the establishment of the Panel and soliciting nominations for members was published in the October 27, 2014 Federal Register (79 FR 63919 through 63920). In the August 7, 2015 Federal Register (80 FR 47491), we announced membership appointments to the Panel along with the first public meeting date for the Panel, which was held on August 26, 2015. Subsequent meetings of the Panel were also announced in the Federal Register. As previously noted, the Secretary approved the rechartering of the Panel on April 25, 2017, for a 2-year period effective through April 25, 2019. The Panel charter provides that Panel meetings will be held up to 4 times annually and the Panel Chair will serve for a period of 3 years, which may be extended at the discretion of the Administrator or his or her duly appointed designee. Additionally, the Panel Chair facilitates the meeting and the Designated Federal Official (DFO) or DFO's designee must be present at all meetings. II. Request for Nominations; Criteria for Nominees We are requesting nominations for members to serve on the Panel. The Panel shall consist of up to 15 individuals with expertise in issues related to clinical diagnostic laboratory tests, which may include molecular pathologists, laboratory researchers, and individuals with expertise in laboratory science or health economics, with regard to issues related to the development, validation, performance, safety, and application of such tests. Panel members serve on a voluntary basis, without compensation, according to an advance written agreement; however, for the meetings, we reimburse travel, meals, lodging, and related expenses in accordance with standard Government travel regulations. Nominees must demonstrate personal experience with clinical diagnostic laboratory tests and services through a past or present history of direct employment with an organization that furnishes clinical diagnostic laboratory tests. (For purposes of this Panel, consultants or independent contractors shall not be representatives of clinical laboratories.) We have special interest in ensuring, while taking into account the nominee pool, that the Panel membership is balanced under the FACA guidelines; therefore nominees will be evaluated based on expertise and factors needed to keep the balance of the Panel. These factors include, but are not limited to, geographic locations within the United States or territories; race; ethnicity; sex; disability; points of view; and area of expertise (for example, medical, scientific, financial, technical, administrative). Additionally, all nominees must have at least 5 years of experience with clinical diagnostic laboratory tests or genetic testing. Based upon either self-nominations or nominations submitted by interested organizations, the Secretary, the CMS Administrator, or the Secretary's or CMS Administrator`s designee, appoints new members to the Panel from among candidates determined to have the required expertise. Nominations will be considered as vacancies occur on the Panel. Nominations should be updated and resubmitted every 3 years to continue to be considered for Panel vacancies. New appointments are made in manner that ensures a balanced membership under FACA guidelines. Our appointment schedule will assure that we have the full complement of members for each Panel meeting. It is not necessary for a nominee to possess expertise in all of the areas listed, but each must have a minimum of 5 years of experience and currently have full-time employment in his or her area of expertise. Generally, members of the Panel serve overlapping terms up to 3 years, based on the needs of the Panel and contingent upon the rechartering of the Panel. A member may serve after the expiration of his or her term until a successor has been sworn in. Any member appointed to fill a vacancy for an unexpired term will be appointed for the remainder of that term. Any interested person or organization may nominate one or more qualified individuals. Self-nominations will also be accepted. Each nomination must include the following: Letter of Nomination stating the reason why the nominee should be considered. Curriculum vitae or resume of the nominee that includes the following: ++ Email address where the nominee can be contacted. ++ Title and current position. ++ Professional affiliation. ++ Home and business address. ++ Home and business telephone and or fax numbers. ++ List of areas of expertise. Written and signed statement from the nominee indicating that the nominee is willing to serve on the Panel under the conditions described in this notice and further specified in the Charter. Brief (1 page; double-spaced) biographical summary of the nominee's experience. The top nominees will be contacted for interest and availability. Phone interviews of nominees may also be requested after review of the nominations. The Secretary, the CMS Administrator, or the Secretary's or CMS Administrator's designee will make the final decision about who will serve on the committee. Formal letters of invitation to serve on the Panel will be extended by the CMS Administrator. To permit an evaluation of possible sources of conflict of interest, potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts. [[Page 45592]] III. Copies of the Charter To obtain a copy of the Panel's Charter, we refer readers to our Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. IV. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) Dated: September 22, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2017-20923 Filed 9-28-17; 8:45 am] BILLING CODE 4120-01-P
![45590 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
maintained and distributed via incurred in furnishing medical services for-profit institutions; Number of
modifications of codes, modifiers and to Medicare beneficiaries and Respondents: 6,821; Total Annual
descriptions, as a direct result of data reimbursement due to or from a Responses: 6,821; Total Annual Hours:
received from applicants. Thus, provider. Form Number: CMS–222–17 443,365. (For policy questions regarding
information collected in the application (OMB control number: 0938–0107); this collection contact Gail Duncan at
is significant to codeset maintenance. Frequency: Annually; Affected Public: 410–786–7278).
The HCPCS codeset maintenance is Private Sector: Business or other for- Dated: September 26, 2017.
an ongoing process, as changes are profit, Not-for-profit institutions;
William N. Parham, III,
implemented and updated annually; Number of Respondents: 1,744; Total
therefore, the process requires continual Director, Paperwork Reduction Staff, Office
Annual Responses: 1,744; Total Annual
of Strategic Operations and Regulatory
collection of information from Hours: 95,920. (For policy questions Affairs.
applicants on an annual basis. As new regarding this collection contact Yaakov
[FR Doc. 2017–20921 Filed 9–28–17; 8:45 am]
technology evolves and new devices, Feinstein at 410–786–3137).
drugs and supplies are introduced to the 3. Type of Information Collection BILLING CODE 4120–01–P
market, applicants submit applications Request: Extension of a currently
to CMS requesting modifications to the approved collection; Title of
HCPCS Level II codeset. Applications Information Collection: Organ DEPARTMENT OF HEALTH AND
have been received prior to HIPAA Procurement Organization/ HUMAN SERVICES
implementation and must continue to Histocompatibility Laboratory Cost Centers for Medicare & Medicaid
be collected to ensure quality decision- Report; Use: Providers of services Services
making. The HIPAA of 1996 required participating in the Medicare program
CMS to adopt standards for coding are required under sections 1815(a) and [CMS–1698–N]
systems that are used for reporting 1861(v)(1)(A) of the Social Security Act
health care transactions. The regulation (42 U.S.C. 1395g) to submit annual Medicare Program; Request for
that CMS published on August 17, 2000 information to achieve settlement of Nominations to the Medicare Advisory
(45 CFR 162.10002) to implement the costs for health care services rendered to Panel on Clinical Diagnostic
HIPAA requirement for standardized Medicare beneficiaries. In addition, Laboratory Tests
coding systems established the HCPCS regulations at 42 CFR 413.20 and 413.24 AGENCY: Centers for Medicare &
Level II codes as the standardized require adequate cost data and cost Medicaid Services (CMS), HHS.
coding system for describing and reports from providers on an annual ACTION: Notice.
identifying health care equipment and basis. The Form CMS–216–94 cost
supplies in health care transactions. report is needed to determine a SUMMARY: This notice requests
HCPCS Level II was selected as the provider’s reasonable costs incurred in nominations to fill vacancies on the
standardized coding system because of furnishing medical services to Medicare Medicare Advisory Panel on Clinical
its wide acceptance among both public beneficiaries and reimbursement due to Diagnostic Laboratory Tests (the Panel).
and private insurers. Public and private or due from a provider. Form Number: The purpose of the Panel is to advise the
insurers were required to be in CMS–216–94 (OMB control number: Secretary of the Department of Health
compliance with the August 2000 0938–0102); Frequency: Annually; and Human Services (DHHS) and the
regulation by October 1, 2002. Form Affected Public: Private Sector: Business Administrator of the Centers for
Number: CMS–10224 (OMB control or other for-profit, Not-for-profit Medicare & Medicaid Services (CMS) on
number: 0938–1042); Frequency: institutions; Number of Respondents: issues related to clinical diagnostic
Annually; Affected Public: Private 102; Total Annual Responses: 102; Total laboratory tests (CDLTs). As announced
Sector: Business or other for-profit, Not- Annual Hours: 4590. (For policy in the notice published in the Federal
for-profit institutions; Number of questions regarding this collection Register on June 16, 2017, entitled
Respondents: 100; Total Annual contact Amelia Citerone at 410–786– ‘‘Medicare Program; Rechartering,
Responses: 100; Total Annual Hours: 3901). Membership, and Announcement of the
1100. (For policy questions regarding 4. Type of Information Collection Advisory Panel on Clinical Diagnostic
this collection contact Kimberley Request: Extension of a currently Laboratory Tests Meeting on August 1,
Combs-Miller at 410–786–6707). approved collection; Title of 2017’’ (82 FR 27705), the Secretary
2. Type of Information Collection Information Collection: Providers of approved the rechartering of the Panel
Request: Revision of a currently services participating in the Medicare on April 25, 2017 for a 2-year period
approved collection; Title of program are required under sections effective through April 25, 2019.
Information Collection: Independent 1815(a) and 1861(v)(1)(A) of the Social
DATES: The agency will receive
Rural Health Clinics/Freestanding Security Act (42 U.S.C. 1395g) to submit
nominations on a continuous basis.
Federally Qualified Health Clinics Cost annual information to achieve
Report; Use: Providers of services settlement of costs for health care ADDRESSES: All nominations should be
participating in the Medicare program services rendered to Medicare sent electronically to the following
are required under sections 1815(a), beneficiaries. In addition, regulations at email address: CDLTPanel@
1833(e) and 1861(v)(1)(A) of the Social 42 CFR 413.20 and 413.24 require cms.hhs.gov.
Security Act (42 U.S.C. 1395g) to submit adequate cost data and cost reports from Web site: For additional information
on the Panel and updates to the Panel’s
asabaliauskas on DSKBBXCHB2PROD with NOTICES
annual information to achieve providers on an annual basis. The Form
settlement of costs for health care CMS–265–11 cost report is needed to activities, we refer readers to our Web
services rendered to Medicare determine a provider’s reasonable costs site at http://cms.gov/Regulations-and-
beneficiaries. In addition, regulations at incurred in furnishing medical services Guidance/Guidance/FACA/
42 CFR 413.20 and 413.24 require to Medicare beneficiaries. Form AdvisoryPanelonClinicalDiagnostic
adequate cost data and cost reports from Number: CMS–265–11 (OMB control LaboratoryTests.html.
providers on an annual basis. The Form number: 0938–0236); Frequency: FOR FURTHER INFORMATION CONTACT:
CMS–222–17 cost report is needed to Annually; Affected Public: Private Persons wishing to nominate
determine a provider’s reasonable costs Sector: Business or other for-profit, Not- individuals to serve on the Panel or to
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![45592 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
III. Copies of the Charter Protection Act of 2000 (BIPA), amounts for ALJ hearings and judicial
To obtain a copy of the Panel’s established the amount in controversy review. Section 422.600 grants any party
Charter, we refer readers to our Web site (AIC) threshold amounts for to the reconsideration, except the MA
at https://www.cms.gov/Regulations- Administrative Law Judge (ALJ) organization, who is dissatisfied with
and-Guidance/Guidance/FACA/ hearings and judicial review at $100 and the reconsideration determination, a
AdvisoryPanelon $1,000, respectively, for Medicare Part right to an ALJ hearing as long as the
ClinicalDiagnosticLaboratoryTests.html. A and Part B appeals. Section 940 of the amount remaining in controversy after
Medicare Prescription Drug, reconsideration meets the threshold
IV. Collection of Information Improvement, and Modernization Act of requirement established annually by the
Requirements 2003 (MMA), amended section Secretary. Section 422.612 states, in
This document does not impose 1869(b)(1)(E) of the Act to require the part, that any party, including the MA
information collection requirements, AIC threshold amounts for ALJ hearings organization, may request judicial
that is, reporting, recordkeeping or and judicial review to be adjusted review if the AIC meets the threshold
third-party disclosure requirements. annually. The AIC threshold amounts requirement established annually by the
Consequently, there is no need for are to be adjusted, as of January 2005, Secretary.
review by the Office of Management and by the percentage increase in the
C. Health Maintenance Organizations,
Budget under the authority of the medical care component of the
Competitive Medical Plans, and Health
Paperwork Reduction Act of 1995 (44 consumer price index (CPI) for all urban
Care Prepayment Plans
U.S.C. 3501 et seq.) consumers (U.S. city average) for July
2003 to July of the year preceding the Section 1876(c)(5)(B) of the Act states
Dated: September 22, 2017. year involved and rounded to the that the annual adjustment to the AIC
Seema Verma, nearest multiple of $10. Section dollar amounts set forth in section
Administrator, Centers for Medicare & 940(b)(2) of the MMA provided 1869(b)(1)(E)(iii) of the Act applies to
Medicaid Services. conforming amendments to apply the certain beneficiary appeals within the
[FR Doc. 2017–20923 Filed 9–28–17; 8:45 am] AIC adjustment requirement to context of health maintenance
BILLING CODE 4120–01–P Medicare Part C/Medicare Advantage organizations and competitive medical
(MA) appeals and certain health plans. The applicable implementing
maintenance organization and regulations for Medicare Part C appeals
DEPARTMENT OF HEALTH AND competitive health plan appeals. Health are set forth in 42 CFR 422, subpart M
HUMAN SERVICES care prepayment plans are also subject and apply to these appeals pursuant to
to MA appeals rules, including the AIC 42 CFR 417.600(b). The Medicare Part C
Centers for Medicare & Medicaid adjustment requirement. Section 101 of appeals rules also apply to health care
Services the MMA provides for the application of prepayment plan appeals pursuant to 42
[CMS–4181–N] the AIC adjustment requirement to CFR 417.840.
Medicare Part D appeals. D. Medicare Part D (Prescription Drug
Medicare Program; Medicare Appeals; Plan) Appeals
A. Medicare Part A and Part B Appeals
Adjustment to the Amount in
Controversy Threshold Amounts for The statutory formula for the annual The annually adjusted AIC threshold
Calendar Year 2018 adjustment to the AIC threshold amounts for ALJ hearings and judicial
amounts for ALJ hearings and judicial review that apply to Medicare Parts A,
AGENCY: Centers for Medicare & review of Medicare Part A and Part B B, and C appeals also apply to Medicare
Medicaid Services (CMS), HHS. appeals, set forth at section Part D appeals. Section 101 of the MMA
ACTION: Notice. 1869(b)(1)(E) of the Act, is included in added section 1860D–4(h)(1) of the Act
the applicable implementing regarding Part D appeals. This statutory
SUMMARY: This notice announces the regulations, 42 CFR 405.1006(b) and (c). provision requires a prescription drug
annual adjustment in the amount in The regulations require the Secretary of plan sponsor to meet the requirements
controversy (AIC) threshold amounts for the Department of Health and Human set forth in sections 1852(g)(4) and (g)(5)
Administrative Law Judge (ALJ) Services (the Secretary) to publish of the Act, in a similar manner as MA
hearings and judicial review under the changes to the AIC threshold amounts organizations. As noted previously, the
Medicare appeals process. The in the Federal Register annually adjusted AIC threshold
adjustment to the AIC threshold (§ 405.1006(b)(2)). In order to be entitled requirement was added to section
amounts will be effective for requests to a hearing before an ALJ, a party to a 1852(g)(5) of the Act by section
for ALJ hearings and judicial review proceeding must meet the AIC 940(b)(2)(A) of the MMA. The
filed on or after January 1, 2018. The requirements at § 405.1006(b). Similarly, implementing regulations for Medicare
calendar year 2018 AIC threshold a party must meet the AIC requirements Part D appeals can be found at 42 CFR
amounts are $160 for ALJ hearings and at § 405.1006(c) at the time judicial 423, subparts M and U. The regulations
$1,600 for judicial review. review is requested for the court to have at § 423.562(c) prescribe that, unless the
DATES: This notice is applicable on jurisdiction over the appeal Part D appeals rules provide otherwise,
January 1, 2018. (§ 405.1136(a)). the Part C appeals rules (including the
FOR FURTHER INFORMATION CONTACT: Liz annually adjusted AIC threshold
B. Medicare Part C/MA Appeals
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Hosna (Katherine.Hosna@cms.hhs.gov), amount) apply to Part D appeals to the
(410) 786–4993. Section 940(b)(2) of the MMA applies extent they are appropriate. More
SUPPLEMENTARY INFORMATION: the AIC adjustment requirement to specifically, §§ 423.1970 and 423.1976
Medicare Part C appeals by amending of the Part D appeals rules discuss the
I. Background section 1852(g)(5) of the Act. The AIC threshold amounts for ALJ hearings
Section 1869(b)(1)(E) of the Social implementing regulations for Medicare and judicial review.
Security Act (the Act), as amended by Part C appeals are found at 42 CFR 422, Section 423.1970(a) grants a Part D
section 521 of the Medicare, Medicaid, subpart M. Specifically, §§ 422.600 and enrollee, who is dissatisfied with the
and SCHIP Benefits Improvement and 422.612 discuss the AIC threshold independent review entity (IRE)
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45778/page/3.svg)
Document Created: 2017-09-29 03:27:12
Document Modified: 2017-09-29 03:27:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The agency will receive nominations on a continuous basis. | |
| Contact | Persons wishing to nominate individuals to serve on the Panel or to obtain further information may submit an email to the following email | |
| FR Citation | 82 FR 45590 |
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